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.

Education level, primary language, and comprehension of the informed consent process.

TO OBTAIN INFORMATION ON HOW PERSONS from diverse backgrounds experience the informed consent process, we surveyed adults with a wide variety of educational levels and different primary languages (English, Spanish, or Vietnamese) who had recently enrolled in a study requiring written informed consent. Of the 100 participants, 62 were non-White, 43 had less than a high school education, and 60 had a primary language other than English. The median score for comprehension was 62% (IQR 50-76%); the median satisfaction score was 86% (IQR 71-100%).

Content Among Locally Approved HIPAA Authorization forms for Research.

THIS STUDY WAS DESIGNED TO ASSESS differences in the content of HIPAA authorization forms now required for clinical research. Authorization forms were collected from 111 institutions, including academic medical centers and commercial Institutional Review Boards. The requirement for an element covering the use of information acquired was fulfilled in 95% of the forms, and 100% had a statement fulfilling the core requirement of a description of the data to be collected.

Widespread emergence of methicillin resistance in community-acquired Staphylococcus aureus infections in Denver.

Background: Increasing rates of methicillin resistance among out-patient Staphylococcus aureus infections led us to assess the epidemiology and outcome of a local outbreak.

Methods: A retrospective cohort study of outpatient skin and soft tissue infections due to S aureus in 2003.

Results: From 2002 to mid-2004, the percentage of outpatient S aureus isolates resistant to methicillin increased from 6 to 45%.

The effectiveness of a verbal opt-out system for human immunodeficiency virus screening during pregnancy.

Objective: We sought to evaluate the use of human immunodeficiency virus (HIV) screening during pregnancy in a health care system using the verbal opt-out method, in which HIV screening was recommended during all pregnancies and women were given an opportunity to refuse testing.

Methods: This was a retrospective cohort study of pregnancies resulting in delivery from 1998 through 2001 at Denver Health Medical Center, an urban public hospital. The main outcome measure was the proportion of documented HIV screening within 9 months before the delivery date.

Conventional and molecular epidemiology of trimethoprim-sulfamethoxazole resistance among urinary Escherichia coli isolates.

Background: Antibiotic resistance is increasing in Escherichia coli, the most common cause of urinary tract infections, but its epidemiology has not been well described. We evaluated the epidemiology of trimethoprim-sulfamethoxazole-resistant E. coli in a large, public health care system in Denver, Colorado.

The effects of local review on informed consent documents from a multicenter clinical trials consortium.

There is increasing controversy about the appropriate role of the local institutional review board in the review of multicenter clinical studies. We evaluated the effects of the local review process at 25 study sites on the consent forms from two studies of the Tuberculosis Trials Consortium, a multicenter trials group. Two independent reviewers classified all changes made in the centrally approved consent forms; a third reviewer evaluated those changes if the two initial reviewers disagreed.