Dataset Information

Clinical indicators for reporting the effectiveness of patient quality and safety-related interventions: a protocol of a systematic review and Delphi consensus process as part of the international Standardised Endpoints for Perioperative Medicine initiative (StEP).

ABSTRACT:

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Prospero registration number

CRD42016042102.

SUBMITTER: Bampoe S

PROVIDER: S-EPMC6278793 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

Clinical indicators for reporting the effectiveness of patient quality and safety-related interventions: a protocol of a systematic review and Delphi consensus process as part of the international Standardised Endpoints for Perioperative Medicine initiative (StEP).

Bampoe Sohail S Cook Tim T Fleisher Lee L Grocott Michael P W MPW Neuman Mark M Story David D Myles Paul P Haller Guy G

BMJ open 20181202 11

<h4>Introduction</h4>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, an ...[more]

PMID: 30798291

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Project description:INTRODUCTION:'Standardised Endpoints for Perioperative Medicine' (StEP) is an international collaboration undertaking development of consensus-based consistent definitions for endpoints in perioperative clinical trials. Inconsistency in endpoint definitions can make interpretation of trial results more difficult, especially if conflicting evidence is present. Furthermore, this inconsistency impedes evidence synthesis and meta-analyses. The goals of StEP are to harmonise definitions for clinically meaningful endpoints and specify standards for endpoint reporting in clinical trials. To help inform this endeavour, we aim to conduct a scoping review to systematically characterise the definitions of clinically important endpoints in the existing published literature on perioperative blood loss and transfusion. METHODS AND ANALYSIS:The scoping review will be conducted using the widely adopted framework developed by Arksey and O'Malley, with modifications from Levac. We refined our methods with guidance from research librarians as well as researchers and clinicians with content expertise. The electronic literature search will involve several databases including Medline, PubMed-not-Medline and Embase. Our review has three objectives, namely to (1) identify definitions of significant blood loss and transfusion used in previously published large perioperative randomised trials; (2) identify previously developed consensus-based definitions for significant blood loss and transfusion in perioperative medicine and related fields; and (3) describe the association between different magnitudes of blood loss and transfusion with postoperative outcomes. The multistage review process for each question will involve two reviewers screening abstracts, reading full-text articles and performing data extraction. The abstracted data will be organised and subsequently analysed in an iterative process. ETHICS AND DISSEMINATION:This scoping review of the previously published literature does not require research ethics approval. The results will be used to inform a consensus-based process to develop definitions of clinically important perioperative blood loss and transfusion. The results of the scoping review will be published in a peer-reviewed scientific journal.

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Dataset Information

Clinical indicators for reporting the effectiveness of patient quality and safety-related interventions: a protocol of a systematic review and Delphi consensus process as part of the international Standardised Endpoints for Perioperative Medicine initiative (StEP).

Introduction

Methods and analysis

Ethics and dissemination

Prospero registration number

Publications

Clinical indicators for reporting the effectiveness of patient quality and safety-related interventions: a protocol of a systematic review and Delphi consensus process as part of the international Standardised Endpoints for Perioperative Medicine initiative (StEP).

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