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A systematic review of clinical outcome reporting in randomised controlled trials of burn care

Research output: Contribution to journalArticle

Original languageEnglish
Article numbere025135
Number of pages19
JournalBMJ Open
Volume9
DOIs
DateAccepted/In press - 3 Dec 2018
DatePublished (current) - 15 Feb 2019

Abstract

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 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. 1,494 verbatim clinical outcomes were reported; 955 were unique. 76.8% of outcomes were measured within six months of injury. Commonly reported outcomes were defined differently. Numbers of unique outcomes per trial varied from one to 37 (median 9; IQR 8). 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 21).

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.

    Research areas

  • Clinical decision-making, Review, Treatment Outcome, Outcome Assessment (Health Care), Burns, Randomized Controlled Trials as Topic

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    Rights statement: This is the final published version of the article (version of record). It first appeared online via BMJ at https://bmjopen.bmj.com/content/9/2/e025135. Please refer to any applicable terms of use of the publisher.

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