In the area of lower limb amputation, core outcome sets “should be adopted in all future studies recruiting patients” said Graeme Ambler (University of Bristol, Bristol, UK), who was speaking at the annual meeting of the Vascular Society for Great Britain and Ireland (VSGBI; 27–29 November 2019, Manchester, UK). Developed in a four-stage process, Ambler discussed how the core outcome sets address a range of concerns involved in the care of amputees.
“Amputation is a feared complication of vascular disease and diabetes, but there are also many stakeholders, so it was not clear to us whose opinion on the most important issues should be listened to,” Ambler noted at the beginning of his presentation. It was further explained by the speaker that the purpose of developing core outcome sets is to aid comparability between studies and allow for additional meta-analysis, as well as directing focus towards the issues most important to patients, carers and medical professionals.
The process of developing new core outcome sets for lower limb amputations “began with a systematic review looking at all outcomes that had previously been reported in research on amputees,” Ambler revealed, before reiterating that 440 studies on lower limb amputations—most of which were observational—were found. In addition to this, a huge number of different outcomes were reported by these various studies; Ambler highlighted that “281 outcomes reported in these 440 studies derived from just one of the investigations,” demonstrating poor research efficiency in this area.
Results of this systematic review were supplemented by consultation with focus groups, which involved all key stakeholders and ensured that no outcome was missed due to not being covered by previous research. Each of the groups, which were divided into patients and carers, allied healthcare professionals and a group of medically trained healthcare professionals, in accordance with the previous development of core outcome sets, had six to 10 participants.
After pooling results from the systematic review and focus group sessions, a total of 50 key domains were established to take forward to a three-round Delphi survey, “which was again completed by all key stakeholders”. About the survey, Ambler said: “Outcomes were rated twice, because we felt that outcomes might be different between studies focused on short-term outcomes, where perioperative issues might be most important, and medium-term studies out to a year or two where issues around mobility and independence might come to the fore.” In the end, 91 people completed all three rounds of the survey.
According to the survey, the key short-term outcomes were death, pain and stump-related complications, as well as hospital care, readmissions and re-amputation. Effective communication between a healthcare team, and patients and carers, was also considered to be incredibly important. “With regard to medium-term outcomes”, Ambler outlined that “somewhat as expected, problems with mobility, independence, social reintegration and quality of life also came up”.
The speaker then explained that core outcome sets were taken to a consensus meeting, held in April 2019 and attended by all key stakeholder groups. While this meeting ratified the findings of the Delphi survey, it was also expressed that issues related to psychological morbidity and deterioration of the other leg were also important.
Summarising the project and its endpoint, Ambler commented: “In conclusion, although we have developed these core outcome sets, there is still a lot of work to do; this is because we need to establish the best way to measure these outcomes, especially factors such as communication which have not been studied at all. That being said, we think these sets should be adopted in all future studies recruiting amputee patients.”