Systematic review of clinical outcome reporting in randomised controlled trials of burn care

Amber E. Young · Anna K. Davies · Sophie Bland · Sara T. Brookes · Jane M. Blazeby

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Meta-analysis and systematic reviews Burn Injury Management and Outcomes Delphi Technique in Research

Abstract

INTRODUCTION: Systematic reviews collate trial data to provide evidence to support clinical decision-making. For effective synthesis, there must be consistency in outcome reporting. There is no agreed set of outcomes for reporting the effect of burn care interventions. Issues with outcome reporting have been identified, although not systematically investigated. This study gathers empirical evidence on any variation in outcome reporting and assesses the need for a core outcome set for burn care research. METHODS: Electronic searches of four search engines were undertaken from January 2012 to December 2016 for randomised controlled trials (RCTs), using medical subject headings and free text terms including 'burn', 'scald' 'thermal injury' and 'RCT'. Two authors independently screened papers, extracted outcomes verbatim and recorded the timing of outcome measurement. Duplicate outcomes (exact wording ± different spelling), similar outcomes (albumin in blood, serum albumin) and identical outcomes measured at different times were removed. Variation in outcome reporting was determined by assessing the number of unique outcomes reported across all included trials. Outcomes were classified into domains. Bias was reduced using five researchers and a patient working independently and together. RESULTS: 147 trials were included, of which 127 (86.4%) were RCTs, 13 (8.8%) pilot studies and 7 (4.8%) RCT protocols. 1494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within 6 months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 5,13). No single outcome was reported across all studies demonstrating inconsistency of reporting. Outcomes were classified into 54 domains. Numbers of outcomes per domain ranged from 1 to 166 (median 11; IQR 3,24). CONCLUSIONS: This review has demonstrated heterogeneity in outcome reporting in burn care research which will hinder amalgamation of study data. We recommend the development of a Core Outcome Set. PROSPERO REGISTRATION NUMBER: CRD42017060908.

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2009The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration 2017The COMET Handbook: version 1.0 2012Developing core outcome sets for clinical trials: issues to consider 2011Using the Delphi Technique to Determine Which Outcomes to Measure in Clinical Trials: Recommendations for the Future Based on a Systematic Review of Existing Studies 2017Core Outcome Set-STAndards for Development: The COS-STAD recommendations 2014Developing Core Outcome Measurement Sets for Clinical Trials: OMERACT Filter 2.0 2016Core Outcome Set–STAndards for Reporting: The COS-STAR Statement 2017A taxonomy has been developed for outcomes in medical research to help improve knowledge discovery

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