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Research

Practices employed by audiologists in the management of adult patients with multidrug-resistant tuberculosis in South Africa

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Pages 363-372 | Received 30 Apr 2015, Accepted 18 Aug 2015, Published online: 11 Sep 2015

Abstract

Introduction: Aminoglycosides used for treating multidrug-resistant (MDR) tuberculosis are ototoxic, leading to a need for audiological monitoring. While audiologists monitor ototoxicity, currently there are no guidelines on monitoring in the South African context. Therefore, the findings of this study might help to motivate the establishment of a more in-depth ototoxicity monitoring policy, which facilitates uniformity among audiologists managing patients with MDR tuberculosis. Therefore, the study aimed to describe the audiological practices employed by audiologists in the management of adult patients with MDR tuberculosis in South Africa.

Method: A descriptive survey design was used. A questionnaire was developed and included elements of the American Speech-Language and Hearing Association (1994) guidelines for monitoring ototoxicity. Ninety-three audiologists contributed data to this study. Descriptive statistics were used in the analysis of the data.

Results: Sixty-eight percent (%) of the respondents were aware of the international guidelines, 93% provided pre-treatment counselling and 87% conducted a baseline assessment. Nineteen percent of the respondents conducted high-frequency audiometry, while 74% carried out a monthly evaluation, 72% performed a full audiological assessment after the cessation of the MDR tuberculosis treatment, and 96% conducted post-treatment counselling. Modifications to the international guidelines include not conducting speech and immittance audiometry, as well as testing certain frequencies. The reasons for these modifications include limited specialised equipment, time constraints, large caseloads and understaffed departments.

Conclusion: There are no explicit guidelines on ototoxicity monitoring in South Africa. Consequently, audiologists are having to modify the international guidelines. Thus, there is no consistency in managing patients with MDR tuberculosis. This highlights the need for South Africa to develop context-relevant ototoxicity monitoring guidelines to appropriately manage patients with MDR tuberculosis.

Introduction

Tuberculosis is one of the leading causes of mortality among human immunodeficiency virus (HIV)-infected patients.Citation1 Moreover, the HIV/acquired immune deficiency syndrome (AIDS) epidemic has increased the incidence of tuberculosis, and is a contributing factor to the rising prevalence of MDR tuberculosis.Citation1 South Africa is one of five countries with the largest number of incident cases of tuberculosis (410 000–520 000), mainly owing to the emergence of multidrug-resistant (MDR) tuberculosis.Citation2 MDR tuberculosis occurs if a patient is not treated for tuberculosis, or when the treatment regimen of a tuberculosis patient is inadequate or incomplete, i.e. the patient defaults on the treatment regimen, with the result that stronger or more resistant bacilli survive and prosper.Citation3

MDR tuberculosis is defined as resistance to isoniazid and rifampicin, which requires long-term treatment of injectable aminoglycosides.Citation4 Aminoglycosides are recommended as they are active against various multidrug-resistant Gram-negative bacilli. However, they are toxic to the eighth cranial nerve, resulting in ototoxicity.Citation5 Ototoxicity refers to hearing loss or vestibular dysfunction arising from the use of ototoxic drugs.Citation6 MDR tuberculosis treatment has the ability to destroy the basal hair cells of the basilar membrane, required for high-frequency hearing, and later progresses to affect the frequencies associated with speech communication.Citation7 The high and ultra-high frequencies are the most affected as the treatment progresses, with a notable deterioration in hearing sensitivity between the baseline assessment and the post-treatment evaluation.Citation8 However, methods are not currently being utilised to protect the deterioration of patients’ hearing against the effects of ototoxic medication in South Africa. Thus, the need for the appropriate detection and management of ototoxicity is reliant on effective audiological monitoring.

Audiological monitoring is required for two purposes, i.e. to detect ototoxic changes which affect speech frequencies, and to monitor ototoxic changes once the treatment regimen is complete.Citation9 One of the many responsibilities of an audiologist includes the planning and implementation of an auditory monitoring programme for ototoxicity.Citation10 The reported proportion of patients with hearing loss was greater in programmes where standardised hearing assessments were conducted. This suggests that patients who undergo a standardised method of treatment benefit more by knowing their hearing status as it is monitored from the commencement of treatment, and not when irreversible damage to the auditory system has occurred.Citation7 Internationally, the American Academy of Audiology (AAA)Citation11 position statement and American Speech-Language-Hearing Association (ASHA)Citation12 clinical practice guidelines assist audiologists in implementing appropriate ototoxicity monitoring regimes. The ASHACitation12 proposed a method of audiological evaluation for ototoxicity monitoring, where specific criteria to identify ototoxicity are used, as well as the timely identification of at-risk patients, pre-treatment counselling, baseline measures, monitoring evaluations at sufficient intervals to document the progression of hearing loss or fluctuations in sensitivity, and follow-up evaluations to determine the post-treatment effects. Therefore, the roles and responsibilities of audiologists in an ototoxicity monitoring programme include patient education; and baseline, monitoring and post-treatment audiological assessments which inform physicians if an ototoxic-induced change in hearing has been detected, as well as providing aural rehabilitation in the form of amplification and counselling. According to the ASHA,Citation12 the roles and responsibilities of audiologists are as follows:

Designing and implementing an ototoxicity monitoring programme.

Identifying patients who are at risk of ototoxic hearing loss.

Collaboration between the audiologist and medical team concerning patient management and in-service training.

The implementation of appropriate rehabilitation measures.

Patient education generally occurs during pre- and post-treatment counselling as patients are made aware of the usual signs and symptoms of hearing loss, the need for communication strategies and the synergistic effect of noise exposure and ototoxic drugs.Citation10

In addition, the ASHACitation12 has recommended a baseline assessment which must include:

An in-depth case history.

An otoscopic examination.

Immittance audiometry.

Pure-tone audiometry.

Speech audiometry.

Otoacoustic emission (OAE) and/or an auditory brainstem response (ABR) tests.

The follow-up evaluations include all of these tests, with the exception of speech audiometry. However, these guidelines have been developed for the American context. Thus, they can only serve as a guide to South African audiologists.

The policy developed by the South African National Department of Health, i.e. Management of drug-resistant tuberculosis: policy guidelines 2010,Citation13 and the guidelines developed by the Health Professions Council of South Africa (HPCSA), A guideline for planning STA services at all levels of health care, are the only context-relevant guidelines available to South African audiologists.Citation14 The policy developed by the South African National Department of HealthCitation13 provides audiologists with an outline of the process involved in the management of patients with MDR tuberculosis. The Department of Health policy includes aspects which are relevant to ototoxicity, such as the need for a baseline assessment. However, it does not reveal the battery of tests to be used for basic audiological testing, or even ototoxicity monitoring. Thus, the Department of Health needs to review and/or amend the audiological aspects of the current policy to ensure that audiologists across the country have standardised and more specific guidelines to follow in the audiological management of patients with MDR tuberculosis.

The current HPCSA guideline was developed to facilitate rehabilitation service planning and implementation at all levels of health care. The guidelines contain aspects relating to the audiological management of a patient undergoing ototoxic treatment. This guideline is not specific to the assessment and/or management of a patient with MDR tuberculosis. However, it advises audiologists to be aware of indicators relating to ototoxicity, such as the percentage of baseline audiograms completed upon the initiation of ototoxic medication (i.e. within 24 hours), the percentage of patients with signs or symptoms relating to ototoxicity, patients who received medical intervention within 24 hours, and audiological intervention at least six weeks post cessation of ototoxic treatment. However, this guideline does not mention pre-treatment counselling or topics which need to be addressed during this crucial time in the management of a patient with MDR tuberculosis. This guideline fails to provide audiologists with the specific battery of tests that should be utilised when conducting ototoxicity monitoring, or how to assess patients who may be non-responsive. Moreover, the guideline does not mention post-treatment management, with the exception of hearing aid fittings and follow-up evaluations at specialised tuberculosis hospitals. While, this guideline serves the purpose of making speech-language therapists and audiologists aware of the services that are needed at the different levels of care, it is evident that specific guidelines for ototoxicity monitoring are required.

There are financial constraints to the healthcare system in developing countries, such as South Africa, because of competing budgetary demands from life-threatening and/or communicable diseases. In addition, patients with HIV/AIDS are at higher risk of developing tuberculosis and MDR tuberculosis,Citation1,15 and minimal audiological services are available.Citation16 However, it is important for audiologists to know that they are ethically obligated to follow evidence-based best practice guidelines. Audiologists are responsible for providing a service that is within their scope of practice, or to make other arrangements to make access to the service possible. Therefore, this study aimed to describe these practices so that the information can be used to devise contextually relevant, evidence-based ototoxicity monitoring protocols for patients with MDR tuberculosis. Furthermore, the findings of this study may help to motivate the establishment of a more in-depth South African National Department of Health and HPCSA ototoxicity monitoring policy, allowing for uniformity among audiologists managing patients with MDR tuberculosis in South Africa.

Method

Aims

The aim of the study was to describe the audiological practices employed by audiologists in the management of adult patients with MDR tuberculosis in South Africa.

Objectives

The study objectives were to describe specific criteria used in identifying ototoxicity and the pre-treatment and baseline audiological practices, and to describe the ototoxicity monitoring protocols, and post-treatment and audiological management practices employed by audiologists.

Study design

A descriptive survey design was used in the study, with a quantitative method of analysis.

Study population

Stratified sampling was used, and audiologists in South Africa were targeted.

Inclusion criteria

Inclusion criteria were audiologists with a year or more of working experience to ensure that they were familiar with the protocols and guidelines pertaining to the audiological management of patients with MDR tuberculosis. They also had to have had experience working with patients diagnosed with MDR tuberculosis.

Exclusion criterion

Audiologists who did not have any experience working with patients diagnosed with MDR tuberculosis were excluded from the study.

Description of the respondents

A total of 205 respondents completed the questionnaire. However, only 93 respondents were eligible to participate when the selection criteria were applied. Some respondents failed to answer some of the questions. However, because of the poor response rate, a decision was taken to include questionnaires in which more than 90% of the questions had been answered. This resulted in all 93 questionnaires being included. Therefore, there is variation with respect to some of the presented results. A description of the respondents in the study is provided in Table .

Table 1: Demographic profile (n = 93)

Data-collection tool

A questionnaire (Appendix A) developed by the researcher, in consultation with the ASHACitation12 and AAACitation11 guidelines for ototoxicity monitoring, was used for data collection. This was used to gain understanding of and/or to identify the audiological practices utilised by South African audiologists in comparison with international audiologists. It helped the researcher to identify areas of ototoxicity monitoring that are being followed or modified by audiologists in South Africa. The questionnaire contained 64 questions, of which 15 were open-ended and 49 closed-ended questions, which addressed various aspects, including background information, baseline monitoring, periodic monitoring, post treatment, as well as the audiological management of patients with MDR tuberculosis.

Data-collection procedure

Upon receiving ethical clearance (HSS/1449/013 M) from the University of KwaZulu-Natal Humanities and Social Sciences Research Ethics Committee, and adherence to the ethical principles of the World Medical Association Declaration of Helsinki, the pilot study was conducted. The information documents, consent forms and questionnaires were emailed to eight audiologists, informing them of the study. The questionnaire was used in the pilot study, and a comments form was utilised to record comments and suggestions. The respondents who participated in the pilot study were not included in the main study. Upon amendment of the questionnaire, the information documents, containing the web address of the survey, were posted to audiologists on the HPCSA database. In addition, audiology associations, such as the South African Association of Audiologists and the South African Speech-Language-Hearing Association, were also asked to send out a broadcast email pertaining to the study, including the web address needed by the respondents to access the questionnaire. Audiologists were given a month in which to respond to the survey. Letters and emails reminding them of the study were sent out two weeks after the initial communication.

Data analysis

The data from the questionnaires were captured on an Excel® spreadsheet and analysed using Stata® version 13. A descriptive method of analysis was used to interpret the results. Some of the “Yes” or “No” questions were tabulated or converted into graphs and frequency counts. Open-ended questions were analysed thematically. During the data analysis, it was accepted that participants’ responses to some of the questions would vary as some of them did not answer all of the questions.

Results

Sixty-eight (73%) of the 93 respondents indicated that they conducted ototoxicity monitoring at the time of the study. Seventy-four respondents (80%) were aware of the ototoxicity monitoring guidelines.

According to Figure , 50 (68%) of the 74 respondents were familiar with the ASHA and AAA guidelines used for ototoxicity monitoring.

Figure 1: Awareness of the available protocols and guidelines (n = 74)

Figure 1: Awareness of the available protocols and guidelines (n = 74)

Seventy-two (87%) of the 83 respondents conducted a baseline assessment prior to administration of MDR tuberculosis treatment, while 11 (13%) respondents indicated the following reasons for not doing so:

The patient was only referred once a complaint about hearing loss had been received.

There was a shortage of staff.

Infrastructure that met the requirements of the Occupational Health and Safety Act was not in place.

There was only one booth.

There was no ventilation.

There was a lack of space.

The patient was referred from the tuberculosis hospital (out of town), which did not have an in-house audiologist. Therefore, it was considered impractical to conduct a baseline assessment.

Nine (12%) of the 72 respondents conducted the baseline assessment within 12 hours of administering aminoglycoside treatment, while 33 (46%) did so within 24 hours, 5 (7%) within 48 hours, 13 (18%) within 72 hours, and 12 (17%) after 72 hours of treatment.

As reflected in Table , 65 (80%) of the 81 respondents indicated that they conducted the battery of tests to be used during the baseline assessment, including an otoscopic examination, immittance audiometry, air conduction testing, bone conduction testing, high-frequency average (HFA), speech recognition threshold, speech detection threshold, OAE and ABR. However, of the 81 respondents, 65 (80%) indicated that they did not perform HFA when conducting the baseline assessment.

Table 2: Audiological tests used during the baseline assessment (n = 81)

Fifty-six (72%) of the 78 respondents said that they would perform a full audiological assessment if changes to the hearing sensitivity were experienced. Seventy (91%) of 77 respondents indicated that periodic testing was not conducted 2-3 days per week for those patients receiving MDR tuberculosis treatment. Fifty-two (74%) of these 70 respondents reported that they performed assessments monthly, and the remaining 18 (26%) stated that assessments were carried out fortnightly.

Seventy-two (97%) of the 74 participants indicated that ototoxicity monitoring would be easier for audiologists if South African guidelines and/or protocols were available, while 2 (3%) participants did not believe that it would be easier even if this was the case. Fifty-three (72%) of the 74 respondents indicated that a full audiological assessment was conducted after the cessation of treatment. However, the remaining 21 (28%) respondents reported that they would follow-up on the monitoring results only if the need arose. Thirty-three (44%) of the 75 participants conducted follow-up assessments at three months, 6 (8%) at six months, and 1 (1%) at one year. Thirty-five (47%) respondents conducted follow-up assessments at one month, three months, six months and one year.

Figure indicates the modifications that were made to the international guidelines. Twenty-five (60%) of the 42 respondents reported that they only conducted air conduction tests, 22 (52%) that they did not perform speech audiometry, 1 (2%) that only certain frequencies were tested, 1 (2%) that all of the stated modifications were used, and 4 (10%) who had selected “Other” indicated that they did not conduct immittance audiometry.

Figure 2: Modifications made to the international guidelines (n = 42)

Figure 2: Modifications made to the international guidelines (n = 42)

Figure depicts the reasons given for modifying the international guidelines. Sixty-three (85%) of the 74 respondents reported that they modified the battery of tests owing to time constraints, 58 (78%) because of a lack of resources, 55 (74%) because of a lack of guidelines and 54 (73%) due to the department being understaffed. Four (5%) respondents reported that the main reason the battery of tests was modified was because ototoxicity monitoring was seldom practised, and because the ototoxicity monitoring international guidelines were not suitable in the South African context.

Figure 3: Reasons for modifications to the international guidelines

Figure 3: Reasons for modifications to the international guidelines

Discussion

The purpose of the present research was to describe the practices employed by audiologists in the management of adult patients with MDR tuberculosis. The study found was that ototoxicity monitoring was essential owing to the high incidence of MDR tuberculosis in South Africa.Citation2 This was attributed to the alarming increase in co-infection with HIV, and the result of low adherence to treatment by patients with tuberculosis in South Africa.Citation17 Therefore, it can be assumed that a large number of people are on aminoglycoside treatment.

Audiologists need to be aware that the use of aminoglycosides can also cause delayed hearing loss.Citation18 Consequently, it is suggested that ototoxicity monitoring programmes are needed in order to monitor the audiological status of these patients because of the ototoxic nature of aminoglycosides.Citation19

However, only 93 respondents reported that they conducted ototoxicity monitoring in patients with MDR tuberculosis, so it can be deduced that a large number of patients do not receive this audiological service. Furthermore, only 80% of the respondents were aware of the international protocols. Thus, audiologists in South Africa need to follow the international guidelines as they are readily available. However, one of the respondents believed that specific South African ototoxicity monitoring guidelines were available. However, he or she could have been referring to the HPCSA guideline.Citation14 This suggests that there is a need for audiologists to obtain guidance and training on ototoxicity monitoring, and to be aware of the relationship between MDR tuberculosis and ototoxicity monitoring.

According to the international guidelines, the baseline assessment should be conducted within 72 hours of administering the ototoxic treatment.Citation11,12 The fact that 17% of the respondents were not compliant in this regard indicates that these patients were not being correctly monitored, and this could have affected the outcome of the results. This would further suggest that a highly efficient patient identification and/or referral system is required for timely assessments.Citation7 According to the AAA, the following tests are recommended during a baseline assessment: pure-tone thresholds in the conventional frequency range, HFA, tympanometry, speech audiometry and testing of OAEs.Citation11 Eighty percent of the respondents were aware of the audiological tests required for baseline hearing assessments when conducting ototoxicity monitoring. In addition, there have been improvements in the battery of tests for patients presenting with ototoxicity. Until very recently, only conventional testing methods, i.e. pure-tone audiometric testing, were used.Citation20 However, recently, more specific information was gained with the use of HFA and OAEs, which permit the early detection of ototoxic hearing loss.Citation21 However, 80% of the respondents did not conduct HFA because they lacked the necessary equipment. This highlights the constraints experienced by audiologists relating to HFA and its use in South Africa. HFA enables audiologists to gain threshold information from 8-20 kHz, the frequency region which is initially affected by the use of aminoglycosides.Citation8 This indicates that it is imperative that HFA is included in the assessment as it covers the upper regions of hearing, which are not usually tested during a conventional audiometric evaluation.Citation22 However, the necessary specialised equipment required to conduct HFA owing to financial constraints is lacking.Citation16 In addition, service delivery is greatly affected as high-frequency results provide early identification of ototoxic hearing loss, which reduces the number of patients who are referred to audiologists once irreversible damage to their auditory system has occurred.Citation10

According to the international guidelines, patients undergoing ototoxic treatment need to be monitored 2-3 days a week.Citation12 In this way, any changes to the auditory system can be detected early, and suitable amendments made to the treatment regime. However, 91% of the study particpants reported that they did not conduct assessments 2-3 days per week. This could be attributed to high caseloads and time constraints. Regardless, South African audiologists are not adhering to international best practice guidelines, and instead are modifying these guidelines in a way that is relevant within the South African context.

Context-relevant standards would allow for easier implementation of ototoxicity monitoring as they would support the needs of professionals and patients involved in the process of MDR tuberculosis management. According to the study, 97% of the respondents indicated that ototoxicity monitoring would be easier for audiologists if South African guidelines and/or protocols were available. Audiologists noted that the international guidelines were not suitable in the South African context, and attempted to modify the guidelines to make them contextually relevant. Fifty-seven percent of the 74 respondents reported that they made modifications to the international guidelines. The modifications included not conducting speech audiometry, only testing certain frequencies, and not performing immittance audiometry. The inability to complete these tests negatively impacts on the reliability of the results obtained as these tests are used in conjunction with one another to determine the accurate hearing sensitivity of the patient. This impacts on the programme as standard protocol is not being followed, and this then impacts on the results obtained from patients. The use of a standardised method of testing would make it easier to document the progression of ototoxicity. In turn, this would allow for a more efficient referral system to specialised services, and would assist with obtaining the epidemiological statistics needed to improve or gain further insight into ototoxicity. Furthermore, a standardised method of testing would improve clinical case management within a tuberculosis programme as it would provide a scheduled timing of the administration of the treatment, or the possible changes which occur when progression in ototoxicity occurs.Citation7

Conclusion

South Africa has one of the highest MDR tuberculosis infection rates in the world, and this has placed considerable strain on the healthcare system, highlighting the need for ototoxicity monitoring. Although audiologists are practising in a way that allows for maximisation of the resources in order to provide high-quality health care, it is clear that they are not fully engaging with the evidence-based practice guidelines, i.e. of the ASHA and AAA. This is required if there is to be a standard method of monitoring patients receiving ototoxic MDR tuberculosis treatment. Consequently, the South African National Department of Health and the HPCSA need to develop appropriate ototoxicity monitoring guidelines for audiologists in order to improve case management and provide standardised audiological services to patients with MDR tuberculosis throughout the country.

Limitations

The findings of this study must be viewed in the context of the small sample size owing to the poor response rate. However, it should be acknowledged that some respondents with dual qualifications practised only speech therapy, while others who were registered with HPCSA were practising abroad. Therefore, the exact number of audiologists practising in the field of ototoxicity monitoring in South Africa could not be determined. A second limitation was that a number of respondents failed to respond to some of the questions. Finally, more information, such as the impact of modification to the international guidelines, related to the South African context and the possible benefits of the modification to an ototoxicity monitoring program should have been addressed, as this would have provided insight into its application in the South African context.

Clinical implications

Audiologists should utilise HFA and sensitive range for ototoxicity in the South African context, as these have proven to be an effective means of ototoxicity monitoring.Citation20 Furthermore, the South African National Department of Health and the HPCSA should establish a ototoxicity monitoring protocol which is context relevant.

References

Appendix A

Questionnaire

Section A: Biographical details

Please fill in or tick () the relevant answer

Section B: Ototoxicity monitoring (the identification of patients with multidrug-resistant tuberculosis

Section C: Ototoxicity monitoring (the baseline test)

Section D: Ototoxicity monitoring (monitoring procedures)

Section E: Ototoxicity monitoring (post-treatment management)