Question

Study objectives: To describe the epidemiology and clinical consequences of noncompliance with directly observed therapy (DOT) for treatment of tuberculosis.

Design: Retrospective review.

Setting: An urban tuberculosis control program that emphasizes DOT.

Patients: All patients treated with outpatient DOT from 1984 to 1994.

Measurements and results: We defined noncompliance as follows: (1) missing ≥2 consecutive weeks of DOT; (2) prolongation of treatment >30 days due to sporadic missed doses; or (3) incarceration for presenting a threat to public health. Poor outcomes of therapy were defined as a microbiologic or clinical failure of initial therapy, relapse, or death due to tuberculosis. Fifty-two of 294 patients (18%) who received outpatient DOT fulfilled one or more criteria for noncompliance. Using multivariate logistic regression, risk factors for noncompliance were alcohol abuse (odds ratio, 3.0; 95% confidence interval, 1.2 to 7.5; p=0.02) and homelessness (odds ratio, 3.2; 95% confidence interval, 1.5 to 7.2; p=0.004). Noncompliant patients had poor outcomes from the initial course of therapy more often than compliant patients: 17 of 52 (32.7%) vs 8 of 242 (3.3%); relative risk was 9.9; 95% confidence interval was 4.5 to 21.7 (p<0.001).

Conclusions: In an urban tuberculosis control program, noncompliance with DOT was common and was closely associated with alcoholism and homelessness. Noncompliance was associated with a 10-fold increase in the occurrence of poor outcomes from treatment and accounted for most treatment failures. Innovative programs are needed to deal with alcoholism and homelessness in patients with tuberculosis.

a. What is the sample? How big is n? From what larger population was this sample drawn? (1pt)

b. Is this manipulative or observational? What was the explanatory or predictor variable, and how many patients were in each grouping of this variable? (1pt)

Answer 1

a. Sample is the group of 294 patients who received outpatient DOT. Larger population was group of : All patients treated with outpatient DOT from 1984 to 1994.

b. This is observational study about clinical consequences of noncompliance with directly observed therapy (DOT) for treatment of tuberculosis. Explanatory variable is "Noncompliance". From given data, it is not possible to say how many patients were in each grouping of this variable, however total 52 patients were non-compliant.

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