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Developing lay summaries and thank you notes in paediatric pragmatic clinical trials.

Publication ,  Journal Article
Zimmerman, KO; Perry, B; Hanlen-Rosado, E; Nsonwu, A; Lane, MD; Benjamin, DK; Becker, M; Corneli, A ...
Published in: Health Expect
June 2022

INTRODUCTION: Better transparency of research results and participant engagement may help address poor participant accrual in paediatric clinical research. We conducted formative research to assess the acceptability of lay summaries and thank you notes, as well as to refine and expand guidance on participant and family engagement in Pediatric Trials Network's (PTN) pragmatic paediatric clinical research. METHODS: Informed by draft PTN guidance, we conducted in-depth qualitative interviews with adolescent clinical trial participants and caregivers of paediatric participants in four trials conducted by PTN across eight sites. Participants were shown multiple versions of mock lay summaries and thank you notes and asked questions on their preferences for content and layout, and on trial communications. We used applied thematic analysis to analyse the data. RESULTS: We interviewed 27 individuals engaged in PTN research: 24 caregivers and 3 adolescents. During a trial, participants want regular updates on study progress, reminders of the study purpose and reassurances of data confidentiality. After the trial, participants want to learn the aggregated results, particularly medication effectiveness. Participants reported that lay summaries should include a review of the study's purpose, methods and length, and that they expect to learn individual-level results. Participants stated that thank you notes must be of sufficient length to be meaningful. CONCLUSIONS: This is the first study to describe stakeholder preferences for thank you note content and layout. Using these findings, we finalized PTN's trial communication guidance for use in future PTN trials. Research is needed to determine the effect of lay summaries and thank you notes on improving public transparency regarding clinical trials and paediatric trial recruitment and completion. PATIENT OR PUBLIC CONTRIBUTION: By design, stakeholders (adolescent trial participants and caregivers of pediatric trial participants) contributed to PTN's guidance on the content and layout of lay summaries and thank you notes through their participation in the in-depth interviews.

Duke Scholars

Published In

Health Expect

DOI

EISSN

1369-7625

Publication Date

June 2022

Volume

25

Issue

3

Start / End Page

1029 / 1037

Location

England

Related Subject Headings

  • Public Health
  • Pragmatic Clinical Trials as Topic
  • Humans
  • Communication
  • Caregivers
  • Adolescent
  • 4206 Public health
  • 4203 Health services and systems
  • 1701 Psychology
  • 1117 Public Health and Health Services
 

Citation

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Chicago
ICMJE
MLA
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Zimmerman, K. O., Perry, B., Hanlen-Rosado, E., Nsonwu, A., Lane, M. D., Benjamin, D. K., … Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee, . (2022). Developing lay summaries and thank you notes in paediatric pragmatic clinical trials. Health Expect, 25(3), 1029–1037. https://doi.org/10.1111/hex.13448
Zimmerman, Kanecia O., Brian Perry, Emily Hanlen-Rosado, Adora Nsonwu, Morgan D. Lane, Daniel K. Benjamin, Mara Becker, Amy Corneli, and Amy Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. “Developing lay summaries and thank you notes in paediatric pragmatic clinical trials.Health Expect 25, no. 3 (June 2022): 1029–37. https://doi.org/10.1111/hex.13448.
Zimmerman KO, Perry B, Hanlen-Rosado E, Nsonwu A, Lane MD, Benjamin DK, et al. Developing lay summaries and thank you notes in paediatric pragmatic clinical trials. Health Expect. 2022 Jun;25(3):1029–37.
Zimmerman, Kanecia O., et al. “Developing lay summaries and thank you notes in paediatric pragmatic clinical trials.Health Expect, vol. 25, no. 3, June 2022, pp. 1029–37. Pubmed, doi:10.1111/hex.13448.
Zimmerman KO, Perry B, Hanlen-Rosado E, Nsonwu A, Lane MD, Benjamin DK, Becker M, Corneli A, Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Developing lay summaries and thank you notes in paediatric pragmatic clinical trials. Health Expect. 2022 Jun;25(3):1029–1037.
Journal cover image

Published In

Health Expect

DOI

EISSN

1369-7625

Publication Date

June 2022

Volume

25

Issue

3

Start / End Page

1029 / 1037

Location

England

Related Subject Headings

  • Public Health
  • Pragmatic Clinical Trials as Topic
  • Humans
  • Communication
  • Caregivers
  • Adolescent
  • 4206 Public health
  • 4203 Health services and systems
  • 1701 Psychology
  • 1117 Public Health and Health Services