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News

Article

Participant Motivations Key to Success in Clinical Trials

Key Takeaways

  • Effective participant engagement in RCTs is vital for recruitment, retention, adherence, and response rates, impacting study outcomes and costs.
  • The MEL-SELF RCT emphasizes understanding participant motivations, such as personal health benefits and altruism, to enhance engagement.
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Motivators like health benefits, altruism, and trust in clinicians enhance participant retention and adherence in melanoma research, according to MEL-SELF findings.

Doctor filling out paperwork | Image Credit: © toeytoey - stock.adobe.com

Image Credit: © toeytoey - stock.adobe.com

Research engagement is essential to the success of randomized clinical trials (RCTs), as it influences recruitment, retention, adherence, and response rates. Studies that fail to engage participants effectively may suffer from low recruitment, adherence challenges, and high dropout rates, leading to underpowered studies, increased costs, and delayed access to effective interventions.1 Despite its importance, limited research exists on effective strategies to foster engagement across all stages of RCTs, particularly in dermatology. A recent analysis examined insights gained from a Study Within A Trial (SWAT) embedded in the MEL-SELF RCT, which focuses on increasing engagement in melanoma surveillance through patient-led approaches.2

Background

The analysis stated the engaging participants in clinical trials involves more than recruitment and consent; it extends to retention, adherence, and task compliance, all of which are critical to a study's integrity and outcomes. Researchers suggested that identifying what motivates participants to engage in trials can guide the development of targeted strategies to improve engagement. According to the PRioRiTy (Prioritizing recruitment and retention in randomized trials) study, understanding participant motivations is essential for both recruitment and retention.3 Common motivators in other clinical domains include perceived personal benefits, altruism, trust in clinicians, low burden, and financial incentives, yet these have not been thoroughly explored within dermatology trials.

The MEL-SELF RCT and the Embedded SWAT

The MEL-SELF trial out of Australia investigated whether patient-led melanoma surveillance, enhanced by smartphone-supported self-examination and teledermatology, results in earlier detection of new or recurrent melanomas compared to traditional clinician-led surveillance.2 A pilot trial highlighted challenges with participant engagement, prompting the development of an embedded SWAT to explore motivations and expectations among trial participants.4 By addressing these insights, the SWAT aimed to refine participant engagement strategies for the current trial and future dermatology studies.

Methodology and Participant Demographics

Participants in the MEL-SELF RCT were adults with a history of localized melanoma who owned a smartphone and could perform skin self-examination (SSE) with the assistance of a partner. The trial involved an active run-in phase, where participants completed a baseline questionnaire, SSE, and photo submissions of skin lesions before randomization. The SWAT examined responses from the first 100 participants who completed this phase, using content analysis of 2 open-ended questions about their motivations for joining the study and their expectations.

Of the initial 100 participants, 98 responded to the question on motivations, and 97 on expectations. The demographic profile indicated a predominantly female sample (59%), with an average age of 56 years, mostly from urban areas, and highly educated. Approximately half of the participants resided in the highest socioeconomic quintile.

Key Findings on Motivations and Expectations

Using content analysis, the SWAT identified recurring themes in motivations and expectations that highlight both general and melanoma-specific factors influencing research engagement.

  • Personal Health Benefit: Researchers said a significant portion of participants cited the potential for personal health benefit as a primary motivator. This included gaining confidence in their surveillance techniques, achieving peace of mind through frequent monitoring, and having access to advanced technology for early melanoma detection. Many participants hoped that patient-led monitoring would empower them to identify changes in their skin earlier, potentially leading to better outcomes.
  • Altruism and Contribution to Research: Altruistic motivations were also common, with participants expressing a desire to contribute to advancements in melanoma care. Some mentioned a personal connection to melanoma, such as a family history, which reinforced their commitment to contributing to research that might benefit others at risk.
  • Trust in Clinicians and the Research Process: Trust in the clinicians leading the trial and the rigor of the research process was another important factor. Participants who felt supported by knowledgeable professionals were more likely to engage with the demanding trial requirements.
  • Ease of Participation and Use of Technology: The analysis stated many respondents appreciated the integration of technology, particularly the smartphone-based skin self-examination and teledermatology components. Participants noted that these tools facilitated convenient and efficient participation. The ease of use, combined with remote monitoring capabilities, reduced the burden of participation and increased motivation to adhere to the trial tasks.
  • Financial and Logistical Considerations: Although less frequently cited, some participants appreciated that financial support, in the form of reduced travel costs for clinic visits or provision of required resources, made the trial more accessible. Logistical support, including clear guidance on the use of SSE tools and regular reminders, also played a role in sustaining engagement.

Practical Implications for Future Trials

The findings from the MEL-SELF trial SWAT underscore several practical strategies for enhancing participant engagement in trials. Emphasizing perceived health benefits, such as early detection and personal health improvements, can serve as a strong motivator for participants. Researchers stated supporting altruistic goals by communicating the potential broader impact of their involvement in advancing melanoma research appeals to participants' desire to contribute to meaningful change. Building a supportive and transparent environment through regular communication fosters trust, making participants more likely to adhere to study requirements. Utilizing user-friendly technology, like smartphone-based tools for self-monitoring, minimizes the burden of participation and makes the process more convenient. Additionally, the analysis found addressing financial and logistical barriers by offering financial support, clear instructions, and reminders can alleviate practical challenges, encouraging greater retention and adherence across trial phases.

Conclusion

The analysis found improving participant engagement in dermatology RCTs, such as the MEL-SELF trial, hinges on addressing participants' motivations and reducing burdens. Insights from the analysis underscore the importance of considering both general and condition-specific motivators in trial design. Researchers suggested that tailored engagement strategies informed by participant motivations and expectations can enhance recruitment, adherence, and retention, ultimately leading to more effective and impactful dermatology research.

References

  1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet. 2009;374(9683):86-89. doi:10.1016/S0140-6736(09)60329-9
  2. Ackermann D, Hersch J, Jordan D, et al. Participant motivators and expectations in the MEL-SELF randomized clinical trial of patient-led surveillance for recurrent melanoma: Content analysis of survey responses. JMIR Dermatol. 2024;7:e58136. Published 2024 Oct 17. doi:10.2196/58136
  3. Healy P, Galvin S, Williamson PR, et al. Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership - the PRioRiTy (Prioritising Recruitment in Randomised Trials) study. Trials. 2018;19(1):147. Published 2018 Mar 1. doi:10.1186/s13063-018-2544-4
  4. Ackermann DM, Dieng M, Medcalf E, et al. Assessing the potential for patient-led surveillance after treatment of localized melanoma (MEL-SELF): A pilot randomized clinical trial [published correction appears in JAMA Dermatol. 2022 Jun 1;158(6):706. doi: 10.1001/jamadermatol.2022.1379] [published correction appears in JAMA Dermatol. 2022 Jun 01;158(6):706. doi: 10.1001/jamadermatol.2022.1933]. JAMA Dermatol. 2022;158(1):33-42. doi:10.1001/jamadermatol.2021.4704
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