Reynolds Penny S
Department of Anesthesiology, Statistics in Anesthesiology Research (STAR) Core, College of Medicine, University of Florida, Gainesville, Florida.
J Extra Corpor Technol. 2020 Jun;52(2):126-134. doi: 10.1182/ject-2000020.
Best-practice clinical decision-making for patient blood management (PBM) and transfusion in cardiac surgery requires high-quality, timely information. However, evidence will be misleading if published information lags too far behind evolving practice, or if trial results are biased, incomplete, or unreported. The result is that providers are deprived of accurate data, and patients will not receive best possible care. Publicly accessible trial registries provide information for structured audits of reporting compliance, and appraisal of evidence attrition and distortion. Trials related to blood management and transfusion in cardiac surgery and those registered in were evaluated for relevance, reliability, transparency, timeliness, and prevalence of unreported trial results. Evidence was considered to have "disappeared" if no results were posted to the registry and no related PUBMED publications were available by July 2019. Data were summarized by descriptive statistics. A total of 181 registered trials were surveyed; 52% were prospectively registered. Most commonly reported primary outcomes were laboratory surrogate measures (34%). Patient- and practice-relevant outcomes-mortality/major morbidity (7%), transfusion (27%), and major bleeding (28%)-were less common. Only seven studies posted results to the registry within the mandated 12 months from study completion; median time to posting was 17 (interquartile range [IQR] 13, 37) months. Trial results for 58% were unreported 3-9 years after trial completion. A staggering amount of clinical trial evidence for PBM in cardiac surgery is missing from publicly accessible records and the literature. Investigators must be incentivized to promptly and completely report all results. Penalties for noncompliance are already in place and should be enforced. Simplified information linkage, centralized and routine audit cycles, and prioritization of robust "living" reviews may be more positive motivators. Implementation will require a sea change in the prevailing culture of research reporting, plus coordinated efforts of clinicians, applied statisticians, information technology specialists, and research librarians.
心脏手术中患者血液管理（PBM）和输血的最佳临床决策需要高质量、及时的信息。然而，如果已发表的信息远远落后于不断发展的实践，或者试验结果存在偏差、不完整或未报告，那么证据将会产生误导。结果是，医疗服务提供者无法获得准确的数据，患者也无法得到最佳的治疗。公开可访问的试验注册库为报告合规性的结构化审核以及证据损耗和失真的评估提供信息。对与心脏手术中的血液管理和输血相关的试验以及在[具体注册库名称]注册的试验进行了相关性、可靠性、透明度、及时性以及未报告试验结果的发生率评估。如果到2019年7月没有向注册库公布结果且没有相关的PubMed出版物，则认为证据“消失”。数据通过描述性统计进行汇总。共调查了181项注册试验；52%为前瞻性注册。最常报告的主要结局是实验室替代指标（34%）。与患者和实践相关的结局——死亡率/严重并发症（7%）、输血（27%）和大出血（28%）——则不太常见。只有7项研究在规定的研究完成后12个月内向注册库公布了结果；公布结果的中位时间为17（四分位间距[IQR]13，37）个月。58%的试验结果在试验完成后3至9年未报告。公开可访问的记录和文献中缺少大量关于心脏手术中PBM的临床试验证据。必须激励研究人员及时、完整地报告所有结果。对违规行为的处罚已经存在，应予以执行。简化信息链接、集中和常规审核周期以及对有力的“动态”综述进行优先排序可能是更积极的激励措施。实施将需要对现行的研究报告文化进行彻底改变，以及临床医生、应用统计学家、信息技术专家和研究馆员的共同努力。
