Prediction using machine learning of cumulative drug use for neuropathic pain treatment and its determinants in people with diabetic neuropathy in a national cohort

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001018
• Study ID:
  1000001018
• Official title and acronym:
  Prediction using machine learning of cumulative drug use for neuropathic pain treatment and its determinants in people with diabetic neuropathy in a national cohort
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Observational, longitudinal, retrospective cohort study based on real-world data from BIFAP. The study population will include adults aged 18 years or older with an incident recorded diagnosis of diabetic neuropathy between 1 January 2019 and 31 December 2021. Each patient will have an individualised three-year follow-up from the first recorded diagnosis. The main objective is to develop and validate a predictive model to estimate, from baseline patient characteristics, the three-year cumulative defined daily dose of drugs used for neuropathic pain treatment, specifically tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors and α2δ subunit ligands. Secondary objectives are to identify baseline predictors by drug family and to characterise longitudinal patterns of registered pharmacological use. Candidate predictors will include demographic, clinical, laboratory, pharmacological and healthcare utilisation variables available at or before the index date. Analyses will be conducted in R and Python using reproducible workflows, including gradient boosting approaches with Tweedie loss and, as an alternative approach, multitask hurdle neural network models. Model performance, sensitivity analyses and interpretability using SHAP or DeepSHAP will be assessed.
• Study status:
  Planned

Research institutions and networks

Institutions

CSEU La Salle

Spain

Study timelines

Date when funding contract was signed

Planned:13/05/2026

Actual:13/05/2026

Study start date

Planned:15/06/2026

Data analysis start date

Planned:01/10/2026

Date of final study report

Planned:28/02/2027

Sources of funding

More details on funding

Academic study promoted by CSEU La Salle, Universidad Autónoma de Madrid.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

http://doi.org/10.17605/OSF.IO/5TP8Q