Core Outcome Measures in Effectiveness Trials

Development of a Core Outcome Set for studies enrolling patients undergoing major lower limb amputation for peripheral arterial disease

General Information

The development of standardised reporting sets, agreed by a consensus of stakeholders: patients; healthcare professionals and lay representatives is important to ensure that future research is comparable and directed towards the right outcomes. Although there has been some work looking at longer term functional outcomes in amputees, there is no consensus about important short and medium term outcomes for patients undergoing a major lower limb amputation. We therefore feel that it is important for future research in these patients that we develop a core set of outcomes which should be reported in any study involving these patients. By developing this core outcome set, we hope to facilitate future meta-analysis and thus improve the long-term applicability of research. This work will take a mixed-methods approach, utilising both quantitative and qualitative aspects and will be undertaken in four key stages.

Systematic review
The process will begin with a systematic review of previously run studies of patients undergoing major lower limb amputation. The full text of papers which appear relevant on initial screening will be obtained for further analysis. The review will then report all primary and secondary outcomes reported in relevant trials.

Qualitative focus groups
In tandem with and informed by the systematic review, we will collect qualitative data to identify the key issues relating to short and medium term care of patients undergoing major lower limb amputation. We will do this by conducting focus groups with key stakeholders (patients and health and social care workers). If a certain group cannot be represented in the focus group we may interview them on a separate occasion.

Consensus survey
Results will be synthesised from the systematic review and qualitative focus groups to create a list of outcomes including both those from the literature and those which were raised by focus groups. Stake holders (patients and health and social care workers) will then be polled to determine which of the outcomes revealed by the systematic review and focus groups qualitative study are considered to be important in a general context using a 3-phase Delphi process.

Nominal Group analysis
After preliminary analysis of the results of the surveys, results will be presented to a steering committee for discussion and voting on the final set of core outcomes.

Link to protocol:

Supervisors: Christopher P Twine, Adrian Edwards, Emma Thomas-Jones
Principal investigator: Graeme K Ambler
Other contributors: David C Bosanquet, Lucy Brookes-Howell, Mark Kelson, Deborah Fitzsimmons, Naina Verma

Further Study Information

Current Stage:
March 2017 - December 2017
Funding source(s):
Funded by Health and Care Research Wales as part of the Research for Patient and Public Benefit (RfPPB) scheme (grant number 1198).

Health Area

Disease Category
Heart & circulation

Disease Name
Peripheral Arterial Disease

Target Population

Age Range
18 - 100


Nature / type of Intervention


Delphi process
Focus group(s)
Nominal group technique (NGT)
Systematic review

The development process will begin with a systematic review, which will inform the content of the topic guide for focus groups involving stakeholders, leading to a Delphi consensus survey aimed at deriving consensus. The results of the consensus survey will then be discussed by the steering group, who will decide on the final core outcome set by resolving any remaining uncertainty or residual lack of consensus following the Delphi process.

Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Patient/ support group representatives
Service providers
Service users

Study Type

COS for clinical trials or clinical research

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