Which diabetes specific patient reported outcomes should be measured in routine care? A systematic review to inform a core outcome set for adults with Type 1 and 2 diabetes mellitus: The European Health Outcomes Observatory (H2O) programme

Diabetes mellitus; Patient reported outcome measures; Type 1Diabetis mellitus; Mesures de resultat informades pel pacient; Tipus 1Diabetes mellitus; Medidas de resultado informadas por el paciente; Tipo 1Objectives The objective was to identify candidate patient reported outcomes with potential to inform individual patient care and service development for inclusion in a digital outcome set to be collected in routine care, as part of an international project to enhance care outcomes for people with diabetes. Methods PubMed, COSMIN and COMET databases were searched. Published studies were included if they recommended patient reported outcomes that were clinically useful and/or important to people with diabetes. To aid selection decisions, recommended outcomes were considered in terms of the evidence endorsing them and their importance to people with diabetes. Results Twenty-seven studies recommending 53 diabetes specific outcomes, and patient reported outcome measures, were included. The outcomes reflected the experience of living with diabetes (e.g. psychological well-being, symptom experience, health beliefs and stigma) and behaviours (e.g. self-management). Diabetes distress and self-management behaviours were most endorsed by the evidence. Conclusions The review provides a comprehensive list of candidate outcomes endorsed by international evidence and informed by existing outcome sets, and suggestions for measures. Practice implications The review offers evidence to guide clinical application. Integrated measurement of these outcomes in care settings holds enormous potential to improve provision of care and outcomes in diabetes.H2O has received funding from the Innovative Medicines Initiative (IMI) 2 Joint Undertaking under grant agreement No 945345-2. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme, EFPIA, Trial Nation and JDRF International. The funding source was not involved in the study design; the collection, analysis, and interpretation of data; the writing of the report, or the decision to submit the article for publication. The manuscript reflects only the author's view. The IMI, the European Union, EFPIA, or any Associated Partners are not responsible for any use that may be made of the information it contains