Scholarlink

Background <p>Clinical trial participants have a right to know the results of the trials in which they participate. Trial results are often not shared directly with participants and concerns with privacy and resource constraints may prevent researchers from contacting participants after trial completion.</p> Questions/Purposes <p>The objectives of this cross-sectional study were to explore the feasibility of contacting orthopaedic fracture trial participants after trial completion and to determine the preferences and priorities of the participants who wished to know the results.</p> Patients/Methods <p>Following the publication of the primary manuscript, we attempted to contact participants from the completed PREPARE trial at Hamilton Health Sciences to determine if they would like to know the trial results. We asked participants about their preferences for receiving trial results, their experiences upon learning them, and if they wished to learn which treatment they received.</p> Results <p>Twenty-eight percent (181/641) of PREPARE trial participants contacted agreed to participate in this study. We found that 95.5% (95% CI 91.0%—97.9%) of respondents wished to know the trial results and the preferred method was through viewing summary posters via an online link (78.2%; 95% CI 71.1%—84.0%). Most felt satisfied after learning the trial results (67.8%; 95% CI 59.5%- 75.2%) and 82.2% (95% CI 75.2%—87.5%) wanted to know which treatment they received. Fifty-one percent (95% CI 42.7%—58.7%) reported that learning the results increased their likelihood of participating in a future trial.</p> Conclusions <p>Although it was challenging to both contact and re-engage participants after completing an orthopaedic trial that involved minimal participant burden, our study findings suggest that learning the trial results may have a positive impact on individual participants and the research community. Given the limited understanding of results among our respondents, researchers should have processes in place to engage participants meaningfully throughout the trial and proactively discuss with them how the results will be shared once the trial is complete.</p> Level of evidence <p>IV.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Closing the loop: Benefits and challenges of sharing clinical trial results with participants after trial close-out

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年2月4日

查看全文
  • Jodi L. Gallant,
  • Tristan Paranavitana,
  • Sofia Bzovsky,
  • Kaitlyn Pusztai,
  • Paula McKay,
  • Debra Marvel,
  • Jeffrey L. Wells,
  • Julie Menard,
  • Jamal Al-Asiri,
  • Joseph T. Patterson,
  • Gerard Slobogean,
  • Sheila Sprague,
  • Mohit Bhandari,
  • Anthony D. Harris,
  • C. Daniel Mullins,
  • Lehana Thabane,
  • Amber Wood,
  • Gregory J. Della Rocca,
  • Joan Hebden,
  • Kyle J. Jeray,
  • Lucas S. Marchand,
  • Lyndsay M. O’Hara,
  • Robert Zura,
  • Christopher Lee,
  • Michael J. Gardner,
  • Jenna Blasman,
  • Jonah Davies,
  • Stephen Liang,
  • Monica Taljaard,
  • P. J. Devereaux,
  • Gordon H. Guyatt,
  • Diane Heels-Ansdell,
  • Jana Palmer,
  • Jeff Friedrich,
  • Nathan N. O’Hara,
  • Frances Grissom,
  • I. Leah Gitajn,
  • Saam Morshed,
  • Robert V. O’Toole,
  • Bradley A. Petrisor,
  • Franca Mossuto,
  • Manjari G. Joshi,
  • Jean-Claude D’Alleyrand,
  • Justin Fowler,
  • Jessica Rivera,
  • Max Talbot,
  • David Pogorzelski,
  • Shannon Dodds,
  • Jordan Leonard,
  • Silvia Li,
  • Alejandra Rojas,
  • Gina Del Fabbro,
  • Olivia Paige Szasz,
  • Alexandra Minea,
  • Kevin Murphy,
  • Andrea Howe,
  • Yasmin Degani,
  • Haley Demyanovich,
  • Michelle Medeiros,
  • Genevieve Polk,
  • Eric Kettering,
  • Nirmen Mahal

摘要

Background

Clinical trial participants have a right to know the results of the trials in which they participate. Trial results are often not shared directly with participants and concerns with privacy and resource constraints may prevent researchers from contacting participants after trial completion.

Questions/Purposes

The objectives of this cross-sectional study were to explore the feasibility of contacting orthopaedic fracture trial participants after trial completion and to determine the preferences and priorities of the participants who wished to know the results.

Patients/Methods

Following the publication of the primary manuscript, we attempted to contact participants from the completed PREPARE trial at Hamilton Health Sciences to determine if they would like to know the trial results. We asked participants about their preferences for receiving trial results, their experiences upon learning them, and if they wished to learn which treatment they received.

Results

Twenty-eight percent (181/641) of PREPARE trial participants contacted agreed to participate in this study. We found that 95.5% (95% CI 91.0%—97.9%) of respondents wished to know the trial results and the preferred method was through viewing summary posters via an online link (78.2%; 95% CI 71.1%—84.0%). Most felt satisfied after learning the trial results (67.8%; 95% CI 59.5%- 75.2%) and 82.2% (95% CI 75.2%—87.5%) wanted to know which treatment they received. Fifty-one percent (95% CI 42.7%—58.7%) reported that learning the results increased their likelihood of participating in a future trial.

Conclusions

Although it was challenging to both contact and re-engage participants after completing an orthopaedic trial that involved minimal participant burden, our study findings suggest that learning the trial results may have a positive impact on individual participants and the research community. Given the limited understanding of results among our respondents, researchers should have processes in place to engage participants meaningfully throughout the trial and proactively discuss with them how the results will be shared once the trial is complete.

Level of evidence

IV.