A Systematic Review of Educational Interventions to Equip Health and Social Care Professionals to Promote End-of-Life Supportive Care when a Parent with Dependent Children is Dying with Cancer.

OBJECTIVES: This systematic review aimed to determine the content, mode of delivery, assessment, and outcomes of educational interventions to equip health and social care professionals when delivering end of life supportive care for parents dying with cancer who have dependent children. DATA SOURCES: A mixed-methods systematic review was undertaken. Six electronic database were searched from their inception until September 2023 (Medline OVID, CINAHL, EMBASE, PsycINFO, Web of Science, and ERIC), supplemented by citation chaining, grey literature searches using Google Advanced Search and relevant professional bodies. Quality assessment was conducted independently by two researchers on the included studies. A convergent integrated approach was utilised for data synthesis. CONCLUSION: The review identified two educational interventions; highlighting a dearth of training opportunities to equip health and social care professionals to provide supportive care to families when a parent is at end of life with cancer. Despite health and social care professionals reported need and desire for upskilling in this area of clinical practice, there is a severe lack of evidence-based educational interventions. It is imperative that effective educational interventions are made accessible to professionals. IMPLICATIONS FOR NURSING PRACTICE: There is an imminent need for robust educational interventions to be developed, as health and social care professionals often lack the knowledge, skills and confidence on how best to support families when a parent of dependent children is at end of life. Health and social care professionals engagement with high-quality, evidence-based and theory-driven educational interventions has the potential to impact professionals' provision of family-centred cancer care at end of life. This could lead to better mental and physical outcomes for the whole family at end of life and in bereavement.

Development and Implementation of an Online Education Program on Advanced Breast Cancer for European Cancer Nurses: ABC4Nurses Project: a Brief Report.

Breast cancer is now the most commonly diagnosed cancer worldwide. Approximately 30% of those who present with early breast cancer later develop advanced breast cancer (ABC). Additionally, approximately 6% have advanced breast cancer at diagnosis. New treatment options result in an extended lifespan dominated by cycles of deterioration and stable disease. Specialist nurse knowledge is key to multidisciplinary care of people with ABC; however, access to education on ABC for nurses is not universally available in Europe. This paper describes the development and implementation of an online bespoke program on ABC care for specialist and generalist nurses in Europe. The project team is affiliated with the European Oncology Nurses Society (EONS) and comprises specialist breast cancer nurses, oncology nurse academics and breast cancer advocates associated with EUROPA DONNA Turkey, an independent non-profit European breast cancer organisation. The program development involved (1) a systematic review of ABC educational resources for cancer nurses; (2) a modified four-round Delphi study to seek agreement on curriculum content and (3) curriculum development, conversion to an interactive online platform and translation into four European languages. The program evaluation will be guided by Kirkpatrick's framework. The phases described in this short report could guide others involved in developing bespoke cancer education programs.

Consensus views on an advanced breast cancer education curriculum for cancer nurses: A Delphi study.

BACKGROUND: Specialist nursing care is a core indicator of quality care for people living with advanced breast cancer. However, access to and quality of nurse education programmes in advanced breast cancer is variable. OBJECTIVES: This study aims to define the topics for inclusion in an international curriculum for an advanced breast cancer education programme. METHODS: A modified four-round Delphi study was undertaken with experts by profession and experience in advanced breast cancer. Thirty-four topics related to advanced breast cancer and six online teaching and learning methods were pre-selected following a systematic review. Between September 2021 and March 2022, the expert panel determined the importance of topics for inclusion in the education programme. Consensus was defined by at least 80 % agreement on the highest three points on a 9-point Likert scale. RESULTS: A total of 31 experts participated in rounds 1-3 of this study, and 156 experts by profession and experience participated in an additional fourth round, including people living with advanced breast cancer (n = 72, 46 %), healthcare professionals (n = 46, 29 %), family members or caregivers of a person diagnosed with advanced breast cancer (n = 30, 19 %) and advocacy professionals working in the area of advanced breast cancer (n = 8, 5 %). In round 4, 36 topics and five of six learning methods reached consensus. CONCLUSIONS: The results of this study provide a framework to develop education programmes in advanced breast cancer, defining the essential elements of curriculum content for such programmes. The results highlight the need for advanced breast cancer education programmes to use multiple teaching and learning methods to promote nurses' understanding of person-centred supportive care and the physical, psychosocial and spiritual issues experienced by people living with advanced breast cancer.

Scientific, ethical, and legal considerations for the inclusion of pregnant people in clinical trials.

Clinical trials to address the COVID-19 public health emergency have broadly excluded pregnant people from participation, illustrating a long-standing trend of clinical trial exclusion that has led to a clear knowledge gap and unmet need in the treatment and prevention of medical conditions experienced during pregnancy and of pregnancy-related conditions. Drugs (includes products such as drugs, biologics, biosimilars and vaccines) approved for a certain medical condition in adults are also approved for use in pregnant adults with the same medical condition, unless contraindicated for use in pregnancy. However, there are limited pregnancy-specific data on risks and benefits of drugs in pregnant people, despite their approval for all adults. The United States Food and Drug Administration-approved medical products are used widely by pregnant people, 90% of whom take at least 1 medication during the course of their pregnancy despite there being sparse data from clinical trials on these products in pregnancy. This overall lack of clinical data precludes informed decision-making, causing clinicians and pregnant patients to have to decide whether to pursue treatment without an adequate understanding of potential effects. Although some United States Food and Drug Administration initiatives and other federal efforts have helped to promote the inclusion of pregnant people in clinical research, broader collaboration and reforms are needed to address challenges related to the design and conduct of trials that enroll pregnant people, and to forge a culture of widespread inclusion of pregnant people in clinical research. This article summarizes the scientific, ethical, and legal considerations governing research conducted during pregnancy, as discussed during a recent subject matter expert convening held by the Duke-Margolis Center for Health Policy and the United States Food and Drug Administration on this topic. This article also recommends strategies for overcoming impediments to inclusion and trial conduct.

Prospect of Direct Benefit in Pediatric Trials: Practical Challenges and Potential Solutions.

Clinical research in pediatric patients is necessary to develop safe and effective medicines for children. US Food and Drug Administration (FDA) human subject protection regulations (21 Code of Federal Regulations 50, subpart D) require that, with limited exceptions, research in children that exceeds a defined level of risk must offer a prospect of direct benefit to the individual child that is sufficient to justify those risks. Growing attention to the merits of initiating pediatric clinical trials earlier in the drug and biological product development process has led the FDA to look more closely at the meaning of the regulatory term prospect of direct benefit. In collaboration with the FDA, the Duke-Margolis Center for Health Policy convened a workshop with leading experts in the fields of biomedical ethics, pediatric clinical research, and pediatric product development, as well as patient representatives, to discuss the FDA's approach to characterizing prospect of direct benefit in the context of scientific advances in product development. Workshop topics included the extrapolation of adult efficacy data to children, use of nonclinical models of disease, use of modeling and simulation to support pediatric dosing, and reliance on biomarkers and surrogate end points in clinical research. Discussion from the workshop is provided herein to communicate the challenges that investigators, industry sponsors, regulators, and institutional review boards face when evaluating pediatric research and to outline several approaches to maximize prospect of direct benefit, minimize unnecessary risks and burden, and facilitate timely access to safe and effective medicines for children.

Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm Birth.

Chronic pulmonary and respiratory conditions associated with preterm birth are incompletely characterized, complicating long-term treatment and development of more effective therapies. Stakeholders face challenges in the development of validated, clinically meaningful endpoints that adequately measure morbidities and predict or represent health outcomes for preterm neonates. We propose in this paper a research agenda, informed by the input of experts from a 2018 workshop we convened on this topic, to advance endpoint and treatment development. We discuss the necessity of further evaluation of existing endpoints and the improved characterization of disease endotypes. We also discuss key steps to the development of optimized short- and long-term endpoints that can be linked to meaningful health outcomes. Finally, we discuss the importance of limiting variability in data collection and the application of new clinical trial endpoints as well as the critical nature of multi-stakeholder collaboration to advancing therapeutic development for this vulnerable patient population.

FDA postmarketing safety labeling changes: What have we learned since 2010 about impacts on prescribing rates, drug utilization, and treatment outcomes.

PURPOSE: Prior literature reviews have identified gaps in understanding of how postmarketing safety labeling changes and related FDA communications impact key clinical and behavioral outcomes. We conducted a review of newly published studies on this topic to determine what new evidence exists and to identify which gaps may still remain. We believe that this information can support FDA as it develops and implements future risk communication approaches. METHODS: We searched PubMed and Embase for studies published between January 1, 2010, and August 7, 2017 that examined the impact of labeling changes or associated FDA safety-related communications. For each study, we extracted information on research design and findings for key clinical outcomes and behaviors. We also conducted a ROBINS-I review to identify potential for bias in the research design of each study. RESULTS: We found that the estimated impacts of FDA labeling changes on several key outcomes-including adverse events-varied. Labeling changes also yielded unintended consequences on drug prescribing in some cases, despite low provider adherence. Finally, some studies we reviewed exhibited potential for bias due to confounding, among other factors. CONCLUSIONS: The new studies we reviewed contain many of the same limitations identified in previously published reviews. While there are several challenges to conducting this research there is substantial room for improvement in the quality of the evidence base. More information, particularly with respect to the types of populations and medications affected by labeling changes, is needed to support the development of more effective and targeted safety communications.

Short-term intermittent PTH 1-34 administration enhances bone formation in SCID/Beige mice.

The anabolic effect of intermittent PTH on bone is variable depending on the species studied, duration/mode of administration, and location of skeletal response investigated. We tested the hypothesis low dose, short term, intermittent PTH 1-34 administration is sufficient to enhance bone formation without altering bone resorption. To test our hypothesis, mice were treated intermittently with one of three concentrations of PTH 1-34 (1 microg/kg; low, 10 microg/kg, or 20 microg/kg; high) for three weeks. The skeletal response was identified by quantifying: serum markers of bone turnover, cancellous bone parameters in distal femur, proximal tibia, and lumbar vertebrae by microCT, and number of osteoblasts and osteoclasts in distal femur. Mice receiving 20 microg/kg of PTH 1-34 demonstrated a 30% increase in serum osteocalcin, but no differences in serum calcium, type I collagen teleopeptides, or TRACP 5b. For all bones, microCT analysis suggested mice receiving 20 microg/kg of PTH 1-34 had increased cancellous bone mineral density, trabecular thickness and spacing, but decreased trabecular number. A 60% increase in the number of alkaline phosphatase positive osteoblasts in the distal femur was also observed in tissue sections; however, the number of TRAP positive osteoclasts was not different between test and control groups. While animals administered 10 microg/kg demonstrated similar trends for all bone turnover indices, such alterations were not observed in animals administered PTH 1-34 at 1 microg/kg per day. Thus, PTH 1-34, administered intermittently for three weeks at 20 microg/kg is sufficient to enhance bone formation without enhancing resorption.

Two decades of nurse-led research on smoking during pregnancy and postpartum: concept development to intervention trials.

Tobacco use during pregnancy and postpartum is a leading cause of preventable morbidities for women and their infants. Over the past two decades, nursing research has addressed this recalcitrant clinical problem from a variety of conceptual and methodological perspectives. The 64 published studies (1988-2009) that met inclusion criteria for this systematic review represent the full research trajectory from concept development to intervention testing. Meta-analysis demonstrated an overall significant trend in nursing intervention efficacy (OR = 1.14, 95% CI = 1.08-1.2) for studies that examined comparable prenatal and postpartum smoking cessation outcomes. Implications for future nursing research and evidence-based policy are presented.

Postpartum tobacco use: developing evidence for practice.

Most women who quit smoking during pregnancy return to tobacco use within 6 months after delivery. Findings demonstrate that minimal intervention effectiveness exists with strategies to prevent postpartum smoking relapse. This article provides a synthesis of current research on postpartum tobacco use. Whether in the labor and delivery suite, the postpartum floor, or the neonatal ICU, acute and critical care nurses have a valuable role to help reduce the incidence of tobacco-related maternal and child outcomes.