Diabetes is a major global health problem affecting half a billion people worldwide. Its global prevalence is rising at an alarming rate and has been forecast to reach 780 million by 2045. As the cases of diabetes rapidly rises, so are the cases of diabetic neuropathy, a common complication with a lifetime prevalence of more than 50% among people with diabetes. Diabetic neuropathy is characterised by peripheral nerve dysfunction, typically leading to sensorimotor symptoms such as unsteadiness, pain and/or numbness in the distal extremities. Other patterns of diabetic neuropathy also exist but are not as well understood as the sensorimotor type. Diabetic neuropathy can lead to a reduced quality of life, and further complications include diabetic foot ulceration and Charcot neuropathic osteoarthropathy, which are associated with significant morbidity and mortality.
There have been several landmark diabetic neuropathy clinical trials, however, there has been heterogeneity in the outcomes measured leading to challenges in evidence synthesis. In addition, it has been proposed that promising novel therapies for diabetic neuropathy may have failed in clinical trials due to the outcomes measured. Currently, there is no published core outcome set for diabetic neuropathy clinical trials.
The aim of this study is to develop a core outcome set for diabetic neuropathy clinical trials. This will involve 1) reviewing outcomes measured in diabetic neuropathy clinical trials, 2) identifying which are the most important to diabetic neuropathy stakeholders (e.g. patients, caregivers, healthcare professionals, researchers and charities) and 3) reaching a consensus on a core outcome set.
To develop a core outcome set for diabetic neuropathy clinical trials.
ContributorsMiss Sasha Smith (1,2)
Mr Amaan Din (2)
Mr James O'Neill - Patient Representative
Mr Pasha Normahani (1,2) - Supervisor
Professor Alun Davies (1,2) - Supervisor
1. Section of Vascular Surgery, Department of Surgery and Cancer, Imperial College London, UK
2. Imperial Vascular Unit, Imperial College Healthcare NHS Trust, London, UK
Disease Category: Endocrine & metabolic
Disease Name: Diabetic neuropathy
Age Range: 18
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Researchers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- Delphi process
- Focus group(s)
- Interview
- Literature review
- Survey
- Systematic review
- A systematic review of the literature on diabetic neuropathy clinical trials will be conducted to identify and synthesise the outcomes measured.
- A literature review of qualitative research studies investigating patients’ opinions will be conducted to identify and synthesis outcomes most important to patients.
- Focus groups and semi-structured interviews with diabetic neuropathy patients, caregivers and patient support group representatives will be performed to identify which outcomes are most important to these stakeholders.
- A wide range of international stakeholders (e.g. patients, healthcare professionals, researchers, charities) will be surveyed to identify which outcomes are most important to these stakeholders.
- A multi-round Delphi process will be undertaken to develop a core outcome set for diabetic neuropathy clinical trials.