A particular type of cross‐sectional, single‐group study is one in which incidence or prevalence of a condition is determined. A prevalence study determines how many cases of a condition or disease there are in a given population, or it might establish the frequency of a clinical finding in a study sample. For example, researchers might use hospital and pharmacy records to establish how many people have insulin‐receiving diabetes in a defined hospital catchment area. Then again, another study might estimate the proportion of older people in residential facilities whose ears are occluded by earwax (Figure 5.4).
Figure 5.4 Prevalence of a clinical feature, determined in a cross‐sectional study.
Source: From Culbertson et al. (2004), © 2004, Elsevier.
Incidence studies are rather similar but refine the above kind of study in two ways: the incidence of a condition is the number of new cases arising in a defined population over a defined time. Figure 5.5 describes such a study – to determine in a defined area of 22 adjoining electoral wards in South London, the number of first‐in‐a‐lifetime strokes, according to ethnic origin. The researchers established the incidence (sometimes called inception rate) of stroke in each of the ethnic groups under scrutiny – per 1000 population per year. Strictly speaking it is this incorporation of time, as well as the proportion of cases, that makes incidence a rate, while prevalence is merely a proportion.
Figure 5.5 Extract from a cross‐sectional (incidence) study about frequency of stroke.
Source: From Wolfe et al. (2002), © 2002, BMJ Publishing Group Ltd.
Figure 5.5 shows how the data were collected from hospitals and the community. Some incidence research data, as in this case, are derived from case‐registers – many of which have been set up with research and clinical service in mind, routinely recording data useful for both purposes. In other cross‐sectional studies the researchers undertake a survey of the study sample, where their survey – whether by interview, or by electronic or paper self‐report – has been set up specifically for the research project. For example, researchers might ask nurses who visit patients in their homes to describe, by filling in a paper questionnaire, how their patients are using prescribed medicines (Figure 5.6).
Figure 5.6 Use of a survey method in a cross‐sectional study.
Source: From Ellenbecker et al. (2004), © 2004, Elsevier.
LONGITUDINAL STUDIES
When researchers study a group of subjects over time in a longitudinal study, there is more research work to be done than in a cross‐sectional study; subjects must be followed up one or more times to determine their prognosis or outcome.
The kinds of observational studies we've seen above are among the simplest form of clinical research. In the next chapter, more complex observational studies are described – quantitative analytic studies. What they have in common (and in this way they differ from the above study types) is that they generally involve comparison of two or more groups of people and often attempt to infer something about cause of symptoms or conditions.
CHAPTER 6 Analytic Studies
Remember from the previous chapter that, compared with descriptive studies of a single group, analytic studies are more complex (and often more interesting). Analytic studies will usually involve some comparison and frequently aim to elucidate cause and effect in some way. Four kinds of observational analytic study will be described here:
Ecological studies
Cross‐sectional, two‐group studies
Case–control studies
Cohort analytic studies
ECOLOGICAL STUDIES
A neat way of tackling questions about the cause of disease or other health events is to sit in a library (or, more likely, at a computer), locate routinely collected data, and put population data about disease frequency (e.g. regional deaths from lung cancer) together with data about exposure to a risk (e.g. regional data on tobacco consumption). By so doing, you might find that regions with high lung cancer death rates were also the ones with high tobacco consumption. Suppose also that you found the corollary – that low mortality areas were associated with low tobacco consumption – then your findings would support a link between the supposed risk (smoking) and the target disorder (lung cancer).
The real study used as an example in Figure 6.1 concerns whether smoking might be an important risk factor for the loss of life arising from fires in people's homes. Researchers from Atlanta, Georgia looked into this observation by assembling data for the year 2004 from two separate databases – one that holds death certificate data by state and another that provides smoking data by state. The graph set out in Figure 6.1 shows how the researchers use the data to shed more light on whether smoking is associated with death in domestic fires.
Figure 6.1 Findings from an ecological study about smoking and domestic fires.
Source: From Diekman et al. (2008), © 2008, BMJ Publishing Group Ltd.
But you may by now have spotted a flaw in this type of study: we don't know whether the individual people who died in house fires were smokers. Put another way, it is possible for a study of this design to come up with these findings even if every person who died in a house fire was a non‐smoker. This flaw is sometimes called the ecological fallacy and is a consequence of the use of aggregated data rather than the more usual research method of collecting data for each individual study participant. The other three types of analytic study set out below are more satisfactory approaches to cause‐and‐effect questions because they are able to relate the supposed risk factor directly to the outcome in each study participant.
CROSS‐SECTIONAL, TWO‐GROUP STUDIES
Some cross‐sectional studies aim to shed light on cause and effect by recording whether people with a disease were more likely than people without the same disease to have experienced exposure to a risk factor. For example, for more than half a century researchers have recognized that patients with schizophrenia,