54 RESEARCH SERIES Emerg Med J: first published as 10.1136/emj.20.1.54 on 1 January 2003. Downloaded from Observational research methods. Research design II: cohort, cross sectional, and case-control studies C J Mann ............................................................................................................................. Emerg Med J 2003;20:54–60 Cohort, cross sectional, and case-control studies are While an appropriate choice of study design is collectively referred to as observational studies. Often vital, it is not sufficient. The hallmark of good research is the rigor with which it is conducted. A these studies are the only practicable method of checklist of the key points in any study irrespec- studying various problems, for example, studies of tive of the basic design is given in box 1. aetiology, instances where a randomised controlled trial Every published study should contain suffi- cient information to allow the reader to analyse might be unethical, or if the condition to be studied is the data with reference to these key points. rare. Cohort studies are used to study incidence, causes, In this article each of the three important and prognosis. Because they measure events in observational research methods will be discussed with emphasis on their strengths and weak- chronological order they can be used to distinguish nesses. In so doing it should become apparent between cause and effect. Cross sectional studies are why a given study used a particular research used to determine prevalence. They are relatively quick method and which method might best answer a particular clinical problem. and easy but do not permit distinction between cause and effect. Case controlled studies compare groups COHORT STUDIES retrospectively. They seek to identify possible predictors These are the best method for determining the of outcome and are useful for studying rare diseases or incidence and natural history of a condition. The studies may be prospective or retrospective and outcomes. They are often used to generate hypotheses sometimes two cohorts are compared. that can then be studied via prospective cohort or other studies. Prospective cohort studies A group of people is chosen who do not have the .......................................................................... outcome of interest (for example, myocardial inf- arction). The investigator then measures a variety http://emj.bmj.com/ ohort, cross sectional, and case-control of variables that might be relevant to the develop- studies are often referred to as observa- ment of the condition. Over a period of time the Ctional studies because the investigator sim- people in the sample are observed to see whether ply observes. No interventions are carried out by they develop the outcome of interest (that is, the investigator. With the recent emphasis on evi- myocardial infarction). dence based medicine and the formation of the In single cohort studies those people who do Cochrane Database of randomised controlled not develop the outcome of interest are used as trials, such studies have been somewhat glibly internal controls. on October 1, 2021 by guest. Protected copyright. maligned. However, they remain important be- Where two cohorts are used, one group has cause many questions can be efficiently answered been exposed to or treated with the agent of by these methods and sometimes they are the interest and the other has not, thereby acting as only methods available. an external control. The objective of most clinical studies is to determine one of the following—prevalence, inci- Retrospective cohort studies dence, cause, prognosis, or effect of treatment; it These use data already collected for other is therefore useful to remember which type of purposes. The methodology is the same but the study is most commonly associated with each study is performed posthoc. The cohort is objective (table 1) “followed up” retrospectively. The study period may be many years but the time to complete the study is only as long as it takes to collate and ana- lyse the data. Table 1 ....................... Objective Common design Advantages and disadvantages DrCJMann, Department The use of cohorts is often mandatory as a of Accident and Emergency Prevalence Cross sectional randomised controlled trial may be unethical; for Medicine, Taunton and Incidence Cohort Somerset Hospital, Cause (in order of Cohort, case-control, cross example, you cannot deliberately expose people to Taunton, Somerset, UK reliability) sectional cigarette smoke or asbestos. Thus research on risk Prognosis Cohort factors relies heavily on cohort studies. Correspondence to: Treatment effect Controlled trial As cohort studies measure potential causes Dr C J Mann; [email protected] before the outcome has occurred the study can ....................... demonstrate that these “causes” preceded the www.emjonline.com Observational research methods 55 Box 1 100 A&E attenders with minor injuries for the outcome of diabetes mellitus will probably produce only one patient with Emerg Med J: first published as 10.1136/emj.20.1.54 on 1 January 2003. Downloaded from Study purpose the outcome of interest. The efficiency of a prospective cohort The aim of the study should be clearly stated. study increases as the incidence of any particular outcome increases. Thus a study of patients with a diagnosis of deliber- Sample ate self harm in the 12 months after initial presentation would The sample should accurately reflect the population from be efficiently studied using a cohort design. which it is drawn. Another problem with prospective cohort studies is the loss The source of the sample should be stated. of some subjects to follow up. This can significantly affect the The sampling method should be described and the sample outcome. Taking incidence analysis as an example (incidence size should be justified. = cases/per period of time), it can be seen that the loss of a few Entry criteria and exclusions should be stated and justified. cases will seriously affect the numerator and hence the calcu- The number of patients lost to follow up should be stated and lated incidence. The rarer the condition the more significant explanations given. this effect. Control group Retrospective studies are much cheaper as the data have The control group should be easily identifiable. already been collected. One advantage of such a study design The source of the controls should be explained—are they from is the lack of bias because the outcome of current interest was the same population as the sample? not the original reason for the data to be collected. However, Are the controls matched or randomised—to minimise bias because the cohort was originally constructed for another and confounding. purpose it is unlikely that all the relevant information will Quality of measurements and outcomes have been rigorously collected. Retrospective cohorts also suffer the disadvantage that Validity—are the measurements used regarded as valid by people with the outcome of interest are more likely to remem- other investigators? ber certain antecedents, or exaggerate or minimise what they Reproducibility—can the results be repeated or is there a rea- now consider to be risk factors (recall bias). son to suspect they may be a “one off”? Blinded—were the investigators or subjects aware of their Where two cohorts are compared one will have been subject/control allocation? exposed to the agent of interest and one will not. The major Quality control—has the methodology been rigorously disadvantage is the inability to control for all other factors that adhered to? might differ between the two groups. These factors are known as confounding variables. Completeness A confounding variable is independently associated with Compliance—did all patients comply with the study? both the variable of interest and the outcome of interest. For Drop outs—how many failed to complete the study? example, lung cancer (outcome) is less common in people Deaths with asthma (variable). However, it is unlikely that asthma in ? Missing data—how much are unavailable and why itself confers any protection against lung cancer. It is more Distorting influences probable that the incidence of lung cancer is lower in people Extraneous treatments—other interventions that may have with asthma because fewer asthmatics smoke cigarettes (con- affected some but not all of the subjects. founding variable). There are a virtually infinite number of Confounding factors—Are there other variables that might potential confounding variables that, however unlikely, could influence the results? just explain the result. In the past this has been used to sug- http://emj.bmj.com/ Appropriate analysis—Have appropriate statistical tests been gest that there is a genetic influence that makes people want used? to smoke and also predisposes them to cancer. Validity The only way to eliminate all possibility of a confounding variable is via a prospective randomised controlled study. In All studies should be internally valid. That is, the conclusions this type of study each type of exposure is assigned by chance can be logically drawn from the results produced by an and so confounding variables should be present in equal appropriate methodology. For a study to be regarded as valid numbers in both groups. it must be shown that it has indeed demonstrated what it says on October 1, 2021 by guest. Protected copyright. it has. A study that is not internally valid should not be Finally, problems can arise as a result of bias. Bias can occur published because the findings cannot be accepted. in any research and reflects the potential that the sample The question of external validity relates to the value of the studied is not representative of the population it was drawn results of the study to other populations—that is, the generalis- from and/or the population at large. A classic example is using ability of the results. For example, a study showing that 80% employed people, as employment is itself associated with gen- of the Swedish population has blond hair, might be used to erally better health than unemployed people.