Core Outcome Measures in Effectiveness Trials

A core outcome set for Perthes’ Disease of the hip effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey

General Information

Summary:
Background:

Perthes’ disease is an idiopathic osteonecrosis of a developmental hip that is most frequent in Northern Europe. Currently, the absence of a common set of standardized outcomes makes comparisons between interventions challenging. This study aims to summarise the outcomes used in clinical trials that involve Perthes’ disease, and define a set of core outcomes to ensure that the variables of primary importance are measured and reported in future research related to children with Perthes’ disease.

Methods and Analysis:

A systematic review of the current literature will be used to identify a list of outcomes reported in previous studies. This list will be evaluated by experts in Perthes’ disease using a Delphi survey divided in two rounds. Additional data will be collected interviewing a group of additional key stakeholders (patients and patients’ parents). The final outcomes list obtained from the Delphi survey and from the stakeholders’ interviews, will be then used to define a consensus meeting among a representative group of key stakeholders in order to define the COS to be reported in future clinical trials related to Perthes’ disease.

Discussion:

The absence of high-quality research and clear guidelines concerning the management of Perthes’ disease is, at least in part, due to the difficulties in the comparison of the results obtained from different studies. The development of a Core Outcomes Set (COS) seeks to standardise outcomes collected in future research, to readily enable comparisons between studies to be made, and to facilitate meta-analyses of research.


Contributors:
Mr Donato Giuseppe Leo, School of Sport and Exercise Sciences, Liverpool John Moores University (UK);

Mr Wei Justin Leong, Alder Hey Children's Hospital Liverpool (UK);

Dr Tina Gambling, School of Healthcare Sciences, Cardiff University (UK);

Prof Andrew Long, Faculty of Medicine and Health, University of Leeds (UK);

Dr Rebecca Murphy, School of Sport and Exercise Sciences, Liverpool John Moores University (UK);

Prof Helen Jones (Supervisor), School of Sport and Exercise Sciences, Liverpool John Moores University;

Mr Daniel Perry (Supervisor); Institute of Translational Medicine, University of Liverpool (UK) & Alder Hey Children's Hospital Liverpool (UK)

Further Study Information

Current Stage:
Ongoing
Date:
June 2017 - February 2018
Funding source(s):
This work is funded by the Liverpool John Moores University Faculty of Engineering & Technology (FET) - Faculty of Sciences (SCS) Joint PhD Studentships 2016/17.

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Perthes' Disease

Target Population

Age Range
2 - 16

Sex
Either


Nature / type of Intervention
Surgery
Conservative

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Survey
Systematic review

A systematic review of the current literature will be used to identify a list of outcomes reported in previous studies. This list will be evaluated by experts in Perthes’ disease using a Delphi survey divided in two rounds. Additional data will be collected interviewing a group of additional key stakeholders (patients and patients’ parents). The final outcomes list obtained from the Delphi survey and from the stakeholders’ interviews, will be then used to define a consensus meeting among a representative group of key stakeholders in order to define the COS to be reported in future clinical trials related to Perthes’ disease.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)

Study Type

COS for clinical trials or clinical research

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.