A Conceptual Model of Patient Experiences of Painful Diabetic Peripheral Neuropathy to Support Clinical Outcomes...

Painful diabetic peripheral neuropathy (pDPN) is associated with nerve damage caused by diabetes mellitus (Type 1 or Type 2) and affects approximately 30% of the diabetes population globally. Many patients are unsatisfied with analgesic treatments for pDPN.

To support research using treatment outcomes that are meaningful and relevant to patients, this study explored patient-focused concepts including the symptoms and quality of life (QOL) impacts of pDPN based on a targeted literature review (TLR) of qualitative studies and qualitative concept elicitation interviews (n = 25) with people with pDPN. Findings were harmonized in a conceptual model characterizing the patient experience of pDPN.

The TLR included eight studies and the US Food and Drug Administration's Voice of the Patient report on neuropathic pain associated with peripheral neuropathy. The TLR and qualitative interviews identified 57 unique concepts of interest to patients, divided into ten domains. Harmonized findings showed that people with pDPN described highly impactful experiences of pain and co-occurring symptoms of numbness, tingling, and muscle weakness. pDPN impacted four areas of QoL including physical, social, emotional and cognitive functioning.

Findings highlight the burden of living with pDPN. The resulting evidence-based conceptual model of pDPN provides more detailed insight into key pDPN symptoms and their impacts on QoL compared to previous models, and may help to inform the selection of clinical outcome assessments for clinical trials of treatment for the condition to ensure the meaningfulness of novel therapies to patients.