Introduction
It is becoming increasingly common to return individual-level research results to participants, especially in genetic studies (1). Yet, when the study ends, it is rare for participants to learn the study’s aggregate results (2). The contributors to this include limited time and funding, limited expertise in effective communication with non-medical audiences, and journal embargo policies. The ethical reasons for returning aggregate trial results include respect for participants’ time, promoting trust, and sharing information with those who made the results possible. However, there is a paucity of evidence to inform effective approaches to provide aggregate study results to participants (3–5).
Methods
The purpose of this report is to detail our approach to returning the aggregate results of a recent randomized controlled trial to participants (6). Based on focus group input, we developed three communication formats, using principles of low-health literacy/numeracy: a 1-page text-based summary, a 1-page infographic, and a 2-minute video. Each format offered both English and Spanish versions. The content of each method was identical, highlighting why the research was conducted; what was done; and what was found. The messaging also emphasized our appreciation for research participants. Participants received a text message with a web-link to aggregate results. To study the acceptability of these formats and identify participant preferences, we also invited participants to complete a brief survey. Interested participants completed electronic informed consent and received a $10 gift card. The Vanderbilt University Medical Center IRB approved this study.
For each communication method, participants were asked about the ease of understanding and to rank their preferred format. Participants were also asked whether receiving these results would impact their participation in future research studies.
Results
Among the 610 participants in the original trial (90% Latino, 10% Black, non-Hispanic), we sent 551 text messages (the number of participants retained at the end of the study), 206 participants accessed the results website (a secure REDCap database), and 120 completed the survey. All three communication formats were rated as “very easy” or “somewhat easy” to understand, including 85% for the print-based method, 83% for the infographic, and 93% for the video. In addition, 97% of participants reported that each format provided sufficient information. The preferred communication format was video (63%), followed by the infographic (28%), and the print-based (9%) versions. Among participants who completed the survey, 72% indicated that they were “very willing” to participate in future research with 21% “somewhat willing,” 6% “neutral”, and <1% “somewhat unwilling.” Receiving these results increased willingness to participate in research among 73% of respondents, with 25% no change.
Discussion
Returning aggregate research results to a population of low-income predominantly Latino participants suggested that the approach was easily understood, sufficient, and increased willingness to participate in future research. The preferred method of receiving results was a video summary, but a multi-modal distribution approach may be most effective, based on participant choice.
This study has some limitations. First, the time between study completion and communication of study results was more than 2 years, an intrinsic limitation to the current paradigm of reporting results. Second, many participants had changed cell-phone numbers, limiting the reach of this process to approximately one-third of the original sample and introducing the possibility of a responder-bias.
The time is right to set new standards in research dissemination. Dissemination plans and journal policies should address the return of aggregate study findings to research participants. This represents an untapped opportunity to improve the relationship between the academic research enterprise and the public. And, it’s the right thing to do.
Impact:
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What is the key message of your article?
Returning aggregate research results to a population of low-income predominantly Latino participants suggested that the approach was easily understood, sufficient, and increased willingness to participate in future research. The preferred method of receiving results was a video summary, but a multi-modal distribution approach may be most effective, based on participant choice.
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What does it add to the existing literature?
This reports an evaluation of preferred methods for returning aggregate research results to participants.
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What is the Impact?
We are proposing a new paradigm in dissemination of aggregate research, where aggregate results are regularly returned at the end of the trial.
Acknowledgements:
We express our gratitude for our community partners, Metro Parks and Recreation in Nashville, TN and the Nashville Library Foundation, as well as our appreciation to all our GROW families and staff. We also thank the Vanderbilt Institute for Clinical and Translational Research Dissemination Core team including Stephanie Mayers, Sarah Cook, Donald Alcendor, and our three community team members, Neely Williams, Ingrid Cochran, and Amy Richardson.
Funding: This research was supported by grants (U01 HL103620, U01 HL103561, NIH DK056350) with additional support from the remaining members of the COPTR Consortium (U01 HD068890, U01 HL103622, U01 HL103629),from the National Heart, Lung, and Blood Institute and the Eunice Kennedy Shriver National Institute of Child Health and Development and the Office of Behavioral and Social Sciences Research. The content expressed in this paper is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, And Blood Institute, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health, or the U.S. Department of Health and Human Services. The REDCap Database and some community engagement activities were supported by NCATS/NIH, grant number: UL1 TR000445. Dr. Heerman’s time was supported by a K23 grant from the NHLBI (K23 HL127104). Also, part of Dr. Barkin’s time was supported by a P30 grant from the NIDDK (2P30DK092986-07).
Footnotes
Ethical Considerations: Participants completed an electronic informed consent process, approved by the Vanderbilt University Medical Center IRB.
Conflict of Interest Disclosures: We have no conflicts of interest to report.
References
- 1.Wong CA, Hernandez AF, Califf RM 2018. Return of Research Results to Study Participants: Uncharted and UntestedReturn of Research Results to Study ParticipantsReturn of Research Results to Study Participants. JAMA 320:435–436. [DOI] [PubMed] [Google Scholar]
- 2.Shalowitz DI, Miller FG 2008. Communicating the results of clinical research to participants: attitudes, practices, and future directions. PLoS Med 5:e91. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Long CR, Stewart MK, Cunningham TV, Warmack TS, McElfish PA 2016. Health research participants’ preferences for receiving research results. Clin Trials 13:582–591. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4.Aldinger CE, Ligibel J, Shin IH, Denninger JW, Bierer BE 2018. Returning aggregate results of clinical trials: Empirical data of patient preferences. Journal of Clinical and Translational Science 2:356–362. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Long CR, Stewart MK, McElfish PA 2017. Health research participants are not receiving research results: a collaborative solution is needed. Trials 18:449. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Barkin SL, Heerman WJ, Sommer EC, Martin NC, Buchowski MS, Schlundt D, Po’e EK, Burgess LE, Escarfuller J, Pratt C, Truesdale KP, Stevens J 2018. Effect of a Behavioral Intervention for Underserved Preschool-Age Children on Change in Body Mass Index: A Randomized Clinical Trial. JAMA 320:450–460. [DOI] [PMC free article] [PubMed] [Google Scholar]