Lange Toni, Rataj Elisabeth, Kopkow Christian, Lützner Jörg, Günther Klaus-Peter, Schmitt Jochen
Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany; University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, TU Dresden, Dresden, Germany.
Center for Evidence-based Healthcare, University Hospital and Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany.
J Arthroplasty. 2017 Feb;32(2):653-665.e1. doi: 10.1016/j.arth.2016.09.014. Epub 2016 Sep 28.
BACKGROUND: The Outcome Measures in Rheumatology (OMERACT) initiative developed a core outcome set (COS) of domains to assess effectiveness of interventions for knee osteoarthritis. These domains (pain, physical function, patient global assessment, imaging at 1 year) should be assessed in every trial to make research evidence meaningful and comparable. We systematically evaluated and critically appraised the use of measurement instruments and outcome domains in prospective studies evaluating patients with knee osteoarthritis undergoing total knee arthroplasty (TKA) and assessed their accordance with the OMERACT COS. METHODS: Literature search was performed until August 26, 2014, in Medline and Embase. Clinical trials and prospective observational studies with ≥50 participants and a follow-up of ≥1 year were included. We collected general study characteristics, comprehensive information on measurement instruments, and corresponding domains used. RESULTS: This systematic review identified low accordance of used outcome domains with the OMERACT COS of domains published in 1997. Only 4 of 100 included studies included all recommended core domains. Pain (85% of studies) and physical function (86%) were assessed frequently, whereas patient global assessment (21%) and joint imaging (≥1 year; 27%) were rarely assessed. There was substantial heterogeneity in the use of measurement instruments (n = 111) investigating TKA. CONCLUSION: More efforts are required to implement the existing COS. In addition, a more consistent use of adequate measurement instruments is important to make research evidence on TKA more relevant, better comparable, and thus more useful for guideline developers and clinical decision makers.
背景:风湿病结局评估(OMERACT)计划制定了一套核心结局集(COS),用于评估膝关节骨关节炎干预措施的有效性。在每项试验中都应评估这些领域(疼痛、身体功能、患者整体评估、1年时的影像学检查),以使研究证据具有意义且具有可比性。我们系统地评估并批判性评价了在评估接受全膝关节置换术(TKA)的膝关节骨关节炎患者的前瞻性研究中测量工具和结局领域的使用情况,并评估了它们与OMERACT COS的一致性。 方法:截至2014年8月26日,在Medline和Embase中进行文献检索。纳入了参与者≥50名且随访时间≥1年的临床试验和前瞻性观察性研究。我们收集了一般研究特征、测量工具的全面信息以及所使用的相应领域。 结果:该系统评价发现,所使用的结局领域与1997年发表的OMERACT领域COS的一致性较低。在纳入的100项研究中,只有4项研究纳入了所有推荐的核心领域。疼痛(85%的研究)和身体功能(86%)被频繁评估,而患者整体评估(21%)和关节影像学检查(≥1年;27%)很少被评估。在研究TKA的测量工具使用方面存在很大异质性(n = 111)。 结论:需要做出更多努力来实施现有的COS。此外,更一致地使用适当的测量工具对于使TKA的研究证据更具相关性、更具可比性,从而对指南制定者和临床决策者更有用至关重要。
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