Core Outcome Measures in Effectiveness Trials

Development of a standard set of outcomes for adult spinal deformity

General Information

Summary:
Healthcare providers managing adult spinal deformity (ASD) are under increasing pressure to demonstrate the value (ratio of outcomes to costs) of treatment provided in the evolving reimbursement systems. A feedback loop involving standardized routine outcomes measurement across the full cycle of care is an important prerequisite for improvement of outcomes and evidence-based decisions about cost-effectiveness. A 7-round modified-Delphi study, based on a systematic review on patient-related outcomes, will be performed among members of the Scoliosis Research Society members to define such a standard set of outcomes for ASD (i.e. 6 online and 1 final face-to-face meeting). 25 panelists, covering all continents will participate to reach consensus (threshold set at =75% agreement) about outcome domains, measurement instruments and factors influencing outcome (case-mix and risk).Guidelines for COS development and report will be applied. The frameworks of ICF (WHO) and Porter's three-tiered outcome hierarchy will be used to cover all important domains of human functioning and to achieve a standard language.

Contributors:
prof. M. (Marinus) de Kleuver, MD PhD - Principle Investigator; Radboud univesity medical center Department of Orthopedic surgery, Nijmegen, The Netherlands
prof. S.D.(Steven)GLassman, MD - co-Principle Investigator; Norton Leatherman Spine Center, Louisville, Kentucky, USA
M.L.(Miranda) van Hooff, PhD - study coordinator; Radboud univesity medical center Department of Orthopedic surgery, Nijmegen, The Netherlands
T.M. (Tsjitske) Haanstra; Radboud univesity medical center Department of Orthopedic surgery, Nijmegen, The Netherlands
S.S.A. (Sayf) Faraj, MD;Radboud univesity medical center Department of Orthopedic surgery, Nijmegen, The Netherlands
prof. D. (David) Polly Jr., MD; Department of Orthopedic Surgery, University of Minnesota, Minneapolis, USA
A.K. (Anna) Wright, PhD; Neuroscience Institute, Virginia Mason Hospital, Seattle, Washington, USA

Further Study Information

Current Stage:
Ongoing
Date:
October 2017 - 2019
Funding source(s):
Scoliosis Research Society

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Spinal deformity

Target Population

Age Range
25 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus conference
Delphi process
Systematic review

Preparatory stage - systematic review of outcome domains and outcomes measurement.
Formal consensus procedure - modified Delphi study (6 online rounds) and 1 face to face consensus conference meeting.
Guidelines for COS development are used and for report COS-STAR will be used.


Stakeholders Involved

Clinical experts
Epidemiologists
Methodologists
Patient/ support group representatives
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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