Case detection delay in leprosy: Testing tool reliability and measurement consistency in Ethiopia, Mozambique, and Tanzania

PLoS Negl Trop Dis. 2024 Jul 5;18(7):e0012314. doi: 10.1371/journal.pntd.0012314. eCollection 2024 Jul.

Abstract

Background: Case detection delay (CDD) in leprosy is defined as the period between the onset of the first signs and symptoms and the time of diagnosis. A tool, consisting of a questionnaire and a detailed guide for researchers, which includes photos of typical skin signs and notes on establishing the timing of events, was developed to determine this period of delay in months in recently diagnosed leprosy patients. The aims of the study were to determine the reliability and consistency of this CDD assessment tool.

Methods: This study was conducted in Ethiopia, Mozambique and Tanzania. Two types of consistency were considered: over time (test-retest reliability) and across different researchers (interrater reliability). A CDD questionnaire was administered to 167 leprosy patients who were diagnosed within 6 months prior to their inclusion. One month later, the same or another researcher re-administered the CDD questionnaire to the same patients. Both test-retest and interrater reliability were assessed using the intraclass correlation coefficient (ICC), where a value greater than or equal to 0.7 is considered acceptable.

Results: In this study, 10 participants (6.0%) were under 15 years of age, and 56 (33.5%) were women. In the test-retest assessment, the mean CDD from the first and second interviews was 23.7 months (95% CI 14.4-34.8) and 24.0 months (95% CI 14.8-33.2), respectively. The ICC for test-retest reliability was 0.99 (95% CI 0.994-0.997). For the interrater reliability assessment, the first and second interviews revealed a mean CDD of 24.7 months (95% CI 18.2-31.1) and 24.6 months (95% CI 18.7-30.5), respectively, with an ICC of 0.90 (95% CI 0.85-0.94). A standard error of measurement of 0.46 months was found in the test-retest and 1.03 months in the interrater measurement. Most answers given by participants during the first and second interviews were matching (≥86%). Most non-matching answers were in the 0-2 month delay category (≥46%).

Conclusion: The tool, including a questionnaire to determine the CDD of newly diagnosed leprosy patients, was validated in three African countries. The test-retest and interrater measurements demonstrated that the instrument is reliable and measures consistently. The tool can be used in routine leprosy programmes as well as in research settings.

Trial registration: This trial is registered with The Netherlands Trial Register (NTR), now available via International Clinical Trial Registry Platform (ICTRP) with registration number NL7294 (NTR7503), as well as with The Pan African Clinical Trials Registry (PACTR) with registration number PACTR202303742093429.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Child
  • Delayed Diagnosis
  • Ethiopia
  • Female
  • Humans
  • Leprosy* / diagnosis
  • Male
  • Middle Aged
  • Mozambique
  • Reproducibility of Results
  • Surveys and Questionnaires
  • Tanzania
  • Young Adult

Grants and funding

This project is part of the EDCTP2 programme supported by the European Union awarded to NLR/LM (grant number RIA2017NIM-1839-PEP4LEP), and the Leprosy Research Initiative (LRI; www.leprosyresearch.org) awarded to NLR/LM (grant number 707.19.58. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.