|Ahead of print publication
Exploring the trend of use of qualitative methods in randomized controlled trials
SR Disha, K Merin Eldhose, Yashashri Shetty
Department of Pharmacology and Therapeutics, Main College Building, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
|Date of Submission||23-Jun-2022|
|Date of Acceptance||02-Aug-2022|
|Date of Web Publication||14-Nov-2022|
Department of Pharmacology and Therapeutics, Main College Building, Seth GS Medical College and KEM Hospital, Parel, Mumbai - 400 012, Maharashtra
Source of Support: None, Conflict of Interest: None
| Introduction|| |
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. It studies social–human phenomena at the source, making attempt to understand and interpret in terms of meanings which participants bring to them. 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. 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|| |
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|| |
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|| |
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. Integrating quantitative–qualitative data and findings when undertaking RCTs is another issue for which no well-structured guidelines are available. 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. The US dominated in such studies because such RCTs are more commonly being done in developed countries. 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. 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.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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