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People Centered Tuberculosis Care Verses Standard Directly Observed Therapy : Study Protocol For A Cluster Randomized Controlled Trial

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People-Centered Tuberculosis Care Verses Standard Directly Observed Therapy: Study Protocol For a Cluster Randomized Controlled Trial
This study involved reviewed a program to determine the effectiveness of a program to control drug sensitive TB by improving the treatment adherence of patients. The study compared the results of a patient program involving education and counseling of the patient and family members followed by Text messages and phone calls to remind them to take medications and monitor treatment and side effects. This is compared to the WHO recommended treatment of requiring the patient to make daily visits to TB outpatient centers for drug administration.
Causality Criteria Criteria to Evaluate Studies …show more content…

Outcomes are classified as cured, completed treatment, dead, failed, defaulted, and transferred. Treatment is successful only if the outcome is cured. Secondary Outcomes include patient knowledge, depression status, and quality of life.
What was the Study Design:
The study was designed as an open-label, stratified cluster randomized controlled superiority trial with two parallel equal arms (intervention and control). TB outpatient centers defined the clusters, with equal numbers of clusters assigned to intervention and control arms.
What was the Study Population?
Drug-sensitive tuberculosis patients in the continuation phase of treatment in the intervention arm and their family members.
What was the Main Result?
Improvement in TB treatment strategies can have a significant public health and economic impact.

Internal Validity
Observation bias
Recall bias
Confounding
Chance Internal Validity (Non-Causal Factors)?
This is not relevant to the study as the study is observation of patients already infected and studies outcome results not infection methods.
Are the results likely to be affected by observation bias?
No, the results are self-reported by patients on questionnaires during interviews with medical staff.
Are results likely to be affected by recall bias?
Potentially. For the study group, taking medications was self-reported after text and phone call reminders, so no medical staff witnessed medication administration. Secondary outcomes such as

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