Abstract
Introduction: Lassa fever (LF) is endemic over most of West Africa and a third of LF survivors develop sensorineural hearing loss (SNHL). Multiple LF vaccine candidates are in the development pipeline. In February 2020, the Brighton Collaboration Safety Platform for Emergency vACcines (SPEAC) project has developed a case definition to assess SNHL as an adverse event of special interest for LF vaccines [1,2].
Objective: To assess the applicability of this SNHL case definition to data collected in routine clinical care settings at a tertiary hospital in Ghana.
Methods: The study subjects were patients aged 18–59 years who attended the Eye, Ear, Nose and Throat Department at the Komfo Anokye Teaching Hospital between 1 January 2007 and 30 June 2020. We used the keywords “hearing loss”, “sensorineural hearing loss”, or “SNHL” to retrospectively identify eligible patients from electronic (EMR) and paper medical records. We applied the Brighton Collaboration criteria for level of diagnostic certainty (LOC) ascertainment to up to 300 potential SNHL cases, by date from the most recent patient backwards. The following parameters were assessed: (1) completeness to obtain information on each criterion of the case definition; (2) ability to assign LOC up to level 3, and what LOC was ascertainable; (3) ability to achieve the same LOC for the same case by different assessors; and (4) reasons for being unable to classify cases.
Results: Overall, 860 eligible cases were identified; data from 42 EMR and 258 paper case records were abstracted (median age 43 years, 55% male). Most SNHL cases were assessable (85.0%) and assigned level 1 LOC (84.3%); missing information on otoscopy (86.7%) was the main reason for being unable to classify cases. Consistency of LOC classification between assessors was 99.3%. Completeness on the recorded evidence of otoscopy (38.1% vs 93.7%, p < 0.001), tympanometry (38.1% vs 93.4%, p < 0.001), and audiometry (30.9% vs 93.0%, p < 0.001) was lower in EMRs than in paper records. Other diagnostic tools, including Tuning fork exam, auditory brainstem response test, otoacoustic emissions test, behavioral or neurodevelopmental assessment, and remote screening were rarely documented.
Conclusion: The Brighton Collaboration SNHL case definition would be applicable to retrospectively ascertain and classify cases in resource-limited settings. Developing an EMR template to document otoscopy results may improve the feasibility at this hospital to ascertain SNHL in the context of an LF vaccine trial or post-introduction.
Objective: To assess the applicability of this SNHL case definition to data collected in routine clinical care settings at a tertiary hospital in Ghana.
Methods: The study subjects were patients aged 18–59 years who attended the Eye, Ear, Nose and Throat Department at the Komfo Anokye Teaching Hospital between 1 January 2007 and 30 June 2020. We used the keywords “hearing loss”, “sensorineural hearing loss”, or “SNHL” to retrospectively identify eligible patients from electronic (EMR) and paper medical records. We applied the Brighton Collaboration criteria for level of diagnostic certainty (LOC) ascertainment to up to 300 potential SNHL cases, by date from the most recent patient backwards. The following parameters were assessed: (1) completeness to obtain information on each criterion of the case definition; (2) ability to assign LOC up to level 3, and what LOC was ascertainable; (3) ability to achieve the same LOC for the same case by different assessors; and (4) reasons for being unable to classify cases.
Results: Overall, 860 eligible cases were identified; data from 42 EMR and 258 paper case records were abstracted (median age 43 years, 55% male). Most SNHL cases were assessable (85.0%) and assigned level 1 LOC (84.3%); missing information on otoscopy (86.7%) was the main reason for being unable to classify cases. Consistency of LOC classification between assessors was 99.3%. Completeness on the recorded evidence of otoscopy (38.1% vs 93.7%, p < 0.001), tympanometry (38.1% vs 93.4%, p < 0.001), and audiometry (30.9% vs 93.0%, p < 0.001) was lower in EMRs than in paper records. Other diagnostic tools, including Tuning fork exam, auditory brainstem response test, otoacoustic emissions test, behavioral or neurodevelopmental assessment, and remote screening were rarely documented.
Conclusion: The Brighton Collaboration SNHL case definition would be applicable to retrospectively ascertain and classify cases in resource-limited settings. Developing an EMR template to document otoscopy results may improve the feasibility at this hospital to ascertain SNHL in the context of an LF vaccine trial or post-introduction.
| Original language | English |
|---|---|
| Pages (from-to) | 1244-1244 |
| Journal | Drug Safety |
| Volume | 45 |
| Issue number | 10 |
| Early online date | Oct 2022 |
| DOIs | |
| Publication status | Published - 2022 |
| Externally published | Yes |