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Hillary J Mull,1,2 Marlena H Shin,1 Ryann L Engle,1 Amy M Linsky,1,3,4 Emily Kalver,1 Rebecca Lamkin,1 Jennifer L Sullivan1,5 1VA Boston Healthcare System, Center for Healthcare Organization and Implementation Research (CHOIR), Boston, MA, USA; 2Department of Surgery, Boston University School of Medicine, Boston, MA, USA; 3General Internal Medicine, Boston University School of Medicine, Boston, MA, USA; 4General Internal Medicine, VA Boston Healthcare System, Boston, MA, USA; 5Department of Health Law, Policy and Management, Boston University School of Public Health, Boston, MA, USACorrespondence: Hillary J MullVA Boston Healthcare System, Center for Healthcare Organization and Implementation Research (CHOIR), Boston, MA, USATel +1-857-364-2766Email Hillary.Mull@va.govBackground: Atrial fibrillation (AFib) is associated with high morbidity and mortality. Traditionally, AFib was treated with warfarin, yet recent evidence suggests patients may favor direct oral anticoagulants (DOACs). Variation in preferences is common and we explored patients’ perceptions of satisfaction and convenience of DOACs versus warfarin within the Veterans Health Administration (VA).Patients and Methods: We administered a cross-sectional survey, the Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2), to Veterans residing in New England, age ≥ 65, diagnosed with AFib, and actively taking anticoagulant medication in fiscal year 2018. Survey recipients were randomly selected among patients on warfarin (n=200) or DOACs (n=200). A selection of survey respondents agreed to a follow-up semi-structured interview (n=16) to further investigate perceptions of satisfaction and convenience.Results: Of 400 patients, 187 completed the PACT-Q2 survey (49% on DOACs; 51% on warfarin). DOACs received significantly higher convenience ratings than warfarin (87.6, SD 13.5 vs 81.1, SD 18.8; p=0.007); there was no difference in satisfaction (64.2, SD 20.5 SD, warfarin vs, 67.3, SD 19.4, DOACs). Interview results showed that participants perceived their treatment to be convenient. However, participants expressed challenges related to the convenience of taking warfarin or DOACs, such as warfarin users having to follow dietary recommendations or DOAC users desiring some additional monitoring to answer questions or concerns. Overall, warfarin and DOAC users reported satisfaction with ongoing monitoring methods, although a few DOAC users expressed uncertainties with the frequency of monitoring. For most participants, concerns about side effects did not differ by anticoagulant type nor affect satisfaction.Conclusion: Our survey and interview results showed variable patient satisfaction and perceptions of convenience with both DOACs and warfarin. Although DOACs are increasingly prescribed for AFib, some Veterans felt that regular follow-up on warfarin was advantageous. Our findings demonstrate the importance of patient-centered decision-making in AFib treatment in the VA patient population.Keywords: qualitative research, patient-centered care, patient perceptions, atrial fibrillation, anticoagulant medication, Veterans

OBJECTIVES: Despite recognition that implementation of evidence-based clinical practices (EBPs) usually depends on the structure and processes of the larger health care organizational context, the dynamics of implementation are not well understood. This project's aim was to deepen that understanding by implementing and evaluating an organizational model hypothesized to strengthen the ability of health care organizations to facilitate EBPs. CONCEPTUAL MODEL: The model posits that implementation of EBPs will be enhanced through the presence of three interacting components: active leadership commitment to quality, robust clinical process redesign incorporating EBPs into routine operations, and use of management structures and processes to support and align redesign. STUDY DESIGN: In a mixed-methods longitudinal comparative case study design, seven medical centers in one network in the Department of Veterans Affairs participated in an intervention to implement the organizational model over 3 years. The network was selected randomly from three interested in using the model. The target EBP was hand-hygiene compliance. Measures included ratings of implementation fidelity, observed hand-hygiene compliance, and factors affecting model implementation drawn from interviews. FINDINGS: Analyses support the hypothesis that greater fidelity to the organizational model was associated with higher compliance with hand-hygiene guidelines. High-fidelity sites showed larger effect sizes for improvement in hand-hygiene compliance than lower-fidelity sites. Adherence to the organizational model was in turn affected by factors in three categories: urgency to improve, organizational environment, and improvement climate. IMPLICATIONS: Implementation of EBPs, particularly those that cut across multiple processes of care, is a complex process with many possibilities for failure. The results provide the basis for a refined understanding of relationships among components of the organizational model and factors in the organizational context affecting them. This understanding suggests practical lessons for future implementation efforts and contributes to theoretical understanding of the dynamics of the implementation of EBPs. [ABSTRACT FROM AUTHOR]

In the past decade, the use of information technology (IT) to support healthcare delivery has greatly expanded. Introducing new clinical information systems and updating existing systems require continued learning and training among registered nurses (RNs) and other clinicians. Consequently, a 5-item measure was designed as a subscale to the Practice Environment Scale of the Nursing Work Index. This new subscale, the Nursing Information Technology Subscale (NITS) measures RNs' perception of the extent to which IT in their practice environment supports patient care delivery. A psychometric evaluation of the NITS was conducted at 8 Veterans Affairs hospitals. The findings demonstrated that this brief subscale has acceptable reliability as well as convergent and discriminant validity. © 2009 Wiley Periodicals, Inc. Res Nurs Health 33:48-59, 2010 [ABSTRACT FROM AUTHOR]

Background: Immunotherapy with monoclonal antibodies (MAbs) offers safe interventions for the prevention of infection in patients after organ transplantation and for the treatment of cancers and autoimmune diseases. MAb 201 is a severe acute respiratory syndrome-associated coronavirus (SARS-CoV)-specific MAb that prevents establishment of viral replication in vitro and prevents viral replication in vivo when administered prophylactically. The efficacy of MAb 201 in the treatment of SARS was evaluated in golden Syrian hamsters, an animal model that supports SARS-CoV replication to high levels and displays severe pathological changes associated with infection, including pneumonitis and pulmonary consolidation.Methods: Golden Syrian hamsters that were intranasally inoculated with SARS-CoV were treated with various doses of MAb 201 or an irrelevant MAb 24 h after inoculation. Two to 7 days after infection, the hamsters were killed, and their lungs were collected for evaluation of viral titers and pathological findings.Results: Postexposure treatment with MAb 201 can alleviate the viral burden and associated pathological findings in a golden Syrian hamster model of SARS-CoV infection. After a hamster is treated with MAb 201, its viral burden is reduced by 102.4-103.9 50% tissue-culture infectious doses per gram of tissue, and the severity of associated pathological findings, including interstitial pneumonitis and consolidation, is also remarkably reduced.Conclusions: The demonstration of successful postexposure MAb 201 therapy in an animal model that demonstrates viral replication and associated pulmonary pathological findings suggests that MAb 201 may be useful in the arsenal of tools to combat SARS. [ABSTRACT FROM AUTHOR]

To determine the efficacy and safety of 2 inexpensive and easily deliverable antiretroviral (ARV) regimens for the prevention of mother-to-child transmission (MTCT) of human immunodeficiency virus (HIV) type 1 during labor and delivery, HIV-infected pregnant women were screened at 11 maternity health institutions in South Africa and were enrolled in an open-label short course ARV regimen of either nevirapine (Nvp) or multiple-dose zidovudine and lamivudine (Zdv/3TC). The overall estimated HIV-1 infection rates in 1307 infants by 8 weeks were 12.3% (95% confidence interval [CI], 9.7-15.0) for Nvp and 9.3% (95% CI, 7.0-11.6) for Zdv/3TC (P=.11). Excluding infections detected within 72 h (intrauterine), new HIV-1 infections were detected in 5.7% (95% CI, 3.7-7.8) and 3.6% (95% CI, 2.0-5.3) of infants in the Nvp and Zdv/3TC groups, respectively, in the 8 weeks after birth. There were no drug-related maternal or pediatric serious adverse events. Common complications were obstetrical for mothers (Nvp group, 24.3%; Zdv/3TC group, 26.3%) and respiratory for infants (Nvp group, 16.1%; Zdv/3TC group, 17.0%). This study further confirms the efficacy and safety of short-course ARV regimens in reducing MTCT rates in developing countries. [ABSTRACT FROM AUTHOR]

Pediatric AIDS Clinical Trials Group protocol 316 was an international, multicenter, placebo-controlled trial comparing single-dose oral nevirapine (200 mg to mother and 2 mg/kg to infant) with placebo in human immunodeficiency virus (HIV)-infected pregnant women receiving standard antiretroviral therapy. This substudy evaluated the emergence of nevirapine-resistance mutations at 6 weeks postpartum in a subgroup of participants. Maternal risk factors for the emergence of nevirapine-resistance mutations were evaluated. Mutations associated with nevirapine resistance were detectable at delivery, prior to receipt of study drug, in 5 (2.3%) of 217 women. Fourteen (15%; 95% confidence interval, 8%-23%) of 95 women who received intrapartum nevirapine developed a nevirapine-resistance mutation 6 weeks postpartum. The most common mutation was K103N, which was present in 10 women. The risk for development of a new nevirapine-resistance mutation did not correlate with CD4 cell count or HIV-1 RNA load at delivery or with type of antepartum antiretroviral therapy. The risk of nevirapine resistance should be considered when determining the risks or benefits of intrapartum nevirapine in women receiving antepartum antiretroviral therapy. Copyright © 2002 Infectious Diseases Society of America [ABSTRACT FROM AUTHOR]

Nevirapine, a potent nonnucleoside reverse transcriptase inhibitor, produces a transient antiviral effect at < or = 200 mg/day due to the selection of resistant virus. To examine if higher levels of nevirapine could produce sustained antiviral activity, its safety, pharmacokinetics, and antiviral activity at 400 mg/day were studied in 21 patients. There was a rapid reduction in immune complex-dissociated p24 antigen and serum human immunodeficiency virus RNA concentration in all patients, and 8 of 10 patients had > 50% reduction at 8 weeks. Nevirapine-resistant virus was isolated from all subjects tested at 12 weeks: The mean plasma trough level (4.0 micrograms/mL [15.8 microM]) exceeded the mean IC50 of resistant virus. Rash developed in 48% of patients and was a dose-limiting toxicity factor in 6. These data suggest that clinical testing of potent antiviral compounds that select for drug-resistant virus is justified to determine if serum levels of drug sufficient to overcome resistant virus can be attained. [ABSTRACT FROM AUTHOR]

HIV counselling and testing was provided to 4267 individuals between September 1987 and June 1992 at a multi-site program, including community clinics, drug treatment programs, and a men's prison in central Massachusetts. Half of those tested reported the risk behaviors targeted by the programs: injection drug use (38.1%) and sexual contact with a drug injector (12.6%). The objectives of this study were to examine 1) factors associated with repeat HIV testing among these initially seronegative, and 2) behavior change following counselling and testing. Initially 7.4% were HIV positive, and 12.4% of those testing negative were retested within one year. Risk behavior was the only strong independent predictor of retesting (odds ratios of 3.8 and 4.2 for men reporting sex with men and recent drug injectors, respectively). Changes in risk behaviors between the time of the initial test and the second test were assessed (n = 207). Among those who continued to inject drugs at follow-up there was a reduction in the percent visiting shooting galleries (p = 0.05); no other significant behavior changes were reported. While selection bias may be responsible in part for the minimal behavior change observed, continued monitoring of risk behavior and counselling are warranted. [ABSTRACT FROM AUTHOR]