MindMap Gallery Epidemiology
This is a mind map about epidemiology. Epidemiology is the science that studies the distribution and determinants of diseases and health conditions among specific groups of people, and studies strategies and measures to prevent diseases and promote health.
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Mappa mentale per l’analisi della formazione francese ai Mondiali 2026. Punti chiave: attacco stellare guidato da Mbappé, con triplice minaccia (profondità, taglio, sponda). Criticità: centrocampo poco creativo – la costruzione offensiva dipende dagli attaccanti che arretrano. Difesa solida (Upamecano, Saliba, Koundé). Portiere Maignan. Variabili: gestione infortuni e condizione fisica dei big. Ideale per scout, giornalisti e tifosi.
Mappa mentale per il piano di inserimento dei nuovi dipendenti nella prima settimana. Strutturata per giorni: Giorno 1 – benvenuto, configurazione strumenti, presentazione team. Secondo giorno – formazione su policy aziendali e obiettivi del ruolo. Terzo giorno – affiancamento e primi task guidati. Il quarto giorno – riunioni con dipartimenti chiave e feedback intermedio. Il quinto giorno – revisione settimanale, definizione obiettivi a breve termine e integrazione culturale.
Mappa mentale per l’analisi della formazione francese ai Mondiali 2026. Punti chiave: attacco stellare guidato da Mbappé, con triplice minaccia (profondità, taglio, sponda). Criticità: centrocampo poco creativo – la costruzione offensiva dipende dagli attaccanti che arretrano. Difesa solida (Upamecano, Saliba, Koundé). Portiere Maignan. Variabili: gestione infortuni e condizione fisica dei big. Ideale per scout, giornalisti e tifosi.
Mappa mentale per l’analisi della formazione francese ai Mondiali 2026. Punti chiave: attacco stellare guidato da Mbappé, con triplice minaccia (profondità, taglio, sponda). Criticità: centrocampo poco creativo – la costruzione offensiva dipende dagli attaccanti che arretrano. Difesa solida (Upamecano, Saliba, Koundé). Portiere Maignan. Variabili: gestione infortuni e condizione fisica dei big. Ideale per scout, giornalisti e tifosi.
Epidemiology
Chapter One Introduction
Section 1 A brief history of epidemiology
1. History of epidemiological development
1. Early stage of formation
(1) Ancient Greece
Hippocrates - "Air, Water and Place", a systematic statement on the relationship between the natural environment and health and disease
(2) Mid-15th century
①Venice, Italy—Seaport Quarantine
②Sui Dynasty—Quarantine
(3) 1662
John Graunt, London, UK - Life table proposed to establish a comparison group
2. Early stage of discipline formation
(1) 1747, James Lind, UK, comparative treatment trial of scurvy, pioneering epidemiological clinical trial
(2) 1796, British Edward Jenner—Vaccinium prevents smallpox, pioneering active immunization
(3) In the 18th century, France's Pierre Charles Louis - Comparative observation of bloodletting, life table tuberculosis, and British William Farr - pioneered routine data on population and death
(4) 1848-1854, John Snow, England—Punctuated map method for the distribution of cholera cases.
3. Scientific development period
The first stage - the 1940s and 1950s
Created research methods for chronic non-communicable diseases, including risk estimation methods.
for example
(1) British Doll and Hill—cohort study, relationship between smoking and lung cancer
(2) Framingham, USA - long-term follow-up observation, cardiovascular research.
(3) In 1951, Jerome Cornfield proposed relative risk, odds ratio, etc.
(4) In 1954, Jonas Edward Salk organized field trials of polio vaccine.
(5) In 1959, Mantel and Haenszel proposed the hierarchical analysis method
The second stage - 1960s to 1980s
This was a period of considerable development in methods of epidemiological analysis, including the distinction between confounding and bias, interactions, and the practical development of case-control study designs.
for example
(1) KSackett summarized 35 possible biases that may occur in analytical research
(2) In 1985, Miettinen proposed three major categories of comparison, selection, and information bias.
(3) Jerome Cornfield was established in the Framingham Cardiovascular Disease Study and used a logistic regression model
The third stage - the 1990s
It is a period when epidemiology intersects with other disciplines, updates concepts and models, continuously introduces new sub-disciplines, and expands the application fields of epidemiology.
For example, in 1993, Schulte proposed ecological epidemiology
2. Achievements in my country’s epidemiology
1. Before the founding of New China
Dr. Wu Liande - plague (drought), cholera, pioneer and founder of epidemiology in my country.
2. After the founding of New China
(1) Professor Su Delong - schistosomiasis, cholera, Shanghai dermatitis (caused by mulberry worm), proposed the idea that liver cancer may be related to drinking water.
(2) He Guanqing—one of the pioneers and founders of the discovery that the Chinese sandfly is the vector of kala-azar disease
(3) Qian Yuping - Carry out epidemiology of acquired immunodeficiency syndrome and promote discipline construction and development.
(4) Focusing on prevention, the five major parasitic diseases including schistosomiasis have been basically eliminated and controlled nationwide, and smallpox and classical cholera have been eliminated.
3. After reform and opening up
Research, legalization and prevention tasks of chronic diseases
Section 2 Definition of Epidemiology
1. Definition
Epidemiology is the science that studies the distribution of diseases and health conditions among the population and their influencing factors, and studies strategies and measures to prevent diseases and promote health.
2. Interpretation of the definition
Three levels of epidemiological research content
1. Disease
(Including communicable diseases, non-communicable diseases, parasitic diseases, etc.)
2. Damage
(Including accidents, disabilities, mental retardation, physical and mental injuries, etc.)
3. Health
Including various functional states of body physiology and biochemistry, pre-disease state and longevity, etc.
“That is, a state of complete physical, mental and social adaptability in all aspects, not just the absence of disease or infirmity.”
Three stages of epidemiological tasks
1. Reveal the phenomenon
i.e. reveal prevalence (mainly infectious diseases) or distribution (other diseases, injuries and health)
This can be achieved through descriptive epidemiological methods.
2. Find out the reason
That is, starting from the analysis object to find out the rules and causes of prevalence and distribution.
Proposed etiological hypotheses can be tested or validated with the help of analytical epidemiological methods.
3. Provide measures
That is, rationally using the results of the first two stages to find prevention or control strategies and measures.
It can be verified by experimental epidemiological methods.
Three basic methods of epidemiological research
Observation (most important)
Experimental Method
mathematical method
Three major elements in epidemiology
principle
method
application
Three categories of epidemiology
describe
analyze
experiment
Section 3 Principles and Applications of Epidemiology
1. Basic principles
(1) Distribution of disease and health among the population
disease epidemics
Three distributions of disease
Distribution of disease
(2) The pathogenesis of the disease
infection process in body
molecular epidemiology
The epidemic process of infectious diseases
infectious disease epidemiology
(3) The relationship between man and the environment → Ecology
(4) Etiology → Multiple causes theory
(5) Principles of etiology inference
Causes and principles of inference
(6) Principles and strategies of disease prevention and control→tertiary prevention
prevention strategies
(7) Mathematical model of disease development
2. Application
(1) Disease prevention and health promotion
One of the fundamental tasks of epidemiology is to prevent disease.
Prevention includes preventing the disease from occurring when there is no disease, and controlling or reducing it until it is eliminated after it occurs → the guiding ideology of tertiary prevention.
Such as measles vaccination to reduce the cases of measles.
(2) Disease monitoring
It is an effective measure to implement the prevention-oriented policy.
That is, monitoring the disease that occurs and the measures that have been taken are a dynamic process of investigating epidemiological work. Once the disease breaks out, timely action will be taken.
Such as used in the eradication of smallpox.
Practice preventive strategies regularly
(3) Research on disease causes and risk factors️Cause inference
Only by thoroughly understanding the reasons for the occurrence, frequency or prevalence of diseases
Only in this way can a certain disease be better prevented or even eliminated.
(4) Natural history of the disease️Follow-up study
Study the development patterns of human diseases and health through epidemiological methods,
for further application in disease prevention and health promotion.
Research in depth️
(5) Evaluation of the effectiveness of disease prevention and treatment️
Used to evaluate disease prevention and treatment, health promotion and the final effect of health work
Special features️
Such as experimental epidemiology (the incidence of childhood vaccinations), pharmacoepidemiology (surveillance of new drugs after they are launched)
Section 4 Epidemiological Research Methods
1. Observation method - according to whether there is a control group established in advance
describe epidemiology
Mainly describes the distribution of diseases or health states
It plays the role of revealing phenomena and providing clues for etiology research→proposing hypotheses.
Analytical method
Current situation research
monitor
ecological research
generate hypotheses
Analyze epidemiology
Find out the reasons to test or verify the hypothesis of scientific research
Analytical method
Case-control study (can both generate and test hypotheses)
array research
test hypothesis
2. Experimental method
Experimental epidemiology – Used to confirm or confirm a hypothesis.
Clinical Trials
Field Test
individual test
community trial
Test hypothesis
3. Mathematical methods
theoretical epidemiology
After we have a clear understanding of the occurrence patterns of diseases, we can also rise to a theoretical level and use mathematical models to predict diseases.
Section 5 Epidemiological Characteristics
①Characteristics of the group
Epidemiology is the study of disease phenomena and health status among populations
That is to say, we start from various distribution phenomena of the crowd and use distribution as the starting point for studying all problems.
②Contrast characteristics
It is the core of epidemiological research methods (disease population, comparison of certain probability with normal and subclinical population)
Only through comparative investigation and comparative analysis can we discover the causes or clues to the disease.
(3) Characteristics of probability theory and mathematical statistics
Epidemiology rarely uses absolute numbers to express various distribution situations, and often uses frequency indicators;
Epidemiological work requires large enough numbers.
(4) Social psychological characteristics
The occurrence of diseases is not only related to the environment inside the human body,
It is also inevitably affected and restricted by the natural environment and social environment.
(5) Prevention-oriented characteristics
Epidemiology always adheres to the prevention-oriented approach, faces the entire population, and focuses on disease prevention.
Especially primary prevention, protecting the health of the population.
(6) Characteristics of development
In response to major health issues in different periods, the definition and tasks of epidemiology have been continuously developed and improved.
Section 6 The relationship between epidemiology and other disciplines and the prospects of epidemiology
1. Relationship with other disciplines
2. Outlook
(1) Emphasize both macro and micro aspects.
(2) Pay equal attention to communicable diseases and non-communicable diseases.
(3) Health protection and health promotion coexist.
(4) Develop field epidemiology.
(5) Pay attention to ethical issues in epidemiological research.
(6) Strengthen the role of epidemiology in the evidence-based wave.
Chapter 2 Distribution of Diseases
Section 1 Disease Frequency Measurement Indicators
1. Definition of disease distribution
It refers to the existence status of the disease in different groups of people, at different times and in different regions, as well as its occurrence and development rules.
The main content is to describe the group phenomena of disease onset, illness and death, as well as their characteristics and patterns.
2. Disease frequency measurement indicators
(1) Incidence frequency measurement indicators
1. Incidence rate (epidemic intensity)
(1) Definition
It refers to the frequency of new cases of a certain disease among a certain range of people within a certain period of time.
(2) Calculation formula
Incidence rate = (new cases of a certain disease in a certain group of people during a certain period/number of exposed people in this group of people during the same period)*K
(3) Factors to be considered when calculating
①Number of new cases
If a person gets sick multiple times during the observation period, it should be counted as multiple new cases.
②Number of exposed population
①Definition
Refers to people who may develop a certain disease in a certain area during the observation period.
②Should not be included in the exposed population
a. People who are unlikely to become new cases due to illness
b. Suffering from disease
c. Those who have acquired lasting immunity through vaccination, such as measles
③Observation period
It is usually 1 year, but a shorter or longer time can also be determined.
(4) Application
①Indicators of disease prevalence intensity reflect the degree of impact of the disease on the health of the population.
② is the risk of disease in the population.
③ By comparing the incidence rates, we can understand the epidemic characteristics of the disease, explore the etiological factors, propose etiological hypotheses, and evaluate the effectiveness of preventive measures.
2. Attack rate (degree of exposure)
(1) Definition
Usually refers to the incidence rate within a certain limited range within a short period of time.
(2) Calculation formula
It is the same as the incidence rate, but its observation time is shorter and can be measured in days, weeks, ten days, and months, which is more flexible.
(3) Advantages
Ability to more accurately measure incidence frequency based on exposure levels
(4) Application
It is often used in outbreaks and epidemics of food poisoning, occupational poisoning or infectious diseases.
3. Recurrence rate (infectious diseases)
(1) Definition
Also called secondary incidence
Refers to the period between the shortest incubation period and the longest incubation period of some infectious diseases
The number of sick contacts among susceptible contacts as a percentage of the total number of susceptible contacts.
Neither the numerator nor the denominator includes the first case.
(2) Subsequent cases
Also known as second generation cases
Refers to cases that appear between the shortest and longest incubation period of the disease after the first case.
(3) Calculation formula
Subsequent incidence rate = (number of sick contacts among susceptible contacts during the incubation period/total number of susceptible contacts) * 100%
(4) Application
① Commonly used in epidemiological investigations of infectious diseases
② Compare the infectious power of infectious diseases
③Analyze epidemic factors of infectious diseases
④Evaluate the effectiveness of health and epidemic prevention measures.
(2) Disease frequency measurement indicators
1. Prevalence (chronic diseases)
(1) Definition
Also known as the prevalence rate, it refers to the proportion of new and old cases of a certain disease in the total population within a specific period of time.
Divided into point prevalence and time prevalence according to time
(2) Type
①Time point prevalence (taking into account the number of deaths)
The observation time generally does not exceed 1 month;
Time-point prevalence = the number of new and old cases of a certain disease in a certain group of people at a certain time point/the number of people at that time point*K.
② Time prevalence (not considering the number of deaths)
Refers to a specific period of time, usually several months.
Prevalence rate during the period = the number of new and old cases of a certain disease in a certain group of people during an observation period/the average number of people in the same period *K.
(3) Reasons affecting the prevalence rate
rise
Ⅰ. Molecule - old and new cases↑
a. New cases
① Increase in new cases (increased incidence rate)
②Improvement of diagnostic level
③Increase reporting rate
④Immigration of susceptible persons
b. Old cases
⑤The level of treatment is improved → death is avoided, but recovery is not achieved and the course of the disease is prolonged.
⑥The life span of uncured patients is extended
free from death
⑦Immigration of cases
Ⅱ. Denominator - average population in the same period↓
⑧Relocation of healthy people
reduce
Ⅰ. Molecule - old and new cases↓
a. New cases
① Fewer new cases (decreasing incidence rate)
b. Old cases
②Shorten the course of disease
③Improved cure rate
cure
④Increased case fatality rate
die
⑤Relocation of cases
Ⅱ. Denominator - average population in the same period↑
⑥The healthy people move in
(4) Relationship between prevalence, incidence, and course of disease
When the incidence of a disease and the course of the disease remain stable over a considerable period of time,
Prevalence depends on two factors, incidence and disease duration.
Prevalence = incidence x disease duration.
(5)Application
①It is often used to reflect the current status of the disease. For chronic diseases with a long course, it can reflect its prevalence.
②Can be used to estimate the severity of a disease’s harm to residents’ health
③ Health economics evaluation and analysis can provide scientific basis for medical facility planning, estimation of hospital bed turnover, demand for health facilities and manpower, evaluation of medical quality and investment in medical expenses.
(6) Comparison with incidence rate
(1) Prevalence
①Data source
Current situation survey, screening, etc.
② Calculate the numerator
The sum of the number of new cases and existing cases during the observation period (number of new and old cases)
③Calculate the denominator
Number of people surveyed (time point prevalence)
Average population size (prevalence rate during period)
④Observation time
Shorter, usually 1 month or several months
⑤Applicable disease types
Chronic or long-lasting diseases
⑥Usage
Current disease status or prevalence of chronic diseases
⑦Influencing factors
There are many factors that affect the changes in incidence, post-illness outcomes and patient course, etc.
⑧Features
static description
(2)Incidence rate
①Data source
Disease reporting, disease surveillance, cohort studies
② Calculate the numerator
Number of new cases during the observation period
③Calculate the denominator
Exposed population or average population
④Observation time
Usually 1 year or more
⑤Applicable disease types
various diseases
⑥Usage
Disease epidemic intensity
⑦Influencing factors
Relatively few, disease prevalence, diagnostic level, disease reporting quality, etc.
⑧Features
dynamic description
2. Infection rate (infectious diseases)
(1) Definition
It refers to the proportion of people currently infected with a certain pathogen among the people tested within a certain period of time.
Usually expressed as a percentage.
(2) Application
①Apply to the investigation of invisible infections, pathogen carriers and mild or atypical cases.
② Often used to study the infection status of certain infectious or parasitic diseases and evaluate the effectiveness of prevention and control work.
③ Provides a basis for estimating the epidemic situation of a certain disease and formulating prevention and control measures. It is also a common indicator for evaluating the health status of the population.
(3) Calculation formula
Infection rate = (number of infected persons/number of persons tested)*100%
(3) Death and survival frequency measurement indicators
1. Mortality (risk of death)
(1) Related concepts
(1) Mortality rate
Indicates the proportion of the total number of deaths in a certain group of people within a certain period of time,
It is the most commonly used indicator to measure the risk of death in a population.
(2) Death rate
①Definition
The mortality rate can be calculated separately according to different demographic characteristics (such as age, gender, occupation, etc.). This is the death rate.
②Function
It can provide information on changes in deaths from a certain disease among people, time and regions.
Used to explore causes and evaluate preventive measures.
(3) Cumulative mortality rate
①Definition
It refers to the ratio of the number of deaths to a certain population within a certain period of time.
Sometimes it can be obtained by adding up the death rates of various ages, usually expressed as a percentage.
②Function
Usually used to describe the cumulative probability of dying from malignant tumors before a certain age.
(4)Standardized mortality rate
①Definition
When comparing mortality rates in different regions, the mortality rates need to be standardized.
The standardized mortality rate is called the standardized mortality rate or adjusted mortality rate
For example, the age-standardized mortality rate is the mortality rate calculated based on the age composition of the standard population.
② Several common test points about age-standardized mortality rates
Situation one
Question: Why is the pre-standardized crude mortality rate in place A < place B, and the age-standardized crude death rate in place A > place B (the death rate in place A increases)?
Answer: It may be that the proportion of elderly people in A before the bidding is less than that in B. After the bidding, the impact of the elderly will not be big, and the mortality rate of A will ⬆
Situation 2
Question: Why does the pre-standardized crude mortality rate in place A ≥ place B, and the age-standardized crude mortality rate in place A ≤ place B (the mortality rate in place A decreases)?
Answer: It may be because if the proportion of elderly people in Township A before standardization is greater than that in Township B, the contribution of age after standardization will be greatly weakened, and the standardized mortality rate in Township A ⬇
After age standardization, the influence of differences in age composition is eliminated, and the influence of the elderly population group becomes smaller. The influence of the elderly group (with a higher mortality rate) in the original group becomes smaller after standardization, and the influence of the entire population becomes smaller. The standardized mortality rate also decreases
(2) Application
①An indicator that reflects the total death level of a population and is used to measure the mortality risk of a population in a certain period and region.
② It can not only reflect the health status of people in a region and the level of health care work in different periods, but also provide a scientific basis for the needs and planning of health care work in the region.
③The mortality rate can provide information on the changes in the distribution of deaths from a certain disease and can be used to explore the cause of the disease and evaluate prevention and control measures.
④ It can be used as an indicator of the risk of disease. When the mortality rate is high and the survival time is short, the mortality rate can reflect the incidence rate of the population, such as pancreatic cancer.
(3) Calculation formula
Mortality rate = (total number of deaths in a certain group of people in a certain year/average population of the same group of people in the same year)*k
crude mortality rate
2. Case fatality rate (acute infectious diseases/chronic diseases)
(1) Definition
Indicates the proportion of deaths due to a disease to patients with that disease within a certain period of time.
Indicates the risk of death of a patient from a certain disease.
Commonly expressed as a percentage.
(2) Application
① Indicates the death probability of a patient diagnosed with a certain disease, which can reflect the severity of the disease, as well as the medical level and diagnostic capabilities.
②It is often used for acute infectious diseases and can also be used for chronic diseases.
③Affected by the severity of the disease, the level of diagnosis and treatment, and the virulence of the pathogen, it changes with changes in medical level, cause of disease, environment, host and other factors.
(3) Calculation formula
Case fatality rate = number of deaths due to a certain disease in a certain period / number of patients with a certain disease in the same period * 100%
Calculations relate only to patients with the disease studied.
3. Infant mortality rate IMR (developmental level)
(1) Definition
It is an indicator reflecting the level of infant mortality within one year of age.
Refers to the ratio of the number of deaths of infants under one year old to the number of births.
(2) Application
① It is an important indicator that reflects the medical level, social and economic strength, people's living standards and scientific and technological development level of a country or region. It is also one of the important basis for measuring the quality of the population.
②Reflects the medical and health status of a certain region, and also indicates to a certain extent the health status and quality of life of the population in the region, especially the level of maternal and child health care.
(3) Calculation formula
Infant mortality rate = total number of infant deaths in a certain year / total number of live births in the same year * 1,000 per thousand
4. Survival rate (chronic disease)
(1) Definition
Refers to the proportion of patients who have received a certain treatment or a certain disease and are still alive after n years of follow-up.
(2) Application
①Reflects the degree of harm to life caused by the disease,
② Used to evaluate the long-term efficacy of certain diseases with a long course
③ Commonly used in the research of chronic diseases such as cancer, cardiovascular disease, and tuberculosis
(3) Calculation formula
Survival rate = number of patients who are still alive after n years of follow-up/number of cases who have been followed up for n years*100%
(4) Disease burden indicators
(1) Potential years of life lost (PYLL)
(1) Definition
It is the sum of the differences between the life expectancy and the actual age of death of people in a certain age group of diseases,
That is the loss of life due to death.
(2) Content
① Not only the level of mortality is considered, but also the impact of age at the time of death on life expectancy. Measure the harm of a certain cause of death to the population, identify key diseases, and clarify key health issues.
② It is a direct indicator for measuring the burden of disease in the population and an important indicator for evaluating the health level of the population. It further measures the life loss caused by death based on the number of deaths and life expectancy, emphasizing the impact of early death on the population. Damage to population health.
③It can be used to calculate the total number of years of life lost by people who died from different diseases and different age groups, and to compare the characteristics and trends of potential life years in different disease areas and at different times.
④ Comprehensively estimate the relative importance of various causes of death that lead to premature death in a certain group, providing a basis for determining key diseases in different age groups.
(2) Disability-adjusted life years (DALY)
(1) Definition
Refers to the total healthy life years from onset to death due to damage,
Includes years of life lost (YLL) due to premature death
and years of healthy life lost (YLD) due to disability due to disease.
(2) Content
① It is a quantitative indicator that combines the loss of life span caused by premature death caused by various diseases with the loss of healthy life span caused by disability and budgets it, and is a comprehensive indicator that reflects the impact of diseases on the loss of life span of the population.
② Carry out hygiene evaluation to compare and evaluate the health status between regions.
③ Determine the disease burden of different diseases, as well as identify the main diseases that endanger the health of the population and key populations and regions
Section 2 Disease Epidemic Intensity
1. Disease epidemic intensity
Commonly used expressions include spread, outbreak, epidemic and pandemic.
It refers to the changes in the incidence of disease among people in a certain area within a certain period of time and the degree of connection between cases.
The incidence rate is used to describe the changing characteristics of the number of new cases of a certain disease in a certain area within a unit time.
In order to determine whether to adopt conventional prevention countermeasures or activate an emergency plan.
2. Commonly used descriptions of epidemic intensity
1. Distribute
(1) Definition
Refers to the general level of incidence rate over the past years.
There is no obvious connection between the cases in terms of time and place of onset, and they appear to occur sporadicly.
Generally speaking, for a larger area, it is usually compared with the local incidence rate of the disease in the past three years.
(2) Common situations
① Diseases in which immunity is long-lasting after illness, or diseases in which the population maintains a certain level of immunity due to vaccination, often appear sporadic, such as measles.
② Some diseases that are mainly invisible infections often exist in sporadic forms, such as poliomyelitis and Japanese encephalitis.
③Some infectious diseases whose transmission mechanism is not easy to realize can also appear sporadic, such as typhus and anthrax
④Some long-term latent infectious diseases also exist in sporadic form, such as leprosy
2. Outbreak
(1) Definition
Refers to local areas or collective units,
A sudden occurrence of many patients with the same symptoms in a short period of time.
(2) Features
①These people often have the same source of infection or transmission route.
②Most patients often appear at the same time between the shortest and longest incubation period of the disease. Such as outbreaks of measles, hand, foot and mouth disease, mumps, hepatitis A and other diseases in day care institutions.
3. Popular
(1) Definition
It means that the incidence rate of a certain disease in a certain area significantly exceeds the annual incidence rate of the disease.
(2) Features
① Compared with sporadic cases, when an epidemic occurs, there are obvious temporal and spatial connections between cases.
②The prevalence of a certain disease indicates that there may be common transmission factors
4. Pandemic
definition
The incidence rate of a certain disease significantly exceeds the annual incidence rate of the disease,
The disease spreads rapidly and covers a wide area.
In a short period of time, it has become a worldwide epidemic across provincial, national and even state boundaries.
Such as influenza and cholera.
Section 3 Distribution of Diseases
1. Crowd distribution
1. Age distribution - one of the most important demographic characteristics of the population
(1) Cross-sectional analysis
①Definition
Mainly analyze different age groups in the same period or different age groups in different years
changes in incidence, prevalence or mortality,
It is mostly used for age distribution analysis of infectious diseases or diseases with short incubation periods in a certain period.
The relationship between causative factors and age cannot be clearly demonstrated.
②Research objects
Different age groups in the same period or different age groups in different years
③Research content
Changes in incidence, prevalence, or mortality
④Research conclusion
The relationship between causative factors and age cannot be clearly demonstrated.
⑤Research on diseases
a. Infectious diseases at a certain period
b. Diseases with short incubation period
⑥Application
It is mostly used for age distribution analysis of infectious diseases or diseases with short incubation periods in a certain period.
(2) Birth cohort analysis
①Definition
A group of people born during the same period is called a birth cohort.
Follow them for several years to observe the onset of disease,
A method that combines age distribution and time distribution of disease using birth cohort data.
②Research objects
A group of people born during the same period (birth cohort)
③Research content
Follow up for several years to observe the incidence
④Research conclusion
Clearly present the relationship between causative factors and age
⑤Research on diseases
chronic
⑥Research significance
Evaluate long-term trends in age distribution of diseases and provide clues to the causes, etc.
2. Gender distribution
① Genetic characteristics of males and females
②Endocrine metabolism
③Physiological and anatomical characteristics
④Differences in intrinsic qualities
⑤ Characteristics of exposure to pathogenic factors
3. Occupational distribution - main considerations
(1) Occupation
It is the working environment, socioeconomic status, health and education level, and physical labor intensity of the workers.
and mental stress and other factors.
(2) Occupational distribution of diseases
Related to exposure to pathogenic factors in the working environment.
(3) Exposure to occupationally related carcinogens and their effects
Relevant to working conditions and protective facilities.
(4) Different professional groups
Different occupational groups have different types of diseases and different prevention and treatment priorities.
(5) Occupational exposure time and past occupational history
influence on disease occurrence.
4. Racial and ethnic distribution
Different ethnic groups have been affected by certain natural environment, social environment and genetic background for a long time.
Disease distribution also shows variability. Such as sickle cell anemia in black people.
5. Marriage and family
For example, married women have a higher incidence of cervical cancer.
6. Behavioral lifestyle
For example, smoking can cause lung cancer and esophageal cancer.
7. Floating population
Such as malaria and plague.
8. Religious beliefs
Such as Judaism️Cervical cancer, penile cancer
society
2. Regional distribution
1. Distribution among countries and in different regions within countries
(1) Distribution of diseases among different countries. Such as AIDS️global, cholera️India.
(2) Distribution of diseases in different regions within the same country. Nasopharyngeal cancer in Guangdong and esophageal cancer in Henan.
2. Urban and rural distribution
1. Spread of disease
1. City
①The urban population density is high and the living area is narrow,
②High population mobility and congested traffic,
③Respiratory infectious diseases spread easily.
④Such as chickenpox, meningococcal meningitis, and influenza.
2. Rural areas
① Rural areas have low population density and inconvenient transportation.
② Relatively little contact with the outside world, respiratory infectious diseases are not easy to spread,
③Once an infectious disease is introduced, it can spread rapidly, causing outbreaks and epidemics.
2. Popular characteristics
1. City
①The urban birth rate is relatively stable, with a large proportion of young adults.
② When a large number of rural people pour into cities, the cities will always maintain a certain number of people susceptible to certain infectious diseases, resulting in certain infectious diseases that can occur all year round, and can form outbreaks or epidemics, which are often characterized by cyclical epidemics.
2. Rural areas
①The flow of rural population between urban and rural areas,
② The difference in the incidence of some infectious diseases between urban and rural areas has reduced or disappeared.
3. Prevalence of chronic diseases
1. City
Urban industries are concentrated, there are many vehicles, and the air, water, and environment are seriously polluted.
② The prevalence of chronic diseases has increased significantly, such as hypertension and lung cancer, which are higher than in rural areas.
2. Rural areas
The continuous development of rural areas has also led to increased environmental pollution.
The incidence of hypertension, diabetes, etc. is on the rise.
4. Occupational related diseases
1. City
Diseases caused by occupational factors related to air pollution and noise are common
2. Rural areas
Rural labor intensity is high, working conditions and protective conditions are poor, and occupational poisoning and occupational injuries occur from time to time.
5. Medical level and related health facilities
1. City
①Medical level
The city has a high level of medical care and centralized facilities.
The medical care system is relatively sound and the incidence of intestinal infectious diseases is low.
②Related health facilities
The urban water supply and drainage facilities are complete and well managed.
The level of drinking water hygiene is high and the prevalence of intestinal infectious diseases is limited.
2. Rural areas
Sanitary conditions in rural areas are poor, and intestinal infectious diseases and insect-borne infectious diseases are more likely to spread.
3. Local aggregation
(1) Definition of local agglomeration
The frequency of disease incidence and illness in a certain area is higher than that in surrounding areas,
The frequency of disease in the area exceeds random probability, which is called regional clustering of disease.
It is suggested that specific pathogenic factors in this region have an impact on population health.
(2)locality
(1) Definition of locality
Due to the influence of natural factors or social factors,
A certain disease often exists in a certain area or only occurs in a certain range of people.
It is said to be local when it does not need to be imported from other places.
These diseases are called endemic diseases.
(2) Endemic diseases
①Definition
Also called endemic diseases,
Refers to a relatively stable and frequent disease that is limited to certain areas.
It often exists in a certain area or population and has a relatively stable incidence rate.
Such as diseases caused by excess or lack of certain trace elements required for normal human metabolism in the natural geographical environment.
②Basic
(1) Residents in this area have a high incidence rate.
(2) People living in other areas have low or even no incidence of the disease.
(3) After moving to the area for a period of time, the incidence rate is consistent with that of local residents.
(4) After moving out of the area, the incidence rate decreases, and the symptoms of the disease are relieved or healed on their own.
(5) The same disease can also occur in local susceptible animals.
(3)Classification
①Statistical locality
Due to social factors such as living conditions, sanitary conditions and religious beliefs,
As a result, the incidence of certain diseases in some areas has been significantly higher than in other areas for a long time.
It has little connection with the natural environment of the place and is said to be statistically endemic.
Such as dysentery and other intestinal infectious diseases.
(social factors)
②Natural locality
Some diseases are affected by the natural environment,
The situation that exists only in a specific area is called natural endemism.
Such as schistosomiasis, endemic goiter, etc.
③Natural epidemic focus
The pathogens of some diseases do not depend on humans in the process of propagating species.
And spread among wild animals or domestic animals,
People become infected when they accidentally intervene in this process.
This condition is called natural foci, and these diseases are called natural foci diseases.
Such as plague, epidemic hemorrhage, forest encephalitis, etc.
(natural factors)
(3)Imported diseases
Also known as exotic diseases,
Any infectious disease that does not exist or has been eliminated in the country or region,
When introduced from abroad or other regions, it is called an imported infectious disease.
Such as AIDS.
3. Time distribution
1. Short-term fluctuations
(1) Definition
It is generally a disease epidemic or outbreak that lasts for several days, weeks or months.
It is the special way of existence of the disease
(2) Points of differentiation from outbreaks
Outbreak→smaller range
Short-term fluctuation → larger range
(3) Example
Food poisoning in collective canteens
Outbreaks of typhoid, dysentery, and measles
chemical poisoning
2. Seasonality
(1)Definition
The incidence of diseases increases in certain seasons
(2)Form
①Strictly seasonal
The incidence is mostly concentrated in a few months and is not released in other months.
Such as insect-borne transmission, Japanese encephalitis
②Seasonal increase
It occurs all year round, but the incidence rate only increases in certain months.
Such as intestinal infectious diseases, respiratory infectious diseases
3. Periodicity
(1) Definition
It means that the frequency of disease fluctuates regularly at certain time intervals.
There is a peak of popularity every few years.
Commonly seen in respiratory infectious diseases, including influenza, epidemic cerebrospinal meningitis, whooping cough, chickenpox, diphtheria, etc.
(2) Common reasons affecting periodicity and interval time
(1) Factors such as dense population, heavy traffic and poor sanitary conditions are conducive to the spread of diseases.
When there is a source of infection and a sufficient number of susceptible people,
When there are no effective preventive measures, its epidemic characteristics show a certain periodicity.
(2) The communication mechanism is easy to implement
When susceptible individuals accumulate in sufficient numbers, they can spread rapidly.
After a disease epidemic, the speed at which new susceptible people accumulate,
Especially the increase in newborns affects the time between disease cycles,
The faster the accumulation, the shorter the interval. disease
(3) Diseases that can form stable immunity after illness
After an epidemic, the incidence rate can drop rapidly.
The longer the post-epidemic population immunity level lasts, the longer the period interval.
(4) Pathogen mutation and the speed of mutation
The occurrence of periodicity also depends on the pathogen mutating and how quickly it mutates,
It is an important factor affecting the interval between disease cycles.
4. Long-term trends
(1) Definition
Also called long-term variation or long-term change,
refers to a long period of time, usually several years or decades,
Changes in clinical characteristics, distribution status, epidemic intensity, etc. of the disease
Such as gastric cancer and scarlet fever.
(2) The main reasons are:
①Changes in the cause or causative factors,
②Mutation of pathogens,
③Changes in the body’s immune status,
④The improvement of medical treatment and prevention level,
⑤The degree of improvement of the reporting and registration system, etc.
4. Comprehensive description of disease groups, regions, and time—immigration epidemiology
(1) Definition
By observing the differences in disease incidence or mortality among immigrants, local residents in the place of immigration, and people in the place of origin
To explore the relationship between the occurrence of diseases and genetic factors or environmental factors.
It is a typical example of comprehensive description of disease population, region and time distribution.
(2) Principles to follow
①Environmental factors - proximity to the country of immigration
If the difference in morbidity or mortality of a disease is mainly the result of environmental factors,
Then the incidence or mortality rate of the disease in the immigrant population is different from that of the population in the country of origin (region).
And the morbidity or mortality rate is close to that of the local population in the country of immigration.
②Genetic factors - close to the original country
If the difference in incidence or mortality of a disease is mainly related to genetic factors,
Unlike the morbidity or mortality rates in the native population of the country of immigration,
The incidence or mortality rate of the disease among immigrant populations is similar to that of the population in the country of origin (region).
(3) Application
It is often used to explore the causes and prevalence factors of tumors, chronic diseases or certain genetic diseases.
Chapter 3 Descriptive Research
Section 1 Overview
1. The concept of descriptive research
①Refers to data obtained through routine monitoring records or special investigations (including laboratory test results)
②Group according to different regions, different times and different crowd characteristics
③Describe the distribution of relevant diseases or health states, relevant characteristics and exposure factors among the population
④ Carry out comparative analysis on this basis to obtain the characteristics of the distribution of the disease in three regions (population, region and time)
⑤ Then obtain clues to the cause and put forward a hypothesis of the cause.
2. Types of descriptive research
1. Current situation research
Also called a cross-sectional study or a prevalence study.
By focusing on a specific point in time or period,
Collection and description of data on the distribution of diseases and health conditions and related factors among groups of people within a specific range,
Provide clues to the cause for further research.
2. Case reports
A detailed introduction to a single case or a small number of clinical cases of a rare disease,
Belongs to the category of qualitative research.
3. Case series analysis
The type of research method most familiar to clinicians.
For a group of (several, tens, hundreds, thousands of cases) clinical data of patients with the same disease,
Organize, compile statistics, analyze, summarize and draw conclusions.
4. Case study
concept
Also called case investigation,
Refers to going to the scene of the disease, the contact history of new cases, the disease or health status of family members and surrounding people
and investigate environmental factors that may be related to the disease
Purpose
① Find out the causes and conditions of the cases under study,
②The purpose of controlling the spread of the epidemic and eliminating the source of the epidemic to prevent the recurrence of similar diseases.
Research object
Generally, they are patients with infectious diseases or non-infectious diseases, or cases with unknown causes.
related to cases
5. Historical data analysis
historical data, that is, data
It is used to study the distribution characteristics of diseases, disease risk factors, and evaluate the effects of disease prevention and control measures.
Important sources of information
Through retrospective investigation, the researcher extracted and utilized relevant historical data and conducted statistical analysis.
6. Follow-up study
Also called longitudinal study,
It is to observe diseases, health conditions or health events through regular follow-up visits,
Dynamic changes over time in a fixed population.
Continuous observation of research objects can be carried out,
It can be used to study the natural history of diseases, provide clues for etiological research, and propose or test etiological hypotheses.
7. Ecological research
Also called correlation research,
Study the relationship between an exposure factor and disease at a population level,
Taking the group as the unit of observation and analysis,
By describing the exposure to certain factors and the frequency of disease in different populations,
Analyze the relationship between the exposure factor and the disease.
This is a broad-based study that can only provide certain clues to the cause.
3. Characteristics of descriptive research
1. Use observation as the main research method, without taking any intervention measures on the research objects, and only observe, collect and analyze relevant data.
2. The allocation of exposure factors is not random, and a control group is generally not established at the beginning of the study.
3. The temporal relationship between exposure and outcome cannot be determined, but it can provide clues for subsequent analytical or experimental research.
4. Uses of descriptive research
1. Describe the distribution and occurrence and development of diseases or health conditions
2. Identify high-risk groups and evaluate the effectiveness of preventive measures
3. Obtain clues to the cause of the disease and propose a hypothesis of the cause.
Section 2 Current Situation Research
1. Overview of current research
(1) Concept
(1)Definition
By focusing on a specific point in time or period,
and collection and description of the distribution of diseases or health conditions and related factors among a specific range of people.
Provide clues to the cause for further research
(2)Two dimensions
①Time angle️
Current situation research collects data from a specific time section.
Also called cross-sectional research.
②From the perspective of observation and analysis indicators️
Generally, it is the prevalence rate of the survey group within a specific period of time,
Therefore, it is also called prevalence study.
(2) Features
1. Generally, there is no control group during the design stage.
However, during data processing and analysis,
Groupings can be based on exposure characteristics or disease status.
2. A specific point in time or period
Current situation research focuses on a specific point in time
or the status and association of exposure and disease in a group over a specific period of time.
Such as the time to measure high blood pressure and diagnose whether it is high blood pressure.
3. Restrictions on establishing causal links
Reason one
The research subjects in current studies are generally patients with longer survival time.
It is possible to treat factors that influence survival as factors that influence morbidity.
Reason two
Generally revealed is the relationship between exposure and disease in a certain group at a certain point in time or within a certain period.
The temporal relationship between exposure to disease cannot be determined.
For example, the relationship between colon cancer and serum cholesterol, the survival period of the research subjects is long/the time point of revelation.
4. Causal inference can be made from the inherent exposure factors of the research object.
Factors such as gender, race, blood type, genotype, etc.
It exists before the onset of the disease and does not change depending on whether you have the disease or not.
5. Replace or estimate past conditions with current exposure characteristics
Prerequisite 1
Current exposure or exposure levels correlate well with past conditions or are shown to vary little.
For example, some environmental or occupational exposure factors have remained stable for several years or longer.
Prerequisite 2
The changing trend or pattern of exposure levels of known research factors,
Use this trend or pattern to estimate past exposure levels.
Prerequisite three
Recalling past exposure or exposure levels is highly unreliable,
Current exposure data can be used to estimate past exposure.
6. Repeat regularly to obtain incidence data
It is required that the time interval between current situation studies should not be too long,
There was little change in incidence over this time frame, and the course of the disease was stable.
Incidence rate = the difference between two occurrence rates divided by the time interval.
(3) Type
1. Census
(1) Concept
That is, a comprehensive investigation,
It refers to a survey in which all people (overall) within a specific range at a specific point in time or period are used as the research object.
(2) Purpose
① Early detection, early diagnosis and early treatment of patients, such as cervical cancer screening for women.
② Understand the prevalence of chronic diseases and the distribution of acute infectious diseases, such as hypertension census and census in epidemic areas.
③ Understand the health level of local residents, such as dietary and nutritional status surveys.
④ Understand the normal value ranges of various physiological and biochemical indicators of the human body, such as the measurement of adolescent height and weight.
sample survey
(1) Concept
refers to the method of random sampling,
Conduct a survey on a representative sample of the population within a specific range at a specific point in time or period,
Use sample statistics to estimate the range of population parameters.
(2)Purpose
The situation of the population is inferred through the investigation and research of the research objects in the sample.
(3)Attention
When the sampling ratio is greater than 75%, a census is used.
Sampling must be randomized and the sample size must be adequate.
3. Comparison of the advantages and disadvantages of census and sample survey
(1) Census
advantage
①The survey objects are the entire target population, and there is no sampling error.
② The distribution of multiple diseases or health conditions among the target population can be investigated simultaneously.
③ It can detect all cases, "three mornings", describe the distribution and characteristics of the disease, and provide clues for etiology analysis and research.
shortcoming
① It is not suitable for diseases with low prevalence and no simple and easy diagnostic methods.
②The workload is large, it is difficult to be meticulous, and there are missed checks.
③The investigation staff covers a wide range of areas and is not uniform, making it difficult to ensure the quality of the investigation
④ It consumes manpower and material resources and is expensive.
(2) Sampling survey
advantage
① Save time, manpower and material resources.
②The scope of investigation is small, and the investigation work is easy to do in detail.
shortcoming
①The design, implementation and data analysis are more complicated than the census.
②Duplication or omission of information is difficult to detect.
③ Sampling surveys are not suitable for research subjects with excessive variation or diseases that require census and treatment.
④Sampling surveys are not suitable for diseases with too low prevalence.
(4) Purpose
(1) Grasp the distribution of diseases or health conditions in the current population.
(2) Provide research clues to the cause of the disease.
(3) Identify high-risk groups.
(4) Evaluate the effectiveness of disease surveillance, vaccination and other prevention and control measures.
2. Design and implementation of current research
(1) Determine the research purpose️
Understand health conditions or conduct population health surveys.
(2) Clarify the type of research️
Census or sampling.
(3) Determine the research object️
Children/Individuals/Special Populations.
(4) Determine sample content and sampling method
1. Sample size
(1) Factors affecting sample size
①Expected prevalence rate (p)
②Requirements for accuracy of survey results
That is, the larger the allowable error (d), the
The smaller the sample size required;
③Required significance level (α)
The smaller the α value, the higher the significance level requirement.
The larger the sample size requirement.
(2)Sample size calculation formula
2. Sampling method
1. Non-random sampling
(1)Definition
When selecting samples, subjective factors are added.
Make each individual in the population have an unequal chance of being selected
(2)Classification
typical survey
chance encounter sampling
purposive sampling
quota sampling
snowball sampling
spatial sampling
2. Random sampling
(1)Definition
Need to follow the randomization principle
(2)Classification
(1) Simple random sampling
①Definition
Also called simple random sampling,
From the total N objects,
Draw n numbers by lottery or other random methods (such as random numbers),
form a sample.
②Advantages and disadvantages
①Advantages
①The simplest and most basic sampling method,
②The basis of various other sampling methods
②Disadvantages
①The overall quantity is large, and numbering and sampling are troublesome.
②The individuals drawn are scattered, which makes data collection difficult and less applicable.
③Scope of application
The basis for other sampling methods,
Mostly used in general but not too big
(2) Systematic sampling
①Definition
Also called mechanical sampling,
It's in a certain order,
A sampling method that mechanically selects units every few units.
③Principle
①Advantages
① Sampling can be carried out without knowing the number of units in the population.
②It is easier to carry out with crowds on site.
③ The sample is drawn from the units distributed in various parts of the population. The distribution is relatively even and the representativeness is good.
②Disadvantages
If the distribution of each unit in the population has a cyclical trend, and the extracted intervals coincide with this period or its multiples,
This may bias the sample.
For example, there is seasonality in the time distribution of diseases and cyclical changes in survey factors. Failure to pay attention will bias the results.
④Scope of application
Random distribution of individuals according to sampling order
(3) Stratified sampling
definition
①Definition
First, the population is divided into several sub-populations (layers) according to certain characteristics.
Then simple random sampling is performed from each stratum to form a sample.
If the sampling proportions of each stratum are the same, it is called proportional stratified random sampling.
If the proportions of each stratum are different, it becomes the optimal allocation stratified random sampling.
②Advantages and disadvantages
①Advantages
① High accuracy, convenient organization and management, and individuals at each level in the population have an equal chance of being drawn.
② In addition to estimating the overall parameter value, the situation within each layer can also be estimated separately.
②Disadvantages
When there are many layers, investigation and analysis are troublesome.
③Principle
The smaller the variation within a layer, the better, and the larger the variation between layers, the better.
④Scope of application
Mainly used when there are large differences between layers
(4) Cluster sampling
①Definition
Divide the population into several groups,
Select some of these groups as observation units to form a sample.
If all individuals in the sampled group are included in the survey, it is called simple cluster sampling;
If some individuals are surveyed after re-sampling, it is called two-stage sampling.
②Advantages and disadvantages
①Advantages
①Easy to organize and implement, which can save manpower and material resources;
②The smaller the difference between groups, the more groups are sampled and the higher the accuracy.
②Disadvantages
The sampling error is large and is usually increased by 1/2 based on the sample size of simple random sampling.
③Principle
The smaller the variation within a layer, the better, and the larger the variation between layers, the better.
④Scope of application
Small differences between groups
(5) Multi-stage sampling
①Definition
Carry out the sampling process in stages,
The sampling methods used in each stage are different, that is, the above sampling methods are used in combination,
It is commonly used in large-scale epidemiological surveys.
For example, the large-scale chronic disease survey conducted in my country adopted this method.
②Advantages and disadvantages
①Advantages
① You can make full use of the advantages of various sampling methods and overcome their respective shortcomings.
②And can save manpower and material resources.
②Disadvantages
Before sampling, it is necessary to understand the demographic information and characteristics of survey units at all levels.
③Scope of application
large epidemiological survey
3. Comparison of sampling errors
Cluster sampling > Simple random sampling > Systematic sampling > Stratified sampling
(5) Data collection - ensure homogeneity of data and unified standards
1. Determine the content of data to be collected
①Basic personal situation.
②Occupational situation.
③Living habits and health care conditions.
④ Women’s fertility status.
⑤Environmental information.
⑥Demographic information.
2. Investigator training
Personnel participating in the investigation should be uniformly trained according to standard methods.
Let them master the investigation methods and ensure the consistency of data collection methods and standards.
3. Data collection method
(1) Obtained through experimental measurement or inspection.
(2) Prepare a questionnaire and survey the research subjects to obtain exposure and disease information.
(3) Utilize relevant information from routine data, routine registrations and reports, special inquiries and correspondence surveys, clinical examinations and other special examinations
(6) Data sorting and analysis
(1) The completeness and accuracy of the original data.
(2) Organizing of original data, such as grouping, designated sorting tables, etc.
(3) Continuous variable → distribution distribution type (whether normal or not).
(4) Calculate various rates, such as commonly used prevalence rates, positivity rates, detection rates, etc.;
(5) Standardized rate (region, etc.).
(6) Two different ideas can be used in the analysis: ① conduct comparative analysis and research based on grouping based on exposure; ② conduct comparative analysis and research based on grouping based on disease.
3. Common biases in current research and their control
(1) Definition of bias
It refers to the systematic errors generated in all aspects from research design and implementation to data processing and analysis.
As well as the tendency difference between the research results and the real situation caused by the one-sided interpretation and inference of the results,
This in turn leads to mischaracterization of the link between exposure and disease. (Bias can be avoided or reduced)
(2) Common biases
(1) Selection bias
①Select research objects subjectively.
② Randomly transform the sampling method.
③No response bias
Respondents are unwilling to cooperate or are unable or unwilling to participate in the survey for other reasons, thus reducing the response rate.
If the response rate is less than 70%, it will be difficult to use the survey results to estimate the overall status of the entire study.
④Survivor bias
The subjects investigated were all survivors.
This makes the survey results have certain limitations and one-sidedness, and cannot fully reflect the actual situation.
(2) Information bias
①Reporting bias
When respondents were asked relevant questions, their answers were inaccurate due to various reasons.
②Recall bias
The respondent has unclear recollection of past exposure or disease history,
In particular, healthy respondents tend to forget past exposures because they have no experience with the disease.
③Survey bias
Investigators consciously delve into certain characteristics of certain people,
Rather than paying attention to or treating these characteristics in other people carelessly.
④Measurement bias
During the data collection process, the measurement tools and inspection methods are uncertain, and the laboratory operations are not standardized.
(3) Confounding bias
In data analysis, the existence of confounding factors leads to discrepancies between the results and the actual situation.
(3) Control
(1) Strictly comply with the requirements of the sampling method and ensure the effective implementation of the randomization principle in the sampling process.
(2) Improve the compliance and examination rate of research subjects.
(3) Correctly select measurement tools and detection methods.
(4) To organize the research work well, investigators must be trained and have unified standards and understanding.
(5) Do a good job in reviewing and rechecking the information.
(6) Choose the correct statistical analysis method and pay attention to identifying confounding factors and their effects.
4. Advantages and disadvantages of current research
(1) Advantages
(1) Randomly select a representative sample, the research results have strong generalization significance, and the credibility of the overall estimate based on the sample is high.
(2) There is a naturally formed control group from the same group, making the combination comparable
(3) A single investigation can observe multiple factors at the same time, all of which are indispensable in the process of exploring the cause of the disease.
(2) Disadvantages
(1) It can only reflect the individual’s disease and exposure status at the time of the investigation, and it is difficult to determine the temporal relationship between causes and consequences.
(2) Incidence data cannot be obtained unless the same current status survey is conducted continuously in a stable group.
(3) If some of the research subjects are in the incubation period or preclinical stage of the disease being studied, they may be mistaken for normal people, which will bias the research results and underestimate the disease level of the research group.
Section 4 Ecological Research
1. Overview of ecological research
(1) Concept
Also called correlational research, it is a type of descriptive research
It studies the relationship between certain exposure factors and diseases at the group level.
Using groups as the unit of observation and analysis
By describing the exposure to certain factors and the frequency of disease in different populations
Analyze the relationship between the exposure factor and the disease.
(2) Features
(1) The individual is not the unit of observation and analysis, but the group is the unit. (the most basic feature)
(2) It is impossible to know the causal relationship between individual exposures to effects (diseases).
(3) The information provided is not complete, but a rough descriptive study.
(3) Purpose
(1) Provide clues to the cause and generate hypotheses about the cause
It is widely used in the study of the etiology of chronic diseases or the study of the relationship between environmental variables and population disease states.
Provide a basis for the establishment of research hypotheses.
(2) Evaluate the effectiveness of population intervention measures
In disease surveillance, ecological studies can be applied to estimate and monitor disease trends,
Provide basis for formulating strategies and measures for disease prevention and control
(4) Comparison of similarities and differences between current research and ecological research
(1) Similarities
Both are descriptive studies,
It is a cross-sectional study of a certain disease or health condition among people within a specific range at a specific time.
(2) Differences
①Current situation research
Collect and describe data on an individual basis,
②Ecological research
Describe the group as the unit of observation and analysis.
2. Types of ecological research
(1) Comparative ecological research
(1) Definition
By observing the distribution of a certain disease among different groups of people or regions,
Etiological hypotheses are then proposed based on differences in disease distribution.
Comparative ecological studies do not require exposure data or complex data analysis methods.
(2) For example, the distribution of gastric cancer in various places;
Gastric cancer mortality in coastal areas is higher than in other areas️
The environment or diet in coastal areas may be one of the risk factors for gastric cancer.
(2) Ecological trend research
(1) Definition
Continuously observe changes in the average exposure level of a factor in a population
its relationship with changes in the incidence and mortality of a certain disease, and understand its changing trends;
By comparing the changes in disease frequency before and after exposure levels, the connection between a certain factor and a certain disease can be judged.
Often used interchangeably with comparative ecological research.
(2) For example
Smoking rate among the cardiovascular disease MONICA program population, etc.;
Changes in cardiovascular disease morbidity and mortality.
3. Data collection for ecological research (source)
(1) Application of geographic information system
(2) Application of big data
4. Advantages and Disadvantages of Ecological Research
(1) Application/Advantages and Disadvantages
(1) Conventional data or ready-made data (such as databases) can be used, which can save time, manpower, and material resources and obtain results faster.
(2) It can provide clues to the causes of diseases with unknown causes, which is the most significant feature of ecological research.
(3) For situations where the individual exposure dose cannot be measured, it is the only research method available. Such as the relationship between air pollution and lung cancer.
(4) It can be used when the exposure factor studied has a small range of variation in a population and it is difficult to measure the relationship between the exposure factor and the disease. For example, research on the relationship between dietary structure and several cancers.
(5) Suitable for evaluation of population intervention measures. Such as health education and health promotion.
(6) In disease monitoring, ecological trend research can be used to estimate the development trend of a certain disease.
(2) Limitations
(1) Ecological fallacy (the main flaw)
①Definition
Since ecological research takes a group of individuals in different situations as the unit of observation and analysis,
And the existence of confounding factors and other reasons cause the research results to be inconsistent with the real situation.
②Cause of occurrence
① Lack of data on the joint distribution of exposure and outcome.
② Suspicious confounding factors cannot be controlled.
③The exposure levels in relevant data are only approximate values or average levels, and are not the actual exposure of individuals. The relationship between exposure and disease cannot be accurately evaluated, resulting in a misinterpretation of the link between exposure and research outcomes.
(2) Confounding factors are often difficult to control
In particular, some variables related to sociodemographic and environmental aspects are easy to correlate with each other (multicollinearity problem)
(3) It is difficult to confirm the causal link between two variables.
Chapter 4 Cohort Study
Section 1 Overview
1. Concept
1. Cohort study
Also known as cohort study, incidence study, follow-up study, longitudinal study
It divides people into different groups whether they are exposed to a certain factor and the degree of exposure.
Track the outcome of each group,
Compare differences in outcome frequencies between groups,
An observational research method to determine whether there is a causal link and the magnitude of the link between exposure factors and outcomes.
2. Exposed
Refers to the fact that the research subject has been exposed to a certain substance to be studied (such as heavy metals)
or have certain characteristics to be studied (such as age, gender, genetic traits, etc.) or behavior (such as smoking),
Simultaneous exposure must be a factor that needs to be explored in this study and is closely related to the specific research purpose.
Exposure can be harmful or beneficial.
3. Risk factors
Also called risk factors,
Generally refers to the ability to cause a specific adverse outcome (such as a disease),
or a factor that increases the probability of its occurrence,
Including many factors such as personal behavior, lifestyle, environment and genetics.
The opposite of a risk factor is called a protective factor, and both can be used as research factors,
Can be collectively referred to as determining factors or influencing factors.
4. Queue
(1) Definition
A group of people within a specific range is called a queue
(2) Classification
Ⅰ. According to the nature of the queue definition
①Birth cohort
For example, a group of people born within a specific period is called a birth cohort.
② Exposure queue
A group of people with a common experience or certain common exposure characteristics can be called an exposure cohort.
Ⅱ. According to the time when people enter the queue, they are divided into
①Fixed queue
It means that people all enter the queue at a certain fixed time or within a short period of time.
They will then be followed up and observed until the end of the observation period, and no new members will be added.
②Dynamic queue
That is, after a queue is determined, the original queue members can continue to exit.
New observation subjects can be added at any time, that is, the cohort members change dynamically during the study period.
Such as the American Framingham Cardiovascular Study.
2. Basic principles
1. Basic principles process
It is to select the required research objects among a specific group of people,
Based on current or past exposure to a factor to be studied, or its different exposure levels,
Stratify the research subjects into different groups and follow them up for a period of observation.
Check and register the occurrence of expected outcomes to be studied in each group of people (such as disease, death, etc.),
Compare the incidence rates of outcomes in each group to evaluate and test the relationship between research factors and outcomes.
2. Basic characteristics of basic principles
Belongs to observation method
The exposures in the study were not artificially administered or randomly assigned,
It exists objectively before research and is not determined by the will of the researcher.
Set up a control group
A control group is usually established during the research design stage.
Control groups can also be established as needed during the data analysis phase.
The control group can be from the same population as the exposed group, or it can be from a different population.
cause and effect
In a cohort study, the subject's exposure is established at the outset (before the onset of disease).
Then explore the relationship between exposure factors and diseases, that is, first determine the causes, and then observe the effects longitudinally.
Strong ability to test causal links between exposures and outcomes
The researchers grasped the exposure status of the study subjects and followed up on the occurrence of outcomes.
and the outcome occurs in an exact number of exposed people,
Able to accurately calculate the incidence of outcomes,
The ability to estimate the risk of a certain outcome among the exposed population and determine the causal relationship is strong.
3. Research purpose
1. Test the hypothesis of etiology
Strong ability to test etiological hypotheses,
A cohort study can test the causal association between an exposure and one or more outcomes.
2. Evaluate the effectiveness of preventive measures
When certain possible precautions (exposures) are not given by humans,
When it is a spontaneous behavior of the research subjects, a cohort study can be used to evaluate the effect of this preventive measure.
For example, eating a lot of vegetables can prevent the occurrence of intestinal cancer, and quitting smoking can reduce the risk of lung cancer in smokers.
3. Study the natural history of disease
It can be observed that after being exposed to a certain factor, the
The entire process of disease gradually occurring, developing, and ending
Including changes and manifestations in the subclinical stage,
4. Marketing monitoring of new drugs
It can be considered a cohort study with a larger sample size and longer qualified observation time than the phase III clinical trial.
4. Research Type
(1) Research type
(1) Prospective cohort study
(1) Definition
Also known as immediate cohort study,
The grouping of study subjects is based on the current exposure status of the study subjects.
At this time, the outcome of the research has not yet appeared, and it will take a period of prospective observation to obtain it.
(2) Advantages
① Directly obtain first-hand information on exposure and outcomes. The data has less bias and the results are credible.
②Chronological order enhances the credibility of etiology inference
③The incidence rate can be obtained
(3) Disadvantages
①The sample of people to be observed is very large
②The observation time is long and the cost is high.
(2) Historical cohort study
(1) Definition
Also known as non-immediate cohort study or retrospective cohort study
The study subjects were grouped according to the time at the beginning of the study,
Made based on historical information available to the researcher regarding the subject’s exposure at a certain point in the past;
The study outcomes were already present at the start of the study and did not require prospective observation.
(2) Advantages
It has the characteristics of saving time, effort and quick results.
(3) Disadvantages
The data is not under the control of the researcher when it is accumulated, and the content may not meet the requirements.
(3) Bidirectional cohort study
Also called a mixed cohort study,
That is, based on historical cohort studies, continue prospective observation for a period of time,
It is a design model that combines prospective cohort studies with historical cohort studies.
Qian has the above two types of advantages and makes up for their respective shortcomings.
(2) Selection principles for different research types
(1) Prospective cohort study
① There should be clear test hypotheses, and the exposure factors of the test must be accurately identified
②The morbidity or mortality rate of the disease under study should be relatively high, such as not less than 5%.
③ The measurement of exposure factors should be clearly defined, and the exposure data of the observed population should be obtained with certainty.
④Clearly specify the outcome variables.
⑤There are enough people to observe.
⑥Most of the observation population should be followed up to the end of the study, and complete and reliable data should be obtained.
⑦ Have sufficient human, material and financial resources.
(2) Historical cohort study
①~⑤, ⑥ It requires sufficiently complete and reliable historical records or archival data on the exposure and outcome of the research subjects during a certain period in the past.
(3) Bidirectional cohort study
Historical cohort study Prospective study, that is, historical The time from exposure to present observation cannot meet the research requirements
If the ending event does not occur or does not occur completely.
Section 2 Research Design and Implementation
1. Determine research factors
① Usually determined on the basis of descriptive studies and case-control studies.
② Exposure factors should generally be quantified. In addition to exposure levels, exposure time, exposure methods, suspected confounding factors, and demographic characteristics of the research subjects should also be considered.
③Exposure measurement should use sensitive, precise, simple and reliable methods.
2. Determine the outcome of the study
1. Definition of outcome variables
Also called outcome variable, referred to as outcome,
It refers to the expected result events that will occur during follow-up observation, that is, the event that the researcher hopes to follow up and observe.
The outcome is the natural end point of observation in a cohort study.
2. Determine the research outcome
(1) The determination of research outcomes should be comprehensive, specific and objective.
a. The outcome is not limited to morbidity and death, but also changes in health status and quality of life;
b. It can be either the ultimate outcome (such as morbidity or death) or an intermediate outcome (such as changes in molecules or serum);
c. Outcome variables can be either qualitative or quantitative, such as serum antibody titers, urine glucose, and blood lipids;
d. The outcome variable can be either negative (such as disease occurrence) or positive (such as disease recovery).
(2) Clear and unified standards should be given for the measurement of outcome variables and strictly adhered to during the entire research process.
3. Determine the research site and research population
1. Determine the research site
(1) A sufficient number of qualified research subjects are required
(2) It also requires local leaders to pay attention and the masses to understand and support,
(3) The local culture and education level is high, the medical and health conditions are good, and the transportation is convenient.
(4) Representativeness of the scene.
2. Requirements of the research population
(1) Select representative people from the target population.
(2) Not suffering from the disease under study.
(3) Divide into exposed groups and non-exposed groups
1. Selection of exposed groups
1. Professional group
To study the relationship between a suspected occupational exposure and disease or health,
Relevant occupational groups must be selected as the exposed groups.
Historical records of exposure and disease among occupational groups are often more comprehensive, true, and reliable.
Occupational groups were selected as exposed groups in historical cohort studies.
2. Specially exposed groups
is the only option for studying some rare and special exposures.
Prospective cohort studies are generally not easy or allowed to be conducted, and historical cohort studies are often used.
Such as victims of atomic bombings and people who have received radiation therapy to study the relationship between rays and leukemia.
3. General population
(1) Definition
That is, the entire population within a certain area,
Select the exposure group of people who are exposed to the factor to be studied.
(2) Requirements
(1) It does not intend to observe the incidence of disease in special groups, but focuses on the general population and future prevention and treatment in the general population, so that the research results have universal significance.
(2) The factors and diseases studied are common among the general population, especially when studying the living habits or environmental factors of the general population. Such as the American Femingham Study Cardiovascular Cohort Study.
4. Organized groups of people
(1) Definition
can be regarded as a special form of the general population,
Such as hospital association members, trade union members, social groups, etc.
(2) Purpose
Utilizing their organizational system facilitates effective collection of follow-up data and increases comparability.
For example, Doll and Hill studied the relationship between smoking and lung cancer.
2. Selection of control groups
1. Principles (requirements)
Try to ensure comparability with the exposed group as much as possible, that is, the control group is not exposed to the factor under study,
Various other influencing factors or population characteristics (age, gender, ethnicity, occupation, education level, etc.) should be as similar as possible to the exposure group.
2. Type
1. Internal control
definition
That is, select a group of research populations,
The subjects exposed to the factor under study are regarded as the exposed group, and the remaining non-exposed subjects are regarded as the control group.
That is, the selected group of research subjects includes both the exposure group and the control group.
For example, this can be done for fluorine in drinking water, nitrates in vegetables, and human blood pressure.
advantage
It is easier to choose a comparison.
It can accurately understand the incidence of the research subjects as a whole, and the comparability is good.
2. External control
definition
When selecting occupational groups or special exposed groups as the exposed group, it is often necessary to find controls outside the group.
advantage
The influence of the exposed group, that is, the "contamination" of the exposed group, can be avoided during follow-up observations.
shortcoming
Effortless and time-consuming
3. Total population comparison
definition
It can be considered a type of external control, which uses readily available morbidity or mortality statistics in the entire region.
That is, the entire population is used as a control, rather than setting up a control group in parallel with the exposed group for investigation.
Generally used when the proportion of exposed persons in the total population is very small, the standardized ratio is used.
When using special exposed groups or occupational groups as exposure groups, the total population is often used as the control.
advantage
Comparative information is easily available
shortcoming
The data is rough and comparable.
Controls may include exposed populations.
4. Multiple controls
definition
Or called multiple comparisons,
That is, using two or more of the above methods at the same time to select multiple groups of people for comparison.
To reduce the bias caused by using only one control.
advantage
Reduce bias and enhance the reliability of results.
shortcoming
A lot of work.
4. Determine sample size
1. Issues to consider when calculating sample size
(1) Ratio of exposed group to control group
Generally, the sample size of the control group should not be smaller than that of the exposure group, usually the same amount.
(2) Loss to follow-up rate
It is necessary to estimate the loss to follow-up rate in advance and appropriately expand the sample size.
Assuming that the loss to follow-up rate is 10%, 10% can be added to the calculated sample size as the actual sample size.
2. Factors affecting sample size
1. The incidence of the disease studied in the general population (control population) (p₀))
2. The difference in incidence between the exposed group and the control group (d)
The larger the d value, the smaller the sample size required.
If the incidence rate p₁ of the exposed group cannot be obtained, an estimate of its relative risk (RR) can be obtained.
p₁ can be obtained from P1=RR×p₀.
3. Required significance level
That is, the Type I error (false positive error) α value when testing a hypothesis.
The smaller the probability of false positive errors, the larger the sample size required.
Usually α=0.05 or 0.01 is chosen. When 0.01 is chosen, the sample size required is larger than when 0.05 is chosen.
4. Effectiveness
Also called certainty (1-β),
β is the probability of Type II error (false negative error) when testing the hypothesis.
And 1-β is the ability to avoid false negatives when testing a hypothesis, that is, efficacy.
If the required power (1-β) is larger, that is, the β value is smaller, the larger the sample size required.
Usually β is 0.10, sometimes 0.20 is used.
3. Calculation of sample size (exposed group = control group)
p₁ and p₀ represent the expected incidence rates of the exposed group and the control group respectively,
`p is the average of the two incidence rates, q=1-p
5. Data collection and follow-up
1. Collection of baseline data
(1) Check the health records or files of hospitals, factories, units and individuals.
(2) Interview research subjects or other people who can provide information.
(3) Conduct physical examination and laboratory examination on the research subjects.
(4) Environmental investigation and testing.
2. Follow-up
(1) Follow-up objects
① The selected research subjects should be followed until the observation termination period.
② Follow-up interviews are required for those who are lost to follow-up. If the follow-up cannot be traced, try to understand the reasons and analyze the reasons for the loss to follow-up.
(2) Follow-up methods
① Direct face-to-face interviews, telephone interviews, environmental and disease monitoring, hospital medical records, etc.
② The same follow-up method should be adopted for the exposed group and the control group, and should remain unchanged throughout the follow-up process.
(3) Follow-up content
Generally, the content is consistent with the baseline data, but the focus of follow-up collection is on outcome variables.
(4) Observation end point
Refers to the research object showing the expected results and reaching the observation endpoint.
This study subject will no longer be followed up.
The emphasis is on the expected results
If the expected outcome of an observation is coronary heart disease but a subject develops hypertension, the observation endpoint should not be considered to have been reached.
(5) Observation end time
①Definition
Refers to the deadline for the entire research work,
That is the time when results are expected to be available.
②Two factors need to be considered
(1) The termination time directly determines the length of the observation period, which is based on the incubation period.
(2) Number of observer years required.
(6) Follow-up interval
If the observation time is short, data can be collected once at the end of the observation.
If it is longer, multiple follow-up visits are needed. Generally, the follow-up interval for chronic diseases can be set at 1 to 2 years.
(7) Followers
① Depending on the content of the follow-up, the investigator can be an ordinary interviewer, a laboratory technician, a clinician, etc., but the follow-up investigator must be carefully trained.
② The researcher can participate in the follow-up, but it is best not to participate in person, because the researcher's follow-up is prone to subjective bias, and uninformed outsiders can obtain more objective information.
6. Quality control
1. Selection of investigators
① Rigorous work style and scientific attitude - honest and reliable.
② Generally, applicants should have a high school or university degree and professional knowledge.
③The age, gender, race, language, socioeconomic status, etc. of the investigator should preferably match and have affinity with the research object.
2. Investigator training
①The investigator’s work style, scientific attitude, investigation skills and techniques, clinical and laboratory work experience, etc. will directly affect the investigation results.
②Authenticity and reliability. 1. Training before data collection, mastering unified methods and techniques, and conducting assessments.
3. Develop an investigator manual
There are many investigators involved, and it is necessary to list all operating procedures, precautions, and complete explanations of the questionnaire over a long period of time.
4. Supervision
① Have another investigator conduct a repeated sampling survey;
② Carry out numerical inspection or logical error detection in a timely manner manually or by computer;
③ Observe the work of each investigator regularly;
④ Compare the distribution of variables collected by different investigators;
⑤Analyze the time trend of variables;
⑥ Use audio recording during interviews, or use other multimedia technologies, etc.
Section 3: Collection and analysis of data
1. Data organizing mode
2. Calculation of person hours
1. Calculate person-years per person (exact method).
2. Use the approximation method to calculate person-years.
3. Use the life table method to calculate person-years.
3. Calculation of rate
(1) Commonly used indicators
1. Cumulative incidence (CI)
① Scope of application
① Mainly chronic diseases, the research population is large and stable, and the research data is relatively complete
②Reflects the risk of disease within a specific period of time.
③The change range of the value is [0~1]
④When reporting, the length of accumulation time must be stated.
②Formula
Cumulative incidence (CI) = the number of cases during the observation period/the number of cases at the beginning of the observation.
2. Incidence density (ID)
Scope of application
①The research population is unstable and the observation time is long
②When each object is observed at different times.
③The calculated rate has instantaneous frequency properties
④ reflects the speed.
⑤The commonly used unit of person-time is person-year
⑥The value range is from [0~¥)
⑦ When reporting, it must be reported to the unit at the same time.
formula
Incidence density (ID) = number of cases during the observation period/total number of observation hours.
3. Standardized ratio death ratio (SMR)
① Scope of application
① When the number of research subjects is small and the incidence of outcome events is relatively low,
②Value change range [0~¥)
②Formula
SMR = observed number of deaths in the study population (o) / expected number of deaths calculated as standard population mortality rate (E)
③Meaning
SMR>1 means that the actual number of deaths is greater than the expected number of deaths.
SMR<1 means the actual number of deaths is less than the expected number of deaths.
④Essence
Taking the morbidity (mortality) rate of the entire population as the standard,
Calculate the theoretical number of incidences (deaths) in the observation population, that is, the expected number of incidences (deaths),
Then find the ratio of the actual number of cases (deaths) to the expected number of cases (deaths) in the observed population to get the standardized incidence (death) ratio
The most commonly used indicator is the standardized mortality ratio (SMR)
⑤Epidemiological significance
How many times is the risk of dying from a disease in the population being studied compared to the standard population?
4. Standardized Proportional Mortality Ratio (SPMR)
① Scope of application
① Unable to obtain population data over the years
②Only the number of deaths, cause, date and age
③Value change range [0~¥)
②Formula
SPMR=actual deaths/expected deaths,
The expected number of deaths = the number of deaths from a certain cause in the entire population/the number of all deaths x the actual number of deaths per unit.
(2) Significance test
1. U test
When the study sample size is large and both p and 1-p are not too small, for example, when np and n(1-p) are both greater than 5, the frequency distribution of the sample rate approximates a normal distribution. At this time, the principle of normal distribution can be applied To test whether the difference in rates is significant, use the U test method to test the difference in rates between the exposed group and the control group.
2. Other inspection methods
If the rate is relatively low and the sample is small, the direct probability method, binomial distribution test or Poisson distribution test can be used instead.
When the rate is slightly larger and the sample is slightly larger, the significance test of the rate can be performed using the chi-square test of the four-grid table data.
The test of SMR or SPMR is actually a test of the deviation of the result value from 1. The test method can be x² test or scoring test.
4. Estimation of effects
1. Relative risk (RR)
(1) Risk ratio and rate ratio
①Risk ratio (OR)
Risk of the exposed group (measured as cumulative incidence)
Risk ratio compared to the control group
②Rate Ratio (RR)
Ratio of incidence density between exposed group and control group
(2) Epidemiological significance
① Both risk ratio and rate ratio are the most useful indicators that reflect the strength of the association between exposure and morbidity (death). However, the values of risk ratio and rate ratio in the same study are different because the cumulative incidence rate and incidence density are not equal.
②RR indicates how many times the risk of illness or death in the exposed group is that of the control group.
③The larger the RR value, the greater the effect of exposure and the greater the strength of the association between exposure and outcome.
④It has etiological significance.
(3) Formula
Formula①
RR=Ie/I0,
What is calculated is a point estimate, which is a sample value.
Formula②
To infer the overall parameter level, its confidence interval needs to be calculated, usually using 95% CI
Woolf method
95% confidence interval of InRR=InRR±1.96√Var(InRR)
Its inverse natural logarithm is the 95% confidence interval of RR.
(4) Relative risk and correlation strength
2. Attributable risk (AR)
(1) Concept
Also called specific risk, risk difference (RD), excess risk
is the absolute value of the difference between the incidence rate in the exposed group and the incidence rate in the control group
Indicates the extent to which a hazard is specifically attributable to an exposure factor.
(3) Epidemiological significance
① Refers to the increased number of disease occurrences in the exposed population compared with the non-exposed population. If the exposure factors are eliminated, this number of disease occurrences can be reduced.
②It has disease prevention and public health significance
For example, from the perspective of RR, smoking has a greater effect on lung cancer, and the causal link is stronger;
However, from the perspective of AR, smoking has a greater effect on cardiovascular disease, and the social effect of prevention will be greater.
(3) Formula
(4) Relationship with RR
RR and AR are calculated by comparing the rates in the exposed group with those in the control group,
Describe the biological effect of the exposure, i.e., how causative the exposure is
3. Attributable risk percentage (AR%)
(1) Concept
Also known as etiology score (EF)
Refers to the morbidity or mortality in the exposed population, the proportion attributable to the exposure as a percentage of the total morbidity or death
(2) Epidemiological significance
The proportion of the hazard that is specifically attributable to the exposure
(3) Formula
4. Population attributable risk (PAR)
(1) Concept
The portion of total population incidence that is attributable to exposure.
(2) Epidemiological significance
The increased incidence of disease among the exposed population compared with the general population
(3) Formula
PAR=It-I0
(4) Relationship with PAR%
PAR and PAR% are calculated by comparing the rates of the entire population and the control group.
and the extent to which morbidity or mortality in this population might be reduced by eliminating this factor.
They are related both to RR and AR and to the proportion of exposed persons in the population.
5. Population attributable risk percentage (PAR%)
(1) Concept
Also called population etiology score (PEF), the percentage of all morbidities (or deaths) in the total population
(2) Epidemiological significance
Describe the proportion of the population that is attributable to exposure
(3) Formula
6. Analysis of dose-effect relationship
(1) Meaning
If there is a dose-response relationship for an exposure,
That is, the greater the dose of exposure, the greater the effect.
The more likely that exposure is the cause.
(2) Specific analysis methods
First list the incidence rates at different exposure levels,
Then the lowest exposure level group was used as the control,
Calculate the relative risk and attributable risk for each other exposure level group.
When necessary, a trend test should be conducted on changes in risk (or rate).
Section 4 Common biases and their control
1. Selection bias
(1) Definition
Due to improper selection of research subjects,
If there is a lack of representativeness (the exposed group cannot represent the exposed population,
The control group cannot represent the non-exposed population) and the exposed group is not comparable to the control group, etc.
The resulting research results deviate from the real situation.
(2) Common situations
① Some of the subjects initially selected to participate in the study refuse to participate;
②When conducting historical cohort research, some people’s files were lost or incompletely recorded;
③The research subjects are composed of volunteers, who are often either relatively healthy or have some special tendencies or habits.
④ Early-stage patients, who are not discovered at the beginning of the study, can cause selection bias in research subjects. Also called misclassification bias.
⑤Loss to follow-up bias
(1) Definition
Refers to the fact that research subjects are lost to follow-up and the relationship between exposure and outcome may be distorted due to loss of follow-up.
This distortion is called attrition bias.
(2) Situation
(1) If the number of people lost to follow-up in the exposure group and the control group is equal, and the incidence rates of those who were lost to follow-up and those who were not lost to follow-up are the same in each group, it can be considered that the loss of follow-up has no major impact on the research results.
(2) If the incidence rate of those who are lost to follow-up in the exposed group is higher than that of those who are not lost to follow-up, the incidence rate obtained from continuing observers will be lower than the actual incidence rate of all study subjects, causing the relationship between exposure and outcome to be underestimated;
(3) If the incidence rate of lost to follow-up in the exposed group is lower than that of those who were not lost to follow-up, the bias effect will be opposite.
(3) Control
(1) Check whether the lost person has died and the cause of death. If the mortality rates for the studied disease are the same for those who are lost to follow-up and those who are not lost to follow-up, it can be speculated that the morbidity rates between them may also be similar.
(2) Compare the data on certain characteristics obtained during the baseline survey of those who were lost to follow-up and those who were not lost to follow-up. The more similar the baseline characteristics of the two are, the smaller the possibility of different disease incidence rates.
(3) The best way to control loss to follow-up bias is to reduce loss to follow-up as much as possible.
(3) Control
(1) Correct sampling method and adhere to the principle of randomization as much as possible.
(2) Select objects strictly according to the prescribed standards.
(3) Try to improve the response rate and compliance of research subjects.
(4) When conducting historical cohort studies, the target population’s archives are required to be complete. Lost or incomplete records must be within certain limits, otherwise they should be selected with caution.
(5) If volunteers join or selected research subjects refuse to participate, their basic information should be understood and compared with the normal participants. If there is no difference in basic characteristics, the selection bias can be considered reduced, otherwise it cannot be ignored .
2. Information bias
(1) Definition
Systematic errors or biases in obtaining exposure, outcome, or other information,
Also known as misclassification bias, such as judging those with disease as not having the disease, judging those with exposure as not exposed, etc.
(2) Type
(1) Non-specific misclassification bias
If misclassification bias occurs to the same extent in all observed groups,
The results will only affect the accuracy of diagnosis but not the relative relationship between two or more groups.
Their relative risk will generally be closer to 1 than it actually is.
(2) Specific misclassification bias
If misclassification bias occurs in one group but not in the other group, or if the degree of misclassification is different between the two groups,
The result may be higher or lower than the actual relative risk.
(3) Control
①Choose accurate and stable measurement methods, calibrate instruments, and strict experimental operating procedures.
② Treat every research subject equally, improve clinical diagnosis technology, clarify various standards, and strictly implement regulations, etc.
③ Earnestly train investigators, improve inquiry and investigation skills, unify standards, and provide education on responsibility and integrity.
3. Confounding bias
(1) Definition
Refers to the fact that the relationship between research factors and results is distorted due to the effect of a third variable.
This third variable is called a confounding variable or confounding factor.
The confounding factor must be an influencing factor of the disease and is related to the factor being studied.
It was unevenly distributed between the exposed and control groups.
Gender and age are the most common confounding factors.
(2) Control
(1) In the research and design stage
① Certain restrictions can be placed on the research subjects (such as a certain age group, a certain gender) in order to obtain homogeneous research samples
② Matching method can be used in comparison selection to ensure the comparability of the two groups on some important variables.
(2) In the data analysis stage
First, the possibility of confounding should be judged based on the criteria for confounding.
Use stratified analysis, standardization or multi-factor analysis methods.
Section 5 Advantages, Disadvantages and Other Practice Types
1. Advantages
1. The exposure data of the research subjects were collected before the outcome occurred, and were personally observed by the researchers in accordance with the design. The data are complete and reliable, and the information bias is relatively small.
2. The morbidity or mortality of the exposed group and the control group can be directly obtained, indicators reflecting the intensity of disease risk such as RR and AR can be directly calculated, and the etiological effects of exposure can be fully and directly analyzed.
3. The cause of disease occurs first, and the disease occurs later. The time sequence of causal phenomena is reasonable. In addition, there is less bias. Various indicators for measuring disease risk intensity can be directly calculated. Its ability to test etiological hypotheses is strong and can generally be used. Confirm the causal link.
4. Helps understand the natural history of human diseases
5. Sometimes it is possible to obtain the outcome data of multiple unexpected diseases, and the relationship between one cause and multiple diseases can be analyzed.
2. Limitations
1. It is not suitable for research on the causes of diseases with very low incidence.
2. The follow-up time is long, and it is difficult for subjects to maintain compliance, which is prone to loss-to-follow-up bias.
3. During the follow-up process, the outcome is easily affected and the analysis is complicated.
4. Research consumes a lot of manpower, material resources, financial resources and time, and its organization and logistics work are also quite arduous.
3. Other practice types
1. Cohort study based on a comprehensive cohort
(1)Definition
At the beginning of the study, subjects are not selected based on a certain exposure factor, but all people within a certain range who meet certain conditions are selected to form a comprehensive cohort (without grouping), and the exposure status of the cohort population to multiple suspicious factors is collected and their health is checked. situation;
Prospective observation, including changes in exposure to various suspected causes and the occurrence of various health outcomes;
After the study ends, the cohort members are divided into different exposure groups and control groups based on their exposure to a certain suspicious factor at the beginning of the study, and then the relationship between the exposure and possible related outcomes is analyzed according to the cohort study method.
(2)Features
(1) At the beginning of the study, there were no specific research factors and no grouping, but a large amount of information on suspicious factors was collected;
(2) In the final analysis, the researcher selects one research factor at a time according to his own interests, divides the cohort into the exposure group and the control group according to the presence or absence of the research factor in the baseline survey, and compares the outcome incidence rates of each group.
(3) It is essentially a cohort study. In the later stage of the study, the analysis report for each research factor is divided into the exposure group and the control group according to the presence or absence of the factor at the beginning of the study. It is prospective and based on the cause. For those who seek results, exposure also happens naturally.
(4) It can be understood as a complex of multiple cohort studies, which is very suitable for comprehensive etiological research on a certain type of disease, especially when the cause is not very clear and various diseases may have some common causes or complex relationships. Be applicable;
(5) This design is very suitable for studying the relationship between multiple causes and diseases, can reduce the cost of a single study, improve research efficiency, and effectively overcome some limitations of traditional cohort studies. For example, the Framingham Cardiovascular Disease Study in the United States and the Prospective Chronic Disease Study in China are typical studies of this type.
2. Cohort research based on big data
(1)Definition
This kind of research is essentially a historical cohort study based on big data.
Convenient and fast, it can overcome the limitations of manpower, material resources, financial resources and time.
(2)Basic ideas
① First raise the research question (such as the relationship between obesity and hypertension);
② Find the exposure group and control group from big data (for example, those with normal blood pressure and obesity 10 years ago are the exposure group, and those with normal blood pressure and weight during the same period are the control group);
③ Check the current outcome (blood pressure) information of the two groups;
④Analyze the relationship between exposure and outcome
Chapter 5 Case-Control Study
Section 1 Overview
1. Basic principles
(1) Take a group of patients who are currently diagnosed with a specific disease as the case group,
(2) Use a group of comparable individuals who do not suffer from the disease as a control group
(3) Collect the research subjects’ past exposure history to various possible risk factors through questioning, laboratory examination or medical history review
(4) Measure and use statistical tests to compare whether the difference in the exposure ratio of each factor (ie, exposure rate) between the case group and the control group is statistically significant.
(5) Evaluate the impact of various biases on research results, and use etiological inference technology to determine whether one or some exposure factors are risk factors for the disease, so as to achieve the purpose of exploring and testing etiological hypotheses.
(6) It is an analytical research method from effect to cause. It is a method to trace the presumed etiological factors after the disease occurs, and can test the etiological hypothesis to a certain extent. Suitable for rare diseases
2. Basic characteristics
1. Observational research
The exposure of the research subjects is natural rather than artificially controlled, and it is an observational study.
2. The research objects are divided into case group and control group.
The research subjects are divided into case group and control group according to whether they have the outcome of the study.
3. From “effect” to “cause”
A case-control study is a method of tracing possible causes of an outcome (disease or event) after it has occurred.
4. The strength of the argument for causal connection is relatively weak.
Case-control studies cannot observe the development process from cause to effect.
The demonstration of a causal link is not as strong as in a cohort study.
3. Research Type
(1) Unmatched case-control study
(1) Definition
Also called a grouped case-control study,
That is, among the case and control populations specified in the design,
A certain number of research subjects were selected for comparison between groups.
There are no other restrictions or regulations on the selection of controls.
Generally, the number of controls should be equal to or greater than the number of cases.
However, the number of cases and controls does not need to be strictly proportional.
(2) Advantages
This method is easier to implement than the matching method.
(3) Disadvantages
However, the ability of the method itself to control confounding factors is weak.
This should be compensated for in the statistical analysis.
(2) Matched case-control study
(1) Definition
That is, the selected controls are required to be consistent with the cases in certain factors or characteristics.
The goal is to balance matching factors between cases and controls,
This eliminates the interference of these factors on the results.
(2) Advantages
This method can increase the statistical testing capabilities during analysis and improve research efficiency.
(3) Disadvantages
However, it also increases the difficulty of selecting controls, and data collection and statistical analysis are more troublesome.
(3) Several main research methods derived from
③Nested case-control study
(1) Definition
It is a case-control study based on a cohort study.
It is a design form that combines cohort study and case-control study.
(2)Basic design methods
On the basis of cohort studies, during a certain observation period,
When the number of new cases of the disease under study accumulates to a certain number,
Then all cases can be concentrated to form a "case group";
At the time of onset of each case, among non-affected persons from the same cohort,
Controls are randomly selected according to certain matching conditions to form a "control group";
Then, baseline data of cases and controls are extracted, and the collected biological specimens are tested.
Statistical analysis of data was performed according to the method of matched case-control study.
"Nest type" means that cases and controls are all from the same specific cohort, just like birds from one nest.
④Case-cohort study
Case group: all cases
Control group: randomly selected from all cohort members included at baseline
(1) Definition
It is also a design form that combines cohort study and case-control study.
(2)Basic design methods
is when the cohort study begins,
Randomly select a representative sample according to a certain proportion of the cohort as the control group;
At the end of the observation, all cases of the studied disease that appeared in the cohort were regarded as the case group.
Compare with the randomly selected control group above.
(3) Differences from nested case-control study
①Inclusion criteria for control research subjects
nested case-control study
Controls were randomly selected from all cohort members enrolled at baseline;
case-cohort study
Controls were individually matched to cases.
②The role of the control group
nested case-control study
Can serve as a common control group for multiple disease outcomes;
case-cohort study
Studies on different disease outcomes have different control groups.
⑤Case-case study
(1) Definition
Also called a simple case study,
The two groups compared are both cases, a direct comparison of two subgroups of the same disease.
(2) Application
② Suitable for studying the differences in causes between the two groups
Identical or similar risk factors will be masked or underestimated.
②It can also be used to study the interaction between genetic and environmental factors.
⑥Case-crossover study
transient effect
(1) Definition
One or more time periods before the onset of each case are used as the "control" time period,
Exposure at the time of disease onset is compared with exposure during a "control" time period for the same individual.
Only a few situations are suitable for case-crossover studies.
(2) Application
① Suitable for studying the transient effects of exposure, that is, the impact of exposure on the occurrence of acute events.
②Case-crossover studies are self-control, and the comparability of individuals at different time points is better.
(3) Requirements
①The individual’s exposure must be changing throughout time, not constant;
② Both the induction period and the effect period of exposure must be short, otherwise the recent onset of disease may be caused by exposure in the distant past.
4. Purpose
(1) For research on the causes or risk factors of diseases
①Especially suitable for studying certain diseases with long incubation period and rare diseases.
② One or several etiological hypotheses can also be tested based on preliminary formation of etiological hypotheses from descriptive studies or exploratory case-control studies.
(2) Research on influencing factors of health-related events
The purpose is to provide a basis for making corresponding health decisions.
For example, research on factors related to accidental injuries, quality of life of the elderly, longevity, obesity and overweight, etc.
(3) Research on disease prognostic factors
Based on the different outcomes of the same disease, such as death and recovery or the presence or absence of complications, we divide them into "case groups" and "control groups"
Conduct a retrospective investigation to trace the relevant factors that led to a certain outcome
Various treatments such as those received
and other factors such as disease stage, condition and age, socioeconomic level, etc.
Through comparative analysis, the main factors affecting disease prognosis are discovered to guide clinical practice.
(4) Research on factors influencing clinical efficacy
Section 2 Research Design and Implementation
1. Determine the research purpose
2. Clarify the type of research
Unmatched or frequency-matched case-control studies
individual matched case-control study
3. Determine the research object
(1) Selection of cases
1. Definition of case
(1) Cases should meet unified and clear disease diagnostic criteria.
(2) Try to use internationally accepted or domestically unified diagnostic standards, and use gold standards as much as possible, and apply pathological diagnosis as much as possible when necessary.
(3) For diseases for which there are no clear diagnostic criteria, the criteria can be customized according to the needs of research, but attention should be paid to balancing the false positive rate and false negative rate of the diagnostic criteria to make the diagnostic criteria moderately lenient and stringent.
(4) For a special research purpose, researchers can stipulate or restrict certain characteristics of research subjects, such as elderly cases, female cases, severe cases, cases in a certain city, etc.
2. Type of case
(1) New cases
①Advantages
①Includes patients with different conditions and prognosis, and is well representative.
② The patient was investigated shortly after diagnosis, and the recall information about the exposure is relatively accurate and reliable, not affected by various prognostic factors, and the medical records are easy to obtain.
②Disadvantages
It is difficult to obtain the expected number of cases within a certain range or within a certain period of time.
This is especially true for rare diseases
(2) Current cases
①Advantages
Obtain sufficient number of cases in a smaller range or within a shorter period of time.
②Disadvantages
Current cases have been ill for a longer period of time, and their recall of exposure history is less reliable than that of new cases, making it difficult to distinguish the temporal sequence of exposure and disease occurrence.
(3) Death cases
①Advantages
It can be used for research on diseases that mainly rely on relatives and friends to provide information, such as childhood leukemia.
However, possible bias must be fully taken into account when collating and analyzing data.
②Disadvantages
The exposure information of deceased cases is mainly provided by their family members, which is less accurate.
3. Source of cases
(1) Select cases from hospitals
①Meaning
i.e. from one or several hospitals
Even among the inpatient or outpatient confirmed cases in all hospitals in a certain geographical area,
Select consecutive cases within a period that meet the requirements.
②Advantages and disadvantages
①Advantages
Cases from hospitals can save costs and provide good cooperation.
The information is easy to obtain, and the information is relatively complete and accurate.
②Disadvantages
However, the patients received by different hospitals have different characteristics.
If cases are only selected from one hospital, the representativeness will be poor. In order to reduce bias,
Cases should be selected from hospitals of different levels and types as much as possible.
(2) Select cases from the community population
①Meaning
That is, taking all the cases of a certain disease in a certain area during a certain period of time
or a random sample of them as research subjects.
Qualified cases can be selected using disease surveillance data or resident health records or obtained from current situation survey data.
Patients with a certain disease occurring in a population cohort can also be selected.
②Advantages and disadvantages
①Advantages
The advantage is that the cases are well represented and the results can be extrapolated to this population with a high degree of credibility.
②Disadvantages
However, the investigation work is more difficult and consumes a lot of manpower and material resources.
(2) Selection of comparisons
1. Principles for selecting comparisons
① Must be a person who is confirmed not to suffer from the disease under study based on the same diagnostic criteria as the case.
② The control should be representative of the source population where the cases occurred, that is, the exposure distribution of the control should be consistent with the exposure distribution of the case source population.
2. Source of comparison
(1) Patients with other diseases diagnosed in the same or multiple medical institutions
①Advantages
Easy to select, relatively cooperative, and can use archival data, widely used
②Disadvantages
The exposure distribution of source controls often differs from the source population of cases.
For example, individuals with study exposures are more likely to come to the hospital sick and become controls, resulting in higher exposure levels for hospital controls than for the case source population.
③The following principles should be followed when selecting hospitals for comparison
①Patients admitted for diseases known to be related to the exposure factors under study cannot be used as controls.
This exclusion criterion was based on the disease present at the visit rather than the history of the disease.
For example, studying the link between smoking and leukemia,
When using hospital controls, patients admitted to the hospital for cardiovascular disease, respiratory disease and other smoking-related diseases cannot be used as controls;
However, those with a history of cardiovascular disease or respiratory disease who were admitted to the hospital due to trauma are still eligible controls.
②The control group should be composed of patients with as many types of diseases as possible
Purpose
To avoid over-representing a certain type of patient,
This disease has common risk factors with the disease under study, thus affecting the authenticity of the research results.
(2) Non-disease cases or healthy people in the community or group population
①Advantages
It is not prone to the selection bias problem that the above-mentioned hospital comparison may face,
②Disadvantages
However, implementation is difficult and expensive, and the selected comparison is difficult to match.
(3) Neighbors of the case or healthy people in the same residential area or non-cases of the disease
Helps control for the confounding effects of socioeconomic status for a matched design.
(4) The case’s spouse, compatriots, relatives, classmates or colleagues, etc.
Helps exclude the influence of certain environmental or genetic factors on the results and is used in matching designs.
3. Choose a comparison method
(1) Non-matching
In a non-matching design, there are no restrictions or requirements when selecting a control.
(2) Match
①Definition
Matching, or matching, requires the control to be consistent with the case in certain characteristics or factors.
Ensure that controls and cases are comparable so that the interference of matching factors can be eliminated when comparing the two groups.
②Purpose
Mainly to improve research efficiency,
The second is to control the interference of confounding factors.
③Classification
frequency matching
Refers to the proportion of people in the control group who have certain factors or characteristics that are consistent or similar to the case group.
individual matching
Matching was performed on an individual basis between controls and cases.
One case can be matched with one control. This situation is called matching.
One case can also be matched with multiple controls, such as 1:2, 1:3...1:r matching.
④ Matching variables (when matching is not appropriate)
① It must be a known confounding factor, or there is good reason to suspect that it is a confounding factor, otherwise it should not be matched.
②Intermediate variables in the disease causal chain should not match
For example, smoking affects blood lipids, and blood lipids are causally related to cardiovascular disease.
In case-control studies examining the relationship between smoking and cardiovascular disease,
The association between smoking and disease may disappear when cases and controls are matched by lipid levels.
③ Factors that are only related to the suspected cause but not the disease should not be matched
For example, contraceptive use is associated with religious beliefs;
However, religious beliefs have no relationship with the diseases studied;
Religious affiliation should not be used as a matching factor.
⑤Notes
Generally, the number of matching controls is ≤ 4
As the r value increases, the efficiency gradually increases,
However, the increase is getting smaller and smaller, while the workload increases significantly, especially when it exceeds 1:4
The scope of matching should be based on feasibility
Generally speaking, when the total sample size is fixed,
If the sources of cases and controls are sufficient,
Statistical efficiency is highest when the ratio of cases to controls is 1:1.
Matching variables must be known confounders
Overmatching will reduce research efficiency
⑥Problems that may occur when matching
①Increased the difficulty of selecting comparisons
②Limited sample size
③The interaction between matching factors and other factors will not be analyzed
④Overmatching
Match factors that do not have a confounding effect as matching variables,
Try to make the control group and the case group consistent in many aspects,
As a result, the factors studied also tended to be consistent,
The result is reduced research efficiency.
⑤ Time-consuming and labor-intensive, and data collection is complicated
⑥Research variables that researchers are interested in cannot be used as matching factors
4. Determine sample size
(1) Factors affecting sample size
①The exposure rate (P0) of the study factor in the control group or population.
②The strength of the association between the research factors and the disease, that is, the odds ratio (OR).
③The significance level of the statistical test hypothesis that you hope to achieve, that is, the Type I error (false positive) probability (a), generally takes a=0.05.
④ The desired statistical test hypothesis performance is also called power (1-p). p is the probability of type II error (that is, false negative). Generally, p=0.1.
(2) Unmatched case-control sample size estimation
(3) Estimation of sample size for 1:1 paired case-control study
Find the number of pairs (m) in which the exposure status of cases and controls is inconsistent:
Then find the total number of pairs to be investigated (M):
(4) Sample size estimation of 1:r matched case-control study
The number of controls is rXn.
The number of cases (n) required for a case-control study when the number of cases and controls is not equal
5. Determine research factors
6. Data collection methods
Section 3: Collection and analysis of data
1. Organizing of data
2. Analysis of data
(1) Descriptive statistics
1. General feature description
That is, the distribution frequency of the general characteristics of the research subjects, such as age, gender, occupation, place of residence, etc., and the clinical classification of the cases is described.
If it is a random sample of cases from a certain population, it needs to be compared with the characteristics of all cases in the corresponding time and region.
2. Balance test
That is to compare whether certain basic characteristics of the case group and the control group are similar or identical.
The purpose is to test the comparability of the two groups. If the difference between two groups in some basic characteristics is statistically significant,
Then its possible impact on the research results should be considered and controlled during inferential analysis.
(2) Inferential analysis
1. Analysis of non-matching (grouped) design data
1. Analysis of association between exposure and disease→X² test
1. Definition
That is, by comparing the difference in exposure rates of certain research factors between the case group and the control group,
Analyze whether the exposure is associated with the disease, and if there is an association between the exposure and the disease, further analyze the strength of the association.
2. Form
3. Formula
①Basic formula of X² test for four-grid table
②Continuous correction formula
When the theoretical number of a grid in the four-grid table is ≥1 but <5, and the total number of cases is >40
2. Association strength analysis→OR (odds ratio)
1. Definition
①Reason
Generally, there are no observed numbers of exposed and non-exposed groups in case-control studies.
The incidence rate cannot be calculated, and the RR cannot be calculated directly, but the odds ratio (OR) can be used to approximate the RR.
②Ratio or ratio
It refers to the ratio of the possibility of something happening to the possibility of not happening.
③Odds ratio (OR)
Also known as odds ratio, odds ratio,
It is the ratio of the exposure ratio of the case group and the control group.
Its meaning refers to how many times the risk of disease in exposed persons is that of non-exposed persons.
OR is exactly the ratio of the cross product ad and bc of the four numbers on the two diagonals in the four-square table,
Therefore OR is also called the cross product ratio.
2. Formula
3. Epidemiological significance
①OR>1
It shows that there is a "positive" correlation between exposure and disease.
That is, exposure can increase the risk of disease, and exposure factors are risk factors for disease;
②OR<1
It shows that there is a "negative" relationship between exposure and disease.
That is, exposure can reduce the risk of disease, and exposure factors are protective factors;
②OR=1
Demonstrates no statistical link between exposure and disease
3. Calculate the 95% confidence interval of OR
(1) Miettinen method
The 95% CI of OR=OR^ (1±1.96X²).
(2) Woolf method
①Formula
Var(lnOR)=1/a 1/b c/1 1/d
②Two situations when conducting multiple case-control studies
①If OR 95%CI does not include 1
This means that there is a 95% chance that OR is not equal to 1.
The fact that the OR of this study is not equal to 1 is not due to sampling error.
The factors studied can be considered to be related to the disease studied;
②If OR 95%CI includes 1
It means that 95% of the studies may have an OR value equal to 1 or close to 1.
That is, the studied factors are not related to the studied disease.
③Attention
When the value of a certain cell in the four-cell table is 0,
You can add 0.5 to the value of each grid, and then find the sum of its reciprocals.
4. Estimated attributable risk percentage (AR%) and population attributable risk percentage (PAR%)
①Calculation formula of AR%
②Calculation formula of PAR%
The exposure rate of the control group can represent the situation of the case source population
The exposure rate of the control group can be used to represent the population exposure rate Pe
2. Analysis of 1:1 matching data
1. Analysis of the correlation between exposure and disease
(1) Form
(2)McNemarx² test
①When the sample size is large
②When (b c)<40
1. Analysis of the correlation between exposure and disease
3. Calculate the 95% confidence interval of OR → Miettinen method
3. Stratified analysis of non-matching data
1. Definition
Stratified analysis divides the research objects into different strata according to the presence or degree of potential confounding factors.
The distribution of exposure factors between the case group and the control group was then compared in each stratum.
If it can be divided into several sub-strata according to a certain confounding factor,
Calculate the OR of each layer separately and perform a homogeneity test
If the homogeneity test results show that the difference in OR values of each stratum is not statistically significant, it means that the data of each stratum is homogeneous.
If the homogeneity test results show that the difference in OR values of each stratum is statistically significant,
It reminds that the data at each level are not homogeneous and it is not appropriate to calculate the combined OR value.
Instead, the interaction between stratification factors and exposure factors should be further analyzed.
2. Form
4. Calculation steps
(1) Determine whether it is a confounding factor
①It is to study the risk factors of diseases
②Related to the factors studied
③Not an intermediate variable in the disease causal chain
(2) Stratified and tabulated by confounding factors
For example, in a case-control study on the relationship between oral contraceptives and myocardial infarction,
Age is related to oral contraceptive use and the occurrence of myocardial infarction, and may be a confounding factor
The study subjects were divided into two strata according to age: <40 years old and ≥40 years old.
a. With oral contraceptives
b. With myocardial infarction
(3) Calculate the OR value of each layer
①OR without considering the influence of age
②OR after stratification by age
③Compare the size of OR between stratified and non-stratified
④ After stratification by age, the Woolf homogeneity test method is commonly used to test the homogeneity of two-level ORi.
⑤The significance of homogeneity test
① There is no statistical significance in the OR values of each stratum, and the data are homogeneous.
Calculate the total OR, Mantel-Haenszel OR
②The differences in OR values of each stratum are statistically significant, and the data are not homogeneous.
Further analysis of the interaction between stratification factors and exposure factors
(4) Calculate X²MH
(5) Calculate OR and its 95% CI
4. Analysis of dose-response relationship
(1) Organize and summarize the data into RxC contingency table format
(2) Conduct inspection of RxC contingency table data
(3) Calculate the OR value of each exposure level.
(4) Trend test
In the formula, xi=i at the i-th exposure level,
The reference group is xo=0.
(5) Research efficacy
①Definition
Also called power, it can be explained as the ability to reject the null hypothesis,
That is, when the null hypothesis does not hold, the probability that the hypothesis is rejected.
It is generally believed that the power of a study should be above 80%.
②Calculation formula
Section 4 Bias and its Control
1. Selection bias
(1) Definition
A case-control study selects only a sample of the source population.
Because there are differences in certain characteristics between the selected research subjects and those who were not selected
The systematic error caused by this is called selection bias
(2) Common selection bias
(1) Admission rate bias
(1)Definition
Also known as Berkson's bias, this bias often occurs in hospital-based case-control studies.
That is, when hospital patients are selected as cases and controls,
The cases are only specific cases in this hospital or certain hospitals, rather than a random sample of all patients.
The control is a certain part of the hospital's patients, rather than a random sample of the entire target population.
Due to the influence of many factors such as the hospital's medical conditions, the patient's living area, socioeconomic culture, etc.,
Patients are selective about hospitals and hospitals are selective about patients
Especially when the admission rates for various diseases are different, this can lead to systematic errors in certain characteristics between the case group and the control group.
(2)Control method
① Select cases and controls from the community population as much as possible to ensure better representation.
② If a hospital-based case-control study is conducted, it is best to select all cases or random samples of a certain disease that have been continuously observed within a certain period of time in multiple hospitals of different levels and types. Controls were selected among patients from multiple departments and with multiple diseases.
③ Patients who seek treatment for diseases known to be related to the exposure factors under study should not be used as controls in order to avoid or reduce admission rate bias.
(2) Current cases-new case bias
(1)Definition
Also called Neiman bias
That is, if the survey objects are selected from current cases, that is, surviving cases, especially current cases with a long disease course,
Some of the exposure information obtained may only be related to survival and not necessarily to the onset of the disease.
thereby erroneously estimating the etiological role of these factors;
Another situation is that survivors of a certain disease have changed some of their original exposure characteristics (such as lifestyle habits) due to the disease.
They tend to mistake these altered exposure profiles for pre-disease conditions when they are surveyed,
This leads to errors in the association between these factors and diseases.
(2)Control
Selecting new cases as research subjects can avoid or reduce such bias.
(3) Detection of symptom bias
(1)Definition
also called exposure bias
Although a certain factor is not the cause of the disease under study, individuals with this factor are prone to certain symptoms or signs.
often seek medical treatment as a result, thereby increasing the detection rate of early cases of the disease under study.
If the case group in a case-control study includes more of these early cases,
As a result, the exposure degree of the case group is overestimated, and the resulting systematic error is symptom detection bias.
(2)Control
When collecting cases in the hospital, it is best to include early, middle and late-stage patients from different sources in order to reduce this bias
2. Information bias
(1) Definition
Also known as observation bias or measurement bias,
It is a systematic error caused by flaws in the methods of measuring exposures and outcomes in the process of collecting and organizing information.
(2) Common information bias
(1) Recall bias
(1)Definition
Bias resulting from systematic errors in the accuracy and completeness of a study subject's recall of exposure or past history
Its occurrence is related to the length of the interval between the investigation time and the incident, the importance of the incident, the composition of the respondents and the questioning techniques.
(2) Control
① Make full use of objective recorded data, pay attention to the questioning method during the questionnaire survey, and appropriately adopt some survey techniques, such as selecting an important indicator that is related to the exposure history and is not easily forgotten by people for investigation to help the research subjects associate and recall, which will help Reduce recall bias.
② Selecting new cases as investigation objects can also reduce the occurrence of recall bias.
(2) Survey bias
(1)Definition
May come from the investigator or the subject of the investigation.
The investigation environments and conditions of cases and controls are different.
Or investigators use different questioning methods for cases and controls,
Or the inconsistency or inaccuracy of exposure measurement methods, instruments, equipment or reagents used can lead to investigation bias.
(2) Control
① Provide good training for investigators, unify the questioning methods and investigation techniques for cases and controls, use quantitative or hierarchical objective indicators as much as possible, have the same investigator investigate cases and controls, and the investigation environment should be as consistent as possible to reduce investigation bias.
② The investigator clearly explains the purpose of the investigation to the respondents and tries to gain their trust and cooperation, which can reduce reporting bias.
③The inspection instruments and reagents used should be sophisticated and uniform, should be calibrated before use, and should be checked frequently during use to reduce measurement bias.
3. Confounding bias
(1) Definition
When we study the association between a factor and a disease,
Because a certain person is related to the disease,
and the influence of external factors related to the exposure factors under study,
The bias caused by concealing or exaggerating the relationship between the exposure factors under study and the disease is called confounding bias.
This external factor is called a confounding factor.
(2) Control
In the research design stage, methods such as restriction and matching of research objects can be used to control confounding bias;
In the data analysis stage, stratified analysis or multifactor analysis can be used to control confounding bias.
Section 5 Comparison with the advantages and limitations of cohort studies
1. Cohort study
advantage
1. Since the exposure data of the research subjects are collected before the outcome occurs and are observed personally by the researchers, the data are reliable and there is generally no recall bias.
2. The morbidity or mortality of the exposed group and the control group can be directly obtained, indicators such as RR and AR that reflect the intensity of the association between exposure and disease can be directly calculated, and the etiological effects of exposure can be fully and directly analyzed.
3. Because the exposure occurs first and the disease occurs later, the cause and effect time sequence is clear, and there is less bias, it has a strong ability to test etiological hypotheses and can generally confirm the etiological link.
4. During the follow-up observation process, it helps to understand the natural history of the disease in the population
5. Be able to observe multiple diseases caused by one exposure factor at the same time and analyze the relationship between one exposure and multiple diseases.
shortcoming
1. Not suitable for research on the causes of diseases with very low incidence rates
2. Due to the long follow-up time, it is difficult for research subjects to maintain compliance and is prone to loss-to-follow-up bias.
3. Research consumes a lot of manpower, material resources, financial resources and time. The organization and logistics work are also quite arduous and difficult to implement.
4. During the follow-up process, unknown variables are introduced into the population, or changes in known variables in the population can affect the outcome and complicate data collection and analysis.
2. Case-control study
advantage
1. It is especially suitable for research on the causes of rare diseases and long-latency diseases. Sometimes it is often the only choice for research on the causes of rare diseases.
2. It saves manpower, material resources, financial resources and time, and is easier to organize and implement.
3. The relationship between multiple exposures and a certain disease can be studied at the same time, which is especially suitable for exploratory etiology research.
4. This method has a wide range of applications. It is not only used to explore the causes of disease, but also is widely used to analyze the causes of other health events.
limitation
1. Factors that are not suitable for studying factors with a very low exposure proportion in the population
2. When selecting research subjects, it is difficult to avoid selection bias.
3. It is difficult to avoid recall bias when obtaining past information.
4. The timing of exposure and disease is often difficult to determine, and the ability to demonstrate causality is not as strong as cohort studies.
5. The incidence of disease in the exposed group and the non-exposed group cannot be measured, and the RR cannot be directly analyzed. The OR can only be used to estimate the RR.
Chapter 11 Epidemiology of Infectious Diseases
Section 1 Overview
1. Definition
1. Infectious diseases: diseases caused by pathogens and can be transmitted between people, animals and animals, and between people and animals. Pathogens (bacteria, viruses, rickettsiae, spirochetes, parasites, etc.) are transmitted directly or indirectly through infected humans, animals or reservoir hosts, infecting susceptible persons.
2. Epidemiology of infectious diseases: It emerged during the long-term struggle between humans and infectious diseases and played an important role in controlling infectious diseases. The epidemiology of infectious diseases aims to study the occurrence, development and influencing factors of infectious diseases in the population, and to formulate strategies and measures to prevent, control and eliminate infectious diseases.
2. Popularity
(1) Overview of global infectious disease epidemics
(1) Since the 19th century, humans have gradually deepened their understanding of infectious diseases and adopted effective prevention and control measures (such as vaccines, etc.), which has enabled many infectious diseases that were once rampant in history to be effectively controlled.
(2) In 1980, humans successfully eradicated smallpox. In 1988, the global polio eradication campaign was launched, and polio cases worldwide decreased by 99.9%; most countries have now achieved the polio-free goal.
(3) Infectious diseases are still an important cause of harm to human health, especially in developing countries. The number of people who die from infectious diseases in the world every year accounts for about 25% of the total deaths, mainly in developing countries such as Africa.
(4) Along with the decrease of classic infectious diseases, new infectious diseases continue to appear.
(2) Overview of the prevalence of infectious diseases in my country
① The harm of AIDS is serious, and the pattern of HIV infection is changing from high-risk groups to the general population. The number of reported deaths and mortality rates top the list.
②The situation of viral hepatitis prevention and control remains severe.
③ Tuberculosis is making a comeback. In recent years, the morbidity and mortality rate of tuberculosis ranks second among the legally reportable Class A and B infectious diseases, and there is an epidemic of multi-drug-resistant tuberculosis.
④ New and re-emerging infectious diseases occur frequently. Among the more than 40 emerging infectious diseases in the world, there are more than 20 in my country.
⑤The incidence of common infectious diseases such as hand, foot and mouth disease, infectious diarrhea, and influenza is still at a high level.
Section 2 The process of infection
1. Pathogens
1. Characteristics of pathogens
(1) Infectiousness
Refers to the ability of pathogens to invade the host's body, survive, reproduce, and cause infection.
It is commonly measured by the secondary incidence rate (also known as the secondary incidence rate). The infectivity of different pathogens varies greatly.
(2) Pathogenicity
Refers to the ability of pathogens to cause disease after invading the host.
The virulence associated with a pathogen depends on the rate at which the pathogen reproduces in the body, the extent of tissue damage caused, and the toxicity of the toxins produced by the pathogen.
Pathogenicity can be measured by the proportion of exposed individuals who develop clinical disease.
(3) Toxicity
Refers to the ability of pathogens to cause severe disease after infecting the body
Virulence emphasizes the severity of the disease caused and can be evaluated by the case fatality rate and the proportion of severe cases.
(4) Antigenicity or immunogenicity
Refers to the ability of a pathogen to induce specific immunity in the host.
2. Pathogen mutation
(1) Antigenic variation
Gene mutations of pathogens lead to changes in their antigenicity
As a result, the specific immunity originally acquired by the population loses its effect, leading to epidemics of diseases.
(2) Virulence variation
The virulence of pathogens can vary due to environmental factors and host resistance, including increased and decreased virulence.
Attenuated strains of pathogens can be used to prepare vaccines to prevent infectious diseases.
(3) Drug resistance variation
It refers to the change of a pathogen from being sensitive to a certain antibacterial (viral) drug to being insensitive or resistant.
Drug-resistant mutations can be passed on to future generations through drug-resistant genes or gene mutations, or can be transferred to other microorganisms through microbial symbiosis.
3. Viability of pathogens outside the host
The ability of pathogens to survive outside the host has an impact on the prevalence of infectious diseases.
2. Host
1. Host’s defense mechanism
(1) Skin and mucous membrane barrier
(2) Phagocytosis
(3) Specific immune response
2. Genetic susceptibility of the host.
3. Other factors of the host
3. Infectious process
1. Infection spectrum
Also known as the infection gradient, it refers to the severity of the host's response to the pathogen infection process.
Including latent infection, overt infection, severe clinical symptoms or death.
Reflects the outcome of the infection process.
2. Classification
(1) Infectious diseases with mainly latent infections: such as poliomyelitis, epidemic cerebrospinal meningitis and Japanese encephalitis, etc.
(2) Infectious diseases dominated by overt infections: such as chickenpox, measles, etc.
(3) Infectious diseases that mainly cause death: such as rabies, etc.
Section 3 Popular Process
1 Overview
1. Epidemic process: refers to the process in which pathogens are discharged from the source of infection, invade the bodies of susceptible people through a certain transmission route, and form new infections, which continue to occur and develop.
2. Basic links: The epidemic process must have three basic links: source of infection, transmission route and susceptible population. These three links are interdependent and synergistic, and jointly affect the epidemic of infectious diseases. Without any one of these links, infectious diseases cannot spread and become popular among the population.
3. Transmission route: refers to the entire process that a pathogen goes through in the external environment after it is discharged from the source of infection and before it invades a new susceptible host.
4. Source of infection: refers to people and animals that have pathogens growing and multiplying in their bodies and capable of expelling pathogens.
5. Transmission factors: inanimate substances such as water, air, food, soil, etc. that are used by external pathogens to enter the susceptible host.
6. Transmission vector: living organisms such as insect vectors that are used by external pathogens to enter susceptible hosts. Transmission factors and transmission media are the media through which external pathogens enter the susceptible host and are not transmission routes.
2. Basic links
1. Source of infection
1. Patient
There are a large number of pathogens in the patient's body, and he has certain clinical symptoms that are conducive to the elimination of pathogens, which can expel a large amount of pathogens and increase the chance of infection in susceptible people.
Patients are important sources of infection.
2. Pathogen carriers
definition
Refers to people who are infected with pathogens without clinical symptoms but can excrete the pathogens, including carriers, virus carriers and worm carriers.
type
⑴Patient carriers in the incubation period
Refers to a person who carries and can excrete pathogens outside the body during the incubation period.
Such as diphtheria, measles, dysentery, cholera, etc.
(2) Convalescent pathogen carriers
Refers to people who can still excrete pathogens within a certain period of time after clinical symptoms disappear.
People who can still shed pathogens within three months after clinical symptoms disappear are called temporary pathogen carriers.
Those who live for more than three months are called chronic pathogen carriers.
Generally, the pathogen-carrying state can be confirmed to be lifted only when three consecutive negative tests are performed.
Such as hepatitis B, typhoid fever, cholera, etc.
(3) Healthy pathogen carriers
Refers to a person who has never had an infectious disease but can excrete pathogens
It is of less epidemiological significance as a source of infection.
However, some infectious diseases have a large number of healthy pathogen carriers, such as hepatitis B and epidemic cerebrospinal meningitis, which can also become important sources of infection.
3. Infected animals
(1) Zoonotic diseases mainly involving animals
It is mainly spread and continued among animals, and can be transmitted to humans under certain conditions.
Generally not spread from person to person
Such as rabies, forest encephalitis, leptospirosis, etc.
(2) Zoonotic diseases that are mainly caused by humans
Diseases generally spread among humans and occasionally infect animals
Such as human tuberculosis, amoebic dysentery, etc.
(3) Zoonotic diseases that attach equal importance to humans and animals
Both humans and animals can be sources of infection and can be sources of infection for each other.
Such as schistosomiasis.
(4) True zoonotic diseases
Pathogens must use humans and animals as their final hosts and intermediate hosts respectively, that is, the life history of the pathogen must be completed collaboratively in humans and animals, and both are indispensable.
Such as bovine taeniasis, swine taeniasis, etc.
2. Transmission channels
horizontal transmission
1. Transmitted through the air
Classification
1. Transmission via droplets: Droplets containing a large amount of pathogens are discharged into the environment through the mouth and nose when the infectious source exhales, sneezes, and coughs. Susceptible people can directly inhale the droplets and cause infection. Droplet transmission mainly affects close contacts around the source of infection. This kind of transmission is more likely to occur in some crowded and poorly ventilated public places, and is a common mode of transmission of influenza viruses, Bordetella pertussis and meningococci that have weak environmental resistance.
2. Transmission via droplet nuclei: Droplet nuclei are composed of proteins and pathogens remaining when droplets lose moisture in the air. Droplet nuclei can drift in the air in the form of aerosols and remain for a long time. Some desiccation-resistant pathogens, such as Mycobacterium tuberculosis, can be transmitted in this way.
3. Transmission through dust: Larger droplets or secretions containing pathogens fall on the ground and are suspended in the air with dust after drying. Susceptible people can become infected after inhaling them. Pathogens that are highly resistant to the outside world, such as Mycobacterium tuberculosis and Bacillus anthracis spores, can be transmitted in this way.
popular features
①The transmission route is easy to achieve, spreads widely, and has a high incidence rate;
② There is obvious seasonality, with high incidence in winter and spring;
③In people without immune prophylaxis, the disease occurs cyclically;
④It is more likely to occur in areas with crowded living conditions and high population density.
2. Transmission through water Transmission through water
1. Transmitted through drinking water
The main reason is that the water source is contaminated, such as damage to the tap water pipe network causing sewage to seep in, feces or dirt contaminating the water source, etc. Secondary pollution of urban high-rise residential reservoirs is a current issue worthy of attention.
popular features
①The distribution of cases is consistent with the water supply range, and there is a history of drinking from the same water source;
②Except for breast-feeding infants, there is no difference in age, gender, or occupation;
③If the water source is often polluted, cases will continue all year round;
④The outbreak or epidemic can be subsided after the contaminated water source is stopped or disinfection and purification measures are taken.
2. Transmission through contact with infected water
Usually when people come into contact with infected water (contaminated and infectious water), pathogens invade the body through the skin and mucous membranes. Such as schistosomiasis, leptospirosis, etc.
popular features
①The patient has a history of exposure to epidemic water;
②The incidence varies by region, season and occupation;
③A large number of susceptible people enter the epidemic area, which may cause an outbreak or epidemic;
④ Strengthening personal protection and taking measures against infectious diseases are effective in controlling the spread of the disease.
3. Transmitted through food Transmitted through food
① The patient has a history of eating the same food, and those who do not eat will not get sick;
②The incubation period of patients is short, and a large amount of contamination can cause an outbreak;
③The outbreak or epidemic will subside after the supply of contaminated food is stopped.
④If food is contaminated multiple times, the outbreak or epidemic can last for a long time.
4. Transmission through contact
1. Direct contact transmission
Refers to the spread of disease caused by direct contact between susceptible people and the source of infection without the involvement of external factors.
Such as sexually transmitted diseases, rabies, etc.
2. Indirect contact transmission
Also known as daily contact transmission, it refers to the transmission caused by susceptible people coming into contact with items contaminated by pathogens.
popular features
① Cases are mostly sporadic, but they can spread among families or people living together, leading to clustering of cases in families and people living together;
② There are more cases among people with poor sanitary conditions and poor hygiene habits.
5. Transmission by arthropods Transmission by arthropods
Classification
1. Mechanical carriage: Pathogens of intestinal infectious diseases (such as typhoid, dysentery, etc.) can survive for several days on the surface and in the body of non-blood-sucking arthropods such as flies and cicadas, but do not develop in their bodies. Arthropods excrete pathogens through contact, vomiting and feces, contaminating food or tableware, etc., and infecting contacts.
2. Biological transmission: Blood-sucking arthropods bite infected people with pathogens in their blood, inhale the pathogens into their bodies, and then bite susceptible people to spread diseases, such as dengue fever, malaria, etc. Pathogens develop and reproduce in arthropods. After a period of proliferation or completion of a certain stage in their life cycle, arthropods become infectious. The period from when an arthropod inhales a pathogen to when it becomes infectious is called the "outer incubation period."
popular features
① It has certain regional characteristics, and the distribution of cases and transmission media is consistent.
② There is obvious seasonality, and the rise and fall of cases is consistent with the activity season of the vector.
③Some infectious diseases have occupational distribution characteristics. For example, forest encephalitis is common among loggers and field workers.
④ There is a certain age difference, with more cases among children in old epidemic areas; the age difference among cases in new epidemic areas is not obvious.
6. Transmitted through soil Transmitted through soil
(1) The diseases transmitted through soil are mainly intestinal parasitic diseases (ascariasis, hookworm, whipworm, etc.) and bacterial diseases that can form spores (such as anthrax, tetanus, etc.).
(2) The epidemiological significance depends on the survival time of the pathogen in the soil, the contact opportunities between people and the soil, personal hygiene habits and working conditions, etc.
7. Iatrogenic transmission
① Disease transmission caused by contaminated medical equipment when susceptible persons receive treatment or examination;
② Transmission caused by contamination of blood transfusions, medicines or biological agents, such as patients suffering from hepatitis B, AIDS, etc. due to blood transfusions.
vertical communication
(1) Transplacental transmission: Some pathogens can pass through the placental barrier, and infected pregnant women can pass the pathogens to their fetuses through the placental blood, causing intrauterine infection. Such as rubella virus, HIV and hepatitis B virus.
(2) Ascending transmission: pathogens pass through the vagina of pregnant women and reach the chorion or placenta, causing intrauterine infection of the fetus, such as herpes simplex virus, Candida albicans, etc.
(3) Transmission during delivery: During delivery, the fetus becomes infected while passing through the mother's severely infected birth canal. Such as gonococcus, herpes virus, etc.
3. Susceptible groups
1. Population susceptibility: The susceptibility of the population as a whole to infectious diseases is called population susceptibility.
2. Population immunity: that is, the resistance of a population to the invasion and spread of infectious pathogens, which can be measured by the proportion of immune people in the population.
3. The main factors causing increased susceptibility of the population include
①Increase in newborns
For babies over 6 months old, their maternal antibodies gradually disappear and acquired immunity has not yet formed, making them susceptible to many infectious diseases.
②Migration of susceptible populations
Residents in endemic areas acquire specific immunity due to illness or latent infection. When residents from non-endemic areas who lack corresponding immunity move in, the susceptibility of people in endemic areas will increase.
③ Decrease in the immune population: When the population's post-illness (including latent infection) immunity or artificial immunity gradually fades over time and the immune population dies, the population's susceptibility increases.
④ Emergence of new pathogens or mutation of pathogens: When new pathogens appear or certain pathogens mutate, the population will become more susceptible due to a general lack of immunity.
4. The main factors leading to reduced susceptibility of the population include
① Vaccination: This is the most important factor in reducing the population's susceptibility to infectious diseases. According to the epidemic monitoring and population immunity status, vaccination of the population according to the prescribed immunization program can effectively improve the specific immunity of the population and reduce the susceptibility of the population.
② Infectious disease epidemic: After an infectious disease epidemic, a considerable number of susceptible people acquire immunity due to illness or latent infection, making the population less susceptible to the disease within a period of time after the epidemic. The strength and duration of immunity after an infectious disease or latent infection vary depending on the disease.
3. Epidemic focus and epidemic process
1. Definition of epidemic focus
Refers to the range that the source of infection and the pathogens it excretes can spread to the surrounding area.
It is the basic unit that constitutes the epidemic process of infectious diseases.
Usually, a small-scale epidemic focus or a single infectious source is called an epidemic point, and a larger-scale epidemic focus or a number of epidemic sources connected into one area is called an epidemic area.
2. Conditions for the formation of epidemic foci
The formation of an epidemic focus requires conditions that enable the continued spread of infectious agents and pathogens.
The size of the epidemic focus is related to the type of infectious disease, and mainly depends on the existence time and activity scope of the infectious source, the characteristics of the transmission route, and the immune status of the surrounding people.
3. Conditions for elimination of epidemic foci
①The source of infection has been removed (hospitalization, death, or moved to another place) or the pathogen is no longer shed (cured);
② Through various measures, the pathogens discharged from the source of infection to the external environment are eliminated;
③ All susceptible contacts around the source of infection have passed the longest incubation period of the disease and no new cases or new infections have occurred.
4. The relationship between the epidemic focus and the epidemic process
(1) A series of interconnected and successive epidemic foci constitute the epidemic process of infectious diseases.
(2) The epidemic process of infectious diseases depends on the overall effect produced by the interaction of the source of infection, the route of transmission and the susceptible population.
(3) The epidemic process can continue only when the overall effect is conducive to the formation of new epidemic foci.
(4) Each epidemic foci is caused by the previous epidemic foci, and it itself is the basis for the formation of new epidemic foci.
(5) The epidemic focus is the basic unit of the epidemic process. Once the epidemic focus is eliminated, the epidemic process will be over.
4. Various stages of infectious diseases
1. Infectious period
definition
The entire period during which a patient sheds pathogens is called the infectious period.
epidemiological significance
(1) For diseases with a short infectious period, secondary cases often appear in clusters;
(2) For diseases with a long infectious period, subsequent cases will appear one after another and may last for a long time.
(3) The infectious period is an important basis for determining the isolation period of patients with infectious diseases.
(4) After the host is infected with the pathogen, it does not become infectious immediately, but takes a certain period of time.
2. Incubation period
definition
Refers to the period from the invasion of the pathogen into the body to the appearance of the earliest clinical symptoms or signs.
The same infectious disease has a fixed incubation period.
The epidemiological significance and uses of the incubation period
① Determine the time when the patient was infected, which is used to trace the source of infection and determine the route of transmission.
② Determine the period of stay for examination, quarantine and medical observation of contacts, which is generally the average incubation period plus 1 to 2 days. Infectious diseases that cause serious harm can be kept for examination and quarantine according to the longest incubation period of the disease.
③Determine the time of immunization.
④Evaluate the effectiveness of control measures.
⑤Influence the epidemic characteristics of the disease. Generally, infectious diseases with short incubation periods often appear in the form of outbreaks, while infectious diseases with long incubation periods last longer.
3. Clinical symptom stage
definition
Refers to the period during which a patient develops specific clinical symptoms and signs
epidemiological significance
At this time, a large number of pathogens grow and reproduce in the patient's body, and there are many clinical symptoms that are conducive to the elimination of pathogens. This is the most infectious period and has important epidemiological significance.
4. Recovery period
definition
At this time, the patient's clinical symptoms have disappeared and the body is in a period of gradual recovery.
epidemiological significance
① During this period, patients begin to develop immunity and eliminate pathogens from the body, and are generally no longer contagious, such as measles, chickenpox, etc.
②However, patients with some infectious diseases (such as hepatitis B, dysentery, etc.) can still excrete pathogens during the recovery period;
③ A few patients with infectious diseases can shed pathogens for a long time, even for a lifetime, such as typhoid fever.
Section 4 Prevention Strategies and Measures
1. Prevention strategies
1. Population-wide strategy: It targets the entire population and adopts preventive measures aimed at reducing the entire population’s exposure to disease risk factors, such as routine vaccination of children.
2. High-risk group strategy: It is to reallocate limited health resources to key groups, which is more in line with the principle of cost-effectiveness, such as vaccination for key groups.
3. Two-way strategy: combining universal prevention for the entire population with focused prevention for high-risk groups.
2. Prevention and control measures
1. Infectious disease surveillance
1. Statutory reportable infectious diseases
(1) Class A infectious diseases (2 types): plague, cholera.
(2) Class B infectious diseases (26 types): SARS, AIDS, viral hepatitis, poliomyelitis, human infection with highly pathogenic avian influenza, human infection with H7N9 avian influenza, measles, epidemic hemorrhagic fever ( Now known as renal syndrome (hemorrhagic fever), rabies, Japanese encephalitis, dengue fever, anthrax, bacterial and amoebic dysentery, tuberculosis, typhoid and paratyphoid, epidemic cerebrospinal meningitis, whooping cough, diphtheria, Neonatal tetanus, scarlet fever, brucellosis, gonorrhea, syphilis, leptospirosis, schistosomiasis, malaria. Among them, the prevention and control measures of Class A infectious diseases (Class A management) are adopted for infectious SARS, pulmonary anthrax and new coronavirus pneumonia.
(3) Category C infectious diseases (11 types): influenza (including influenza A H1N1), mumps, rubella, acute hemorrhagic conjunctivitis, leprosy, epidemic and endemic typhus, kala-azar, Hydatid disease, filariasis, infectious diarrheal diseases other than cholera, bacterial and amoebic dysentery, typhoid and paratyphoid, hand, foot and mouth disease
2. The main contents of infectious disease surveillance include
① Demographic data; ② Incidence, mortality and distribution of infectious diseases; ③ Pathogen type, virulence, drug resistance variation; ④ Determination of population immunity level; ⑤ Animal host and vector insect population distribution and pathogen carrying status; ⑥ Transmission Investigation of dynamics and influencing factors; ⑦ Evaluation of the effectiveness of prevention and control measures; ⑧ Epidemic prediction; ⑨ Special investigations (such as outbreak investigation, underreporting investigation), etc.
3. Responsible reporting units and reporters: The "Infectious Disease Information Reporting Management Standards (2016 Edition)" stipulates that medical institutions at all levels, disease prevention and control institutions, and blood supply institutions are responsible reporting units; their personnel performing duties and rural areas Doctors and individual practitioners are responsible epidemic reporters.
4. Diagnosis and classification: The responsible reporter should promptly diagnose patients or suspected patients with infectious diseases in accordance with the diagnostic standards for infectious diseases. Diagnosis is divided into five categories: suspected cases, clinically diagnosed cases, laboratory confirmed cases, pathogen carriers and those with positive test results.
5. Registration and reporting: After discovering infectious disease patients, suspected patients and pathogen carriers required to be reported during diagnosis and treatment, the first-diagnosing doctor should fill in the "Infectious Disease Report Card of the People's Republic of China" in accordance with the requirements or use electronic medical records or electronic health records. Automatically extract electronic infectious disease report cards that comply with exchange document standards.
6. Reporting procedures and methods: Infectious disease reporting is subject to localized management. The infectious disease report card is filled in by the first-diagnosis doctor or other personnel performing duties. Reporting method: Infectious disease epidemic information shall be reported directly online. Medical institutions that do not have the conditions to implement direct online reporting must report the infectious disease report card to the local county-level disease prevention and control agency within the specified time limit.
7. Reporting time limit
(1) When outbreaks of Class A and B infectious diseases, or other infectious diseases and diseases of unknown origin are discovered, the infectious disease report card should be reported online within 2 hours.
(2) For other Category B and C infectious disease patients, suspected patients and carriers of infectious disease pathogens that are required to be reported, the responsible reporting unit that implements online direct reporting should make an online report within 24 hours after case diagnosis.
2. Measures against sources of infection
1. Measures for patients
(1) Early detection and diagnosis: It helps patients receive timely treatment, effectively controls the source of infection, and blocks the spread of the disease;
(2) Timely and accurate reporting of infectious diseases: it can correctly judge epidemic trends and provide scientific basis for formulating infectious disease prevention and control strategies and measures;
(3) Isolate patients: Separate them from susceptible people around them. Once patients with infectious diseases or suspected patients are discovered, hierarchical management must be implemented immediately to reduce or eliminate the spread of pathogens;
(4) Treating patients: It helps to weaken their role as a source of infection and prevent the spread of infectious diseases among the population.
2. Measures against pathogen carriers
(1) Pathogen carriers of Category A infectious diseases and Category B infectious diseases under Category A management shall be isolated and treated.
(2) The occupations and behaviors of some carriers of infectious diseases are subject to certain restrictions. For example, carriers of typhoid fever or viral hepatitis pathogens who have not been cured for a long time are not allowed to engage in the catering industry; carriers of AIDS and hepatitis B viral pathogens are strictly prohibited from donating blood.
3. Measures for contacts
(1) Observation: that is, isolation and observation. Close contacts of Category A infectious diseases should be detained for examination, that is, their scope of activities should be restricted, and they should be diagnosed, tested and treated in designated places.
(2) Medical observation: Close contacts of Category B and Category C infectious diseases should be subject to medical observation, that is, they should receive physical examination, etiological examination and necessary sanitary treatment while working and studying normally.
(3) Emergency vaccination and drug prophylaxis: Emergency vaccination or drug prophylaxis can be used for close contacts of infectious diseases with serious harm and long incubation period.
4. Measures against animal sources of infection
Based on the degree of harm and economic value of infected animals to humans, measures such as isolation and treatment, killing, burning, and deep burial should be adopted. Do a good job in vaccination and quarantine of domestic animals and pets.
3. Measures against transmission routes
1. Disinfection
definition
It is a measure to eliminate or kill pathogens in the external environment using chemical, physical, biological and other methods.
Classification
(1) Preventive disinfection: Disinfect places and items that may be contaminated by infectious pathogens when no clear source of infection is found. Such as dairy products disinfection, drinking water disinfection, tableware disinfection, etc.
(2) Disinfection of epidemic sources: Disinfect places where there are or have been sources of infection. Its purpose is to destroy pathogens shed by infectious sources.
A. Disinfection at any time: refers to the timely disinfection of excreta, secretions, contaminated items and places when the source of infection is still at the source of infection;
B. Terminal disinfection: It is a thorough disinfection of the epidemic source after the source of infection has recovered, died or left, so as to eliminate the pathogens spread by the source of infection in the external environment. Terminal disinfection is only required for infectious diseases caused by pathogens with strong external resistance, such as plague, cholera, viral hepatitis, tuberculosis, typhoid, anthrax, diphtheria, etc., while diseases such as influenza, chickenpox, and measles generally do not require terminal disinfection. Not disinfected.
2. Insecticide
4. Measures for susceptible groups
1. Vaccination
2. Drug prevention
3. Personal protection
Section 5 Immunization Program and Evaluation of Its Effects
1. Vaccination
definition
It uses artificially prepared antigens or antibodies to inoculate the body through appropriate channels, so that the body can obtain specific immunity to certain infectious diseases, so as to improve the immunity level of individuals or groups and prevent and control the occurrence and epidemic of related infectious diseases.
Common types
1. Artificial automatic immunity
It refers to the use of artificial immunization methods to inoculate antigens such as vaccines and toxoids into the human body, so that the body's own immune system can generate specific immunity to related infectious diseases.
2. Artificial passive immunity
It is to inoculate the human body with blood or preparations containing specific antibodies, so that the body passively acquires specific immunity and is protected.
This type of immunity works quickly but lasts for a short time. It is mainly used for emergency preventive immunotherapy.
3. Artificial passive automatic immunity
It refers to inoculating the body with antigenic substances and antibodies at the same time, so that the body can quickly obtain specific antibodies and stimulate the body to produce lasting immunity.
It is usually an immunization method used to protect infants and young children or frail contacts during epidemics, but it can only be used for a few infectious diseases.
. For example, when diphtheria is prevalent, contacts of susceptible persons are vaccinated with diphtheria antitoxin and diphtheria toxoid; infants born to HBsAg-positive mothers are simultaneously injected with hepatitis B immune globulin and hepatitis B vaccine at birth to block mother-to-child transmission of hepatitis B virus.
2. Immunization plan
1. Definition of immunization program
Refers to the plans, plans and strategies formulated to use effective vaccines to vaccinate susceptible groups in accordance with the national infectious disease prevention and control plan.
In accordance with the vaccine varieties, immunization procedures or vaccination plans determined by the country or province, autonomous region or municipality directly under the Central Government,
Carry out vaccination in a planned manner among the population to improve the immunity level of the population and achieve the purpose of preventing, controlling and eliminating corresponding infectious diseases.
2. Contents of immunization program
(1) National expanded immunization program: Based on the original 6 national immunization program vaccines, acellular DPT vaccine will be used to replace DTP vaccine, and hepatitis A vaccine, meningococcal meningitis vaccine, Japanese encephalitis vaccine, and measles-mumps vaccine will be included in the national Immunization program and routine vaccination of school-age children.
(2) Carry out hemorrhagic fever vaccination for key populations in key areas;
(3) Implement emergency vaccination of anthrax vaccine and leptospirosis vaccine for high-risk groups in key areas.
(4) Prevent 15 infectious diseases including hepatitis B, tuberculosis, polio, whooping cough, anthrax and leptospirosis through the implementation of the expanded national immunization program.
3. Evaluation of the effectiveness of immunization programs
(1) Immunological effect evaluation: The immunological effect is evaluated by measuring the antibody seroconversion rate, average antibody titer and antibody duration in the population after vaccination. Antibody positive conversion rate = number of antibody positive conversions/number of vaccinated people × 100%.
(2) Epidemiological effect evaluation: Randomized double-blind controlled field trial results can be used to calculate the vaccine protection rate and effect index. Vaccine protection rate = incidence rate in the control group - incidence rate in the vaccinated group/incidence rate in the control group × 100%; vaccine effectiveness index = incidence rate in the control group/incidence rate in the vaccinated group.
(3) Immunization program management evaluation: main assessment and evaluation indicators; card establishment rate, vaccine qualified vaccination rate, national immunization program vaccine coverage (full vaccination) rate, etc.
Chapter 10 Public Health Surveillance
Section 1 Overview
1. Basic concepts of public health surveillance
1. Public health surveillance
definition
Refers to the long-term, continuous and systematic collection of data on public health issues among the population
Obtain important public health information after scientific analysis and interpretation
And provide timely feedback to the people or institutions who need this information to guide the process of formulating, improving and evaluating public health intervention measures and strategies.
Basic Features
(1) Continuously and systematically collect health-related data to discover the distribution characteristics and changing trends of public health problems.
(2) Scientifically organize, analyze and interpret the collected original data to transform it into valuable and important public health information.
(3) Feed back public health information to relevant departments and personnel in a timely manner and make full and reasonable use of it to achieve the ultimate goal of monitoring.
2. Passive monitoring
Refers to lower-level units regularly reporting monitoring data to higher-level agencies, while higher-level units passively accept
Mainly based on relevant laws and regulations
my country's notifiable infectious disease reporting information system, public health emergency reporting system, and adverse drug reaction (ADR) monitoring spontaneous reporting system mostly fall into the category of passive surveillance.
3. Active monitoring
Refers to the investigation and collection of information specially organized by superior units based on the special needs of public health issues such as disease prevention and control.
my country's immunization rate monitoring, investigations into underreporting of infectious diseases carried out to correct infectious disease reporting and monitoring data, and monitoring activities for certain key diseases or certain behavioral factors mostly fall under the category of active surveillance.
4. Regular reports
Refers to routine monitoring reports on diseases or various health-related issues specified by the health administration department.
For example, my country's notifiable infectious disease reporting information system clearly stipulates the types of reported diseases. The reporting scope covers the whole country and is mainly implemented by legally responsible reporting agencies and reporters.
5. Sentinel surveillance
In order to have a clearer understanding of the distribution of certain diseases in different regions and different groups of people, as well as the corresponding influencing factors, etc.,
According to the epidemic characteristics of the disease to be monitored, a number of representative regions and/or groups of people are selected, and surveillance is carried out continuously according to a unified surveillance plan.
The most typical one is HIV sentinel surveillance.
6. Second generation monitoring
On the basis of traditional monitoring content, behavioral monitoring is added, mainly targeting behavioral risk factors that can be changed
More comprehensive information is provided to better guide intervention.
2. Purpose and application
(1) Purpose of public health surveillance
1. Describe the distribution characteristics and changing trends of health-related events
(1) Quantitatively assess the severity of public health problems and identify major public health problems.
(2) Discover abnormalities in the distribution of health-related events, promptly investigate the causes and take preventive measures to effectively curb the development and spread of adverse health events.
(3) Predict the development trend of health-related events and correctly estimate the demand for health services. (4) Study the influencing factors of the disease and identify high-risk groups.
2. Evaluate the effectiveness of public health intervention strategies and measures
Public health surveillance is continuous and systematic observation. The changing trends of diseases or related events can provide the most direct and reliable basis for the evaluation of the effects of intervention strategies and measures.
(2) Application of public health surveillance
1. Identify one or more cases and intervene to prevent infection or reduce morbidity and mortality.
2. Evaluate the impact of health events on public health or judge and measure its trends.
3. Demonstrate the need for public health intervention projects and resources, and rationally allocate resources in the formulated public health plan.
4. Monitor the effectiveness of prevention and control methods and intervention measures.
5. Identify high-risk groups and geographical areas to carry out intervention and guide analysis and research.
6. Establish hypotheses to guide analytical research on the causes, spread and progression of the disease.
Section 2 Types and Contents of Public Health Surveillance
(1) Disease surveillance
①Infectious disease surveillance
type
Category A (2 types, mandatory management of infectious diseases)
Category B (27 species, strict management of infectious diseases)
Category C (11 species, monitoring and managing infectious diseases), 40 species in total.
Main content and purpose
a. Discover and diagnose cases in a timely manner for tracking and control; discover new infectious diseases or new public health problems.
b. Understand the distribution of cases among the three rooms and determine the existence of epidemics or outbreaks in a timely manner so as to initiate outbreak investigation and control the epidemic.
c. Monitor population immunity levels, serotypes and/or genotypes of pathogens, virulence, drug resistance and their mutations, as well as the types, distribution, and pathogen carrying status of animal hosts and urban worms to understand changes in diseases. trends, identify high-risk groups or areas, and provide information for the formulation and adjustment of intervention strategies and measures.
d. Monitor the progress and effects of public health intervention projects (strategies and measures).
②Chronic non-communicable disease surveillance
Monitoring content varies according to the major health issues or monitoring purposes of each country and region.
Mainly including malignant tumors, cardiovascular and cerebrovascular diseases, diabetes, mental diseases, occupational diseases, birth defects, etc.
③Hospital infection surveillance
Collect and analyze the occurrence, distribution and influencing factors of hospital infections among certain groups of people (mainly hospitalized patients) in a long-term, systematic and continuous manner
and submit and feedback monitoring results to relevant departments and departments
Provide scientific basis for the prevention, control and management of hospital infections.
④Monitoring of cause of death
The purpose is to understand the mortality and cause of death distribution of the population
Through statistical analysis of causes of death
Can reflect the health level of the monitored population
And determine the main causes of death and disease prevention and control priorities in different periods.
(2) Symptom monitoring
Also called syndromic surveillance or syndromic surveillance
Refers to the long-term, continuous and systematic collection of the frequency of occurrence of specific clinical syndromes or disease-related phenomena.
This provides a monitoring method for early detection, early warning and rapid response to the occurrence or prevalence of certain diseases.
(3) Monitoring of behavior and behavioral risk factors
Monitoring the causes of public health events
Monitoring of general behaviors (non-specific behaviors or phenomena that have not been determined to be causally related to a specific disease) is often done to search for clues to the cause.
Monitoring specific behavioral risk factors can predict the occurrence of related diseases or public health events to a certain extent.
(4) Other public health surveillance
Including environmental monitoring, food hygiene monitoring, nutrition monitoring, school hygiene monitoring, adverse drug reaction monitoring, family planning direct medication use and adverse reaction monitoring, etc.
Section 3 Methods, steps and evaluation of public health surveillance
1. Method
(1) Monitoring methods
1. Population-based surveillance
Definition: It refers to carrying out on-site work with specific groups of people to monitor the dynamic changes of specific diseases.
Features
① It can not only be regular report monitoring covering the entire target population, but also monitoring points or sentinel points.
② Monitoring with good representative monitoring points can obtain more accurate, reliable and timely data, which is less expensive and more efficient.
2. Hospital-based monitoring
It refers to work carried out with the hospital as the site and patients as the target, mainly monitoring nosocomial infections, pathogen resistance, birth defects, etc.
The notifiable infectious disease reporting and monitoring system and the passive monitoring of adverse drug reactions are both hospital-based monitoring.
3. Laboratory-based monitoring
Mainly refers to the use of laboratory methods to monitor pathogens or other disease-causing factors.
For example, the routine influenza virus isolation, typing and identification work carried out by the WHO and my country's influenza laboratory surveillance system.
4. Case-based monitoring
It refers to the monitoring of special individual cases and clustered cases based on the disease prevention and control system, combined with clinical medical institutions and other health care units.
Counting the number of disease outbreak events is often easier and more practical than counting individual cases, especially for diseases with potential outbreak risks, poor reporting quality, or diverse clinical types.
In our country, public health emergency surveillance and food safety incident surveillance are all case-based surveillance.
5. Monitoring based on indicators
Various monitoring systems that can collect quantitative data
Such as notifiable infectious disease reporting information system, symptom monitoring system, behavioral risk factor monitoring system, etc.
Quantitative data can be provided for outbreak/epidemic early warning mechanisms (EIM).
6. Event-based monitoring
Collecting event information reported from media and Internet searches, news analysis, domestic and foreign notifications, public complaints and reports, health consultations, etc. can also provide clues and basis for EIM.
(2) Monitoring methods and technologies
(1) Case registration
(2) Unrelated anonymous monitoring
(3) Record connection
(4) Collect monitoring information online
(5) Online direct reporting system
(6) Automatic early warning technology
(7) Geographic information system.
(3) Points of attention in public health surveillance
1. Case definition and surveillance cases
2. Static crowd and dynamic crowd
3. In-depth and timely analysis, communication and sharing of monitoring information
4. Confidentiality system
2. Basic procedures
data collection
Data management and analysis
Information exchange and feedback
Information Utilization 4
3. Evaluation
1. Quality evaluation of monitoring system
1. Completeness
Refers to the diversity of monitoring content or indicators included in the monitoring system
Including the completeness of reporting sentinel and surveillance forms, the completeness of case reports, and the completeness of surveillance data.
2. Sensitivity
Refers to the ability of a surveillance system to detect and confirm public health problems
It mainly includes two aspects: the proportion of surveillance cases reported by the surveillance system to the actual cases, and the ability of the surveillance system to judge the outbreak or epidemic of a disease or other public health event.
3. Specificity
Refers to the surveillance system’s ability to rule out non-public health problems
If the surveillance system can correctly identify random fluctuations in disease population phenomena,
Thus, the ability to avoid or reduce early warning and false alarms can be achieved.
4. Timeliness
Refers to the time interval from the occurrence of a public health event to the detection by the surveillance system and feedback to relevant departments.
Reflects the information reporting and feedback speed of the monitoring system.
Timeliness is particularly important for acute infectious disease outbreaks and public health emergencies, which will directly affect the effectiveness and efficiency of intervention.
5. Representativeness
Refers to the extent to which the public health problems discovered by the surveillance system can represent the actual occurrence of the target population.
The lack of representative monitoring information may lead to errors in health decision-making and a waste of health resources.
6. Simplicity
It means that the data collection, monitoring methods and system operation of the monitoring system are simple and easy to implement, have high work efficiency, save time and save health resources.
7. Flexibility
Refers to the ability of the surveillance system to make timely adjustments or changes to new public health issues, operating procedures or technical requirements to adapt to new needs.
2. Benefit evaluation of monitoring system
1. Health economics evaluation
2. Positive predictive value
3. Acceptability
4. Interconnection and sharing between monitoring systems
3. Functional evaluation of the monitoring system
Chapter 9 Prevention Strategies
Section 1 Health, influencing factors and medical model
1. Health: personal health, crowd or collective health.
2. Factors affecting health
(1) Individual factors
1. Genetic and biological factors
2. Lifestyle factors
3. Socioeconomic status factors
(2) Environmental factors
1. Natural environment
2. Built environment
3. Social and economic environment
(3) Health service factors
3. Medical model
(1) Biomedical model
(2) Bio-psycho-social medical model
Section 2 Prevention Strategies and Measures
1. Strategies and measures
1. Strategy: It is the guiding ideology and action plan that leads the overall situation and is formulated to achieve a specific goal. It is strategic and overall;
2. Measures: They are the specific methods and steps taken to achieve the expected goals, they are specific prevention and control means, they are tactical and local.
3. The connection between the two
(1) Strategies and measures are closely related and influence each other.
(2) Only by taking a series of necessary measures that are effective against diseases or health problems under the guidance of effective strategies can the desired results be achieved.
(3) Without considering the feasibility and effectiveness of the measures, it will be difficult to achieve the expected goals.
(4) Although measures are subordinate to strategies, the development of some measures sometimes promotes changes in strategies.
2. Disease prevention
1. Definition of disease prevention
That is, a series of activities to prevent the occurrence of disease (or injury) and disability, and to prevent or delay their development.
2. Natural history of disease
3. Third-level preventive measures
1. First level prevention
definition
also known as etiology prevention
Take measures to target the causes or risk factors before the disease (or injury) occurs, reduce the level of harmful exposure, enhance the individual's ability to resist harmful exposure, prevent the occurrence of the disease (or injury) or at least delay the occurrence of the disease.
It is the fundamental measure to eliminate or eliminate disease (or injury).
measure
①Prevent harmful exposure in the environment
②Improve the body’s resistance: immunization
③Protect individuals from harmful exposures
④Educate individuals to change risky behaviors
2. Secondary prevention
definition
Also known as "three early" prevention, namely early detection, early diagnosis and early treatment
In the early stages of the disease, the symptoms and signs have not yet appeared or are difficult to detect. By detecting and diagnosing the disease early and providing appropriate treatment in a timely manner, there is a greater chance of cure;
Or if the disease is incurable, treatment can be used to prevent the disease from progressing to a more severe stage or at least slow its progression, reducing the need for more complex treatments.
measure
Early detection of diseases can be achieved through screening, case finding, regular physical examinations, etc.
3. Tertiary prevention
definition
Also known as clinical prevention or disease management
After the symptoms and signs of the disease become apparent
In the early stage, appropriate treatment can relieve symptoms, prevent further deterioration of the disease, prevent the occurrence and recurrence of acute events, and prevent the occurrence of comorbidities and disabilities.
In the late stage of the disease, through early detection and management of comorbidities, rehabilitation treatment of existing disabilities can be carried out to restore the individual's physical and social functions to the maximum extent, improve the quality of life, and extend the life span.
Tertiary prevention aims to reduce the burden of disease and disability on individuals, families and society.
measure
Symptomatic treatment and rehabilitation
Understanding of tertiary prevention: (1) In many cases, it is difficult to draw clear boundaries between the various stages of the natural history of the disease, so there are certain difficulties in clearly distinguishing these tertiary preventions. The three are conceptually different. Or sometimes there is some overlap in practice. (2) Similar measures will belong to different levels of prevention due to different target diseases to be prevented.
4. Prevention strategies
1. High-risk group strategy—achieved through health protection
definition
It is a strategy to achieve first-level prevention based on clinical medical thinking.
For a small group of individuals with a high risk of future disease, targeted measures should be taken based on the risk factors to reduce the risk exposure level and the risk of future disease.
advantage
Utilization of resources may be more cost-effective
shortcoming
①Most lifestyles are greatly influenced and restricted by the behavioral norms of the society in which we live and the behavior of the people around us.
② High-risk strategies essentially require a small number of people to behave differently, which undoubtedly limits the effectiveness of this strategy. It is a strategy that treats the symptoms rather than the root cause.
2. Whole-population strategy—achieved through health promotion
definition
It is a strategy to achieve first-level prevention based on public health thinking.
Rather than identifying which individuals are at high and low risk for future disease, by eliminating harmful exposures, especially those environmental exposures that are difficult for individuals to detect or control, or by targeting the determinants of harmful exposures in the population,
That is, measures should be taken to reduce the level of harmful exposure of the entire population based on the cause of the disease, thereby reducing the overall disease burden in the population.
advantage
① It is expected to shift the risk distribution curve of the entire population toward a low-risk direction.
② Promote some or even all high-risk individuals to move out of high-risk areas, and the incidence of outliers will be reduced accordingly.
③Since most people benefit, the total health benefits to the entire population are very considerable
shortcoming
The average gain per person from prevention is negligible.
3. Health protection and health promotion
1. Health protection
Also known as health protection, it means taking targeted measures to protect individuals or groups of people from health threats from harmful substances (such as biological, physical, and chemical harmful substances) from the external environment.
2. Health education
It is to help individuals and groups master health care knowledge and establish health concepts through information dissemination and behavioral intervention. On the premise of obtaining information and improving awareness,
Educational activities and processes to voluntarily adopt behaviors and lifestyles that are conducive to health.
3. Health management
It is the process of comprehensively supervising the health risk factors of individuals or groups, with the purpose of obtaining the maximum health purpose with minimum investment.
The evaluation is based on the individual's health status, that is, based on the individual's disease risk factors, the doctor provides individual guidance, dynamically tracks the risk factors and intervenes in a timely manner.
4. Health promotion
It is the process of enhancing people's ability to control factors that affect their health and improve their own health.
It is a comprehensive social and political activity process
It not only includes health education that directly strengthens individual behaviors and life skills so that people know how to stay healthy
Also includes social action to improve social, economic and environmental conditions through policies, legislation, economic instruments and other forms of environmental engineering to reduce their adverse effects on public and individual health
Thereby creating a socially supportive environment and prompting people to implement behaviors that maintain and improve health
Health promotion covers three strategies, prevention and health education based on medical interventions, and health protection based on legislative, economic or social measures.
Section 3 Disease prevention strategies and practices at home and abroad
1. Basic contents of primary health care
① Carry out publicity and education on current popular health issues and their prevention and control methods;
② Promote food supply and proper nutrition;
③ Supply sufficient safe drinking water and basic sanitation facilities;
④Women and children’s health care, including family planning;
⑤ Carry out immunization against major infectious diseases;
⑥Prevent and control endemic diseases;
⑦Proper treatment and management of common diseases and injuries;
⑧Provide basic medicines.
2. Health status
① People can stay healthy in the families, schools and workplaces where they live and work;
② People will use more effective methods to prevent diseases, reduce the pain caused by inevitable diseases and disabilities, and grow better, grow older, and finally die happily;
③All health resources are equally distributed among all members of society;
④ All individuals and families, through their own active participation, can enjoy basic health care in an acceptable and affordable manner;
⑤ People will realize that they have the ability to shed the burden of disease that can be avoided, shape the lives of themselves and their families, win health, and understand that disease is not inevitable.
3. Three means of health promotion
① Advocacy ② Empowerment ③ Coordination.
4. Five action strategies include
① Develop public policies to promote health
②Create a supportive environment
③Strengthen community action
④Develop personal skills
⑤Adjust the direction of health services.
Chapter 8 Causes, Discovery and Inference
Section 1 Basic Concept of Causes of Disease
1. Definition of cause
(1) Definition 1
causes of disease,
That is, factors or events that can affect the occurrence of future diseases.
(2) Definition 2
Factors that can increase the probability of disease among people,
It can be considered as the cause of the disease,
When one or more of them does not exist,
The frequency of disease occurrence in the population will decrease.
2. Causes and causal relationships
1. Time sequence
The cause event must occur before the effect event.
2. Related relationships
Effect events change with changes in cause events.
3. Due to degeneration
Changes in effect events are caused by changes in cause events.
3. Diversity of causal relationships
1. Single cause and single effect
2. Single cause and multiple effects
suggestive of pleiotropic effects
points to the possibility that blocking or controlling a single cause could prevent many different diseases.
3. Multiple causes and single effect
Revealing the multi-causal nature of disease
It points out the possibility of a multi-pronged approach to control the occurrence and development of a certain disease.
4. Multiple causes and multiple effects
Increased complexity and uncertainty in etiology research
It also reveals the possibility of preventing diseases through multiple ways.
5. Direct causes and indirect causes
① Indicates the existence of a cause chain.
② It is suggested that cutting off any link in the cause chain can achieve the purpose of preventing disease.
③It indicates the possibility of more disease prevention strategies.
4. Steps of causal inference
1. Descriptive research to establish an etiological hypothesis
①Proposing an etiological hypothesis is the starting point for etiological research
Describe the distribution characteristics of the disease among the three regions through current situation surveys and ecological studies,
Compare the reasons for distribution differences to provide clues to the cause.
②Mill’s criterion
The method of finding similarities, the method of finding differences, the method of finding similarities and differences, the method of covariation, and the method of remainder.
2. Analytical research to test hypotheses
① Commonly used case-control studies and cohort studies. Generally, a case-control study is done first, and then a cohort study is done.
③Case-control studies are not limited by the frequency of disease and can obtain results in a short time. However, this study infers "cause" from "effect", so it can only determine the correlation between the two;
④ Cohort studies go from "cause" to "effect". By directly comparing the incidence rates between the exposed group and the non-exposed group, the relative risk is calculated, so that the etiological hypothesis can be tested more effectively.
3. Experimental research to verify the hypothesis
②Most of the research methods used are intervention experiments or quasi-experiments
② By reducing the presence of etiological factors in the population through intervention, the incidence or mortality of the disease will be significantly lower than that of the control group or before intervention, ultimately proving the etiological hypothesis.
4. Causal derivation
(1) Eliminate random errors, spurious and indirect connections, and confounding bias;
(2) Judging causality (Hill criterion)
Time sequence, strength of association, dose-response relationship,
Consistency of results, experimental evidence, biological plausibility,
Biological consistency, specificity, similarity, and predictive power.
Temporal order is a necessary condition for judging causality.
Section 2 Etiology theory and etiology model
1. Triangular model of causes of infectious diseases
1. Definition of the triangular model of the etiology of infectious diseases
The model clearly proposes that there are multiple factors affecting the occurrence and development of infectious diseases in the population, and attributes them to three aspects, namely host, pathogen and environment.
The three are indispensable for the epidemic of infectious diseases, and their relationship can be described by the equilibrium relationship of an equilateral triangle.
Show that they are equal, interrelated and mutually restrictive.
2. Meaning
(1) Within a certain time frame, the three interact and restrict each other to maintain a dynamic balance. Once one or more factors among the three change and destroy this balance, the incidence of disease in the population will increase. Decline or rise, even disappear or cause an outbreak.
(2) Find measures that can be used to cut off any one (or multiple) links in the triangle and block the connection between any two factors to control the epidemic of the disease.
(3) Revealing the existence of factors other than pathogens that can be used to prevent and control infectious diseases
(4) It reveals the possibility of preventing infectious diseases when the pathogen is unknown, which is an important theoretical basis for humans to control infectious diseases.
2. Wheel model of etiology
1. Definition of wheel model
Put sick people or animals at the center
Surrounded by the physical, chemical, biological and social environment in which they live,
The causative factors of infectious diseases are only a part of the biological environment.
2. Meaning
(1) It is believed that the environment, host and pathogens are not in an equal and separate relationship, and their importance is also prioritized. It also suggests the existence of direct causes and indirect causes, as well as the difference between distal causes and proximal causes.
(2) The wheel model also expands the concept of environment, suggesting that more environmental factors can cause disease, pointing out more intervention targets, and providing more options for disease prevention.
3. Ecological model of health determinants
1. Definition of ecological model
It is a further development of the wheel model,
The center of the model is still the human body, including a person's gender, age, genetics and other characteristics
Then classify other causes and divide them into different levels,
Each layer contains many related but different factors.
and emphasize the interaction of various factors on health
2. Meaning
① Reveals more factors that can be used to improve health and prevent disease.
②Individual characteristics are the root cause of disease
③ Indicates the existence of direct and indirect causes
④ Reveals more new ways to promote health and prevent diseases
⑤ Emphasis on the social and ecological factors that people are commonly exposed to, and points out the role of improving the social and ecological environment in preventing diseases.
4. Cause chain
1. Definition of causal chain
Between causes that occur one after another in time and are mutually causal,
And the relationship between these causes and the final disease can be described by a chain of causes.
2. Meaning
① In a cause chain, removing any cause can cut off the entire cause chain, thereby preventing diseases from occurring through this cause chain.
②A disease may have multiple causal chains that act independently or interact with each other.
5. Cause Network
1. Definition of etiology network
Very few diseases have only a single chain of causes,
In fact, a disease often has multiple independent or interrelated causal chains.
Different cause chains of the same disease are interconnected and intertwined.
Forming a more complex and complete etiological relationship network,
This overall network structure of connections from etiology to onset is called etiology network.
2. Meaning
① Removing any factor in a causal chain can completely cut off the entire causal chain, thereby preventing diseases from occurring through this causal chain. This provides multiple options for blocking the causal chain and increases the methods and possibilities of prevention.
② Different causal chains may have different effects on the occurrence of the disease. Effective prevention should cut off the main causal chains.
③ Different causal chains may independently affect the occurrence of the disease, and cutting off multiple causal chains at the same time will definitely prevent more cases.
7. Main uses of etiology models
① Used to explain the relationship between causes and the relationship between causes and diseases
②Indicate the direction of the cause to reveal new causes
③ Used to explain the role of etiology and explain epidemiological concepts and principles.
Section 3 Sufficient etiology-component etiology model
1. Basic concepts
1. Sufficient cause
Consists of one or more component causes
It is the minimum condition required for the occurrence of a disease or the smallest combination of components required for the cause of the disease.
It is a sufficient condition for the occurrence of disease, and its formation is equivalent to the occurrence of disease.
The least means that if one is missing, the disease will not occur, and one more is not necessary for the disease to occur.
2. Component causes
Be a component or subunit of a sufficient cause (e.g., smoking)
One or more component causes constitute a sufficient cause,
A component cause can occur in one or more sufficient causes of a disease.
And they are indispensable. If the cause of any one component is missing, the disease will not occur.
3. Necessary causes
is an essential component of the cause of disease
is a component cause that is required by all sufficient necessary causes of the disease
If the cause of this component does not exist,
Any sufficient cause of the disease would not be realized and the disease would not occur,
If the disease has already occurred, the cause must exist.
4. Complementary causes of component causes
Component causes in the same sufficient cause are complementary component causes.
5. Complementary causes of sufficient causes
All sufficient causes of the same disease are complementary sufficient causes of each other
2. Classification
3. Application
1. The sufficient etiology-component etiology model answers two important paradoxes of the etiology theory.
①Why does the disease occur even though there is no cause?
Because the vast majority of chronic non-communicable diseases have no obvious underlying cause,
Disease can occur through other adequate causes than the cause in question.
②A certain cause exists but the disease does not occur?
It's because the cause of concern is not a sufficient cause.
A disease occurs only when its complementary causes are present,
Most of the causes of chronic non-communicable diseases fall into this category.
2. Prevent all cases that can occur through these sufficient causes
Because any component cause is a necessary cause for a sufficient cause that requires it,
So removing any one component cause is equivalent to removing all the sufficient diseases associated with it.
3. Explain many core concepts of epidemiology
Such as incidence rate, size of exposure or treatment effect, effect modification, attributable risk, disease latency, etc.
Section 4 Discover and verify the cause of disease
1. Rules and methods for discovering the cause of disease
(1) Basis for studying the causes of disease
Three basic conditions for causality
(2) Rules for discovering the cause of disease
Mill's laws of causal inference. ️
(3) Research methods to discover the cause of disease
Koch's Laws for the discovery of infectious disease pathogens,
Detect chronic non-communicable diseases,
Epidemiological studies of multiple etiologies. ️
(4) Etiology inference
Hill's 9 criteria for etiological inference,
Systematic review,
GRADE's inference principles.
2. Mill’s law of causal inference
1. Seek common ground
Observe different occasions when a certain phenomenon occurs
If all but one condition is the same on different occasions, the other conditions are different
This same condition may be the cause of a certain research phenomenon.
2. Seeking differences
Compare situations where a phenomenon occurs and situations where it does not occur
If these two situations are the same except for one difference
This difference is the reason for this phenomenon.
3. The method of finding common similarities and differences (or simply the method of finding together)
If there is only one common factor in various occasions when a certain phenomenon under examination occurs (seeking common ground)
And there is no common factor in all the occasions where the phenomenon under investigation does not occur (seeking agreement)
This common factor (multiple differences) is the cause of the phenomenon under examination.
4. Co-variation method
When there is a variation or a change in a certain phenomenon,
There is a corresponding variation or subsequent change in another phenomenon,
Regardless of the variations and changes in the latter, there may be a causal relationship between the two.
5. Residual method
If a compound phenomenon is determined to be caused by a compound cause,
Subtract the parts that have been confirmed to have causal connections, and the remaining parts must also have causal connections.
3. Mill’s Law and Epidemic Research Design
Muller's law is the logical basis for epidemiological research design, suggesting the experimental sequence of different research designs.
Seek common ground
Can be used to formulate hypotheses about etiology
Common search method and common change method
Can be used to initially verify the existence of the cause
Contrast comes from difference method
Indispensable criteria for studying causal relationships
Cohort studies and randomized controlled trials
Organically integrates Mill's four laws,
And at the same time, the time sequence and variability of cause and effect were verified.
It is the most reliable method to verify causality in the population.
Section 5 Causal Relationship Inference
1. General principles of scientific inference - three levels and two aspects of etiological inference
(1) Three levels of etiological inference
①Inferences within a single study (authenticity)
②Inference based on all existing similar studies
③Inference based on all relevant evidence
(2) Two aspects of etiology inference
①Inference from over-qualitative conclusions
②Inference on quantitative results
2. Evaluate the authenticity of a single study
(1) Authenticity and research quality
Study quality is an overall measure of the degree to which research bias is controlled
Research quality determines the authenticity of research results
The higher the quality, the smaller the bias,
The higher the authenticity of the results, the
The more likely it is that the conclusion is correct.
(2) Factors that determine research quality
(1) Research design type
(2) Bias control measures
(3) Sample size
(3) Methods to evaluate research quality
Research design and evidence quality, in order from high to low, are
Cohort study️→Case-control️→Cross-sectional study️→Case series study
3. Inference based on comprehensive evidence: Hill’s criterion for etiological inference
1. Hill’s etiology inference criteria
1. Time sequence
The time relationship in which the cause must occur before the effect is a necessary condition for judging causality.
(2) Association strength
It is an indicator used to evaluate the degree of correlation between the cause and the disease.
It is generally measured by relative risk indicators, such as relative risk and odds ratio.
(3) Dose-response relationship
Refers to the phenomenon that the incidence of disease changes with the intensity or number of suspected causes.
(4) Consistency of results
Also called reproducibility, it refers to the consistency of similar research results.
The higher the consistency, the greater the likelihood of a causal relationship.
(5) Experimental evidence
Refers to experimental research evidence about a relationship
Studies on the causes of disease in the population are all observational studies.
This can be confirmed with more reliable experimental studies.
(6) Biological plausibility
The degree to which a certain etiological hypothesis is consistent or consistent with facts, knowledge, and theories related to the disease,
or to the extent that the former is not inconsistent with the latter.
The higher the biological plausibility, the greater the likelihood of causation.
(7) Biological consistency
Refers to a certain etiological hypothesis combined with existing more general biomedical facts,
The greater the biological consistency, the greater the likelihood of causation.
The extent to which knowledge and theory are consistent or consistent, or the extent to which the former can be explained by the latter.
(8) Specificity
Refers to the degree of exclusivity or specificity between a cause and a disease
If one cause can only cause one disease,
The higher the specificity, the greater the likelihood of causation.
or causes disease only in a special group of people, and the disease has only one cause,
The relationship between the cause and the disease is highly specific.
(9) Similarity
Refers to the existence of known similar causes and causal relationships of diseases,
The possibility of new causal relationships will be enhanced by the existence of comparable causal relationships.
(10) Predictive power
Use the theory to make a prediction about the future or the past,
Data is then collected to evaluate the accuracy of the predictions.
2. Supplement to Hill’s Criterion
1. Time sequence, correlation strength and dose-response relationship are necessary and specific conditions for judging causality. Necessary means that they must exist, and if they do not exist, the existence of causality can be denied; specific means that these two conditions are unique to establishing causality, and are information that must be provided for every etiology study, but they are not arguments. Necessary conditions for other questions, such as when demonstrating diagnostic accuracy, are not required.
2. The other seven conditions are: information between relevant studies or knowledge outside of epidemiological studies. They are non-specific conditions and are general standards used in scientific inferences, among which the consistency of results is the most important. They are non-essential conditions, that is, the lack of any one or all seven items is not enough to deny the existence of causality.
3. All 10 conditions are not sufficient conditions: Even if the relationship between two events meets all 10 conditions, it cannot be 100% sure that it is a causal relationship.
3. The Hill criterion has several obvious and important flaws.
1. Failure to consider whether the original research collected is comprehensive and complete.
2. There is no evaluation of the authenticity of the original research evidence.
3. The Hill criterion conflates information provided within a study and that can be observed between studies with information outside epidemiological studies and considers them to be equally important.
4. Consistency is the most critical condition, but Hill has no quantitative definition of what consistency is, so it is difficult to judge.
4. Inferences from all the evidence: a systematic review
Chapter 7 Screening
Section 1 Overview
1. Definition of screening or screening
1. Definition
Targeting preclinical or early disease stages
using quick and easy tests, inspections or other methods,
Taking those individuals who may be sick or defective but appear to be healthy from a population of people whose disease is unnoticed or undiagnosed,
A series of medical and health service measures to identify those who may not be sick
2. Diagram of natural history of disease and screening
3. Screening flow chart
4. Concept explanation
Screening is generally led by national or regional governments.
A systematic project that mobilizes the participation of the whole society, also known as "three mornings" prevention,
Including early detection of target diseases, early diagnosis, and treatment of positive patients at various stages (early treatment)
and a series of medical and health service practice activities for medical follow-up of negative patients.
2. Purpose and type of screening
(First, the purpose
(1) Discover hidden cases (secondary prevention)
For example, there are a large number of undiagnosed diabetic patients among healthy people.
Diabetes screening can detect these patients as early as possible.
(2) Identify high-risk groups (primary prevention)
Such as screening for high blood pressure to prevent stroke,
Screening for hypercholesterolemia prevents coronary heart disease.
(3) Understand the natural history of diseases and reveal the “iceberg phenomenon” of diseases
Cervical cancer screening for rural women through large population screening,
(4) Guide the rational allocation of limited health resources
(2) Type
1. According to the scope of screening objects
(1) Cluster screening
Refers to situations where the disease incidence (incidence) rate is very high,
Conduct undifferentiated universal screening of all subjects within a certain range of people.
(2) Selective screening
Also known as high-risk population screening,
It refers to selecting people at high risk of a disease for screening.
Examples include annual lung cancer screening for smokers over the age of 60 and silicosis screening for miners.
2. According to the number of screening items
(1) Single screening test
Refers to using a screening test to screen for a disease.
(2) Multiple screening tests
Refers to the use of multiple screening tests to screen for a disease.
For example, if chest X-ray, erythrocyte sedimentation rate, and Mycobacterium tuberculosis in sputum are used to detect suspected pulmonary tuberculosis patients at the same time,
It can increase the probability of patient detection.
(3) Screening for multiple diseases
It is to carry out screening for multiple diseases in a group of people at the same time.
For example, the “Two Cancers (Breast Cancer and Cervical Cancer) Screening” carried out among rural women in my country,
Health resources can be saved to the greatest extent.
3. According to the purpose of screening
(1) Therapeutic screening
such as colorectal or breast cancer screening,
Can detect and treat early stage patients for therapeutic screening
(2) Preventive screening
Screening for high blood pressure, for example, can prevent stroke.
4. According to the method of screening organization
(1) Proactive screening
It is to take the initiative to attack.
Through organized publicity and introduction,
Mobilize the public to go to screening service locations for examination.
For example, newborn disease screening.
(2) Opportunistic screening
It is a passive screening test.
It combines routine medical services with screening.
During the patient treatment process, non-specialist patients are screened.
It can expand the coverage of screening and increase participant participation.
For example, the non-hypertensive clinic carries out the "blood pressure measurement for first-time patients" project.
3. Implementation Principles of Screening
1. Screening diseases
(1) The screened disease or related health status should be a major public health problem in the area at this stage, which can cause serious harm to the health and life of the population, have a high prevalence or mortality rate, and is one of the main causes of death for the population.
(2) The natural history of the target disease is clear, there is a long enough preclinical period and identifiable disease markers, there are methods for early diagnosis, and early intervention can significantly reduce mortality.
(3) Have a clear understanding of the intervention effects and adverse reactions at different stages of the disease.
2. Screening test
(1) Screening tests should be accurate, simple, economical, safe, and easily accepted by subjects.
(2) There are screening methods available that meet different levels of economic development and health resources.
3. Disease treatment
There are effective intervention programs for different stage outcomes detected by screening.
And ensure that early treatment should be better than late treatment.
4. Screening project implementation plan and evaluation
(1) Whether the target group is clear;
(2) Whether the screening-treatment procedure is effective, whether it has health economic value, whether it complies with the principles of fairness, accessibility, and ethics, and whether the benefits to the population outweigh the harm.
(3) It is also necessary to evaluate the quality control, funding guarantee and project risk response mechanism of screening.
Section 2 Evaluation of Screening Tests
1. Definition of screening test
1. Definition
Methods used to identify individuals who may have a disease or are at risk for a disease in an apparently healthy population
It can be questionnaires, physical examinations, X-rays and other physical examinations, or cytology or biological macromolecule marker detection technology
A good screening test should have good authenticity, reliability and predictability
2. Characteristics
①Simplicity
It means easy to learn and easy to operate.
Even non-professionals can operate it with proper training.
②Cheapness
In principle, when the health benefits are certain,
The lower the cost of a screening test, the better.
③Quickness
It means getting results quickly.
④Safety
It means it will not cause trauma to the subjects.
In principle, the initial screening method should not use inspection methods that may cause trauma (such as tissue biopsy, endoscopy, etc.).
⑤Acceptability
Refers to being easily accepted by the target group.
3. Differences from diagnostic tests
(1) Screening test
①Purpose
Distinguish between individuals who may have the disease and those who may not
②Object
Apparently healthy people or asymptomatic patients
③Requirements
Fast, simple, non-invasive and easy to accept, with high sensitivity,
Find as many possible patients as possible
④Result
Positive (suspected case)/negative (possibly disease-free)
⑤Expenses
Economical and cheap
⑥Processing
Those who are positive should undergo further diagnostic tests to confirm the diagnosis
(2) Diagnostic test
①Purpose
Distinguishing sick people from people suspected of having the disease but not actually having the disease
②Object
Patients or those who screen positive
③Requirements
Complex, high sensitivity and specificity,
Results are more accurate and authoritative
④Result
Case/non-case
⑤Expenses
Generally more expensive
⑥Processing
Those who are positive should be closely observed and treated promptly
2. Evaluation methods and indicators for screening tests
(1) Authenticity
1 Overview
1. The meaning of authenticity
Also known as validity or accuracy
Refers to the degree to which the measured value is consistent with the actual value.
2. Authenticity evaluation
Using the idea of comparative research,
Compare screening tests to standard methods of disease,
That is, the degree of consistency of the “gold standard” judgment results.
2. Research design
(1) Case-non-case (control) design with hospital as the research site
①Meaning
That is, first use the "gold standard" to determine the affected and non-affected groups of a certain disease;
Randomly select the case group and non-case group,
The two groups of subjects are then blindly tested using the screening test to be evaluated;
②Features
①Relatively economical and easy to operate,
②Wide scope of application
③Special attention should be paid to the representativeness of the case group and non-case group to the screening target population.
④The case-non-case design cannot directly calculate the predictive value.
③Design points
1. Determine the gold standard
①Meaning
Refers to the most accurate and reliable method for diagnosing diseases currently recognized by the clinical medical community.
②Purpose
Accurately distinguish whether the subject is a patient of a certain disease
③Common gold standard types
There are pathological diagnosis, biopsy, surgical findings,
Microbial culture, autopsy or special examination, imaging diagnosis, comprehensive clinical judgment, etc.
2. Select research objects
①General principles
Subjects should be representative of the target population for which the screening test may be used,
And try to meet the random sampling principle.
②Specific requirements
(1) Case group
The purpose of screening is to detect preclinical or early-stage patients,
Case selection should include cases with mild symptoms of early disease.
The various clinical types of the disease (different degrees of illness, course, typical and atypical, etc.) should also be considered
(2) Non-case group
Those who are confirmed by the gold standard as not suffering from the target disease,
Include non-patients and/or patients with diseases that are easily confused with the target disease.
3. Sample size calculation
①The sensitivity of the screening test is used to estimate the sample size of the case group.
②The specificity of the screening test is used to estimate the sample size of the non-case group.
③ Significance test level α; ④ Allowable error δ.
4. Determine screening outcome classification criteria or cutoff values
①The results of the screening test need to have clear and clearly differentiated positive and negative judgment criteria.
② If the screening test is a classification or grade indicator, positive or negative can be determined based on professional knowledge;
③If the test value is a continuity indicator, the specific value for judging a positive result, that is, the cut-off value, needs to be determined.
5. Blind measurement
Ensure that cases and controls are included in the entire examination process, including archiving, collection of biological materials, and testing procedures.
Each link in the result analysis report is treated consistently.
Blinding is generally used to control information bias.
(2) Cross-sectional design with the community as the research site
①Meaning
That is to draw a representative sample of the target population,
At the same time, all study subjects were tested blindly using gold standards and screening tests.
Afterwards, the case group and non-case group were judged based on the gold standard test.
②Features
①The sample is more representative of the target population for screening
②The predictive value indicator can also be directly estimated
③The required sample size is large and the research cost is high.
3. Data compilation and authenticity evaluation indicators
1. Data organization
1. Form organization
2. Related concepts
(1) True positive (TP)/false negative (FN)
Patients diagnosed by the gold standard,
Those judged positive by the screening test are called true positives (TP);
Those judged to be negative are called false negatives (FN).
(2) False positive (FP)/true negative (TN)
Non-patients diagnosed by gold standard
Those judged as positive by the screening test are called false positives (FP);
If it is judged to be negative, it is called true negative (TN).
2. Authenticity evaluation index
(1) Sensitivity/false negative rate
①Sensitivity
①Definition
Also known as true positive rate
That is, the percentage of people who actually have the disease and are judged positive by the screening test criteria,
It reflects the screening test's ability to detect patients.
②Formula
②False negative rate
①Definition
Also called missed diagnosis rate,
Refers to the percentage of people who actually have the disease but are determined to be negative by a screening test,
It reflects cases where screening tests miss patients.
②Formula
It is a complementary relationship, sensitivity = 1-false negative rate
(2) Specificity/false positive rate
①Specificity
①Definition
Also known as true negative rate
That is, the percentage of people who are actually disease-free and judged negative by the screening test criteria.
It reflects the ability of a screening test to identify and exclude patients.
②Formula
②False positive rate
①Definition
Also known as misdiagnosis rate
That is, the percentage of people who are actually free of the disease but are judged positive by a screening test.
It reflects situations where screening tests misdiagnose patients.
②Formula
It is a complementary relationship, specificity = 1-false positive rate
(3) Correct index
①Definition
Also called Youden index
is the sum of sensitivity and specificity minus 1
Indicates the overall ability of a screening method to identify true patients from non-patients.
The correct index range is between 0 and 1.
The larger the index, the higher the authenticity.
②Formula
(4) Likelihood ratio (LR)
①Definition
It is a comprehensive index that reflects both sensitivity and specificity.
When selecting a screening test, one should choose one with a high positive likelihood ratio,
Methods with low negative likelihood ratios have the best accuracy of the test.
② Calculated based on screening results
①Positive likelihood ratio (LR)
①Definition
The ratio of the true positive rate to the false positive rate of a screening result.
The larger the ratio, the greater the probability that a positive test result is a true positive.
②Formula
②Negative likelihood ratio (-LR)
①Definition
The ratio of the false negative rate to the true negative rate of a screening test result.
The smaller the ratio, the greater the probability that a negative test result is a true negative.
②Formula
(2) Reliability
1 Overview
(1)The meaning of reliability
Also called reliability, precision or repeatability
means that under the same conditions,
When the same subject is repeatedly measured using a measurement tool (such as a screening test),
consistency of results
The reliability evaluation has nothing to do with the result of gold standard diagnosis of disease.
(2) Research design
①Concept
Reliability evaluation research is usually carried out simultaneously with authenticity evaluation.
Two or more examiners use the same examination procedure to conduct simultaneous blind examination of the study population.
②Example
① Multiple people read a batch of X-ray films at the same time;
② Use the same method to test the same group of people multiple times, such as repeating blood pressure measurements three times, and then compare the consistency of the results.
2. Reliability index
(1) Data on continuity measurement
① For multiple repeated measurements of the same sample or a group of homogeneous samples (samples with small individual differences), the standard deviation and coefficient of variation can be used to reflect reliability. The smaller the values of the two indicators, the higher the precision of the method. The higher
② Carry out two repeated measurements on a batch of heterogeneous samples (objects), and the correlation coefficient (r) of the two measured values can be used to evaluate the degree of consistency. Generally, if r>90%, it can be considered that the consistency of the screening method is good.
③ Paired t test can also be used to analyze the consistency of repeated measurement results. If the difference between the two groups is not statistically significant, it can be considered that the consistency of repeated measurements is good.
(2) Classified measurement data
①Table organization format
It is generally organized into a matching four-grid table.
Note that the numbers in the grid indicate the frequency of consistent/inconsistent results between the two tests.
②Common evaluation indicators
①Conformity rate (consistency rate)
②Kappa value
①Definition
Often used to evaluate the consistency of two test results,
Its calculation takes into account the impact of chance factors and is a more objective indicator.
The value range is [-1, 1]
②Calculation formula
③Meaning
①Kapp value ≥0.75 means excellent consistency;
② Between 0.4 and 0.75, it is medium or highly consistent;
③When the Kappa value is ≤0.40, the consistency is poor.
3. Factors affecting the reliability of screening tests
(1) Biological variation of subjects
Due to biological variations such as individual biological cycles,
This causes fluctuations in clinical measurement values obtained from the same subject at different times.
(2)Observer
Because the technical level of the same measurer varies between measurers and at different times,
Differences in size control and expectation bias can lead to inconsistent results from repeated measurements.
(3)Laboratory conditions
When measurements are repeated, the measuring instrument is unstable and the test method itself is unstable.
Kits produced by different manufacturers or from different batches produced by the same manufacturer have different purity and content of active ingredients.
(3) Predicted value
1. Concept
Positive and negative screening test results are used to estimate the likelihood that a subject is a patient or non-patient.
This type of indicator reflects the benefits obtained after the screening test is actually applied to population screening.
2. Methods for estimating predicted values
1. Direct calculation method → carried out in the community
(1) Positive predictive value (Pr)
①Definition
Among those who were found positive by screening
Proportion of people with target disease
formula
(2) Negative predictive value (Pr-)
①Definition
Among those who were found negative by screening
Proportion of people who do not have the target disease
②Formula
2. Indirect calculation method → carried out in hospitals
3. The relationship between predicted value, authenticity index and prevalence rate
(1) The impact of prevalence rate on predicted value
When the sensitivity and specificity are constant, that is, when the screening test is constant
Disease prevalence decreases, positive predictive value decreases, negative predictive value increases
(2) The impact of sensitivity and specificity on predicted values
When the population prevalence remains unchanged
① Sensitivity increases and specificity decreases,
The positive predictive value decreases and the negative predictive value increases.
②Explanation
Since the base of the non-disease population in the natural population is always much larger than the disease population
Among them, the increase in the number of false positives will be much greater than the number of true positives, and the denominator will increase more significantly than the numerator.
② Sensitivity decreases and specificity increases,
The positive predictive value increases and the negative predictive value decreases
(4) Determine the positive cutoff value of the continuity measurement index
1. Independent bimodal distribution
1. Distribution map
2. Distribution explanation
① There is no overlap in the distribution curves of patients and non-patients.
② In principle, the cutoff value is selected at the minimum value H among patients, and the judgment accuracy of the screening test can reach 100%.
③The cutoff value is usually determined based on the upper limit of the 99% to 99.9% CI of the non-patient test value.
④ For diseases with extremely low incidence (<10/100,000), an upper limit of 99.9% can be selected to ensure 100% sensitivity and avoid excessive false positive detection rates.
2. Partially overlapping bimodal distribution
1. Distribution map
2. Distribution explanation
①The distribution of the total population is bimodal, and the distribution curves of patients and non-patients overlap in a small part. Between H and X there are both patients and non-patients, forming an overlapping area.
② When the cutoff value moves toward the highest value direction (X) of non-patients, the specificity increases, the sensitivity decreases, and more non-patients can be found.
③When the cutoff value moves toward the patient's lowest value direction (H), the sensitivity increases and the specificity decreases. Can detect as many suspicious patients as possible.
3. Requirements for selecting cutoff values
① If the prognosis of the disease is poor, missed diagnosis of patients may bring serious consequences, and there are currently reliable treatments, the cutoff value should be moved in the direction of increasing sensitivity, that is, moved in the direction of the highest value for non-patients (X), as much as possible Suspicious patients are found in many places, but this will increase false positives.
② If the follow-up diagnosis and treatment method of the disease is not ideal, the cutoff value should be moved in the direction of improving specificity, that is, in the direction of the lowest value (H) for patients, to identify non-patients as much as possible and reduce the psychological impact of false positives on participants. Stress, such as liver cancer screening.
③Screening tests should comprehensively consider sensitivity and specificity to achieve a balance, and set the critical point at the junction of the distribution curves of non-patients and patients. In actual operation, the receiver operating characteristic curve (ROC) is generally used to determine the optimal cutoff value.
4. Basic principles of ROC curve
1. ROC curve chart
2. Basic principles of ROC curve
A series of cutoffs can be divided by ranking patient and non-patient measurements from smallest to largest.
The corresponding sensitivity and specificity can be calculated for each cutoff value.
Plot 1-specificity as the abscissa and sensitivity as the ordinate,
The sensitivity and 1-specificity values corresponding to each cutoff value constitute the coordinate point,
Connecting multiple coordinate points is the ROC curve
3. Function
① The coordinate point closest to the upper left corner of the coordinate axis can simultaneously satisfy the relatively optimal sensitivity and specificity of the screening test, and its corresponding value is the optimal cutoff value.
② The surface area (AUC) formed by the ROC curve and the X-axis can reflect the authenticity of the detection method
③The closer the AUC is to 1.0, the higher the authenticity of the detection method; when it is equal to 0.5, the authenticity is the lowest and has no application value.
④The area under the AUC curve can also be used to directly compare the authenticity of two or more screening tests.
3. Unimodal continuous distribution
1. Distribution map
2. Distribution explanation
① The distribution of the total population is unimodal, and the distributions of patients and non-patients are intertwined with each other, resulting in poor discrimination. At this time, no matter how the cutoff value is selected, there may be a large misjudgment rate.
②This type of indicator is usually used as a preliminary screening method. The cutoff value can be selected as the inflection point in the graph. At this time, although the misdiagnosis rate is high, missed diagnosis can be avoided as much as possible.
③If the measured values of patients are completely included in the range of non-patients and have a wide distribution, it is not appropriate to use this type of indicator for disease screening.
Section 3 Evaluation of Screening Effects
1. Screening effect evaluation stages and research methods
1. The first stage (on-site intervention study)
Generally, rigorously designed randomized controlled trials are used.
The research subjects are divided into two groups randomly either individually or as a cluster.
The intervention group needs to undergo continuous periodic screening.
The control group received routine medical services.
2. The second phase (screening demonstration area construction phase)
This stage uses multi-center community experimental research.
Continuous observation of biological indicators and health economics effect indicators of mid- and long-term effects of screening
and the occurrence of adverse events in screening and treatment, etc.
Explore how screening works in real-world settings.
3. The third stage (verification and application stage)
At this stage, observational research methods are mostly used to further verify under real conditions;
The long-term biological effects of screening, the health economic benefits and the sustainability of the program.
Commonly used epidemiological methods include retrospective cohort studies, case-control studies, and ecological studies.
2. Screening project evaluation content and indicators
(1) Income
1. Definition
Also called harvest,
Refers to how many previously undetected patients can be treated through screening
(Preclinical patients, high-risk groups) receive diagnosis and treatment
This type of indicator reflects the benefits of early diagnosis and early treatment due to screening in the short term.
2. Commonly used indicators include
①Positive predictive value
This is the most commonly used revenue metric
The positive predictive value is high, indicating that among the positive people screened,
The proportion of real patients is high and screening has high efficiency.
②Referral rate or screening positive rate
That is, the proportion of the number of people who screen positive to the number of people who are screened.
Referral rates are related to high sensitivity or low specificity of screening tests,
If the target population base is large, this indicator should not be too high.
Otherwise it does not comply with the principles of health economics.
③Early diagnosis/early treatment rate
That is, the proportion of early cases among all cases detected by screening,
If the early diagnosis rate of screening is significantly higher than the early diagnosis rate of normal medical procedures,
It can be considered that the benefits of screening are better.
3. Methods to increase screening income
1. Strategies for high-risk groups
Screening among high-risk groups can increase the positive predictive value,
It is also more in line with the principle of low cost and high efficiency.
2. Choose a reasonable screening plan
(1) Choose a high-sensitivity method
If early diagnosis of the disease being screened is significant,
The purpose of screening is to avoid missing cases as much as possible,
Highly sensitive methods should be chosen whenever possible.
(2) Use joint testing
①Meaning
When implementing screening, two or more screening tests can be used to examine the same subject,
To improve the sensitivity or specificity of screening and increase the benefits of screening,
This method is called joint testing.
②Form
①Series test
①Definition
Also called series of tests,
That is, a set of screening tests are connected in a certain order.
Those who are positive in the initial screening will enter the next round of screening.
A person is considered positive only if all screening test results are positive.
This method can improve specificity, but will reduce sensitivity.
②Example
For example, to screen for diabetes, first conduct a urine glucose test.
Those who are positive will have their blood sugar checked 2 hours after the meal.
A screening test is considered positive only if both are positive.
In order to further confirm the diagnosis of glucose tolerance.
③Meaning
For the initial screening method, try to choose a method with high sensitivity.
For the second round of screening, methods with higher specificity should be chosen as much as possible.
②Parallel test
Also called parallel testing,
That is, all screening tests are carried out in parallel at the same time,
A positive result on any one of the screening tests is considered positive.
This method can make up for the problem of insufficient sensitivity of both methods.
Improves the overall sensitivity of screening, but reduces specificity.
When designing parallel screening programs, the cost-benefit ratio of screening methods should be fully considered.
(3) Starting age and screening interval for screening
①General principles
It should be determined based on the point at which the population will benefit most.
②Starting age
such as cervical cancer screening
Starting screening after the age of 30 can detect 92% of early cancers.
Based on this, the starting age for screening can be determined to be 30 years old.
③Screening interval
Screening intervals should be adjusted based on the accuracy of the method,
Using methods with high sensitivity and specificity, screening intervals can be longer;
Less sensitive methods that can reduce missed diagnoses by increasing screening frequency
(2) Biological effect evaluation
1. Definition
Screening can improve the middle of the disease
or terminal outcome status (morbidity or prognosis).
Usually the adoption rate indicator.
The effectiveness of screening is generally demonstrated through comparative studies.
Therefore, it is necessary to calculate the relative comparison index.
2. Effect evaluation indicators
1. Outcome measurement indicators
(1) Attributable mortality rate
①Meaning
It is an end-point outcome indicator to evaluate the long-term benefits of the screening population.
The effectiveness of screening can be illustrated by comparing differences in mortality between people who are screened and people who are not screened.
②Example
For example, some countries have used urine testing for vanillic acid (VMA) acid to screen children for neuroblastoma.
The project was terminated after decades of operation because no subsequent reduction in population-attributable mortality was observed.
It can be seen that the reduction of attributable mortality is the most convincing conclusive indicator in the evaluation of screening effectiveness.
(2) Cure rate, recurrence rate, mortality rate, survival rate and survival time
①Meaning
These are intermediate outcome measures for assessing early or medium-term benefit in the screened population.
If screened cases have lower recurrence or mortality rates than unscreened cases,
A higher survival rate or longer survival time indicates that screening may be effective.
1-year, 3-year, and 5-year survival rates are commonly used to evaluate cancer screening programs.
②Attention
Attention should be paid to the impact of time-related bias such as lead time and disease duration.
2. Related indicators
(1) In randomized controlled trials
Commonly used indicators include effectiveness index (IE), protection rate,
Attributable risk or absolute risk reduction (AR)
(2)Under observational study
①Cohort study
Attributable mortality risk ratio (RR) between screened and non-participated populations
②Case control
Odds ratio (OR) of death cases and controls participating in screening
3. Number of people to be screened (NNBS)
In screening studies, mortality from the target disease is used as the outcome measure.
After a certain period of follow-up,
Calculate the difference in disease-attributable mortality (AR) between the control group and the screening group
Taking the reciprocal value of AR, we get NNBS=1/AR
This indicator represents one fewer death from a target disease case,
How many people need to be screened? The smaller the number, the better.
(3) Health economics evaluation
1. Screening costs
It is the resource consumed in the process of providing health services.
Screening costs include program costs (expenses for program training, management, organization),
Personal direct costs (diagnosis, treatment, transportation and escort, etc.) and personal indirect costs (loss of productivity), etc.
2. Cost-effectiveness analysis
Effect refers to the biological effect achieved in terms of health improvement after the screening program is implemented.
For example, the recurrence rate and mortality rate are reduced, and the survival period is prolonged.
The cost-effectiveness indicator is the cost-effectiveness ratio (CER), such as the cost per one year of extended survival.
3. Cost-utility analysis
Utility is an indicator that combines biological effects with people's subjective feelings about the results and functional status.
It cares not only about how long patients can survive, but also about the quality of survival.
The indicator of cost-utility analysis is cost-utility ratio (CUR).
4. Cost-benefit analysis
Benefit refers to the monetary value of improved health outcomes.
Cost-benefit ratio (CBR) is the best evaluation indicator in the economic evaluation of public health projects.
Note that currency values may change over time,
Currency discounts and changes in interest rates need to be taken into account.
5. Health Economics Model
Commonly used methods mainly include Markov models.
(4) Safety and ethics evaluation and project sustainability evaluation
1. Safety and ethical issues
2. Policy, economic and human support environment
3. Crowd acceptance
3. Common biases in screening effectiveness evaluation
1. Leading time bias
(1)Schematic diagram
(2) Definition
Refers to the time point (age) of preclinical screening diagnosis
The time interval to the time of routine clinical diagnosis (age)
It is the natural course stage of the disease.
If screening only detects the disease earlier,
The illusion that screened people live longer than unscreened people will be observed
That is, lead time bias.
When evaluating the screening effect using life years as an indicator, the leading time should be deducted.
Otherwise, the screening effect will be overestimated.
(3)Example
For example, the average age at clinical diagnosis of cervical cancer is 50 years old.
If the sick people are screened between the ages of 30 and 50,
Then the average age of diagnosis can be advanced to 45 years old, with a lead time of 5 years.
2. Disease course bias
The likelihood of a disease being detected is related to how quickly the disease progresses.
If patients with slowly progressive disease (lung cancer, adenocarcinoma) account for a larger proportion in the screening group,
It may be observed that the screened group has a higher probability of survival or a longer survival time than the unscreened group.
There will be a disease duration bias.
The effectiveness of screening is overestimated.
3. Volunteer bias
Health behaviors may determine willingness to screen,
Those who participate in screening may have higher education levels and better personal economic status than those who do not participate.
Pay more attention to your own health and have lower incidence of bad behaviors and habits.
The risk of morbidity or death may be lower among people who are screened than among people who are not screened.
The effectiveness of screening is overestimated.
4. Overdiagnosis bias
Screening detects too many early cases and increases the burden of diagnosis and treatment.
This phenomenon is called "overdiagnosis."
These indolent cases are detected through screening,
Diagnosed with the disease and included in the patient population,
Patients that lead to discovery have more survivors or longer mean survival,
overdiagnosis bias
Screening effectiveness is overestimated.
Chapter 6 Experimental Epidemiology
Section 1 Overview
1. Definition
According to the research purpose, the researcher
Randomly assign research subjects to experimental groups and control groups according to a predetermined research plan
artificially impose or reduce certain processing factors
Then track and observe the effects of the processing factors
Compare and analyze outcomes between two groups of people
To judge the effect of treatment factors.
2. Basic characteristics and uses
(1) Characteristics
①It is a prospective study
② One or more intervention treatments must be applied
③The research subjects are from a general population that meets the inclusion and exclusion criteria and signed informed consent.
④ Form experimental groups and control groups through random allocation
(2) Purpose
①Verify the hypothesis of etiology
②Evaluate the effectiveness of disease prevention and treatment, such as the effectiveness of vaccines in preventing infectious diseases
③The effect of comprehensive intervention measures, such as dietary adjustment, appropriate exercise, smoking cessation and alcohol restriction, in preventing chronic non-communicable diseases
④Evaluate the effectiveness of health care strategies and policy implementation. For example, in disease treatment studies, the effect of a single drug, combination of drugs, surgery or treatment regimen can be evaluated.
3. Main types
(1) Three common types
(1) Clinical trial RCT
1. Definition
Also called a randomized controlled trial or randomized clinical trial (RCT),
Emphasis on grouping trials and applying intervention measures based on individual patients.
Patients can be both hospitalized and non-hospitalized.
It is usually used to test and evaluate the effect of a certain drug or treatment method.
2. Features
①Take patients as research subjects.
②Research is mostly conducted in hospitals.
③Most of them are therapeutic trials.
④The research subjects should be as consistent as possible in terms of baseline characteristics.
⑤ Randomly allocate treatment measures and hide the allocation plan as much as possible.
⑥Use blinding method as much as possible.
⑦ If there is no current treatment for the disease under study, a placebo can be used as a comparison.
3. Principle diagram
4. Clinical staging - pre-market clinical trials
(1) Phase I
Through tolerance testing and pharmacokinetic studies,
To determine the safe and effective dosage range of new drugs
And the rules of drug absorption, metabolism and elimination in the human body.
Usually performed on 20-80 volunteers.
(2) Phase II
In a small number of specific cases,
Conduct rigorous randomized blinded clinical trials under controlled conditions,
To further determine the safety and effectiveness of this drug.
Usually no more than 200 people.
(3) Phase III
performed on a larger number of cases,
It is a randomized multicenter clinical trial.
The purpose is to evaluate the safety, effectiveness and optimal dosage of drugs.
Usually hundreds or thousands of people are needed.
Premarket clinical trials
(4) Stage IV
Further observe the efficacy and monitor side effects.
Post-market surveillance
(2) On-site
1. Definition
Also called a population prevention trial
Using people who are not yet sick as research subjects,
The basic unit subject to treatment or some preventive measure is the individual, not the subpopulation.
For example, influenza A (H1N1) vaccine trials and EV71 vaccine phase II and phase III clinical trials are all field trials.
2. Features
①Research subjects are usually non-patients;
②The research locations are communities, schools, factories and other sites;
③Most of them are preventive tests;
④ Usually requires more research subjects;
⑤Measures need to be randomly assigned on an individual basis;
⑥The extent and reasons for non-compliance with assigned measures should be measured;
⑦Use blinding method as much as possible.
3. Principle diagram
4. Field trials compared with clinical trials
① Requires more research subjects and higher costs
② It is mostly used in preventive research on very common and very serious diseases, such as the evaluation of the effectiveness of large doses of vitamin C in preventing common colds and the trial of the Salk vaccine to prevent polio.
③When disease outcomes are rare, studies are more effective in high-risk groups, such as the hepatitis B vaccine trial among gay men in New York.
(3) Community
1. Definition
Also called Community Intervention Project (CIP),
Conduct experimental observations on the population as a whole,
Often used to assess or evaluate certain preventive measures or methods,
A whole can be a community or various subpopulations of a population.
Add iodine to table salt to prevent endemic goiter
2. Features
①The research site is the community;
② Allocation to prevention measures based on community population or certain population groups/subgroups;
③ Often used to assess or evaluate certain preventive measures or methods;
④ The method of cluster random allocation of measures is generally used to ensure that the comparison groups should be as comparable as possible;
⑤r If the study only includes two communities, it is required that the baseline characteristics between the intervention community and the control community have similar distributions
(3) Similarities and differences among the three types
1. Similarities
They all belong to experimental epidemiology, all involve human intervention, and all adopt random grouping.
2. Differences
1. Clinical trials
①Research object
patient
②Research site
Mostly hospitals
③Research purpose
Usually used to test and evaluate the effect of a certain drug or treatment method
④Example
A study on clopidogrel combined with aspirin versus aspirin alone in the treatment of high-risk groups for acute non-disabling cerebrovascular events
2. Field test
①Research object
non-patient
②Research site
Communities, schools, factories, etc.
③Research purpose
It is mostly used in preventive research on very common and serious diseases.
④Example
Evaluation of the effectiveness of high-dose vitamin C in preventing colds and Salk vaccine trial to prevent polio
3. Community experiment
①Research object
A population or subpopulations of a population
②Research site
Community
③Research purpose
Often used to assess or evaluate certain preventive measures or methods
④Example
Add iodine to table salt to prevent endemic goiter
Section 2 Research Design and Implementation
1. Clarify the research question→PICO
①Patient or Population
②Intervention
③Control
④Outcome
2. The actual test site
1. The population at the test site is relatively stable, has little mobility, and must be sufficient.
2. The diseases studied in the trial have a high and stable incidence rate in the area, so that at the end of the trial, there will be enough cases to achieve effective statistical analysis.
3. When evaluating the immunological effect of vaccines, areas where the disease has not been prevalent in the near future should be selected.
4. The test area has better medical and health conditions, relatively complete health and epidemic prevention and health care institutions, a relatively complete registration and reporting system, and good medical institutions and diagnostic capabilities.
5. The leaders of the experimental area (unit) pay attention to it, the people are willing to accept it, and there are good conditions for cooperation and cooperation.
3. Select research objects
1. Select groups of people who are effective for intervention measures
2. Select groups with a higher expected incidence rate
3. Select groups of people who are not harmful to the intervention.
4. Select people who can carry out the experiment to the end.
5. Select people with good compliance
4. Estimating sample size
1. Main factors affecting sample size
(1) The numerical difference in outcome event indicators between the experimental group and the control group. The smaller the difference, the larger the sample size required.
(2) Significance level α value
(3) Confidence 1-β
(4) One-sided inspection or two-sided inspection. One-sided tests require smaller sample sizes than two-sided tests.
(5)The number of research object groups. The larger the number of groups, the larger the sample size required.
2. Calculation of test sample size
(1) Counting data
(2) Measurement data
5. Randomization and group concealment and blinding
(1) Randomization grouping method → balancing confounding factors
1. Simple random grouping
Research subjects are grouped on an individual basis using methods such as coin toss, drawing lots, and random number tables.
2. Block randomization
Treat a group of subjects with similar conditions (such as age, gender, and similar illness) as a block
The number of research subjects (usually 4 to 6 cases) in each block is equal.
Then, pure random allocation method was used to group the research subjects within each block.
This method is suitable for studies with small sample sizes.
The advantage is that during the grouping process, the number of cases in the treatment group and the control group remains relatively consistent at any time, and different blocks can be designed according to trial requirements.
3. Stratified random grouping
According to the characteristics of the research object,
That is, some important factors that may have a confounding effect (such as age, gender, disease duration, condition, etc.) are first stratified,
Then perform simple random grouping within each stratum, and finally merge into experimental group and control group.
4. Cluster random grouping
Distribution by community or group,
That is, a family, a school, a hospital, a village or a residential area are randomly grouped.
(2) Group concealment → Prevent selection bias
1. Definition
In order to prevent the investigators and patients who recruited patients from knowing the randomization plan before grouping,
A method to prevent early decryption of the random group treatment plan is called concealment of the random group treatment plan, or group concealment for short.
2. Simple grouping and hiding
You can use the envelope method to put each grouping plan into an opaque envelope.
Write the code on the outside of the envelope, seal it and give it to the researcher.
After a subject enters the study, the survey subjects will be numbered one by one.
Then open the corresponding numbered envelopes and group them according to the distribution plan in the envelopes.
and take appropriate intervention measures
2. Grouping principle (random grouping, group concealment)
①The allocation of random numbers must be carried out only after a patient is confirmed to be included;
②The random allocation plan must be concealed;
③The allocation of random numbers to a patient must be completed once, and once determined, it must not be changed;
④The grouping time of a patient should be as close as possible to the start of treatment.
6. Establish comparison
(1) The necessity of establishing controls - factors affecting the effect of intervention experiments
1. Unpredictable ending
Due to the objective existence of individual biological differences,
Often the same disease manifests itself inconsistently in different individuals,
That is, the natural history of disease onset, progression, and outcome is inconsistent.
For some diseases whose natural history is unclear,
Its "curative effect" may be a natural consequence of the disease's progression;
Without a comparable control group, it is difficult to distinguish the true efficacy of the treatment.
2. Regression to the mean
This is a phenomenon often seen clinically.
That is, some extreme clinical symptoms or signs tend to regress to the mean.
3. Hawthorne effect
In experimental research (intervention research), after the subjects know that they have become the object of special attention,
A tendency to change one's behavior or state,
independent of the specific effects of the intervention they received,
It is patients who are eager to please their physicians and make them feel that their medical activities are successful.
This is a psychological and physiological effect on the patient, which has a positive impact on the therapeutic effect.
Sometimes dislike of a certain doctor or distrust of a certain hospital can also have a negative effect.
4. Placebo effect
①Definition
A positive psychological effect shown by patients with certain diseases due to their dependence on medicine.
Therefore, when the improvement of subjective symptoms is used as the evaluation index of efficacy,
Its "effect" may include a placebo effect.
②Placebo
An item that is indistinguishable from an active therapeutic drug in appearance, color, taste, or smell, but has no specific known therapeutic ingredients.
It can increase confidence, relieve illness, and reduce uncomfortable symptoms in one-third of patients. This phenomenon is called the placebo effect.
5. Influence of potential unknown factors
Human knowledge always has limitations,
It is likely that there are other factors that influence the intervention effect that are not yet recognized by us.
(2) Comparison type
1. Distinguish based on control measures
(1) Standard therapy control (effective control)
It is the most commonly used control method in clinical trials.
It is compared with the conventional or best current treatment (drugs or surgery).
Applicable to diseases for which treatments with proven efficacy are known.
(2) Placebo control
There are no effective treatments for the disease studied
Or it should be used only after the use of placebo has no effect on the condition of the research subjects.
2. According to whether the research subjects receive a single control measure or alternately receive intervention and control measures.
(1) Parallel comparison
During the experiment, the research subjects were randomly divided into two groups, A and B.
Intervention measures and control measures were given separately, and the intervention measures were not changed in between.
(2) Cross-reference
That is, during the experiment, the research subjects were randomly divided into two groups, A and B.
In the first stage, the people in Group A are given intervention measures, and the people in Group B are the control group.
After a period of intervention, the two groups were switched, with Group B receiving the intervention measures and Group A serving as the control.
3. Others - self-control
Refers to comparing the same group of people before and after the test
7. Application of blinding
1. Classification
1. Single blind
This means that the research subjects do not know whether they are in the experimental group or the control group.
2. Double blind
Refers to the fact that neither the research subjects nor the research implementers understand the trial grouping situation.
Instead, the study designer arranges and controls the entire experiment.
3. Triple blind
It is an extension of the double-blind trial. The research implementers, research subjects, and personnel responsible for data collection and analysis are not aware of the grouping situation, thus better avoiding bias.
Prevent selection bias and information bias
2. Four levels
1. The person responsible for assigning patients to treatment groups does not know what treatment the patient is receiving.
2. The patient himself does not know what treatment he is receiving.
3. Physicians caring for patients in the study did not know what treatment each patient received.
4. Study implementers cannot distinguish who is in the treatment group when evaluating the results.
3. Open trial
①Definition
An unblinded trial is called an open trial
That is, both the research subjects and the research implementers know the grouping of the experimental group and the control group, and the experiment is conducted openly.
②Applicable situations
This is mostly applicable to clinical trials where there are objective observation indicators or where blinding is difficult to implement.
Such as observations on the intervention effects of surgery and changes in lifestyle habits (including diet, exercise, smoking, etc.).
③Advantages and disadvantages
a. Advantages
Easy to design and implement,
The study conductor is aware of the groupings,
Facilitate timely processing of research objects
b. Disadvantages
prone to bias
8. Determine outcome variables and their measurement methods
(1) Determine outcome variables
1. Main outcome indicators
It is best to choose a primary endpoint that predicts clinical outcome (disease),
For example, the primary endpoints of stroke clinical trials are disability and mortality rates, which can better evaluate the effects of intervention measures.
2. Primary endpoint
It usually consumes manpower, material resources, and time. Generally, clinical research will consider some surrogate/secondary endpoints.
Such as neurological deficit degree score, etc.
(2) Determine the measurement method
9. Determine the trial observation period
1. Infectious diseases
The observation period is shorter, and the observation period for chronic diseases is longer.
For example, when evaluating the effectiveness of a vaccine in preventing a certain infectious disease, the observation time can be started from the date of receiving intervention measures.
The longest incubation period of the infectious disease is the minimum observation period,
If it is necessary to observe the length of the protection time, the observation period can be extended according to the actual situation.
2. Chronic diseases
The effect of intervention on chronic diseases such as tumors and cardiovascular diseases needs to be observed over a longer period of time, even for decades.
In principle, the observation period should not be too long and should be limited to the shortest time that can produce results.
10. Collect information
1. As a prospective study, experimental epidemiological studies usually use specially designed case report forms to collect baseline, follow-up and outcome data of research subjects.
2. Contents of follow-up observation
①The implementation status of intervention measures;
②Information on influencing factors (factors influencing prognosis);
③Outcome variables. Follow-up investigators need to receive unified training and can participate in follow-up work only after passing the assessment.
3. Methods for collecting follow-up data
① Interview research subjects or insiders;
② Through physical examination or sampling testing of research subjects;
③ Obtain from relevant units, mostly files and records, such as meteorological and environmental monitoring data, hospital medical records, etc.;
④ Investigation of the environment, such as living and environmental sanitation conditions, drinking water sources, water quality, working environment, etc.
Section 3 Data Collection and Analysis
1. Organizing of data
(1) Exclusion
Refers to the fact that research subjects were not included for various reasons before randomization.
The exclusion has no impact on the internal validity of the study results,
However, it may affect the extrapolation of the research results. The more research subjects are excluded, the smaller the scope of the generalization of the results.
(2) Withdraw
(1)Definition
Refers to the withdrawal of research subjects from the experimental group or control group after random assignment.
This will cause the original sample size to be insufficient, reduce the power (or power) of the study, and easily lead to selection bias.
(2) Reason for withdrawal
① Unqualified research subjects: Generally, unqualified research subjects are eliminated or intention-to-treat analysis
② Non-compliant research subjects: cannot be eliminated, and intention-to-treat analysis must be used
③Lost to follow-up: When analyzing data, the characteristics of those lost to follow-up must be analyzed to make full use of the data.
2. Analysis of data
(1) Analysis method
1. Group diagram and basic purpose of RCT
1. RCT grouping framework diagram
2. Basic purpose → obtain effectiveness and effect
(1) Effectiveness of test
It reflects the therapeutic effect under an ideal state.
That is, participants in the trial actually accepted and completed the treatment.
(2) Effect of test
Refers to the actual effect of treatment under general clinical conditions,
Participants may not comply, change treatment methods, or discontinue treatment, etc.
ITT analysis evaluates this kind of result
That is, the actual outcome of a patient after being given a certain treatment.
2. Method
1. Intention-to-treat analysis
Also called pragmatic experimentation or program effects analysis,
Refers to all patients randomly assigned to any group in the RCT,
Regardless of whether they completed the trial or actually received the treatment,
All were retained in the original group for result analysis.
Avoid selection bias and maintain comparability between treatment groups.
When evaluating the authenticity of the project (actual application effect),
ITT is the most effective method, but ITT may underestimate treatment effects
2. Effectiveness analysis
This is also called adherent analysis, also called explanatory testing or biological efficacy testing.
Complier analysis only analyzes people who comply with the trial.
The original randomization was not completely followed,
Imbalance among treatment groups will overestimate the treatment effect.
3. Accept treatment analysis
Healer analysis can overestimate treatment effects.
(2) Statistical analysis data set
1. FAS set
Based on the principle of intentionality,
All randomized subjects should be included in the analysis,
It is called the full analysis set (FAS), and some schemes refer to the population of this set as the ITT population.
The FAS set is from all randomized subjects,
Obtained by eliminating subjects using minimal and reasonable methods.
2. PPS set
Based on the principle of compliance with the plan,
Of all randomized subjects,
Only the part of the study that is carried out completely according to the planned design can be included in the analysis.
Called the conforming scenario set (PPS).
3. SAS set
For security analysis,
Do not use the principle of intentionality and the principle of conformity to the plan,
But the principle of "exposure",
i.e. all subjects who have taken at least one dose of study drug,
Safety indicators must be observed,
This forms the Security Analysis Set (SAS).
3. Evaluation indicators
(1) Basic principles for selecting indicators
① Not only use qualitative indicators but also use objective quantitative indicators as much as possible;
②The measurement method has high authenticity (validity) and reliability (dependability);
③It should be easy to observe and measure, and easy to be accepted by subjects.
(2) Commonly used indicators for evaluation
1. Main indicators to evaluate the effectiveness of treatment measures
(1) Efficient
The number of effective cases includes the number of people who were cured and the number of people who improved)
(2) Cure rate
(3) N-year survival rate
(4) Others
Assessment of the effectiveness of treatment measures
Case fatality rate, duration of disease, and severity of illness can also be used
And the evaluation of indicators such as pathogenic status, sequelae incidence, and recurrence rate after the disease;
2. Main indicators for evaluating the effectiveness of preventive measures
(1) Protect PR
P₁ and P₂ are the incidence rates of the control group and experimental group respectively.
Q₁ and Q₂ are the non-incidence rates of the control group and experimental group respectively.
n₁ and n₂ are the number of people in the control group and experimental group respectively.
(2)Effectiveness index IE
(3) Number needed to treat (NNT)
①Definition
Refers to preventing an adverse event from occurring,
The number of patients a clinician needs to treat using a certain therapy within a period of time,
From a scientific perspective, NNT is equal to the reciprocal of absolute risk.
②Risk evaluation index
(4) Others
Assessment of effectiveness of preventive measures
It can be evaluated by indicators such as antibody positive conversion rate, geometric mean antibody titer, and changes in disease severity;
To assess the cause of prevention, indicators such as disease incidence and infection rate can be used.
Section 4: Advantages and disadvantages of experimental epidemiological research and issues that should be paid attention to
1. Advantages and Disadvantages
1. Main advantages
1. Be able to standardize the analysis and judgment of selected research objects, intervention factors and results.
2. Randomized grouping improves comparability and reduces confounding bias.
3. Prospective research can draw positive conclusions.
2. There are shortcomings
1. The requirements are high, the control is strict, and the difficulty is high. It is sometimes difficult to achieve in actual work.
2. The research subjects are not representative enough, which will affect the inference of the test results to the overall population to varying degrees.
3. The study population is large, the implementation requirements of the trial plan are strict, the follow-up time is long, and compliance is not easy to achieve well.
2. Issues that should be paid attention to
(1) Class experiment
1. Definition
A complete experimental epidemiological study must have four basic characteristics: randomization, control, intervention, and prospective.
If an experimental study lacks one or more of these characteristics, the experiment is called a quasi-experiment or natural experiment.
It is often used when the number of research subjects is large and the scope is wide, but the actual situation does not allow random grouping of research subjects.
2. According to whether a control group is established, it can be divided into
1. No parallel control group
(1) Compare yourself before and after
That is, the same subjects are compared before and after receiving the intervention.
For example, to observe the blood pressure lowering effect of a certain drug,
The blood pressure levels of hypertensive patients before and after taking the drug can be compared.
(2) Compare with known results without the intervention.
For example, it is known that mothers carrying HBsAg have an average probability of mother-to-child transmission of hepatitis B virus (HBV) of 40% to 50%.
At this stage, if we want to observe the effect of hepatitis B vaccine in blocking mother-to-child transmission, it is not necessary to set up a control group.
2. Set up a control group
Although a parallel control group was established, the grouping of study subjects was not random.
For example, to evaluate the preventive effect of a certain vaccine, compare schools A and B.
(2) Ethical and moral issues
(3) Preliminary test
(4) Studying registration issues
(5) Complete and transparent issue of results reporting