Ototoxicity in MDR-TB - Health Implementation Science Success

Implementation science is focussed is to identify the factors, processes, and methods that can successfully embed evidence-based Interventions in policy and practice to achieve population health.

Population health is “the health outcomes of a group of individuals, including the distributions of such outcomes within the groups”. Health outcomes and their distribution are determined by interacting factors related to biology; health care systems; psychosocial, economic, and physical environments; and policies across the life span.

Ototoxicity is the negative effect certain medications have that can cause hearing loss. Even common medication such as Aspirin or ibuprofen pose a risk.  It is well documented but largely ignored and rarely discussed.

Tuberculosis is a global health problem and is second only to HIV in deaths caused by infectious disease. Drug-resistant and Multidrug-resistant tuberculosis (DR-TB and MDR-TB) are virulent forms of TB that do not respond to anti-TB drugs available today. MDR-TB necessitates use of medications which are associated with permanent sensorineural hearing loss. Hearing loss following treatment for MDR-TB using aminoglycosides has been reported to occur in up to 57% of patients.

Starting in 2015, eMoyo collaborated with Janssen, the South African National Department of Health and CDC to support the successful implementation of a national ototoxicity management programme for DR-TB patients in South Africa.

Below is a summary of the intervention's programmatic performance  in South Africa for the defined period.

Background

The key elements for the initiation of the decentralized management of DR-TB care in South Africa are:

  1. Access to laboratory services
  2. Access and availability of DR-TB drugs
  3. A doctor or a nurse to initiate care
  4. Access to Audiology services

The type of audiometric equipment available in clinical settings as well as the amount of audiologists available in the national public health sector (461) has historically made the required National standard to prevent DR-TB patients developing hearing loss an insurmountable task and resulted in delayed hearing screening and inadequate monitoring of ototoxicity. Traditional equipment requires that testing be performed within a soundbooth, which is also a source of cross-contamination for these high infectious patients. Traditional equipment is costly, is installed in a static location and due to its size and weight cannot be easily transported.

This meant that many patients receiving treatment for DR-TB were at risk of going deaf due to the medication and that this full extent of this risk was largely unknown.

What was done

To improve the monitoring of ototoxicity and implement a strategy of early intervention in the Drug Resistant TB programme, 126 high-frequency portable audiometers (KUDUwave™ Pro) with telemedicine capabilities were deployed to selected health facilities and all the end users appropriately and continuously trained over the course of the programme. Testing of high-frequencies ( hearing levels above, KUDUwave audiometers are specifically designed to eliminate the need for a soundbooth by combining the required technology into a single, lightweight and portable device.

Automated, user-friendly software made it easy for both mid-level workers as well as professional staff to perform testing. This was overseen by audiologists who were able to intervene where ototoxicity was detected. The device's inherent portability and compact nature made it convenient to move around, affording the opportunity to take the service to where the patients were rather than relying on already ill patients traveling to clinics. The data generated from the audiological tests was uploaded to a central server where an online interpretation report was generated. This meant that  reports could then be generated and viewed via the internet, allowing clinicians to make determinations and stakeholders to monitor testing remotely.

Results

The initial phase of the program (January 2015 – December 2016) saw 4869 patients receiving baseline testing and initiation into the program. Of which, 2775 (57%) presented with ototoxicity.

Prior to the implementation of the program, only 31% of patients receiving treatment received baseline hearing screening tests. This increased to 69% post-implementation and enabled more patients to be monitored for ototoxicity on subsequent visits.

Previously only 30% of patients received audiological follow-up tests. This also increased to 70%

New alternative medication was made available which does not present the risk of ototoxicity prevalent in previous medications.

CONCLUSION

The intervention facilitated the early identification of ototoxicity and associated risk factors that created an opportunity for the adjustment of clinical management that can conserve the hearing of DR TB patients.

There has been a significant reduction in the time from diagnosis to the baseline Audio screening and treatment initiation.

This successful initiative has influenced policy changes to effect an aminoglycoside free regimen in South Africa which has greatly reduced the risk of drug-related hearing loss in MDR-TB treatment.

Due to the success of this program in South Africa, the initiative has now been expanded to India, Zimbabwe and Indonesia.

Examples of System Generated Recording and Reporting Dashboard: