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ICON 2020-国际科学肌腱病研讨会共识:跟腱病临床试验报告的结局测量的系统评价。

ICON 2020-International Scientific Tendinopathy Symposium Consensus: A Systematic Review of Outcome Measures Reported in Clinical Trials of Achilles Tendinopathy.

机构信息

Department of Physical Therapy, University of Delaware, 540 South College Avenue, Newark, DE, 19713, USA.

Physiotherapy Department, School of Primary and Allied Health Care, Faculty of Medicine Nursing and Health Science, Monash University, Melbourne, VIC, Australia.

出版信息

Sports Med. 2022 Mar;52(3):613-641. doi: 10.1007/s40279-021-01588-6. Epub 2021 Nov 19.

Abstract

BACKGROUND

Nine core domains for tendinopathy have been identified. For Achilles tendinopathy there is large variation in outcome measures used, and how these fit into the core domains has not been investigated.

OBJECTIVE

To identify all available outcome measures outcome measures used to assess the clinical phenotype of Achilles tendinopathy in prospective studies and to map the outcomes measures into predefined health-related core domains.

DESIGN

Systematic review.

DATA SOURCES

Embase, MEDLINE (Ovid), Web of Science, CINAHL, The Cochrane Library, SPORTDiscus and Google Scholar.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES

Clinical diagnosis of Achilles tendinopathy, sample size ≥ ten participants, age ≥ 16 years, and the study design was a randomized or non-randomized clinical trial, observational cohort, single-arm intervention, or case series.

RESULTS

9376 studies were initially screened and 307 studies were finally included, totaling 13,248 participants. There were 233 (177 core domain) different outcome measures identified across all domains. For each core domain outcome measures were identified, with a range between 8 and 35 unique outcome measures utilized for each domain. The proportion of studies that included outcomes for predefined core domains ranged from 4% for the psychological factors domain to 72% for the disability domain.

CONCLUSION

233 unique outcome measures for Achilles tendinopathy were identified. Most frequently, outcome measures were used within the disability domain. Outcome measures assessing psychological factors were scarcely used. The next step in developing a core outcome set for Achilles tendinopathy is to engage patients, clinicians and researchers to reach consensus on key outcomes measures.

PROSPERO REGISTRATION

CRD42020156763.

摘要

背景

已经确定了 9 个跟腱病的核心领域。对于跟腱病,使用的结果测量指标差异很大,这些指标如何适应核心领域尚未得到研究。

目的

确定所有用于前瞻性研究评估跟腱病临床表型的现有结果测量指标,并将这些结果测量指标映射到预先确定的与健康相关的核心领域。

设计

系统综述。

数据来源

Embase、MEDLINE(Ovid)、Web of Science、CINAHL、The Cochrane Library、SPORTDiscus 和 Google Scholar。

选择研究的资格标准

跟腱病的临床诊断,样本量≥10 名参与者,年龄≥16 岁,研究设计为随机或非随机临床试验、观察队列、单臂干预或病例系列。

结果

最初筛选了 9376 项研究,最终纳入了 307 项研究,共有 13248 名参与者。在所有领域共确定了 233 种(177 个核心域)不同的结果测量指标。为每个核心域确定了结果测量指标,每个域的使用范围在 8 到 35 种独特的结果测量指标之间。包括预先确定的核心域结果测量指标的研究比例从心理因素域的 4%到残疾域的 72%不等。

结论

确定了 233 种用于跟腱病的独特结果测量指标。最常使用的是残疾域内的结果测量指标。用于评估心理因素的结果测量指标很少使用。为跟腱病制定核心结局集的下一步是让患者、临床医生和研究人员参与进来,就关键结局测量指标达成共识。

PROSPERO 注册号:CRD42020156763。

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