evaluating tools to communicate scleroderma research results to patients

Conditions: Scleroderma; Systemic Sclerosis

Summary: sharing research results with patients is required by ethical regulations. yet, most researchers do not share results from their studies with patients. the investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients. the first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. participants will be randomly assigned to receive the dissemination tool or comparator. study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs.

background: research ethics guidance mandates that study results be shared with participants, and cihr's knowledge translation strategy emphasizes dissemination to others with relevant lived experiences. yet, most researchers do not share results with patients, and do not know which dissemination tools (e.g., lay summaries, infographics, podcasts) or tool features best facilitate effective communication. only 3 randomized controlled trials (rcts) have compared tool effectiveness, and none assessed which approaches work best for which patients. comparative effectiveness trials are needed to build an evidence base to help us understand what tools are most effective for communicating different types of research to different patients. the investigators will use the multinational scleroderma patient-centered intervention network (spin) cohort to conduct a series of rcts to compare tools among people with systemic sclerosis, or scleroderma. the first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. objectives: an effective tool must communicate information patients want to know, understandably, in an easy-to-use format. the trial will compare the effectiveness of an infographic and lay summary, overall and for patients with different sociodemographic or educational characteristics. primary objectives: the first trial will compare tools based on (1) information completeness; (2) understandability; and (3) ease of use, as prioritized by our patient advisory team. secondary objectives: the investigators will 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, analyze effects by participant characteristics (e.g., age, country, language, education level, ehealth literacy). methods: parallel-group rct that will compare 2 tools (infographic and plain-language summary comparator. for this trial, spin patients and researchers will select systemic sclerosis research to disseminate. tools will be developed by experienced tool developers, patients, and researchers. spin cohort participants (n = 1,250 and growing) will be invited to enrol, and those enrolled will be randomized to a dissemination tool and complete outcomes. analyses will be intent-to-treat and use proportional odds regression models.

Eligibility criteria:
inclusion criteria: 1. enrollment in spin cohort, which requires a systemic sclerosis (ssc) classification by a site physician based on 2013 american college of rheumatology/european league against rheumatism criteria, ≥18 years old, being fluent in english or french, and have completed one spin cohort assessment in the last year. 2. external enrollment with patient-reported physician classification of ssc and age 18 or older. exclusion criteria: patients not able to access or respond to questionnaires via the internet are excluded.

Keywords: scleroderma knowledge translation dissemination tools e-health intervention systemic sclerosis