Self-management interventions in patients with long-term conditions: a structured review of approaches to reporting inclusion, assessment, and outcomes in multimorbidity

Background: Multimorbidity has many potential implications for healthcare delivery, but a particularly important impact concerns the validity of trial evidence underpinning clinical guidelines for individual conditions. Objective: To review how authors of published trials of self-management interventions reported inclusion criteria, sample descriptions, and consideration of the impact of multimorbidity on trial outcomes. Methods: We restricted our analysis to a small number of exemplar long-term conditions: type 2 diabetes mellitus, coronary heart disease, and chronic obstructive pulmonary disease. We focussed our search on published Cochrane reviews. Data were extracted from the trials on inclusion/exclusion, sample description, and impact on outcomes. Results: Eleven reviews consisting of 164 unique trials were identified. Sixty percent of trials reported excluding patients with forms of multimorbidity. Reasons for exclusion were poorly described or defined. Reporting of multimorbidity within the trials was poor, with only 35% of trials reporting on multimorbidity in their patient samples. Secondary analyses, exploring the impact of multimorbidity, were very rare. Conclusions: The importance of multimorbidity in trials is only going to become more important over time, but trials often exclude patients with multimorbidity, and reporting of multimorbidity in trials including such patients is generally poor. This limits judgements about the external validity of the results for clinical populations. A consistent approach to the conduct and reporting of secondary analyses of the effects of multimorbidity on outcomes, using current best-practice guidance, could lead to a rapid development of the evidence base.