Evaluation of patient's experiences with daily DOTS

Background/aims: Past few decades have seen major revisions in the Tuberculosis (TB) control programs time and again with a goal to strengthen the delivery of services and achieve elimination of the disease. Daily Directly Observed Treatment, Short-course (DOTS) Fixed dose combination (FDC) was one such major leap and aimed to simplify the treatment regimen, reduce pill burden, avoid drug monotherapy, improve compliance, reduce chances of drug resistance, decrease stigma and make the treatment more patient friendly. We intended to study the impact and acceptance of this changed FDC daily DOTS at the grass root level. Clinical and microbiological parameters were also studied alongwith.

Methods: Prospective study was conducted in the Department of Pulmonary Medicine, Government Medical College and Hospital, Chandigarh from October, 2018 to October, 2020.138 sputum smear positive patients were enrolled at the time of initiation of treatment and studied till end of intensive phase (IP). Baseline socio-demographic and clinical details, any adverse drug reactions (ADR's), their subsequent management and sputum smear conversion at end IP were noted. Various patient and disease related factors were studied in relation to sputum smear conversion and ADR's. At end IP, experiences of the patients with the newly introduced daily regimen were assessed by using a structured questionnaire. The data was tabulated and statistically analyzed.

Results: Mean age of the patients was 39.31 ± 1.5 years. Majority were males, literate, married, employed, from urban background and moderately built. During IP, 59 (42.8%) patients experienced ADR's. 31/59 patients needed admission while 28/59 patients were managed on outpatient basis. 31/59 patients improved with symptomatic management, while 28/59 patients required change in anti tubercular drugs for a short period of time. All the patients were shifted back to FDC daily DOTS after a few days. Though 59 patients reported ADR's, only 44/59 patients missed their doses. Rest 15/59 patients continued with the treatment despite mild ADR's and reported for management without missing any dose. Follow-up smear at end IP was negative in 130/138 patients (94.2%). 93.5% patients preferred their family member as the DOTS provider. More than 90% of the patients were satisfied with basic provisions like treatment room privacy, cleanliness, safe drinking water and sign boards at DOTS centre. Satisfaction with the health care worker (HCW) (assessed by enquiring about the behavior of the HCW, explanation given about the disease and treatment, pre-treatment counseling, occurrence of ADR's, consequences of irregular treatment, warning signs for consultation, advise on nutrition requirement and follow-up information) was reported by 97.8% patients. Sputum conversion rates were significantly higher in unemployed (p = 0.043). Non-adherence to treatment was significantly associated with ADR's (p < 0.001). Sputum conversion rates and ADR's were unaffected by education, rural/urban background, BMI, co-morbidities, addiction and previous history of anti-tubercular treatment.

Conclusion: Daily DOTS achieved appreciable sputum conversion rates at end IP. Non-adherence to treatment and ADR's were managed well with adequate psychosocial support, counseling, timely monitoring and treatment. FDC daily DOTS emerged as a highly acceptable regimen owing to various comprehensive measures adopted at the grass root level.