Development of core outcome sets for people undergoing major lower limb amputation for complications of peripheral vascular disease

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

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

Abstract

Background
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. We aimed to define short- and medium-term core outcomes 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-term and medium-term studies. Results of the Delphi were discussed at a face-to-face consensus meeting, and recommendations made for each core outcome set.

Results
A systematic review revealed 45 themes to carry 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 1, 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-term 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.

Conclusions
We established consensus on 11 core outcomes for short- and medium-term studies. We recommend that all future studies involving patients undergoing major lower limb amputation should report these outcomes.
Original languageEnglish
Pages (from-to)730-738
Number of pages9
JournalEuropean Journal of Vascular and Endovascular Surgery
Volume60
Issue number5
Early online date11 Aug 2020
DOIs
Publication statusPublished - 1 Nov 2020

Keywords

  • Lower limb amputation
  • Outcomes
  • Methodology
  • Systematic review
  • Consensus survey

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