Title: PERCEIVE: PrEdiction of Risk and Communication of outcomE followIng major lower limb amputation- a collaboratiVE study
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Background: Major lower limb amputation (MLLA) carries significant risk of mortality and need for revision surgery [1-3]. Rates of these complications and likelihood of ambulation with a prosthesis are difficult to predict. Surgeons generally use their own estimates of risk (‘gestalt’) to inform decision- making and communicate risk. MLLA risk prediction tools are infrequently used [4-11]. The accuracy of surgeons’ gestalt is currently unknown. Neither is it known how well MLLA risk information is communicated, and how effective patient-surgeon communication is in informing decision-making. Aims: PERCEIVE is a multi-methods study of risk perception, communication and the extent and experiences of shared decision making (SDM) around the time of MLLA. The objectives are divided into quantitative, qualitative and data synthesis: Quantitative: 1. Determine how well surgeons, and other healthcare professions (HCPs), predict risk and outcomes at the time of MLLA. 2. Determine how well pre-existing scoring tools evaluate these risks and outcomes. Qualitative: 1. Explore and describe how HCPs evaluate risks and outcomes when considering MLLA. 2. Explore and describe how risks are communicated and options discussed with patients and relatives/carers, assessing the extent of SDM in patient-surgeon consultations. 3. Explore and describe patients’ perceptions of decision-making, the communication of risks and benefits of MLLA, and expectations for rehabilitation. Data synthesis: 1. Use quantitative and qualitative findings to propose intervention(s) to improve risk perception, communication and/or SDM around MLLA. 2. Formulate a logic model for the intervention(s) and its future evaluation(s). Methods: Surgeons, anaesthetists and specialist physiotherapists will be asked to estimate outcomes (risk of death and surgical revision, chance of ambulation) at the time of MLLA. Baseline demographic data used to complete pre-existing risk prediction tools will be captured. Outcomes will be assessed at 1 year using hospital records, and the predictive performance of HCPs compared with that of risk prediction tools. The quantitative work will involve the collaborative surgical research model. The group has expertise in this approach and has just delivered what we believe to be the largest UK cross-sectional study of vascular surgical practice in groin wound incisions [12]. The qualitative work will comprise audio-recording of consultations between patients and surgeons at which MLLA is discussed, and follow-up semi-structured interviews with HCPs, patients and relatives/carers. Both aspects will provide complementary data regarding current MLLA decision-making and consent. Through a process of data synthesis with patients and HCPs, we will identify intervention(s) for improving MLLA risk prediction, communication and/or SDM with patients, and a logic model for its/their evaluation. Potential benefits: Getting MLLA decision making right has the potential to improve patient outcomes and cost efficiency within the Welsh NHS. Our preliminary PPI work has identified recurring themes around MLLA: MLLA undertaken where palliation would be preferable, or MLLA deferred in patients with complex and painful foot wounds, where a timely MLLA would have improved outcomes. Good decision making to offer MLLA only when patients are likely to benefit in terms of quality of life will ensure prudent healthcare spending.

Lay abstract: Having a leg amputation is a high-risk life changing event and deciding whether to have an amputation or not can be extremely difficult. For patients with extensive foot wounds and/or pain (due to diabetes or artery blockages), this may involve balancing up the risks and benefits of surgery with continuing as they are. If very elderly patients develop leg problems which are only treatable by amputation, patients (and relatives/carers) face a difficult decision of surgery versus management of symptoms. Making the right decision at the right time is crucial. The wrong decision can result in a reduced quality of life, patient and/or family regret, increased NHS costs and reduced engagement in rehabilitation. In many areas of medicine, such as cancer treatment, tools are used to determine patient prognosis, risks of surgery, and probable outcomes, which is crucial in successful shared decision-making. Amputation surgery is almost completely lacking these aspects, and as a result, there are marked differences in amputation practice across Wales (and the UK). This work will look in detail at amputation risk perception, communication and decision-making, both from a patient/family and a surgeon/clinician point of view. At the centre of PERCEIVE is the patient asking, “what is likely to happen to me if I have (or don’t have) my amputation?”

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: GENERIC HEALTH RELEVANCE