The quality of reporting of orthopaedic randomized trials with use of a checklist for nonpharmacological therapies
The quality of reporting of orthopaedic randomized trials with use of a checklist for nonpharmacological therapies
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DOI：
10.2106/jbjs.f.01591
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发表时间：
2007-09-01
影响因子：
5.3
通讯作者：
Bhandari, Mohit
中科院分区：
文献类型：
--
作者：
Chan, Simon;Bhandari, Mohit
背景：报告随机对照试验的综合标准声明因其对外科试验的适用性而受到限制。作为回应，报告试验综合标准小组最近制定了一份评估非药物试验报告的清单，以解决外科试验的报告问题。我们的目的是(1)将非药物治疗清单应用于2004年至2005年多个期刊的骨科随机对照试验，(2)调查未报告清单中列出的方法学保障措施的作者，以确定他们是否实际实施了这些措施。我们假设缺乏方法保障的报告并不一定意味着没有进行。方法：检索2004年1月至2005年12月8份期刊的相关骨科随机对照试验。我们将评估非药物试验报告的清单应用于所有符合条件的研究。我们联系了作者，以确定实际使用的方法保障措施，特别是在出版物中尚未明确细节的情况下。结果：我们纳入了85份科学报告中的87项随机对照试验。在评估非药物治疗清单的随机对照试验时，73项研究（84%）报告不清楚治疗分配隐藏。只有17项研究（20%）提到了外科医生的技能或经验。分别在48项（55%）、63项（72%）、64项（74%）、40项（46%）和33项（38%）研究中，患者、病房工作人员、康复工作人员、临床结果评估者和非临床结果评估者的盲法不明确。来自43个随机对照试验的作者回应了我们的调查。调查结果显示，41%（95%置信区间，25%至58%）的试验有足够的分配隐瞒性，而这在报告中是不清楚的。尽管研究者的手术经验很少被报道，但大多数作者（70%）承认他们已经定义了“外科专业标准”，如最小病例标准、专业培训和临床表现。调查还显示，28%至40%的试验对相关群体进行了盲法，尽管出版物中对这种盲法的报道并不清楚。结论：骨科文献报道的质量参差不齐。读者不应该假设在随机对照试验中没有报告的减少偏倚的保障措施没有发生。我们的研究强调了一致使用诸如评估非药物试验报告清单之类的工具来评估外科试验方法学的必要性。
Background: The Consolidated Standards of Reporting Trials statement for the reporting of randomized controlled trials has been limited by its applicability to surgical trials. In response, a Checklist to Evaluate a Report of a Nonpharmacological Trial was recently developed by the Consolidated Standards of Reporting Trials group to address reporting issues in surgical trials. We aimed (1) to apply the checklist for nonpharmacological therapies to orthopaedic randomized controlled trials across multiple journals from 2004 through 2005, and (2) to survey authors when methodological safeguards itemized in the checklist were not reported to determine whether they actually had been performed. We hypothesized that lack of reporting of a methodological safeguard did not necessarily mean it had not been conducted.Methods: We searched for relevant orthopaedic randomized controlled trials across eight journals in the period from January 2004 through December 2005. We applied the Checklist to Evaluate a Report of a Nonpharmacological Trial to all eligible studies. We contacted authors to determine what methodological safeguards were actually used, especially when details remained unclear from the publication.Results: We included eighty-seven randomized controlled trials from eighty- five scientific reports. In assessing the randomized controlled trials with the checklist for nonpharmacological therapies, seventy-three studies (84%) had unclear reporting of treatment allocation concealment. Only seventeen studies (20%) mentioned surgeon skill or experience. The blinding of patients, ward staff, rehabilitation staff, clinical outcome assessors, and nonclinical outcome assessors was unclear in forty-eight (55%), sixty-three (72%), sixty-four (74%), forty (46%), and thirty-three studies (38%), respectively. Authors from forty-three randomized controlled trials responded to our survey. The results of the survey showed that 41% (95% confidence interval, 25% to 58%) of the trials had adequate allocation concealment when this had been unclear from the report. Although the surgical experience of the investigators was rarely reported, most authors (70%) acknowledged that they had defined "surgical expertise criteria" such as minimum case criteria, specialized training, and clinical performance. The survey also showed that 28% to 40% of the trials had blinding of relevant groups despite the fact that the reporting of such blinding had been unclear in the publications.Conclusions: The quality of reporting in the orthopaedic literature was highly variable. Readers should not assume that bias-reducing safeguards that were not reported in a randomized controlled trial did not occur. Our study reinforces the need for the consistent use of a tool like the Checklist to Evaluate a Report of a Nonpharmacological Trial to assess the methodology of surgical trials.