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最小重要差异在退行性膝关节疾病结局中的应用:一项系统评价和案例研究以提供快速建议。

Application of minimal important differences in degenerative knee disease outcomes: a systematic review and case study to inform Rapid Recommendations.

作者信息

Devji Tahira, Guyatt Gordon H, Lytvyn Lyubov, Brignardello-Petersen Romina, Foroutan Farid, Sadeghirad Behnam, Buchbinder Rachelle, Poolman Rudolf W, Harris Ian A, Carrasco-Labra Alonso, Siemieniuk Reed A C, Vandvik Per O

机构信息

Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

出版信息

BMJ Open. 2017 May 11;7(5):e015587. doi: 10.1136/bmjopen-2016-015587.

Abstract

OBJECTIVES

To identify the most credible anchor-based minimal important differences (MIDs) for patient important outcomes in patients with degenerative knee disease, and to inform Rapid Recommendations for arthroscopic surgery versus conservative management DESIGN: Systematic review.

OUTCOME MEASURES

Estimates of anchor-based MIDs, and their credibility, for knee symptoms and health-related quality of life (HRQoL).

DATA SOURCES

MEDLINE, EMBASE and PsycINFO.

ELIGIBILITY CRITERIA

We included original studies documenting the development of anchor-based MIDs for patient-reported outcomes (PROs) reported in randomised controlled trials included in the linked systematic review and meta-analysis and judged by the parallel Rapid Recommendations panel as critically important for informing their recommendation: measures of pain, function and HRQoL.

RESULTS

13 studies reported 95 empirically estimated anchor-based MIDs for 8 PRO instruments and/or their subdomains that measure knee pain, function or HRQoL. All studies used a transition rating (global rating of change) as the anchor to ascertain the MID. Among PROs with more than 1 estimated MID, we found wide variation in MID values. Many studies suffered from serious methodological limitations. We identified the following most credible MIDs: Western Ontario and McMaster University Osteoarthritis Index (WOMAC; pain: 12, function: 13), Knee injury and Osteoarthritis Outcome Score (KOOS; pain: 12, activities of daily living: 8) and EuroQol five dimensions Questionnaire (EQ-5D; 0.15).

CONCLUSIONS

We were able to distinguish between more and less credible MID estimates and provide best estimates for key instruments that informed evidence presentation in the associated systematic review and judgements made by the Rapid Recommendation panel.

TRIAL REGISTRATION NUMBER

CRD42016047912.

摘要

目的

确定退行性膝关节疾病患者重要结局中最可靠的基于锚定的最小重要差异(MID),并为关节镜手术与保守治疗的快速推荐提供依据。

设计

系统评价。

结局指标

基于锚定的膝关节症状和健康相关生活质量(HRQoL)的MID估计值及其可信度。

数据来源

MEDLINE、EMBASE和PsycINFO。

纳入标准

我们纳入了原始研究,这些研究记录了在相关系统评价和荟萃分析中纳入的随机对照试验中报告的基于锚定的患者报告结局(PRO)的MID的制定情况,并被平行的快速推荐小组判定为对其推荐至关重要:疼痛、功能和HRQoL的测量。

结果

13项研究报告了针对8种PRO工具和/或其测量膝关节疼痛、功能或HRQoL的子领域的95个基于经验估计的基于锚定的MID。所有研究均使用过渡评级(变化的总体评级)作为锚定来确定MID。在有多个估计MID的PRO中,我们发现MID值存在很大差异。许多研究存在严重的方法学局限性。我们确定了以下最可靠的MID:西安大略和麦克马斯特大学骨关节炎指数(WOMAC;疼痛:12,功能:13)、膝关节损伤和骨关节炎结局评分(KOOS;疼痛:12,日常生活活动:8)和欧洲五维健康量表(EQ-5D;0.15)。

结论

我们能够区分更可信和较不可信的MID估计值,并为关键工具提供最佳估计值,这些估计值为相关系统评价中的证据呈现以及快速推荐小组的判断提供了依据。

试验注册号

CRD42016047912。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/241a/5777462/9f809d303c5b/bmjopen-2016-015587f01.jpg

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