Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India.
<h4>Background</h4>The World Health Organization recommends direct observation of treatment (DOT) to support patients with tuberculosis (TB) and to ensure treatment completion. As per national programme guidelines in India, a DOT provider can be anyone who is acceptable and accessible to...
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Public Library of Science (PLoS)
2016-01-01
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| Online Access: | https://doi.org/10.1371/journal.pone.0148488 |
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| author | Paresh Vamanrao Dave Amar Niranjan Shah Pankaj B Nimavat Bhavesh B Modi Kirit R Pujara Pradip Patel Keshabhai Mehariya Kiran Vaman Rade Soma Shekar Kuldeep S Sachdeva John E Oeltmann Ajay M V Kumar |
| author_facet | Paresh Vamanrao Dave Amar Niranjan Shah Pankaj B Nimavat Bhavesh B Modi Kirit R Pujara Pradip Patel Keshabhai Mehariya Kiran Vaman Rade Soma Shekar Kuldeep S Sachdeva John E Oeltmann Ajay M V Kumar |
| author_sort | Paresh Vamanrao Dave |
| collection | DOAJ |
| description | <h4>Background</h4>The World Health Organization recommends direct observation of treatment (DOT) to support patients with tuberculosis (TB) and to ensure treatment completion. As per national programme guidelines in India, a DOT provider can be anyone who is acceptable and accessible to the patient and accountable to the health system, except a family member. This poses challenges among children with TB who may be more comfortable receiving medicines from their parents or family members than from unfamiliar DOT providers. We conducted a non-inferiority trial to assess the effect of family DOT on treatment success rates among children with newly diagnosed TB registered for treatment during June-September 2012.<h4>Methods</h4>We randomly assigned all districts (n = 30) in Gujarat to the intervention (n = 15) or usual-practice group (n = 15). Adult family members in the intervention districts were given the choice to become their child's DOT provider. DOT was provided by a non-family member in the usual-practice districts. Using routinely collected clinic-based TB treatment cards, we compared treatment success rates (cured and treatment completed) between the two groups and the non-inferiority limit was kept at 5%.<h4>Results</h4>Of 624 children with newly diagnosed TB, 359 (58%) were from intervention districts and 265 (42%) were from usual-practice districts. The two groups were similar with respect to baseline characteristics including age, sex, type of TB, and initial body weight. The treatment success rates were 344 (95.8%) and 247 (93.2%) (p = 0.11) among the intervention and usual-practice groups respectively.<h4>Conclusion</h4>DOT provided by a family member is not inferior to DOT provided by a non-family member among new TB cases in children and can attain international targets for treatment success.<h4>Trial registration</h4>Clinical Trials Registry-India, National Institute of Medical Statistics (Indian Council of Medical Research) CTRI/2015/09/006229. |
| format | Article |
| id | doaj-art-ee7f353323144ecc877d5038c2ed300e |
| institution | Kabale University |
| issn | 1932-6203 |
| language | English |
| publishDate | 2016-01-01 |
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| series | PLoS ONE |
| spelling | doaj-art-ee7f353323144ecc877d5038c2ed300e2025-08-20T03:46:12ZengPublic Library of Science (PLoS)PLoS ONE1932-62032016-01-01112e014848810.1371/journal.pone.0148488Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India.Paresh Vamanrao DaveAmar Niranjan ShahPankaj B NimavatBhavesh B ModiKirit R PujaraPradip PatelKeshabhai MehariyaKiran Vaman RadeSoma ShekarKuldeep S SachdevaJohn E OeltmannAjay M V Kumar<h4>Background</h4>The World Health Organization recommends direct observation of treatment (DOT) to support patients with tuberculosis (TB) and to ensure treatment completion. As per national programme guidelines in India, a DOT provider can be anyone who is acceptable and accessible to the patient and accountable to the health system, except a family member. This poses challenges among children with TB who may be more comfortable receiving medicines from their parents or family members than from unfamiliar DOT providers. We conducted a non-inferiority trial to assess the effect of family DOT on treatment success rates among children with newly diagnosed TB registered for treatment during June-September 2012.<h4>Methods</h4>We randomly assigned all districts (n = 30) in Gujarat to the intervention (n = 15) or usual-practice group (n = 15). Adult family members in the intervention districts were given the choice to become their child's DOT provider. DOT was provided by a non-family member in the usual-practice districts. Using routinely collected clinic-based TB treatment cards, we compared treatment success rates (cured and treatment completed) between the two groups and the non-inferiority limit was kept at 5%.<h4>Results</h4>Of 624 children with newly diagnosed TB, 359 (58%) were from intervention districts and 265 (42%) were from usual-practice districts. The two groups were similar with respect to baseline characteristics including age, sex, type of TB, and initial body weight. The treatment success rates were 344 (95.8%) and 247 (93.2%) (p = 0.11) among the intervention and usual-practice groups respectively.<h4>Conclusion</h4>DOT provided by a family member is not inferior to DOT provided by a non-family member among new TB cases in children and can attain international targets for treatment success.<h4>Trial registration</h4>Clinical Trials Registry-India, National Institute of Medical Statistics (Indian Council of Medical Research) CTRI/2015/09/006229.https://doi.org/10.1371/journal.pone.0148488 |
| spellingShingle | Paresh Vamanrao Dave Amar Niranjan Shah Pankaj B Nimavat Bhavesh B Modi Kirit R Pujara Pradip Patel Keshabhai Mehariya Kiran Vaman Rade Soma Shekar Kuldeep S Sachdeva John E Oeltmann Ajay M V Kumar Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India. PLoS ONE |
| title | Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India. |
| title_full | Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India. |
| title_fullStr | Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India. |
| title_full_unstemmed | Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India. |
| title_short | Direct Observation of Treatment Provided by a Family Member as Compared to Non-Family Member among Children with New Tuberculosis: A Pragmatic, Non-Inferiority, Cluster-Randomized Trial in Gujarat, India. |
| title_sort | direct observation of treatment provided by a family member as compared to non family member among children with new tuberculosis a pragmatic non inferiority cluster randomized trial in gujarat india |
| url | https://doi.org/10.1371/journal.pone.0148488 |
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