Developing a validated methodology for identifying clozapine treatment periods in electronic health records

BMC Psychiatry. 2024 Aug 27;24(1):584. doi: 10.1186/s12888-024-06022-5.

Abstract

Background: Clozapine is the only recommended antipsychotic medication for individuals diagnosed with treatment-resistant schizophrenia. Unfortunately, its wider use is hindered by several possible adverse effects, some of which are rare but potentially life threatening. As such, there is a growing interest in studying clozapine use and safety in routinely collected healthcare data. However, previous attempts to characterise clozapine treatment have had low accuracy.

Aim: To develop a methodology for identifying clozapine treatment dates by combining several data sources and implement this on a large clinical database.

Methods: Non-identifiable electronic health records from a large mental health provider in London and a linked database from a national clozapine blood monitoring service were used to obtain information regarding patients' clozapine treatment status, blood tests and pharmacy dispensing records. A rule-based algorithm was developed to determine the dates of starting and stopping treatment based on these data, and more than 10% of the outcomes were validated by manual review of de-identified case note text.

Results: A total of 3,212 possible clozapine treatment periods were identified, of which 425 (13.2%) were excluded due to insufficient data to verify clozapine administration. Of the 2,787 treatments remaining, 1,902 (68.2%) had an identified start-date. On evaluation, the algorithm identified treatments with 96.4% accuracy; start dates were 96.2% accurate within 15 days, and end dates were 85.1% accurate within 30 days.

Conclusions: The algorithm produced a reliable database of clozapine treatment periods. Beyond underpinning future observational clozapine studies, we envisage it will facilitate similar implementations on additional large clinical databases worldwide.

Keywords: Algorithm; CRIS; Clozapine; Databases; EHR; Maudsley; Psychosis; Schizophrenia.

Publication types

  • Validation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Algorithms*
  • Antipsychotic Agents* / adverse effects
  • Antipsychotic Agents* / therapeutic use
  • Clozapine* / adverse effects
  • Clozapine* / therapeutic use
  • Databases, Factual
  • Electronic Health Records* / statistics & numerical data
  • Female
  • Humans
  • London
  • Male
  • Middle Aged
  • Schizophrenia, Treatment-Resistant / drug therapy

Substances

  • Clozapine
  • Antipsychotic Agents