Victor Williams

94 Chapter 4 Data management Data sources and approach to data collection The data used for this study was from routine patient care. Data from patients at baseline, during follow-up visits (2nd and 5th months) and at the end of treatment were extracted from patient treatment cards and registers for analysis (Supplementary file 1). In addition, some sociodemographic variables that are not routinely collected at baseline (Education status – none/primary/secondary/tertiary; marital status – single/married/widowed; smoking – yes/no; alcohol – yes/no; family history of DM – yes/no) were also collected. One of the challenges observed at the health facilities that hindered access to blood glucose testing was the variable availability of glucometers and glucose test strips [23]. To mitigate this, we provided glucose meters (similar to that issued by MOH) and test strips to all the sites participating in the study during patient enrolment and follow-up. Healthcare workers at the TB clinic were already trained on using the glucometer, so there was no need for another training. At the commencement of the study, the different study sites were oriented on the research and provided with a logbook to document blood glucose and blood pressure measurements for patients at baseline, 2nd and 5th months. The Eswatini Ministry of Health requires all patients to have random blood glucose tests at baseline, months 2, 5 and at the end of treatment for screening purposes. Study variables Included study variables are broadly classified into baseline sociodemographic variables – region, age (<25, 25–34, 35–44, 45–54, ³55 years), sex, weight, height, educational status, marital status, occupation, smoking, drinking alcohol, and a family history of DM; baseline clinical variables – blood glucose measurement, systolic blood pressure (SBP) and diastolic blood pressure (DBP) (categorised into normal, elevated, high blood pressure (HBP) stage 1, high blood pressure (HBP) stage 2) and hypertensive crises) [24]; HIV status, comorbidities, date of TB diagnosis, type of TB, baseline GeneXpert, baseline culture, TB lam; and follow-up variables – blood glucose measurement, systolic blood pressure, diastolic blood pressure, sputum microscopy, GeneXpert, TB treatment outcome and date of TB treatment outcome. Blood glucose measurements were done at baseline, 2nd and 5th month using a glucometer. They were reclassified as normal (random <11.1mmol/l or fasting≤5.5mmol/l) or elevated (pre-DM: fasting >5.5 to 6.9 mmol/l or DM: random ≥11.1mmol/l or fasting ≥7.0 mmol/l) to enable a comparison of the proportion of patients with normal/elevated

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