More a marathon than a hurdle: towards children’s informed consent in a study on safety

Informed consent is critical in research with children. Although much has been written about the need to see consent as an ongoing process, less has considered how to do it in practice. This article reflects on the authors’ experiences of conducting a piece of research focusing on children’s experiences of safety from abuse within institutional contexts. It draws on feedback provided by participants and the guidance of three Children’s Reference Groups. The importance of presenting information in accessible and appropriate ways, of providing opportunities for participants to negotiate their participation and for in-the-moment challenges be dealt with collaboratively and reflexively are stressed. To illustrate our approach, we provide a number of consent tools and describe how they were utilised

Reading, writing and responsibility :young carers and education

The aims of this research were to: Identify the major issues and concerns of young carers in the education system, including the barriers to them achieving satisfactory outcomes in education and receiving appropriate supports and services (including external referrals); Identify the information needs of teachers and other school staff in appropriately supporting young carers within the school environment; Identify strategies to meet the information needs of teachers and the support needs of young carers within educational settings

Neonatal Safety Information Reported to the FDA During Drug Development Studies.

BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015. METHODS: FDA databases were searched for BPCA and/or PREA studies that enrolled neonates. Studies that enrolled a minimum of 3 neonates were analyzed for the presence and content of neonatal safety data. RESULTS: The analysis identified 40 drugs that were studied in 3 or more neonates. Of the 40 drugs, 36 drugs received a pediatric labeling change as a result of studies between 1998 and 2015, that included information from studies including neonates. Fourteen drugs were approved for use in neonates. Clinical trials for 20 of the drugs reported serious adverse events (SAEs) in neonates. The SAEs primarily involved cardiovascular events such as bradycardia and/or hypotension or laboratory abnormalities such as anemia, neutropenia, and electrolyte disturbances. Deaths were reported during studies of 9 drugs. CONCLUSIONS: Our analysis revealed that SAEs were reported in studies involving 20 of the 40 drugs evaluated in neonates, with deaths identified in 9 of those studies. Patients enrolled in studies were often critically ill, which complicated determination of whether an adverse event was drug-related. We conclude that the traditional means for collecting safety information in drug development trials needs to be adjusted for neonates and will require the collaboration of regulators, industry, and the clinical and research communities to establish appropriate definitions and reporting strategies for the neonatal population

Family planning and reproductive health: Briefing sheets for a gender analysis

This series of briefing sheets, developed by the Population Council, represents a starting point for the application of gender to the family planning (FP) and reproductive health (RH) arena. The information covers five key areas of RH: gender-based abuse, FP and gender issues among adolescents, sexuality and FP, men’s and women’s social and economic responsibilities for childrearing, and the complicated nexus between gender and FP/RH. In so doing, it provides a strong foundation for gender training. This concept was first developed to fulfill a need for gender training within the regional Operations Research/Technical Assistance Projects. To date, two such workshops have been funded by USAID. These activities not only reflect a clear commitment by USAID to the inclusion of gender in all aspects of programmatic planning and implementation but also to the empowerment of women in every phase of the development process. This tool will help guide program planners and policymakers toward making gender equity in FP and RH programs a reality for both women and men

Verification and Validation of NASA-Supported Enhancements to Decision Support Tools of PECAD

This section of the evaluation report summarizes the verification and validation (V&V) of recently implemented, NASA-supported enhancements to the decision support tools of the Production Estimates and Crop Assessment Division (PECAD). The implemented enhancements include operationally tailored Moderate Resolution Imaging Spectroradiometer (MODIS) products and products of the Global Reservoir and Lake Monitor (GRLM). The MODIS products are currently made available through two separate decision support tools: the MODIS Image Gallery and the U.S. Department of Agriculture (USDA) Foreign Agricultural Service (FAS) MODIS Normalized Difference Vegetation Index (NDVI) Database. Both the Global Reservoir and Lake Monitor and MODIS Image Gallery provide near-real-time products through PECAD's CropExplorer. This discussion addresses two areas: 1. Assessments of the standard NASA products on which these enhancements are based. 2. Characterizations of the performance of the new operational products

International Perspectives of Nurses, Midwives and Allied Health Professionals Clinical Academic Roles: Are We at Tipping Point?

Healthcare research activity improves patient outcomes. Nurses, Midwives and Allied Health Professions (NMAHPs) make an important contribution to clinical research. Within the United Kingdom (UK), there is a 25-year history of increasing healthcare research capacity and capability through clinical academic roles. Medical colleagues were the first to introduce the role in 2005. In 2007, a national policy identified inequalities in access to and success of research training fellowships between medical and nursing healthcare professionals. This was followed by a number of national initiatives, which continue to evolve to the present day. There is evidence that the UK has reached the ‘tipping point’ to increase NMAHP research capacity and capability through clinical academic roles. Despite these initiatives substantial gaps remain. Outside, the UK, the term ‘clinical academic’ is not well understood. There is evidence of the presence of senior clinical academic roles, a clinical professor within Australia and the United States, for example, but there is a lack of opportunities and of a formulised research training pathway at a junior level. There is interest and appreciation of the NMAHP research-active clinical academic within the clinical setting in the Nordic countries and China, but the pace of change is slow due to co-existing priorities involving change and innovation. There is a need to develop and agree both national and international definitions that describes the NMAHP research-focused clinical academic role activity

Prostate cancer and supportive care:a systematic review and qualitative synthesis of men’s experiences and unmet needs.

Prostate cancer is the second most common cancer in men worldwide, accounting for an estimated 1.1 million new cases diagnosed in 2012 (www.globocan.iarc.fr). Currently, there is a lack of specific guidance on supportive care for men with prostate cancer. This article describes a qualitative systematic review and synthesis examining men's experience of and need for supportive care. Seven databases were searched; 20 journal articles were identified and critically appraised. A thematic synthesis was conducted in which descriptive themes were drawn out of the data. These were peer support, support from partner, online support, cancer specialist nurse support, self‐care, communication with health professionals, unmet needs (emotional support, information needs, support for treatment‐induced side effects of incontinence and erectile dysfunction) and men's suggestions for improved delivery of supportive care. This was followed by the development of overarching analytic themes which were: uncertainty, reframing, and the timing of receiving treatment, information and support. Our results show that the most valued form of support men experienced following diagnosis was one‐to‐one peer support and support from partners. This review highlights the need for improved access to cancer specialist nurses throughout the care pathway, individually tailored supportive care and psychosexual support for treatment side effects

Activity interventions to improve the experience of care in hospital for people living with dementia: a systematic review

Background: An increasingly high number of patients admitted to hospital have dementia. Hospital environments can be particularly confusing and challenging for people living with dementia (Plwd) impacting their wellbeing and the ability to optimize their care. Improving the experience of care in hospital has been recognized as a priority, and non-pharmacological interventions including activity interventions have been associated with improved wellbeing and behavioral outcomes for Plwd in other settings. This systematic review aimed at evaluating the effectiveness of activity interventions to improve experience of care for Plwd in hospital. Methods: Systematic searches were conducted in 16 electronic databases up to October 2019. Reference lists of included studies and forward citation searching were also conducted. Quantitative studies reporting comparative data for activity interventions delivered to Plwd aiming to improve their experience of care in hospital were included. Screening for inclusion, data extraction and quality appraisal were performed independently by two reviewers with discrepancies resolved by discussion with a third where necessary. Standardized mean differences (SMDs) were calculated where possible to support narrative statements and aid interpretation. Results: Six studies met the inclusion criteria (one randomized and five non-randomized uncontrolled studies) including 216 Plwd. Activity interventions evaluated music, art, social, psychotherapeutic, and combinations of tailored activities in relation to wellbeing outcomes. Although studies were generally underpowered, findings indicated beneficial effects of activity interventions with improved mood and engagement of Plwd while in hospital, and reduced levels of responsive behaviors. Calculated SMDs ranged from very small to large but were mostly statistically non-significant. Conclusions: The small number of identified studies indicate that activity-based interventions implemented in hospitals may be effective in improving aspects of the care experience for Plwd. Larger well-conducted studies are needed to fully evaluate the potential of this type of non-pharmacological intervention to improve experience of care in hospital settings, and whether any benefits extend to staff wellbeing and the wider ward environment.This article is freely available via Open Access. Click on the Publisher URL to access it via the publisher's site.Funding was provided by the Health Services and Delivery Research programme of the National Institute for Health Research, and the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) South West Peninsula, now recommissioned as NIHR Applied Research Collaboration (ARC) South West Peninsula. The funding body had no role in design of the study, analysis and interpretation of the data or writing of the manuscript.published version, accepted version, submitted versio