Incorporating patients' perspectives into the initial stages of core outcome set development: a rapid review of qualitative studies of type 2 diabetes.

Conducting systematic reviews of qualitative studies to incorporate patient perspectives within the early stages of core outcome set (COS) development can be resource intensive. We aimed to identify an expedited approach to be used as part of the wider COS development process. Specifically, we undertook a rapid review of qualitative studies of patients' views and experiences of type 2 diabetes. We searched MEDLINE from inception to June 2017 to identify studies reporting qualitative empirical findings of perspectives of people with type 2 diabetes. Qualitative methodological filters were used to minimize irrelevant references. Drawing on content analysis, data synthesis involved identifying text in eligible studies relevant to outcomes of type 2 diabetes and interpreting and categorizing this according to the 38 core domains of the Core Outcome Measures in Effectiveness Trials taxonomy. Of 146 studies screened, 26 were included. Four hundred and fifty-eight outcomes were derived from the included studies. In comparison to the outcomes extracted from clinical trials, more life impact outcomes were derived from the qualitative studies, but fewer physiological/clinical outcomes. Outcomes relating to 'mortality/survival' and 'role functioning' were more prevalent in studies conducted in low/middle-income countries. This rapid review and synthesis of qualitative studies identified outcomes that had not previously been identified by a systematic review of clinical trials. It also identified differences in the types of outcomes given prominence to in the clinical trials and qualitative literatures. Incorporating qualitative evidence on patient perspectives from the outset of the COS development process can help to ensure outcomes that matter to patients are not overlooked. Our method provides a pragmatic and resource-efficient way to do this. For those developing international COS, our method has potential for incorporating the perspectives of patients from diverse countries in the early stages of COS development.