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
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 re...
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2025-05-01
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| Online Access: | https://doi.org/10.1186/s13063-025-08846-2 |
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| author | 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 SPIN Investigators |
| author_facet | 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 SPIN Investigators |
| author_sort | Brett D. Thombs |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-4d5c131d257b45369cda99b9e2688b0d |
| institution | DOAJ |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-4d5c131d257b45369cda99b9e2688b0d2025-08-20T03:09:20ZengBMCTrials1745-62152025-05-0126111410.1186/s13063-025-08846-2Master 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 TrialsBrett D. Thombs0Claire Adams1Elsa-Lynn Nassar2Marie-Eve Carrier3Meira Golberg4Kanika Bharthi5Amanda Wurz6Annabelle South7Linda Kwakkenbos8Sabrina Hoa9Danielle B. Rice10Geneviève Guillot11Amanda Lawrie-Jones12Maureen Sauvé13Susan J. Bartlett14Catherine Fortune15Amy Gietzen16Karen Gottesman17Marie Hudson18Laura K. Hummers19Vanessa L. Malcarne20Maureen D. Mayes21Michelle Richard22James Stempel23Robyn K. Wojeck24Kathleen Blagrave25Jill T. Boruff26Vanessa Cook27Nicole Culos-Reed28Ole Fröbert29Katie Gillies30Vera Granikov31Lars G. Hemkens32Elizabeth Yakes Jimenez33Agnes Kocher34Catarina Leite35Mathew A. W. T. Lim36Nancy Maltez37John Michalski38Tracy Mieszczak39Mwidimi Ndosi40Janet Pope41François Rannou42Ken Rozee43Sharon E. Straus44Matthew R. Sydes45Lehana Thabane46John Varga47Tami Yap48Merrick Zwarenstein49Luc Mouthon50Andrea Benedetti51SPIN InvestigatorsLady Davis Institute of the Jewish General HospitalLady Davis Institute of the Jewish General HospitalLady Davis Institute of the Jewish General HospitalLady Davis Institute of the Jewish General HospitalLady Davis Institute of the Jewish General HospitalLady Davis Institute of the Jewish General HospitalSchool of Kinesiology, University of the Fraser ValleyMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College LondonDepartment of Clinical Psychology, Behavioural Science Institute, Radboud UniversityDivision of Rheumatology, Université de MontréalDepartment of Psychology, St Joseph’s Healthcare HamiltonSclérodermie QuébecScleroderma Australia and Scleroderma VictoriaScleroderma Society of Ontario and Scleroderma CanadaDepartment of Medicine, McGill UniversityOttawa Scleroderma Support GroupNational Scleroderma Foundation, Tri-State ChapterNational Scleroderma FoundationLady Davis Institute of the Jewish General HospitalJohns Hopkins University School of MedicineSan Diego State UniversityUniversity of Texas McGovern School of MedicineScleroderma AtlanticScleroderma ChicagoAmgen IncResearch Ethics Board, Centre Intégré Universitaire de Santé Et de Services Sociaux du Centre-Ouest-de-L’Île-de-MontréalSchulich Library of Physical Sciences, Life Sciences, and Engineering, McGill UniversityLady Davis Institute of the Jewish General HospitalFaculty of Kinesiology, University of CalgaryDepartment of Cardiology, Orebro University HospitalAberdeen Centre for Evaluation, University of AberdeenCentre de Recherche du Centre Hospitalier de L, Université de MontréalPragmatic Evidence Lab, Research Center for Clinical Neuroimmunology and Neuroscience Basel, University of Basel and University Hospital BaselCollege of Population Health, University of New Mexico Health Sciences CenterInstitute of Nursing Science, University of BaselUniversity of MinhoMelbourne Dental School, University of MelbourneDepartment of Rheumatology, Ottawa HospitalNational Scleroderma Foundation, Michigan ChapterScleroderma Support GroupSchool of Health and Social Wellbeing, University of the West of EnglandDivision of Rheumatology, St Joseph’s Hospital, Western UniversityUniversité Paris Descartes, Université de ParisScleroderma AtlanticKnowledge Translation Program, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, University of TorontoMRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College LondonDepartment of Health Research Methods, Evidence, and Impact, McMaster UniversityDivision of Rheumatology, Department of Internal Medicine, University of MichiganMelbourne Dental School, University of MelbourneCentre for Studies in Family Medicine, Department of Family Medicine, Schulich School of Medicine & Dentistry, University of Western OntarioService de Médecine Interne, Centre de Référence Maladies Autoimmunes Et Autoinflammatoires Systémiques Rares d’Ile de France, de l’ , Est Et de L’Ouest, Hôpital CochinDepartment of Epidemiology, Biostatistics, and Occupational Health, McGill UniversityAbstract 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).https://doi.org/10.1186/s13063-025-08846-2Knowledge translationPatient engagementPatient and public involvementPatient-oriented researchRandomized controlled trialsResearch dissemination |
| spellingShingle | 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 SPIN Investigators 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 Trials Knowledge translation Patient engagement Patient and public involvement Patient-oriented research Randomized controlled trials Research dissemination |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Knowledge translation Patient engagement Patient and public involvement Patient-oriented research Randomized controlled trials Research dissemination |
| url | https://doi.org/10.1186/s13063-025-08846-2 |
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