Objective
Every year, thousands of patients with peripheral vascular disease undergo major lower limb amputation. Despite this, evidence for optimal management is weak. Core outcome sets capture consensus on the most important outcomes for a patient group to improve the consistency and quality of research. The aim was to define short and medium term core outcome sets for studies involving patients undergoing major lower limb amputation.
Methods
A systematic review of the literature and focus groups involving patients, carers, and healthcare professionals were used to derive a list of potential outcomes. Findings informed a three round online Delphi consensus process, where outcomes were rated for both short and medium term studies. The results of the Delphi process were discussed at a face to face consensus meeting, and recommendations were made for each core outcome set.
Results
A systematic review revealed 45 themes to cazrry forward to the consensus survey. These were supplemented by a further five from focus groups. The consensus survey received responses from 123 participants in round one, and 91 individuals completed all three rounds. In the final round, nine outcomes were rated as “core” for short term studies and a further nine for medium term studies. Wound infection and healing were rated as “core” for both short and medium term studies. Outcomes related to mortality, quality of life, communication, and additional healthcare needs were also rated as “core” for short term studies. In medium term studies, outcomes related to quality of life, mobility, and social integration/independence were rated as “core”. The face to face stakeholder meeting ratified inclusion of all outcomes from the Delphi and suggested that deterioration of the other leg and psychological morbidity should also be reported for both short and medium term studies.
Conclusion
Consensus was established on 11 core outcomes for short and medium term studies. It is recommended that all future studies involving patients undergoing major lower limb amputation should report these outcomes.
Graeme K. Ambler
Lucy Brookes-Howell
Jac A.R. Jones
Naina Verma
David C. Bosanquet
Emma Thomas-Jones
Adrian G.K. Edwards
Christopher P. Twine
Disease Category: Heart & circulation
Disease Name: Peripheral Arterial Disease
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- Service providers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- Delphi process
- Focus group(s)
- Systematic review
- Consensus meeting
A systematic review of the literature and focus groups involving patients, carers, and healthcare professionals were used to derive a list of potential outcomes. Findings informed a three round online Delphi consensus process, where outcomes were rated for both short and medium term studies. The results of the Delphi process were discussed at a face to face consensus meeting, and recommendations were made for each core outcome set.