制定马尾综合征核心结局集的方案：系统文献回顾、定性访谈、德尔菲调查和共识会议。

Protocol for the development of a core outcome set for cauda equina syndrome: systematic literature review, qualitative interviews, Delphi survey and consensus meeting.

机构信息

Institute of Translational Medicine, University of Liverpool, Liverpool, UK.

Institute of Psychology Health and Society, University of Liverpool, Liverpool, UK.

出版信息

BMJ Open. 2019 May 1;9(4):e024002. doi: 10.1136/bmjopen-2018-024002.

DOI:10.1136/bmjopen-2018-024002

PMID:31048424

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6502054/

Abstract

INTRODUCTION

Cauda equina syndrome (CES) is a serious neurological condition most commonly due to compression of the lumbosacral nerve roots, which can result in significant disability. The evidence for acute intervention in CES is mainly from retrospective studies. There is heterogeneity in the outcomes chosen for analysis in these studies, which makes it difficult to synthesise the data across studies. This study will develop a core outcome set for use in future studies of CES, engaging with key stakeholders and using transparent methodology. This will help ensure that relevant outcomes are used in future and will facilitate attempts to summarise data across studies in systematic reviews.

METHODS AND ANALYSIS

A systematic literature review will document all the outcomes for CES after surgery mentioned in the literature. The qualitative interviews with patients with CES will be semistructured, audio recorded, transcribed and thematically analysed with the use of NVivo V.10 to identify outcomes and determine the themes described. The outcomes from the literature review and patient interviews will be combined and prioritised to determine what the most important outcomes are in CES research studies to patients and healthcare professionals. The prioritisation will be done through a two-round iterative Delphi survey and a consensus meeting. This process will decide the core outcome set for patients with CES.

ETHICS AND DISSEMINATION

REC and HRA approval was obtained on the 6/12/16 for the qualitative interviews from South Central-Hampshire A REC. REC reference 16/SC/0587. REC and HRA approval was obtained on 26/3/18 for the Delphi process and consensus meeting from North West-Greater Manchester Central REC. REC reference was 18/NW/0022. The final core outcome set will be published and freely available.

TRIAL REGISTRATION NUMBER

This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 824.

摘要

简介

马尾综合征（CES）是一种严重的神经系统疾病，最常见于腰骶神经根受压，可导致严重残疾。CES 急性干预的证据主要来自回顾性研究。这些研究分析中选择的结果存在异质性，使得难以在研究间综合数据。本研究将通过与主要利益相关者合作并使用透明方法，为 CES 的未来研究制定核心结局集。这将有助于确保未来使用相关结局，并有助于尝试在系统评价中汇总研究间的数据。

方法和分析

系统文献综述将记录文献中提到的 CES 手术后的所有结局。CES 患者的定性访谈将采用半结构化、录音、转录，并使用 NVivo V.10 进行主题分析，以确定结局并确定描述的主题。文献综述和患者访谈的结果将结合起来并进行优先排序，以确定 CES 研究对患者和医疗保健专业人员最重要的结局是什么。通过两轮迭代 Delphi 调查和共识会议来进行优先排序。这个过程将决定 CES 患者的核心结局集。

伦理和传播

2016 年 12 月 6 日，South Central-Hampshire A REC 为定性访谈获得了 REC 和 HRA 批准，REC 参考号为 16/SC/0587。2018 年 3 月 26 日，North West-Greater Manchester Central REC 为 Delphi 流程和共识会议获得了 REC 和 HRA 批准，REC 参考号为 18/NW/0022。最终的核心结局集将发布并免费提供。