Factors associated with the publication outcomes of paediatric proceedings presented at 2010‐2016 the International Associations for Dental Research annual meetings

The International Associations for Dental Research (IADR) annual meeting is one of the most important dental meetings throughout the world, and researches about paediatric dentistry presented in this platform are often used to guide clinical work. To evaluate the publication outcomes of oral and poster paediatric proceedings, which were accepted by the International Associations for Dental Research (IADR), annual meetings from 2010 to 2016 and to analyse the possible factors influencing an abstract's progression to publication. Oral and poster abstracts were retrieved from the official website of IADR (2010‐2016). Searching for subsequent publications was conducted in PubMed and Google Scholar (up to March 2019). Two authors independently selected studies, collected, and analysed data. A total of 1396 abstracts were identified, including 275 oral presentations and 1121 poster presentations. Finally, 606 were published in peer‐reviewed journals, with a publication rate of 43.41%. Abstracts were published earlier if it is from Europe, well funded, presented orally, or with large sample size. The high publication rate of the IADR proceedings supported the impact of IADR annual meetings on paediatric dentistry in the last 10 years.     

Reliability and validity of the Japanese version of the Biological Rhythms Interview of assessment in neuropsychiatry-self report for delayed sleep-wake phase disorder

ObjectiveThe Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) might be applicable for assessing delayed sleep-wake phase disorder (DSWPD). We aimed to investigate the reliability and validity of the Japanese version of the BRIAN self-report (J-BRIAN-SR) in DSWPD patients and determine a cutoff score to identify the presence of the disorder.MethodsWe enrolled 60 newly diagnosed DSWPD outpatients and 64 age-matched healthy controls. We used Cronbach's alpha for internal reliability to evaluate J-BRIAN-SR. We confirmed the reliability of the A test and re-test using Pearson's correlation coefficient in the controls. We used confirmatory factor analysis to evaluate the factor structure of J-BRIAN-SR and referenced the Morningness-Eveningness Questionnaire (MEQ) to check concurrent validity. We analyzed the receiver operating characteristic curve (ROC) to determine the J-BRIAN-SR cutoff point for the presence of DSWPD.ResultsThe 18-component scores of the J-BRIAN-SR had an overall reliability coefficient (Cronbach's alpha) of 0.82. We confirmed a high test-retest reliability using an intraclass correlation coefficient (r = 0.84). The correlation between J-BRIAN-SR and MEQ was 0.38 (p = 0.003). The J-BRIAN-SR that we extracted by exploratory factor analysis consisted of three factors. A score of 40 points provided a sensitivity of 80.0% and a specificity of 75.6% for the positivity of DSWPD.ConclusionsThe results of the present study revealed that J-BRIAN-SR is a valid and reliable instrument for screening and evaluating the severity of DSWPD. Our findings will be useful to physicians and patients in Japan and those in clinical settings.     

Twenty-five years of the WHO vaccines prequalification programme (1987–2012): Lessons learned and future perspectives

The World Health Organization (WHO) vaccines prequalification programme was established in 1987. It is a service provided to United Nations procurement agencies to ensure that the vaccines supplied through these agencies are consistently safe and effective under conditions of use in national immunization programmes. This review describes the purpose and aims of the programme, its evolution during 25 years of existence, its added value, and its role in the context of the WHO strategy to ensure the global availability of vaccines of assured quality. The rationale for changes introduced during the implementation of the programme is provided. The paper also discusses the resources involved, both human and financial, its performance, strengths and weaknesses and steps taken to maximize its efficiency. This historical perspective is used to inform proposed future changes to the service.     

Development of Research Agenda in Prostate Artery Embolization: Summary of Society of Interventional Radiology Consensus Panel

PurposeTo summarize the Society of Interventional Radiology Foundation’s Research Consensus Panel development of a research agenda on prostate artery embolization (PAE).Materials and MethodsPAE for the treatment of lower urinary tract symptoms has been shown to be safe and effective in decreasing symptoms and prostate size. Lack of randomized controlled trials (RCTs) on PAE in the United States has prevented inclusion in American Urologic Association guideline recommendations for treatment of lower urinary tract symptoms resulting from benign prostatic hyperplasia. Recognizing the need for well-designed trials, the SIR Foundation funded a Research Consensus Panel to prioritize a research agenda. The panel included interventional radiologists, urologists, SIR Foundation leadership, and industry representatives. The goal of the meeting was to discuss weaknesses with current data and study design for development of US trials to report long-term outcomes data.ResultsFinal consensus on a research design could not be made because the group was split on 3 research designs: (i) RCT of PAE versus sham with crossover of the sham group. (ii) RCT of PAE versus simple prostatectomy. (iii) RCT of PAE versus holmium laser enucleation of the prostate/thulium laser enucleation of the prostate. The panel recommended a nonindustry-funded registry to obtain real-world data.ConclusionsLevel 1 data are required to be included in the American Urologic Association guidelines for treatment of benign prostatic hyperplasia. Because of concerns with all 3 study designs, the panel did not reach a consensus. Further meetings are planned with the panel to select among these research designs.     

Authorship decision-making in the field of orthopedic surgery and sports medicine

PurposeTo facilitate decision-making in authorship positions, the International Committee of Medical Journal Editor (ICMJE) developed a guideline that stipulates criteria authors should meet in order to merit authorship. Authors who did not meet these criteria and still enlisted as authors, are called ‘honorary’ authors. In this study, the prevalence and characteristics of honorary authorship (HA) is assessed in the field of Orthopedics and Sports Medicine.MethodsA survey was distributed among corresponding authors of articles published in 2019 in six Orthopedics-dedicated journals.Results479 of the 1392 approached authors responded, leading to a response rate of 34.4%. 91.6% of the respondents were aware of the ICMJE guidelines, whereas 67.8% were aware of the issue of HA. Overall, the prevalence of guideline-based HA was 41.9%, while the prevalence of self-perceived HA was 14.7%. Having a senior member automatically enlisted as author on the departments, was associated with a higher rate of guideline-based HA (OR 5.03) and self-perceived HA (OR 3.31).ConclusionsThe prevalence of HA in the field of Orthopedics and Sports Medicine is high, but comparable to other medical fields. Transparency in authorship decision-making is crucial to maintain liability in scientific articles.     

Paraaortic dissection in “total mesopancreas excision” and “mesopancreas-first resection” pancreaticoduodenectomies for pancreatic cancer: Useless,optional, or necessary?A systematic review

The mesopancreas does not have well-defined boundaries but is continuous and connected through its components with the paraaortic area. The mesopancreatic resection margin has been indicated as the primary site for R1 resection after PD in pancreatic head cancer and total mesopancreas excision has been proposed to achieve adequate retropancreatic margin clearance and to minimize the likelihood of R1 resection. However, the anatomy of the mesopancreas requires extended dissection of the paraaortic area to maximize posterior clearance. The artery-first surgical approach has been developed to increase local radicality at the mesopancreatic resection margin. During PD, the artery-first approach begins with dissection of the connective tissues around the SMA. However, the concept of the mesopancreas as a boundless structure that includes circumferential tissues around the SMA, SMV, and paraaortic tissue highlights the need to shift from artery-first PD to mesopancreas-first PD to reduce the risk of R1 resection. From this perspective the “artery-first” approach, which allows for the avoidance of R2 resection risk, should be integrated into the “mesopancreas-first” approach to improve the R0 resection rate.In total mesopancreas excision and mesopancreas-first pancreaticoduodenectomies, the inclusion of the paraaortic area and circumferential area around the SMA in the resection field is necessary to control the tumour spread along the mesopancreatic resection margin rather than to control or stage the spread in the nodal basin.     

Innovation in Chemistry,Manufacturing, and Controls—A Regulatory Perspective From Industry

This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through consortia, enabling industry to supply key information to regulators in a transparent yet well-defined manner, and utilizing mutually understood risk-benefit analyses to produce drugs with appropriate safety, efficacy, and quality characteristics.     

Ethical global health in nursing education: An integrative review

AimThe purpose of this integrative review is to provide a comprehensive review of ethical considerations for host communities and nursing programs in planning, implementing and evaluating global health experiences for nursing students.BackgroundGlobal health experiences for nursing students are proliferating rapidly across university settings while at the same time decreasing the average time spent in the host country engaged with local communities. Global health experiences are an area where students can experience ethics as it is applied across varied contexts including resource limited international settings. As nursing education expands its global programming, exploring the ethical implications of designing, implementing and evaluating GHEs becomes pivotal to build respectful, sustainable relationships with global partners and best prepare nursing students for ethical professional practice in an interconnected world.DesignWe conducted an integrative review to examine ethical considerations in development of ethical global health experiences that benefit, rather than harm, host communities and participating nursing student guests.MethodsThe search included articles published in English language, peer-reviewed journals between 1998 and 2021 that discussed ethics in the context of nursing students traveling internationally for global health experiences. Eighteen articles met criteria for review.ResultsOverall, findings demonstrate relatively little research specific to ethical engagement in global health experiences. The articles in this integrative review discussed a range of ethical attributes including reciprocity or collaboration, respect, sustainability or commitment, justice and openness. Recommendations based on research and non-research articles are provided.ConclusionsEthical comportment in global health experiences requires careful planning, implementation and evaluation to assure an equitable and sustainable partnership between host community, faculty and nursing student guests.