Using an empirical binomial hierarchical Bayesian model as an alternative to analyzing data from multisite studies.

This article explores the statistical methodologies used in demonstration and effectiveness studies when the treatments are applied across multiple settings. The importance of evaluating and how to evaluate these types of studies are discussed. As an alternative to standard methodology, the authors of this article offer an empirical binomial hierarchical Bayesian model as a way to effectively evaluate multisite studies. An application of using the Bayesian model in a real-world multisite study is given.

Improving ambulatory prescribing safety with a handheld decision support system: a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of a personal digital assistant (PDA)-based clinical decision support system (CDSS) on nonsteroidal anti-inflammatory drug (NSAID) prescribing safety in the outpatient setting. DESIGN: The design was a randomized, controlled trial conducted in a university-based resident clinic. Internal medicine residents received a PDA-based CDSS suite. For intervention residents, the CDSS included a prediction rule for NSAID-related gastrointestinal risk assessment and treatment recommendations. Unannounced standardized patients (SPs) trained to portray musculoskeletal symptoms presented to study physicians. Safety outcomes were assessed from the prescriptions given to the SPs. Each prescription was reviewed by a committee of clinicians blinded to participant, intervention group assignment, and baseline or follow-up status. MEASUREMENTS: Prescriptions were judged as safe or unsafe. The main outcome measure was the differential change in unsafe prescribing of NSAIDs for the intervention versus the control group. RESULTS: At baseline, the mean proportion of cases per physician with unsafe prescriptions for the two groups was similar (0.27 vs. 0.29, p > 0.05). Controlling for baseline performance, intervention participants prescribed more safely than controls after receiving the CDSS (0.23 vs. 0.45 [F = 4.24, p < 0.05]). With the CDSS, intervention participants documented more complete assessment of patient gastrointestinal risk from NSAIDs. CONCLUSION: PARTICIPANTS provided with a PDA-based CDSS for NSAID prescribing made fewer unsafe treatment decisions than participants without the CDSS.

An exploration of family influences on smoking among ethnically diverse adolescents.

In an attempt to better understand mechanisms through which families might influence adolescent smoking, focus group data collected as part of a larger study of ethnic and gender differences in teen smoking were analyzed for family-related themes. Across six sites, 132 focus groups were conducted with African American, American Indian, Hispanic, Asian/Pacific Islander, and White youth. Similarities across race/ethnicity were evident in the content of antismoking messages and the feeling among youth that they would get in trouble with their parents if caught smoking. African American and Asian/Pacific Islander youth appeared more concerned about their parents thinking less of them if they smoked than were youth from other racial/ethnic groups. White and American Indian youth were more likely to discuss that their parents felt it was their own decision as to whether or not to smoke than were the other groups.

Impact of patient feedback on residents' handheld computer use: a multi-site study.

Handheld computers are being proposed as a resource for ambulatory care, yet physician reluctance to use the devices in the presence of patients is reported to be a barrier to optimal use. This study examined patient attitudes toward the use of handheld computers and the impact of those attitudes on the physicians' use of the handheld computers in the patient care setting. Most patients hold favorable attitudes toward physician use of handheld computers. Providing these data to physicians, however, did not uniformly lead to significant increases in handheld use in the presence of the patient. More understanding of the factors that influence behavior change and methods that will decrease barriers to the use of handhelds is needed

Using formative evaluation to improve a smoking cessation intervention for pregnant women.

Triangulation analysis was used to assess qualitative data collected to examine smoking cessation materials and methods prior to a large randomized clinical trial with pregnant smokers. The patient education program's components were tested with 265 patients receiving Medicaid-insured care in 9 public clinics. The formative evaluation process conducted during this pilot study of the Smoking Cessation and Reduction in Pregnancy Trial included assessment of A Pregnant Woman's Guide to Stop Smoking (Windsor et al., 2002), a companion video, clinic reinforcement, and patient-centered counseling. Focus groups were conducted, with 23 (82%) of the nurses and social workers who provided the intervention. Twenty-nine (20.8%) of the women who received the intervention were interviewed individually. The qualitative data were examined to identify convergence and divergence among and between providers and patients about presentation, use of components, and program impact. Findings were used to refine the intervention to enhance patient and staff receptivity, specifically to ensure participant comprehension and shorten time required of busy staff.

Data collection in a multisite project: Teleform.

Data collection, entry, validation, and management are salient time- and resource-consuming dimensions of all research projects. This is especially true for multisite studies, which pose unique, additional challenges because of their research design requirements. To save time and reduce the number of manual data entry errors, automated processing systems are becoming more widely used. Our research team chose Teleform for data entry and collection for the Smoking Cessation or Reduction in Pregnancy Trial study. This article presents our experience with this new technology.

Measurements for active cigarette smoke exposure in prevalence and cessation studies: why simply asking pregnant women isn't enough.

Tobacco smoke exposure during and after pregnancy may cause maternal, fetal, and infant morbidity and mortality. The purpose of this review is to (a). describe existing methods of measuring active tobacco exposure among pregnant women and (b). illustrate the usefulness of these measures in validating self-reported smoking status among these women. Medline, PsycINFO, and Academic Search Elite were used to identify measures of cigarette smoking exposure, prevalence reports, cessation and validity studies, and research on deception about smoking during pregnancy. Review of the research on smoking cessation among pregnant women since 1966 revealed that 36% of studies (9 out of 25) located used only self-report to assess smoking status. The remaining 16 studies used either significant other reports or at least one type of biochemical test to confirm self-report. Deception rates were reported at baseline only, follow-up only, or both in 15 studies. Three federal agencies in the United States collect data on self-reported smoking during pregnancy. Smoking prevalence rates are inconsistent among these agencies. This article demonstrates that measuring smoking status during pregnancy via self-report alone leads to discrepancies in national prevalence rates, deceptions in clinical practice disclosure, and inconsistencies in research study results. Evaluation studies that confirm smoking status among pregnant women by biochemical methods provide more accurate prevalence rates and lead to the most effective behavioral interventions to achieve cessation. National statistics should carry a disclaimer indicating the likelihood of underestimation. Researchers and clinicians should be trained in best-practice, evidence-based behavioral methods to assess prenatal smoking status and to assist those who desire to quit.

Patient perceptions of physician use of handheld computers.

BACKGROUND: Handheld computers have advantages for healthcare providers including portability and integration into office workflow. However, negative patient perceptions of physician use of handheld computers in the examining room might limit integration. OBJECTIVE: To survey patients' perceptions of handheld use, and compare those with their providers' perceptions. METHODS: A survey of patient attitudes toward handhelds was conducted among patients at a low-income university clinic. Internal Medicine residents providing care were also surveyed. RESULTS: Patients (N=93) were mostly female (79%) and ethnic minorities (67%) with average age of 39. Only 10% of patients did not like the idea of a handheld computer in the exam room. Other negative attitudes were also seen in a minority of patients. Some physicians (23%) reported reservations about using the handheld computer with patients. CONCLUSIONS: Negative attitudes were rare among patients, but some providers were concerned about using the handheld in the exam room.

Presenting the female condom to men: a dyadic analysis of effect of the woman's approach.

Although male partner resistance to female condom use has been reported, little is understood about circumstances under which partners will agree to female condom use. This study documents the experiences of couples who have worked together to achieve female condom use. As part of a prospective female condom efficacy study, female participants (age 18-34) received a behavioral intervention and an assortment of take-home items. Selected women and their partners were recruited for a qualitative interview focusing on their experience with the female condom. Interviews were transcribed, double-coded, and verified using a standard retrieval coding system. Twenty-six pairs of linked interviews were analyzed dyadically: 9 couples who used the female condom "consistently," 12 "experimenters," and 5 "non-users." Women who successfully promoted the female condom to their partners used multiple presentation strategies. Initial male partner reaction did not predict continued use beyond the first trial. In conclusion, employment of multiple strategies facilitates successful introduction of the female condom into a sexual partnership.