Safety and management of niraparib monotherapy in ovarian cancer clinical trials.

Niraparib is a poly (ADP-ribose) polymerase inhibitor that has shown a significant improvement in progression-free survival irrespective of biomarker status in patients with advanced epithelial ovarian cancer. This review focuses on the adverse events associated with niraparib and their management to maintain efficacy of niraparib treatment and improve quality of life for patients. In five trials assessing efficacy of niraparib in patients with advanced epithelial ovarian cancer (PRIMA, NOVA, NORA, QUADRA, and PRIME), treatment-emergent adverse events of any grade were reported in nearly all patients (≥99%) receiving niraparib; the events were grade ≥3 in 51-74% of patients. Across all lines of therapy, treatment-emergent adverse events led to dose interruptions in 62-80% of patients receiving niraparib and dose reductions in 47-71%. Hematologic events were most frequently reported, including thrombocytopenia, anemia, and neutropenia. Common non-hematologic events included gastrointestinal events, which were generally low grade (<5% were grade ≥3). Clinical strategies to manage these and other events, such as fatigue and insomnia, cognitive behavioral therapy and pharmacologic agents, are summarized. Once-daily niraparib dosing may be advantageous for some patients for many reasons, including night-time dosing which may help alleviate gastrointestinal symptoms. An individualized starting dose (determined by baseline body weight and platelet count) of niraparib demonstrated an improved safety profile while maintaining efficacy. Patients receiving the niraparib individualized starting dose had fewer grade ≥3 adverse events, dose interruptions, and dose reductions than patients receiving a fixed starting dose. The safety profile of niraparib across five pivotal studies in advanced epithelial ovarian cancer was consistent across multiple lines of treatment, including as maintenance therapy in first-line and recurrent settings and as treatment in heavily pre-treated patients. Long-term safety data from the NOVA trial confirmed that, with appropriate and early dose modifications, niraparib is well tolerated.

British Gynaecological Cancer Society recommendations and guidance on patient-initiated follow-up (PIFU).

The National Cancer Survivorship Initiative through the National Health Service (NHS) improvement in the UK started the implementation of stratified pathways of patient-initiated follow-up (PIFU) across various tumor types. Now the initiative is continued through the Living With and Beyond Cancer program by NHS England. Evidence from non-randomized studies and systematic reviews does not demonstrate a survival advantage to the long-established practice of hospital-based follow-up regimens, traditionally over 5 years. Evidence shows that patient needs are inadequately met under the traditional follow-up programs and there is therefore an urgent need to adapt pathways to the needs of patients. The assumption that hospital-based follow-up is able to detect cancer recurrences early and hence improve patient prognosis has not been validated. A recent survey demonstrates that follow-up practice across the UK varies widely, with telephone follow-up clinics, nurse-led clinics and PIFU becoming increasingly common. There are currently no completed randomized controlled trials in PIFU in gynecological malignancies, although there is a drive towards implementing PIFU. PIFU aims to individualize patient care, based on risk of recurrence and holistic needs, and optimizing resources. The British Gynaecological Cancer Society wishes to provide the gynecological oncology community with guidance and a recommendations statement regarding the value, indications, and limitations of PIFU in endometrial, cervical, ovarian, and vulvar cancers in an effort to standardize practice and improve patient care.

The impact of a complex workplace dietary intervention on Irish employees' off-duty dietary intakes.

A paucity of evidence exists regarding the impact of workplace dietary interventions on employees' off-duty dietary intakes. This study assessed the impact of workplace dietary interventions that included nutrition education and environmental dietary modification both alone and in combination on employees' dietary intakes inside (on-duty) and outside (off-duty) of work. A pre-post study on employees' on and off-duty dietary intakes was undertaken. Data were obtained from a complex workplace dietary intervention study (Food Choice at Work Trial). Four manufacturing workplaces were allocated to: Control (n = 111), nutrition education (n = 226), environmental dietary modification (n = 113) and nutrition education and environmental dietary modification combined (n = 400) (2013-14). Seven- to nine-month follow-up data were obtained for 517 employees (61% response) [Control (n = 67), Education (n = 107), Environment (n = 71) and Combined (n = 272)]. Dietary intakes were measured using 24-h dietary recalls. Differences between on and off-duty mean dietary intakes were compared and regression analyses adjusted for potential confounders. Significant reductions in on-duty intakes of total fat (-14.2 g/day, p = 0.000), saturated fat (-7 g/day, p = 0.000), salt (-1.4 g/day, p = 0.000) and total sugars (-8.9 g/day, p = 0.003) were observed in the Combined and in the Environment [total fat (-11.4 g/d, p = 0.017) and saturated fat (-8.8 g/day, p = 0.000)]. In the Combined, significant changes were also observed in off-duty intakes of total fat (-10.0 g/day, p = 0.001), saturated fat (-4.2 g/day, p = 0.001), salt (-0.7 g/day, p = 0.020) and total sugars (-8.1 g/day, p = 0.020). Food service can have a positive impact in our everyday environments, including inside and outside of work. Dietary interventions combining nutrition education and environmental dietary modification can improve employees' on and off-duty dietary intakes.

Expert recommendations on the management of hypertension in patients with ovarian and cervical cancer receiving bevacizumab in the UK.

Bevacizumab is an anti-vascular endothelial growth factor monoclonal antibody that may prolong survival in ovarian and cervical cancer when given in combination with chemotherapy. It works by blocking the signalling pathways that are required for tumour angiogenesis, potentially limiting the cancer's ability to grow and spread. Hypertension is a known side effect of all angiogenesis inhibitors and could lead to interruption or premature discontinuation of effective anti-cancer treatment. Hypertension may also act as a barrier to the initiation of such treatment. In this review, we aim to present clear and practical recommendations on the management of blood pressure in ovarian and cervical cancer patients before, during and after bevacizumab treatment. This guidance covers considerations before initiating bevacizumab therapy and recommendations on the management of patients who develop hypertension, or who experience worsening of pre-existing hypertension, during bevacizumab treatment, and once the course of bevacizumab has been completed. These recommendations were developed collaboratively by a group of clinicians, comprising cardiologists, oncologists, a general practitioner and specialist oncology nurses, with expertise and practical experience in either oncology or hypertension. The aim of these recommendations is to support oncologists with hypertension assessment and management to facilitate starting or continuing bevacizumab.

The Role of the Specialist Nurse in Gynaecological Cancer.

PURPOSE OF REVIEW: To explore the role of the specialist nurse within gynaecological cancer. RECENT FINDINGS: There are many different job titles associated with the role of the specialist nurse. Nursing roles are evolving not only to meet the increasing demands on services but also within the ever changing landscape of cancer treatments and improvement in survival. Women and their families need specialist nurses to guide and support them on their cancer journey, along the treatment trajectory and into survivorship. This paper explores specialist nurse roles generally, and within our service which have been adapted to meet service and patient needs within a gynaecological cancer centre. Irrelevant of title, specialist nurses are best suited to meet the patients' needs. The fundamental ethos of the care should always remain having the patients' best interest at heart, acting as their advocate - in essence giving them a voice when they need it.

Examining the implementation of a community paediatric clinic in a socially disadvantaged Irish community: A retrospective process evaluation.

BACKGROUND: Understanding interventions and their implementation is essential for improving community initiatives. Kidscope is a community paediatric development clinic providing free health and developmental assessment and onward referral for children aged zero to six years in an urban area of southern Ireland where many children experience complex needs. Established in 2010, Kidscope developed an inter-disciplinary, multi-agency community team by drawing on the strengths of local services and practitioners to deliver holistic approaches to child health and development. Recent studies examining stakeholder engagement and Kidscope outcomes highlighted the need to examine implementation to better understand the processes and mechanisms of the clinic and how events have affected outcomes. METHODS: Guided by the UK Medical Research Council Framework for Developing and Evaluating Complex Interventions, this study used a post-hoc qualitative process evaluation study design with multiple data sources; stakeholder perspectives (interviews, focus group, questionnaires) and document analysis (annual reports, meeting minutes, work plans). A diverse set of research questions were developed in conjunction with a Patient and Public Involvement Group. Guiding frameworks supported thematic analysis of primary data, document analysis of secondary data, and triangulation of findings across datasets. RESULTS: Data analysis yielded 17 themes and 18 sub-themes. Successful implementation hinged on developing a coalition of linked practitioners and services whose skills were utilised and enhanced within Kidscope to deliver a high-quality healthcare model to vulnerable children and families. Relational and multi-disciplinary working, innovative approaches to implementation and sustainability, training and education provision, and the accessible community location were among the mechanisms of change resulting in improved child, family, practitioner, and system-level outcomes. External factors such as COVID-19 and deficits in Ireland's disability services posed significant barriers to fidelity. CONCLUSION: This study provides evidence of the processes, mechanisms, and model of care employed by a community-based paediatric clinic to successfully engage society's most vulnerable families and promote health equity. This study makes an important contribution to the field of implementation research by offering an example of a robust approach to conceptualising and measuring implementation outcomes of community healthcare initiative in a changing, real-world context.

Parent perspectives of engaging with a community paediatric clinic with linked child development supports in a disadvantaged area of Ireland.

Parent experiences of child health services can be used to understand their value and optimise the support provision to families during critical developmental periods. A gap in the literature exists regarding parental perspectives of linked child development supports, particularly in disadvantaged areas. This study examined parent experiences of the impact and value of a community paediatric clinic (Kidscope) with linked, multi-agency supports in a disadvantaged area of Ireland. Using a qualitative analysis design, 10 parents participated in one-to-one interviews. A Community Advisory Group consulted on interview schedules. Data was thematically analysed in line with Braun & Clarke's Framework. Five themes and twenty-two sub-themes emerged. Kidscope's linked, multi-agency approach was valuable for engaging families, addressing developmental delay, supporting readiness for education, and developing parent-child relationships. Relational working and a child and family centred model of care empowered parents to become active agents in children's health. Coronavirus disease 2019, national deficits in healthcare, and staff turnover impeded service delivery. Kidscope and linked supports work in partnership to disrupt the impact exclusion from healthcare has on vulnerable children and families. This study provides evidence of an effective integrated paediatric service delivery model designed around vulnerable children and families and highlights areas for improvement.

Sustainable Development Goals in Ireland: How Public Health Nurses Are Contributing Through Engagement in an Interagency Community Pediatric Clinic.

Introduction: United Nations Sustainable Development Goals (SDGs) were adopted as a plan of action for people, planet, and prosperity by 2030. SDG 3 aims to ensure healthy lives and promote well-being for all ages, and other goals focus on reduction of inequality, abolition of poverty, decent work for all, and building effective, accountable, and inclusive institutions. A community pediatric clinic, Kidscope, was established in a vulnerable Irish community offering free developmental assessment and onward referral of children 0 to 6 years. The Kidscope model involves multiagency input with local public health nurses (PHNs) acting as fundamental partners in the provision of specialist early years support to vulnerable children and families. This study evaluates PHN involvement in Kidscope in the context of SDGs. Objective: To record and understand PHN roles within Kidscope and to capture their contribution to achieving SDGs in a disadvantaged Irish community. Methods: Qualitative stakeholder analysis and mapping design. Snowball sampling identified participants. Data collection involved scoping interviews, questionnaires, one-to-one interviews, and a focus group. A Stakeholder Matrix Table was developed in line with the guiding framework. Transcripts were thematically analyzed. Results: PHNs are key stakeholders in Kidscope contributing to clinic development, delivery, and sustainability. Six themes were identified: lead referrers, in-clinic support, learning and education, child and family follow-up, specialist early years role, and partnership working. PHNs contribute to six SDGs through the Kidscope model. Conclusion: PHNs are fundamental partners in achieving SDGs in a disadvantaged Irish community through ameliorating childhood developmental delay by intercepting the gap within Ireland's early intervention system and disrupting the impact exclusion to healthcare has on vulnerable children and their families. Findings underscore a shift from the current "cradle to grave" model of working toward a specialist early years PHN role.

Exploring Undergraduate Medical Student Experiences of Training Within a Community-Based Paediatric Clinic.

Background: Undergraduate medical education in Ireland comprises of clinical training largely within teaching hospitals, with less emphasis on training in community settings. Studies show a move beyond traditional models of training is needed, particularly in the domain of community child health. A multi-agency, inter-disciplinary community paediatric clinic was established in a disadvantaged area of southern Ireland. Kidscope provides health and developmental assessment for children aged 0-6 years and acts as a training clinic for medical students who complete a one day placement during the final year of their undergraduate medical degree. The aim of this study was to capture student experiences and to understand the perceived impact of community-based training on undergraduate medical education. Methods: A descriptive study design was used. Research tools included a mixed-methods online questionnaire and qualitative reflective essays. Microsoft Excel generated descriptive statistics from quantitative questionnaire responses. Braun and Clarke's framework guided thematic analysis of qualitative data. Data integration and reporting were conducted in line with mixed-methods research design standards. Results: Fifty-two medical students consented to participate. Thirty-two (62%) responded to the online questionnaire. Twenty reflective essays were randomly selected. Ninety-four percent felt the clinic provided an opportunity to apply knowledge and skills, 96% reported the experience strongly improved their understanding of child health and development, and 90% reported the experience was extremely valuable to their overall learning. Qualitative analysis showed engagement with a vulnerable population in the community increased student knowledge, informed practice, and heightened awareness of social deprivation and its impact on child development. Conclusion: Exposure to a community-based paediatric clinic influenced undergraduate medical student training through experiential and transformative learning. Our experience of teaching clinical skills in the community could be replicated across medical fields to the benefit of the wider community. Supplementary Information: The online version contains supplementary material available at 10.1007/s40670-022-01699-3.

Community paediatric clinics and their role in supporting developmental outcomes and services for children living in disadvantaged communities.

Children living in disadvantaged communities have substantially increased risk for deleterious health and developmental outcomes. A considerable proportion of developmental delay is avoidable; however if children do not receive appropriate treatment within this critical period, damage can be irreparable. Community paediatric clinics provide medical and developmental assessment; deliver health promotion services, counselling, and advice to caregivers; and referral to services. The aim of this study was to systematically search, appraise, and synthesise the literature exploring the role of community paediatric clinics in supporting developmental outcomes and services for children living in disadvantaged communities. Electronic databases were searched using a carefully developed search strategy. Validated tools and appropriate guidelines assessed quality and confidence in evidence. Data analysis and mixed-methods synthesis was guided by the Segregated Framework for Mixed-Method Systematic Reviews. Eighteen studies were selected for inclusion. Areas of emphasis in the literature include the identification and monitoring of developmental delay; engagement of vulnerable families; relational working with children, families, and local services; referral to early intervention services; parental empowerment, practitioner capacity building; and tackling barriers to healthcare access. Through use of a child and family-centred model of care, community paediatric clinics can better meet the needs of vulnerable populations.

British Gynaecological Cancer Society (BGCS) cervical cancer guidelines: Recommendations for practice.

Cervix cancer in many countries is declining and screening programmes and immunisation will reduce the incidence in the next few decades. This guideline attempts to cover management of invasive disease reflecting diagnosis and imaging including new imaging and sentinel lymph node biopsies. Smaller volume disease is usually managed surgically whereas advanced disease is treated with (chemo)- radiation. It also includes discussion of fertility sparing procedures. Practices are changing frequently for all aspects of care usually in attempts to reduce complications and improve quality of life. The management of advanced disease is treated by chemotherapy and the use of newer agents is also discussed. Other sections discuss specialist situations such as cancer in pregnancy, rare cervical tumours, late effects and supportive measures and fertility preserving approaches.

British Gynaecological Cancer Society (BGCS) vulval cancer guidelines: Recommendations for practice.

The purpose of this guideline is to collate evidence and propose evidence-based guidelines for the diagnosis and management of adult patients with vulva carcinoma treated in the UK. Malignant melanoma may present via similar routes and will be discussed. The reader is referred to the Ano-uro-genital Mucosal Melanoma Full Guideline [1] for more detailed recommendations. The management of vulval sarcoma is outside of the scope of this guideline. For further information, including details of guideline development and GRADE of recommendations, please see BGCS website for details (https://www.bgcs.org.uk/professionals/guidelines-for-recent-publications/).