Outcome measures are highly variable across type 1 diabetes (T1D) screening studies to date, precluding comparison and synthesis of results. We aim to develop a core outcome set (COS) for T1D screening that is meaningful to patients/families to integrate into our pilot program. We will: (1) identify all outcomes measured in recent T1D screening studies, (2) identify additional outcomes important to families with T1D, parents in the general population, and health care providers with expertise in T1D, (3) achieve consensus across stakeholders on a COS to be used in T1D screening initiatives, and (4) identify and recommend measurement instruments used for each outcome in the COS.
While there are relevant COSs registered in the COMET database related to Type 1 diabetes, there is no COS for diabetes screening studies and as described above, outcome measures in screening studies are highly variable. The existing COSs have a focus on clinical trials/intervention research (792), clinical outcomes for individuals with diabetes (1227), and routine diabetes care (1093, 2386, 2952). However, some of these COSs include patient reported outcome measures (1093, 2386, 2952), which would be relevant to screening studies and will be incorporated and/or modified in our COS development. While existing outcomes relevant to screening will be included in our COS, existing COS are not sufficient for this context and a new set is warranted.
Diane Wherrett, Ashish Marwaha, Holly Witteman, Peter Senior, Pranesh Chakraborty, Albert Tsui, Bruce Verchere, Despoina Manousaki, Audrey L’Espérance, Conrad Pow, Jon McGavock, Monika Kastner, Michael Wilson, Constadina Panagiotopoulos, Constantin Polychronakos, Nadine Taleb, Elizabeth T. Rosolowsky, Angeliki Makri, Carol Huang, Meranda Nakhla, Elizabeth Cummings, Sahsa Delorme, Lucie Dupuis, Cecilia Hamming, Noah Ivers, Ahmed Abou-Setta, Andrew Paterson, Shazan Ahmed, Farid Mahmud, Kristin Taylor, Remi Rabasa Lhoret, Jan Dutz, Kirstine Bell, Rachel Besser, Kurt Griffin, Parth Narendran, Richard Oram, Mariam Rewers.
Disease Category: Child health, Endocrine & metabolic
Disease Name: Type 1 Diabetes
Age Range: 0 - 120
Sex: Either
Nature of Intervention: Screening
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Governmental agencies
- Patient/ support group representatives
- Policy makers
- Service providers
- Service users
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Literature review
- Semi structured discussion
We will follow a six-step process to develop the COS that is aligned with the COS-Standardized Protocol Statement and the COMET guidelines. The six steps include: (1a) rapid review, (1b) candidate outcomes survey, (2) outcome preparation, (3) multi-round Delphi surveys, (4) consensus meeting, (5) establishing outcome measurement instruments, and (6) dissemination.