Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
Interventions (I) or exposures (E) that are applied to different groups of subjects
Figure: Tree of different types of studies (Q1, 2, and 3 refer to the three questions below)
Derrick Bennett and John Emberson have a PowerPoint on question and study design from the MSc in EBHC.
Download PowerPoint presentation ...
Our first distinction is whether the study is analytic or non-analytic. A non-analytic or descriptivestudy does not try to quantify the relationship but tries to give us
a picture of what is happening in a population, e.g., the prevalence, incidence, or experience of a group. Descriptive studies include case reports, case-series,
qualitative studies and surveys (cross-sectional) studies, which measure the frequency of several factors, and hence the size of the problem. They may
sometimes also include analytic work (comparing factors "" see below).
An analytic study attempts to quantify the relationship between two factors, that is, the effect of an intervention (I) or exposure (E) on an outcome (O). To
quantify the effect we will need to know the rate of outcomes in a comparison (C) group as well as the intervention or exposed group. Whether the researcher
actively changes a factor or imposes uses an intervention determines whether the study is considered to be observational (passive involvement of researcher),
or experimental (active involvement of researcher).
In experimental studies, the researcher manipulates the exposure, that is he or she allocates subjects to the intervention or exposure group. Experimental
studies, or randomised controlled trials (RCTs), are similar to experiments in other areas of science. That is, subjects are allocated to two or more groups to
receive an intervention or exposure and then followed up under carefully controlled conditions. Such studies controlled trials, particularly if randomised and
blinded, have the potential to control for most of the biases that can occur in scientific studies but whether this actually occurs depends on the quality of the
study design and implementation.
In analytic observational studies, the researcher simply measures the exposure or treatments of the groups. Analytical observational studies include
case""control studies, cohort studies and some population (cross-sectional) studies. These studies all include matched groups of subjects and assess of
associations between exposures and outcomes.
Observational studies investigate and record exposures (such as interventions or risk factors) and observe outcomes (such as disease) as they occur. Such
studies may be purely descriptive or more analytical.
We should finally note that studies can incorporate several design elements. For example, a the control arm of a randomised trial may also be used as a cohort
study; and the baseline measures of a cohort study may be used as a cross-sectional study.
2.
descriptive
analytic.
Yes?
2.
No?
RCT
Observational study
For observational study the main types will then depend on the timing of the measurement of outcome, so our third question is:
Q3. When were the outcomes determined?
1.
2.
3.
Crossover Design
A controlled trial where each study participant has both therapies, e.g, is randomised to treatment A first, at the crossover point they then start treatment B. Only
relevant if the outcome is reversible with time, e.g, symptoms.
Advantages:
all subjects serve as own controls and error variance is reduced thus reducing sample size needed;
all subjects receive treatment (at least some of the time);
statistical tests assuming randomisation can be used;
blinding can be maintained.
Disadvantages:
Cohort Study
Data are obtained from groups who have been exposed, or not exposed, to the new technology or factor of interest (eg from databases). No allocation of
exposure is made by the researcher. Best for study the effect of predictive risk factors on an outcome.
Advantages:
ethically safe;
subjects can be matched;
can establish timing and directionality of events;
eligibility criteria and outcome assessments can be standardised;
administratively easier and cheaper than RCT.
Disadvantages:
Case-Control Studies
Patients with a certain outcome or disease and an appropriate group of controls without the outcome or disease are selected (usually with careful consideration
of appropriate choice of controls, matching, etc) and then information is obtained on whether the subjects have been exposed to the factor under investigation.
Advantages:
Cross-Sectional Survey
A study that examines the relationship between diseases (or other health-related characteristics) and other variables of interest as they exist in a defined
population at one particular time (ie exposure and outcomes are both measured at the same time). Best for quantifying the prevalence of a disease or risk factor,
and for quantifying the accuracy of a diagnostic test.
Advantages: