PERCEIVE is a multi-methods study of risk perception, communication, and the extent and experiences of shared decision making (SDM) around the time of major lower limb amputation (MLLA). The study has a quantitative, qualitative, and synthesis component.

MLLA intends to improve quality of life for some patients but carries significant risks such as chronic stump pain, phantom limb pain, wound infection, wound breakdown, the need for MLLA revision surgery, medical morbidity (e.g. lower respiratory tract infection and acute myocardial infarction), psychological morbidity, and mortality. Decision making around MLLA is complex, and ideally clinicians could use accurate estimations of outcomes to help patients in the shared decision making process. Additionally, little is understood about the process of shared decision making before MLLA.

PERCEIVE’s objectives are divided into quantitative, qualitative, and synthesis (triangulation):

• The quantitative aspect of PERCEIVE intended to quantify the accuracy of healthcare professionals in predicting outcomes after MLLA, and compare their performance to statistical outcome prediction tools.
• The qualitative aspect of PERCEIVE intended to analyse in depth the communication, consent, risk prediction and decision-making process in relation to major lower limb amputation.
• Synthesis intends to develop a logic model that outlines a pathway to developing intervention(s) that aim to improve shared decision-making with patients where MLLA is considered as a treatment option.

PERCEIVE’s quantitative component was a prospective multicentre observational study which included patients undergoing MLLA. Healthcare professional’s accuracy in predicting outcomes at 30-days and 1-year postoperatively was evaluated and compare to statistical outcome prediction tools. Healthcare professionals outperformed most outcome prediction tools in predicting 30-day outcomes (mortality, morbidity, MLLA revision), but they tended to overestimate the risks. They also overestimated the risks of 1-year outcomes (mortality, MLLA revision, ambulation) but were less accurate and were outperformed by some outcome prediction tools.

PERCEIVE’s qualitative component was a qualitative study that audio-recorded consultations between patients and surgeons at which MLLA was discussed as a treatment option at three NHS hospitals. Semi-structured follow-up interviews with patients and with healthcare professionals who care for patients undergoing MLLA were conducted. PERCEIVE’s qualitative component has completed recruitment and the manuscript is currently being written.

The synthesis component of PERCEIVE includes a triangulation workshop where the results of the quantitative and qualitative were discussed with patients, relatives/carers of patients who had undergone MLLA, and healthcare professionals. The triangulation workshop consisted of presentations, open discussions, and guided discussions within the above groups. A logic model of how the results of PERCEIVE may inform the design of future studies aiming to improve shared decision making before MLLA is being developed based on the triangulation workshop findings.

The protocol for this study has been published in BJS Open-quantitative (https://doi.org/10.1093/bjsopen/zrab118) and BMJ Open-qualitative (https://bmjopen.bmj.com/content/12/1/e053159.full).

Short term results have been published in BJS: https://doi.org/10.1093/bjs/znac309