bluuebunny/crossref_metadata_2025 huggingface dataset:
Outcomes of women with positive oncogenic HPV and reflex cytology showing possible high‐grade squamous intraepithelial lesion
Authors: Ng Hamon Y.K. , Tan Jeffrey H.J. , Marceglia Alexandra H. , Bittinger Sophie , Dundas Kristy E. , Talia Karen L. , Wrede C. David H.
Published: July 2021

Aim

To examine outcomes in women following cervical screening detection of oncogenic human papillomavirus (HPV), with reflex cytology showing possible high‐grade squamous intraepithelial lesion (pHSIL).

Materials and methods

A retrospective observational study of 523 women seen in the Royal Women’s Hospital Colposcopy Clinic from 1 January 2018 to 31 July 2020.

Results

Two hundred eighty‐two (53.9%) women had histology‐confirmed HSIL, encompassing CIN2 or worse (CIN2+), including seven cancers (1.3%) and two adenocarcinoma in situ (AIS) (0.4%). In 81.2% (229/282) of women with CIN2+, this was detected on cervical biopsy at initial colposcopy, with another 8.9% (25/282) of CIN2+ detected at cervical excision following initial colposcopy and the remaining 9.9% (28/282) at follow‐up colposcopy thereafter. When discordant cervical biopsy results were discussed at multidisciplinary meeting (MDM), 66.7% of women with pHSIL cytology upgraded to definite HSIL were found to have CIN2+, but only 20.8% when pHSIL cytology was retained and none when downgraded to low‐grade (LSIL) or normal. No significant difference was found in the proportion of CIN2+ based on patient age above or below 40, HPV16 and/or 18 versus non 16/18, or whether discordant findings were reviewed at MDM.

Conclusions

We propose a pathway for management of women with positive oncogenic HPV and reflex pHSIL cytology. MDM review is recommended when CIN2+ is not identified on cervical biopsy at initial colposcopy. Conservative management is safe with low risk of CIN2+ when LBC prediction of pHSIL is confirmed or downgraded at MDM with no high‐grade change on colposcopy or repeat cytology.
Critical Ethnography and Research Relationships: Some Ethical Dilemmas
Authors: Ryder Andrew
Published: July 2021

Ethnography can be a deeply challenging form of research in which the researcher has to navigate the boundaries of acceptable observation and avoid the pitfalls of intrusion. In the last twenty years, legalistic and contractual ethical codes have gained prominence and influence in social research. Despite the welcome focus on ethical issues, ethical codes rarely prompt the researcher to share the research outcomes with the research participants or prompt the researcher to actively consider using the research to shape and change policy frameworks to have positive impacts for those at the margins. Through a fictionalized account of the struggles of an ethnographic researcher, the article highlights such tensions by exploring their reflexive analysis of relationships with research participants located at the margins.
Immunologic markers and risk of hepatocellular carcinoma in hepatitis B virus‐ and hepatitis C virus‐infected individuals
Authors: Koshiol Jill , Argirion Ilona , Liu Zhiwei , Kim Lam Tram , O’Brien Thomas R. , Yu Kelly , McGlynn Katherine A. , Petrick Jessica L. , Pinto Ligia , Chen Chien‐jen , Hildesheim Allan , Pfeiffer Ruth M. , Lee Mei‐Hsuan , Yang Hwai‐I
Published: July 2021

Background

Clinical and experimental studies suggest immunologic proteins contribute to hepatocellular carcinoma (HCC) development.

Aim

To evaluate circulating immunologic markers and HCC risk.

Methods

From a Taiwanese cohort of chronically hepatitis B virus (HBV)‐infected individuals followed over time (REVEAL‐HBV), we sampled 175 who developed HCC, 117 cirrhosis only, and 165 non‐cirrhotic controls. From a similar Taiwanese cohort of chronically hepatitis C virus (HCV)‐infected individuals (REVEAL‐HCV), we included 94 individuals who developed HCC, 68 cirrhosis only and 100 non‐cirrhotic controls. We compared pre‐diagnostic plasma levels of 102 markers in HCC cases to non‐cirrhotic and cirrhotic controls using polytomous logistic regression. A priori markers included insulin‐like growth factor binding protein‐3 (IGFBP‐3), intercellular adhesion molecule 1 (ICAM‐1) and interleukin 6 (IL‐6). P‐values for other markers were corrected for multiple testing (false discovery rate = 10%).

Results

In both REVEAL‐HBV and REVEAL‐HCV, increasing levels of ICAM‐1 were associated with increased risk of HCC compared to non‐cirrhotic controls (P‐trend 0.02 and 0.001, respectively). In both REVEAL‐HBV and REVEAL‐HCV, two novel markers [C‐X‐C motif chemokine 11 (CXCL11) and hepatocyte growth factor (HGF)] were positively associated [strongest odds ratioquartile 4 versus 1 (OR) 4.55 for HGF in HCV], while two [complement factor H related 5 (CFHR5) and stem cell factor (SCF)] were negatively associated (strongest ORQ4vQ1 0.14 for SCF in HCV) with development of HCC compared to non‐cirrhotic controls.

Conclusions

We confirmed the association for ICAM‐1 and identified 4 additional proteins associated with HBV‐ and HCV‐related HCC. These findings highlight the importance of immunologic processes in HBV‐ and HCV‐related HCC.
Fear leads to suffering: Fears of compassion predict restriction of the moral boundary
Authors: Crimston Charlie R. , Blessing Sarah , Gilbert Paul , Kirby James N.
Published: July 2021

Empirical investigations into the psychological drivers of more or less expansive moral thinking are lacking from the psychological literature. One potential driver that warrants deeper investigation is compassion – a prosocial motivation to both identity and alleviate suffering. The current research examined the extent to which compassion, and fears of compassion, act as a driver and inhibitor, respectively, of a morally expansive mindset. We tested these associations across three studies (N = 749) and found robust support for our predictions. Specifically, stronger compassion to others, and greater fears of extending compassion to others, were linked to enhanced and reduced moral expansiveness, respectively. Moreover, over and above empathy and mindfulness, fears of compassion and compassion uniquely predicted moral expansiveness. Finally, compassion was found to consistently mediate the relationship between fears of compassion to others and moral expansiveness. Our findings further our understanding of the psychological factors that may drive and restrict morally expansive mindsets and hold implications for the broader domains of moral decision‐making and prosocial motivation as well as the application of practices that are designed to facilitate a compassionate mindset (e.g., Compassionate Mind Training).
Emotional Valence Precedes Semantic Maturation of Words: A Longitudinal Computational Study of Early Verbal Emotional Anchoring
Authors: Martínez‐Huertas José Á. , Jorge‐Botana Guillermo , Olmos Ricardo
Published: July 2021

We present a longitudinal computational study on the connection between emotional and amodal word representations from a developmental perspective. In this study, children's and adult word representations were generated using the latent semantic analysis (LSA) vector space model and Word Maturity methodology. Some children's word representations were used to set a mapping function between amodal and emotional word representations with a neural network model using ratings from 9‐year‐old children. The neural network was trained and validated in the child semantic space. Then, the resulting neural network was tested with adult word representations using ratings from an adult data set. Samples of 1210 and 5315 words were used in the child and the adult semantic spaces, respectively. Results suggested that the emotional valence of words can be predicted from amodal vector representations even at the child stage, and accurate emotional propagation was found in the adult word vector representations. In this way, different propagative processes were observed in the adult semantic space. These findings highlight a potential mechanism for early verbal emotional anchoring. Moreover, different multiple linear regression and mixed‐effect models revealed moderation effects for the performance of the longitudinal computational model. First, words with early maturation and subsequent semantic definition promoted emotional propagation. Second, an interaction effect between age of acquisition and abstractness was found to explain model performance. The theoretical and methodological implications are discussed.
The National Heart, Lung, and Blood Institute‐funded Production Assistance for Cellular Therapies (PACT) program: Eighteen years of cell therapy
Authors: El Fiky Ashraf , Ibenana Laarni , Anderson Robert , Hare Joshua M. , Khan Aisha , Gee Adrian P. , Rooney Cliona , McKenna David H. , Gold Joseph , Kelley Linda , Lundberg Martha S. , Welniak Lisbeth A. , Lindblad Robert
Published: July 2021

The Production Assistance for Cellular Therapies (PACT) Program, is funded and supported by the US Department of Health and Human Services’ National Institutes of Health (NIH) National Heart Lung and Blood Institute (NHLBI) to advance development of somatic cell and genetically modified cell therapeutics in the areas of heart, lung, and blood diseases. The program began in 2003, continued under two competitive renewals, and ended June 2021. PACT has supported cell therapy product manufacturing, investigational new drug enabling preclinical studies, and translational services, and has provided regulatory assistance for candidate cell therapy products that may aid in the repair and regeneration of damaged/diseased cells, tissues, and organs. PACT currently supports the development of novel cell therapies through five cell processing facilities. These facilities offer manufacturing processes, analytical development, technology transfer, process scale‐up, and preclinical development expertise necessary to produce cell therapy products that are compliant with Good Laboratory Practices, current Good Manufacturing Practices, and current Good Tissue Practices regulations. The Emmes Company, LLC, serves as the Coordinating Center and assists with the management and coordination of PACT and its application submission and review process. This paper discusses the impact and accomplishments of the PACT program on the cell therapy field and its evolution over the duration of the program. It highlights the work that has been accomplished and provides a foundation to build future programs with similar goals to advance cellular therapeutics in a coordinated and centralized programmatic manner to support unmet medical needs within NHLBI purview.
An indirect treatment comparison of the efficacy of semaglutide 1.0 mg versus dulaglutide 3.0 and 4.5 mg
Authors: Pratley Richard E. , Catarig Andrei‐Mircea , Lingvay Ildiko , Viljoen Adie , Paine Abby , Lawson Jack , Chubb Barrie , Gorst‐Rasmussen Anders , Miresashvili Nino
Published: July 2021

Aim

To compare the effects of semaglutide 1.0 mg versus dulaglutide 3.0 and 4.5 mg on HbA1c and body weight in patients with type 2 diabetes.

Materials and Methods

A Bucher indirect comparison was conducted to compare efficacy outcomes of semaglutide 1.0 mg versus dulaglutide 3.0 and 4.5 mg using published results from the SUSTAIN 7 and AWARD‐11 trials. Sensitivity analyses using individual patient data from SUSTAIN 7 and aggregate data from AWARD‐11 were conducted to explore the impact of adjustment for cross‐trial imbalances in baseline characteristics.

Results

Semaglutide 1.0 mg significantly reduced HbA1c versus dulaglutide 3.0 mg, with an estimated treatment difference (ETD) of −0.24%‐points (95% confidence interval [CI] −0.43, −0.05), with comparable reductions in HbA1c versus dulaglutide 4.5 mg with an ETD of −0.07%‐points (95% CI −0.26, 0.12). Semaglutide 1.0 mg significantly reduced body weight versus dulaglutide 3.0 and 4.5 mg with an ETD of −2.65 kg (95% CI −3.57, −1.73) and −1.95 kg (95% CI −2.87, −1.03), respectively. Sensitivity analyses supported the primary analysis findings.

Conclusions

This indirect comparison showed significantly greater reductions in HbA1c with semaglutide 1.0 mg versus dulaglutide 3.0 mg and comparable HbA1c reductions versus dulaglutide 4.5 mg. Semaglutide 1.0 mg significantly reduced body weight versus both dulaglutide 3.0 and 4.5 mg. With several glucagon‐like peptide‐1 receptor agonists available, information regarding their comparative efficacy can be valuable to clinicians.
Optimizing type 1 diabetes after multiple daily injections and capillary blood monitoring: Pump or sensor first? A meta‐analysis using pooled differences in outcome measures
Authors: Thomas Maria G. , Avari Parizad , Godsland Ian F. , Lett Aaron M. , Reddy Monika , Oliver Nick
Published: July 2021

Aims

Most people living with type 1 diabetes self‐manage using multiple daily injection (MDI) insulin regimens and self‐monitoring of blood glucose (SMBG). Continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) are adjuncts to education and support self‐management optimization. The aim of this systematic review and meta‐analysis was to assess which first‐line technology is most effective.

Methods

Electronic databases (MEDLINE, EMBASE and WEB OF SCIENCE) were systematically searched from 1999 to September 2020. Randomized controlled trials comparing either CSII with MDI or CGM with SMBG in adults with type 1 diabetes were included. Data were extracted in duplicate by two reviewers, and were analysed to assess individual and overall treatment effect measures (PROSPERO registration: CRD42020149915).

Results

Glycated haemoglobin was significantly reduced for CGM when compared with SMBG [Cohen's d − 0.62 (95% CI −0.79 to −0.45)] and for CSII when compared with MDI [Cohen's d − 0.44 (95% CI −0.67 to −0.22)]. Rates of severe hypoglycaemia were significantly reduced with CGM compared with SMBG, but did not change for CSII when compared with MDI. Episodes of diabetic ketoacidosis were more likely to occur with CSII than MDI. Both CSII and CGM reduced glucose standard deviation, compared with MDI and SMBG respectively.

Conclusions

Both CGM and CSII remain impactful interventions compared with SMBG and MDI but in adults with type 1 diabetes and in the contexts in which they have been studied, CGM might have a greater positive impact on glycaemic variability and severe hypoglycaemia than CSII, when added to MDI and SMBG. A head‐to‐head study, including patient reported outcomes, is required to explore these findings further.
Examining disorganization in patients with first episode psychosis: Findings from a 1‐year follow‐up of the ‘Parma early psychosis’ program
Authors: Pelizza Lorenzo , Leuci Emanuela , Maestri Davide , Quattrone Emanuela , Azzali Silvia , Paulillo Giuseppina , Pellegrini Pietro
Published: July 2021

Aim

Disorganization has been considered as a clinical domain close to the core of psychosis. However, it has received poor attention, especially at the illness onset. Moreover, most of the studies examining disorganized symptoms have been conducted in patients with chronic psychosis and research in the early stages of illness is still relatively scarce. Thus, the aims of this study were (a) to longitudinally monitor the stability of disorganization in patients with first episode psychosis (FEP) across a 1‐year follow‐up period, and (b) to investigate any relevant association of disorganized symptoms with functioning, psychopathology and the specific treatment components of an ‘early intervention in psychosis’ (EIP) program along the 1 year of follow‐up.

Methods

At baseline, 312 FEP participants (aged 12–35 years) completed the positive and negative syndrome scale (PANSS) and the global assessment of functioning (GAF). Spearman's correlations and multiple linear regression analysis were used.

Results

At baseline, disorganization showed significant associations with all PANSS subscores, and a relevant negative correlation with GAF score. Across the follow‐up, FEP individuals showed a significant improvement in disorganization severity. This decrease was specifically related to both baseline antipsychotic dosage and the number of individual cognitive‐behavioural therapy sessions offered across the 1‐year follow‐up period.

Conclusions

Disorganization is clinically relevant in FEP patients, already ate the enrollment in an EIP program. However, it tends to improve over time together with the delivery of specialized, person‐tailored FEP interventions within a specific EIP protocol.
Genital movements are not restricted to spermatozoa transfer in a haplogyne spider
Authors: Cargnelutti Franco , Calbacho‐Rosa Lucia , Peretti Alfredo Vicente
Published: July 2021

Internally fertilized animals are characterized by the transfer of their spermatozoa during copulation. However, the duration of copulation is highly variable, which suggests that they may serve for other functions apart from spermatozoa transfer. For example, during copulation, males can stimulate the female by using genitalic movements and/or by positioning their spermatozoa adequately within the female genitalia. In the spider Holocnemus pluchei, males perform strong squeezes and torsion movements with their pedipalps (part of their genitalia actively related to copulation) inside the female genitalia and transfer their spermatozoa during Phase I of copulation. However, the exact moment in which such transfer occurs and its relation to the pedipalp movements are still unknown. Herein, we first have identified the precise moment when the spermatozoa transfer occurs during phase I and its relation to genital movements by interrupting mating couples at the beginning, at middle and at end of this phase. Subsequently, the spermatozoa number remaining in male genitalia and stored in female genitalia were counted. We detected no relation between the number of genital movements and the spermatozoa number present in both, female and male genitalia and body size. As stated above, male genital movements serve another role during copulation in addition to spermatozoa transfer in a context of post‐copulatory sexual selection; most likely, they stimulate the female in a cryptic female choice framework.
Evidence of stock connectivity, hybridization, and misidentification in white anglerfish supports the need of a genetics‐informed fisheries management framework
Authors: Aguirre‐Sarabia Imanol , Díaz‐Arce Natalia , Pereda‐Agirre Iker , Mendibil Iñaki , Urtizberea Agurtzane , Gerritsen Hans D. , Burns Finlay , Holmes Ian , Landa Jorge , Coscia Ilaria , Quincoces Iñaki , Santurtún Marina , Zanzi Antonella , Martinsohn Jann T. , Rodríguez‐Ezpeleta Naiara
Published: July 2021

Understanding population connectivity within a species as well as potential interactions with its close relatives is crucial to define management units and to derive efficient management actions. However, although genetics can reveal mismatches between biological and management units and other relevant but hidden information such as species misidentification or hybridization, the uptake of genetic methods by the fisheries management process is far from having been consolidated. Here, we have assessed the power of genetics to better understand the population connectivity of white (Lophius piscatorius) and its interaction with its sister species, the black anglerfish (Lophius budegassa). Our analyses, based on thousands of genome‐wide single nucleotide polymorphisms, show three findings that are crucial for white anglerfish management. We found (i) that white anglerfish is likely composed of a single panmictic population throughout the Northeast Atlantic, challenging the three‐stock based management, (ii) that a fraction of specimens classified as white anglerfish using morphological characteristics are genetically identified as black anglerfish (L. budegassa), and iii) that the two Lophius species naturally hybridize leading to a population of hybrids of up to 20% in certain areas. Our results set the basics for a genetics‐informed white anglerfish assessment framework that accounts for stock connectivity, revises and establishes new diagnostic characters for Lophius species identification, and evaluates the effect of hybrids in the current and future assessments of the white anglerfish. Furthermore, our study contributes to provide additional evidence of the potentially negative consequences of ignoring genetic data for assessing fisheries resources.
The evolution of barriers to exploitation: Sometimes the Red Queen can take a break
Authors: Goodman Jonathan R. , Ewald Paul W.
Published: July 2021

We propose a general barrier theory as an evolutionary framework for understanding coevolutionary effects of conflicts of interest in natural and human systems. It is generalized from the barrier theory of cancer, which describes how cancer develops through the evasion of mechanisms, that block unregulated cellular reproduction and survival. Barriers are naturally evolved or artificially implemented mechanisms for blocking exploitation; restraints are mechanisms that impede but do not block exploitation. When conflicts of interest arise, selection will favor exploiters that are capable of overcoming barriers and restraints. When barriers are in place, they halt, at least temporarily, coevolutionary arms races (the Red Queen can stop running). Barriers occur in a broad spectrum of interactions characterized by conflicts of interest: barriers to cellular survival (apoptosis) and reproduction (cell cycle arrest) may block a virus from replicating its genome through reproduction of its host cell. Vaccines may completely protect against targeted pathogens. A plant may escape herbivory by evolving defensive chemicals that block herbivory. Obligate mutualisms may evolve when barriers to horizontal transmission favor symbionts that increasingly lose mechanisms that contribute to horizontal transmission. Here, we show how the barrier theory applies across a spectrum of natural and social systems.
Requirement prioritization framework using case‐based reasoning: A mining‐based approach
Authors: Ali Sadia , Hafeez Yaser , Hussain Shariq , Yang Shunkun , Jamal Muhammad
Published: July 2021

In the current era of technology and development, component‐based software development (CBSD) has been progressively implemented. Components are used in large products for multiple users with diverse viewpoints and are highly configurable to provide higher satisfaction. Components are reused because of their similar functionality to reduce complexity and ensure the correct interaction between interfaces during product development. However, implementation of component functionalities creates complications due to improper specification, prioritization of components requirements, encapsulated functionalities, and more human interaction. Furthermore, due to configurability and the involvement of multiple stakeholders, ambiguity and semantic issues arise in the behaviour of reusable components. To overcome semantic‐based specification and prioritization components' related issues, we propose a framework that uses text mining and case‐based reasoning (CBR) techniques. Results of our empirical evaluation demonstrate that the proposed framework significantly outperforms the conventional technique.
Improving estimates of the state of global fisheries depends on better data
Authors: Ovando Daniel , Hilborn Ray , Monnahan Cole , Rudd Merrill , Sharma Rishi , Thorson James T. , Rousseau Yannick , Ye Yimin
Published: July 2021

Implementation of the United Nations Sustainable Development Goals requires assessments of the global state of fish populations. While we have reliable estimates of stock status for fish populations accounting for approximately half of recent global catch, our knowledge of the state of the majority of the world's “unassessed” fish stocks remains highly uncertain. Numerous publications have produced estimates of the global status of these unassessed fisheries, but limited quantity and quality of data along with methodological differences have produced counterintuitive and conflicting results. Here, we show that despite numerous efforts, our understanding of the status of global fish stocks remains incomplete, even when new sources of broadly available data are added. Estimates of fish populations based primarily on catch histories on average performed 25% better than a random guess. But, on average, these methods assigned fisheries to the wrong FAO status category 57% of the time. Within these broad summaries, the performance of models trained on our tested data sources varied widely across regions. Substantial improvements to estimates of the state of the world's exploited fish populations depend more on expanded collection of new information and efficient use of existing data than development of new modelling methods.
Lessons From the Field: Developing a Multisite Divorce Education Evaluation Tool
Authors: Markham Melinda Stafford , Ferraro Anthony J. , Russell Luke T. , Beckmeyer Jonathon J. , Zimmermann McKenzie L. , Guyette Erin , Pippert Hilary D.
Published: July 2021

Objective

In this Lessons from the Field, we describe the lessons we learned from developing the Divorce Education Assessment Collaborative (DEAC) and creating a longitudinal evaluation plan for divorce education programs across geographically, programmatically, and format‐diverse programs.

Background

Although divorce education programs are commonly mandated for divorcing parents, variability in program content, format, and design can make it difficult to determine the efficacy of such programs. We contend developing a standardized evaluation tool, and making it freely available to programs, is essential for identifying best practices and moderators of program effectiveness.

Experience

Members of the DEAC share their experiences and insights regarding successes and challenges in coordinating and collaborating to develop an evaluation tool that is concise, but provides key information about program effectiveness and participants' program experiences.

Conclusion

Identifying and bringing together an idea champion, invested stakeholders, and critical resources (e.g., seed funding, teleconferencing, document collaboration software) were key components in the development of an effective multisite divorce education evaluation tool.

Implications

The strategies used to develop the DEAC may serve as a model for collaborative projects that bridge practice and research.
The AFCC‐Ontario Parenting Plan Guide and Template: Jurisdictionally‐Specific Resources for Family Justice Professionals and Parents
Authors: Bala Nicholas , Himel Madam Justice Andrea
Published: July 2021

This article discusses the development of the concept of parenting plans and the different approaches to providing materials that can help parents and professionals to make individualized, future‐oriented plans for children post‐separation. More than a quarter century after American states began to enact laws to encourage the use of parenting plans, Canada amended its legislation to abandon the proprietary concepts of “custody” and “access,” and encourage the use of parenting plans rather than “custody orders”. To support the making and use of individualized, child‐focused parenting plans, the Ontario Chapter of the Association of Family and Conciliation Courts (AFCC‐O) prepared its Parenting Plan Guide and Parenting Plan Template. These web‐based materials are available without charge to parents and their professional advisors. The Guide discusses the value of parental co‐operation and planning, while recognizing that in cases where there are serious issues of abuse, violence or parental mental health, a protective judicial role and court orders may be needed. The Guide offers advice on the making of developmentally‐appropriate parenting plans, and the Template provides possible alternatives for the wording of specific clauses. While the available parenting plan materials from different jurisdictions have broadly similar content, there is value in having family justice organizations, including chapters of the AFCC, develop their own materials, that are consistent with the laws, justice processes and resources of their jurisdiction. The Ontario experience suggests that judges, lawyers and parents may be more likely to use jurisdictionally‐specific materials rather than more generic resources.
Family Law and Therapeutic Jurisprudence: A Caring Combination—Introduction to the July 2021 Special Issue of Family Court Review
Authors: Babb Barbara A.
Published: July 2021

Therapeutic jurisprudence, referred to as TJ, has its origins in mental health law and now applies internationally to every area of law, including family law. This article briefly defines TJ, discusses its relevance to family law, and introduces FCR readers to the eight special issue articles. The publications describe TJ's connection to family law in various contexts and from several countries, including Singapore, Ireland, New Zealand, Israel, and the United States.
COVID‐19 vaccines: what do we know so far?
Authors: Dhillon Paraminder , Altmann Daniel , Male Victoria
Published: July 2021

When the novel coronavirus was described in late 2019, it could not have been imagined that within a year, more than 100 vaccine candidates would be in preclinical development and several would be in clinical trials and even approved for use. The scale of the COVID‐19 outbreak pushed the scientific community, working in collaboration with pharmaceutical companies, public health bodies, policymakers, funders and governments, to develop vaccines against SARS‐CoV‐2 at record‐breaking speed. As well as driving major amendments to the usual timeframe for bringing a vaccine to fruition, the pandemic has accelerated the development of next‐generation technologies for vaccinology, giving rise to two frontrunner RNA vaccines. Although none of the critical safety and efficacy steps have been skipped within the compressed schedules, and the technologies underpinning the novel vaccines have been refined by scientists over many years, a significant proportion of the global population is sceptical of the benefits of COVID‐19 vaccines and wary of potential risks. In this interview‐based article, we give an overview of how the vaccines were developed and how they work to generate a robust immune response against COVID‐19, as well as addressing common questions relating to safety and efficacy.
Economic and health impacts of introducing Helicobacter pylori eradication strategy into national gastric cancer policy in Japan: A cost‐effectiveness analysis
Authors: Kowada Akiko , Asaka Masahiro
Published: July 2021

Background

Helicobacter pylori (H. pylori) eradication reduces gastric cancer risk. Since 2013, a population‐wide H. pylori eradication strategy for patients with chronic gastritis has begun to prevent gastric cancer in Japan. The aim of this study was to evaluate the economic and health effects of H. pylori eradication strategy in national gastric cancer prevention program.

Materials and Methods

We developed a cohort state‐transition model for H. pylori eradication and no eradication over a lifetime horizon from a healthcare payer perspective, and performed one‐way and probabilistic sensitivity analyses. We targeted a hypothetical cohort of H. pylori‐positive patients aged 20, 30, 40, 50, 60, 70, and 80. The main outcomes were costs, quality‐adjusted life‐years (QALYs), life expectancy life‐years (LYs), incremental cost‐effectiveness ratios, gastric cancer cases, and deaths from gastric cancer.

Results

H. pylori eradication was more effective and cost‐saving for all age groups than no eradication. Sensitivity analyses showed strong robustness of the results. From 2013‐2019 for 8.50 million patients, H. pylori eradication saved US$3.75 billion, increased 11.11 million QALYs and 0.45 million LYs, and prevented 284,188 cases and 65,060 deaths. For 35.59 million patients without eradication, H. pylori eradication has the potential to save US$14.82 billion, increase 43.10 million QALYs and 1.66 million LYs, and prevent 1,084,532 cases and 250,256 deaths.

Conclusions

National policy using population‐wide H. pylori eradication to prevent gastric cancer has significant cost savings and health impacts for young‐, middle‐, and old‐aged individuals in Japan. The findings strongly support the promotion of H. pylori eradication strategy for all age groups in high‐incidence countries.
Embodying legal precarity: Living with ongoing short‐term protection in Germany
Authors: Suerbaum Magdalena
Published: July 2021

Immigration regimes pay particular attention to the migrant’s body in the process of legal and bureaucratic inscription. Legal precarity, defined by the repeated reception of short‐term protection from deportation, is an existential and deeply embodied experience. The analysis of Schwangerschaftsduldung (temporary suspension of deportation based on pregnancy) and protection for unaccompanied minors, two legal situations in Germany, can shed light on how the migrant’s body receives centre stage in the process of legal status determination and shows how the long journey to relative legal stability deeply affects the body. The two legal categories have in common a temporal limitation and an association with bodily transformations. By centring on the legal trajectories of three migrants, this article shows how the body is taken as the marker of vulnerability and (un)deservingness and becomes the bearer of legal precarity.
Endocrine adverse effects of immune checkpoint inhibitors
Authors: Walters Anthony G. B. , Braatvedt Geoffrey
Published: July 2021

Immune checkpoint inhibitors are increasingly being utilised as an effective therapy for a variety of cancers. However, they have the potential to cause serious autoimmune toxicities in multiple organ systems termed ‘immunotherapy‐related adverse events’. Endocrine toxicities are common, can occur well after commencement of therapy and can result in significant morbidity and mortality if not recognised. This makes it important for all physicians, in addition to endocrinologists and oncologists, to understand the nature of these reactions and the general approach to their diagnosis and management. This review aims to provide an overview of the epidemiology, pathophysiology, clinical presentation and management of the endocrine adverse events.
Renal manifestations of syphilis
Authors: Shettigar Reshma , Schollum John , Putt Tracey , Chan Ling , Lau Michael , Walker Robert
Published: July 2021

Syphilis is a sexually transmitted disease caused by spirochaete Treponema pallidum. The incidence of syphilis is rising across the globe. It has been described in the literature as a great imitator due to the vast range of clinical manifestations that can occur in the disease. Renal manifestations are rare but a feature of secondary syphilis. It can cause glomerulopathies, tubular pathology and vasculitic lesions in the kidney. Membranous nephropathy is the most commonly reported glomerular lesion associated with syphilis. With two recent cases of secondary membranous nephropathy due to syphilis, it is timely to review the current state of knowledge, and discuss the different renal manifestation of syphilis, its pathology and treatment options.
Near‐death of Australia's Medicines Safety Update
Authors: McEwen John , Boyd Ian W.
Published: July 2021

The Therapeutic Goods Administration has since 2013 neglected its long tradition of publishing regular bulletins and updates about medicine safety issues directed to Australian healthcare professionals. Recent publication policy is confused with information about clinically important safety issues published only in the alternative Safety Information Alerts and, unlike other comparable regulators, a failure to publish direct healthcare professional communications.
Customization in educational computer games and its effect on learning: Experimental study with primary school children
Authors: Javora Ondřej , Děchtěrenko Filip , Tetourová Tereza , Volná Kristina , Brom Cyril
Published: July 2021

The instructional effects of customization features in child learning games have rarely been examined. This value‐added study addresses the existing gap with regards to user‐initiated cosmetic customization of environment elements (i.e., non‐avatar customization). Participants (N = 143;Mage = 9.41) studied a biological topic for about 20 min: either using the experimental version of a learning game with customization features, or from a control version without them. Null results were found as concerns between‐group differences: both for motivation‐related variables and learning outcome measures. These findings indicate that user‐initiated cosmetic customization features can be omitted by game designers, especially in settings where children are assigned specific instructional materials from which to study.
Patch test informed consent form: position statement by European Academy of Dermatology and Venereology Task Force on Contact Dermatitis
Authors: Balato A. , Scala E. , Ayala F. , Bauer A. , Crépy M.‐N. , Gonçalo M. , Duus Johansen J. , John S.M. , Rustemeyer T. , Wagner N. , Wilkinson M. , Giménez‐Arnau A.
Published: July 2021

Background

To our knowledge, an international consensus is lacking regarding the development of an adequate informed consent form for a patch test (PT) and the information that should be included in such document.

Objectives

The aim of the study was to reach a consensus on the specific points that need to be addressed in a PT consent form.

Methods

A Delphi survey, comprising 2 rounds and 1 final discussion, was used to gather and analyse data, which was conducted over the Internet. Each statement that reached a consensus with the respondents (9 expert dermatologists from Europe) was defined as a median consensus score (MED) of ≥7 and agreement among panelists as an interquartile range (IQR) of ≤3. All study participants were members of the EADV task force on contact dermatitis.

Results

The expert panel addressed several topics that should be included in an informed consent form for a PT: introduction, preparation for PT, testing procedure, allowed activities, adverse events and additional authorizations.

Conclusions

Our results assess recommendations regarding points to be contained in an informed consent form for a PR. Future actions towards standardization and harmonization of this specific consent form are needed.
Effects of floods on infrastructure users in Kenya
Authors: Njogu Humphrey Waita
Published: July 2021

Events associated with climate change such as floods increase outages of infrastructure services. Developing countries largely react rather than being proactive in managing the effects of floods on infrastructure. This is clearly demonstrated by inadequate level of preparedness experienced before, during, and after events of floods. This research discusses the effects of floods on infrastructure users in Kenya based on a primary study carried out in 27 counties out of 47 counties in Kenya. The research findings show that events of floods in Kenya disrupt provision of infrastructure services by damaging road networks, energy facilities, buildings, and social facilities. The study reveals Kenya spend huge amount of resources in recovery phase to address the effects of floods. The study notes that local communities play a critical role in responding and recovery from floods. The study also reveals Kenya lacks climate sensitive policies, legislation, and development plans that make reference to resilience in order to protect infrastructure against known and foreseen climate risks. The study recommends that building resilience in infrastructure to respond and withstand the effects of floods demands common vision among different stakeholders.
Efficacy and safety of rifampicin in patients with persistent hepatocellular secretory failure
Authors: Shi Mingxia , Sheng Li , Lian Min , Miao Qi , Wang Qixia , Xiao Xiao , Ma Xiong
Published: July 2021

Background and Aim

Persistent hepatocellular secretory failure (PHSF) is a rare condition of severe cholestasis caused by drugs, toxins, infection, or temporary biliary obstruction. Real‐world data on rifampicin in cholestasis, particularly among patients with deep jaundice, are scarce. We aimed to expand the knowledge on the efficacy and safety of rifampicin treatment in PHSF patients.

Methods

Sixteen patients with PHSF who had received rifampicin treatment (150–300 mg/d) at our institution from September 2016 to July 2020 were included. Treatment efficacy was assessed by 20% improvement in serum total bilirubin (TBIL) concentration at 4 weeks. Follow‐up was continued until the concentration of TBIL returned to normal.

Results

Among the 16 enrolled patients, 12 had predisposing factors (drugs, infection, or transient biliary obstruction). ATP8B1 or ABCB11 mutations were detected in the other four patients without trigger events. UGT1A1 mutations were found in 7/10 patients. Before rifampicin treatment, the median TBIL level was 352 μmol/L (range 171–591 μmol/L). TBIL > 20% improvement was observed in 14 patients at 4 weeks. TBIL levels of 14 patients eventually returned to normal after 6–12 weeks of rifampicin treatment. The remaining two patients who did not respond to rifampicin finally recovered after nasobiliary drainage. Except for one patient with transient drug‐induced hepatitis, no other serious adverse events were observed.

Conclusions

Rifampicin could be a promising option for most PHSF patients. Most PHSF patients have UGT1A1 deficiency, which may be the target of rifampicin.
Different transformations underlie blowhole and nasal passage development in a toothed whale (Odontoceti:Stenella attenuata) and a baleen whale (Mysticeti:Balaenoptera physalus)
Authors: Roston Rachel A. , Roth V. Louise
Published: July 2021

Reorientation of the nasal passage away from the anteroposterior axis has evolved rarely in mammals. Unlike other mammals, cetaceans (e.g., whales, dolphins, and porpoises) have evolved a “blowhole”: posteriorly repositioned nares that open dorsad. Accompanying the evolution of the blowhole, the nasal passage has rotated dorsally. Neonatal cetaceans possess a blowhole, but early in development, cetacean embryos exhibit head morphologies that resemble those of other mammals. Previous workers have proposed two developmental models for how the nasal passage reorients during prenatal ontogeny. In one model, which focused on external changes in the whole body, dorsad rotation of the head relative to the body results in dorsad rotation of the nasal passage relative to the body. A second model, based on details of the cartilaginous nasal skull, describes dorsad rotation of the nasal passage itself relative to the palate and longitudinal axis of the skull. To integrate and revise these models, we characterized both external and internal prenatal changes in a longitudinal plane that are relevant to nasal passage orientation in the body and head of the pantropical spotted dolphin (Odontoceti:Stenella attenuata). These changes were then compared to those in a prenatal series of a baleen whale, the fin whale (Mysticeti:Balaenoptera physalus), to determine if they were representative of both extant cetacean suborders. In both species, the angle between the nasal passage and the sagittal axis of the foramen magnum decreased with age. InS. attenuata, this was associated with basicranial retroflexion and midfacial lordosis: the skull appeared to fold dorsad with the presphenoid as the vertex of the angle. In contrast, inB. physalus, alignment of the nasal passage and the sagittal axis of the plane of the foramen magnum was associated with angular changes within the posterior skull (specifically, the orientations of the supraoccipital and foramen magnum relative to the posterior basicranium). With these results, we propose a new developmental model for prenatal reorientation of the odontocete nasal passage and discuss ways in which mysticetes likely deviate from this model.
Exploring mentorship practices in clinical education in nursing homes: A qualitative mixed‐methods study
Authors: Frøiland Christina T. , Husebø Anne Marie Lunde , Akerjordet Kristin , Kihlgren Annica , Laugaland Kristin
Published: July 2021

Aims and objectives

To explore registered nurses’ mentorship practices of first‐year nursing students in nursing home placements.

Background

Enabling nursing students to develop professional competence through clinical placements relies heavily on registered nurses’ mentorship practices. Despite renewed interest in nursing homes as an important clinical placement setting, studies are scarce on registered nurses’ mentorship practices in this context.

Design

An exploratory, qualitative mixed‐methods design.

Methods

The data consisted of 126 h’ observation of two registered nurse mentor–student dyads, supplemented by in‐depth interviews (n = 12) with registered nurse mentors. The data were collected in three Norwegian nursing homes and analysed using content analysis. The consolidated criteria for reporting qualitative research (COREQ) checklist were used to report the findings.

Results

The registered nurses’ mentorship practices of first‐year nursing students in nursing home clinical placement were characterised by (1) variability and uncertainty in pedagogical supervisory approaches, (2) lack of management support and engagement of staff members in supervision, (3) lack of supervisory continuity and (4) a peripheral role in formal assessment discussions.

Conclusions

A marginal nursing home context, alongside a mismatch between registered nurses’ roles and first‐year students’ learning objectives, introduces considerable vulnerability that impedes effective mentorship practices. Targeted efforts to enhance mentorship practices in nursing homes are warranted to promote full use of the learning potential in this context. Developing and testing educational interventions is necessary to effectively enhance registered nurses’ pedagogical competence, alongside engagement and support from nurse managers and nurse educators.

Relevance to clinical practice

This study provides insight into barriers to effective mentorship practices of first‐year nursing students in nursing home placements. These barriers warrant attention from nursing home managers and nurse education institutions towards improvements that enhance effective mentorship practices vital for students’ learning, professional growth and future recruitment to care for older people.
Borrowing to Save? The Impact of Automatic Enrollment on Debt
Authors: BESHEARS JOHN , CHOI JAMES J. , LAIBSON DAVID , MADRIAN BRIGITTE C. , SKIMMYHORN WILLIAM L.
Published: July 2021

Does automatic enrollment into a retirement plan increase financial distress due to increased borrowing outside the plan? We study a natural experiment created when the U.S. Army began automatically enrolling newly hired civilian employees into the Thrift Savings Plan. Four years after hire, automatic enrollmentincreases cumulative contributions to the plan by 4.1% of annual salary, but we find little evidence ofincreased financial distress. Automatic enrollment causes no significant change in credit scores, debt balances excluding auto debt and first mortgages, or adverse credit outcomes, with the possible exception of increasedfirst‐mortgage balances in foreclosure.