Bampoe Sohail, Cook Tim, Fleisher Lee, Grocott Michael P W, Neuman Mark, Story David, Myles Paul, Haller Guy
Centre for Perioperative Medicine, University College London, London, UK.
Anaesthesia and Intensive Care, Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.
BMJ Open. 2018 Dec 2;8(11):e023427. doi: 10.1136/bmjopen-2018-023427.
Clinical indicators are used to measure and quantify the safety and quality of patient care. They are also often used as endpoints in clinical trials. Definitions of clinical indicators in common use are extremely heterogeneous, limiting their applicability. As part of the international Standardised Endpoints in Perioperative Medicine initiative, this study will identify clinical indicators by systematically reviewing the anaesthesia and perioperative medicine literature, and will provide consensus, clinically useful definitions for those indicators using a Delphi process.
An electronic database search will be conducted of Medline (PubMed/OVID), EMBASE and the Cochrane Library in order to meet this review's objectives that are: (1) To identify clinical indicators and their definitions used in randomised controlled trials that assess patient-related quality and safety interventions in perioperative medicine; (2) To select a shortlist of recommended indicators and definitions that are the most suitable for evaluation of quality and safety interventions following an expert-based consensus-gaining process (Delphi method) and (3) To provide a classification scale for each indicator related to its clarity of definition, validity (strength), reliability, feasibility (ease of use) and frequency of use. This systematic review protocol is reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidance.
Ethical approval is not required for this systematic review and Delphi process. The results of this study will be disseminated to the anaesthesia and perioperative medicine clinical and academic community through national and international presentations and through publication in a peer reviewed journal.
CRD42016042102.
临床指标用于衡量和量化患者护理的安全性和质量。它们也经常被用作临床试验的终点。常用临床指标的定义极为多样，限制了它们的适用性。作为围手术期医学国际标准化终点倡议的一部分，本研究将通过系统回顾麻醉和围手术期医学文献来确定临床指标，并将使用德尔菲法为这些指标提供共识性的、临床有用的定义。
将对Medline（PubMed/OVID）、EMBASE和Cochrane图书馆进行电子数据库检索，以实现本综述的目标，即：（1）识别在评估围手术期医学中与患者相关的质量和安全干预措施的随机对照试验中使用的临床指标及其定义；（2）在基于专家的共识达成过程（德尔菲法）后，选择最适合评估质量和安全干预措施的推荐指标和定义的入围清单；（3）为每个指标提供一个分类量表，涉及定义的清晰度、有效性（强度）、可靠性、可行性（易用性）和使用频率。本系统评价方案按照系统评价和Meta分析方案的首选报告项目指南进行报告。
本系统评价和德尔菲法过程无需伦理批准。本研究结果将通过国内和国际会议报告以及在同行评审期刊上发表，传播给麻醉和围手术期医学的临床及学术团体。
PROSPERO注册号：CRD42016042102。
