Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

Simon Lewin, Claire Glenton, Andrew D Oxman, Simon Lewin, Claire Glenton, Andrew D Oxman

Abstract

Objective: To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions.

Design: Review of randomised controlled trials of interventions to change professional practice or the organisation of care.

Data sources: Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group.

Methods: Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done.

Results: 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable.

Conclusions: Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.

Conflict of interest statement

Competing interests: ADO was an investigator for two of the included trials and CG worked in the unit in which these trials were coordinated.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787326/bin/lews609891.f1_default.jpg
Use of qualitative studies in sampled randomised controlled trials

References

    1. Campbell M, Fitzpatrick R, Haines A, Kinmonth A-L, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. BMJ 2000;321:694-6.
    1. Medical Research Council. A framework for development and evaluation of RCTs for complex interventions to improve health. London: MRC, 2000.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ 2008;337:a1655.
    1. Hawe P, Shiell A, Riley T, Gold L. Methods for exploring implementation variation and local context within a cluster randomised community intervention trial. J Epidemiol Community Health 2004;58:788-93.
    1. Oakley A, Strange V, Bonell C, Allen E, Stephenson J, Team RS. Process evaluation in randomised controlled trials of complex interventions. BMJ 2006;332:413-6.
    1. Murphy E, Dingwall R, Greatbatch D, Parker S, Watson P. Qualitative research methods in health technology assessment: a review of the literature. Health Technol Assess 1998;2(16).
    1. Pearson A. Cochrane Qualitative Research Methods Group. About the Cochrane Collaboration (Methods Groups). Cochrane Library 2007;(2):CE000142.
    1. Rousseau N, McColl E, Eccles M, Hall L. Qualitative methods in implementation research. In: Thorsen T, Makela M, eds. Changing professional practice. Theory and practice of clinical guidelines implementation. Copenhagen: Danish Institute for Health Services Research and Development, 1999.
    1. Gibson G, Timlin A, Curran S, Wattis J. The scope for qualitative methods in research and clinical trials in dementia. Age Ageing 2004;33:422-6.
    1. Donovan J, Mills N, Smith M, Brindle L, Jacoby A, Peters T, et al. Quality improvement report: improving design and conduct of randomised trials by embedding them in qualitative research: ProtecT (prostate testing for cancer and treatment) study. Commentary: presenting unbiased information to patients can be difficult. BMJ 2002;325:766-70.
    1. Wainberg ML, Alfredo Gonzalez M, McKinnon K, Elkington KS, Pinto D, Gruber Mann C, et al. Targeted ethnography as a critical step to inform cultural adaptations of HIV prevention interventions for adults with severe mental illness. Soc Sci Med 2007;65:296-308.
    1. Bero L, Eccles M, Grilli R, Grimshaw J, Gruen R, Mayhew A, et al. Cochrane Effective Practice and Organisation of Care Group. About the Cochrane Collaboration (Cochrane Review Groups (CRGs)). Cochrane Library 2007;(1).
    1. Cochrane Effective Practice and Organisation of Care Review Group. The data collection checklist. Ottawa: Cochrane Effective Practice and Organisation of Care Review Group, 2007.
    1. Critical Appraisal Skills Programme (CASP). Making sense of evidence: 10 questions to help you make sense of qualitative research. 2007. .
    1. Harrison R, MacFarlane A, Wallace P, Murray E. Patients’ perceptions of joint teleconsultations: qualitative evaluation. Health Expect 2006;9:81-90.
    1. Petty DR, Zermansky AG, Raynor DK, Lowe CJ, Buttress AD, Vail A, et al. “No thank you”: why elderly patients declined to participate in a research study. Pharm World Sci 2001;23:22-7.
    1. Davies BL, Hodnett E. Labor support: nurses’ self-efficacy and views about factors influencing implementation. J Obstet Gynecol Neonatal Nurs 2002;31:48-56.
    1. Graham ID, Logan J, Davies B, Nimrod C. Changing the use of electronic fetal monitoring and labor support: a case study of barriers and facilitators. Birth 2004;31:293-301.
    1. Oakley A, Strange V, Stephenson J, Forrest S, Monteiro H. Evaluating processes. A case study of a randomized controlled trial of sex education. Evaluation 2004;10:440-62.
    1. Riley T, Hawe P, Shiell A. Contested ground: how should qualitative evidence inform the conduct of a community intervention trial? J Health Serv Res Policy 2005;10:103-10.
    1. Glasgow RE, Lichtenstein E, Marcus AC. Why don’t we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition. Am J Public Health 2003;93:1261-7.
    1. Eccles M, Grimshaw J, Walker A, Johnston M, Pitts N. Changing the behavior of healthcare professionals: the use of theory in promoting the uptake of research findings. J Clin Epidemiol 2005;58:107-12.
    1. Farmer A, Grimshaw J, Mayhew A, McGowan J, Graham I, Driedger M, et al. Systematic reviews of knowledge translation interventions: contributions of process evaluations and contact with authors. CCOHTA final performance report. Ottawa: University of Ottawa, 2005.
    1. Oxman AD, Fretheim A, Flottorp S. The OFF theory of research utilization. J Clin Epidemiol 2005;58:113-6; discussion 117-20.
    1. Perkins M, Jensen P, Jaccard J, Gollwitzer P, Oettingen G, Pappadopulos E, et al. Applying theory-driven approaches to understanding and modifying clinicians’ behavior: what do we know? Psychiatr Serv 2007;58:342-8.
    1. West R. Time for a change: putting the transtheoretical (stages of change) model to rest. Addiction 2005;100:1036-9.
    1. Grol R, Wensing M, Eccles M. Improving patient care. The implementation of change in clinical practice. Oxford: Butterworth Heineman, 2004.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe