ArticleTrials2013
Qualitative research within trials: developing a standard operating procedure for a clinical trials unit.
Article in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
38 citing papers in PubMed, 4 syntheses or guidelines pooled it, 77 citations in OpenAlex.
- The value of qualitative research in randomized controlled trials involving drugs and medical devices: a systematic mapping review.International journal of technology assessment in health care · 2026Pooled it
- Pooled it
- Exploring qualitative methods reported in registered trials and their yields (EQUITY): systematic review.Trials · 2018Pooled it
- What Is Important to the Younger Person (≤50 Years) When Having a Total Hip Arthroplasty: A Systematic Literature Review.Orthopedic nursingPooled it
- A qualitative study exploring depressed participants' experiences of receiving Augmented Depression Therapy (ADepT).BMJ open · 2025Trial
- General practice staff and patient experiences of a multicomponent intervention for people at high risk of poor health outcomes: a qualitative study.BMC primary care · 2024Trial
- Trial
- Trial
- How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme.Trials · 2022Trial
- Optimizing qualitative methods in implementation research: a resource for editors, reviewers, authors, and researchers to dispel ten common misperceptions about qualitative research methods.Implementation science : IS · 2025Article
- What is it like to microdose LSD for depression? a thematic analysis of participant interviews from an open-label trial.Therapeutic advances in psychopharmacology · 2025Article
- Article
- Understanding Health Worker and Community Antibiotic Prescription-Adherence Practices for Acute Febrile Illness: A Nested Qualitative Study in the Shai-Osudoku District of Ghana and the Development of a Training-and-Communication Intervention.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Article
- Risk Management in Clinical Trials: Assessment of Current Practices at Portuguese Clinical Trial Sites.Risk management and healthcare policy · 2023Article
- Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.HRB open research · 2023Article
- "There is nothing better than participating in this study": Living the PAPAartis cardiovascular randomised controlled trial.Contemporary clinical trials communications · 2022Article
- A pilot mixed-methods randomized controlled trial of verbal versus electronic screening for adverse social determinants of health.Journal of the American College of Emergency Physicians open · 2022Article
- Using qualitative process evaluation in the development of a complex intervention to advance person-centred practice by pharmacists: The Medicines and Alcohol Consultation (MAC).SSM. Qualitative research in health · 2021Article
- Visual Participatory Analysis: A Qualitative Method for Engaging Participants in Interpreting the Results of Randomized Controlled Trials of Health Interventions.Journal of mixed methods research · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundQualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design.
methodsHealth services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP).
resultsThe qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component.
conclusionsWe recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.