The impact of patient engagement on trials and trialists in Ontario, Canada: An interview study with IMPACT awardees

Abstract

Background A key component of patient-oriented research is the engagement of patients as partners in the design and conduct of health research. While there is now national infrastructure and networks to support the engagement of patients as partners, there remain calls for promising practices and success stories. In particular, there remains a keen interest in evaluating the impact that patient engagement has on health research studies. We aimed to investigate the impact that patient engagement had on health research conducted in Ontario, Canada. Methods Our sampling frame was studies that were awarded funding by the Ontario SPOR SUPPORT Unit. Semi-structured interviews were conducted with 10 principal investigators, members of research teams, and patient partners. Interviews explored the role of patient partners, the perceived impact of the patient engagement on the study, challenges faced, and advice for other researchers considering patient engagement. Data were analysed using the thematic analysis method with transcripts coded independently by two members of the study team. All coding and subsequent theme generation were discussed until consensus was achieved. Results There was variation in the methods used to engage patients and other stakeholders, the roles that patients and stakeholders occupied, and where they had input. Interviewees discussed two major areas of impact of patient engagement on research: impact on the study about which they were being interviewed, which tended to relate to improved relevancy of the research to the study population, and impact on themselves which led to changes in their own practice or approaches to future research. Identified challenges to patient engagement included: identifying and reaching patient advisors or patient partners, time-related challenges, and maintaining engagement over the course of the research. Conclusions There remains a need to further build out the concept of relevancy and how it may be operationalised in practice. Further, the longer-term impacts of patient engagement on researchers and research teams remains under-explored and may reveal additional elements for evaluation. Challenges to patient engagement remain, including identifying and maintaining engagement with partners that reflect the diversity of the population of interest.

Beyond Participation: Evaluating the Role of Patients in Designing Oncology Clinical Trials

“…Patient involvement in clinical trials encounters several significant challenges, including logistical issues such as the time and resources required to facilitate in-depth patient engagement, alongside a scientific discord between medical experts and lay perspectives on research [ 43 , 44 ]. Other challenges involve integrating patient insights into the traditional hierarchical structure of scientific evidence while ensuring a diverse and representative patient sample [ 43 , 44 , 45 , 46 ]. Various strategies can be used to address these challenges.…”

Methods of Recruitment for Surgical and Perioperative Randomized Controlled Trials: A Rapid Review

“…To assess whether future changes to recruitment are successful, increased reporting on recruitment to surgical and perioperative RCTs is needed. Mail an initial contact letter to increase the time provided to patients to review study purpose and design prior to surgery Davis [22] Coordinate recruitment efforts between the clinical and research team through an initial contact about the study from the surgeon followed by informed consent with a member of the research team Davis [22] Use an iterative process to continuously optimize the recruitment strategy by obtaining feedback for recruiters and self-assessment [23] Targeted recruitment strategies For larger samples, consider using both clinical and research personnel to recruit and multiple recruitment centers [24][25][26][27] For more invasive studies, avoid informal recruitment from the wards [22,[28][29][30][31] Based on your patient population, consider advertising using as television, newspaper, Internet sources, and local media for a broader recruitment range [21]…”

“…Although absent from this present study's included pilot RCTs, a valuable recruitment strategy involves patients as partners in study design and implementation, commonly referred to as patient-oriented research, patient-centered design, or patient and public involvement (PPI) [25][26][27]. PPI may have occurred within the pilot studies included; however, it was not reported in any capacity identifiable to the reviewers.…”

Examining the involvement of guardians of children with acute lymphoblastic leukemia in Tanzania as public contributors to inform the design and conduct of the GuardiansCan project: A mixed‐methods study protocol

“…22 Routine adoption of public contribution in research is associated with the growing evidence-based concerning its impact. 23,24 Identified impacts include setting important and relevant research questions, improving recruitment rates, developing understandable participant-facing study materials, [25][26][27] improving the rigor and validity of data analysis and interpretation, 28 and developing wider dissemination and communication strategies. 29 Public contribution in research also improves knowledge among, and empowers, public contributors.…”