Development of Core Outcome Sets for Patients Undergoing Major Lower Limb Amputation for Complications of Peripheral Vascular Disease

Abstract

Introduction: Despite advances in techniques for revascularisation, around 5000 patients each year undergo major lower limb amputation (MLLA) in the UK alone. Despite this, the evidence for optimal management of these patients is weak. Core Outcome Sets attempt to capture consensus on the most important outcomes for a patient cohort to improve the efficiency of future research. The aim of this work was to establish consensus on Core Outcomes Sets for studies involving patients undergoing MLLA. Methods: A list of outcomes was developed by systematic review to establish previously reported outcomes; and supplemented by focus groups involving healthcare professionals, patients and carers to identify additional areas which have not previously received research attention. Topics from these were then taken forward to a three-round Delphi consensus process, where outcomes were rated on a Likert scale from 1 (unimportant) to 9 (critical). Outcomes were rated for both short-term studies, with primary outcomes in the region of 30 days, and medium-term studies, with primary outcomes measured between a few months and 2 years following surgery. Results of the Delphi survey were then discussed at a face-to-face meeting of stakeholders, and recommendations made for Core Outcome Sets. Results: The systematic review revealed 444 distinct outcomes from 440 included studies involving a total of 442885 patients. Of these, 281 outcomes were reported by only a single study. These were reduced to a set of 44 broad themes to carry forward to the consensus survey. Focus groups revealed a further six themes which were felt to be important by participants, but which had not previously been reported in the research literature. The consensus survey received responses from 123 participants in round 1, and 91 individuals completed all three rounds. In the final round, stump wound infection and wound healing were rated as 'core' for both short-term and medium-term studies. Mortality; cause of death; effectiveness of analgesia; need for re-admission; need for additional operations; perioperative complications; and effective communication between patients, carers and healthcare professionals were rated as 'core' for short-term studies. Pain in the residual limb/stump/phantom; supply of a prosthetic limb; prosthetic limb use, comfort and fitting; level of independent mobility; participation in work and social activities; independent living; and quality of life were rated as 'core' for medium-term studies. 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; length of hospital stay should also be reported for short-term studies, and that mortality should also be reported for medium-term studies. Conclusion: Studies concerning patients undergoing MLLA have historically been highly in-efficient, with huge numbers of different outcomes reported and little overlap between studies. We have established consensus on 9 core outcomes for short- and medium-term studies. Three additional outcomes were proposed at a face-to-face stakeholder meeting for each time period. We recommend that all future studies involving patients undergoing MLLA should report these outcome sets. Disclosure: Nothing to disclose