Planificar la respuesta a los riesgos

Participants had to meet specific selection criteria for inclusion in the study (See Table 5.1 for inclusion criteria and Table 5.2 for exclusion criteria). Previously, the study coordinator obtained consent to assess whether they fit the criteria (Appendix C). The study coordinator determined these inclusion criteria, who was a professional nurse. She

determined whether the participants met the inclusion and exclusion criteria. The criteria, justifications, and method for choosing and ensuring the inclusion and exclusion criteria can be seen below.

Table 5.1

Inclusion Criteria of participants in the sample

Criteria Justification Method

Both male and female participants

Male and females have shown to display slight differences in hearing, specifically in the high frequencies where the male population displays poorer hearing (4 kHz to 8 kHz)

(Osterhammel & Osterhammel, 1978). Gender differences have also been shown to affect otoacoustic emission (OAE) results, with regards to phase delay (Bowman, Brown & Kimberley, 2000).

Both genders were considered for the study. At SRH,

recruitment took place from both the male and female wards.

Both HIV-positive and HIV-negative patients.

HIV can cause opportunistic infections and neural disturbances that may place participants at greater risks for hearing loss (Friedmann & Arnold, 1993).

However, excluding participants based on HIV status would have reduced the sample size, due to the high HIV prevalence within the DR-TB population.

The patient’s HIV status was detailed in the consent procedure where participants were informed about the criteria, and the necessity of the researcher to know their HIV status; whether they were positive or negative.

As per the NDoH (2011) guidelines, all HIV infected patients who are not on ARV therapy should be initiated on this treatment once drug-resistant TB is diagnosed. This was done accordingly.

Consent to HIV test (if one not already present)

If participants did not have a documented HIV test, they were requested to consent to an HIV test. This was a requirement of the study and thus conducted in the screening procedures. If

When their HIV status was not available, and consent was given, HIV testing, counselling and initiation of treatment was done according to NDoH protocols.

Criteria Justification Method they did not wish to consent, they were not included in the

study.

Written informed consent

Consent forms part of ethical practice for clinical research (SA GCP, 2006).

This was done according to the South African Good Clinical Practice guidelines (SA GCP, 2006).

Patients treated at HJH and SRH and anticipated to return for treatment for three months.

As HJH and SRH are two of the main sites of DR-TB treatment in Johannesburg, they were chosen.

The study coordinator was in constant communication with the nursing staff involved in new intake of all new intake patients at these hospitals to ensure enrolment when possible

Patients who were

As the study was investigating the injectables, those patients on kanamycin or capreomycin were included.

The treatment plan and specific injectable were discussed by the study coordinator with the doctor prior to enrolment, to ensure that the participant was to be treated with either kanamycin or capreomycin.

Proficient in English, isiZulu or SeSotho

For informed consent to be carried out appropriately, the participants’ comprehension must be addressed. In South Africa, this must be conducted by using culturally accepted

The study coordinator obtained details regarding the

participant’s language of choice during the screening procedure.

Criteria Justification Method practices and the participant’s language of choice (SA GCP,

2006).

According to the South Africa Statistics in the 2011 Census in the provincial profile, English (20.1%), isiZulu (23.4%) and SeSotho (9.6%) were the top three spoken languages in Johannesburg (Stats SA, 2011).

Thus, proficiency in the top three languages was required for the study coordinator to be fluent.

She asked which language was the patient comfortable in and would prefer the discussion about the research to be in.

Between the ages of 18 to 55 years

Presbycusis usually presents in the fifth decade of life, generally above 55 years of age (Arvin, Prepageran & Raman, 2011).

As all participants were required to give informed consent to participate in the study, the minimum age of 18 years was selected as all adults are assumed to have the capacity to consent unless otherwise proven.

The participant’s date of birth was obtained during the

screening procedure. Identification documents were checked to confirm to date of birth.

Normal middle ear status at baseline as determined by otoscopy and tympanometry.

An abnormal Tympanogram can indicate middle ear dysfunction which could affect DPOAEs as well as PTA.

This is because OAEs cannot be conducted reliably as the presence of middle ear pathology results in severely diminished OAEs (Swanepoel et al., 2007).

Furthermore, a conductive hearing loss is often indicated by air conduction threshold that is worse than the bone conduction

Hearing screening was conducted once consent was obtained.

Screening measures included otoscopy, tympanometry, and PTA.

Normal middle ear status for this study was classified as:

• Type A tympanogram [ECV of 0.2 to 2.0 ml, SC of 0.2 to 1.8 ml; MEP of +50 to -100daPa (Jerger, 1975)],

Criteria Justification Method threshold. Conductive losses are associated with outer and

middle ear systems (Moore & Zouridakis, 2003).

• Type As with a slightly decreased static compliance, however, not yet flat compliance as with a Type B tympanogram (Martin & Clark, 2003) or a

• Type Ad with slightly increased static compliance.

Patients with Type B tympanograms (flat compliance) or Type C tympanograms (negative pressure) were excluded but were referred for medical management.

Participants who developed middle ear infection during the course of their treatment (and research) were not excluded.

Patients with no hearing loss of >70 dB at 3 or more frequencies bilaterally

Ototoxic hearing loss can vary in the degree of the loss. The audiometer can only record hearing loss up to 110 dBHL.

Should a severe hearing loss (70 dB) worsen by more than 40 dB, it cannot be recorded.

Any hearing loss with a lesser degree of severity at baseline would have a broader range to allow accurate measures.

Screening audiometry was conducted by the study coordinator to ensure the hearing was within these limits.

Table 5.2

Exclusion Criteria of participants in the sample

Criteria Justification Method

Diagnosis of Diabetes Mellitus

Diabetes Mellitus has shown to cause hearing impairment, and this would have impacted on the reliability of the results (Kakarlapudi et al., 2003).

Potential participants were asked if they had diabetes during the screening procedure. If they had diabetes, they were then excluded.

Limited language Proficiency in English, isiZulu and/or SeSotho

In order for informed consent to be carried out appropriately, the participants’ comprehension must be addressed. In South Africa, this must be conducted by using culturally accepted practices and the participant’s language of choice (SA GCP, 2006).

According to the South Africa Statistics in the 2011 Census in the Provincial Profile, English (20,1%), isiZulu (23.4%) and SeSotho (9.6%) were the top three spoken languages in Johannesburg (Stats SA, 2011).

Thus, proficiency in the top three languages was required for the study coordinator to be fluent.

The study coordinator obtained details regarding the

participant’s language of choice during the screening procedure.

She asked the language of preference and subsequently conducted the informed consent procedures in this language.

Should the language of preference not be either English, isiZulu or SeSotho, the potential participant was not included in the study.

Substance abuse is associated with poor medication adherence (Magura, Rosenblum & Fong, 2011). If the participant was not adherent to the DR-TB treatment regimen, it could have affected the outcomes of the study.

The study coordinator gauged this during the screening procedure.

She enquired regarding alcohol use, frequency, and type as well as substance abuse in the case history. The study coordinator had been involved in several drug trials previously and also used her experience to gauge this.

Criteria Justification Method

Aminoglycosides can stay in an individual’s system for six months and possibly cause ototoxicity (Mudd et al. 2016). As the focus of the study was capreomycin and kanamycin, possible effects of previous aminoglycoside toxicity needed to be excluded.

The study coordinator obtained a comprehensive medical history from potential participants which included previous treatment (See Screening Case Report forms in Appendix D). This was confirmed by reviewing the participants’ available medical records. Individuals who were treated with intravenous aminoglycosides and/or polypeptide within the last seven months were excluded from participation in the study.

Patients with hearing loss of >70 dB at three or more frequencies

bilaterally

Ototoxic hearing loss can vary in the degree of the loss. The audiometer can only record hearing loss up to 110 dBHL.

Should a severe hearing loss (70 dB) worsen by more than 40 dB, it cannot be recorded. This would thus have impacted the validity of the measures, as should the hearing loss progress even more than 40 dB; it could not have been documented with these audiometric measures.

The study coordinator conducted screening audiometry to ensure the hearing was not greater than 70 dB at three or more

frequencies bilaterally.