SynthesisInternational journal of technology assessment in health care2026
The value of qualitative research in randomized controlled trials involving drugs and medical devices: a systematic mapping review.
Synthesis in International journal of technology assessment in health care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe use of qualitative research with randomized controlled trials (RCTs) has grown exponentially over the last decade, but little is known about how it is contributing to trial procedures and interventions. This review systematically mapped the value that qualitative research has had in RCTs of drugs and medical devices.
methodsWe searched five electronic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, and ASSIA) and the NIHR Journals Library to identify original, peer-reviewed qualitative research conducted in the context of specific RCTs (pilot or full). Drawing on studies published between January 2019 and December 2020, we identified and classified examples illustrating how qualitative research had contributed to the trial. This created a list of questions qualitative methods can address in RCTs.
resultsOf 207 included studies, only 22 percent explicitly articulated their value. Most frequently reported contributions included: (a) explaining trial findings; (b) ensuring that interventions meet the needs of key stakeholders; and (c) making the trial feasible and viable (e.g., through improved trial design and conduct). A total of 776 examples demonstrating how qualitative methods had enhanced the trial were classified into twenty-seven subcategories. A list of sixty potential questions was developed to assist future research design.
conclusionsThe value of qualitative research in trials is expanding. While qualitative methods have traditionally been associated with complex interventions, this review highlights their relevance to trials involving drugs and devices. Future trials could benefit from expanding the use of qualitative methods to deepen understanding of outcomes, strengthen measurement validity, and capture experiences of conditions.
Indexed as
Identifiers
What Socratic 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 Socratic graph.