Standardised Outcome Reporting for the Nutrition Management of Complex Chronic Disease: A Rapid Review

Abstract

Individuals with coexisting chronic diseases or with complex chronic disease are among the most challenging and costly patients to treat, placing a growing demand on healthcare systems. Recommending effective treatments, including nutrition interventions, relies on standardised outcome reporting from randomised controlled trials (RCTs) to enable data synthesis. This rapid review sought to determine how the scope and consistency of the outcomes reported by RCTs investigating nutrition interventions for the management of complex chronic disease compared to what is recommended by the core outcome sets (COS) for individual disease states. Peer-reviewed RCTs published between January 2010 and July 2020 were systematically sourced from PubMed, CINAHL and Embase, and COS were sourced from the International Consortium for Health Outcomes Measurements (ICHOM) and the Core Outcome Measures in Effectiveness Trials (COMET) database. A total of 45 RCTs (43 studies) and 7 COS were identified. Outcomes were extracted from both the RCTs and COS and were organised using COMET Taxonomy Core Areas. A total of 66 outcomes and 439 outcome measures were reported by the RCTs. The RCTs demonstrated extensive outcome heterogeneity, with only five outcomes (5/66, 8%) being reported with relative consistency (cited by ≥50% of publications). Furthermore, the scope of the outcomes reported by studies was limited, with a notable paucity of patient-reported outcomes. Poor agreement (25%) was observed between the outcomes reported in the RCTs and those recommended by the COS. This review urges greater uptake of the existing COS and the development of a COS for complex chronic disease to be considered so that evidence can be better synthesised regarding effective nutrition interventions.