Author Of 1 Presentation
P0199 - Declining to participate in a randomised controlled trial of a cognitive occupation-based program for people with multiple sclerosis. (ID 827)
Abstract
Background
The enhancement of recruitment strategies has become an important objective for many clinical trials and though research has investigated a variety of research design manipulations in this respect, there is a dearth of research on the perspectives of those who decline participate. Such exploration is also important to consider given that those who decline is often not accounted for in terms of accurately representing the population under investigation. Though this ‘flaw’ is inherent in all research that studies human participants, enhanced efforts to diminish decline and increase recruitment is not only important for statistical purposes, but also for strengthening the validity of conclusions regarding implementation in ‘real-world’ scenarios.
Objectives
To explore individuals’ decisions to decline participation in research trialling a Cognitive Occupation-Based program for people with MS (COB-MS) thus, informing feasibility assessment of the trial; and to extend research on recruitment to randomised controlled trials, more generally.
Methods
Seven semi-structured telephone interviews were conducted with willing participants who had previously declined to participate in COB-MS. Data were examined through thematic analysis, via an iterative, recursive process; characterised by continual re-reading of the data, data coding and thematic identification (e.g. development of categories/themes and hierarchical ordering). Thematic analysis facilitated the exploration of potentially important factors that required consideration in an under-researched topic. Subsequently, findings were presented to the public and patient involvement (PPI) panel for consultation regarding the implications of these findings.
Results
Results are presented and discussed in light of extant theory and research. Preliminary results suggest that reasons for declining may include misinterpretation of the participant information sheet, feelings regarding appropriateness of their candidacy for COB-MS, inability to commit to the COB-MS program and particular issues regarding the design of the study and/or program. Including perspectives of PPI panel added valuable insights that supported fuller interpretation and ensured ‘trustworthiness’ to the data.
Conclusions
Though reasons for declining to participate can be many and diverse, some could be avoided through further consideration and ‘amendment’ during future trial development. Development of program-specific Patient & Public Involvement panels may be particularly useful in this context. Despite the numbers who declined to participate, the COB-MS trial was well received by those who did not participate, who expressed finding the program to be acceptable and accessible.