Major lower limb amputation, defined as an amputation above the level of the ankle joint, is a substantial cause of morbidity and mortality. Limited data exist on the burden, aetiology and outcomes of major lower limb amputations in sub-Saharan Africa (SSA). This is despite increasing rates of diabetes, peripheral arterial disease and trauma, with further projected increases in these conditions, which often precede major lower limb amputation. The Regional Assessment of Amputations in sub-Saharan Africa (RAMPs) study aims to address this knowledge gap by performing a multicentre, prospective study of major lower limb amputations across the region.
We describe a prospective, multicentre observational cohort study enrolling patients undergoing major lower limb amputation at hospitals in SSA over a consecutive 6-month period. Consecutive patients will be included, and data will be collected from medical records until discharge, death or 30 days postoperatively, whichever is sooner. The primary outcome is in-hospital or 30-day mortality. Secondary outcomes include the aetiology of amputations and in-hospital complications. We will also examine systems and processes using a facility survey of each participating centre. The study will collect system-level, patient-level and outcome-level data. Our sample size calculation suggests 904 patients need to be recruited.
The RAMPs study will provide a snapshot of the current outcomes and aetiology of major lower limb amputation in SSA. It will show if variation in outcomes and aetiology in patients in the region exists and provide information on the healthcare processes and systems in those who may be at risk of lower limb amputation. Ethical approval has been granted by the University of Birmingham (Science, Technology, Engineering and Mathematics Committee reference: ERN_2929-Jan2025) and the College of Surgeons of East, Central and Southern Africa (COSECSA Institutional review board reference COSECSA/REC/2025/07). Findings will be disseminated throughout the region at local, national and international conferences and through at least one peer-reviewed manuscript.
Patient-reported experience measures (PREMs) capture patients’ healthcare journey experiences. No validated PREMs are specific to vascular surgery patients. This study aims to develop and validate a vascular surgery-specific PREM to assess patient experience and satisfaction.
Patient Reported Experience Measures In Vascular Surgery Enhancement Study is a two-phase multisite sequential mixed-methods study. The qualitative phase will develop a draft PREM; the quantitative phase will validate it. The study will be conducted across three major vascular units in Wales. Up to 40 patients and healthcare professionals will participate in the qualitative phase. Approximately 150–200 patients will be recruited for the quantitative validation. Inclusion criteria are: (1) age ≥18; (2) recent vascular procedure; (3) inpatient vascular care; (4) not cognitively impaired; (5) consent to participate and (6) English or Welsh proficiency. Primary outcomes will be construct validity and reliability. Secondary outcomes will include patient engagement, healthcare provider perspectives and health system impacts. Thematic analysis will be conducted using NVivo. Psychometric validation will include item analysis, internal consistency testing and factor analysis.
The study was approved by the London—Camberwell St Giles Research Ethics Committee, coordinated by the Health Research Authority and Health and Care Research Wales (REC reference: 24/PR/0522).