Publications by authors named "Patricia Morgan"

24 Publications

  • Page 1 of 1

Stroke Imaging Selection Modality and Endovascular Therapy Outcomes in the Early and Extended Time Windows.

Stroke 2021 Jan 12;52(2):491-497. Epub 2021 Jan 12.

Department of Neurosciences, Drexel Neurosciences Institute, Philadelphia, PA (E.V.).

Background And Purpose: Advanced imaging has been increasingly used for patient selection in endovascular stroke therapy. The impact of imaging selection modality on endovascular stroke therapy clinical outcomes in extended time window remains to be defined. We aimed to study this relationship and compare it to that noted in early-treated patients.

Methods: Patients from a prospective multicentric registry (n=2008) with occlusions involving the intracranial internal carotid or the M1- or M2-segments of the middle cerebral arteries, premorbid modified Rankin Scale score 0 to 2 and time to treatment 0 to 24 hours were categorized according to treatment times within the early (0-6 hour) or extended (6-24 hour) window as well as imaging modality with noncontrast computed tomography (NCCT)±CT angiography (CTA) or NCCT±CTA and CT perfusion (CTP). The association between imaging modality and 90-day modified Rankin Scale, analyzed in ordinal (modified Rankin Scale shift) and dichotomized (functional independence, modified Rankin Scale score 0-2) manner, was evaluated and compared within and across the extended and early windows.

Results: In the early window, 332 patients were selected with NCCT±CTA alone while 373 also underwent CTP. After adjusting for identifiable confounders, there were no significant differences in terms of 90-day functional disability (ordinal shift: adjusted odd ratio [aOR], 0.936 [95% CI, 0.709-1.238], =0.644) or independence (aOR, 1.178 [95% CI, 0.833-1.666], =0.355) across the CTP and NCCT±CTA groups. In the extended window, 67 patients were selected with NCCT±CTA alone while 180 also underwent CTP. No significant differences in 90-day functional disability (aOR, 0.983 [95% CI, 0.81-1.662], =0.949) or independence (aOR, 0.640 [95% CI, 0.318-1.289], =0.212) were seen across the CTP and NCCT±CTA groups. There was no interaction between the treatment time window (0-6 versus 6-24 hours) and CT selection modality (CTP versus NCCT±CTA) in terms of functional disability at 90 days (=0.45).

Conclusions: CTP acquisition was not associated with better outcomes in patients treated in the early or extended time windows. While confirmatory data is needed, our data suggests that extended window endovascular stroke therapy may remain beneficial even in the absence of advanced imaging.
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http://dx.doi.org/10.1161/STROKEAHA.120.031685DOI Listing
January 2021

Noncontrast Computed Tomography Alberta Stroke Program Early CT Score May Modify Intra-Arterial Treatment Effect in DAWN.

Stroke 2019 09 26;50(9):2404-2412. Epub 2019 Jul 26.

The Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Department of Neurology, Emory University School of Medicine, Atlanta, GA (D.C.H., R.G.N.).

Background and Purpose- It is unknown whether noncontrast computed tomography (NCCT) can identify patients who will benefit from intra-arterial treatment (IAT) in the extended time window. We sought to characterize baseline Alberta Stroke Program Early CT Score (ASPECTS) in DAWN (DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo) and to assess whether ASPECTS modified IAT effect. Methods- Core lab adjudicated ASPECTS scores were analyzed. The trial cohort was divided into 2 groups by qualifying imaging (computed tomography versus magnetic resonance imaging). ASPECTS-by-treatment interaction was tested for the trial coprimary end points (90-day utility-weighted modified Rankin Scale (mRS) score and mRS, 0-2), mRS 0 to 3, and ordinal mRS. ASPECTS was evaluated separately as an ordinal and a dichotomized (0-6 versus 7-10) variable. Results- Of 205 DAWN subjects, 123 (60%) had NCCT ASPECTS, and 82 (40%) had diffusion weighted imaging ASPECTS. There was a significant ordinal NCCT ASPECTS-by-treatment interaction for 90-day utility-weighted mRS (interaction P=0.04) and mRS 0 to 2 (interaction P=0.02). For both end points, IAT effect was more pronounced at higher NCCT ASPECTS. The dichotomized NCCT ASPECTS-by-treatment interaction was significant only for mRS 0 to 2 (interaction P=0.04), where greater treatment benefit was seen in the ASPECTS 7 to 10 group (odds ratio, 7.50 [2.71-20.77] versus odds ratio, 0.48 [0.04-5.40]). A bidirectional treatment effect was observed in the NCCT ASPECTS 0 to 6 group, with treatment associated with not only more mRS 0 to 3 outcomes (50% versus 25%) but also more mRS 5 to 6 outcomes (40% versus 25%). There was no significant modification of IAT effect by diffusion weighted imaging ASPECTS. Conclusions- Baseline NCCT ASPECTS appears to modify IAT effect in DAWN. Higher NCCT ASPECTS was associated with greater benefit from IAT. No treatment interaction was observed for diffusion weighted imaging ASPECTS.
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http://dx.doi.org/10.1161/STROKEAHA.118.024583DOI Listing
September 2019

Sleep quality, sleepiness and the influence of workplace breaks: A cross-sectional survey of health-care workers in two US hospitals.

Chronobiol Int 2018 06 8;35(6):849-852. Epub 2018 May 8.

b Sleep and Performance Research Center , Washington State University , Spokane , WA , USA.

This study assessed sleep quality, sleepiness and use of workplace break opportunities in 1285 health-care workers via an online questionnaire. Two hospitals were surveyed - one with and one without a fatigue mitigation policy. Across all respondents, 68.9% reported generally taking breaks of at least 30 min and 21.7% had access to a quiet place to rest, with no significant differences between hospitals. The presence of a fatigue mitigation policy was not associated with reduced sleepiness. However, accounting for hospital and shift characteristics, employees with access to a quiet place to rest while on break had significantly lower self-reported sleepiness scores.
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http://dx.doi.org/10.1080/07420528.2018.1466791DOI Listing
June 2018

The Multiple-Patient Simulation Toolkit: Purpose, Process, and Pilot.

Nurs Educ Perspect 2018 May/Jun;39(3):180-181

About the Authors Sabrina Beroz, DNP, RN, CHSE, is a professor, Montgomery College Health Sciences Institute and Center, Tacoma Park, Maryland. Nancy Sullivan, DNP, RN, is an assistant professor and clinical simulation director, Johns Hopkins University School of Nursing, Baltimore, Maryland. Vanessa Kramasz, MSN, RN, is a nursing faculty and simulation facilitator at Gateway Technical College, Burlington, Wisconsin, and a simulation consultant. Patricia Morgan, MSN, RN, is a senior instructor, Faculty of Nursing, University of Calgary, Calgary, Alberta, Canada. This project was conducted while participating in the 2015 National League for Nursing Leadership Institute for Simulation Educators. The authors wish to acknowledge Drs. Pamela Jeffries, Mary Anne Rizzolo, and Susan Forneris for their support and wisdom throughout the project. For more information, write to Dr. Beroz at

Educating nursing students to safely care for multiple patients has become an important but challenging focus for nurse educators. New graduate nurses are expected to manage care for multiple patients in a complex and multifaceted health care system. With patient safety as a priority, multiple-patient assignments are necessary in order for nursing students to learn how to effectively prioritize and delegate care. The purpose of this project was the construction of an adaptable and flexible template for the development of multiple-patient simulations. Through utilization, the template moved to a toolkit adding an operational guide, sample-populated template, and bibliography.
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http://dx.doi.org/10.1097/01.NEP.0000000000000236DOI Listing
September 2019

After the Gap Analysis: Education and Practice Changes to Prepare Nurses of the Future.

Nurs Educ Perspect 2017 Sep/Oct;38(5):250-254

About the Authors Audrey Marie Beauvais, DNP, MSN, MBA, RN, CNL, is an associate dean and associate professor, Fairfield University Marion Peckham Egan School of Nursing and Health Studies, Fairfield, Connecticut. Meredith Wallace Kazer, PhD, APRN, FAAN, is dean and professor, Fairfield University Marion Peckham Egan School of Nursing and Health Studies. Barbara Aronson, PhD, RN, CNE, is a professor and coordinator, EdD in Nursing Education, Southern Connecticut State University Department of Nursing, New Haven. Suzanne E. Conlon, MSN, is a professor and academic chairperson, Gateway Community College Nursing Program, New Haven. Pamela Forte, DNP, RN, is a clinical coordinator, Southern Connecticut State University Department of Nursing. Kathleen S. Fries, PhD, RN, CNE, is -director, Nursing and Allied Health Programs, Norwalk Community College Nursing Program. Judith M. Hahn, PhD, RN, NEA-BC, is with the Yale New Haven Hospital Department of Professional Practice. Russell Hullstrung, MPA, RN, is a director, eLearning Education, Yale New Haven Health Institute for Excellence. Meg Levvis, PhD, RN, is chairperson and an associate professor, Central Connecticut State University, New Britain. Paula McCauley, DNP, APRN, ACNP-BC, CNE, is an associate clinical professor, University of Connecticut School of Nursing, Storrs. Patricia Padula Morgan, PhD, RN, CNE, is chair, Department of Nursing, and associate dean, School of Health and Natural Sciences, University of Saint Joseph, West Hartford. Linda Perfetto, MS, RN, CNE, CNOR, is director of system nursing curricular operations, Connecticut Community Colleges, Hartford. Lisa M. Rebeschi, PhD, RN, CNE, is chairperson and associate professor, Southern Connecticut State University, New Haven. Sheila B. Solernou, MSN, RN, is division director, Gateway Community College Division of Allied Health and Nursing, New Haven. Patricia Span, PhD, RNC, CPHQ, is a strategy and learning specialist, Yale New Haven Health Patient Services Administration. Lisa J. Sundean, MSN, MHA, RN, is a PhD and statewide director, Connecticut Nursing Collaborative-Action Coalition, East Berlin. The work of the Connecticut Nursing Collaborative-Action Coalition has been supported by two grants from the Robert Wood Johnson Foundation. For more information, contact Dr. Beauvais at

Aim: The purpose of the study was to describe the Connecticut Nursing Collaborative-Action Coalition's work in identifying and addressing gaps between nursing education and practice based on the Institute of Medicine's Future of Nursing report.

Background: Massachusetts Nurse of the Future (NOF) Competencies highlight the knowledge, skills, and attitudes/behaviors required for professional nurses. Integrating these concepts into the educational system will prepare the nursing workforce to respond to current/future health care needs and population health issues.

Method: Education and practice partners in four regions conducted a gap analysis of the education to practice transition for new graduate nurses using NOF as a framework for assessment.

Results: Gaps in competencies were similar across regions. However, each organization uniquely addressed curricular gaps to best prepare nurses of the future.

Conclusion: Curriculum improvements will provide students the advantage of being prepared for the rapid changes happening in health care.
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http://dx.doi.org/10.1097/01.NEP.0000000000000196DOI Listing
July 2018

The significant work of parenting.

Work 2015 ;50(3):411-2

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http://dx.doi.org/10.3233/WOR-152004DOI Listing
December 2016

Midlife mothers favor `being with' children over work and careers.

Work 2015 ;50(3):477-89

College of Nursing, East Carolina University, Greenville, NC, USA.

Background: The majority of American women juggle careers and the demands of mothering. The experiences of midlife mothers on the issues of work and motherhood are important to explore because birth rates for older women continue to rise in the United States and in other countries including the U.K. and Canada.

Objective: To present a unique viewpoint on work and mothering from the perspectives and experiences of older first-time mothers.

Methods: A purposive sample of thirteen women aged 45-56 years old participated in two in-depth interviews. Findings emerged in the context of a larger hermeneutic phenomenological study that aimed to understand older first-time mothers' perceptions of health and mothering during the transition to menopause.

Results: A paradox emerged in which the realities of motherhood did not meet the women's expectations. They were surprised by the centrality of commitment they felt towards the child and voiced strong ideals about how to do mothering right that included making changes to work schedules to be more available to their children.

Conclusion: Health care professionals should be aware of specific issues that exist for older first-time mothers including adjustments to work. This knowledge will inform the support, education and care provided for these women.
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http://dx.doi.org/10.3233/WOR-141958DOI Listing
December 2016

Molecular evolution of the HIV-1 Thai epidemic between the time of RV144 immunogen selection to the execution of the vaccine efficacy trial.

J Virol 2013 Jul 10;87(13):7265-81. Epub 2013 Apr 10.

U.S. Military HIV Research Program, Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, Maryland, USA.

The RV144 HIV-1 vaccine trial (Thailand, 2003 to 2009), using immunogens genetically matched to the regional epidemic, demonstrated the first evidence of efficacy for an HIV-1 vaccine. Here we studied the molecular evolution of the HIV-1 epidemic from the time of immunogen selection to the execution of the efficacy trial. We studied HIV-1 genetic diversity among 390 volunteers who were deferred from enrollment in RV144 due to preexisting HIV-1 infection using a multiregion hybridization assay, full-genome sequencing, and phylogenetic analyses. The subtype distribution was 91.7% CRF01_AE, 3.5% subtype B, 4.3% B/CRF01_AE recombinants, and 0.5% dual infections. CRF01_AE strains were 31% more diverse than the ones from the 1990s Thai epidemic. Sixty-nine percent of subtype B strains clustered with the cosmopolitan Western B strains. Ninety-three percent of B/CRF01_AE recombinants were unique; recombination breakpoint analysis showed that these strains were highly embedded within the larger network that integrates recombinants from East/Southeast Asia. Compared to Thai sequences from the early 1990s, the distance to the RV144 immunogens increased 52% to 68% for CRF01_AE Env immunogens and 12% to 29% for subtype B immunogens. Forty-three percent to 48% of CRF01_AE sequences differed from the sequence of the vaccine insert in Env variable region 2 positions 169 and 181, which were implicated in vaccine sieve effects in RV144. In conclusion, compared to the molecular picture at the early stages of vaccine development, our results show an overall increase in the genetic complexity of viruses in the Thai epidemic and in the distance to vaccine immunogens, which should be considered at the time of the analysis of the trial results.
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http://dx.doi.org/10.1128/JVI.03070-12DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3700312PMC
July 2013

Issues in women's participation in a phase III community HIV vaccine trial in Thailand.

AIDS Res Hum Retroviruses 2013 Nov 25;29(11):1524-34. Epub 2013 Feb 25.

1 Center of Excellence for Biomedical and Public Health Informatics, Faculty of Tropical Medicine, Mahidol University , Bangkok, Thailand .

To assess qualities and outcomes of women participating in a large, community-based HIV vaccine trial, the present study was conducted among female participants of the RV 144 prime-boost trial in Thailand from 2003 to 2009. Qualities of participation refer to complete vaccination, retention, and status change. Outcomes of participation refer to incident rate, adverse event, and participation impact event. A total of 6,334 (38.6%) women participated in the trial, of whom about 50% were classified as low risk and 11% as high risk. About 85% of participants completed four vaccinations and 76% were included in the per-protocol analysis of the on-time vaccination schedule. More women (88%) completed 42 months follow-up compared with men (85%). Women aged 21 and above had more adverse events compared to younger age groups. More women (5%) compared with men (3%) reported participation impact events (PIEs). High-risk women had more PIEs and a higher infection rate compared to the low-risk group. Complete vaccination and retention on last follow-up were more common in married women aged above 21, and being a housewife. Female volunteers showed the same qualities and outcomes of participation as males in the HIV vaccine trial. There was no statistically significant difference in vaccine efficacy between men and women, especially among the high-risk and married women. The study highlighted the important behavioral, social, and cultural issues that could be considered for future HIV vaccine trial designs.
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http://dx.doi.org/10.1089/AID.2012.0265DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3809940PMC
November 2013

Randomized controlled trial of laxative use in postcolostomy surgery patients.

J Wound Ostomy Continence Nurs 2012 Sep-Oct;39(5):524-8

Stomal Therapy Nursing, Stomal Therapy Department, Prince of Wales Hospital, Sydney, New South Wales, Australia.

Purpose: We compared a standardized postoperative laxative protocol to laxatives provided on an ad hoc basis by the surgical team.

Subjects And Setting: Forty-five patients who underwent colostomy surgery participated in the study. The research setting was 2 acute care facilities in south-eastern Sydney, New South Wales, Australia.

Methods: A randomized controlled trial was conducted. The intervention group (n 5 19) received a standardized laxative protocol postsurgery. Two types of laxatives were selected for first-line treatment: sterculia and frangula bark (Normacol Plus), a bulking agent and stimulant; and liquid paraffin (Agarol), a stool softener. An iso-osmotic polyethylene glycol macrogel (Movicol) was chosen as second-line treatment. The comparison group (n = 26) received laxative intervention(s) as preferred by the surgical team. Constipation, measured as fecal loading on plain abdominal film, stomal therapy nurse activity, patient comfort, and length of hospital stay were compared between intervention and control groups.

Results: The presence of fecal loading favored the intervention group (1 episode in the treatment group vs 7 episodes in the comparison group; χ5 = 3.8; P = .05). This finding suggests that the laxative protocol given to the treatment group was more likely to prevent fecal loading/constipation when compared to the ad hoc laxative group. Stomal therapy nurse activity in terms of the number of empty bag changes was significantly higher in the comparison group (F 5 4.8; P 5 .03).

Conclusion: The findings of this study support the benefits of a standardized laxative protocol for prevention of constipation. Data collection was discontinued after 3 years due to a contamination effect developing, because our surgeons observed the utility of the laxative protocol and incorporated it into their routine practice. Further experimental research is needed to explore the best constipation prevention approaches for postcolostomy surgery patients.
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http://dx.doi.org/10.1097/WON.0b013e3182648cc9DOI Listing
February 2013

Risk behaviour and time as covariates for efficacy of the HIV vaccine regimen ALVAC-HIV (vCP1521) and AIDSVAX B/E: a post-hoc analysis of the Thai phase 3 efficacy trial RV 144.

Lancet Infect Dis 2012 Jul 30;12(7):531-7. Epub 2012 May 30.

US Military HIV Research Program, Division of Retrovirology, Walter Reed Army Institute of Research, Rockville, MD, USA.

Background: The Thai phase 3 HIV vaccine trial RV 144 showed modest efficacy of a vaccine against HIV acquisition. Baseline variables of age, sex, marital status, and risk did not modify vaccine efficacy. We did a post-hoc analysis of the trial's data to investigate behavioural risk and efficacy every 6 months after vaccination.

Methods: RV 144 was a randomised, multicentre, double-blind, placebo-controlled efficacy trial testing the combination of the HIV vaccines ALVAC-HIV (vCP1521) and AIDSVAX B/E to prevent HIV infection or reduce setpoint viral load. Male and female volunteers aged 18-30 years were recruited from the community. In this post-hoc analysis of the modified intention-to-treat population (16,395 participants), HIV risk behaviour was assessed with a self-administered questionnaire at the time of initial vaccination in the trial and every 6 months thereafter for 3 years. We classified participants' behaviour as low, medium, or high risk. Both the acquisition endpoint and the early viral-load endpoint were examined for interactions with risk status over time and temporal effects after vaccination. Multiple proportional hazards regression models with treatment and time-varying risk covariates were analysed.

Findings: Risk of acquisition of HIV was low in each risk group, but 9187 (58·2%) participants reported higher-risk behaviour at least once during the study. Participants classified as high or increasing risk at least once during follow-up were compared with those who maintained low-risk or medium-risk behaviour as a time-varying covariate, and the interaction of risk status and acquisition efficacy was significant (p=0·01), with greater benefit in low-risk individuals. Vaccine efficacy seemed to peak early--cumulative vaccine efficacy was estimated to be 60·5% (95% CI 22-80) through the 12 months after initial vaccination--and declined quickly. Vaccination did not seem to affect viral load in either early or late infections.

Interpretation: Future HIV vaccine trials should recognise potential interactions between challenge intensity and risk heterogeneity in both population and treatment effects. The regimen tested in the RV 144 phase 3 trial might benefit from extended immunisation schedules.

Funding: US Army Medical Research and Materiel Command and Division of AIDS, National Institute of Allergy and Infectious Disease, National Institutes of Health.
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http://dx.doi.org/10.1016/S1473-3099(12)70088-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3530398PMC
July 2012

Triple whammy: women's perceptions of midlife mothering.

MCN Am J Matern Child Nurs 2012 May-Jun;37(3):156-62

Department of Nursing, University of New England, Portland, ME, USA.

Purpose: To understand women's experiences as older first-time mothers during the transition to menopause.

Study Design And Methods: A hermeneutic, phenomenological study exploring the lived experiences of 13 women aged 39 to 47 when they achieved first-time motherhood. Women were mothering one or more children aged 12 or younger and experiencing symptoms of perimenopause. Data were generated through two in-depth interviews with each woman. Meaning was mutually negotiated through dialogue with the women and simultaneously with the text, as well as through ongoing data analysis.

Results: Four themes emerged: Achieving First-Time Motherhood at Midlife, Intensive Mothering, Out of Sync, and Perimenopause as a State of Uncertainty.

Clinical Implications: Increasingly, nurses and nurse midwives will be caring for women aged 40 and older as they navigate motherhood during the transition to menopause. Through their stories, women can share concerns they have about mothering at an older age, and the effect of perimenopausal symptoms on their mothering experiences. Nurses should offer anticipatory guidance to women who delay motherhood until midlife, provide information about the transition to menopause, and assess the older mother's level of social support. Nurses can help build capacity for support within community and professional resources, such as hospital supported mother/baby and breastfeeding support groups.
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http://dx.doi.org/10.1097/NMC.0b013e31824b4570DOI Listing
July 2012

Uncertainty during perimenopause: perceptions of older first-time mothers.

J Adv Nurs 2012 Oct 4;68(10):2299-308. Epub 2012 Jan 4.

Department of Nursing, University of New England, Portland, Maine, USA.

Aim: This article is a report of a study exploring older first-time mothers' perceptions of health during their transition to menopause.

Background: Increasing numbers of women world-wide are delaying motherhood, yet little is known about the unique phenomenon created when midlife motherhood is closely followed by the transition to menopause. A literature search revealed that the effect of these overlapping life transitions on women's health was unknown.

Design: A hermeneutic phenomenological approach utilizing Gadamer's philosophical underpinnings guided the study.

Method: A purposive sample of thirteen women aged 45-56 years who were mothering children aged 12 years or younger and experiencing symptoms of perimenopause was recruited. Two in-depth interviews were conducted with each woman and meaning was mutually negotiated through participative dialogue with the women, ongoing construction and thematic analysis of data collected between 2004 and 2007.

Findings: The key theme 'Perimenopause as a State of Uncertainty' is an interpretation of older first-time mothers' perceptions of health during perimenopause and is the focus of this article. Hermeneutic interpretation culminated in the construct 'uncertainty' as theoretical embodiment of the women's lived experience. An uncertain temporality, projection of the lifespan and valuing health as precious enabled these women to transform uncertainty into opportunities for health promotion to 'be there' for their children.

Conclusion: Nurses, nurse practitioners and midwives will increasingly be caring for midlife mothers and need to understand the unique issues of older mothers to offer education and health promotion that support healthy transitions to menopause.
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http://dx.doi.org/10.1111/j.1365-2648.2011.05923.xDOI Listing
October 2012

Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand.

PLoS One 2011 21;6(12):e27837. Epub 2011 Dec 21.

Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.

Background: A prime-boost vaccination regimen with ALVAC-HIV (vCP1521) administered intramuscularly at 0, 4, 12, and 24 weeks and gp120 AIDSVAX B/E at 12 and 24 weeks demonstrated modest efficacy of 31.2% for prevention of HIV acquisition in HIV-uninfected adults participating in a community-based efficacy trial in Thailand.

Methodology/principal Findings: Reactogenicity was recorded for 3 days following vaccination. Adverse events were monitored every 6 months for 3.5 years, during which pregnancy outcomes were recorded. Of the 16,402 volunteers, 69% of the participants reported an adverse event any time after the first dose. Only 32.9% experienced an AE within 30 days following any vaccination. Overall adverse event rates and attribution of relatedness did not differ between groups. The frequency of serious adverse events was similar in vaccine (14.3%) and placebo (14.9%) recipients (p = 0.33). None of the 160 deaths (85 in vaccine and 75 in placebo recipients, p = 0.43) was assessed as related to vaccine. The most common cause of death was trauma or traffic accident. Approximately 30% of female participants reported a pregnancy during the study. Abnormal pregnancy outcomes were experienced in 17.1% of vaccine and 14.6% (p = 0.13) of placebo recipients. When the conception occurred within 3 months (estimated) of a vaccination, the majority of these abnormal outcomes were spontaneous or elective abortions among 22.2% and 15.3% of vaccine and placebo pregnant recipients, respectively (p = 0.08). Local reactions occurred in 88.0% of vaccine and 61.0% of placebo recipients (p<0.001) and were more frequent after ALVAC-HIV than AIDSVAX B/E vaccination. Systemic reactions were more frequent in vaccine than placebo recipients (77.2% vs. 59.8%, p<0.001). Local and systemic reactions were mostly mild to moderate, resolving within 3 days.

Conclusions/significance: The ALVAC-HIV and AIDSVAX B/E vaccine regimen was found to be safe, well tolerated and suitable for potential large-scale use in Thailand.

Trial Registration: ClinicalTrials.govNCT00223080.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0027837PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3244387PMC
April 2012

Social and cultural influences on tobacco-related health disparities among South Asians in the USA.

Tob Control 2012 Jul 27;21(4):422-8. Epub 2011 Jun 27.

School of Public Health, University of California, Berkeley, California, USA.

Objective: To explore and understand key cultural contexts of tobacco use among South Asian communities in the USA.

Design: Focus groups, with homogeneous compositions of gender, generational status and length of time in the USA, were conducted in two distinct South Asian ethnic enclaves. Focus group findings were triangulated with observational data regarding the availability of culturally specific tobacco from commercial ethnic outlets and cultural events.

Subjects: Respondents included 88 men and women of South Asian descent, aged 18-65 years, immigrant and native born, representing diversity of religion, socioeconomic status and region of origin, with the use of at least one culturally specific tobacco product in previous 24 months.

Results: A large number of culturally specific products were commonly used by community members. Knowledge of product-specific health risks was lacking or inaccurate. Many culturally specific tobacco products were considered to have beneficial properties. South Asian tobacco items were used to preserve cultural traditions and express ethnic identity in a new dominant culture. The social and cultural values ascribed to use helped distinguish community members from mainstream society and from other minority populations.

Conclusions: Many cultural factors govern tobacco use among diverse global populations. Especially for migrants with a common regional origin, the role of ethnic identity may strongly influence culturally specific tobacco patterns. Qualitative inquiry helps elucidate such culturally framed behaviour in culturally diverse populations. These cultural contexts should be integrated into research and practice. Understanding multidimensional factors influencing non-traditional tobacco use is essential to ensure that comprehensive tobacco control strategies address tobacco-related disparities.
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http://dx.doi.org/10.1136/tc.2010.042309DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3292671PMC
July 2012

Millennials considered: A new generation, new approaches, and implications for nursing education.

Nurs Educ Perspect 2008 Mar-Apr;29(2):74-9

Department of Nursing and Health Services Management, University of New England, Portland, Maine, USA.

A new generation is pursuing degrees in nursing. These students, 18 to 24 years old, aptly called Millennials, are technologically competent and described as optimistic and group oriented. Their propensity for multitasking, reliance on electronics, and need for immediate feedback often perplex and frustrate faculty and challenge customary approaches to teaching and learning. They often express doubt regarding their academic readiness for college. This article explores the authors' experiences with freshmen students of the Millennial generation and shares insights for working successfully with this cohort of learners. The authors assert that by developing strong partnerships with students, faculty may be able to bridge the generational gap to promote mutual understanding, personal growth, and academic success.
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http://dx.doi.org/10.1097/00024776-200803000-00007DOI Listing
June 2008

Behavioral and social issues among volunteers in a preventive HIV vaccine trial in Thailand.

J Acquir Immune Defic Syndr 2005 Dec;40(5):592-9

Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

Behavioral and social issues were investigated in 363 phase I/II preventive HIV-1 vaccine trial volunteers in Thailand. These issues included risk behavior, HIV knowledge, distress, and social consequences of vaccine trial participation. Data were collected at baseline and at 4-, 8-, and 12-month follow-up visits. Volunteers reported relatively low levels of risk behaviors at baseline and at follow-up. Overtly negative reactions from family or friends were reported by 5.9%. No experiences of discrimination in employment, health care, or insurance were reported. Mean levels of distress were low throughout the trial, and HIV-related knowledge was high, although it was common to consider the possibility of HIV transmission through casual contact. Findings add to the evidence that preventive HIV vaccine trials are feasible in Thailand.
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http://dx.doi.org/10.1097/01.qai.0000171725.09812.a5DOI Listing
December 2005

Safety and immunogenicity of an HIV subtype B and E prime-boost vaccine combination in HIV-negative Thai adults.

J Infect Dis 2004 Aug 20;190(4):702-6. Epub 2004 Jul 20.

Royal Thai Component, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.

ALVAC-HIV (vCP1521) and AIDSVAX B/E were evaluated in a phase 1/2 trial of human immunodeficiency virus (HIV)-negative Thai adults. Of 133 volunteers enrolled, 122 completed the trial. There were no serious vaccine-related adverse events, nor were there intercurrent HIV infections. Lymphoproliferative responses to glycoprotein 120 E were induced in 63% of the volunteers, and HIV-specific CD8 cytotoxic T lymphocyte responses were induced in 24%. Antibody responses increased in frequency and magnitude in association with the dose level of AIDSVAX B/E. Binding and neutralizing antibodies to the MN strain were induced in 100% and 98%, respectively, of the volunteers receiving 600 microg of AIDSVAX B/E, and such antibodies to E strains were induced in 96% and 71%, respectively, of these volunteers. This vaccine combination was well tolerated and was immunogenic, meeting milestones for advancement to phase 3 evaluation.
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http://dx.doi.org/10.1086/422258DOI Listing
August 2004

A joint clinical research center in Thailand: role in HIV vaccine development.

Southeast Asian J Trop Med Public Health 2003 Mar;34(1):126-35

Department of Retrovirology, US Army Medical Component, Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.

In 1992 the Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand, collaborated with the Phramongkutklao Army Medical Center to set up the Joint Clinical Research Center (JCRC). The purpose of the Center is to conduct clinical research in support of HIV vaccine development and testing. To date, eight HIV vaccine-related research protocols have been conducted at the JCRC, involving 1,668 volunteers. The JCRC has been, and continues to be, a key site for the transfer of clinical trial expertise to new sites at universities, government clinics and hospitals in Thailand and other countries. Overall rates of follow-up have been excellent, while protocol violations and data clarification errors have been minimal.
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March 2003

Multifetal pregnancies: evolution of methods of initiation and impact of REI certification for patients seeking reduction.

Fetal Diagn Ther 2003 Mar-Apr;18(2):132-6

Madigan Army Medical Center, Tacoma, WA 98431, USA.

Objective: Multifetal pregnancy as a result of ovulation induction (OI) and assisted reproductive technologies (ART) correlate with Board certification in reproductive endocrinology and infertility (REI).

Design: Retrospective chart analysis of 304 patients referred to Wayne State University (WSU) and Thomas Jefferson University (TJU) for multifetal pregnancy reduction (MFPR) from March 1986 to January 1995 compared to 275 patients referred from January 1 to December 31, 2000 at MCP Hahnemann University.

Material And Methods: Chart review for fetal number, pregnancy generation (OI or ART) and physician REI Board certification from the American Board of Specialties Obstetrics and Gynecology. Information was available on 296 of 304 patients studied in the 1986-1995 WSU cohort and 275 patients studied from the MCP Hahnemann 2000 cohort.

Results: Analysis of 296 multifetal pregnancies at WSU and TJU for REI Board status showed non-REI Board-certified (NREI) physicians generated 174 pregnancies with quadruplets or more compared to 122 quadruplets or more by REI Board-certified physicians. Board certification did not impact quadruplet or more rates for OI or ART (p < 0.368). Of 275 patients with triplets or more at MCP Hahnemann, 156 (56.7%) were from ARTs versus 41.2% from 1986-1995 (chi(2) = 13.1, p < 0.001). Quintuplets or more decreased from 18.5 to 9.7% (chi(2) = 8.3, p = 0.004), and for REIs from 22.1 to 9.6% (chi(2) = 4.7, p < 0.01), while 14.4% of cases coming from non-REIs had quintuplets versus 9.6% from REIs (p = NS).

Conclusions: Cases of MFPR from ARTs have risen, while percentage of cases with quintuplets have fallen in half. We found no difference in quintuplets between REIs and non-REIs overall, but REI quintuplets fell significantly, and NREI has not.
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http://dx.doi.org/10.1159/000068550DOI Listing
September 2003

Myosin light chain phosphorylation and growth cone motility.

J Neurobiol 2002 Sep;52(3):175-88

Department of Biological Sciences and Neuroscience Research Center, University at Albany-SUNY, New York 12222, USA.

According to the treadmill hypothesis, the rate of growth cone advance depends upon the difference between the rates of protrusion (powered by actin polymerization at the leading edge) and retrograde F-actin flow, powered by activated myosin. Myosin II, a strong candidate for powering the retrograde flow, is activated by myosin light chain (MLC) phosphorylation. Earlier results showing that pharmacological inhibition of myosin light chain kinase (MLCK) causes growth cone collapse with loss of F-actin-based structures are seemingly inconsistent with the treadmill hypothesis, which predicts faster growth cone advance. These experiments re-examine this issue using an inhibitory pseudosubstrate peptide taken from the MLCK sequence and coupled to the fatty acid stearate to allow it to cross the membrane. At 5-25 microM, the peptide completely collapsed growth cones from goldfish retina with a progressive loss of lamellipodia and then filopodia, as seen with pharmacological inhibitors, but fully reversible. Lower concentrations (2.5 microM) both simplified the growth cone (fewer filopodia) and caused faster advance, doubling growth rates for many axons (51-102 microm/h; p <.025). Rhodamine-phalloidin staining showed reduced F-actin content in the faster growing growth cones, and marked reductions in collapsed ones. At higher concentrations, there was a transient advance of individual filopodia before collapse (also seen with the general myosin inhibitor, butanedione monoxime, which did not accelerate growth). The rho/rho kinase pathway modulates MLC dephosphorylation by myosin-bound protein phosphatase 1 (MPP1), and manipulations of MPP1 also altered motility. Lysophosphatidic acid (10 microM), which causes inhibition of MPP1 to accumulate activated myosin II, caused a contracted collapse (vs. that due to loss of F-actin) but was ineffective after treatment with low doses of peptide, demonstrating that the peptide acts via MLC phosphorylation. Inhibiting rho kinase with Y27632 (100 microM) to disinhibit the phosphatase increased the growth rate like the MLCK peptide, as expected. These results suggest that: varying the level of MLCK activity inversely affects the rate of growth cone advance, consistent with the treadmill hypothesis and myosin II powering of retrograde F-actin flow; MLCK activity in growth cones, as in fibroblasts, contributes strongly to controlling the amount of F-actin; and the phosphatase is already highly active in these cultures, because rho kinase inhibition produces much smaller effects on growth than does MLCK inhibition.
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http://dx.doi.org/10.1002/neu.10083DOI Listing
September 2002

Recruiting volunteers for a multisite phase I/II HIV preventive vaccine trial in Thailand.

J Acquir Immune Defic Syndr 2002 Aug;30(5):503-13

Faculty of Nursing and Research Institute of Health Sciences, Chiang Mai University, Chiang Mai, Thailand.

Factors believed to be predictive of retention through the recruitment and screening processes for preventive HIV trials were investigated in a large multisite phase I/II HIV vaccine trial in Thailand. Retention through recruitment was equal to or greater than in previous smaller trials with similar populations. The data suggested that recruitment proceeded in a stepwise manner with different influences at each step. Demographic and motivational variables were most important in predicting retention in making and keeping screening appointments. Altruistic or mixed altruistic and nonaltruistic motives were associated with greater retention. Laboratory/medical variables appeared to be the main influence on retention during screening, although some volunteers withdrew for different reasons. The frequent presence of mixed (altruistic and nonaltruistic) motives at initial contact suggests that motivation for trials is more complex than has been previously acknowledged.
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http://dx.doi.org/10.1097/00126334-200208150-00006DOI Listing
August 2002

Direct effect of estradiol-17β on progesterone accumulation by ovarian granulosa cells from rhesus monkeys.

Am J Primatol 1989 ;17(1):87-92

Wisconsin Regional Primate Research Center, Madison.

We have previously demonstrated that estradiol-17β (E) administered in vivo induces atresia of the dominant ovarian follicle (DF). Whether this effect is exerted directly at the ovarian level or by central mediation has not been confirmed. The present study was designed to assess whether E in amounts similar to those found in monkey follicular fluid (FF) directly alters in vitro progesterone (P) accumulation by granulosa cells (GC) aspirated from follicles in cycling rhesus monkeys. Follicular contents were aspirated from three to five animals on each of days 8-13 of the cycle. GC were plated at a density of 50,000 viable GC/0.5 ml medium; GC were incubated with 0 or 2-2,000 ng/ml E, and cultures were maintained for 72 h. P accumulation by GC collected on day 8 and treated with 2 ng/ml E was augmented 37.5 ± 5.5% (X ± S. E. M.; P<.05) over controls but was diminished significantly at 20 ng/ml ( -55 ± 18% with respect to controls), 200 ng/ml ( -73.7 ± 13.2%), and 2,000 ng/ml ( -77.3 ± 18.4%). A similar dose-response relationship was noted on other cycle days. At a concentration of 2,000 ng/ml, E significantly reduced P 91.5 ± 8.5% (day 10), 81.5 ± 18.5% (day 11), 84.3 ± 4.7% (day 12), and 53.7 ± 15.8% (day 13). We conclude that E at concentrations found in FF can inhibit P output by monkey GC through a direct action.
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http://dx.doi.org/10.1002/ajp.1350170109DOI Listing
January 1989

Atresia of the dominant ovarian follicle in rhesus monkeys is detected within 24 hours of estradiol treatment.

Am J Primatol 1989 ;18(3):237-243

Wisconsin Regional Primate Research Center, Madison.

Following treatment with estradiol-17β (E) on day 6 of the menstrual cycle, degenerative alterations in the microenvironment of the dominant follicle (DF) (follicular fluid [FF], granulosa cells [GC], and oocyte) are readily apparent on day 10, or 96 h after E administration. The present study was designed to determine how early such changes could be detected and which indices of atresia were observed first. The DF was identified during laparoscopy on day 5 or 6 of the cycle, and four capsules containing crystalline E were inserted s.c. for 24 h. Contents of the DF were aspirated at 24, 48, and 72 h following initiation of E treatment. General size and appearance of the DF did not change distinctly with E treatment; however, by 48 h FF viscosity was increased markedly. GC viability was not altered with treatment. FF concentrations of estrogen (E) were dramatically reduced at 24 h. These differences were maintained at 48 h and at 72 h. E accumulation by cultured GC was significantly reduced by > eightfold. There appeared a similar trend for reduced progesterone (P) in FF and decreased P production by GC in vitro. These results demonstrate that degenerative alterations in the DF indicative of atresia can be detected as early as 24 h after initiation of E treatment; the index of atresia appearing earliest is a reduction in FF concentrations of E, and the first morphological changes in the DF can be observed 24 h later. This study indicates that biochemical alterations precede morphologic changes with E-induced atresia, and should allow us to begin to determine the earliest events and putative initiation sites of atresia.
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http://dx.doi.org/10.1002/ajp.1350180307DOI Listing
January 1989