Long-term Cross-reactivity Against Nonvaccine Human Papillomavirus Types 31 and 45 After 2- or 3-Dose Schedules of the AS04-Adjuvanted Human HPV-16/18 Vaccine.

This analysis focused on long-term cross-reactive immunogenicity against nonvaccine human papillomavirus (HPV) types 31 and 45 following 2 doses of AS04-adjuvanted HPV-16/18 vaccine in girls aged 9-14 years or following 3 doses in women aged 15-25 years, for up to 3 years (HPV-070 study) and up to 5 years (HPV-048 study) after the first vaccination. Both schedules elicited antibodies against HPV-31 and HPV-45 up to 5 years after first dose. The antibody concentration was similar in young girls as compared to women. Specific CD4+ T-cell and B-cell responses to HPV-31 and HPV-45 at month 36 were similar across groups. Clinical trials registration: NCT01381575 and NCT00541970.

Teaching evidence-based nursing practice to student nurses in developing countries: strategies for novice nurse educators.

Introduction Globally, Evidence based nursing practice (EBNP) is becoming an expected norm for nursing practice. The small-scale activities surrounding this practice in African countries indicate a need for better approaches to enhance EBNP. One of these approaches is strengthening nursing education through EBNP education. Objectives The purpose of this paper is to provide strategies to African novice nurse educators to teach EBNP, with the ultimate goal of promoting it in clinical settings when the student nurses enter professional practice. Methods This is a discussion paper based on the results of a systematic review. Results In this paper, the authors create an understanding of EBNP, describe the state of nursing education in Africa, and propose the EBNP content to be taught as well as how to teach it. Conclusions Emphasis is on educational strategies that create student engagement, promote critical thinking, unite clinical and classroom settings, and are cost-effective within the context of Africa.

Forward view: advancing health library and knowledge services in England.

This article is the fourth in a series on New Directions. The National Health Service is under pressure, challenged to meet the needs of an ageing population, whilst striving to improve standards and ensure decision making is underpinned by evidence. Health Education England is steering a new course for NHS library and knowledge services in England to ensure access to knowledge and evidence for all decision makers. Knowledge for Healthcare calls for service transformation, role redesign, greater coordination and collaboration. To meet user expectations, health libraries must achieve sustainable, affordable access to digital content. Traditional tasks will progressively become mechanised. Alongside supporting learners, NHS librarians and knowledge specialists will take a greater role as knowledge brokers, delivering business critical services. They will support the NHS workforce to signpost patients and the public to high-quality information. There is a need for greater efficiency and effectiveness through greater co-operation and service mergers. Evaluation of service quality will focus more on outcomes, less on counting. These changes require an agile workforce, fit for the future. There is a bright future in which librarians' expertise is used to mobilise evidence, manage and share knowledge, support patients, carers and families, optimise technology and social media and provide a keystone for improved patient care and safety.

Communities of practice in nursing academia: a growing need to practice what we teach.

Although the community of practice (CoP) concept has been heavily utilized in business literature since its inception in the 1990s, it has not been significantly featured in nursing research. With student-centered approaches increasingly infusing nursing classrooms, including opportunities for collaborative learning and the development of student learning communities, it may be time to ask: Do we practice what we teach? Nursing academia faces challenges related to recruitment and retention, scholarly productivity and engagement of new faculty, and increasing demands for collaborative research. Challenges, some would argue, that could be addressed through CoPs; a sentiment reflected in the recent expansion of nursing CoP literature. What is the current state of the application of this concept in nursing academia and what barriers present in the promotion and development of CoPs in the academy? This article addresses these questions and provides guidance for those in search of community.

A student evaluation workshop with rural nursing preceptors.

Increasingly, clinicians and faculty members are motivated to provide students quality preceptorship placements in rural areas, particularly in light of the potential for recruitment of new graduates to underserved areas. Invariably, student performance evaluation is an onerous task for many preceptors and one in which they often feel ill-prepared. Rural preceptors may face additional challenges given the lesser availability of educational resources and professional development. In this article, the authors detail the development, pilot testing, and evaluation of a workshop on student evaluation that was created in collaboration with rural nurse preceptors.

Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study.

BACKGROUND: Highly pathogenic avian influenza H5N1 viruses remain a threat to human health, with potential to become pandemic agents. METHODS: This phase III, placebo-controlled, observer-blinded study evaluated the immunogenicity, cross-reactivity, safety, and lot consistency of 2 doses of oil-in-water (AS03(A)) adjuvanted H5N1 A/Indonesia/05/2005 (3.75 µg hemagglutinin antigen) prepandemic candidate vaccine in 4561 adults aged 18-91 years. RESULTS: Humoral antibody responses in the H5N1 vaccine groups fulfilled US and European immunogenicity licensure criteria for pandemic vaccines in all age strata 21 days after the second dose. At 6 months after the administration of the primary dose, serum antibody seroconversion rates continued to fulfill licensure criteria. Neutralizing cross-clade immune responses were demonstrated against clade 1 A/Vietnam/1194/2004. Consistency was demonstrated for 3 consecutive H5N1 vaccine lots. Temporary injection-site pain was more frequent with H5N1 vaccine than placebo (89.3% and 70.7% in the 18-64 and ≥65 years strata vs 22.2% and 14.4% in the placebo groups). Unsolicited adverse event frequency, including medically attended and serious events, was similar between groups through day 364. CONCLUSIONS: In adults and elderly adults, AS03(A)-adjuvanted H5N1 candidate vaccine was highly immunogenic for A/Indonesia/05/2005, with cross-reactivity against A/Vietnam/1194/2004. Temporary injection site reactions were more frequent with H5N1 vaccine than placebo, although the H5N1 vaccine was well tolerated overall. Clinical Trials Registration. NCT00616928.

Modification, Translation, and Psychometric Testing of the Arabic Version of the Belongingness Scale-Clinical Placement Experience.

BACKGROUND: This paper aimed to describe the modification, translation, and psychometric testing of the Arabic version of the Belongingness Scale-Clinical Placement Experience (BES-CPE). METHODS: This study included the following phases: modification of the original BES-CPE based on the qualitative findings from a previous study; translation and back-translation of the scale; evaluation of the content validity by experts from Saudi Arabia; evaluation of the internal consistency reliability; and other psychometric properties of the Arabic BES-CPE. RESULT: The results demonstrated acceptable psychometric properties. The Cronbach' s alpha ranged from 0.68 to 0.92. CONCLUSION: The Arabic BES-CPE is a promising tool that can be used to assess Saudi nursing students' sense of belonging. However, testing the tool with other undergraduate nursing students in a different context is recommended.

Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study.

The immunogenicity of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix®, GlaxoSmithKline Biologicals) administered according to its licensed vaccination schedule (3-dose, 3D) and formulation (20 µg of each HPV antigen; 20/20F) has previously been demonstrated. This partially-blind, controlled, randomized trial (NCT00541970) evaluated 2-dose (2D) schedules using the licensed 20/20F or an alternative formulation containing 40 µg of each antigen (40/40F), compared with the licensed 3D schedule. Healthy females stratified by age (9-14, 15-19, 20-25 y) were randomized to receive 2 doses of 20/20F at Months (M) 0,6 (n=240), 40/40F at M0,6 (n=241) or 40/40F at M0,2 (n=240), or 3 doses of 20/20F at M0,1,6 (licensed schedule/formulation, n=239). One month after the last dose, the 3D schedule was not immunologically superior to 2D schedules except in the 40/40F M0,2 group for HPV-16 (lower limit of 95% CI geometric mean antibody titer (GMT) ratio [2D/3D] < 0.5). For both HPV-16 and HPV-18, the 2D schedules in girls 9-14 y were immunologically non-inferior to the 3D schedule in women 15-25 y (the age group in which efficacy has been demonstrated) (upper limit of 95% CI for GMT ratio [3D/2D] < 2) one month after the last dose. At Month 24, non-inferiority was maintained for the 2D M0,6 schedules in girls 9-14 y versus the 3D schedule in women 15-25 y. All formulations had acceptable reactogenicity and safety profiles. These results indicate that the HPV-16/18 vaccine on a 2D M0,6 schedule is immunogenic and generally well tolerated in girls 9-14 y and that the 2D schedule is likely adequate for younger females.

Safety and cross-reactive immunogenicity of candidate AS03-adjuvanted prepandemic H5N1 influenza vaccines: a randomized controlled phase 1/2 trial in adults.

BACKGROUND: The tocopherol-based oil-in-water emulsion adjuvant system family (AS03) improves antigen sparing with split-virion H5N1 influenza vaccines, representing an important development for pandemic preparedness. In this phase 1/2 randomized, controlled, observer-blinded study in 680 adults, we assessed the immunogenicity and safety of A/Indonesia/5/05 H5N1 (IBCDC-RG2, clade 2.1) prepandemic candidate vaccines produced at 2 separate manufacturing sites. METHODS: Two doses, each of which contained 3.75 microg of hemagglutinin antigen, were given 21 days apart either without adjuvant or with an adjuvant system containing 11.86 mg or 5.93 mg of tocopherol (AS03). RESULTS: The AS03-adjuvanted A/Indonesia/05/2005 (NIBRG-14) vaccines were significantly more immunogenic than nonadjuvanted vaccine in homologous assays. Neutralizing cross-clade immunogenicity against clades 1, 2.2, and 2.3 was demonstrated at day 42 with all vaccines; at 6 months, seroconversion rates were highest for clade 2.2 (60.7%) and for clade 1 (38.3%). Adjuvantation was associated with increased short-term injection-site reactions (pain) in 80% of participants, with such reactions assessed as being of grade 3 severity for 4.0% of doses. No other safety or reactogenicity concerns were identified over 6 months of follow-up. CONCLUSIONS: Humoral responses against the adjuvanted 3.75-microg hemagglutinin antigen vaccines from both manufacturing sites fulfilled European and US licensure criteria for immunogenicity for influenza vaccines.

Teaching evidence-based nursing practice: A systematic review and convergent qualitative synthesis.

BACKGROUND: The benefits that ensue evidence-based nursing practice (EBNP) in health care settings have been globally communicated to the nurses. However, the current clinical activities surrounding EBNP demand the involvement of nursing schools to accelerate this practice. OBJECTIVES: The purpose of this study was to synthesize, describe, and explore the evidence available to teach EBNP to undergraduate student nurses, so the students can continue to integrate EBNP in clinical settings upon becoming professional nurses. DESIGN: Systematic review with convergent qualitative synthesis. DATA SOURCES: Five electronic databases were searched; CINAHL, MEDLINE, EMBASE, ERIC, and Web of Science Core Collection. REVIEW METHODS: This study followed the guidelines for writing systematic reviews by the Joanna Briggs Institute. RESULTS: Two themes were generated; educational strategies, and EBNP knowledge and implementation. The latter theme had six sub-themes of timing, duration, content, delivery method, context, and prerequisites while the former theme had four sub-themes of knowledge acquisition, EBNP use and research utilization, collaborative teaching, and barriers and facilitators. CONCLUSION: Well-designed educational strategies have a positive impact on students' EBNP knowledge and skills. These strategies are well suited for promoting EBNP implementation in clinical settings when students qualify as nurses.

Seeking Divine Intervention to Manage the Advanced Stages of Breast Cancer in Southwestern Nigeria.

BACKGROUND: The World Health Organization records indicate that breast cancer is the most common cancer in women both in developed and developing regions of the world. In developed countries, breast cancer is the second cause of cancer-related deaths, whereas in developing countries, breast cancer is the leading cause of cancer-related mortality in women. The empirical literature on Nigeria indicates that women present with advanced stages of the illness. OBJECTIVES: To explore the health-seeking behaviors of Southwestern Nigerian women with advanced breast cancer from the time they noticed a breast abnormality to their eventual presentation at the hospital for the management of the illness. METHODS: Thirty women with advanced stages of breast cancer in a large tertiary, referral, teaching, and university-affiliated Southwestern Nigeria Hospital were purposively selected for study participation. Participants completed a demographic information form and an in-depth face-to-face, one-on-one, semistructured interview guided by open-ended questions. Data analysis was inductive. RESULTS: Findings revealed that women sought divine interventions for the management of breast cancer. Prayer and spirituality were associated with high levels of optimism among the study participants. CONCLUSION: Nurses should provide information and counseling to women and the general public on the etiology and appropriate management of breast abnormalities and include the importance of a spiritual dimension of care. IMPLICATIONS FOR PRACTICE: Findings indicate the need to introduce a spiritual dimension to the care of women with advanced breast cancer. Findings also indicate the need for a comprehensive population-based breast health education.

A Pilot Trial Using Telemedicine in Radiation Oncology: The Future of Health Care Is Virtual.

Background: Social determinants of health directly affect cancer survival. Driven by advances in technology and recent demands due to COVID-19, telemedicine has the ability to improve patient access to care, lower health care costs, and increase workflow efficiency. The role of telemedicine in radiation oncology is not established. Materials and Methods: We conducted an IRB-approved pilot trial using a telehealth platform for the first post-radiation visit in patients with any cancer diagnosis. The primary endpoint was feasibility of using telehealth defined by completion of five telehealth visits per month in a single department. Secondary endpoints included the ability to assess patients appropriately, patient and physician satisfaction. Physicians were surveyed again during the pandemic to determine whether viewpoints changed. Results: Between May 27, 2016 and August 1, 2018, 37 patients were enrolled in the Telehealth in Post-operative Radiation Therapy (TelePORT) trial, with 24 evaluable patients who completed their scheduled telehealth visit. On average, 1.4 patients were accrued per month. All patients were satisfied with their care, had enough time with their physician and 85.7% believed the telehealth communication was excellent. All physicians were able to accurately assess the patient's symptoms via telehealth, whereas 82.3% felt they could accurately assess treatment-related toxicity. Physicians assessing skin toxicity from breast radiation were those who did not feel they were able to assess toxicity. Discussion and Conclusions: Both health care providers and patients have identified telemedicine as a suitable platform for radiation oncology visits. Although there are limitations, telemedicine has significant potential for increasing access of cancer care delivery in radiation oncology.

Caring for the pregnant woman presenting at periviable gestation: acknowledging the ambiguity and uncertainty.

Counseling the periviable pregnant woman presenting at the edge of viability can often be confusing for the patient and frustrating for the clinician. Although neonatal survival rates have improved dramatically over the last few decades, severe morbidity is still common. This is further complicated by the fact that the information provided to the parents regarding the outcomes may not be up to date or completely accurate. The counseling is also frequently influenced by personal beliefs and biases of the medical staff. An evidence-based approach may improve the experience for both the expectant parents and the health care team.

Saudi female nursing students experiences of sense of belonging in the clinical settings: A qualitative study.

Many studies have reported that nursing students' sense of belonging during their clinical experiences is essential to their motivation to learn. This study was conducted to learn more about the meaning of sense of belonging, the consequences of sense of belonging, and the factors that affect Saudi female nursing students' sense of belonging in clinical settings. Using interpretive description methodology, the data were collected via semi-structured interviews with 16 students about their sense of belonging in clinical settings. It was conducted in three baccalaureate nursing programs in government institutions in Saudi Arabia. Each interview was audiotaped, transcribed verbatim in Arabic, and translated into English, and the data were analyzed using thematic analysis. The results indicated that participation in patient care, a welcoming environment, English language skills, the nationality of nursing staff, and acceptance by nursing staff, patients, and other health care professionals are some of the factors that affect Saudi female nursing students' sense of belonging in clinical settings. The findings may contribute to the creation and support of more effective clinical learning situations for nursing students in Saudi Arabia, improving the quality of their educational experiences and retaining them in the nursing profession.

Standardizing criteria for scheduling elective labor inductions.

Induction of labor has become routine practice in perinatal units across the United States, with rates reaching a high of 21.2% of births in 2003-2004. This article describes the process our institution used to standardize the criteria for scheduling inductions. Specifically, we aimed to increase the consistency in practice for scheduling and performing elective inductions, including mandating gestational age of 39 completed weeks, ensuring cervical ripeness, and disallowing the use of cervical ripening agents. The nurses' participation, from planning to implementation, was critical in the success of this evidence-based practice change.

Patients Undergoing Radiation Therapy Are at Risk of Financial Toxicity: A Patient-based Prospective Survey Study.

PURPOSE: Little is known about the financial burden experienced by patients receiving radiation therapy. Furthermore, currently, no financial toxicity screening tools have been validated for use in radiation oncology. METHODS AND MATERIALS: Physician surveys were used to gauge provider understanding of treatment costs and their willingness to adopt the use of financial toxicity screening tools. Post-treatment patient surveys were used to investigate the covariates of treatment-induced financial risk. RESULTS: Of the 210 radiation oncologists who completed our survey, 53% reported being "very concerned" with treatment-related costs negatively affecting their patients, and 80% believed that a financial toxicity screening tool would be useful in practice. An analysis of patient surveys using logistic regression found age and cancer site to be the most important variables associated with financial toxicity. Thirty-four patients (22%) experienced financial toxicity related to treatment. The financial toxicities experienced were loss of job (28%), loss of income (24%), difficulty paying their rent or mortgage (20%), difficulty paying for transportation (15%), and difficulty paying for meals (13%). CONCLUSIONS: Financial toxicity is an important measure for patients and providers and is experienced by approximately one quarter of patients. Further studies to improve models to predict financial toxicity and how financial toxicity is related to patient outcomes and quality of life are warranted.

Ethically involving students in faculty research.

Students in nursing education programs have a right to privacy as they engage in their learning. At the same time, their faculty may be engaged in nursing education research in order to facilitate student learning. These two goals may conflict when faculty engage students as participants in nursing education research while at the same time facilitating their learning. Faculty as researchers with their students may encounter a conflict of interest in collecting data for their research while providing learning experiences for the same students. As a basic principle, students must be engaged as participants in an ethical manner that respects their rights for privacy. In this article, we explore the issues of faculty as researchers of their students and suggest strategies for addressing these issues.

Sustained immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine administered as a two-dose schedule in adolescent girls: Five-year clinical data and modeling predictions from a randomized study.

In this randomized, partially-blind study ( clinicaltrials.gov ; NCT00541970), the licensed formulation of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (20 µg each of HPV-16/18 antigens) was found highly immunogenic up to 4 y after first vaccination, whether administered as a 2-dose (2D) schedule in girls 9-14 y or 3-dose (3D) schedule in women 15-25 y. This end-of-study analysis extends immunogenicity and safety data until Month (M) 60, and presents antibody persistence predictions estimated by piecewise and modified power law models. Healthy females (age stratified: 9-14, 15-19, 20-25 y) were randomized to receive 2D at M0,6 (N = 240 ) or 3D at M0,1,6 (N = 239). Here, results are reported for girls 9-14 y (2D) and women 15-25 y (3D). Seropositivity rates, geometric mean titers (by enzyme-linked immunosorbent assay) and geometric mean titer ratios (GMRs; 3D/2D; post-hoc exploratory analysis) were calculated. All subjects seronegative pre-vaccination in the according-to-protocol immunogenicity cohort were seropositive for anti-HPV-16 and -18 at M60. Antibody responses elicited by the 2D and 3D schedules were comparable at M60, with GMRs close to 1 (anti-HPV-16: 1.13 [95% confidence interval: 0.82-1.54]; anti-HPV-18: 1.06 [0.74-1.51]). Statistical modeling predicted that in 95% of subjects, antibodies induced by 2D and 3D schedules could persist above natural infection levels for ≥ 21 y post-vaccination. The vaccine had a clinically acceptable safety profile in both groups. In conclusion, a 2D M0,6 schedule of the HPV-16/18 AS04-adjuvanted vaccine was immunogenic for up to 5 y in 9-14 y-old girls. Statistical modeling predicted that 2D-induced antibodies could persist for longer than 20 y.

From practice to midrange theory and back again: Beck's theory of postpartum depression.

This article presents a brief overview of theory as background for a more detailed discussion of midrange theory-its origins, the critical role for midrange theory in the development of nursing practice knowledge, and the criteria for evaluating midrange theory. We then chronicle Cheryl Tatano Beck's program of research on postpartum depression (PPD) and advance the thesis that her theory of PPD, titled Teetering on the Edge, is an exemplar of a substantive midrange nursing theory. We demonstrate Beck's progression from identification of a clinical problem to exploratory-descriptive research, to concept analysis and midrange theory development, and finally to the application and testing of the theory in the clinical setting. Through ongoing refinement and testing of her theory, Beck has increased its generalizability across various practice settings and continually identifies new issues for investigation. Beck's program of research on PPD exemplifies using nursing outcomes to build and test nursing practice knowledge.