Core Outcome Measures in Effectiveness Trials

Defining clinically important perioperative blood loss and transfusion for the Standardised Endpoints for Perioperative Medicine (StEP) collaborative: a protocol for a scoping review

General Information

Abstract:
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.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

http://dx.doi.org/10.1136/bmjopen-2017-016743

Aim:
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.

Authors:
Justyna Bartoszko, Leon Vorobeichik, Mohandas Jayarajah, Keyvan Karkouti, Andrew A Klein, Andre Lamy, C David Mazer, Mike Murphy, Toby Richards, Marina Englesakis, Paul S Myles, Duminda N Wijeysundera

Publication

Journal:
BMJ Open
Volume:
Issue:
Pages:
-
Year:
2017
DOI:
Further Study Information

Date:
Not stated
Funding source(s):
This research received no specific grant from an y funding agency in the public, commercial or not-for-profit sectors.

Health Area

Disease Category
Other

Disease Name
Perioperative Bleeding

Target Population

Age Range
18 - 110

Sex
Either


Nature / type of Intervention
Transfusion

Method(s)

Systematic review

Stakeholders Involved

Clinical experts

Study Type

Systematic review of outcome measures/measurement instruments
Systematic review of outcomes measured in trials

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