Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Patient representative, Bristol, Avon, UK.
BMJ Open. 2019 Feb 15;9(2):e025135. doi: 10.1136/bmjopen-2018-025135.
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.
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.
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).
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.
CRD42017060908.
系统评价汇集试验数据，为支持临床决策提供证据。为了进行有效的综合分析，必须在结果报告中保持一致性。目前还没有一套针对烧伤护理干预效果报告的公认结果集。尽管已经发现了结果报告存在问题，但尚未进行系统研究。本研究旨在收集有关烧伤护理研究中结果报告差异的实证证据，并评估是否需要建立烧伤护理研究的核心结果集。
从 2012 年 1 月至 2016 年 12 月，使用医学主题词和自由文本术语（包括“烧伤”、“烫伤”、“热损伤”和“RCT”），对四个搜索引擎进行了系统检索，以查找随机对照试验（RCT）。两位作者独立筛选论文，逐字摘录结果，并记录结果测量的时间。删除重复（完全相同的措辞，仅拼写不同）、相似（血液中的白蛋白、血清白蛋白）和在不同时间测量的相同结果。通过评估所有纳入试验报告的独特结果数量来确定结果报告的差异。结果被分为不同的领域。通过五位研究人员和一位患者独立和共同使用，减少偏倚。
共纳入 147 项试验，其中 127 项（86.4%）为 RCT，13 项（8.8%）为试验研究，7 项（4.8%）为 RCT 方案。共报告了 1494 个临床结果的逐字摘录；其中 955 个是唯一的。76.8%的结果在损伤后 6 个月内测量。常见的报告结果定义不同。每个试验报告的独特结果数量从 1 到 37 个不等（中位数 9；IQR 5，13）。没有一个单一的结果在所有研究中都有报道，这表明报告的不一致性。结果被分为 54 个领域。每个领域的结果数量从 1 到 166 个不等（中位数 11；IQR 3，24）。
本研究表明，烧伤护理研究中的结果报告存在异质性，这将阻碍研究数据的综合分析。我们建议制定一个核心结果集。
PROSPERO 注册号：CRD42017060908。
