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腕管综合征随机临床试验的诊断标准和结局测量指标:系统评价。

Diagnostic criteria and outcome measures in randomized clinical trials on carpal tunnel syndrome: a systematic review.

机构信息

MD. Hand Surgeon and Master's Student, Discipline of Hand and Upper Limb Surgery, Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil.

MD, PhD. Hand Surgeon, Discipline of Hand and Upper Limb Surgery, Universidade Federal de São Paulo (UNIFESP), São Paulo (SP), Brazil; and Hand Surgeon, Hand Surgery Service, Hospital Alvorada Moema, United Health, São Paulo (SP), Brazil.

出版信息

Sao Paulo Med J. 2023 Apr 17;141(6):e2022086. doi: 10.1590/1516-3180.2022.0086.07022023. eCollection 2023.

DOI:10.1590/1516-3180.2022.0086.07022023
PMID:37075455
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10109546/
Abstract

BACKGROUND

The diagnostic criteria for carpal tunnel syndrome (CTS) lack uniformity. Moreover, because CTS is a syndrome, there is no consensus as to which signs, symptoms, clinical and complementary tests are more reproducible and accurate for use in clinical research. This heterogeneity is reflected in clinical practice. Thus, establishing effective and comparable care protocols is difficult.

OBJECTIVE

To identify the diagnostic criteria and outcome measures used in randomized clinical trials (RCTs) on CTS.

DESING AND SETTING

Systematic review of randomized clinical trials carried out at the Federal University of São Paulo, São Paulo, Brazil.

METHODS

We searched the Cochrane Library, PubMed, and Embase databases for RCTs with surgical intervention for CTS published between 2006 and 2019. Two investigators independently extracted relevant data on diagnosis and outcomes used in these studies.

RESULTS

We identified 582 studies and 35 were systematically reviewed. The symptoms, paresthesia in the median nerve territory, nocturnal paresthesia, and special tests were the most widely used clinical diagnostic criteria. The most frequently assessed outcomes were symptoms of paresthesia in the median nerve territory and nocturnal paresthesia.

CONCLUSION

The diagnostic criteria and outcome measures used in RCTs about CTS are heterogeneous, rendering comparison of studies difficult. Most studies use unstructured clinical criteria associated with ENMG for diagnosis. The Boston Questionnaire is the most frequently used main instrument to measure outcomes.

REGISTRATION

PROSPERO (CRD42020150965- https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=150965).

摘要

背景

腕管综合征(CTS)的诊断标准缺乏统一性。此外,由于 CTS 是一种综合征,对于哪些体征、症状、临床和补充检查在临床研究中更具可重复性和准确性,尚未达成共识。这种异质性反映在临床实践中。因此,很难制定有效的和可比的护理方案。

目的

确定 CTS 随机临床试验(RCT)中使用的诊断标准和结局指标。

设计和设置

在巴西圣保罗联邦大学进行的 CTS 随机临床试验的系统评价。

方法

我们在 Cochrane 图书馆、PubMed 和 Embase 数据库中搜索了 2006 年至 2019 年间发表的关于 CTS 手术干预的 RCT。两名调查员独立提取了这些研究中使用的诊断和结局相关数据。

结果

我们确定了 582 项研究,其中 35 项进行了系统评价。最广泛使用的临床诊断标准是症状、正中神经支配区的感觉异常、夜间感觉异常和特殊检查。评估最多的结局是正中神经支配区的感觉异常和夜间感觉异常。

结论

关于 CTS 的 RCT 使用的诊断标准和结局指标存在异质性,使得研究之间的比较变得困难。大多数研究使用与 ENMG 相关的非结构化临床标准进行诊断。波士顿问卷是最常用的主要衡量结局的工具。

注册

PROSPERO(CRD42020150965- https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=150965)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f96/10109546/80e16348691a/1806-9460-spmj-141-06-e2022086-gf02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f96/10109546/67101e14e9d5/1806-9460-spmj-141-06-e2022086-gf01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f96/10109546/80e16348691a/1806-9460-spmj-141-06-e2022086-gf02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f96/10109546/67101e14e9d5/1806-9460-spmj-141-06-e2022086-gf01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4f96/10109546/80e16348691a/1806-9460-spmj-141-06-e2022086-gf02.jpg

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