Applying mixed methods to pilot feasibility studies to inform intervention trials

Abstract

Background Pilot feasibility studies serve a uniquely important role in preparing for larger scale intervention trials by examining the feasibility and acceptability of interventions and the methods used to test them. Mixed methods (collecting, analyzing, and integrating quantitative and qualitative data and results) can optimize what can be learned from pilot feasibility studies to prepare rigorous intervention trials. Despite increasing use of mixed method designs in intervention trials, there is limited guidance on how to apply these approaches to address pilot feasibility study goals. The purpose of this article is to offer methodological guidance for how investigators can plan to integrate quantitative and qualitative methods within pilot feasibility studies to comprehensively address key research questions. Methods We used an informal consensus-based process informed by key methodological resources and our team’s complementary expertise as intervention researchers and mixed methodologists to develop guidance for applying mixed methods to optimize what can be learned from pilot feasibility studies. We developed this methodological guidance as faculty in the Mixed Methods Research Training Program (MMRTP) for the Health Sciences (R25MH104660) funded by the National Institutes of Health through the Office of Behavioral and Social Science Research. Results We provide the following guidance for applying mixed methods to optimize pilot feasibility studies: (1) identify feasibility domain(s) that will be examined using mixed methods, (2) align quantitative and qualitative data sources for the domain(s) selected for mixing methods, (3) determine the timing of the quantitative and qualitative data collection within the flow of the pilot study, (4) plan integrative analyses using joint displays to understand feasibility, and (5) prepare to draw meta-inferences about feasibility and implications for the future trial from the integrated data. Conclusions By effectively integrating quantitative and qualitative data within pilot feasibility studies, investigators can harness the potential of mixed methods for developing comprehensive and nuanced understandings about feasibility. Our guidance can help researchers to consider the range of key decisions needed during intervention pilot feasibility testing to achieve a rigorous mixed methods approach generating enhanced insights to inform future intervention trials.

Conscious connected breathing with breath retention intervention in adults with chronic low back pain: protocol for a randomized controlled pilot study

“…This will be the first study to examine the effects of a conscious connected breathing with breath retention intervention for individuals with chronic pain. The successful completion of this early stage study will provide data regarding the feasibility and acceptability to conduct a future RCT testing the efficacy and mechanisms of this breathing self-management practice for adults with cLBP [ 131 , 163 ]. The study is designed to be consistent with recommendations for conducting pilot RCTs [ 100 , 117 , 164 , 165 ] and for intervention development [ 61 , 166 , 167 ].…”

“…rated on a 11-point numerical rating scale (NRS) with anchors that match the content of each question (e.g., 0 = not at all acceptable, 10 = extremely acceptable). These assessments are described further in Additional file 1 : Appendix 2 and are similar to those commonly used in other pilot feasibility studies to evaluate the acceptability of an intervention and feasibility of implementing the study protocol [ 126 – 131 ]. In order to capture other aspects of feasibility and acceptability, we will ask participants to answer several open-ended questions about their involvement with the intervention and study procedures more generally (e.g., Were there challenges to participating in this study for you?).…”

“…In order to capture other aspects of feasibility and acceptability, we will ask participants to answer several open-ended questions about their involvement with the intervention and study procedures more generally (e.g., Were there challenges to participating in this study for you?). No formal qualitative analyses will be conducted, but we will review participant responses to identify possible areas of improvement to the interventions or study procedures [ 131 ]. Safety and adverse events will also be recorded after each intervention session using a yes/no symptom checklist and an open-ended prompt for participants to disclose any other possible adverse effects.…”

Use of mixed methods research in intervention studies to increase young people’s interest in STEM: A systematic methodological review

“…MMR intervention designs have received increasing attention in recent years. A growing number of methodological publications ( Sandelowski, 1996 ; Lewin et al, 2009 ; O’Cathain et al, 2013 ; Zhang, 2014 ; Boeije et al, 2015 ; Grissmer, 2016 ; Johnson and Schoonenboom, 2016 ; Maher and Neale, 2019 ; Richards et al, 2019 ; Bouchard and Tulloch, 2020 ; Fetters and Molina-Azorin, 2020 ; Aschbrenner et al, 2022 ), including an entire textbook ( O’Cathain, 2018 ), have described the ways in which designs of this type, when properly implemented, enhance the comprehensiveness, rigor, and efficiency of the intervention study.…”

Piloting a mHealth follow up program in bariatric surgery via a single-arm cohort study

“…Integrating quantitative and qualitative data within pilot feasibility studies can assist with developing comprehensive and nuanced understandings of feasibility. [19] The intervention delivered in this pilot was developed following the French et al, model. [20] Steps in the model include 1) identifying the target behaviours, population, and context, 2) assessing the problem, 3) forming possible solutions, and 4) evaluating the intervention.…”