Publication Recommendations to Report Laboratory Data of Neonates - a Modified Delphi Approach.

BACKGROUND: Clinical and analytical information on laboratory data of neonates in scientific publications is sparse and incomplete. Furthermore, interpreting neonatal laboratory data can be complex due to their time-dependent and developmental physiology, and paucity of well-established age-appropriate reference ranges for neonates. This study aims to develop publication recommendations to report laboratory data of neonates to enhance the quality of these data in research and clinical care. METHODS: A modified Delphi approach was used to develop recommendations in cooperation with the International Neonatal Consortium. A Core Group, including different stakeholders, was responsible for developing the recommendations, in collaboration with a Reflection Group, responsible for providing additional input. RESULTS: The recommendations were classified into three categories: 'Clinical Characteristics', 'Bio-analytical Information' and 'Data-analytical Information'. These were each divided into 'Core Data' (always to be reported) and 'Supplemental Considerations' (to be reported when considered relevant to the study). CONCLUSION: Our recommendations provide guidance on standardization of neonatal laboratory data in publications. This will enhance the comparison, replication, and application of study results in research initiatives and clinical practice. Furthermore, these recommendations also serve as foundational work to develop reference ranges for neonatal laboratory values by standardizing the quality of information needed for such efforts. IMPACT: Standardized reporting of neonatal laboratory data in scientific publications will enhance the comparison, replication, and application of study results in research initiatives and clinical practice, as well as improve reporting to regulatory agencies. To integrate multistakeholder perspectives, a modified Delphi approach was used to develop publication recommendations which strengthens the applicability of the recommendations. Implementation of standardization will likely improve the overall quality of neonatal clinical research and neonatal healthcare. In addition, these recommendations are foundational to develop reference ranges for neonatal laboratory values by standardizing the quality of information needed for such efforts.

Nurses' Knowledge, Communication Needs, and Future Directions in Neonatal Research: Results of an International Survey.

BACKGROUND: Preterm birth is a significant contributor to neonatal morbidity and mortality. Despite legislative efforts to increase pediatric drug development, neonatal clinical trials continue to be infrequent. The International Neonatal Consortium (INC) includes nurses as key stakeholders in their mission to accelerate safe and effective therapies for neonates. PURPOSE: INC developed a survey for nurses, physicians, and parents to explore communication practices and stakeholders' perceptions and knowledge regarding clinical trials in neonatal intensive care units (NICUs). METHODS: A stepwise consensus approach was used to solicit responses to an online survey. The convenience sample was drawn from INC organizations representing the stakeholder groups. Representatives from the National Association of Neonatal Nurses and the Council of International Neonatal Nurses, Inc, participated in all stages of the survey development process, results analysis, and publication of results. RESULTS: Participants included 188 nurses or nurse practitioners, mainly from the United States, Canada, the European Union, and Japan; 68% indicated some level of research involvement. Nurses expressed a lack of effective education to prepare them for participation in research. Results indicated a lack of a central information source for staff and systematic approaches to inform families of studies. The majority of nurses indicated they were not asked to provide input into clinical trials. Nurses were uncertain about research consent and result disclosure processes. IMPLICATIONS FOR PRACTICE AND RESEARCH: This study indicates the need to educate nurses in research, improve NICU research communication through standardized, systematic pathways, and leverage nurse involvement to enhance research communication.

Sleep Problems and Posttraumatic Stress: Children Exposed to a Natural Disaster.

OBJECTIVE: Sleep plays a critical role in children's growth and development. This study examined the frequency and persistence of children's sleep problems following a natural disaster, risk factors for children's sleep problems, and the bidirectional relationship between children's sleep problems and posttraumatic stress symptoms (PTSS) over time. METHODS: This study assessed 269 children (53% female, M = 8.70 years, SD = 0.95) exposed to Hurricane Ike at 8 months (Time 1) and 15 months (Time 2) post-disaster. Children completed measures of hurricane exposure and related stressors, stressful life events, sleep problems, and PTSS. RESULTS: Children's sleep problems were significantly correlated from Time 1 to Time 2 (r = .28, p < .001). Risk factors for sleep problems at Time 2 were younger age, sleep problems at Time 1, and PTSS, not including sleep items, at Time 1. Examinations of the bidirectional relationship between sleep problems and PTSS indicated that PTSS significantly predicted later sleep problems, but sleep problems did not significantly predict later PTSS. CONCLUSIONS: Findings demonstrate that PTSS may contribute to the development and course of children's sleep problems post-disaster.

Food cultures and aging: a qualitative study of grandparents' food perceptions and influence of food choice on younger generations.

OBJECTIVE: To explore food perceptions among grandparents and understand the influence of these perceptions on food choice for the younger generations in their family. DESIGN: Qualitative methodology, thematic analysis of the transcripts from fourteen focus groups. SETTING: Grandparents in the southern region of the United States. SUBJECTS: Participants were fifty-eight Black, Hispanic, and White grandparents, predominantly women (72%), ranging in age from 44-86 years (mean age = 65·4 (sd 9·97) years). RESULTS: Grandparents' perceptions related to personal food choice were related to health issues and the media. Grandparents' perceived influence on their children's and grandchildren's food choices was described through the themes of proximity and power (level of influence based on an interaction of geographic proximity to grandchildren and the power given to them by their children and grandchildren to make food decisions), healthy v. unhealthy spoiling, cultural food tradition, and reciprocal exchange of knowledge. CONCLUSION: Our results highlight areas for future research including nutrition interventions for older adults as well as factors that may be helpful to consider when engaging grandparents concerning food decisions for younger generations to promote health. Specifically, power should be assessed as part of a holistic approach to addressing dietary influence, the term 'healthy spoiling' can be used to reframe notions of traditional spoiling, and the role of cultural food tradition should be adapted differently by race.

The Potential Unique Impacts of Hope and Resilience on Mental Health and Well-Being in the Wake of Hurricane Harvey.

Natural disasters can lead to mental health problems, such as posttraumatic stress disorder (PTSD). Higher levels of loss and/or disruption and prior trauma exposure constitute risk factors for mental illness, whereas protective factors, including hope and resilience, support positive functioning. The present cross-sectional study used structural equation modeling to examine the relative influence of resilience and hope on mental health and well-being 1-3 months after Hurricane Harvey made landfall in August 2017, among a sample of 829 adults in the Greater Houston, Texas area. Resilience was more strongly associated with reduced PTSD symptoms, ß = -.31, 95% CI [-.42, -.21], than was hope, ß = -.17, 95% CI [-;.30, -.04], whereas hope was more strongly associated with components of well-being, ßs = .47-.63. Hope was positively associated with posttraumatic growth, ß = .30, 95% CI [.19, .41], whereas resilience was negatively associated with posttraumatic growth, ß = -.24, 95% CI [-.35, -.12]. These associations remained consistent after considering risk factors, although more variance in trauma-related outcomes was risk factors were included in the model. The present results suggest that considering the influence of both risk and resilience factors provides an enhanced picture of postdisaster mental health.

Response biomarkers in neonatal intervention studies.

BackgroundUp to 90% of all drugs used in neonatal intensive care units (NICUs) have not been clinically tested for safety and efficacy. To promote drug development for neonates, the pharmaceutical industry is moving toward rigorous testing, necessitating the need to development, and validating biomarkers in neonates to predict their response. The objective of this review is to evaluate the quality of the response biomarker reporting in neonatal clinical trials.MethodsA validated literature search strategy was applied. Prospective neonatal intervention studies reporting response biomarkers published in 2014 were included. The data were extracted independently and in duplicate using a data-extraction form.ResultsFollowing the full-text review, 167 published prospective neonatal trials were included; 35% (59/167) reported the use of response biomarkers. In these 59 trials, we identified 275 biomarkers used to measure the response (pharmacodynamics and safety) reported as primary or secondary outcomes. Heart rate and oxygen saturation were the most commonly reported. Measurement and instrumentation data were often not provided.ConclusionWe identified a huge variability in the selection, measurement, and reporting of neonatal response biomarkers in prospective intervention studies. Reporting initiatives are needed to reduce research waste and improve the reproducibility of biomarker use in neonatal intervention studies.

Clinicians' Beliefs, Observations, and Treatment Effectiveness Regarding Clients' Sexual Addiction and Internet Pornography Use.

This study addressed how sex addiction and problematic IP use present to mental health professionals (MHPs), and how MHPs conceptualize and treat these issues. MHPs (N = 183) reported on beliefs about, experiences with, and treatment of problematic sexual behaviors (PBS). Most MHPs saw clients with PBS, but most do not feel competent to treat PBS. Specialized MHPs endorsed seeing more clients with PBS and feeling more effective than nonspecialists. Sexual addiction and problematic IP use share similarities, but differ in etiology and co-occurring problems. Diagnostic ambiguity, insufficient knowledge, and limited dissemination may hinder MHPs ability to assess and treat PBSs.

Narcissism and Internet pornography use.

This study examined the relation between Internet pornography use and narcissism. Participants (N=257) completed an online survey that included questions on Internet pornography use and 3 narcissism measures (i.e., Narcissistic Personality Inventory, Pathological Narcissistic Inventory, and the Index of Sexual Narcissism). The hours spent viewing Internet pornography was positively correlated to participants' narcissism level. In addition, those who have ever used Internet pornography endorsed higher levels of all 3 measures of narcissism than did those who have never used Internet pornography.

The relationship between religiosity and internet pornography use.

Internet pornography (IP) consumption has increased, resulting in functioning and psychological problems. Thus, understanding what variables affect IP uses is needed. One of the variables may be religion. College students (N = 223) completed questions on IP use and religion. About 64 % ever viewed IP and 26 % currently viewed IP, at a rate of 74 min per week. IP use interfered with their relationship with God and spirituality. Religious individuals were less likely to ever or currently view IP. Intrinsic and extrinsic religiosity and alignment of spiritual values were associated with ever use. Results suggest that religiosity matters in IP use and further research is needed.

Health-related quality of life in obese and overweight, treatment-seeking youth.

OBJECTIVE: This study evaluated health related quality of life (HRQOL) in obese children using obesity-specific HRQOL measures and examined potential race and sex differences. PARTICIPANTS: Two-hundred and four children aged 5.03 to 13.48 years (mean +/- SD = 10.18 +/- 1.95) and their parents participated. METHODS: All participants enrolled in a family-based weight loss intervention study. Their height and weight were measured before and after the intervention, and demographic information was collected. Participants also completed a weight related quality of life measure; children completed a self-report version, and parents completed a parent-proxy version. RESULTS: Higher child body mass index z-scores (BMIz) were related to poorer HRQOL per parent and child report. Males reported higher emotional functioning than females, and for race, African American parents reported higher physical functioning for their children than Caucasian parents. No difference in total HRQOL was found for race. CONCLUSIONS: Childhood BMIz is inversely related to quality of life. Compared with male children, females have more impairment in quality of life. However, HRQOL did not differ by race. Also, although parent and child reports do overlap in certain areas, they also each provide unique information. Future researchers and clinicians would be wise to capture both child and parent perspectives regarding quality of life among obese children.

Acceptability of long-acting, progestin-only contraception in Europe: a two-year prospective, non-interventional study.

OBJECTIVES To compare two-year continuation rates and user satisfaction with the levonorgestrel releasing-intrauterine system (LNG-IUS) and the etonogestrel releasing-subdermal implant (ENG implant) in women in Europe. METHODS This prospective, non-interventional study was undertaken at 72 sites in France (n = 61), Great Britain (n = 2), Ireland (n = 3) and Slovakia (n = 6). Women opting to switch their method of contraception to the LNG-IUS or the ENG implant were followed-up over 24 months to document continuation and satisfaction with their chosen contraceptive method. Reasons for discontinuation were documented. RESULTS The data analysed were based on 363 women (LNG-IUS [n = 247] and ENG implant [n = 116]), aged 20 to 45 years, with at least one follow-up visit after contraceptive placement. The documented cumulative continuation rate was 82% in the LNG-IUS group and 67% in the ENG implant group at 24 months. The documented discontinuation rates were 13% and 17%, respectively. Bleeding problems were cited as reason for discontinuation in 4% and 11% of women in the LNG-IUS and ENG implant groups, respectively. CONCLUSIONS The LNG-IUS is associated with higher continuation rates and user satisfaction than the ENG implant in this study of women in Europe, though the groups were not similar in all respects. Bleeding problems with the ENG implant account for most of the reasons for discontinuing its use.

Does perception of relationship type impact sexual health risk?

A sample of 327 men (age, 16-36 years) responded to self-completed questionnaires, which included questions regarding their most recent female sexual partner and specific behaviors pertaining to that partner. Analyses showed significant differences in several variables including condom use and sexually transmitted infection history, among the different relationship types.

Essential role of Drosophila black-pearl is mediated by its effects on mitochondrial respiration.

Black-pearl (Blp) is a highly conserved, essential inner-mitochondrial membrane protein. The yeast Blp homologue, Magmas/Pam16, is required for mitochondrial protein transport, growth, and survival. Our purpose was to determine the role of Drosophila Blp in mitochondrial function, cell survival, and proliferation. To this end, we performed mitotic recombination in Drosophila melanogaster, RNAi-mediated knockdown, MitoTracker staining, measurement of reactive oxygen species (ROS), flow cytometry, electron transport chain complex assays, and hemocyte isolation from Drosophila larvae. Proliferation-defective, Blp-deficient Drosophila Schneider cells exhibited mitochondrial membrane depolarization, a 60% decrease in ATP levels, increased amounts of ROS (3.5-fold), cell cycle arrest, and activation of autophagy that were associated with a selective 65% reduction of cytochrome c oxidase activity. N-acetyl cysteine (NAC) rescued Blp-RNAi-treated cells from cell cycle arrest, indicating that increased production of ROS is the primary cause of the proliferation and survival defects in Blp-depleted cells. blp hypomorph larvae had a 35% decreased number of plasmatocytes with a 45% reduced active mitochondrial staining and their viability was increased 2-fold by administration of NAC, which blocked melanotic lesions. Loss of Blp decreases cytochrome c oxidase activity and uncouples oxidative phosphorylation, causing ROS production, which selectively affects mitochondria-rich plasmatocyte survival and function, leading to melanotic lesions in Blp-deficient flies.

Brief Online Intervention Model Promotes Sustained Helping Behavior Across 6 Months Following a Population-Wide Traumatic Event.

BACKGROUND: Following natural disasters, early helping behavior often dissipates despite remaining disaster-related suffering and affective vulnerability in the community. Interventions that have successfully increased helping behaviors have included components of motivational interviewing (MI) and mindful compassion; however, this research is limited by laboratory-based settings and lengthy training sessions. Brief, portable, and efficient intervention is needed to increase accessibility to large groups simultaneously. METHOD: The current study piloted a brief, online, self-administered MI and mindful compassion intervention administered 4-10 weeks post-Hurricane Harvey examining if it would sustain helping behaviors over the ensuing year. The study also examined potential moderators of the relationship between compassion for others and internalizing symptoms, and whether helping behaviors predicted post-traumatic stress symptoms. RESULTS: The intervention group sustained the use of helping behaviors more than an active control group after 9-12 months. Also, compassion satisfaction and burnout moderated the relationship between compassion for others and post-traumatic stress and depressive symptoms at follow-up. CONCLUSIONS: Results suggest a potentially useful model of how an efficiently distributed intervention might sustain helping behaviors after a natural disaster and provide insight into possible longitudinal risk and protective factors for post-traumatic stress and depressive symptoms among helping volunteers.

Parental Influence on Child Mental Health Post-Hurricane Harvey.

Purpose: Many children who face natural disasters experience significant mental health consequences. Parents play a prominent role in the likelihood of child mental health outcomes after a weather-related disaster. This study aimed to examine the relationship between parent risk factors and children's psychological well-being post Hurricane Harvey. Methods: Parents (n = 140) completed a survey that measured hurricane exposure, parental depression and anxiety, parenting behaviors, and assistance given and received during or after Hurricane Harvey. Additionally, parents were asked to complete questionnaires assessing one of their children's post-disaster psychosocial functioning and distress. Results: Results indicated that heightened parent anxiety was significantly associated with an increased risk for emotional symptoms, conduct problems, and hyperactivity-inattention symptoms in children. Additionally, inconsistency in parental discipline was significantly associated with an increased risk of child conduct problems. Further, higher numbers of assistance types received by parents-a proxy indicator of resource loss-was associated with higher child emotional distress scores. Conclusions: Broader systems-level interventions that address parents' physical and emotional needs may help mitigate maladaptive reactions in children and facilitate greater post-disaster psychosocial adjustment.

Implementing a Bundle to Improve Surgical Site Infection Rates for Patients Undergoing Nonvaginal-Approach Hysterectomy at a Midwestern Teaching Hospital.

Accrediting organizations, third-party payers, and patients review the surgical site infection (SSI) rates of health care organizations. Infection preventionists collaborate with perioperative personnel to decrease SSI rates; they also monitor and report SSI information to national organizations. The standard infection ratio is a comparison of the observed number of SSIs to the predicted number of SSIs based on national benchmark data. Leaders of a midwestern teaching hospital convened an interdisciplinary team (eg, surgeons, perioperative leaders, infection preventionists) to address a standard infection ratio after hysterectomies that was greater than 1.0. The team reviewed national guidelines and published articles on decreasing SSIs (including recommendations for vaginal preparation) before developing and implementing a hysterectomy-specific bundle for SSI prevention. The rate of SSIs decreased 68% after the implementation of the bundle. Perioperative personnel at this facility continue to use the bundle and infection preventionists monitor and report compliance with the bundle's elements.

The neonatal adverse event severity scale: current status, a stakeholders' assessment, and future perspectives.

To support informed decisions on drug registration and prescription, clinical trials need tools to assess the efficacy and safety signals related to a given therapeutic intervention. Standardized assessment facilitates reproducibility of results. Furthermore, it enables weighted comparison between different interventions, instrumental to facilitate shared decisions. When focused on adverse events in clinical trials, tools are needed to assess seriousness, causality and severity. As part of such a toolbox, the international Neonatal Consortium (INC) developed a first version of the neonatal adverse event severity scale (NAESS). This version underwent subsequent validation in retro-and prospective trials to assess its applicability and impact on the inter-observer variability. Regulators, sponsors and academic researchers also reported on the use of the NAESS in regulatory documents, trial protocols and study reports. In this paper, we aim to report on the trajectory, current status and impact of the NAESS score, on how stakeholders within INC assess its relevance, and on perspectives to further develop this tool.