Pearson Nathan A, Tutton Elizabeth, Joeris Alexander, Gwilym Stephen E, Grant Richard, Keene David J, Haywood Kirstie L
Warwick Research in Nursing, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.
Kadoorie Centre, Oxford Trauma and Emergency Care, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Services, University of Oxford, Oxford, UK.
Bone Jt Open. 2022 Oct;3(10):832-840. doi: 10.1302/2633-1462.310.BJO-2022-0080.R1.
To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.
Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed.
Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications).
Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required.Cite this article: 2022;3(10):832-840.
描述胫骨干骺端和/或踝关节骨折非药物随机临床试验（RCT）的结果报告差异及趋势。
检索了五个电子数据库和三个临床试验注册库（2000年1月至2022年2月）。纳入的试验包括患有胫骨干骺端和/或踝关节骨折且无合并伤的患者。由一名 reviewer 进行所有检索、筛选标题和摘要、评估纳入资格并完成数据提取；在每个阶段，随机抽取10%的子集由第二名 reviewer 独立评估和提取。所有提取的结果均映射到《国际功能、残疾和健康分类》框架的修改版本。评估结果报告的质量（可重复性）。
总体而言，纳入了来自27个国家的105项试验（n = 16至669名参与者）。试验比较了手术干预（n = 62）、术后管理方案（n = 17）、康复干预（n = 14）、手术与非手术干预（n = 6）以及术前管理策略（n = 5）。总共在七个领域报告了888项结果评估：263项评估身体结构或功能（占试验的85.7%），136项活动（占试验的68.6%），34项参与（占试验的23.8%），159项健康相关生活质量（占试验的61.9%），247项护理过程（占试验的80%），21项患者体验（占试验的15.2%），以及28项经济影响（占试验的8.6%）。从中描述了337个离散结果。各试验的结果报告不一致。报告质量差异很大（可重复性范围从患者体验的4.8%到并发症的100%）。
描述了结果选择、评估方法和报告质量方面的大量异质性。尽管结果数量众多，但多个试验中报告的结果很少。大多数结果以临床为重点，很少关注对患者重要的长期后果。报告质量差降低了对数据质量的信心，阻碍了用于为护理决策提供信息的数据综合。迫切需要结果报告指南和标准化，以涵盖对多个利益相关者重要的结果。引用本文：2022；3(10):832 - 840。
