National University of Ireland Galway College of Medicine Nursing and Health Sciences, Galway, Ireland
National University of Ireland Galway College of Medicine Nursing and Health Sciences, Galway, Ireland.
BMJ Open. 2021 Nov 2;11(11):e052506. doi: 10.1136/bmjopen-2021-052506.
Diabetes mellitus is the most common metabolic complication of pregnancy and its prevalence worldwide is rising. The number of randomised controlled trials (RCTs) being conducted in people with diabetes is also increasing. Many studies preferentially publish findings on clinical endpoints and do not report patient-reported outcomes (PROs). In studies that do include PROs, PRO reporting is often of poor quality.
We will conduct this systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Using a combination of medical subject headings and keywords (combined using Boolean operators), we will search web-based databases (PubMed, Cochrane and EMBASE) for RCTs published in English between 2013 and 2021. Two reviewers will review titles and abstracts. We will review the full texts of any relevant abstracts and extract the following data: date of publication or recruitment period, journal of publication, country of study, multicentre or single centre, population and number of participants, type of intervention, frequency of PRO assessment and type of PRO (or PRO measurement) used. We will also record if the PRO was a primary, secondary or exploratory outcome. We will exclude reviews, observational studies, unpublished data for example, conference abstracts and trial protocols. Any published RCT that includes data on a PRO as a primary or secondary outcome will then be compared against the Consolidated Standards of Reporting Trials-Patient-Reported Outcome extension checklist, a structured and approved framework for the publication of results of PROs.
Ethical approval to conduct this study was obtained from the ethics committee at Galway University Hospitals on 24 March 2021 (CA 2592). We aim to publish our findings in a peer-reviewed journal and present our findings at national and international conferences.
This systematic review was registered prospectively with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number CRD42021234917.
糖尿病是妊娠中最常见的代谢并发症，其全球患病率正在上升。在糖尿病患者中进行的随机对照试验（RCT）的数量也在增加。许多研究优先发表临床终点的研究结果，而不报告患者报告的结局（PROs）。在确实包括 PRO 的研究中，PRO 的报告质量往往较差。
我们将按照系统评价和荟萃分析的首选报告项目指南进行这项系统综述。我们将使用医学主题词和关键词的组合（使用布尔运算符组合），在 2013 年至 2021 年间，在基于网络的数据库（PubMed、Cochrane 和 EMBASE）中搜索发表在英语中的 RCT。两名审查员将对标题和摘要进行审查。我们将审查任何相关摘要的全文，并提取以下数据：出版日期或招募期、出版杂志、研究国家、多中心或单中心、人群和参与者数量、干预类型、PRO 评估频率和使用的 PRO（或 PRO 测量）类型。我们还将记录 PRO 是主要、次要还是探索性结局。我们将排除综述、观察性研究、未发表的数据，例如会议摘要和试验方案。任何包含 PRO 作为主要或次要结局数据的已发表 RCT 随后将与临床试验报告结局的统一标准（患者报告结局扩展清单）进行比较，这是一个用于发布 PRO 结果的结构化和批准的框架。
我们于 2021 年 3 月 24 日从戈尔韦大学医院的伦理委员会获得了进行这项研究的伦理批准（CA 2592）。我们的目标是在同行评议的期刊上发表我们的研究结果，并在国家和国际会议上展示我们的研究结果。
这项系统综述已在国际前瞻性系统评价注册库（PROSPERO）中进行了前瞻性注册。注册号 CRD42021234917。
