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.

source population for this study comprised almost 1 million individuals. Results: Between 2010-2014, we identified 3.677newly diagnosed PAD patients. Most patients (91%) were diagnosed in primary care, and in primary care at the end of the study (83%). Almost half of all patients (49%) had no APT dispensing record. Within this group, 33% received other anticoagulant therapy (vit.-k antagonist or DOAC). Mono-APT was dispensed as aspirin (40% of patients) or P2Y12inhibitors (2.5% of patients). Dual-APT (DAPT) combining aspirin with a P2Y12-inhibitor was dispensed to 8,5% of the study population. Conclusion: Half of all patients with newly diagnosed PAD are not treated conform (international) guideline recommendations on thromboembolism prevention through APT. At least 33% of all patients with newly diagnosed PAD do not receive any antithrombotic therapy.Evaluation and improvement of APT prescription and thereby improved prevention of (secondary) cardiovascular events is warranted. We advise all physicians to inquire if PAD patients receive APT and if not, to investigate if there is a valid reason to omit prescribing these medicines.