Background: inconsistency and heterogeneity of outcomes measured greatly limits the possibilities of comparing the effectiveness of different self-management interventions (SMI). Consequently, there is a need for a common standard to be used by researchers and influenced by patients, especially because outcomes selected to evaluate the effectiveness of an intervention may not be relevant for patients.
Objectives: to develop a core outcome set (COS) for measuring the effectiveness of SMI among adults living with one of the four prioritized, long-term conditions (LTC): chronic obstructive pulmonary disease (COPD); heart failure (HF); type 2 diabetes (T2DM); and obesity; based on patient preferences and including the views of healthcare professionals (clinicians, nurses and other health workers), researchers and civil society representatives.
Methods: we developed a long list of outcomes focused on each LTC, based on previous EU-funded projects on self-management, and integrated them into an online survey that allowed ranking by patients and patient representatives using a modified two-round Delphi Technique. Simultaneously, we conducted a scoping review of systematic reviews on patients' values/preferences on preferred outcomes regarding self-management. Once the online surveys were completed, we discussed and agreed upon outcomes in a two-day, face-to-face Consensus meeting with patients, patient representatives, healthcare professionals and researchers.
Results: 39 patients and patient representatives participated in round 1 of the online Delphi survey (9 for COPD, 9 HF, 11 T2DM and 10 obesity) and 38 in round 2 (9 for COPD, 9 HF, 11 T2DM and 9 obesity), fulfilling the criterion initially set in the description of the Project Agreement. We combined Delphi survey results with those of the overview of systematic reviews. During the Consensus meeting, 19/39 patients and patient representatives, together with 20 healthcare professionals and researchers, worked in order to reach an agreement on COS. The final selection of COS for each LTC included 16 outcomes for COPD, 16 for HF, 13 for T2DM and 15 for obesity. Supplementary outcomes included one for COPD, nine for HF, four for T2DM and five for obesity (Table 1).
Conclusions: the development of COMPAR-EU COS for LTCs could help to homogenize research efforts and enable more consistent quality results. In turn this could lead to the improvement of the outcomes of data syntheses and increase the value of self-management research data available to undertake meta-analysis. It will also help to better inform clinical decisions and help to understand patients' priorities in these LTCs and support patients' self-management. It could also guide decision making in policy, since the outcome measures show what outcomes are most important to perform patient-centred care.
Patient or healthcare consumer involvement: patients actively participated in the development of this project from its design to its results.