Browsing by Author "Ramma, Lebogang"

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    Auditory characteristics and balance function of diabetic patients
    (2017) Hlayisi, Vera-Genevey; Ramma, Lebogang; Petersen, Lucretia; Rogers, Christine
    Aims and Objectives. This study aimed to describe auditory characteristics and balance function in patients with diabetes between 18-55 years of age as well as determine the association between patients' auditory and balance function with diabetes characteristics (type, duration and control). Background. Diabetes is one of the most prevalent non-communicable diseases worldwide with approximately 422 million people diagnosed globally. This number is projected to rise to 642 million by 2040 if no appropriate interventions are implemented to reverse the rise in the number of people with diabetes. South Africa has the second highest diabetes prevalence in Africa (after Nigeria) with 2.6 million cases. A rise in diabetes prevalence should be a concern for audiologists with increasing literature linking diabetes with the risk of acquiring hearing and balance disorders. However, there is currently a lack of research done in South Africa to investigate auditory and balance disorders in patients with diabetes. Therefore, the current study sought to investigate auditory characteristics and balance function in South African patients diagnosed with diabetes. It is anticipated that the study findings will yield evidence that will highlight the role of an audiologist in the clinical management of patients with diabetes. Research Design. The study utilised an observational cross-sectional matched groups design with a cohort (patients with diabetes) and control (volunteers without diabetes) group of participants. Participants were recruited from a Primary Health Care clinic in Polokwane, Limpopo using purposive and convenience sampling for the cohort and control group respectively. Methodology. Several methods were used to collect data pertinent to this study. These included case history interview and a medical folder review to obtain information related to participants' diabetes status. Furthermore, all participants underwent the following assessments: otoscopy, pure tone audiometry, diagnostic distortion product otoacoustic emissions (DPOAE), vision screening, peripheral neuropathy screening, Dynamic Gait Index test (DGI) and the Modified Clinical Test of Sensory Integration (MCTSIB). Data were analyzed using both descriptive and inferential statistical tests. Results. A total of 192 participants took part in this study; 110 in the cohort and 82 in the control group. There were similar distributions of gender in both groups with the following age distributions (in years) for each group; cohort; median =46, range =20-55, control; median =43, range =21-55. Pure tone audiometry assessments showed a significantly higher prevalence of hearing loss in the cohort (55%) when compared to the control (20%) group (p < .001). Participant age, gender and diabetes duration were associated with the likelihood of having hearing loss (age: odds ratio=2.90, 95% CI: 1.19-7.08, p=0.019; gender (male): odds ratio=.266, 95% CI: .104-.677, p=0.005; diabetes duration: odds ratio=1.12, 95% CI: 1.02-1.22, p=0.013). DPOAE assessments showed significantly higher percentages of abnormalities with signal to noise ratio (p < 0.01) and DPOAE level (p < 0.01) in the cohort compared to the control group. A significantly higher proportion (38%) of participants in the cohort group reported tinnitus when compared to 15% in the control (p < .001). Balance screening assessments with the DGI and the MCTSIB, showed significantly poorer performance in the cohort group than the control (DGI:, p < .001; MCTSIB: p < .001). Conclusion. Overall findings of this study showed that participants who were diagnosed with diabetes had a higher proportion of auditory and balance abnormalities when compared to those in the control group. Older age, male gender and longer duration since diabetes diagnosis were associated with a higher likelihood of having hearing loss. The findings of this study therefore suggest that auditory and balance dysfunction should be considered as comorbidities associated with diabetes. This study also highlighted the role of an audiologist in the managment of patients with diabetes with respect to early identification and management of auditory and balance dysfunctions amongst these patients.
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    Beyond hearing aid fitting: Investigating the feasibility of providing tele-rehabilitation for adult hearing aid users in a South African public health context
    (2021) Khatib, Nuha; Hlayisi, Vera-Genevey; Ramma, Lebogang
    Introduction: Disabling hearing loss is one of the most common sensory deficits; affecting approximately 466 million people worldwide. In the South African context, public health facilities have an uneven ratio between audiologists and patients in need and thus audiological services are often minimal. Successful application of tele-health may increase the scope of audiological services for hearing aid (HA) users. Research is needed to investigate feasibility of tele-health for audiological rehabilitation programmes such as auditory training (AT). Aim and Objectives: This study aimed to investigate the feasibility of implementing a telerehabilitation programme in a South African public health context. Objectives included: 1) determining online AT compliance; 2) determining the effect of online AT on speech perception in noise; 3) assessing experience and benefit of tele-rehabilitation through questionnaires and interviewing; and 4) cost estimation around tele-rehabilitation implementation. Research Design: A convergent mixed methods design with a feasibility approach was utilized. Data collection was through questionnaires, in-booth speech assessments, online AT and face-to-face interviewing. Participants undertook online AT over four weeks. Pre-/post- online AT: the APHAB, QuickSIN, Entrance/Exit Questionnaires, Interviews and System Usability Scale were administered. Descriptive statistics were used to analyse the quantitative data collected, and descriptive thematic analysis was used for the qualitative data. Study sample: Purposive sampling was used and three female adult (35 - 55 years) HA users from a public health facility participated. Results: 1) High compliance rate (84.82%) with 3 hours 25 minutes total clinician contact time, 2) clinical benefit with improvement in listening skills and perceived HA benefit, 3) positive participant feedback, and 4) estimated cost at R1350.00 per person. Conclusions: Findings from this feasibility study can be seen as positive indicators towards the use of tele-health as a delivery modality for audiological rehabilitation, also a tele-health hybrid model is recommended. However, larger-scaled research is needed.
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    Cochleo-vestibular clinical findings among drug resistant Tuberculosis Patients on therapy-a pilot study
    (BioMed Central Ltd, 2012) Ramma, Lebogang; Ibekwe, Titus
    ABSTRACTS:BACKGROUND: To investigate the Cochleo-vestibular clinical and audiometric findings in Multi and Extreme Drug Resistance(MDR and XDR) tuberculosis(TB) patients on treatment and make recommendations. METHODS: A cross-sectional study of adult MDR and XDR-TB patients was conducted in a general hospital in Cape-Town-South-Africa. Ethical approval was secured and all consenting patients administered with pretested and validated questionnaire under the guidance of International Classification of Functioning, Disability and Health(ICF) Checklist-version-2.1a. Audiometric evaluation included: Otoscopy, Diagnostic Audiometry and Tympanometry. The data analyses were done with SPSS version 16, Chi-square and StatCalc-7. RESULTS: Fifty-three adults, ages 18-60 (mean-33 years) comprising 26 males and 27 females participated in the study. Hospital stay duration varied from 1-18 months (mean-6 months) and all were on anti-Koch's second line drugs (regimen 2). MDR TB group were 45(85%) and XDR 8(15%). Vertigo was the most common vestibular symptoms, 24(45%) whereas, tinnitus 23(42%) and hearing loss 13(25%) were most frequent auditory complaints. Bilateral sensorineural hearing losses of varying degrees were confirmed in 23(47%).There was no association between gender and age with hearing loss [chi2 (P = 0.16, alpha = 0.05) and (p = 0.13, alpha = 0.05)]. Furthermore, MDR and XTR TB groups [20/42 Vs 3/8; Z = 0.46 and P = 0.64], showed no difference in pattern of the hearing losses. CONCLUSIONS: A multi-disciplinary close surveillance of MDR and XDR TB patients on therapy is imperative. Finally, researches into therapeutic trials on antidotes and potent safer substitutes for aminoglycosides in the management are recommended.
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    Disability and service delivery perspectives of service users in a rural community in the Eastern Cape
    (2012) Booi, Mpilo Henry; Ramma, Lebogang; Duncan, Madeleine
    Since the advent of democracy in South Africa rural and disabled people have lagged behind in terms of access to services, and that has implications on their enjoyment of socio-economic rights. Although exclusion from access to services is documented in literature, little research has been done to explore rural and disabled people's perspectives on inclusive service delivery. The purpose of this study was to contribute to the literature regarding inclusive service delivery in health, education and social development and citizen participation in rural areas. Insights into perspectives of rural citizens are pertinent for improved and inclusive service delivery. The aim of this study was to describe the perspectives of rural people regarding disability inclusive public sector service delivery in social development, health and education in a remote village in the Eastern Cape, South Africa.
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    Effectiveness of different medical interventions implemented when a change in hearing status is detected during ototoxicity monitoring
    (2022) Gangerdine, Kayleen; Ramma, Lebogang; Petersen, Lucretia
    Background: Fourteen thousand (14, 000) people fell ill with Multi-Drug Resistant (MDR) or Rifampicin-Resistant (RR) Tuberculosis (TB) in South Africa (SA) in 2019. Aminoglycosides, which are commonly used anti-tuberculosis drugs in the treatment for RR/MDR-TB patients, are associated with ototoxicity (cochlear or vestibular). Aminoglycoside-induced cochleotoxicity is characterised by permanent, bilateral, highfrequency (HF) sensorineural hearing loss (SNHL). The impact of hearing loss (HL) due to aminoglycoside-induced cochleotoxicity can influence a patient's communication, psychological, physical functioning and overall well-being negatively and lead to a reduced quality of life (QoL). To reduce the risk of aminoglycoside-induced cochleotoxicity, patients' hearing thresholds are monitored (i.e., cochleotoxicity monitoring) when they are being treated with cochleotoxic aminoglycosides. Cochleotoxicity monitoring is performed to detect a significant threshold shift (STS) early and prevent further deterioration of hearing thresholds and avoid hearing loss which may end up affecting frequencies that are important for speech perception. When a STS or hearing loss is detected during cochleotoxicity monitoring, there are various intervention strategies that can be implemented by the treating medical personnel to avoid further deterioration of patient's hearing thresholds. These strategies may include discontinuing the aminoglycoside, changing the aminoglycoside to a less cochleotoxic alternative in the regimen or changing the frequency of administration of the aminoglycoside. This study, therefore, aimed to determine the effectiveness of different strategies used when a STS in hearing occurred during cochleotoxicity monitoring to prevent further deterioration in hearing thresholds. Methodology: A descriptive prospective repeated-measures design was used in this study. Patients who underwent RR/MDR-TB treatment with Kanamycin, a cochleotoxic aminoglycoside, at Brooklyn Chest Tuberculosis Hospital (BCH) between June to December 2016 were recruited to participate in the study. Only patients (n= 69) with normal hearing thresholds (i.e., pure tone average (PTA) at 500 Hz, 1 kHz and 2 kHz ≤ 25 dB HL) at baseline and age 18 – 55 years were included. Patients who were receiving two aminoglycosides, were retreatment patients or had active middle ear (ME) pathology were excluded from this study. Participants were sampled via a purposive sampling strategy. All audiological testing was performed in a sound-treated booth and participants underwent the following types of assessment; baseline, periodic monitoring, and diagnostic assessment (when indicated). The following tests were performed at baseline: case history, otoscopy (OT), tympanometry (TYMP), conventional pure tone audiometry (cPTA) including air conduction (AC) and bone conduction (BC), and ultra-high frequency audiometry (UHFA). Follow-up monitoring assessment occurred monthly if there was no significant change in hearing thresholds, and biweekly if an STS was detected. The ASHA criteria were used to determine STS. The degree of hearing loss was described as mild, moderate, moderately-severe, severe or profound and the type of hearing loss was either conductive, sensorineural, or mixed. Both descriptive and inferential (Chi-squared, Mann-Whitney U and Kruskal-Wallis) statistical tests were used for data analysis. Results: A total of sixty-nine (69) patients who were undergoing treatment for RR/MDR-TB were recruited to participate in this study. Five participants dropped out of the study due to various reasons, therefore, leaving 64 participants in the study. There was 38 males and 26 females. The median age was 31 [range; 18 - 55] years old. An aminoglycoside-induced cochleotoxicity incidence of 90.6% (58/64) was found in this study. There were no statistically significant associations between the occurrence of STS and age (p = 0.487), sex (p = 0.329) and HIV status (p = 0.764). Three types of intervention strategies were used when a participant experienced an STS: (i) discontinue Kanamycin (Strategy A), (ii) modify the frequency of Kanamycin administration (Strategy B), (iii) and leave the regimen unchanged, i.e., no intervention (Strategy C). A smaller proportion of participants, 12 out of 33, experienced further deterioration of hearing thresholds after intervention strategy A (discontinue Kanamycin) was used, when compared to participants who underwent intervention strategies B and C, but the difference was not statistically significant (p = 0.056). Conclusion: This study found a high incidence of cochleotoxicity among patients receiving Kanamycin treatment for RR/MDR-TB. The results showed that discontinuing Kanamycin led to fewer participants developing further deterioration of hearing thresholds, although not statistically significant. There were no statistically significant associations between the occurrence of STS and age, sex, and HIV status. This study had some limitations; only cochlear hearing loss was investigated, participants were not followed up beyond six months, and genetic testing was not performed. Nonetheless, this study revealed that fewer participants had further significant threshold shifts after discontinuing Kanamycin, and for those patients who still receive regimens containing aminoglycosides, these findings are relevant.
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    Exploring the audiological management of young children (0-6 years) diagnosed with bacterial meningitis
    (2019) Tromp, Nikki; Ramma, Lebogang; Hlayisi, Vera-Genevey
    Background. Internationally, infectious diseases remain the greatest cause of morbidity among young children. Infectious disease burden is particularly high in low-to-mid income countries (LMIC). South Africa has a high prevalence of bacterial meningitis (BM), especially in children under the age of five. BM is also one of the commonest causes of acquired hearing loss in children. Given the fluctuating and transient nature of BM-related hearing loss, there is a need for an effective audiological protocol to facilitate timeous and appropriate audiological management. There is currently no universally accepted protocol for the audiological referral and management of children diagnosed with BM. Consequently, there is a need for an evidence-based protocol that will ensure timely referral and audiological testing of all children diagnosed with BM. Early identification of BM-related hearing loss in children will allow for timeous, appropriate audiological management and associated benefits, such as an option for placement in mainstream schooling. Objectives. This study aimed to explore the audiological management of children diagnosed with BM at a tertiary hospital in the Western Cape, South Africa, with reference to: patterns of referral for audiological assessment following a diagnosis of BM; current audiological protocols for the management of children diagnosed with BM. It was anticipated that this study would generate evidence that could potentially be used to develop appropriate protocols for the audiological management of children diagnosed with BM in LMICs, specifically South Africa. Methods. A retrospective record review was conducted using patient folders of children between 0 and 6 years who were treated for BM between May 2016 and May 2018. Data collection took place at Red Cross War Memorial Children's Hospital, which has a paediatric infectious diseases unit and an audiology department. Demographic and audiological data were recorded on a self-developed data abstraction form and data were analysed descriptively. Results. A total of 291 patient folders were accessed for review in this study. Of those, 40 (13.7%) met the inclusion criteria for the study and were selected for review. The majority of excluded folders were for patients not referred for audiological testing post-BM diagnosis. For those children referred to audiology, average referral time was 15 days (SD = 24 days) and each patient attended an average of only 2 audiology appointments. Otoacoustic emissions testing and tympanometry were the most commonly performed audiological tests in all children. BM-related hearing loss developed in 2/19 of these patients. All patients who were diagnosed with BM-related hearing loss were subsequently fitted with hearing aids – one of whom was fitted unilaterally with a hearing aid and the other, a cochlear implant candidate, was lost to follow-up. Conclusions. The key challenge experienced in this study was low referral rates to audiology (16%), which was followed by poor adherence to follow-up appointments – both of which were found to impede effective audiological management. Effective management and prevention of BM-related hearing loss pose challenges in LMICs. This study highlights the need for a well-defined referral pathway and an evidence-based protocol for the audiological management of children with BM within the South African health care setting. If this could be achieved, the early identification of hearing loss in these children has the potential to provide them with developmental, scholastic, and working opportunities in line with those of children with normal hearing.
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    Factors that influence the utilisation of ototoxicity monitoring services for patients on treatment for drug-resistant tuberculosis
    (2015) Nhokwara, Primrose Tinashe; Rogers, Christine; Ramma, Lebogang
    Multi-drug resistance is increasingly becoming a challenge to tuberculosis control programmes globally. Treatment of multi-drug resistance tuberculosis (MDR-TB) includes aminoglycoside antibiotics which are known to cause hearing loss. Ototoxicity monitoring services are often provided to patients undergoing treatment for MDR-TB for early detection of ototoxic hearing loss to facilitate alerting the patients and relevant medical staff about the presence and progression of any hearing loss. Previously, models of managing patients with MDR-TB required mandatory hospitalization for at least 6 months. This made it relatively easy to monitor the hearing status of patients during their stay in the hospital. However, with recent introduction of policy guidelines that support management of patients with MDR-TB on an outpatients basis, ototoxicity monitoring for these patients will need to be reorganized to align with the new policy guidelines. The extent of the uptake of these services when patients are accessing them as outpatients is however, unknown. This study therefore aimed to describe the patterns of utilisation and explore the barriers and factors that facilitate the use of ototoxicity monitoring services when provided on an outpatient basis in the Cape Town Metropolitan area, Western Cape, South Africa.
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    Genetic and pharmacokinetics factors associated with susceptibility to kanamycin induced cochleotoxicity in a cohort of patients undergoing MDR/RR-TB treatment
    (2023) Ghafari, Nazanin; Ramma, Lebogang
    South Africa is one of the countries with a high incidence of multidrug-resistant tuberculosis (MDR-TB) and rifampicin resistance tuberculosis (RR-TB). The standard MDR/RR-TB regimen prescribed in South Africa, at the time of the present study included Kanamycin, an aminoglycoside with a known cochleotoxic effect. Although kanamycin has recently been removed from the WHO MDR/RR-TB regimen, amikacin, another aminoglycoside derived from kanamycin, with similar structure and cochleotoxic side effects, has remained as part of the regimen for MDR/RR-TB patients with limited treatment options. In addition, some countries (e.g. India and Nigeria) have not completely removed kanamycin from their treatment regimen for MDR/RR-TB. Research has shown that genetic factors and factors affecting the pharmacokinetic of the drug could potentially be useful in identifying those who may be at a higher risk of aminoglycoside-induced cochleotoxicity. However, not much is known about the pharmacokinetics of Kanamycin and there is currently limited research available on the role of mutations involved in aminoglycoside-induced cochleotoxicity in South Africa. Therefore, this study aimed to determine: (1) the incidence of cochleotoxicity in MDR/RR-TB patients who are receiving kanamycin, (2) the pharmacokinetic properties of kanamycin that are associated with increased risk of cochleotoxicity, and (3) the association between participant's susceptibility to develop cochleotoxicity and two potentially pathogenic mitochondrial mutations (T15312C (I189T in MT-CYB) and T10114C (I19T in MT-ND3)). The current study used a prospective cohort design. A total of 102 patients (median age was 34.9 years) on kanamycin-based MDR/RR-TB treatment participated in this study. The study site was the Metro Tuberculosis Hospital Centre, Cape Town. The majority of the participants were males (n = 58, 56.9%,). Sixty five (63.7%) participants were HIVpositive, and 24 (23.5%) had been treated for MDR/RR-TB previously. Participants' hearing thresholds (0.25 to16kHz) were prospectively monitored for cochleotoxicity at the start of their treatment (baseline), and at 4, 8 and 12 weeks. The American SpeechLanguage- Hearing Association criteria (ASHA, 1994) were used to identify significant threshold shift (STS). Kanamycin concentrations were determined using liquid chromatography tandem mass spectrometry (LC-MS/MS), at steady-state in serial plasma samples over 10 hours. The T15312C (I189T in MT-CYB) and T10114C (I19T in MTND3) mutations was detected using PCR, ABI PRISM® 3130xl Genetic Analyser and UniPro UGene. The results of the study revealed 82% (n = 84) of participants developed cochleotoxicity. The duration of treatment with kanamycin was associated with cochleotoxicity with a 120% and 220% increase in incidence of cochleotoxicity from week four of treatment to week eight and week 12 of treatment, respectively. Kanamycin exposure was significantly associated with cochleotoxicity with about 3% increased risk of hearing loss for every 10µg•hr/L increase in kanamycin AUC0-10. The statistical analysis of the relationship between cochleotoxicity and two potentially pathogenic mutations, T15312C and T10114C, was not possible due to the low frequency of these mutations in the sample size. However, T15312C and T10114C were detected in 4.5% and 6%, respectively. Based on the MAF cut-off of 0.01 (1%), they are considered as common mutations. In addition, as T15312C and T10114C were just detected among participants who developed cochleotoxicity and not those who did not, they may be potentially pathogenic. However, since the presence of the known mutations associated with aminoglycoside-induced hearing loss in participants who carry T15312C and T10114C mutations had not been 17 investigated, it was not possible to draw a definite conclusion about the pathogenicity of T15312C and T10114C. The results of the current study indicate that: (1) a high incidence of cochleotoxicity was detected among MDR/RR-TB patients receiving kanamycin, (2) the longer duration of treatment with kanamycin was associated with higher risk of cochleotoxicity, (3) higher Kanamycin AUC0-10 was strongly associated with an increased incidence of cochleotoxicity, and (4) the T15312C and T10114C were common mutations in South African MDR/RR-TB patients who participated in this study and they may be potentially pathogenic for cochleotoxicity, and that should be assessed in future studies. This study recommends that aminoglycoside-sparing regimens should be used for MDR/RR-TB patients. A routine ototoxic monitoring programme (at least once a month) including ultra-high frequency audiometry should be implemented for MDR/RR-TB patients who receive aminoglycosides, from the time of ototoxic drug exposure until six months post treatment. Therapeutic drug monitoring should be implemented for all the MDR/RR-TB patients on aminoglycosides and AUC value should be used for clinical decision making to reduce the risk of cochleotoxicity. Screening for the known mutations that contribute to the risk of cochleotoxicity, prior to the start of aminoglycoside therapy is recommended to lower the incidence of aminoglycoside induced hearing loss, especially in countries such as South Africa with a high incidence of MDR/RR-TB.
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    How can Speech Language Therapists and Audiologists enhance language and literacy outcomes in South Africa? (And why we urgently need to)
    (AOSIS, 2011) Kathard, Harsha; Ramma, Lebogang; Pascoe, Michelle; Jordaan, Heila; Moonsamy, Sharon; Wium, Anna-Marie; Du Plessis, Sandra; Pottas, Lidia; Khan, Nasim Banu
    Basic education in South Africa faces a crisis as learners fail to achieve the necessary outcomes in the related areas of language and literacy. The aims of this paper are twofold. Firstly, we aim to describe and discuss the education crisis by outlining the educational landscape, relevant policy imperatives and implementation challenges in post-apartheid education. The systemic factors contributing to the literacy crisis are emphasised. Secondly, we argue that speech language therapists and audiologists (SLTAs) have a role to play in supporting basic education in South Africa through developing language and literacy. It is suggested that the professions of speech-language pathology and audiology must be socially responsive and population-focused in order to make meaningful contributions to development in South Africa. The potential roles of SLTAs are discussed with suggestions for further actions required by the professions to enable a contextually relevant practice in a resource-constrained environment.
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    How do children at special schools and their parents perceive their HRQoL compared to children at open schools?
    (2010-07-21) Jelsma, Jennifer; Ramma, Lebogang
    Background: There has been some debate in the past as to who should determine values for different health states for economic evaluation. The aim of this study was to compare the Health Related Quality of Life (HRQoL) in children attending open schools (OS) and children with disabilities attending a special school (SS) and their parents in Cape Town South Africa. Methods: The EQ-5D-Y and a proxy version were administered to the children and their parents were requested to fill in the EQ-5D-Y proxy version without consultation with their children on the same day. Results: A response rate of over 20% resulted in 567 sets of child/adult responses from OS children and 61 responses from SS children. Children with special needs reported more problems in the "Mobility" and "Looking after myself" domains but their scores with regard to "Doing usual activities", "Pain or discomfort" and "Worried, sad or unhappy" were similar to their typically developing counterparts. The mean Visual Analogue Scale (VAS) score of SS children was (88.4, SD18.3, range 40-100) which was not different to the mean score of the OS respondents (87.9, SD16.5, range 5-100). The association between adult and child scores was fair to moderate in the domains. The correlations in VAS scores between Open Schools children and female care-givers' scores significant but low (r = .33, p < .001) and insignificant between Special School children and adult (r = .16, p = .24). Discussion: It would appear that children with disabilities do not perceive their HRQoL to be worse than their able bodied counterparts, although they do recognise their limitations in the domains of "Mobility" and "Doing usual activities". Conclusions: This finding lends weight to the argument that valuation of health states by children affected by these health states should not be included for the purpose of economic analysis as the child's resilience might result in better values for health states and possibly a correspondingly smaller resource allocation. Conversely, if HRQoL is to be used as a clinical outcome, then it is preferable to include the children's values as proxy report does not appear to be highly correlated with the child's own perceptions.
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    Influence of the child’s perceived general health on the primary caregiver’s health status
    (BioMed Central, 2018-01-10) Verstraete, Janine; Ramma, Lebogang; Jelsma, Jennifer
    Background: In estimating the impact of an intervention, ignoring the effect of improving the health of one member of the caregiver/child dyad on the Health Related Quality of Life (HRQoL) of the other member may lead to an underestimation of the utility gained. This may be particularly true for infants/young children and their caregivers. The aim of this study was to quantify the interaction between the child’s perceived general health as assessed by the newly developed Toddler and Infant Questionnaire (TANDI) on the reporting of the caregiver’s own HRQoL as assessed by the EQ-5D-3 L. Methods: A sample of 187 caregivers participated. A total of 60 caregivers of acutely-ill (AI) and 60 caregivers of chronically-ill (CI) children were recruited from a children’s hospital. The 67 caregivers of general population (GP) children were recruited at a pre-school. Each caregiver completed the proxy rating of their child’s HRQoL on the TANDI (The TANDI is an experimental HRQoL instrument, modelled on the EQ-5D-Y proxy, for children aged 1-36 months), which comprises of six dimensions of health and a rating of general health on a Visual Analogue Scale (VAS). The caregiver completed the EQ-5D-3 L, a self-report measure of their own HRQoL. Forward stepwise regression models were developed with 1) the VAS score of the caregiver and 2) the VAS score of the child as dependent variables. The independent variables for the caregiver included dummy variables for the presence or absence of problems on the EQ-5D-3 L and the VAS score of the child. The independent variables for the child included dummy variables for each TANDI dimension and the VAS of the caregiver. Results: The TANDI results indicated that in five of the six dimensions AI children had more problems than the other two groups and the GP children were reported to have a significantly higher VAS than the other two groups. The child’s VAS was significantly correlated with the caregiver’s VAS in all groups, but most strongly in the AI group. The preference based scores (using the UK TTO tariff) were only correlated in the AI group. The inclusion of the child’s VAS increased the variance accounted for 11% of the VAS score of the caregiver. Anxiety and depression was the only dimension which accounted for more variance (18%). Similarly the perceived health state, VAS of the caregiver accounted for 14% of the variance in the child’s VAS, second only to problems with play (25%). Conclusion: There does indeed appear to be a strong relationship between the VAS scores of the children and their caregivers. The perceived general health of the child influences the caregivers reporting of their general health, more than their own report of experiencing pain or discomfort or problems with mobility. Thus, improving the HRQoL of the very young child may improve the caregiver’s HRQoL as well. Conversely, if the caregiver has a lower perceived HRQoL this may result in a decrement in the reported VAS of the child, independent of the presence or absence of problems in the different dimensions. This improvement is not currently captured by Cost Utility Analysis (CUA). It is recommended that future research investigates this effect with regards to CUA calculations.
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    Item generation for a proxy health related quality of life measure in very young children
    (2020-01-14) Verstraete, Janine; Ramma, Lebogang; Jelsma, Jennifer
    Abstract Background and aims Very young children have a relatively high prevalence of morbidity and mortality. Health care and supportive technology has improved but may require difficult choices and decisions regarding the allocation of these resources in this age group. Cost-effective analysis (CEA) can inform these decisions and thus measurement of Health-Related Quality of Life (HRQoL) is becoming increasingly important. However, the components of HRQoL are likely to be specific to infants and young children. This study aimed to develop a bank of items to inform the possible development of a new proxy report instrument. Methods A review of the literature was done to define the concepts, generate items and identify measures that might be an appropriate starting point of reference. The items generated from the cognitive interviews and systematic review were subsequently pruned by experts in the field of HRQoL and paediatrics over two rounds of a Delphi study. Results Based on the input from the different sources, the greatest need for a new HRQoL measure was in the 0–3-year age group. The item pool identified from the literature consisted of 36 items which was increased to 53 items after the cognitive interviews. The ranking of items from the first round of the Delphi study pruned this pool to 28 items for consideration. The experts further reduced this pool to 15 items for consideration in the second round. The experts also recommended that items could be merged due to their similar nature or construct. This process allowed for further reduction of items to 11 items which showed content validity and no redundancy. Conclusion The need for an instrument to measure appropriate aspects of HRQoL in infants and young children became apparent as items included in existing measures did not cover the required spectrum. The identification of the final items was based on a sound conceptual model, acceptability to stakeholders and consideration of the observability of the item selected. The pruned item bank of 11 items needs to be subject to further testing with the target population to ensure validity and reliability before a new measure can be developed.
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    The development of an English Health-Related Quality of Life (HRQoL) measure for very young children, to be completed by proxy
    (2018) Verstraete, Janine; Jelsma, Jennifer; Ramma, Lebogang
    Background and Aims: There is an increasing awareness that, in order to monitor health outcomes both mortality and morbidity need to be assessed. A common metric used to measure morbidity and functional limitation is the quality adjusted life year or QALY, which incorporates time spent in a health condition and Health-Related Quality of Life (HRQoL) into the measure. This is of increasing importance in Low Income Countries (LIC) where programmes have been adopted and implemented to address the high burden of child mortality. The ‘first 1000 days’ is one such initiative which has been adopted by the WHO to improve nutritional support, health care and social support for both the mother and child. One of the aims is to improve quality of life during this vulnerable period. As there is currently no appropriate measure of HRQoL in this age group, we set out to develop a valid and reliable, HRQoL instrument for children from 1 month to 3 years old, amenable to the elicitation of preference weights. Methods: The new HRQoL instrument, HRQoL-6D-IT, was based firstly on a mapping review of HRQoL measures for children. The next stage involved eliciting options through cognitive review from caregivers of very young children regarding HRQoL dimensions included in the EQ-5D-Y an existing validated HRQoL measure for older children. The care-givers were requested to identify items to be considered for inclusion, the wording and layout of the new measure. The item pool generated from the literature reviews and cognitive interviews were then assessed through a Delphi study with experts in the field. These items were further reduced through subsequent testing of items and retesting of a preliminary measure. The final items on the HRQoL-6D-IT included: movement, play, pain, relationships, communication and eating and, apart from pain, the descriptors referenced the behaviour of the child to age appropriate behaviour. The HRQoL-6D-IT was then tested for validity and reliability in a group of acutely-ill (AI), chronically-ill (CI) and typically developing (TD) children in two provinces in South Africa: Western and Eastern Cape. Results: The methodology used to identify candidate items was rigorous and yielded items which were developed to be observable with dimension descriptors referring to ‘age appropriate behaviour’. Caregivers were able to reliably report on HRQoL of their very young children from age 1-36 months. The content validity had been established during the development of the instrument. Concurrent validity of the different items (dimensions) was tested between the HRQoL-6D-IT and relevant items from the ASQ, FLACC and NIPS pain scale and Diet History.
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    Open Access
    The efficacy of strategies used to minimise and prevent cisplatin ototoxicity in patients
    (2018) Chakara, Zenzo Stanford; Ramma, Lebogang
    This study aimed to evaluate the efficacy of different treatment modifications used to prevent or minimise hearing loss during Cisplatin-based chemotherapy as part of patient management at Groote Schuur Hospital. The study also sought to compare different ototoxicity grading criteria; namely the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 (CTCAE v4) and TUNE criteria, with respect to early identification of changes in the patient’s hearing thresholds following treatment with ototoxic drugs as well as ability to guide recommendations for aural rehabilitation including hearing amplification. Background Non-communicable diseases (NCD) (including cancer, diabetes, cardiovascular and chronic respiratory diseases) are responsible for an estimated 36 million deaths annually across the world. Approximately 80 % of these deaths occur in developing countries. Cancer, the NCD of interest in this study, causes an estimated 8.2 million deaths per year, globally and about 70 % of these occur in developing countries. In South Africa, cancer is estimated to cause approximately 40 000 deaths per annum, which is more than the number of deaths caused by a combination of HIV/AIDS, TB and malaria every year. Cisplatin is the most common and effective anti-cancer drug for most types of cancers. However, it is also associated with severe adverse effects, including hearing loss. Cisplatin-induced hearing loss is usually bilateral, highfrequency sensorineural hearing loss and is permanent. Cisplatin-induced hearing loss can lead to communication difficulties, lack of participation, loss of employment and social isolation. This decreases patients’ quality of life. Prevention of ototoxicity relies on serial audiologic monitoring to detect any significant change in patients’ hearing thresholds that may be resulting from chemotherapy treatment. When a deterioration in the patient’s hearing thresholds is detected, treating physician(s) can decide on whether to modify the patient’s treatment to prevent further deterioration of hearing or not. Some of the common treatment modifications used by physicians include; reducing the drug dose administered to the patient, changing from Cisplatin to a less ototoxic drug such as Carboplatin or keeping a patient on Cisplatin only regimen (no treatment modification). However, there is 8 currently lack of research evidence that document the effectiveness of these treatment modifications with respect to preservation of the patient’s hearing thresholds. Also, given that there are several ototoxicity grading scales available that can be used to grade severity of ototoxicity-induced hearing loss, there is currently a lack of uniformity regarding communication of the severity of hearing loss across different professionals. There is a need to identify or develop an ototoxicity grading criterion which can be adopted by different professionals to communicate results during ototoxicity monitoring of patients. Research design This study employed a descriptive, quantitative retrospective cohort design. Medical folders of patients who underwent cisplatin chemotherapy treatment and had their hearing thresholds monitored at Groote Schuur Hospital during from 2011 up to 2016 were reviewed. Methods A non-probability, convenience sampling method was used to select medical folders that underwent review. Data which were extracted from the patients’ medical folders includes demographic information (for example age and sex,), chemotherapy treatment information including type and dose of treatment; and audiological information including baseline, checkup and exit audiogram thresholds. Data obtained from the folders were analysed using R, a software environment for statistical computing and graphics. Descriptive statistics and the following inferential statistical tests, Chi-squared, Fisher’s exact tests and the Wilcoxon signed-rank test for paired samples, were used to determine significant associations between hearing loss and several factors revealed in the data. The American Speech-Language and Hearing (ASHA, 1994) criteria were used to determined incidence of significant threshold shift whilst the CTCAE v4 was used to determine both incidence of hearing loss and severity of the loss. The CTCAE v4 and TUNE criteria were compared based on incidence of hearing and ability to predict need for hearing amplification Results A total of 128 medical folders met inclusion criteria for this study and the following were the patient characteristics; median age = 43 years (range: 18 – 75 years); 92 males, 36 females; average length on treatment: 13.45 weeks). Out of these, 64 had information on the type and dose information of chemotherapy drug used during the period when monitoring of ototoxicity was conducted. The American Speech-Language and Hearing (ASHA) criteria revealed 9 ototoxicity in 74.2 % (95/128) of the sample. The Wilcoxon signed-rank test for paired samples showed a significant difference (p = 0.0000000039, p < 0.05) between follow-up and exit monitoring thresholds which indicated a significant decline of patients’ hearing thresholds throughout the treatment duration. There were no statistically significant associations between age, duration of treatment and treatment modification. The study showed three treatment modifications which included dose adjustment (reduction), switching drug and continuing with the same drug. There was no significant association between treatment modifications and hearing loss. The CTCAEv4 criteria identified more people (53.9 %) who experienced a deterioration in their hearing thresholds than TUNE criteria (41.7%). However, TUNE performed better with respect to identifying patients who are likely to be candidates for further audiological rehabilitation including hearing amplification. Conclusion This study found a high incidence of cisplatin-induced hearing loss despite the possible modification of treatment. This shows that current strategies that are used by physicians at GSH Radiation Oncology department to prevent or minimize further deterioration of the patient’s hearing thresholds during cisplatin chemotherapy can arguably be rendered ineffective. This is owing to the inability of conventional audiometry to detect hearing loss before it affects the speech frequencies. There was no significant association between hearing loss and age, dose, duration of treatment and treatment modification. The study also showed that CTCAE v4 grading criteria detected a higher incidence of ototoxicity than the TUNE criteria. However, the TUNE criteria were better at detecting the number of patients who need further audiological rehabilitation than the CTCAE v4. Therefore, both scales have their strengths and weaknesses. Implications of the study include the incorporation of Extended High Frequency Audiometry (EHF) and Distortion Product Otoacoustic Emission (DPOAE) testing into the monitoring protocol where possible to allow for early detection and intervention of ototoxicity. Incorporation of otoprotectors into the prevention protocol is suggested as they have recently shown otoprotective efficacy in animal models without interrupting Cisplatin’s therapeutic agency. Finally, more studies are required to validate the TUNE grading criteria to explore its utility as an ototoxicity grading criterion that can be universally used to communicate ototoxicity outcomes during Cisplatin chemotherapy.