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Exploring the trend of use of qualitative methods in randomized controlled trials

 Department of Pharmacology and Therapeutics, Main College Building, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India

Date of Submission23-Jun-2022
Date of Acceptance02-Aug-2022
Date of Web Publication14-Nov-2022

Correspondence Address:
SR Disha,
Department of Pharmacology and Therapeutics, Main College Building, Seth GS Medical College and KEM Hospital, Parel, Mumbai - 400 012, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/picr.picr_131_22

How to cite this URL:
Disha S R, Merin Eldhose K, Shetty Y. Exploring the trend of use of qualitative methods in randomized controlled trials. Perspect Clin Res [Epub ahead of print] [cited 2023 Mar 24]. Available from: http://www.picronline.org/preprintarticle.asp?id=360881

   Introduction Top

Any meaningful research in education begins with compelling questions. Methods used in research help in translating this curiosity into action and facilitating an exploration of these questions. This is also the reason why the use of qualitative research methods has gained momentum in the field of medicine.[1] It studies social–human phenomena at the source, making attempt to understand and interpret in terms of meanings which participants bring to them.[2] Clinical trials, being complex in nature have a lot of factors playing a role in success in terms of patient recruitment and retention. Trials such as STEP-UP, ProtecT, and SPARE had adopted measures to act on the challenges faced using qualitative methods.[3] As using them in trials offer a vast set of advantages, it was of interest to look for the number of randomized controlled trials (RCTs) that have adopted them.

   Materials and Methods Top

This is an exploratory, retrospective, web-based study. We skimmed RCTs from “clinicaltrials. Gov” and looked for different aspects of the study. RCTs conducted and registered between the year January 2016 and March 2020 were searched with the term “qualitative”. Those who referred it to “quality of life”, statistical/medical tests were eliminated. Descriptive statistics were used.

   Results Top

Only 321 studies fulfilled inclusion criteria and were considered for final analysis. Major areas of specialization were public health (20.25%), followed by psychiatry (14.64%). About 71.03% focused on medical procedures, 14.02% on devices, and 9.97% on drugs. The maximum contribution was made by the US and UK constituting 42.99% and 15.58%, respectively. Information regarding trial sponsorship was available only for 272, of which 152 were government sponsored, 20 pharma sponsored, and 48 jointly sponsored. The most commonly used methods were interviews (52.65%), then questionnaires (19.63%), and focus groups (8.41%). There was no mention of the consent process in 29.28% of studies. Objectives of acceptability (50.1%), feasibility (48.2%), and participant experience (23.3%) regarding intervention were set. The most commonly applied study design was parallel assignment (52.34%). Blinding was done in 28%. The trial phase was not mentioned in 95% of studies. Sample size determination was mentioned only in 4% and sampling method in 3%. Methods of analysis and interpretation were captured for 1.5% of studies. PROM and social parameters were discussed in 47% and 4% of studies, respectively.

   Discussion Top

The major goals of inculcating qualitative research in RCTs are to understand the complexity of interventions and of social contexts in which interventions are tested. Very few trials registered during the time had incorporated qualitative methods similar to one by Simon Lewin et al., where only 30% had associated qualitative work. Constraints on resources, lack of thorough understanding of theoretical basis, methodology evaluation techniques, and poor access to relevant expertise were the major reasons for inadequate usage of qualitative studies along with RCTs in this study.[4] Integrating quantitative–qualitative data and findings when undertaking RCTs is another issue for which no well-structured guidelines are available.[5] The specialty branches represented the major bulk of these studies with the preponderance of medical (43.61%) over the surgical disciplines (13.71%). The deficient application of qualitative research in surgical disciplines may be due to challenges in implementation and data analysis where cross-validation poses a task.[6] The US dominated in such studies because such RCTs are more commonly being done in developed countries.[7] The majority were government funded, which is reflective of efforts to understand the health-care system, and its needs and adopt necessary changes in policymaking.[8] Qualitative studies in RCTs can actually pick up issues in recruitment, reasons for refusal, drop-outs, and failure of clinical trials. Methodology including sampling procedure, study designs, and analysis used were in sync with routinely used qualitative methods.[9]

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Conflicts of interest

There are no conflicts of interest.

   References Top

Cristancho SM, Goldszmidt M, Lingard L, Watling C. Qualitative research essentials for medical education. Singapore Med J 2018;59:622-7.  Back to cited text no. 1
White J. Book review: The SAGE handbook of qualitative research. Eval J Australas 2011;11:52-3.  Back to cited text no. 2
Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: A qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials 2011;12:78.  Back to cited text no. 3
Lewin S, Glenton C, Oxman AD. Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: Methodological study. BMJ 2009;339:b3496.  Back to cited text no. 4
Richards DA, Bazeley P, Borglin G, Craig P, Emsley R, Frost J, et al. Integrating quantitative and qualitative data and findings when undertaking randomised controlled trials. BMJ Open 2019;9:e032081.  Back to cited text no. 5
Meena JK, Jakhetiya A, Pandey A. Qualitative research in surgical disciplines: Need and scope. Indian J Surg 2021;83:3-8.  Back to cited text no. 6
Hulme, D. Integrating Quantitative And Qualitative Research For Country Case Studies Of Development. GPRG, 2007.  Back to cited text no. 7
Crossley M, Vulliamy G. Issues and trends in qualitative research: Potential for developing countries. Int J Educ Dev 1996;16:439-48.  Back to cited text no. 8
Busetto L, Wick W, Gumbinger C. How to use and assess qualitative research methods. Neurol Res Pract 2020;2:14.  Back to cited text no. 9


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