评价早发性脊柱侧凸生活质量及其测量特性的结局指标：系统评价方案。

Outcomes evaluating quality of life and their measurement properties in early-onset scoliosis: protocol for a systematic review.

机构信息

Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK.

Royal Orthopaedic Hospital NHS Foundation Trust, Birmingham, UK

出版信息

BMJ Open. 2021 Sep 6;11(9):e048956. doi: 10.1136/bmjopen-2021-048956.

DOI:10.1136/bmjopen-2021-048956

PMID:34489280

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8422316/

Abstract

INTRODUCTION

Early-onset scoliosis (EOS) is a rare spinal deformity affecting children under the age of 10. Both the condition and its treatment have associated morbidity and can impact quality of life. Understanding this impact can be achieved by using appropriate patient-reported and/or carer-reported outcome measures. The aim of the review described in this protocol is to evaluate the evidence on measurement properties relevant to health-related quality of life outcomes in the EOS population. The focus will be on outcome measures relevant to patients undergoing treatment of EOS under the age of 10.

METHODS/ANALYSIS: This protocol is reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology. The MEDLINE, EMBASE, EMCARE, PubMed, PsychINFO and CINAHL databases will be searched using a two-stage search strategy. The first stage will identify measures of HRQoL used in EOS through screening of titles and abstracts. The second stage will assess the measurement properties of those measures identified through screening of full-text articles. The measurement properties of interest are the 'reliability', 'validity' and 'responsiveness' of the instrument. Only English language articles will be considered. Two reviewers will independently review the search results against the eligibility criteria, perform data extraction and assess for risk of bias, with disputes handled by a third reviewer. Data will be quantitatively pooled where possible or reported as a narrative synthesis. The summarised results for each measurement property will be rated against the criteria for good measurement properties following the COSMIN methodology. Two reviewers will assess the body of evidence for each measurement property using modified Grading of Recommendations, Assessment, Development and Evaluation guidelines.

ETHICS AND DISSEMINATION

No ethical approval is required for this review and the results will be submitted for publication in peer-reviewed publications.

PROSPERO REGISTRATION NUMBER

CRD42020219721.

摘要

简介

早发性脊柱侧凸（EOS）是一种罕见的脊柱畸形，影响 10 岁以下的儿童。该病及其治疗均与发病率相关，并可能影响生活质量。通过使用适当的患者报告和/或照顾者报告的结果测量，可以了解这种影响。本研究旨在评估与 EOS 人群健康相关生活质量结果相关的测量特性的证据。重点将放在与 10 岁以下接受 EOS 治疗的患者相关的测量方法上。

方法/分析：本方案按照系统评价和荟萃分析报告的首选项目以及共识标准选择健康测量仪器（COSMIN）方法学进行报告。将使用两阶段搜索策略对 MEDLINE、EMBASE、EMCARE、PubMed、PsychINFO 和 CINAHL 数据库进行搜索。第一阶段将通过筛选标题和摘要来确定 EOS 中使用的 HRQoL 测量方法。第二阶段将通过筛选全文文章来评估确定的测量方法的测量特性。感兴趣的测量特性是仪器的“可靠性”、“有效性”和“反应性”。仅考虑英语文章。两名审查员将根据入选标准独立审查搜索结果，进行数据提取并评估偏倚风险，如有争议则由第三名审查员处理。在可能的情况下，将对数据进行定量汇总，或按叙述性综合报告。根据 COSMIN 方法，将根据良好测量特性的标准对每个测量特性的汇总结果进行评分。两名审查员将使用修改后的推荐、评估、制定和评估指南对每个测量特性的证据进行评估。