Peripheral arterial disease (PAD) is characterised by either the partial or complete occlusion of = 1 peripheral arteries, most commonly in the lower extremities. Lower limb PAD covers a spectrum of conditions ranging from asymptomatic disease through to intermittent claudication (IC), and, terminally, critical limb ischaemia. PAD is also associated with a significantly increased risk of overall cardiovascular morbidity and mortality, which, additionally, imposes a significant economic and societal burden. Despite these well understood effects of PAD, the annual incidence of PAD continues to rise globally. As of the early 2010s, PAD is firmly established as the third leading cause of atherosclerotic cardiovascular morbidity, following coronary artery disease and stroke. Moreover, this trend is expected to endure as the pathogenesis of PAD is closely associated with increasing age, diabetes mellitus, dyslipidaemia and obesity; all of which are on the rise in both high income (HIC) as well as low to middle income (LMIC) countries alike. As such, it is anticipated that PAD will reach pandemic proportions within our lifetime.
In order to combat this, there has been a sharp increase in the number of clinical trials focused upon improving the outcomes of IC, the most prevalent sub-group of PAD patients. However, despite this, there remains no consensus on which outcomes that should be measured within this group of studies. There is considerable heterogeneity in the outcomes used to reflect walking distance, quality of life, patient compliance and haemodynamic assessment. This lack of standardisation limits the objective comparison of interventions between studies, which, in turn, limits the translation of worthy technologies.
Therefore, the aim of the project is to (1) determine the most important outcomes for all stakeholders and (2) reach consensus on a standardised core outcome set (COS) to be measured and reported upon in studies primarily focussed upon IC.
Akam Shwan, University of Leicester (Principal Investigator)
John Houghton, University of Leicester
Robert Sayers, University of Leicester
Athanasios Saratzis, University of Leicester
Pasha Normahani, Imperial College London
Lydia Hanna, Imperial College London
Coral Pepper, University Hospitals of Leicester NHS Trust
Disease Category: Heart & circulation
Disease Name: Peripheral Vascular Disease, Peripheral Arterial Disease
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Service commissioners
- Service providers
- Service users
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Systematic review
This is a mixed methods study involving three phases to develop a core outcome set (COS) for clinical trials in patients who suffer from intermittent claudication (IC).
A systematic review will identify all outcomes reported in trials and observational studies involving IC. Secondly, qualitative interviews with patients will aim to establish which outcomes are important to these stakeholders. The long list of outcomes generated from the systematic review and interviews will be used to create a three-round modified Delphi process, which will consist of key stakeholders. We have opted for an e-Delphi process as it represents the most pragmatic manner in undertaking this form of research during the COVID-19 pandemic. The results of the first two rounds of the e-Delphi will be discussed during the final third round, which will consist of a live video teleconference. Discussion will focus on the outcomes that did not achieve consensus through the preceding rounds and will conclude with anonymous voting to ratify the final COS.
Three work packages will be undertaken, in accordance with similarly themed COS projects outlined in ‘Core Outcome Measures in Effectiveness Trials’ (COMET) Initiative (8):
Part 1: A systematic literature review of peripheral arterial disease (PAD) centred interventions will be performed to identify a comprehensive list of clinical, patient-reported, healthcare 'process', resource, composite and surrogate outcomes.
Part 2: Semi-structured interviews with people who have undergone PAD interventions will be used to identify additional outcomes to supplement the long list.
Part 3: Surveys of key stakeholders (patients, clinicians, commissioners) in three rounds of an e-Delphi methodology will refine the outcome long-list into a COS.