Peripheral arterial disease is a progressive, stenotic, and occlusive disease process leading to flow limitation of the peripheral arterial vasculature. Symptomatic PAD manifests broadly as two distinct clinical presentations; Intermittent Claudication (IC) and Chronic Limb Threatening Ischaemia (CLTI).
PAD is increasingly recognised as a substantial contributor to cardiovascular morbidity and mortality, the leading cause of death globally. PAD is estimated to affect more than 230 million individuals worldwide and is the third cause of cardiovascular-related deaths after heart disease and stroke.
The incidence and prevalence of PAD are expected to rise sharply given that the pathogenesis of PAD is closely associated with increasing age, diabetes mellitus, and dyslipidaemia; all of which are on the rise. CLTI is a major burden on patients, relatives and carers, the community, and the healthcare systems. All-cause mortality of patients diagnosed with CLTI in 5 years is near to 50%.
The volume and quality of CLTI-related research is sharply increasing. Nonetheless, the outcomes reported in the current literature are very heterogeneous in terms of outcomes, measurement instruments and follow-up duration. Furthermore, reported outcomes are often limb or target lesion related with mortality and morbidity the most frequently reported patient-level outcomes, with patient reported outcome measures less commonly included in studies of CLTI.
This lack of standardisation has led to a plethora of outcomes being reported, making clinical decision-making extremely difficult and meaningful pooled data analyses from the studies impossible. The Global Vascular Guidelines on the management of CLTI make some recommendations on outcome measures and follow-up duration and a core set of reporting outcomes for registries of interventions for PAD have recently been published, however these are yet again very much oriented toward the interventions and are not much patient-centred. So far there is no core outcome set for CLTI. A separate COS for PAD patients with Intermittent Claudication is under development which will be incorporated with this study into a bigger project resulting in development of COS for both subcategories of PAD.
The aim of this study is to develop a core outcome set (COS) for studies on CLTI. This study will be undertaken in accordance with the COS development process described in The Core Outcome Measures in Effectiveness Trials (COMET) Handbook.
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 Arterial Disease, Peripheral Vascular Disease
Age Range: 18
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Families
- Journal editors
- Patient/ support group representatives
- Policy makers
- Researchers
- Statisticians
- COS for clinical trials or clinical research
- Consensus conference
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Nominal group technique (NGT)
- Systematic review
The study will follow a mixed-methods approach comprising four key successive stages: a systematic review of current literature; qualitative interviews with patients, carers and focus groups with researchers and healthcare professionals, e-Delphi consensus process, and a final stakeholder meeting to agree the final COS.