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Trials. 2019 Jun 6;20(1):329. doi: 10.1186/s13063-019-3439-8.

Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions.

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Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.
Department of Global Health and Development, Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
Zambart House, School of Public Health, University of Zambia, Box 50697, Lusaka, 10101, Zambia.
Rollins School of Public Health, Emory University, 1518 Clifton Road NE, Claudia Nance Rollins Building, 7033, Atlanta, GA, 30322, USA.
School of Health and Related Research, University of Sheffield, 30 Regent St, Sheffield, S1 4DA, UK.
Department of Health Promotion and Education, School of Public Health, Ridgeway Campus University of Zambia, Box 50110, Lusaka, 10101, Zambia.
Heilbrunn Department of Population and Family Health, Columbia University Mailman School of Public Health, 722 W 168th St, New York, 10032, NY, USA.
Population Health Sciences, University of Bristol, 39 Whatley Road, Bristol, BS8 2PS, UK.
The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West (NIHR CLAHRC West), University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
Institute for Global Health, University College London, 30 Guilford Street, London, WC1N 1EH, UK.



Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. Although there is increasing recognition that qualitative methods can and should be integrated into RCTs, few frameworks and practical guidance highlight which qualitative methods should be integrated and for what purposes. As a result, qualitative methods are often poorly or haphazardly integrated into existing trials, and researchers rely heavily on interviews and focus group discussions. To improve current practice, we propose a framework for innovative qualitative research methods that can help address the challenges of RCTs for complex public health interventions.


We used a stepped approach to develop a practical framework for researchers. This consisted of (1) a systematic review of the innovative qualitative methods mentioned in the health literature, (2) in-depth interviews with 23 academics from different methodological backgrounds working on RCTs of public health interventions in 11 different countries, and (3) a framework development and group consensus-building process.


The findings are presented in accordance with the CONSORT (Consolidated Standards of Reporting Trials) Statement categories for ease of use. We identify the main challenges of RCTs for public health interventions alongside each of the CONSORT categories, and potential innovative qualitative methods that overcome each challenge are listed as part of a Framework for the Integration of Innovative Qualitative Methods into RCTs of Complex Health Interventions. Innovative qualitative methods described in the interviews include rapid ethnographic appraisals, document analysis, diary methods, interactive voice responses and short message service, community mapping, spiral walks, pair interviews and visual participatory analysis.


The findings of this study point to the usefulness of observational and participatory methods for trials of complex public health interventions, offering a novel contribution to the broader literature about the need for mixed methods approaches. Integrating a diverse toolkit of qualitative methods can enable appropriate adjustments to the intervention or process (or both) of data collection during RCTs, which in turn can create more sustainable and effective interventions. However, such integration will require a cultural shift towards the adoption of method-neutral research approaches, transdisciplinary collaborations, and publishing regimes.


Complex intervention; Innovation; Public health; Qualitative method; RCTs

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