COS-PAD
Research type
Research Study
Full title
Development of Core Outcome Set for Peripheral Arterial Disease
IRAS ID
335006
Contact name
Rob Sayers
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
2 years, 1 months, 28 days
Research summary
Peripheral arterial disease is narrowing or blockage of the arteries (i.e., Blood vessels that take fresh blood to the parts of our body) in the legs that can lead to pain during activity, commonly cramping muscle pain in the calves while walking. This stage of the condition is called Intermittent Claudication which is a life-style limiting stage of the condition. Overtime it may progress to rest pain, ulceration and gangrene, this stage is called Chronic Limb Threatening Ischaemia, which is a debilitating condition and is direct risk to loss of limb or life.
In scientific research; outcomes (also called events and endpoint) are the measures to document the result or impact that a given exposure or intervention has on the specific as well as general health parameters in the population that have the exposure or intervention.
Every distinct finding in the results of a study can be reported in many different ways and potentially hundreds of different outcomes can be reported therefore there will be a confusion (due to the large number and the difference in the outcomes that are reported) to differentiate which outcomes are relevant and which are not. Previous research has demonstrated these issues; therefore, Core Outcome Sets are highly recommended. Core Outcome Set is defined as a set of standard outcomes that are deemed important and relevant to patients, carers, clinicians and policy makers and are required to be reported in the research in particular subject or condition.
Numerous core outcome sets have been developed in various medical specialities for different diseases and conditions and they are proven to be of significance but to date, a core outcome set is not available for peripheral arterial disease, therefore the aim of this study is to develop core outcome sets for peripheral arterial disease.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/LO/0258
Date of REC Opinion
22 May 2024
REC opinion
Further Information Favourable Opinion