Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Mar 16, 2019
Open Peer Review Period: Mar 19, 2019 - May 14, 2019
Date Accepted: Aug 19, 2019
(closed for review but you can still tweet)
Preliminary development of an ototoxicity grading system within a mobile app “Otocalc” for a resource limited setting to guide grading and management of drug-induced hearing loss for patients with Drug Resistant – Tuberculosis
ABSTRACT
Background:
Tuberculosis, affecting millions of people worldwide, is treated with medication including aminoglycosides and polypeptides. Individual genetics in drug response guide different responses to these medications. Individuals respond differently to medication as a result of their genetic inheritance. These differences in genetic inheritance can result in the under- or over-dosing of medication, which may affect the efficacy, or in the case of aminoglycosides and polypeptides used in the treatment of all forms of tuberculosis (TB), result in ototoxicity. When ototoxicity is detected physicians should adjust dosages to minimize further ototoxicity and hearing loss, yet there are no suitable grading systems to define ‘significant’ hearing loss.
Objective:
The aim was to develop a standardized grading system by making use of an eHealth platform to ensure a user-friendly method to interpret hearing test results, calculate significant hearing loss and provide recommendations with regards to dosage adjustments and management. It further aimed to establish the sensitivity of newly developed grading scale.
Methods:
This grading system was developed in South Africa based on data that was obtained from an audiology and pharmacokinetic study in Drug-Resistant Tuberculosis (DR-TB) patients at two DR-TB units at state run hospitals. This feasibility study employed a prospective, cross-sectional, exploratory, descriptive and case series research design, with a total of 22 participants. Participants underwent audiological and pharmacological assessments at baseline and every two weeks for the first three months of treatment. Various professionals (8 in total) were subsequently involved in the development of the eHealth system, including a software engineer, four audiologists, a pharmacist, medical doctor and a nurse. The app underwent 14 modifications which involved data storage, ease of usability, grades and the risk factor checklist.
Results:
An ototoxicity grading system within a mobile app for use by doctors, nurses and audiologists was developed for patients with DR-TB. The purpose of this user-friendly ototoxicity calculator, ‘OtoCalc™’ is to: i) assist health professionals in assessing patients for ototoxicity; ii) establish the clinical significance of ototoxicity, by calculating the grade of hearing loss; iii) monitor the progression of hearing loss; and iv) enable systematic referral and management of patients according to their needs.
Conclusions:
This newly developed system is more sensitive for ototoxicity in DR-TB patients when compared to the existing grading methods. This app needs to be trialed in a larger sample to establish the data security, user-ease and suitability within this population.
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.