How qualitative studies can improve the quality of clinical studies

摘要

Qualitative studies can be done in series or in parallel with quantitative studies. This can occur during the pilot-testing phase of a quantitative study or in the final version of a clinical trial. In either case, the qualitative study can provide insights as to why a quantitative study, such as the evaluation of a medication or treatment regimen, is working or—more important—not working. Issues that may otherwise go undetected that are undermining the efficacy of an intervention within the framework of a clinical trial can, by this technique, be detected. For instance, if in interviews with subjects enrolled in a clinical trial it becomes apparent that they have fears or anxieties about compliance with the treatment regimen, one may suspect that nonadherence could occur and diminish the potential magnitude of a clinical treatment effect. Similarly, participant observation of a complex intervention in a hospital may reveal that the intervention fidelity has been undermined by competing tasks that the hospital staff have to perform.