Análisis comparativo de los resultados obtenidos

The following instruments were used to collect data: a pre-tested semi-structured interviewer- administered questionnaire, a stigma scale, the WHOQOL-BREF and the DR-12 instruments.

1. The semi-structured interviewer-administered questionnaire comprised five sections (see appendix 1):

i. Section A: Socio-demographic data such as information on age, gender, marital status, religious background, household size and type of family

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ii. Section B: Socio-economic data such as highest educational level, occupation, employment status, social class, dwelling status, transportation costs.

iii. Section C: Health-seeking behaviour of respondents including information on what type of health services are routinely utilised, duration between onset of symptoms and seeking care, type of facility chosen for TB care, reasons for delay in seeking treatment

iv. Section D: Knowledge and attitude of respondents to TB including source of information about TB, knowledge about TB prior to diagnosis, knowledge of mode of transmission and infection control practices and length of treatment

v. Section E: Medical and social history including information on alcohol consumption, smoking, HIV status and other relevant information.

vi. Section F: Patients perspectives on the effect of TB on social relationships such relationships with family members, friends and neighbours;

relationships at the workplace and their perception of the effect of TB social networks and their belief system.

2. Stigma Scale: The stigma scale used was the Van-Rie patient perspective toward tuberculosis. Ten items were assessed on the four-point Likert-type scale. The items relate to feelings such as fear, guilt and sorrow in coping with the disease. The options on the instrument were: strongly disagree, disagree, agree and strongly agree, which were coded as 0, 1, 2, and 3 respectively.⁴⁸

3. The World Health Organization Quality of Life Questionnaire-Short Version (WHOQOL-BREF) (see appendix 3): The WHOQOL-BREF was used to assess the HRQOL of the respondents. It is in a questionnaire form which has a 5-point

Likert-54

type scale. It consists of 26 items in four domains, namely the physical health domain the psychological well-being domain, the social relationships domain and the environment. The English and Yoruba version of the instrument were used¹²⁶. The first two questions are like summary questions asking about general satisfaction with life and health. The HRQOL of respondents were assessed in the following periods - at the beginning of treatment; after two months when the intensive phase was completed; and at 6 months

The interviewer-administered technique was used. Participants selected the number on the 5-point scale that best represented their opinion. The scale is positively ranged with 1 indicating low and negative perceptions, and 5 indicating the highest positive perception and a better quality of life score. Negatively worded items were reversed in scoring. The domain scores were computed and transformed to a score out of 100 as per WHO guidelines for scoring the scale. Mean scores were determined for each domain and the overall HRQOL. HRQOL was also classified as good or poor according to the instructions. Transformed scores in each domain corresponding to ≤ 50 were classified as poor while > 50 is considered good.⁷¹

4. TB- Specific DR -12 HRQOL Questionnaire: This is a tuberculosis-specific scale used to assess respondents’ rating of their health. The questionnaire was based on symptoms (score I), physiological, psychological, and social interaction of the patients (score II).The 12 items in the questionnaire evaluated three different dimensions of health:

symptoms associated with TB (for both PTB and EPTB) such as cough, haemoptysis, loss of appetite, loss of weight, fever, breathlessness and chest pain); life activities (such as interest in work, household activities, and exercise activities); social activities (such as emotional symptoms and social adaptability). Every item has a score from 0 to 3, based on a Likert scale.¹⁴²

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5. Illness- related factors: Information on illness-related factors such as Sputum AFB results, HIV status and radiographic findings was abstracted from patient records.

information was elicited from patients on adverse reactions to medication.

3.7.2 Clinical Evaluation

a. Height measurement

Measurements of the standing height (cm) were taken using a portable Leicester^© stadiometer graduated to the nearest 0.1cm. The subjects were asked to remove footwear. All hair ornaments were also removed, and subjects stood up straight against the backboard with both heels together, toes apart and feet flat on the platform. The head aligned in the Frankfort horizontal plane with the horizontal line from the ear canal to the lower border of the orbit of the eye parallel to the floor and perpendicular to the vertical backboard. The headpiece was pressed gently onto the head to ensure it was in contact with the head.

b. Weight measurement

Weight was taken using a Seca^© electronic weighing scale. Subjects were asked to remove their footwear and heavy clothing and stand on the centre of the platform with the weight evenly distributed between the feet. The subjects were asked to wait until the reading on the scale was stable. Weight was measured to the nearest 0.1kg. The weight was measured twice for each respondent and the average reading taken. The scale was standardized using known weights.

Body Mass Index (BMI) was calculated from the measurements of weight and height as ratio of subjects’ weight in kilograms and squared height in meters. The measurement obtained as well as the indices, were then used to classify the individuals according to the WHO (2002) Body Mass Index (BMI) cut-off values.

56 c. Spirometry

Lung function measurement was done using a hand-held electronic spirometer Spirobank^© (Medical International Research, Italy). The procedure was explained and demonstrated to the respondents before the measurement. The lung function parameters that were measured include forced expiratory volume in one Second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio. All lung function tests were carried out in the morning to minimise the effects of diurnal variation. The test was carried out by the investigator and a trained technician. Prior to the test, the date of birth, height and weight of each respondent was entered into the spirometer. The test was carried out with the respondents standing and a nose clip applied.

A Single-use one- way valve disposable mouthpieces and disposable turbines were used for all respondents. Proper hand-washing was ensured for both patients and personnel performing spirometry. Supervising staff, including the investigator also wore N95 face-masks.

3.7.3 Study procedure

a. Pre-test of the Questionnaire

The interviewer administered questionnaire was pre-tested for validity and reliability.

Cronbach alpha was used to assess internal validity of the tools. The pre-test was conducted in a facility and a community not included in the final study locations. The questionnaire was pre-tested on 20 adults with tuberculosis (facility level) and 20 adults from the community level (controls). The questionnaire was also translated into Yoruba language which was then back-translated into English by a person who had no prior knowledge of the original English version.

57 b. Data Collection

Appropriate permissions were obtained from the facilities where subjects were recruited.

Subjects were also recruited in the selected facilities once they were diagnosed as having Pulmonary tuberculosis, either through a Gene Xpert test that reported “Mycobacterium tuberculosis detected, not RIF-resistant”, two positive AFB sputum samples or a physician’s diagnosis. HIV tests were routinely conducted on all patients. The patients were informed about the study and referred for participation after giving an informed consent. Only subjects who gave consent were recruited.

At the baseline, each patient was interviewed using the tools described previously and had a pulmonary function test done in addition to the chest radiograph, sputum AFB and HIV test.

This phase was completed within two weeks of diagnosis. Patients completed the intensive phase at two months and completed the WHOQOL- BREF and DR-12 tool as well as evaluation for adherence and adverse reaction to medication. Spirometry was also conducted in addition to routine sputum investigation. This interview was within two weeks of completing the intensive phase.

The final phase was within a month after completing treatment. Subjects had spirometry done, while sputum AFB results were abstracted from patient records. The HRQOL was also assessed using the WHOQOL-BREF and DR-12. Patients with residual lung function deficits were referred to the Respiratory Medicine unit for further management and follow-up.

c. Training of research assistants

Four individuals were recruited as research assistants; two to administer questionnaires and two to conduct anthropometry and spirometry. The trained personnel had a minimum of post-secondary education. The two recruited to conduct spirometry were already conversant with the procedure having worked at a pulmonary function testing unit. They were however trained on the use of the hand-held spirometer used in this study. They all had background training on

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appropriate conduct during an interview session, conduct of one-on-one interviews, familiarization with the concept and use of the questionnaire soliciting case clinical information and ethics of research. There was also a trouble-shooting session with regards to using the questionnaire and sing the spirometer.

d. Conduct of study

Patient recruitment took place over a 12-month period that started in January 2016.

Recruitment of respondents were staggered at 3 months interval in each study site. The first two assessments would have been conducted before moving to another site. Patients were assessed at initiation within two weeks of diagnosis, within two weeks of completing the intensive phase and within two weeks of completing the continuous phase.