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

Abstract

BackgroundEvery year, Around 5000thousands of patients with peripheral vascular disease undergo major lower limb amputation each year in the UK. 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 MethodsA systematic review of the literature; and focus groups involving patients, carers and healthcare professionals; were used to derive a 'long-list' of potential outcomes. Findings informed a threeround 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. ResultsA 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 4 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 shortand medium-term studies. ConclusionsWe 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.What does this study add to the existing literature and how will it influence future clinical practice?Major lower limb amputation is a common procedure, but evidence for optimal management is weak and the literature is heterogeneous. Through a rigorous four-step process we have established consensus on core outcome sets for this patient group, identifying 11 core outcomes each for short-and medium-term studies involving patients undergoing major lower limb amputation. Adoption of these core sets will improve the consistency and quality of research and audit for this patient group.

Towards a Core Outcome Set for Abdominal Aortic Aneurysm: Systematic Review of Outcomes Reported Following Intact and Ruptured Abdominal Aortic Aneurysm Repair

“…The development of Core Outcome Sets is based on a systematic review to identify the range of outcomes reported, which are discussed by a series of stakeholder focus groups before achieving consensus core outcomes through a series of questionnaires to all stakeholders (Delphi consensus). 7,8 The development process for those undergoing lower limb amputation provides a recent example of this process. 8 The value of developing a core outcome set for AAA repair has been highlighted previously.…”

“…7,8 The development process for those undergoing lower limb amputation provides a recent example of this process. 8 The value of developing a core outcome set for AAA repair has been highlighted previously. 9 Here the first stage is reported: a systematic review to provide the range, frequency, and timing of outcomes reported for both intact and ruptured AAA repair.…”

A Systematic Review and Critical Appraisal of Peri-Procedural Tissue Perfusion Techniques and their Clinical Value in Patients with Peripheral Arterial Disease

“…No diagnostic accuracy or correlation with treatment outcomes, such as wound infection and healing, amputation rate, need for re-admission, quality of life or mobility, were demonstrated. 46 The results of the 26 eligible studies, which were mostly of poor quality according to the QUADAS-2 tool, were not sufficient to substantiate implementation in daily clinical practice yet.…”

“…To do so, a well defined study population of patients with Fontaine III e IV PAD should be included and analysed on major clinical outcomes such as the aforementioned wound infection and healing, amputation rate, need for re-admission, quality of life, and mobility. 46 One of the main reasons to perform endovascular or open revascularisation procedures in patients suffering from PAD is to improve tissue perfusion and skin oxygenation of the lower leg and foot. This is of the utmost importance in patients with ischaemic ulcers, to facilitate healing.…”

Outcomes and prosthesis procedure of major amputations in patients with peripheral arterial disease in our center

“…Estos rangos de edad tan variables se explican por los pacientes recogidos en cada estudio: más bajos en series más centradas en pacientes diabéticos y más altos en aquellos que incluyen pacientes con EAPC (15). En cuanto a las comorbilidades que presentaban nuestros pacientes, destacan por su frecuencia la hipertensión arterial y la diabetes mellitus, factores de riesgo reconocidos en la EAPC y en el riesgo de pérdida de la extremidad (1, [16][17][18][19].…”