What can qualitative research do for randomised controlled trials? A systematic mapping review

Abstract

ObjectiveTo develop an empirically based framework of the aspects of randomised controlled trials addressed by qualitative research.DesignSystematic mapping review of qualitative research undertaken with randomised controlled trials and published in peer-reviewed journals.Data sourcesMEDLINE, PreMEDLINE, EMBASE, the Cochrane Library, Health Technology Assessment, PsycINFO, CINAHL, British Nursing Index, Social Sciences Citation Index and ASSIA.Eligibility criteriaArticles reporting qualitative research undertaken with trials published between 2008 and September 2010; health research, reported in English.Results296 articles met the inclusion criteria. Articles focused on 22 aspects of the trial within five broad categories. Some articles focused on more than one aspect of the trial, totalling 356 examples. The qualitative research focused on the intervention being trialled (71%, 254/356); the design, process and conduct of the trial (15%, 54/356); the outcomes of the trial (1%, 5/356); the measures used in the trial (3%, 10/356); and the target condition for the trial (9%, 33/356). A minority of the qualitative research was undertaken at the pretrial stage (28%, 82/296). The value of the qualitative research to the trial itself was not always made explicit within the articles. The potential value included optimising the intervention and trial conduct, facilitating interpretation of the trial findings, helping trialists to be sensitive to the human beings involved in trials, and saving money by steering researchers towards interventions more likely to be effective in future trials.ConclusionsA large amount of qualitative research undertaken with specific trials has been published, addressing a wide range of aspects of trials, with the potential to improve the endeavour of generating evidence of effectiveness of health interventions. Researchers can increase the impact of this work on trials by undertaking more of it at the pretrial stage and being explicit within their articles about the learning for trials and evidence-based practice.

CollAborative care and active surveillance for Screen-Positive EldeRs with subthreshold depression (CASPER): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness

“…Previous studies have indicated that a sample of approximately 40 trial participants would be sufficient to address these aims from the point of view of service users. 60 All case managers working in York and Leeds at the time of the pilot phase were recruited for interview by invitation through the local trial co-ordinators.…”

Clinicians’ Views and Experiences of Interventions to Enhance the Quality of Antibiotic Prescribing for Acute Respiratory Tract Infections

“…[8][9][10] An understanding of clinicians' views and experiences of using different interventions in practice, in relation to their patients, can help identify the 'active ingredients' of a complex intervention, explore the feasibility, acceptability, and transferability of the intervention, and thus help inform refinement and implementation. Exploring whether an intervention that has been shown to be effective across multiple European countries has different levels of acceptability or is used in different ways in different countries may provide opportunities for changing clinicians' behaviour on a wider scale without having to repeat clinical trials in each new setting.…”

Optimal primary care management of clinical osteoarthritis and joint pain in older people: a mixed-methods programme of systematic reviews, observational and qualitative studies, and randomised controlled trials

“…260,261 In the BEEP trial, linked, longitudinal, qualitative interviews explored participants' experiences of treatment, their views of the acceptability of their treatment, the impact of the interventions on participants' exercise and general physical activity behaviour, and explanations for change in knee symptoms and exercise behaviour over time. The topic guides (see Appendix 3) included questions that explored participants' views of their physiotherapy treatment, how they got on with their exercise programme and what factors they felt helped or hindered them to adhere to the exercises following the end of their treatment contact with the physiotherapist and approximately 12-18 months later.…”