Disability and quality of life trajectory after major lower limb amputation in Zambia and South Africa

Background: Major lower limb amputation, defined as an amputation above the level of the ankle joint (referred to herein as amputation), is a devastating outcome for individuals, families and society. In South Africa and Zambia, rising burdens of diabetes, peripheral arterial disease and trauma, together with the inequities in access to timely preventative and surgical care, are likely to contribute to a significant burden of major lower limb amputations. However, there is limited evidence on the patient pathway to amputation, the barriers to limb salvage care, and the long-term impact of amputation Methods: This protocol describes a mixed-methods study designed to understand the outcomes for those who undergo amputation after 6 months, and to understand how to improve access to quality care for patients at risk of, and undergoing, major lower limb amputations in South Africa and Zambia. The study will be conducted in purposively selected urban and rural districts. A four-delays framework and WHO health systems building blocks and Institute of Medicine quality framework will guide the analysis. The study comprises four work packages. First a facility readiness survey to assess hospital and system readiness for limb salvage and post-amputation care. Second a mixed-methods cohort study which will recruit adults who undergo amputation and aim to understand disability and quality of life outcomes at six months. This will also explore physical and psychosocial impacts of amputation. Third, in-depth interviews will be conducted with clinicians and policy makers across referral networks to examine health-system barriers and facilitators to high quality care. Fourth, a validation and prioritisation workshop will refine the pathway and co-produce feasible, high-impact interventions. Discussion: This study will generate context-specific evidence on pathways to major amputation. It will also inform us on the factors that determine outcomes, and the outcomes after major amputation. These findings will support interventions to reduce preventable amputations, and improve limb-salvage opportunities.