质量改进研究报告规范(Standards for Quality Improvement Reporting Excellence, SQUIRE) 2.0——概述

发布于 2023年8月16日 星期三 21:18:56 浏览:336
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为更加高效利用卫生资源,提升临床医疗保健质量,质量改进研究越来越受到重视,研究数量逐渐增加。质量改进研究报告规范(Standards for Quality Improvement Reporting Excellence, SQUIRE)旨在规范质量改进研究报告,提升质量改进研究的价值。本文概述SQUIRE 2.0的背景、条目清单和使用注意事项。

关键词:质量改进; 质量改进研究; 报告规范; SQUIRE

一、质量改进研究报告规范背景

质量改进研究是指在真实情境分析中提出研究问题,并针对关键问题构建干预措施后再应用于真实情境的研究方法,其目的是改进现有卫生保健中的不足,维持改进的长期效果,持续促进医疗保健质量的提升。与经典的医学科学研究类型比较,质量改进研究不仅要评价干预措施是否有效,更重要的是评判干预措施在真实情境中的适用性、可行性和嵌入度,以及研究对象行为的改进和医疗系统的改变。

现有的一些报告规范,如针对随机对照实验的CONSORT声明、针对观察性研究的STROBE声明、针对诊断试验的STARD声明等,缺乏对干预措施在真实情境中的适用性、可行性和时间变化性的考察,并不适用于质量改进研究。目前的质量改进研究更侧重于从临床管理的角度报告研究结果,而对干预措施构建的科学性和效果评价的严谨性方面报告不足,且因研究设计、干预策略不同,质量改进研究报告时差异较大,影响了质量改进研究的发表与传播。

鉴于此,为了更好地兼顾质量改进研究的实用性与科学性,提升质量改进研究的报告质量,2005年美国卫生保健促进研究所和达特莞斯医学院卫生保健促进研究所联合方法学家、研究人员、期刊编辑成立了国际性合作组,撰写了《质量改进研究报告规范(Standards for Quality Improvement Reporting Excellence, SQUIRE)》草案,又进一步广泛收集资料、多次研讨、作者试用和反复修订,于2008年正式发表。2015年第2版 SQUIRE清单(SQUIRE 2.0)发布,其包含了标题和摘要、引言、方法、结果、讨论、其他信息6个部分、18个条目。

二、SQUIRE 2.0清单

表1 SQUIRE 2.0清单的中英文对照

内容条目序号条目内容
Title and abstract
标题和摘要
Title
标题
1Indicate that the manuscript concerns an initiative to improve healthcare (broadly defined to include the quality, safety, effectiveness, patient-centredness, timeliness, cost, efficiency and equity of healthcare).
体现文章内容为改进医疗保健质量(一般包括:质量、安全性、有效性、以病人为中心、及时性、成本、效率和医疗保健的公平性等字样)
Abstract
摘要
2a. Provide adequate information to aid in searching and indexing.
b. Summarise all key information from various sections of the text using the abstract format of the intended publication or a structured summary such as: background, local problem, methods, interventions, results, conclusions.
a. 提供充足的信息便于检索和索引;
b.采用预投期刊的摘要格式或使用结构式摘要(背景、目的、方法、干预、结果、结论)总结文章关键信息
Introduction  Why did you start?
引言  为什么要开展此项研究?
Problem description
问题描述
3Nature and significance of the local problem.
描述目前存在的问题以及问题的性质和意义
Available knowledge
现有证据
4Summary of what is currently known about the problem, including relevant previous studies.
总结研究问题已有知识,包括既往相关研究
Rationale
理论依据
5Informal or formal frameworks, models, concepts and/or theories used to explain the problem, any reasons or assumptions that were used to develop the intervention(s) and reasons why the intervention(s) was expected to work.
阐述研究问题的正式/非正式框架、模型、概念和(或)理论,采用干预措施的原因或假设,干预措施能够有效的依据
Specific aims
具体目标
6Purpose of the project and of this report.
阐述本研究的具体目标
Methods  What did you do?
方法  如何进行研究?
Context
研究背景
7Contextual elements considered important at the outset of introducing the intervention(s).
描述进行质量改进干预措施的重要背景因素
Intervention(s)
干预措施
8a. Description of the intervention(s) in sufficient detail that others could reproduce it.
b. Specifics of the team involved in the work.
a. 全面描述干预措施的细节,以便他人重复;
b. 详细介绍干预团队的具体情况
Study of the intervention(s)
方案设计
9a. Approach chosen for assessing the impact of the intervention(s).
b. Approach used to establish whether the observed outcomes were due to the intervention(s).
a. 评估干预措施效果的方法;
b. 评估效果是否由干预措施所致的方法
Measures
结局指标
10a. Measures chosen for studying processes and outcomes of the intervention(s), including rationale for choosing them, their operational definitions and their validity and reliability.
b. Description of the approach to the ongoing assessment of contextual elements that contributed to the success, failure, efficiency and cost.
c. Methods employed for assessing completeness and accuracy of data.
a. 评价干预过程和结局指标的具体方法,包括方法选择的依据、操作定义、信效度;
b. 对影响干预成败、效率、成本的重要因素进行持续评估的方法;
c. 用于评估数据完整性和准确性的方法
Analysis
分析方法
11a. Qualitative and quantitative methods used to draw inferences from the data.
b. Methods for understanding variation within the data, including the effects of time as a variable.
a. 描述从数据推断结论的定性、定量分析方法;
b. 了解数据内部变异性的方法,包括时间变量的影响
Ethical considerations
伦理考虑
12Ethical aspects of implementing and studying the intervention(s) and how they were addressed, including, but not limited to, formal ethics review and potential conflict(s) of interest.
实施和评价干预措施的伦理问题及其解决方案,包括但不限于正式的伦理审查和潜在的利益冲突说明
Results  What did you find?
结果  研究发现了什么?
Results
结果
13a. Initial steps of the intervention(s) and their evolution over time (eg, time-line diagram, flow chart or table), including modifications made to the intervention during the project.
b. Details of the process measures and outcomes.
c. Contextual elements that interacted with the intervention(s).
d. Observed associations between outcomes, interventions and relevant contextual elements.
e. Unintended consequences such as unexpected benefits, problems, failures or costs associated with the intervention(s).
f. Details about missing data.
a. 描述干预措施的初始方案及其随时间的演变情况,包括研究过程中对干预措施的修改,可用时间轴、流程图或表格呈现;
b. 报告过程评价和结局评价的详细数据;
c. 描述与干预因素相互作用的情境因素;
d. 干预措施、结局、相关情境因素之间的关联;
e. 非预期中的结果,如意料之外的成效、问题、失败或成本支出;
f. 对缺失数据的描述
Discussion  What does it mean?
讨论  研究结果的意义?
Summary
总结
14a. Key findings, including relevance to the rationale and specific aims.
b. Particular strengths of the project.
a. 总结研究的主要发现及其与理论依据和研究目标的;
b. 总结项目的独特优势
Interpretation
解释
15a. Nature of the association between the intervention(s) and the outcomes.
b. Comparison of results with findings from other publications.
c. Impact of the project on people and systems.
d. Reasons for any differences between observed and anticipated outcomes, including the influence of context.
e. Costs and strategic trade-offs, including opportunity costs.
a. 进一步解释干预措施与结果之间的关联性质;
b. 本次研究结果与其他文献发现的对比;
c. 阐述研究对实践人员和整个系统的影响;
d. 分析实际结果与预期结果之间的差异及原因,尤其是情境因素的影响;
e. 成本与效益的权衡(包括机会成本)
Limitations
局限性
16a. Limits to the generalisability of the work.
b. Factors that might have limited internal validity such as confounding, bias or imprecision in the design, methods, measurement or analysis.
c. Efforts made to minimise and adjust for limitations.
a. 该研究在推广性方面存在的局限性;
b. 研究内部有效性方面的局限性,如设计、方法、测量或分析中存在的混杂或偏倚;
c. 减少和控制局限性的措施
Conclusions
结论
17a. Usefulness of the work.
b. Sustainability.
c. Potential for spread to other contexts.
d. Implications for practice and for further study in the field.
e. Suggested next steps.
a. 总结研究的作用;
b. 可持续性;
c. 预测推广到其他情境中的可能性;
d. 对临床实践及后续研究的意义;
e. 给出后续改进建议
Other information其他信息
Funding
资助
18Sources of funding that supported this work. Role, if any, of the funding organisation in the design, implementation, interpretation and reporting.
阐述当前研究的资助来源,若有,讲明资助者在研究设计、实施、结果解释和论文发表中的作用

三、SQUIRE 2.0使用注意事项

SQUIRE 2.0清单为通过干预措施来改善临床医疗保健质量的研究提供了可参考的报告框架,其不仅能提高质量改进研究的报告质量,还可对质量改进研究的设计起到指导作用。研究者在研究之初可参考该清单来更加合理地设计方案,期刊编辑和审稿人可参考该清单提高对质量改进研究的认识并作为审稿依据。

质量改进研究的设计较为灵活,可为病例报告、历史对照、自身前后对照、时间序列研究、多中心随机对照试验等,且其干预策略也较丰富,常用的有PDCA 循环( plan-do-check-action cycle) 、PDSA循环( plando-study-act cycle)、失效模式分析(Failure Modes Analysis,FMA)、品管圈( quality control circle,QCC)等,因此SQUIRE 2.0清单并非完全适用每一类质量改进研究。作者参考时应对不适用于自己研究的条目加以说明,并对自己认为较为重要但未收录于SQUIRE2.0的条目加以说明。审稿人审稿时也应把握各条目对审阅文章的适用性并对其他认为重要的条目加以评价。

注:本文内容是参考相关文献后对质量改进研究报告规范SQUIRE 2.0原文的概述,仅代表本网站观点。关于SQUIRE 2.0的更多内容详见官方网站(http://www.squire-statement.org/)或Greg Ogrinc等作者发表的论文“SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process (https://pubmed.ncbi.nlm.nih.gov/26369893/)”,邢唯杰等发表的论文“质量改进研究报告规范-SQUIRE清单介绍及解读 (http://www.cjebp.net/CN/abstract/abstract1240.shtml,)”。

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