The Role of Qualitative Research in Randomized Controlled Trials Involving Drugs and Medical Devices: A Systematic Mapping Review
Author(s)
Yuan-Tao Huang, MSc, LLM1, Benjamin Gregory, MSc2, Sharon Greenwood, PhD3, Evi Germeni, PhD1.
1Health Economics and Health Technology Assessment (HEHTA), School of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom, 2Social Medicine, Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, United Kingdom, 3Public Health, School of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.
1Health Economics and Health Technology Assessment (HEHTA), School of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom, 2Social Medicine, Leeds Institute of Health Sciences, School of Medicine, University of Leeds, Leeds, United Kingdom, 3Public Health, School of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.
OBJECTIVES: The benefits of using qualitative research with randomised controlled trials (RCTs) are increasingly recognised. With both fields undergoing significant changes, this review documented the value of qualitative research when conducted with RCTs involving drugs and medical devices.
METHODS: We systematically searched five electronic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, ASSIA), as well as the NIHR Journals Library, to identify original, peer-reviewed qualitative research published between 1 January 2019 and 31 December 2020, and conducted in the context of a specific RCT involving a drug or a medical device. Examples illustrating how qualitative research contributed to the RCTs were identified through line-by-line reading and categorised into an existing framework that was gradually refined. This led to the development of a list of questions that qualitative methods can address in the context of trials, and to deductions about the roles that qualitative inquiries can play.
RESULTS: We included 208 qualitative studies, of which 22.1% (46/208) explicitly articulated their value to the trial. A total of 780 examples demonstrating how qualitative methods had enhanced the trial endeavour were identified and categorised into 27 subcategories. The most frequently identified subcategory focused on assessing the 'feasibility and acceptability of interventions in practice' (19.5%, 152/780). Also, 60 research questions were developed that reflect the nuanced complexity and contextual diversity encountered when conducting trials and implementing interventions in the real world.
CONCLUSIONS: While qualitative methods have conventionally been associated with complex interventions, this review highlights their expanding relevance to trials involving drugs and devices. The proposed list of questions may serve as a reference for those exploring how qualitative methods could be applied across different stages of trials. In addition to its established roles, future trials could further benefit from expanding the use of qualitative methods to deepen the understanding of outcomes, strengthen measurement validity, and capture experiences of health conditions.
METHODS: We systematically searched five electronic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, ASSIA), as well as the NIHR Journals Library, to identify original, peer-reviewed qualitative research published between 1 January 2019 and 31 December 2020, and conducted in the context of a specific RCT involving a drug or a medical device. Examples illustrating how qualitative research contributed to the RCTs were identified through line-by-line reading and categorised into an existing framework that was gradually refined. This led to the development of a list of questions that qualitative methods can address in the context of trials, and to deductions about the roles that qualitative inquiries can play.
RESULTS: We included 208 qualitative studies, of which 22.1% (46/208) explicitly articulated their value to the trial. A total of 780 examples demonstrating how qualitative methods had enhanced the trial endeavour were identified and categorised into 27 subcategories. The most frequently identified subcategory focused on assessing the 'feasibility and acceptability of interventions in practice' (19.5%, 152/780). Also, 60 research questions were developed that reflect the nuanced complexity and contextual diversity encountered when conducting trials and implementing interventions in the real world.
CONCLUSIONS: While qualitative methods have conventionally been associated with complex interventions, this review highlights their expanding relevance to trials involving drugs and devices. The proposed list of questions may serve as a reference for those exploring how qualitative methods could be applied across different stages of trials. In addition to its established roles, future trials could further benefit from expanding the use of qualitative methods to deepen the understanding of outcomes, strengthen measurement validity, and capture experiences of health conditions.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
MSR201
Topic
Health Technology Assessment, Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
PRO & Related Methods
Disease
No Additional Disease & Conditions/Specialized Treatment Areas