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Background <p>Research results are often not communicated to study participants or others with relevant lived experience. Effective communication of research results would help study participants understand their contribution to research and could improve trust in research and likelihood of research participation. Few randomized controlled trials (RCTs), however, have compared the effectiveness of research communication tools, and it is not known which tools work best for different people. We will conduct the Scleroderma Patient-centered Intervention Network—Communicating Latest Evidence and Results (SPIN-CLEAR) trial series via the multi-national SPIN Cohort to compare tool effectiveness. Primary objectives of each RCT will be to compare tools based on (1) information completeness, (2) understandability, and (3) ease of use. We will additionally evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, outcomes by participant characteristics (gender, age, race or ethnicity, country, language, education level, health literacy).</p> Methods <p>An advisory team of people with systemic sclerosis (SSc, also known as scleroderma) participated in developing research questions, selecting outcomes, and designing the series of parallel-arm RCTs that will each compare two or more tools or tool variations to a plain-language summary comparator; the common comparator will facilitate across-trial comparisons. In each RCT, people with SSc and researchers will select a recent SSc research study to disseminate. Tools will be developed by experienced tool developers and people with SSc. SPIN Cohort participants (current <i>N</i> eligible = 1522 from 50 SPIN sites in Australia, Canada, France, UK, USA) and additional participants recruited via social media and patient organization partners who consent to participate will be randomized to a dissemination tool or plain-language summary comparator and complete outcomes. Analyses will be intent-to-treat and use linear regression models.</p> Discussion <p>Each trial in the planned series of trials will build upon knowledge from previous trials. Results will contribute to the evidence base on how to best disseminate results to study participants and others with relevant lived experience.</p> Trial registration <p>ClinicalTrials.gov NCT06373263. Registered on April 17, 2024 (first trial in series).</p>

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Master protocol for a series of cohort-based randomized controlled trials to test tools to communicate research results to study participants and others with relevant lived experience: the SPIN-CLEAR Trials

  • 期刊论文

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  • 发表日期：

    2025年5月8日

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  • Brett D. Thombs,
  • Claire Adams,
  • Elsa-Lynn Nassar,
  • Marie-Eve Carrier,
  • Meira Golberg,
  • Kanika Bharthi,
  • Amanda Wurz,
  • Annabelle South,
  • Linda Kwakkenbos,
  • Sabrina Hoa,
  • Danielle B. Rice,
  • Geneviève Guillot,
  • Amanda Lawrie-Jones,
  • Maureen Sauvé,
  • Susan J. Bartlett,
  • Catherine Fortune,
  • Amy Gietzen,
  • Karen Gottesman,
  • Marie Hudson,
  • Laura K. Hummers,
  • Vanessa L. Malcarne,
  • Maureen D. Mayes,
  • Michelle Richard,
  • James Stempel,
  • Robyn K. Wojeck,
  • Kathleen Blagrave,
  • Jill T. Boruff,
  • Vanessa Cook,
  • Nicole Culos-Reed,
  • Ole Fröbert,
  • Katie Gillies,
  • Vera Granikov,
  • Lars G. Hemkens,
  • Elizabeth Yakes Jimenez,
  • Agnes Kocher,
  • Catarina Leite,
  • Mathew A. W. T. Lim,
  • Nancy Maltez,
  • John Michalski,
  • Tracy Mieszczak,
  • Mwidimi Ndosi,
  • Janet Pope,
  • François Rannou,
  • Ken Rozee,
  • Sharon E. Straus,
  • Matthew R. Sydes,
  • Lehana Thabane,
  • John Varga,
  • Tami Yap,
  • Merrick Zwarenstein,
  • Luc Mouthon,
  • Andrea Benedetti,
  • Christian Agard,
  • Laurent Alric,
  • Marc André,
  • Floryan Beaslay,
  • Elana J. Bernstein,
  • Sabine Berthier,
  • Lyne Bissonnette,
  • Sophie Blaise,
  • Eva Bories,
  • Alessandra Bruns,
  • Carlotta Cacciatore,
  • Patricia Carreira,
  • Marion Casadevall,
  • Benjamin Chaigne,
  • Lorinda Chung,
  • Benjamin Crichi,
  • Thylbert Deltombe,
  • Christopher P. Denton,
  • Tannvir Desroche,
  • Robyn Domsic,
  • James V. Dunne,
  • Bertrand Dunogue,
  • Regina Fare,
  • Dominique Farge-Bancel,
  • Paul R. Fortin,
  • Tracy Frech,
  • Loraine Gauzère,
  • Anne Gerber,
  • Jessica K. Gordon,
  • Brigitte Granel-Rey,
  • Aurélien Guffroy,
  • Geneviève Gyger,
  • Eric Hachulla,
  • Daphna Harel,
  • Monique Hinchcliff,
  • Michael Hugues,
  • Alena Ikic,
  • Sindhu R. Johnson,
  • Nader Khalidi,
  • Kimberly S. Lakin,
  • Marc Lambert,
  • Maggie Larche,
  • David Launay,
  • Yvonne C. Lee,
  • Paul Legendre,
  • Hélène Maillard,
  • Joanne Manning,
  • Isabelle Marie,
  • Maria Martin Lopez,
  • Thierry Martin,
  • Ariel Masetto,
  • Arsène Mekinian,
  • Sheila Melchor Díaz,
  • Morgane Mourguet,
  • Christelle Nguyen,
  • Karen Nielsen,
  • Mandana Nikpour,
  • Louis Olagne,
  • Vincent Poindron,
  • Susanna Proudman,
  • Grégory Pugnet,
  • Loïc Raffray,
  • Alexis Régent,
  • Frederic Renou,
  • Sébastien Rivière,
  • David Robinson,
  • Esther Rodríguez Almazar,
  • Tatiana Sofia Rodríguez-Reyna,
  • Perrine Smets,
  • Vincent Sobanski,
  • Robert F. Spiera,
  • Virginia Steen,
  • Carter Thorne,
  • Damien Wagner,
  • Pearce Wilcox,
  • Mara Cañedo Ayala,
  • Cassidy Dal Santo,
  • Monica D’Onofrio,
  • Marieke Alexandra Neyer

摘要

Background

Research results are often not communicated to study participants or others with relevant lived experience. Effective communication of research results would help study participants understand their contribution to research and could improve trust in research and likelihood of research participation. Few randomized controlled trials (RCTs), however, have compared the effectiveness of research communication tools, and it is not known which tools work best for different people. We will conduct the Scleroderma Patient-centered Intervention Network—Communicating Latest Evidence and Results (SPIN-CLEAR) trial series via the multi-national SPIN Cohort to compare tool effectiveness. Primary objectives of each RCT will be to compare tools based on (1) information completeness, (2) understandability, and (3) ease of use. We will additionally evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, outcomes by participant characteristics (gender, age, race or ethnicity, country, language, education level, health literacy).

Methods

An advisory team of people with systemic sclerosis (SSc, also known as scleroderma) participated in developing research questions, selecting outcomes, and designing the series of parallel-arm RCTs that will each compare two or more tools or tool variations to a plain-language summary comparator; the common comparator will facilitate across-trial comparisons. In each RCT, people with SSc and researchers will select a recent SSc research study to disseminate. Tools will be developed by experienced tool developers and people with SSc. SPIN Cohort participants (current N eligible = 1522 from 50 SPIN sites in Australia, Canada, France, UK, USA) and additional participants recruited via social media and patient organization partners who consent to participate will be randomized to a dissemination tool or plain-language summary comparator and complete outcomes. Analyses will be intent-to-treat and use linear regression models.

Discussion

Each trial in the planned series of trials will build upon knowledge from previous trials. Results will contribute to the evidence base on how to best disseminate results to study participants and others with relevant lived experience.

Trial registration

ClinicalTrials.gov NCT06373263. Registered on April 17, 2024 (first trial in series).