. 2025 May 8;26(1):149.

doi: 10.1186/s13063-025-08846-2.

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

Brett D Thombs^{1

2

3

4

5}, Claire Adams^{6

7}, Elsa-Lynn Nassar^{6

8}, Marie-Eve Carrier⁶, Meira Golberg⁶, Kanika Bharthi⁶, Amanda Wurz⁹, Annabelle South¹⁰, Linda Kwakkenbos^{11

12

13}, Sabrina Hoa¹⁴, Danielle B Rice^{15

16}, Geneviève Guillot¹⁷, Amanda Lawrie-Jones¹⁸, Maureen Sauvé¹⁹, Susan J Bartlett^{20

21}, Catherine Fortune²², Amy Gietzen²³, Karen Gottesman²⁴, Marie Hudson^{6

20}, Laura K Hummers²⁵, Vanessa L Malcarne^{26

27}, Maureen D Mayes²⁸, Michelle Richard²⁹, James Stempel³⁰, Robyn K Wojeck³¹, Kathleen Blagrave³², Jill T Boruff³³, Vanessa Cook⁶, Nicole Culos-Reed³⁴, Ole Fröbert^{35

36}, Katie Gillies³⁷, Vera Granikov³⁸, Lars G Hemkens^{39

40}, Elizabeth Yakes Jimenez⁴¹, Agnes Kocher⁴², Catarina Leite⁴³, Mathew A W T Lim⁴⁴, Nancy Maltez⁴⁵, John Michalski⁴⁶, Tracy Mieszczak⁴⁷, Mwidimi Ndosi^{48

49}, Janet Pope⁵⁰, François Rannou^{51

52}, Ken Rozee²⁹, Sharon E Straus⁵³, Matthew R Sydes^{10

54}, Lehana Thabane⁵⁵, John Varga⁵⁶, Tami Yap⁴⁴, Merrick Zwarenstein⁵⁷, Luc Mouthon^{58

59}, Andrea Benedetti^{60

20

61}; SPIN Investigators

Collaborators, Affiliations

Collaborators

SPIN Investigators:
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

Affiliations

¹ Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, QC, H4.83H3 T 1E2, Canada. brett.thombs@mcgill.ca.
² Department of Psychiatry, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca.
³ Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca.
⁴ Department of Medicine, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca.
⁵ Department of Psychology, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca.
⁶ Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, QC, H4.83H3 T 1E2, Canada.
⁷ Department of Psychiatry, McGill University, Montreal, QC, Canada.
⁸ Department of Psychology, McGill University, Montreal, QC, Canada.
⁹ School of Kinesiology, University of the Fraser Valley, Chilliwack, BC, Canada.
¹⁰ MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.
¹¹ Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.
¹² Department of IQ Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands.
¹³ Centre for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, the Netherlands.
¹⁴ Division of Rheumatology, Université de Montréal, Centre Hospitalier de L, Montreal, QC, Canada.
¹⁵ Department of Psychology, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
¹⁶ Department of Psychiatry & Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.
¹⁷ Sclérodermie Québec, Longueuil, QC, Canada.
¹⁸ Scleroderma Australia and Scleroderma Victoria, Melbourne, VIC, Australia.
¹⁹ Scleroderma Society of Ontario and Scleroderma Canada, Hamilton, ON, Canada.
²⁰ Department of Medicine, McGill University, Montreal, QC, Canada.
²¹ Research Instituteof the, McGill University Health Centre , Montreal, QC, Canada.
²² Ottawa Scleroderma Support Group, Ottawa, ON, Canada.
²³ National Scleroderma Foundation, Tri-State Chapter, Buffalo, NY, USA.
²⁴ National Scleroderma Foundation, Los Angeles, CA, USA.
²⁵ Johns Hopkins University School of Medicine, Baltimore, MD, USA.
²⁶ San Diego State University, San Diego, CA, USA.
²⁷ San Diego Joint Doctoral Program in Clinical Psychology, San Diego State Universityand, University of California , San Diego, CA, USA.
²⁸ University of Texas McGovern School of Medicine, Houston, TX, USA.
²⁹ Scleroderma Atlantic, Halifax, NS, Canada.
³⁰ Scleroderma Chicago, Chicago, IL, USA.
³¹ Amgen Inc, Thousand Oaks, CA, USA.
³² Research Ethics Board, Centre Intégré Universitaire de Santé Et de Services Sociaux du Centre-Ouest-de-L'Île-de-Montréal, Montreal, QC, Canada.
³³ Schulich Library of Physical Sciences, Life Sciences, and Engineering, McGill University, Montreal, QC, Canada.
³⁴ Faculty of Kinesiology, University of Calgary, Calgary, AB, Canada.
³⁵ Department of Cardiology, Orebro University Hospital, Orebro, Sweden.
³⁶ Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.
³⁷ Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
³⁸ Centre de Recherche du Centre Hospitalier de L, Université de Montréal, Montreal, QC, Canada.
³⁹ Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel, University of Basel and University Hospital Basel, Basel, Switzerland.
⁴⁰ Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
⁴¹ College of Population Health, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
⁴² Institute of Nursing Science, University of Basel, Basel, Switzerland.
⁴³ University of Minho, Braga, Portugal.
⁴⁴ Melbourne Dental School, University of Melbourne, Carlton, Melbourne, VIC, Australia.
⁴⁵ Department of Rheumatology, Ottawa Hospital, Ottawa, ON, Canada.
⁴⁶ National Scleroderma Foundation, Michigan Chapter, Detroit, MI, USA.
⁴⁷ Scleroderma Support Group, Rochester, NY, USA.
⁴⁸ School of Health and Social Wellbeing, University of the West of England, Bristol, UK.
⁴⁹ Academic Rheumatology Unit, University Hospitals Bristol and Weston, National Health Service Foundation Trust, Bristol, UK.
⁵⁰ Division of Rheumatology, St Joseph's Hospital, Western University, London, ON, Canada.
⁵¹ Université Paris Descartes, Université de Paris, Paris, France.
⁵² , Paris, France.
⁵³ Knowledge Translation Program, Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.
⁵⁴ British Heart Foundation Data Science Centre, Health Data Research UK, London, UK.
⁵⁵ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
⁵⁶ Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
⁵⁷ Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.
⁵⁸ Service de Médecine Interne, Centre de Référence Maladies Autoimmunes Et Autoinflammatoires Systémiques Rares d'Ile de France, de l' , Est Et de L'Ouest, Hôpital Cochin, Paris, France.
⁵⁹ Assistance Publique Hôpitaux de Paris-Centre, Hôpital Cochin, Université Paris Cité, Paris, France.
⁶⁰ Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada.
⁶¹ Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, QC, Canada.

PMID: 40340935
PMCID: PMC12060389
DOI: 10.1186/s13063-025-08846-2

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

Brett D Thombs et al. Trials. 2025.

. 2025 May 8;26(1):149.

doi: 10.1186/s13063-025-08846-2.

Authors

Collaborators

SPIN Investigators:
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

Affiliations

¹ Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, QC, H4.83H3 T 1E2, Canada. brett.thombs@mcgill.ca.
² Department of Psychiatry, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca.
³ Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca.
⁴ Department of Medicine, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca.
⁵ Department of Psychology, McGill University, Montreal, QC, Canada. brett.thombs@mcgill.ca.
⁶ Lady Davis Institute of the Jewish General Hospital, 3755 Côte-Sainte-Catherine Road, Montreal, QC, H4.83H3 T 1E2, Canada.
⁷ Department of Psychiatry, McGill University, Montreal, QC, Canada.
⁸ Department of Psychology, McGill University, Montreal, QC, Canada.
⁹ School of Kinesiology, University of the Fraser Valley, Chilliwack, BC, Canada.
¹⁰ MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.
¹¹ Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.
¹² Department of IQ Healthcare, Radboud University Medical Center, Nijmegen, the Netherlands.
¹³ Centre for Mindfulness, Department of Psychiatry, Radboud University Medical Center, Nijmegen, the Netherlands.
¹⁴ Division of Rheumatology, Université de Montréal, Centre Hospitalier de L, Montreal, QC, Canada.
¹⁵ Department of Psychology, St Joseph's Healthcare Hamilton, Hamilton, ON, Canada.
¹⁶ Department of Psychiatry & Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.
¹⁷ Sclérodermie Québec, Longueuil, QC, Canada.
¹⁸ Scleroderma Australia and Scleroderma Victoria, Melbourne, VIC, Australia.
¹⁹ Scleroderma Society of Ontario and Scleroderma Canada, Hamilton, ON, Canada.
²⁰ Department of Medicine, McGill University, Montreal, QC, Canada.
²¹ Research Instituteof the, McGill University Health Centre , Montreal, QC, Canada.
²² Ottawa Scleroderma Support Group, Ottawa, ON, Canada.
²³ National Scleroderma Foundation, Tri-State Chapter, Buffalo, NY, USA.
²⁴ National Scleroderma Foundation, Los Angeles, CA, USA.
²⁵ Johns Hopkins University School of Medicine, Baltimore, MD, USA.
²⁶ San Diego State University, San Diego, CA, USA.
²⁷ San Diego Joint Doctoral Program in Clinical Psychology, San Diego State Universityand, University of California , San Diego, CA, USA.
²⁸ University of Texas McGovern School of Medicine, Houston, TX, USA.
²⁹ Scleroderma Atlantic, Halifax, NS, Canada.
³⁰ Scleroderma Chicago, Chicago, IL, USA.
³¹ Amgen Inc, Thousand Oaks, CA, USA.
³² Research Ethics Board, Centre Intégré Universitaire de Santé Et de Services Sociaux du Centre-Ouest-de-L'Île-de-Montréal, Montreal, QC, Canada.
³³ Schulich Library of Physical Sciences, Life Sciences, and Engineering, McGill University, Montreal, QC, Canada.
³⁴ Faculty of Kinesiology, University of Calgary, Calgary, AB, Canada.
³⁵ Department of Cardiology, Orebro University Hospital, Orebro, Sweden.
³⁶ Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.
³⁷ Aberdeen Centre for Evaluation, University of Aberdeen, Aberdeen, UK.
³⁸ Centre de Recherche du Centre Hospitalier de L, Université de Montréal, Montreal, QC, Canada.
³⁹ Pragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel, University of Basel and University Hospital Basel, Basel, Switzerland.
⁴⁰ Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
⁴¹ College of Population Health, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
⁴² Institute of Nursing Science, University of Basel, Basel, Switzerland.
⁴³ University of Minho, Braga, Portugal.
⁴⁴ Melbourne Dental School, University of Melbourne, Carlton, Melbourne, VIC, Australia.
⁴⁵ Department of Rheumatology, Ottawa Hospital, Ottawa, ON, Canada.
⁴⁶ National Scleroderma Foundation, Michigan Chapter, Detroit, MI, USA.
⁴⁷ Scleroderma Support Group, Rochester, NY, USA.
⁴⁸ School of Health and Social Wellbeing, University of the West of England, Bristol, UK.
⁴⁹ Academic Rheumatology Unit, University Hospitals Bristol and Weston, National Health Service Foundation Trust, Bristol, UK.
⁵⁰ Division of Rheumatology, St Joseph's Hospital, Western University, London, ON, Canada.
⁵¹ Université Paris Descartes, Université de Paris, Paris, France.
⁵² , Paris, France.
⁵³ Knowledge Translation Program, Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.
⁵⁴ British Heart Foundation Data Science Centre, Health Data Research UK, London, UK.
⁵⁵ Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
⁵⁶ Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
⁵⁷ Centre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.
⁵⁸ Service de Médecine Interne, Centre de Référence Maladies Autoimmunes Et Autoinflammatoires Systémiques Rares d'Ile de France, de l' , Est Et de L'Ouest, Hôpital Cochin, Paris, France.
⁵⁹ Assistance Publique Hôpitaux de Paris-Centre, Hôpital Cochin, Université Paris Cité, Paris, France.
⁶⁰ Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada.
⁶¹ Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, QC, Canada.

PMID: 40340935
PMCID: PMC12060389
DOI: 10.1186/s13063-025-08846-2

Abstract

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).

Keywords: Knowledge translation; Patient and public involvement; Patient engagement; Patient-oriented research; Randomized controlled trials; Research dissemination; Scleroderma; Systemic sclerosis.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: The SPIN Cohort was approved by the Research Ethics Committee of the Jewish General Hospital, Montreal (JGH REC Protocol #12–123), and by ethics committees of each recruiting site. The SPIN-CLEAR trial was approved by the Research Ethics Committee of the Centre intégré universitaire de santé et de services sociaux du Centre-Ouest-de-l’Île-de-Montréal (#2024–4165). All participants will provide electronic consent via Qualtrics prior to participating in the study. Consent for publication: Not applicable. Competing interests: All authors declare that they have no competing interests.

Figures

**Fig. 2**
Schedule of enrollment, interventions, and assessments

See this image and copyright information in PMC

References

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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

Collaborators

Affiliations

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

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous