Nothing About Us Without Us: A Scoping Review and Priority-Setting Partnership in Type 1 Diabetes and Exercise

Objectives Examine the characteristics of patient engagement (PE) practices in exercise-based randomized trials in type 1 diabetes (T1D), and facilitate T1D stakeholders in determining the top ten list of priorities for exercise research. Design Two methodological approaches were employed: a scoping review and a modified James Lind Alliance priority-setting partnership. Methods Published (Medline, Embase, CINAHL, and Central databases) and grey literature ([www.clinicaltrials.gov][1]) were searched to identify randomized controlled trials of exercise interventions lasting minimum four weeks and available in English. We extracted information on PE and patient-reported outcomes (PROMs) to identify if patient perspectives had been implemented. Based on results, we set out to determine exercise research priorities as a first step towards a patient-engaged research agenda. An online survey was distributed across Canada to collect research questions from patients, caregivers and healthcare providers. We qualitatively analyzed submitted questions and compiled a long-list that a twelve-person stakeholder steering committee used to identify the top ten priority research questions. Results Of 9,962 identified sources, 19 published trials and 4 trial registrations fulfilled inclusion criteria. No evidence of PE existed in any included study. Most commonly measured PROMs were frequency of hypoglycemia (n=7) and quality of life (n=4). The priority-setting survey yielded 194 submitted research questions. Steering committee rankings identified 10 priorities focused on lifestyle factors and exercise modifications to maintain short-term glycemic control. Conclusion Recent exercise-based randomized trials in T1D have not included PE and PROMs. Patient priorities for exercise research have yet to be addressed with adequately designed clinical trials. ### Competing Interest Statement Dr. Yardley reports personal fees and non-financial support from Dexcom Canada, non-financial support from Abbott Nutrition Canada, non-financial support from LifeScan Canada, outside the submitted work. Dr. Hay reports grants from Canadian Institute of Health Research Vanier Scholarship, during the conduct of the study. ### Funding Statement This study was supported by funding from the Canadian Institutes of Health Research Strategy for Patient-Oriented Research (SCA-145101) and an Applied Public Health Chair in Resilience and Obesity in Youth held by Dr. McGavock. JLH was supported by a CIHR Vanier Scholarship. KMS holds a Canada Research Chair in Integrated Knowledge Translation in Rehabilitation Sciences. NK was supported by a University of Manitoba Graduate Fellowship award. The authors do not declare any competing interests in the conduct of these studies. ### Author Declarations All relevant ethical guidelines have been followed and any necessary IRB and/or ethics committee approvals have been obtained. Yes All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes Any clinical trials involved have been registered with an ICMJE-approved registry such as ClinicalTrials.gov and the trial ID is included in the manuscript. Not Applicable I have followed all appropriate research reporting guidelines and uploaded the relevant Equator, ICMJE or other checklist(s) as supplementary files, if applicable. Yes The de-identified datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. [1]: http://www.clinicaltrials.gov