Lady Davis Institute of the Jewish General Hospital, Montreal, Quebec, Canada.
Department of Psychology, McGill University, Montreal, Quebec, Canada.
BMJ Open. 2021 May 4;11(5):e047428. doi: 10.1136/bmjopen-2020-047428.
Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease with a high level of burden, a significant impact on the ability to carry out daily activities, and a considerable negative impact on health-related quality of life. Non-pharmacological interventions could be provided to potentially improve mental and physical health outcomes. However, the effectiveness of non-pharmacological interventions on health and well-being among individuals with SSc has not been well established. The proposed living systematic review aims to identify and evaluate randomised controlled trial (RCT) evidence on the effectiveness of non-pharmacological and non-surgical interventions on mental and physical health outcomes and on the delivery of such services in SSc.
Eligible studies will be RCTs that examine non-pharmacological and non-surgical interventions aimed at improving health outcomes among individuals with SSc or the delivery of services intended to improve healthcare or support of people with SSc (eg, support groups). All RCTs included in a previous systematic review that sought studies published between 1990 and March 2014 will be evaluated for inclusion. Additional trials will be sought from January 2014 onwards using a similar, augmented search strategy developed by a health sciences librarian. We will search the MEDLINE, Embase, CINAHL, PsycINFO, Cochrane Library and Web of Science databases and will not restrict by language. Two independent reviewers will determine the eligibility of identified RCTs and will extract data using a prespecified standardised form in DistillerSR. Meta-analyses will be considered if ≥2 eligible RCTs report similar non-pharmacological interventions and comparable health outcomes. We will conduct a qualitative synthesis for interventions that cannot be synthesised via meta-analysis.
We will post initial and ongoing results via a website, publish results periodically via peer-reviewed journal publication, and present results at patient-oriented events.
CRD42020219914.
系统性硬化症（SSc；硬皮病）是一种罕见的慢性自身免疫性疾病，负担沉重，对日常活动能力有重大影响，并对健康相关生活质量产生相当大的负面影响。可以提供非药物干预措施，以潜在改善心理健康和身体健康结果。然而，非药物干预措施对 SSc 患者的健康和福祉的有效性尚未得到充分证实。拟议的系统综述旨在确定和评估随机对照试验（RCT）证据，以评估非药物和非手术干预措施对心理健康和身体健康结果的有效性，以及在 SSc 中提供此类服务的效果。
合格的研究将是 RCT，这些 RCT 研究旨在改善 SSc 患者的健康结果或提供旨在改善医疗保健或支持 SSc 患者的服务（例如支持小组）的非药物和非手术干预措施。将评估之前系统综述中纳入的所有 RCT，这些 RCT 研究旨在寻找 1990 年至 2014 年 3 月期间发表的研究。自 2014 年 1 月以来，将使用由健康科学图书馆员开发的类似增强搜索策略来搜索额外的试验。我们将搜索 MEDLINE、Embase、CINAHL、PsycINFO、Cochrane 图书馆和 Web of Science 数据库，并且不会限制语言。两名独立的审查员将确定符合条件的 RCT 的资格，并使用 DistillerSR 中预定义的标准化表格提取数据。如果≥2 项合格的 RCT 报告了类似的非药物干预措施和可比的健康结果，则将进行荟萃分析。对于无法通过荟萃分析进行综合的干预措施，我们将进行定性综合。
我们将通过网站发布初步和正在进行的结果，定期通过同行评审期刊发表结果，并在面向患者的活动中展示结果。
PROSPERO 注册号：CRD42020219914。
