Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for Pelvic Girdle Pain; A systematic review, qualitative interviews and Delphi consensus study

General Information

Summary:
Pelvic Girdle Pain (PGP) is a leading cause of disability and economic cost worldwide. There is an urgent need for effective preventative and management strategies. However, emerging studies measure a variety of outcomes rendering synthesis and translation to clinical practice very difficult. A core outcome set (COS), which is a standardised set of outcomes which should be measured and reported worldwide, as a minimum, in all studies for a specific health area/condition, can address this problem by ensuring that data are relevant, useful and usable to make well-informed healthcare choices.

This study aims to develop a consensus-based PGP-COS for use in research and clinical practice, with an ultimate aim to globally promote the health and well-being of people with PGP by consistent and relevant outcome measurement and reporting in any prevention and management strategy.

We will develop this PGP-COS using a systematic review, patient interviews, a Delphi survey and a face-to-face consensus meeting. This project will address 'what' to measure as well as 'how' to measure the COS.

Contributors:
Francesca Wuytack (PI) (Trinity College Dublin);
Valerie Smith (Trinity College Dublin);

Juan Jose Saldaña Mena (Universidad Estatal del Valle de Ecatepec);

Nordic Pelvic Girdle Pain Network:
Annelie Gutke (University of Gothenburg);
Birgitta Öberg (Linköping University);
Nina Vøllestad (University of Oslo);
Siv Mørkved (Norwegian University of Science and Technology);
Lena Nilsson-Wikmar (Karolinska Institutet);
Britt Stuge (University of Oslo);
Hilde Stendal Robinson (University of Oslo);
Jenny Sjödahl(Linköping University).

Further Study Information

Current Stage:
Planning
Date:
October 2017 - September 2019
Funding source(s):
Awaiting response

Health Area

Disease Category
Rehabilitation

Disease Name
Pelvic Girdle Pain

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Interview
Literature review
Systematic review

The consensus Delphi study and face-to-face meeting involves six phases. In the preparation phase, the final steering committee will be formed, ethical approval will be sought and the protocol will be published. The second phase will consist of a systematic review of the literature on PGP to extract outcomes used. This will be added to outcomes emerging from semi-structured interviews with 16 patients from four countries to form the initial list of outcomes for round 1 of the Delphi survey. Approximately 200 key international stakeholders (patients, clinicians, researchers, service providers) will be invited to participate in the 3-round Delphi. A systematic review of outcome measurement instruments for the preliminary COS will then be conducted. The resultant preliminary COS and related measurement instruments will be discussed at a face-to-face consensus meeting to produce a final COS. The international dissemination plan will include open access publication, conference presentations, and snowball dissemination involving all stakeholders.


Stakeholders Involved

Clinical experts
Consumers (patients)
Journal editors
Methodologists
Patient/ support group representatives
Policy makers
Researchers
Service providers
Service users

Study Type

COS for clinical trials or clinical research
COS for practice

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