Evaluation of the Informed Consent Process of a Multicenter Tuberculosis Treatment Trial.

BACKGROUND: Ethical principles obligate researchers to maximize study participants' comprehension during the informed consent process for clinical trials. A pilot evaluation of the consent process was conducted during an international clinical trial of treatment for pulmonary tuberculosis to assess the feasibility of conducting an evaluation in a larger population and to guide these future efforts. METHODS: Study staff administered an informed consent assessment tool (ICAT) to a convenience sample of trial participants, measuring comprehension of consent components as derived from the Common Rule and FDA Title 21 Part 50, and satisfaction with the process. Participating site staff completed a consent process questionnaire about consent practices at their respective sites and provided improvement recommendations. ICAT scores and corresponding practices were compared where both were completed. RESULTS: ICATs (n = 54) were submitted from one site in Spain (n = 10), one in Uganda (n = 30), and five in the United States (n = 14). Participants were primarily male (76%), born in Africa (n = 31, 57%), and had a median age of 27 years (interquartile range [IQR]: 24-42). Median ICAT scores were 80% (IQR: 67-93) for comprehension and 89% (IQR: 78-100) for satisfaction. Ugandan participants scored higher than participants from other sites on comprehension (87% vs. 64%) and satisfaction (100% vs. 78%). Staff from 14 sites completed consent process questionnaires. Median ICAT scores for comprehension and satisfaction were higher at sites that utilized visual aids. Practice recommendations included shorter forms, simpler documents, and supplementary materials. CONCLUSIONS: Participants achieved high levels (≥80%) of comprehension and satisfaction with their current consent processes. Higher ICAT scores at one site suggest an additional evaluation may identify approaches to improve comprehension and satisfaction in future trials. Through this pilot evaluation, complexities and challenges were identified in obtaining consent in a large, international multicenter trial and provided insights for a more robust assessment of the consent process in future trials.

Latent TB infection treatment acceptance and completion in the United States and Canada.

BACKGROUND: Treatment of latent TB infection (LTBI) is essential for preventing TB in North America, but acceptance and completion of this treatment have not been systematically assessed. METHODS: We performed a retrospective, randomized two-stage cross-sectional survey of treatment and completion of LTBI at public and private clinics in 19 regions of the United States and Canada in 2002. RESULTS: At 32 clinics that both performed tuberculin skin testing and offered treatment, 123 (17.1%; 95% CI, 14.5%-20.0%) of 720 subjects tested and offered treatment declined. Employees at health-care facilities were more likely to decline (odds ratio [OR], 4.74; 95% CI, 1.75-12.9; P = .003), whereas those in contact with a patient with TB were less likely to decline (OR, 0.19; 95% CI, 0.07-0.50; P = .001). At 68 clinics starting treatment regardless of where skin testing was performed, 1,045 (52.7%; 95% CI, 48.5%-56.8%) of 1,994 people starting treatment failed to complete the recommended course. Risk factors for failure to complete included starting the 9-month isoniazid regimen (OR, 2.08; 95% CI, 1.23-3.57), residence in a congregate setting (nursing home, shelter, or jail; OR, 2.94; 95% CI, 1.58-5.56), injection drug use (OR, 2.13; 95% CI, 1.04-4.35), age >or= 15 years (OR, 1.49; 95% CI, 1.14-1.94), and employment at a health-care facility (1.37; 95% CI, 1.00-1.85). CONCLUSIONS: Fewer than half of the people starting treatment of LTBI completed therapy. Shorter regimens and interventions targeting residents of congregate settings, injection drug users, and employees of health-care facilities are needed to increase completion.

Factors influencing health care workers' adherence to work site tuberculosis screening and treatment policies.

BACKGROUND: Despite the known risk of tuberculosis (TB) to health care workers (HCWs), research suggests that many are not fully adherent with local TB infection control policies. The objective of this exploratory study was to identify factors influencing HCWs' adherence to policies for routine tuberculin skin tests (TSTs) and treatment of latent TB infection (LTBI). METHODS: Sixteen focus groups were conducted with clinical and nonclinical staff at 2 hospitals and 2 health departments. Participants were segmented by adherence to TST or LTBI treatment policies. In-depth, qualitative analysis was conducted to identify facilitators and barriers to adherence. RESULTS: Among all focus groups, common themes included the perception that the TST was mandatory, the belief that conducting TSTs at the work site facilitated adherence, and a general misunderstanding about TB epidemiology and pathogenesis. Adherent groups more commonly mentioned facilitators, such as the perception that periodic tuberculin skin testing was protective and the employee health (EH) provision of support services. Barriers, such as the logistic difficulty in obtaining the TST, the perception that LTBI treatment was harmful, and a distrust of EH, emerged consistently in nonadherent groups. CONCLUSIONS: This information may be used to develop more effective interventions for promoting HCW adherence to TB prevention policies. Informed efforts can be implemented in coordination with reevaluations of infection control and EH programs that may be prompted by the publication of the revised TB infection control guidelines issued by the Centers for Disease Control and Prevention in 2005.

Tuberculosis contact investigation policies, practices, and challenges in 11 U.S. communities.

To describe the policies and procedures used by 11 urban tuberculosis control programs to conduct contact investigations, written policies were reviewed and semistructured interviews were conducted with program managers and staff. Qualitative analysis showed that contact investigation policies and procedures vary widely. Most policies address risk factor assessment and contact prioritization; however, none of the policies provide comprehensive guidance for the entire process. Staffing patterns vary, but, overall, staff receive little formal training; informal monitoring practices predominate. Comprehensive guidelines and programmatic support are needed to improve the quality of contact investigation processes.