Protocol for a two-arm parallel randomized controlled trial to evaluate patient and researcher co-presentation of research results: the Scleroderma Patient-centered Intervention Network—Patients Alongside Investigators in Research-Sharing (SPIN-PAIRS) trial
摘要
Researchers are mandated ethically to share study results with participants, and funding agencies emphasize dissemination to others with relevant lived experience. Many researchers, however, find it difficult to communicate study purposes, methods, results, and significance to patients. Our Scleroderma Patient-centered Intervention Network (SPIN) piloted “co-presentation,” which involves researchers and patient partners jointly presenting results to other patients. The SPIN Patients Alongside Investigators in Research-Sharing (SPIN-PAIRS) Trial will be conducted as part of a 90-min virtual research event for people with systemic sclerosis (SSc, scleroderma) and will compare patient and researcher partner co-presentation versus researcher-alone presentation. Primary outcomes will be event attendee ratings of presentations on (1) information completeness, (2) understandability, (3) relevance to patients, and (4) trust in findings. Secondary objectives are to (1) conduct subgroup analyses of primary outcomes by participant characteristics (gender, age, race or ethnicity, country, education level, health literacy) and (2) use qualitative interviews to better understand outcome ratings and inform co-presentation.
MethodsThis will be a mixed-method study with (1) a two-arm parallel superiority randomized controlled trial embedded in a patient-oriented research event and (2) interviews with patient and researcher co-presenters, separately, and with trial participants. Pre-event, researchers will be selected to present via an open call for abstracts and a patient-led selection committee. To avoid presentation-related biases, pre-event, researchers will record researcher-alone presentations. They will then receive co-presentation training and develop co-presentations with patient partners, which will also be recorded. Eligible trial participants will be adults aged 18 or older who indicate they have been diagnosed with SSc by a physician. We will recruit participants via social media and email lists from our multinational SPIN Cohort and from patient organization partners to attend the event and rate presentations. Participants will be recruited to register for the event beginning in August 2025. Registered participants will be invited to confirm their registration and enroll in the trial on the day of the event. We will require at least 116 participants for ≥ 80% power but will not restrict the number of enrollees. We will randomly assign event attendees 1:1 to virtual rooms with (1) four pre-recorded patient-researcher co-presentations or (2) four pre-recorded researcher-alone presentations. The same studies will be presented in each arm with live questions and answers after each presentation in each virtual room. Attendees will rate each presentation immediately following the presentation. Participants will not be informed that they are part of a randomized trial, or that two conditions are being compared and will be blind to study comparisons and hypotheses. Presenters will not be blinded during the event. We will compare outcomes, all measured via 0–10 numerical rating scales, using linear mixed models with four observations per participant for each outcome (one observation for each presentation). Interviews will be conducted < 2 weeks post-event, and verbatim transcripts will be analyzed using an inductive-deductive thematic approach.
DiscussionFindings will contribute to the evidence base on effective strategies for sharing results with study participants and others with relevant lived experience.
Trial registration
ISRCTN12805381 (https://www.isrctn.com/ISRCTN12805381)