School of Pharmacy, Sefako Makgatho Health Sciences University, Ga-Rankuwa, South Africa.
Department of Speech Pathology and Audiology, University of the Witwatersrand, Johannesburg, South Africa.
JMIR Mhealth Uhealth. 2020 Jan 14;8(1):e14036. doi: 10.2196/14036.
Tuberculosis (TB) affects millions of people worldwide and is treated with medication including aminoglycosides and polypeptides. Individuals respond differently to medications as a result of their genetic inheritance. These differences in genetic inheritance can result in the underdosing or overdosing of medication, which may affect the efficacy or, in the case of aminoglycosides and polypeptides used in the treatment of all forms of TB, result in ototoxicity. When ototoxicity is detected, physicians should adjust dosages to minimize further ototoxicity and hearing loss; however, there are no suitable grading systems to define significant hearing loss.
The aim of this study was to develop a standardized grading system by making use of an electronic health (eHealth) platform to ensure that a user-friendly method was available to interpret hearing test results, calculate significant hearing loss, and provide recommendations with regard to dosage adjustments and management. It further aimed to establish the sensitivity of the newly developed grading scale.
This grading system was developed in South Africa based on data that were obtained from an audiology and pharmacokinetic study on patients with drug-resistant TB (DR-TB) at two DR-TB units at state-run hospitals. This feasibility study employed a prospective, cross-sectional, exploratory, descriptive case series research design, with a total of 22 participants. Participants underwent audiological and pharmacological assessments at baseline and every 2 weeks for the first 3 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, a medical doctor, and a nurse. The app underwent 14 modifications that involved aspects of data storage, ease of usability, grades, and the risk factor checklist.
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 (1) assist health professionals in assessing patients for ototoxicity, (2) establish the clinical significance of ototoxicity by calculating the grade of hearing loss, (3) monitor the progression of hearing loss, and (4) enable systematic referral and management of patients according to their needs.
This newly developed system is more sensitive than the existing grading methods for determining ototoxicity in patients with DR-TB. This app needs to be trialed in a larger sample to establish data security, ease of use, and suitability within this population.
结核病（TB）影响着全球数百万人，其治疗需要使用包括氨基糖苷类和多肽类在内的药物。由于遗传因素的不同，个体对药物的反应也不同。这种遗传差异可能导致药物剂量不足或过量，从而影响疗效，在治疗所有形式的结核病时使用的氨基糖苷类和多肽类药物的情况下，还可能导致耳毒性。当检测到耳毒性时，医生应调整剂量以最大程度减少进一步的耳毒性和听力损失；但是，目前尚无合适的分级系统来定义显著听力损失。
本研究旨在通过利用电子健康（eHealth）平台开发标准化的分级系统，确保提供一种用户友好的方法来解释听力测试结果、计算显著听力损失，并就剂量调整和管理提供建议。它还旨在确定新开发的分级量表的灵敏度。
该分级系统是在南非开发的，其数据来源于在两家国有医院的耐药结核病（DR-TB）单位进行的一项针对耐多药结核病（DR-TB）患者的听力学和药代动力学研究。这项可行性研究采用了前瞻性、横断面、探索性、描述性病例系列研究设计，共有 22 名参与者。参与者在治疗的前 3 个月中每两周进行一次听力和药理学评估。共有 8 位不同的专业人员（共 8 位）参与了电子健康系统的开发，其中包括软件工程师、4 位听力学家、药剂师、医生和护士。该应用程序经历了 14 次修改，涉及数据存储、易用性、分级和危险因素检查表等方面。
为耐多药结核病患者开发了一种适用于医生、护士和听力学家使用的移动应用程序内的耳毒性分级系统。这款易于使用的耳毒性计算器 OtoCalc 的目的是：（1）帮助卫生专业人员评估患者的耳毒性；（2）通过计算听力损失的等级来确定耳毒性的临床意义；（3）监测听力损失的进展；（4）根据患者的需求系统地转介和管理患者。
与现有的用于确定耐多药结核病患者耳毒性的分级方法相比，该新系统更敏感。该应用程序需要在更大的样本中进行试用，以确定数据安全性、易用性和在该人群中的适用性。
