A daily process investigation of alcohol-involved sexual risk behavior among economically disadvantaged problem drinkers living with HIV/AIDS.

Alcohol use is believed to increase sexual risk behavior among people living with HIV/AIDS (PLWHA). As drinking and sexual risk acts often occur in the same social contexts, this association is difficult to confirm. In this study, electronic daily diaries were completed by 116 PLWHA over 5 weeks. This yielded a total of 1,464 records consisting of data pertaining to discrete occasions of anal and vaginal sex. Simultaneous within- and between-person multilevel analyses were conducted, including situational variables (partner type, partner serostatus, partner drinking) and individual difference variables (gender, level of alcohol dependence). The resulting model explains 27.5% of the variance and reveals that interactions among these situational and individual difference variables predict changes in the estimated rate of unprotected sex (US). Also, in defined contexts, the amount of alcohol consumed prior to sex significantly affects the rate of US among members of the sample. Implications are discussed.

Lessons and pitfalls of interactive voice response in medical research.

Interactive voice response (IVR) technology is a robust method of data collection that has been underutilized in behavioral medicine and clinical pharmacotherapy research. While it is clear that there is an increasing interest in this technology, published research in the medical field has not described its implementation with sufficient detail to evaluate or replicate the use of interactive voice response systems (IVRS) as part of the methodology. In this article, we hope to shed more light on IVRS as an electronic data capture tool in clinical and behavioral research. We will describe how the IVRS work, the advantages and pitfalls of IVRS, and some of the lessons we have learned from administering a number of clinical studies using IVRS. Readers will gain a better understanding of this technology, which will enable them to optimize its usage in clinical research.

Systematic identification and classification of adverse events in human research.

Widely accepted standards and safeguards for research participants now include systematic surveillance and recording of adverse events. In the absence of a uniform regulation or structure for such reporting, each institution must now establish suitable yet efficient procedures to accomplish this task. We report herein our single center experience with a customized data collection, storage and review system specifically designed to identify and react appropriately to adverse events. Adverse events are classified by each investigator using three criteria in specific order: seriousness, expectedness and relatedness to the investigational intervention. Once classified, events are entered into an online database that includes collation, retrieval and search capabilities. Events meeting specified criteria are reviewed and adjudicated on a weekly basis by The University of Connecticut Research Adverse Events Committee, which makes advisory recommendations to the hospital's two Institutional Research Boards ranging from modification of informed consent to study suspension. Three hundred and seventy-one serious adverse events from > 900 studies were reviewed in the previous academic year. Our system, which combines timely on-line reporting with regular surveillance, provides a potential model that meets the need for comprehensive yet practical adverse events assessment and reporting.

Association between interactive voice response adherence and subject retention in a randomized controlled trial.

INTRODUCTION: Interactive voice response (IVR) technology uses the telephone to collect patient reports. This study examined whether IVR adherence during a year-long clinical trial was related to subject retention in the trial. METHODS: As part of a randomized, double-blind, placebo-controlled study of daily multivitamin supplementation for recurrent aphthous stomatitis, 160 study participants were asked to make 1 weekly IVR call for the one-year study duration. RESULTS: The 114 subjects who completed the study made 90.5% of their expected number of IVR calls, as compared to 55.7% of expected calls made by the 46 subjects who withdrew prematurely (p<0.001). Subjects who successfully completed the study were also more likely to initiate their IVR calls as compared to subjects who withdrew from the study (p<0.001). A multivariable model incorporating different adherence variables was able to successfully predict retention status of more than 80% of subjects. IVR adherence during the first few weeks of study participation was strongly predictive of subsequent retention and successful completion of this one-year study. DISCUSSION: Subjects who withdrew prematurely had more missing data than study completers, even after accounting for period of study participation, potentially introducing bias into IVR results. Sub-optimal adherence to weekly IVR might provide an early signal of subsequent premature withdrawal in clinical trials. IVR adherence could be used as a screening tool during a trial period, to identify subjects most likely to stay on long clinical trials. CONCLUSION: IVR adherence may be useful in anticipating retention in long-term clinical studies.

Electronic versus paper diaries: a pilot study of concordance and adherence in head and neck cancer patients receiving radiation therapy.

BACKGROUND: Interactive Voice Response Systems (IVRS) and other electronic data collection methods have begun to replace conventional paper diaries as a way to capture daily patient reports. However, these methods have not been compared in head and neck (H&N) cancer patients receiving radiation therapy. METHODS: 15 subjects with H&N cancer were asked to complete daily IVRS calls and daily paper diaries during radiation therapy. We compared response consistency and comparative adherence across the two methods. RESULTS: 86.1% (1920/2231) of participants' responses were consistent between IVRS and paper diaries. 79.5% of the expected number of paper diaries were completed, compared to 66.2% of IVRS phone calls. CONCLUSIONS: In this pilot study of H&N cancer patients undergoing radiation therapy, concordance was high between responses recorded by paper diaries and IVRS. Although adherence appeared to be higher for the paper diaries, it is possible that they may not have been completed at the proper time.

An evidence based alcohol screening, brief intervention and referral to treatment (SBIRT) curriculum for emergency department (ED) providers improves skills and utilization.

OBJECTIVE: Emergency Departments (EDs) offer an opportunity to improve the care of patients with at-risk and dependent drinking by teaching staff to screen, perform brief intervention and refer to treatment (SBIRT). We describe here the implementation at 14 Academic EDs of a structured SBIRT curriculum to determine if this learning experience improves provider beliefs and practices. METHODS: ED faculty, residents, nurses, physician extenders, social workers, and Emergency Medical Technicians (EMTs) were surveyed prior to participating in either a two hour interactive workshops with case simulations, or a web-based program (www.ed.bmc.org/sbirt). A pre-post repeated measures design assessed changes in provider beliefs and practices at three and 12 months post-exposure. RESULTS: Among 402 ED providers, 74% reported < 10 hours of prior professional alcohol-related education and 78% had < 2 hours exposure in the previous year. At 3-month follow-up, scores for self-reported confidence in ability, responsibility to intervene, and actual utilization of SBIRT skills all improved significantly over baseline. Gains decreased somewhat at 12 months, but remained above baseline. Length of time in practice was positively associated with SBIRT utilization, controlling for gender, race and type of profession. Persistent barriers included time limitations and lack of referral resources. CONCLUSIONS: ED providers respond favorably to SBIRT. Changes in utilization were substantial at three months post-exposure to a standardized curriculum, but less apparent after 12 months. Booster sessions, trained assistants and infrastructure supports may be needed to sustain changes over the longer term.

Using daily interactive voice response technology to measure drinking and related behaviors in a pharmacotherapy study.

BACKGROUND: Interactive voice response technology (IVR) allows investigators to collect daily measures of drinking, medication adherence, mood, and other treatment-relevant variables that may change day to day during a clinical trial. Despite these advantages, no published studies have used IVR in alcohol pharmacotherapy trials. METHODS: Subjects provided daily data via IVR during the 12-week treatment period. Seven subjects completed the trial. RESULTS: We found a high level of participant adherence to the IVR protocol, higher levels of drinking reported by IVR than by a commonly used recall method, and distinct within-day associations between daily mood and alcohol consumption: these could not be obtained through traditional assessment methods. CONCLUSIONS: IVR seems to be feasible for the collection of daily indicators of treatment outcomes and processes in pharmacotherapy studies among problem drinkers.