At present, there is no core outcome set to evaluate the effectiveness of prosthetic interventions for people with lower limb amputation. While the research literature describes the use of many different outcome measures, it is not known which are most important to prosthesis users or those who fund prosthetic interventions.
In the absence of a core outcome set, there is little to guide researchers and clinicians in their selection of the most important outcomes, nor agreement about which should be used to inform policy and investment decisions that ultimately impact prosthesis users.
To establish consensus on the outcomes of importance to users and funders of lower-limb prosthetic interventions, and thereby develop a core outcome set for lower-limb prosthetic interventions.
ContributorsLeigh Clarke, La Trobe University Melbourne (Principal Investigator)
Dr Michael P Dillon, La Trobe University Melbourne (Supervisors)
Prof Alan Shiell, La Trobe University Melbourne (Supervisors)
Dr Emily Ridgewell, La Trobe University Melbourne (Co-Investigator)
Disease Category: Rehabilitation
Disease Name: Lower-limb amputation
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Device, Rehabilitation
- Clinical experts
- Consumers (patients)
- Governmental agencies
- Policy makers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Nominal group technique (NGT)
- Semi structured discussion
- Systematic review
This study involves a four-part method:
1. A systematic review to catalogue the outcomes used to evaluate the effect of prosthetic interventions, and linking of these outcomes to a holistic and internationally recognised framework - the International Classification of Functioning, Disability and Health (ICF) to characterise the extent to which different aspects of health and disability have been measured, and identify gaps.
2. A mapping exercise to compare the linked outcomes from Stage 1 to existing linking research, followed by an expert panel review that aims to ensure all possible outcomes have been included.
3. A two round Delphi survey consensus process using two stakeholder groups (i.e., users and funders of lower limb prosthetic interventions) to establish consensus on the outcomes included.
4. A consensus and ranking meeting with an expert panel to establish the final core outcome set for lower limb prosthetic interventions, as described using the ICF Framework. The modified nominal group technique will be used to review and rank the consensus outcomes from the Delphi survey consensus rounds.