K. El-Boghdadly, Department of Anaesthesia, Guy's & St Thomas' NHS Foundation Trust and King's College London, London, UK F. W. Abdallah, Department of Anesthesia and Pain Medicine, University of Ottawa, Ottawa, Ontario, Canada; and the Department of Anesthesia and the Li Ka Shing Knowledge Institute, University of Toronto, Toronto, Ontario, Canada A. Short, Department of Anaesthesia, Wrightington, Wigan & Leigh NHS Foundation Trust, Wrightington, Lancashire, UK L. Vorobeichik , V. W. S. Chan, Department of Anesthesia, University of Toronto, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada S. G. Memtsoudis, Department of Anesthesiology, Critical Care and Pain Management and Health Care Policy and Research, Weill Cornell Medical College, New York, NY, USA; and the Hospital for Special Surgery, New York, NY, USA.
Clin Orthop Relat Res. 2019 Mar;477(3):606-619. doi: 10.1097/CORR.0000000000000578.
Core outcome sets aim to select and standardize the choice of important outcomes reported in clinical trials to encourage more effective data synthesis, increase the reliability of comparing results, and minimize reporting bias. A core outcome set for elective shoulder surgery has yet to be defined, and therefore a systematic assessment of outcomes and methodology is necessary to inform the development of a core outcome set.
QUESTIONS/PURPOSES: The purpose of this study was to examine randomized controlled trials (RCTs) of patients having elective major or minor shoulder surgery to (1) identify the outcome domains reported; (2) determine specific outcome measurement tools that were utilized; and (3) assess the work for methodological quality and risk of bias.
We conducted a scoping review (a review that identifies the nature and extent of research evidence) to explore the reported outcome domains, outcome tools, and methodological quality from RCTs conducted in shoulder surgery. We considered both major shoulder surgery (defined as arthroplasty, rotator cuff repair, stabilization procedures, biceps tenodesis, or Bankart repairs) and minor shoulder surgery (simple arthroscopy, capsular plication, lateral clavicular excisions, or subacromial decompression). We queried 10 electronic databases for studies published between January 2006 and January 2015. Studies were included if they were prospective, randomized controlled, clinical trials enrolling patients who received an elective shoulder surgical intervention. We extracted data relating to trial characteristics, primary outcomes, tools used to measure these outcomes as well as methodological quality indicators. We assessed indicators of methodological quality by exploring (1) the reproducibility of power analyses; and (2) whether the primary outcomes were powered to minimum clinically important differences. Risk of bias was also assessed with the Jadad score with scores between 0 (very high risk of bias) and 5 (very low risk). Findings were qualitatively analyzed and reported according to systematic and scoping review guidelines. We included 315 studies involving 30,232 patients; 266 studies investigated anesthetic, analgesic, or surgical interventions.
Of the 315 studies included, the most common outcome domains evaluated were analgesic (n = 104), functional (n = 87), anesthetic (n = 56), and radiologic (n = 29) outcomes, with temporal patterns noted. Studies of major shoulder surgery most commonly reported functional primary outcome domains, whereas minor shoulder surgery studies most frequently reported analgesic primary outcome domains. There were 85 different primary outcome tools utilized, which included 20 functional, 20 anesthetic, 13 analgesic, and 12 radiologic. A methodological quality assessment revealed that 24% of studies had reproducible power analyses, 13% were powered to minimum clinically important differences, and risk of bias assessment demonstrated a median (interquartile range [range]) Jadad score of 4 (3-5 [1-5]).
A wide range of outcome domains and outcome assessment tools are in common use in contemporary trials of patients undergoing elective surgery. Although some diversity is important to allow the assessment of patient populations that may have different goals, the large number of tools in common use may impair the ability of future meta-analyses to pool results effectively or even for systematic reviews to synthesize what is known. The limitations of methodological quality in RCTs may be improved by researchers following standard guidelines and considering the minimum clinically important differences in their trials to be of greater use to clinicians and their patients.
Level I, therapeutic study.
核心结局集旨在选择和标准化临床试验报告的重要结局，以鼓励更有效的数据综合，提高结果比较的可靠性，并最小化报告偏倚。然而，择期肩部手术的核心结局集尚未确定，因此需要对结果和方法进行系统评估，以为核心结局集的制定提供信息。
问题/目的：本研究的目的是检查择期大或小肩部手术的随机对照试验（RCT），以确定：（1）报告的结局领域；（2）确定使用的特定结局测量工具；（3）评估工作的方法学质量和偏倚风险。
我们进行了范围综述（一种识别研究证据的性质和范围的综述），以探讨肩部手术 RCT 中报告的结局领域、结局工具和方法学质量。我们考虑了大肩部手术（定义为关节置换术、肩袖修复术、稳定术、肱二头肌肌腱固定术或 Bankart 修复术）和小肩部手术（简单关节镜检查、囊瓣紧缩术、锁骨外侧切除术或肩峰下减压术）。我们查询了 10 个电子数据库，以检索 2006 年 1 月至 2015 年 1 月期间发表的研究。前瞻性、随机对照临床试验，招募接受择期肩部手术干预的患者，符合研究条件。我们提取了与试验特征、主要结局、用于测量这些结局的工具以及方法学质量指标有关的数据。我们通过探讨（1）功效分析的可重复性；（2）主要结局是否有最小临床重要差异的功效来评估方法学质量指标。使用 Jadad 评分评估偏倚风险，评分范围为 0（高度偏倚风险）至 5（低度偏倚风险）。根据系统综述和范围综述指南，对研究结果进行定性分析和报告。我们共纳入了 315 项研究，涉及 30232 名患者；其中 266 项研究评估了麻醉、镇痛或手术干预。
在纳入的 315 项研究中，评估最多的结局领域是镇痛（n=104）、功能（n=87）、麻醉（n=56）和放射学（n=29）结局，且具有时间模式。大肩部手术研究最常报告功能主要结局领域，而小肩部手术研究最常报告镇痛主要结局领域。共使用了 85 种不同的主要结局工具，其中包括 20 种功能、20 种麻醉、13 种镇痛和 12 种放射学工具。方法学质量评估显示，24%的研究具有可重复的功效分析，13%的研究针对最小临床重要差异进行了功效，偏倚风险评估显示 Jadad 评分中位数（四分位距[范围]）为 4（3-5[1-5]）。
在接受择期手术的患者的当代试验中，广泛使用了多种结局领域和结局评估工具。尽管某些多样性对于评估可能具有不同目标的患者群体是重要的，但共同使用的大量工具可能会影响未来荟萃分析有效地汇总结果的能力，甚至影响系统综述综合已知信息的能力。RCT 中方法学质量的局限性可以通过研究人员遵循标准指南和考虑试验中的最小临床重要差异来提高，这些差异对临床医生及其患者可能更有用。
一级，治疗性研究。
