Real-World Pharmacological Treatment Pattern of Neuropathic Pain in China: A Retrospective, Database, Multicenter Study (ReTARdant) Protocol.

Introduction: Neuropathic pain (NP), including diabetic peripheral neuropathic pain (DPNP) and chemotherapy-induced peripheral neuropathy (CIPN) as common subtypes, imposes a significant clinical burden on patients, severely affecting their quality of life. The real-world evidence on demographic characteristics, treatment patterns, and adherence data of DPNP and CIPN is still limited.

Methods: A multicenter, retrospective, observational study using electronic medical record (EMR) systems involving approximately 600 patients with DPNP and 400 with CIPN from nine hospitals was planned. The study period extended from January 1, 2017 to December 31, 2022, which includes the enrollment period, pre-enrollment period, and observation period. Included patients will be adult (aged ≥ 18 years) diagnosed with DPNP or CIPN and receiving at least one index regimen, with index date defined as the initiation date of index regimen. At least one medical record within 12 months after index date will also be required for inclusion. The observation period is defined as the period from the index date to the end of the study data collection for at least 12 months.

Planned outcomes: The primary objective is to describe the demographics, clinical characteristics, and treatment patterns, including types and proportion of treatment regimens, treatment discontinuation/switching/add-on, restarting after discontinuation, duration of index regimen, and time to treatment add-on. The secondary and exploratory measures include the dosing pattern and real-world adherence of regimens.

Trial registration: NCT06546202 (ClinicalTrials.gov).