bluuebunny/crossref_metadata_2025 huggingface dataset:
Targets of influenza human T-cell response are mostly conserved in H5N1
Authors: Sidney John , Kim A-Reum , de Vries Rory D. , Peters Bjoern , Meade Philip S. , Krammer Florian , Grifoni Alba , Sette Alessandro
Published: December 2024

Frequent recent spillovers of subtype H5N1 clade 2.3.4.4b highly pathogenic avian influenza (HPAI) virus into poultry and mammals, especially dairy cattle, including several human cases, increased concerns over a possible future pandemic. Here, we performed an analysis of epitope data curated in the Immune Epitope Database (IEDB). We found that the patterns of immunodominance of seasonal influenza viruses circulating in humans and H5N1 are similar. We further conclude that a significant fraction of the T-cell epitopes is conserved at a level associated with cross-reactivity between avian and seasonal sequences, and we further experimentally demonstrate extensive cross-reactivity in the most dominant T-cell epitopes curated in the IEDB. Based on these observations, and the overall similarity of the neuraminidase (NA) N1 subtype encoded in both HPAI and seasonal H1N1 influenza virus as well as cross-reactive group 1 HA stalk-reactive antibodies, we expect that a degree of pre-existing immunity is present in the general human population that could blunt the severity of human H5N1 infections.

IMPORTANCE

Influenza A viruses (IAVs) cause pandemics that can result in millions of deaths. The highly pathogenic avian influenza (HPAI) virus of the H5N1 subtype is presently among the top viruses of pandemic concern, according to the WHO and the National Institute of Allergy and Infectious Diseases (NIAID). Previous exposure by infection and/or vaccination to a given IAV subtype or clade influences immune responses to a different subtype or clade. Analysis of human CD4 and CD8 T-cell epitope conservation between HPAI H5N1 and seasonal IAV sequences revealed levels of identity and conservation conducive to T cell cross-reactivity, suggesting that pre-existing T cell immune memory should, to a large extent, cross-recognize avian influenza viruses. This observation was experimentally verified by testing responses from human T cells to non-avian IAV and their HPAI H5N1 counterparts. Accordingly, should a more widespread HPAI H5N1 outbreak occur, we hypothesize that cross-reactive T-cell responses might be able to limit disease severity.
Draft annotated genome of the entomopathogenic fungus
Metarhizium pingshaense
isolated from
Spodoptera
species
Authors: Apirajkamol Nonthakorn (Beatrice) , Bachler Andreas , Tay Wee Tek , Mainali Bishwo , Taylor Phillip , Walsh Thomas Kieran
Published: December 2024

The entomopathogenic fungus
Metarhizium pingshaense
infects diverse insect host species. We present an annotated draft genome of
M. pingshaense
(Commonwealth Scientific and Industrial Research Organisation [CSIRO] strain M-1000) isolated from a
Spodoptera
species individual, thereby contributing to future research of
M. pingshaense
as a potential biological control agent.
Complete genome sequence of
Bacillus subtilis
bacteriophage Adastra
Authors: Herbig Andrew F. , Pendergrass Eliana M.
Published: December 2024

Adastra is a lytic bacteriophage that infects
Bacillus subtilis
. Here, we report the sequencing and annotation of the 136,306-bp genome of Adastra and its similarity to other myophages in the SPO1 family.
Draft genome sequence of
Modicisalibacter
sp. strain Wilcox isolated from produced water
Authors: Ajagbe Damilare , Marsh William , Murdoch Robert , Fathepure Babu
Published: December 2024

The draft genome sequence of
Modicisalibacter
sp. strain Wilcox, isolated from produced water, is presented. The genome is 3.6 Mb in size with 3,283 protein-coding genes, including genes for hydrocarbon degradation, heavy metal resistance, and adaptation to high salinity. This genome provides insights into molecular mechanisms of hydrocarbon degradation under hypersaline conditions.
Uncovering novel functions of the enigmatic, abundant, and active
Anaerolineae
in a salt marsh ecosystem
Authors: Payne Paige E. , Knobbe Loren N. , Chanton Patricia , Zaugg Julian , Mortazavi Behzad , Mason Olivia U.
Published: December 2024

Anaerolineae
, particularly uncultured representatives, are one of the most abundant microbial groups in coastal salt marshes, dominating the belowground rhizosphere, where over half of plant biomass production occurs. However, this class generally remains poorly understood, particularly in a salt marsh context. Here, novel
Anaerolineae
metagenome-assembled genomes (MAGs) were generated from the salt marsh rhizosphere representing
Anaerolineales
,
Promineifilales
, JAAYZQ01, B4-G1, JAFGEY01, UCB3, and
Caldilineales
orders. Metagenome and metatranscriptome reads were mapped to annotated MAGs, revealing nearly all
Anaerolineae
encoded and transcribed genes required for oxidation of carbon compounds ranging from simple sugars to complex polysaccharides, fermentation, and carbon fixation. Furthermore, the majority of
Anaerolineae
expressed genes involved in anaerobic and aerobic respiration and secondary metabolite production. The data revealed that the belowground salt marsh
Anaerolineae
in the rhizosphere are important players in carbon cycling, including degradation of simple carbon compounds and more recalcitrant plant material, such as cellulose, using a diversity of electron acceptors and represent an unexplored reservoir of novel secondary metabolites.

IMPORTANCE

Given that coastal salt marshes are recognized as biogeochemical hotspots, it is fundamentally important to understand the functional role of the microbiome in this ecosystem. In particular,
Anaerolineae
are abundant members of the salt marsh rhizosphere and have been identified as core microbes, suggesting they play an important functional role. Yet, little is known about the metabolic pathways encoded and expressed in this abundant salt marsh clade. Using an ‘omics-based approach, we determined that
Anaerolineae
are capable of oxidizing a range of carbon compounds, including simple sugars to complex carbon compounds, while also encoding fermentation and carbon fixation. Surprisingly,
Anaerolineae
encoded and transcribed genes involved in aerobic respiration, which was unexpected given the reduced nature of the salt marsh rhizosphere. Finally, the majority of
Anaerolineae
appear to be involved in secondary metabolite production, suggesting that this group represents an unexplored reservoir of novel and important secondary metabolites.
Genome-resolved year-round dynamics reveal a broad range of giant virus microdiversity
Authors: Fang Yue , Meng Lingjie , Xia Jun , Gotoh Yasuhiro , Hayashi Tetsuya , Nagasaki Keizo , Endo Hisashi , Okazaki Yusuke , Ogata Hiroyuki
Published: December 2024

Giant viruses are crucial for marine ecosystem dynamics because they regulate microeukaryotic community structure, accelerate carbon and nutrient cycles, and drive the evolution of their hosts through co-evolutionary processes. Previously reported long-term observations revealed that these viruses display seasonal fluctuations in abundance. However, the underlying genetic mechanisms driving such dynamics of these viruses remain largely unknown. In this study, we investigated the dynamics of giant viruses using time-series metagenomes from eutrophic coastal seawater samples collected over 20 months. A newly developed computational pipeline generated 1,065 high-quality genomes covering six major giant virus lineages. These genomic data revealed year-round recovery of the viral community structure at the study site and distinct dynamics of viral populations that were classified as persistent (
n
= 9), seasonal (
n
= 389), sporadic (
n
= 318), or others. By profiling the intra-species nucleotide-resolved microdiversity through read mapping, we also identified year-round recovery dynamics at subpopulation level for viruses classified as persistent or seasonal. Our results further indicated that giant viruses with broader niche breadth tended to exhibit higher levels of microdiversity. We argue that greater microdiversity of viruses likely enhances adaptability and thus survival under the virus–host arms race during prolonged interactions with their hosts.

IMPORTANCE

Recent genome-resolved metagenomic surveys have uncovered the vast genomic diversity of giant viruses, which play significant roles in aquatic ecosystems by acting as bloom terminators and influencing biogeochemical cycles. However, the relationship between the ecological dynamics of giant viruses and underlying genetic structures of viral populations remains unresolved. In this study, we performed deep metagenomic sequencing of seawater samples collected across a time-series from a coastal area in Japan. The results revealed a significant positive correlation between microdiversity and temporal persistence of giant virus populations, suggesting that population structure is a crucial factor for adaptation and survival in the interactions with their hosts.
Revealing systematic changes in the transcriptome during the transition from exponential growth to stationary phase
Authors: Lim Hyun Gyu , Gao Ye , Rychel Kevin , Lamoureux Cameron , Lou Xuwen A. , Palsson Bernhard O.
Published: December 2024

The composition of bacterial transcriptomes is determined by the transcriptional regulatory network (TRN). The TRN regulates the transition from one physiological state to another. Here, we use independent component analysis to monitor the composition of the transcriptome during the transition from the exponential growth phase to the stationary phase. With
Escherichia coli
K-12 MG1655 as a model strain, we trigger the transition using carbon, nitrogen, and sulfur starvation. We find that (i) the transition to the stationary phase accompanies common transcriptome changes, including increased stringent responses and reduced production of cellular building blocks and energy regardless of the limiting element; (ii) condition-specific changes are strongly associated with transcriptional regulators (
e.g.
, Crp, NtrC, CysB, Cbl) responsible for metabolizing the limiting element; and (iii) the shortage of each limiting element differentially affects the production of amino acids and extracellular polymers. This study demonstrates how the combination of genome-scale datasets and new data analytics reveals the fundamental characteristics of a key transition in the life cycle of bacteria.

IMPORTANCE

Nutrient limitations are critical environmental perturbations in bacterial physiology. Despite its importance, a detailed understanding of how bacterial transcriptomes are adjusted has been limited. By utilizing independent component analysis (ICA) to decompose transcriptome data, this study reveals key regulatory events that enable bacteria to adapt to nutrient limitations. The findings not only highlight common responses, such as the stringent response, but also condition-specific regulatory shifts associated with carbon, nitrogen, and sulfur starvation. The insights gained from this work advance our knowledge of bacterial physiology, gene regulation, and metabolic adaptation.
Neospora caninum
infection specifically suppresses the expression of a host lncRNA
XR_001919077.1
to facilitate parasite propagation by modulating host cell mitochondrial function and autophagy
Authors: Zhao Shan-Shan , Tao De-Liang , Chen Jin-Ming , Zhang Ming-Yi , Yang Xin , Song Jun-Ke , Liu Qun , Zhao Guang-Hui
Published: December 2024

Neospora caninum
is one of the most common pathogens causing reproductive failure in ruminants (e.g., cattle and goats) worldwide. However, due to a poor understanding of the pathogenic mechanisms of
N. caninum
infection, no effective drugs and vaccines are currently available. Long non-coding RNAs (lncRNAs) have been reported to be important regulators involved in a great number of physiological and pathological processes. Our previous study found that
N. caninum
infection induced significantly aberrant expression of lncRNA profiles in caprine endometrial epithelial cells (EECs). In the present study, we found that
N. caninum
infection specifically suppressed the expression of a novel lncRNA,
XR_001919077.1
, and knockdown of
XR_001919077.1
with small interfering RNA significantly promoted the propagation of
N. caninum
in caprine EECs. Rapid amplification of cDNA ends analysis generated six splice variants of
XR_001919077.1
, with lengths ranging from 592 to 694 nt. Transfection of the full length of each variant markedly inhibited the propagation of
N. caninum
in caprine EECs. Further study suggested that
XR_001919077.1
acted as a sponge of Chi-miR-93-5p to promote the expression of
sirt1
, and the
XR_001919077.1
/Chi-miR-93-5p/
sirt1
axis significantly delayed the
in vitro
growth of
N. caninum
in caprine EECs by regulating host cell mitochondrial function and autophagy. Our findings provide a novel insight to understand the interactions between
N. caninum
and host cells.

IMPORTANCE

The uterus is an indispensable reproductive organ for embryo implantation and fetal growth. The endometrium is more vulnerable to infection by pathogenic microorganisms resulting in an increased risk of miscarriage.
Neospora caninum
is one of the most common pathogens causing miscarriage in ruminants and is able to naturally inhabit the uterus, with
N. caninum
tissue cysts found in the endometrium. Recent advances in
N. caninum
research have revealed aberrant expression of long non-coding RNA (lncRNA) profiles in infected caprine endometrial epithelial cells. In the present study,
N. caninum
, but not
Toxoplasma gondii,
which has similar morphological and biological features to
N. caninum
, specifically suppresses the expression of a host lncRNA,
XR_ 001919077.1
, to impair host’s defense through the competitive endogenous RNA mechanism to modulate the host cell mitochondrial function and autophagy to facilitate parasite propagation. The findings suggest a novel immune evasion strategy of
N. caninum
to facilitate intracellular propagation and provide an alternative path to develop control strategies against neosporosis.
Identifying and counteracting fraudulent responses in online recruitment for health research: a scoping review
Authors: Comachio Josielli , Poulsen Adam , Bamgboje-Ayodele Adeola , Tan Aidan , Ayre Julie , Raeside Rebecca , Roy Rajshri , O’Hagan Edel
Published: December 2024

Objectives

This study aimed to describe how health researchers identify and counteract fraudulent responses when recruiting participants online.

Design

Scoping review.

Eligibility criteria

Peer-reviewed studies published in English; studies that report on the online recruitment of participants for health research; and studies that specifically describe methodologies or strategies to detect and address fraudulent responses during the online recruitment of research participants.

Sources of evidence

Nine databases, including Medline, Informit, AMED, CINAHL, Embase, Cochrane CENTRAL, IEEE Xplore, Scopus and Web of Science, were searched from inception to April 2024.

Charting methods

Two authors independently screened and selected each study and performed data extraction, following the Joanna Briggs Institute’s methodological guidance for scoping reviews and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. A predefined framework guided the evaluation of fraud identification and mitigation strategies within the studies included. This framework, adapted from a participatory mapping study that identified indicators of fraudulent survey responses, allowed for systematic assessment and comparison of the effectiveness of various antifraud strategies across studies.

Results

23 studies were included. 18 studies (78%) reported encountering fraudulent responses. Among the studies reviewed, the proportion of participants excluded for fraudulent or suspicious responses ranged from as low as 3% to as high as 94%. Survey completion time was used in six studies (26%) to identify fraud, with completion times under 5 min flagged as suspicious. 12 studies (52%) focused on non-confirming responses, identifying implausible text patterns through specific questions, consistency checks and open-ended questions. Four studies examined temporal events, such as unusual survey completion times. Seven studies (30%) reported on geographical incongruity, using IP address verification and location screening. Incentives were reported in 17 studies (73%), with higher incentives often increasing fraudulent responses. Mitigation strategies included using in-built survey features like Completely Automated Public Turing test to tell Computers and Humans Apart (34%), manual verification (21%) and video checks (8%). Most studies recommended multiple detection methods to maintain data integrity.

Conclusion

There is insufficient evaluation of strategies to mitigate fraud in online health research, which hinders the ability to offer evidence-based guidance to researchers on their effectiveness. Researchers should employ a combination of strategies to counteract fraudulent responses when recruiting online to optimise data integrity.
Sickle cell retinopathy among Ghanaian high school students: a school-based screening
Authors: Sedhom Jessica , Ahmed Akwasi , DesLauriers Andrew , Ahmed Eunice Agyeman , Ameyaw Baah Christabel , Ackah Peter , Appiah-Berko Maame Temah , Appiagyei Marion , Yeboah-Arhin Obed , Shah Sarthak , Pershing Suzann , Tabin Geoffrey C , Mruthyunjaya Prithvi , Brant Arthur
Published: December 2024

Introduction

Sickle cell disease (SCD) remains a significant health concern, particularly in Ghana and Sub-Saharan African countries. School-based ocular screenings provide a unique opportunity for early detection of sickle cell retinopathy (SCR).

Methods

Students from five major schools in the Kumasi Metropolitan District of Ghana were included. Research assistants educated students on SCD and type 1 diabetes (T1DM) during school-wide assemblies, emphasising destigmatisation and vision health. Students completed questionnaires to self-report SCD or T1DM. Those who self-reported underwent in-depth interviews and dilated fundus exams (DFE).

Results

Of 17 987 total student population, 8168 students completed the survey (45.4% response rate) of which 2.4% of students were aware of their SCD status, while most 69.3% were unaware. No students reported having T1DM. 24 students identified as having SCD (14 haemoglobin SS and 10 HbSC) resulting in a prevalence of 0.07% and 0.05% for SS and SC, respectively. Among the SCD cohort, four had Proliferative SCR (PSCR). Of the students with stage 3 PSCR, one was 15 years old with SS genotype and bilateral stage 3 PSCR; another was 18 years old with SC disease, unilateral stage 3 PSCR. Only one SCD patient (SS genotype) had a history of previous DFE. 20.8% of SCD students were aware of SCD ocular complications and 75% felt uncomfortable sharing their SCD status.

Conclusions

We conclude (1) an alarmingly low rate of self-reporting SCD (11× and 24× lower than expected for SS and SC-SCD, respectively), (2) low health literacy given 0% of students with SC-SCD had previously undergone a DFE and (3) 17% of students had PSCR and 8% of students had treatment-warranted PSCR (stage 3). These findings highlight the need for universal SCD screening, improved health education on the ocular complications of SCD and routine school-based vision screenings for patients with SCD.
How pragmatic are randomised controlled trials evaluating minimally invasive surgery for oesophageal cancer? A methodological review of trial design using the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool
Authors: Chalmers Katy , Cousins Sian , Blencowe Natalie S , Blazeby Jane
Published: December 2024

Background

Surgical interventions are inherently complex and designing and conducting surgical randomised controlled trials (RCTs) can be challenging. Trial design impacts the applicability of trial results to clinical practice. Given the recent growth in numbers of surgical RCTs, there is a need to better understand the validity and applicability of trials in this field.

Objectives

To examine the applicability and validity of RCTs comparing minimally invasive and open surgery for oesophageal cancer and to delineate areas for future research.

Eligibility criteria

RCTs comparing open with minimal invasive oesophagectomy, published January 2012–June 2023. Abstracts, pilot and feasibility studies, and systematic reviews were excluded.

Sources of evidence

Three sequential searches of Ovid MEDLINE, Embase and CENTRAL electronic databases and clinical trials registry databases.

Charting methods

Two independent reviewers screened the articles and used appropriate, validated tools (Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) and Risk of Bias 2) to assess study quality. Trials were considered pragmatic if they were conducted in multiple centres and had a mean score of four or above on the PRECIS-2.

Results

Nine RCTs were identified. One was judged to be pragmatic. The remaining eight were limited by narrow eligibility criteria, being single-centred or having strict intervention protocols. Two studies were low risk of bias, of which one was pragmatic, and three high, due to unblinded outcome assessment. The remaining four studies were of ‘some concern’ due to poor reporting.

Conclusions

Only one trial identified in this review was considered pragmatic. More lenient criteria, as used in other reviews, may increase the proportion. There is a need for clearer guidance on the cut-off values that define a trial as pragmatic. It is recommended that the intended purpose of the trial, whether explanatory or pragmatic, receives more attention during surgical trial study design and conduct.
Modified Delphi expert elicitation of the clinical and economic burden of obstructive hypertrophic cardiomyopathy in England and Northern Ireland
Authors: Hurst Michael , Zema Carla , Krause Taryn , Sandler Belinda , Lemmer Teresa , Noon Kathleen , Alexander Deepak , Osman Faizel
Published: December 2024

Objective

To estimate the resource use of patients with obstructive hypertrophic cardiomyopathy (HCM), stratified by New York Heart Association (NYHA) class, in the English and Northern Irish healthcare systems via expert elicitation.

Design

Modified Delphi framework methodology.

Setting

UK HCM secondary care centres (n=24).

Participants

Cardiologists who actively treated patients with HCM were eligible, of whom 10 from English and Northern Irish centres participated. Recruitment of participants to the study was limited to one expert per site.

Methods

Responses were collected by electronic quantitative survey. Following the discussion of survey results in a virtual panel, aggregated responses from a final survey were analysed and stratified by NYHA class. Data were analysed without (base case) and with (scenario) interventional cardiologists who conduct septal reduction therapies (SRTs).

Results

Based on expert opinion, as NYHA class increased, so did the mean±95% CI number of primary care consultations (classes I–IV: 0.64±0.35; 1.07±0.33; 3.29±1.02; 6.00±2.46, respectively) per patient per annum. This was also observed across all types of secondary care consultations, such as mean±95% CI number of cardiovascular-related outpatient visits (classes I–IV: 0.69±0.26; 0.88±0.24; 2.13±0.78; 3.25±1.42, respectively) and inpatient admissions (classes I–IV: 0.01±0.01; 0.04±0.07; 0.94±0.39; 1.90±0.65, respectively) per annum. Patients in NYHA class III were most likely to undergo SRT in their lifetime (mean±95% CI proportion of patients:17.25%±7.19% or 26.30%±13.61% including interventionalists). Across NYHA, experts estimated that septal myectomy was more costly than alcohol septal ablation (mean±95% CI: £15 675±£10 556 vs £6750±£5900, respectively). Prescription of beta-blockers was higher than calcium channel blockers, irrespective of NYHA class.

Conclusions

Treatment of obstructive HCM is associated with a substantial clinical and economic burden in England and Northern Ireland; the burden of the disease increasing with NYHA class is driven by the need for intensive disease management, hospitalisations and the potential burden of undertaking SRTs.
Development of measures to assess listening-related effort and fatigue in daily life among hearing aid users: protocol for a quantitative field trial
Authors: Micula Andreea , Høy Konvalinka Christensen Jeppe , Wendt Dorothea , Innes-Brown Hamish , Johnsrude Ingrid , Apps Matthew , Dau Torsten , Flensborg-Madsen Trine
Published: December 2024

Introduction

Individuals with hearing loss and hearing aid users report higher levels of listening effort and fatigue in daily life compared with those with normal hearing. However, there is a lack of objective measures to evaluate these experiences in real-world settings. Recent studies have found that higher sound pressure levels (SPL) and lower signal-to-noise ratios (SNR) are linked to increased heart rate and decreased heart rate variability, reflecting the greater effort required to process auditory information. This study aims to establish physiological and acoustic predictors of self-reported listening effort and fatigue in daily life. Additionally, the moderating effects of cognitive abilities, personality traits, stress, fatigue, suprathreshold abilities, noise annoyance, lifestyle and health on the development of listening effort and fatigue will be investigated.

Methods and analysis

A 4-week field trial will be conducted, in which physiological responses will be continuously recorded using Empatica Embrace Plus wristbands. Ambient acoustics will be captured every 20 s via the participants’ (n=60) personal hearing aids, and the participants will provide self-reported momentary assessments through a mobile app throughout the day. Questionnaires will be used to assess personality traits, fatigue, stress and noise annoyance, and gather relevant background information. Cognitive and suprathreshold abilities will also be evaluated. Associations between physiological responses, ambient acoustics and momentary assessments, as well as the potential influence of participant characteristics, will be analysed using multilevel regression models and time-series analyses.

Ethics and dissemination

Informed consent will be obtained from all participants. The study has been exempted from ethical application by the Science Ethics Committee for the Capital Region of Denmark (journal no. F-23028367). Results will be presented at conferences and submitted for publication in peer-reviewed journals.
Scoping review of veterans’ disclosure of mental health concerns or medical conditions in the workplace and other settings: study protocol
Authors: Knight Emma B , O’Quinn Richard , Young Tarli , Brienza Justin P , Ferris Laura J
Published: December 2024

Introduction

Veterans deal with ‘unobservable’ medical or mental health conditions, such as post-traumatic stress disorder, at higher rates than the general population. Disclosure of such conditions is important to provide social, emotional, medical and mental health support, but veterans may face challenges when deciding whether to disclose conditions, including fear of stigma or discrimination. Safe disclosure in the workplace is particularly important, as it allows employees to gain accommodations and enables employers to manage workplace health and safety effectively. The objective of this study is to investigate the state of the literature on veterans’ disclosure of mental health concerns or medical conditions and identify how it has been studied in the workplace context.

Methods and analysis

To conduct the scoping review, several databases will be searched between 10 November 2023 and September 2024 including PubMed, Scopus, Embase, Web of Science, PsycInfo, CINAHL and Cochrane Library, as well as theses databases. Sources will be uploaded to Covidence where two investigators will independently conduct title/abstract and full-text screening, with any conflicts resolved to consensus via discussion with a third investigator. Studies will be included if they are empirical, original research, focused on veterans and disclosure of mental health concerns or medical conditions and written in English. After inclusion, study information will be extracted including key findings about contexts, correlates, processes and outcomes of disclosure in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

Ethics and dissemination

The scoping review will provide insight into the state of the literature on veterans’ disclosure of mental health or medical conditions, particularly in the workplace. Ethical approval is not required as the scoping review will be informed by publicly available data. Findings may be shared through journal articles or conference presentations, and recommendations will be provided to inform future research aimed at improving disclosure processes and outcomes. The scoping review has been pre-registered (https://osf.io/uxrjp).
Long-term impact of COVID-19 pandemic on fear of COVID-19 and psychological distress among the general population in Japan: a longitudinal study
Authors: Adachi Keiichiro , Yada Hironori , Odachi Ryo
Published: December 2024

Objectives

The long-term impact of the COVID-19 pandemic on the mental health issues of the general population in Japan is unclear. Thus, we examined the long-term effects of the COVID-19 pandemic on fear of COVID-19 and psychological distress and determined their causal relationships among the general population in Japan.

Design and setting

A longitudinal online survey was conducted by a Japanese online survey company to investigate the items regarding personal demographics, fear of COVID-19 (Japanese version of the fear of COVID-19 scale) and psychological distress (Japanese version of the Kessler 6 scale).

Participants

The participants were 274 individuals (women=44.2%) with a mean age of 51.6 years (SD=13.6) who responded to the online surveys in September 2020 (Time 1: T1) and January 2023 (Time 2: T2).

Results

The paired t-test showed that fear of COVID-19 decreased significantly from T1 to T2 (t=2.79, df=273, p<0.01, d=0.16). The χ2test showed that the proportion of those at high risk for psychological distress remained the same (χ2=1.33, df=1, n.s.). Furthermore, in a two-panel cross-lagged analysis to determine the causal relationship between fear of COVID-19 and psychological distress, fear of COVID-19 at T1 significantly predicted psychological distress at T2 (β=0.26, p<0.001). Additional multiple regression analyses adjusted for covariates (age, sex, marital status, COVID-19 status, etc) showed that worsening household finances (β=0.11, p<0.05) and avoiding contact with others (β=0.20, p<0.01) were associated with fear of COVID-19 at T2.

Conclusions

During the long-lasting COVID-19 pandemic, fear of COVID-19 decreased, but psychological distress did not change. In addition, fear of COVID-19 predicted psychological distress and was associated with poorer household finances and avoiding contact with others. Mental health professionals and policymakers should continue to support mental health issues following the long-lasting COVID-19 pandemic through interventions focused on promoting financial support and social interactions to reduce fear of COVID-19.
Association between forced expiratory volume in 1 s and relapse-free survival in operable non-small cell lung cancer: a prospective cohort study with propensity score overlap weighting
Authors: Wu Shaoping , Fu Siqian , Ripley-Gonzalez Jeffrey William , Cui Ni , Du Yang , Sylvester Karl , You Baiyang , Xu Ning , Cheng Jing , Dun Yaoshan , Liu Suixin
Published: December 2024

Objectives

Investigate the correlation between the percentage of predicted forced expiratory volume in 1 s (FEV1%pred) and survival outcomes, namely relapse-free survival (RFS) and overall survival (OS), in patients diagnosed with operable early-stage non-small cell lung cancer (NSCLC).

Design

Prospective observational study.

Setting

Clinical settings in Xiangya Hospital, Central South University, Hunan, China.

Participants

From November 2014 to December 2019, 775 operable patients with NSCLC, median age 58 years (IQR 13) with 40.6% women, were consecutively enrolled and underwent preoperative FEV1 assessment. All participants were evaluated using the FEV1%pred assessment. Subsequent treatments and operative interventions followed established protocols for NSCLC.

Results

During the follow-up, which lasted a median of 40 months (range 1–85 months) and continued until December 2021, 202 patients either relapsed or died. Optimal FEV1%pred cut-off was identified using receiver operating characteristic analysis. Results revealed 110 and 71 relapses and deaths per 1000 person-years for patients with FEV1 values of <82%pred and ≥82%pred, respectively. Cox proportional hazards models, adjusted for demographics, medical history and surgery characteristics with propensity score overlap weighting, revealed the significant impact of lower FEV1%pred on decreased RFS and OS. An FEV1%pred less than 82% displayed a significant association with decreased RFS (weighted HR, 1.55; 95% CI, 1.14 to 2.09; p=0.007) and OS (weighted HR, 1.50; 95% CI, 1.01 to 2.23; p=0.04).

Conclusions

Lower FEV1%pred values notably correlate with compromised RFS and OS in individuals operable for early-stage NSCLC, suggesting that FEV1%pred may serve as a valuable tool in evaluating and managing long-term recurrence risk in patients with early-stage NSCLC.

Trial registration number

ChiCTR2100048120.
Multicentre study conducted across centres in the USA, Europe and Australia to assess the safety and effectiveness of a bilateral hypoglossal nerve stimulation system for the treatment of obstructive sleep apnoea in adults: a protocol for a pivotal, multicentre, open-label, single-arm study
Authors: Woodson B Tucker , Suurna Maria V , Gillespie M Boyd , Huntley Tod C , Hancock Melyssa , Santos Angela , Subbaroyan Jeyakumar , Makori Fatima , Fesneau Grégoire , Heiser Clemens , Kent David T
Published: December 2024

Introduction

Obstructive sleep apnoea (OSA) is characterised by blood oxygen desaturations and sleep disruptions manifesting undesirable consequences. Existing treatments including oral appliances, positive airway pressure (PAP) therapy and surgically altering the anatomy of the pharynx have drawbacks including poor long-term adherence or often involving irreversible, invasive procedures. Bilateral hypoglossal nerve stimulation (HNSBL) is a new treatment for managing OSA, and this study is intended to determine whether an HNSBLsystem is a safe and effective treatment option for adults with OSA.

Methods and analysis

This is a pivotal, multicentre, prospective, single-arm study of HNSBLin PAP-intolerant adults with moderate to severe OSA. The device is activated 2 months after implantation with stimulation settings optimised before the final 12-month sleep study. At 12 months, the two coprimary effectiveness endpoints are the percentage of responders based on reduction in the Apnoea-Hypoponea Index, with hypopnoeas associated with 4% oxyhaemoglobin desaturation, and the Oxygen Desaturation Index, using drops in oxygen concentration >4% from baseline (ODI4). Secondary effectiveness endpoints include mean changes in quality-of-life assessments (daytime sleepiness and its effect on activities of daily living, OSA-specific quality of life, daytime sleepiness), levels of intermittent hypoxia, change in hypoxaemic burden and OSA severity.

Ethics and dissemination

The Food and Drug Administration, Advarra Institutional Review Board (IRB), University of Tennessee HSC IRB, University of Pennsylvania IRB, Weill Cornell Medicine IRB, Medical College of Wisconsin/Froedert Hospital, Human Research Protections Programme Vanderbilt University, St. Vincent’s Hospital Melbourne Human Research Ethics Committee, Ethisch Comite Universitair Ziekenhuis Antwerpen and Technische Universitat Munchen reviewed and approved this protocol. Study results will be disseminated through journal publications, updates to ClinicalTrials.gov and the Nyxoah website, and presentations at meetings and conferences.

Trial registration number

NCT03868618.
Determining the feasibility of linked claims and vaccination data for a COVID-19 vaccine pharmacoepidemiological study in Germany—RiCO feasibility study protocol
Authors: Timmesfeld Nina , Ihle Peter , Denz Robin , Meiszl Katherina , Scholz Katrin , Oberle Doris , Drechsel-Bäuerle Ursula , Keller-Stanislawski Brigitte , Diebner Hans H , Meyer Ingo
Published: December 2024

Introduction

In Germany, there has been no population-level pharmacoepidemiological study on the safety of the COVID-19 vaccines. One factor preventing such a study so far relates to challenges combining the different relevant data bodies on vaccination with suitable outcome data, specifically statutory health insurance claims data. Individual identifiers used across these data bodies are of unknown quality and reliability for data linkage.

Methods and analysis

As part of a larger pharmacovigilance study on the COVID-19 vaccines, called RiCO (German ‘Risikoevaluation der COVID-19-Impfstoffe’, Englisch ‘Risk assessment of COVID-19 vaccines’), a feasibility study is being conducted to determine the overall confidence level with which existing data can be analysed in relation to the safety of the COVID-19 vaccine. This RiCO feasibility study will establish a data flow combining claims data and vaccination data for a subsample of the total German population, describe data quality for each dataset from the various sources, estimate the proportion of the different linkage errors and will develop various approaches for linking the data in addition to the simple form of linkage using a common identifier in order to reduce possible linkage errors. These last three points are the core objective of the feasibility study. A secondary objective is to test the viability of the required data flow involving multiple stakeholders from different parts of the healthcare system.

Ethics and dissemination

Results will be published and used to plan the actual pharmacovigilance study on the COVID-19 vaccines for Germany, as well as future research on the role of COVID-19 vaccines as risk or protective factors for long-term COVID-19 effects. In accordance with national legal requirements, permission to use of the statutory health insurance claims data was requested and granted by the national regulatory authority for statutory health insurances. The vaccination data will be used in accordance with the requirements of the national regulation on COVID-19 vaccinations. Ethical approval was not required for this secondary data study and was therefore not sought. The results of the feasibility study will be published in a suitable, peer-reviewed scientific journal. Results will also be presented to stakeholders from German statutory health insurances and government organisations.
Cost-effectiveness of metacognitive therapy for cardiac rehabilitation participants with symptoms of anxiety and/or depression: analysis of a randomised controlled trial
Authors: Shields Gemma E , Camacho Elizabeth , Davies Linda M , Doherty Patrick Joseph , Reeves David , Capobianco Lora , Heagerty Anthony , Heal Calvin , Buck Deborah , Wells Adrian
Published: December 2024

Objectives

The burden of cardiovascular disease (CVD) is increasing. Cardiac rehabilitation (CR) is a complex intervention offered to patients with CVD, following a heart event, diagnosis or intervention, and it aims to reduce mortality and morbidity. The objective of this within-trial economic evaluation was to compare the cost-effectiveness of metacognitive therapy (MCT) plus usual care (UC) to UC, from a health and social care perspective in the UK.

Methods

A multicentre, single-blind, randomised controlled trial (ISRCTN74643496) was conducted in the UK involving 332 patients with CR with elevated symptoms of anxiety and/or depression and compared group-based MCT with UC. The primary outcome of the cost-effectiveness analysis was quality-adjusted life-years (QALYs). The time horizon of the primary analysis was a 12-month follow-up. Missing data were imputed using multiple imputation. Uncertainty was explored by probabilistic bootstrapping. Sensitivity analyses tested the impact of the study design and assumptions on the incremental cost-effectiveness ratio.

Results

In the primary cost-effectiveness analysis, MCT intervention was dominant, with a cost-saving (net cost −£219; 95% CI −£1446, £1007) and QALY gains (net QALY 0.015; 95% CI −0.015, 0.045). However, there is a high level of uncertainty in the estimates. At a threshold of £30 000 per QALY, MCT intervention of around 76% was likely to be cost-effective.

Conclusions

Results suggest that intervention may be cost-saving and health-increasing; however, findings are uncertain and subject to limitations. Further research should aim to reduce the uncertainty in the findings (eg, with larger sample sizes) and explore potential longer-term economic benefits associated with MCT in this setting.
Protocol for a mixed-methods randomised controlled trial evaluating the psychosocial effects of an expressive arts-based intervention on adults with age-related macular degeneration
Authors: Ho Rainbow Tin Hung , Cheong Allen Ming Yan , Wan Adrian Ho Yin , Lo Temmy Lee Ting , Fong Ted Chun Tat , Chan Caitlin Kar Pui , Li Qing , Chan Wai Chi
Published: December 2024

Introduction

Age-related macular degeneration (AMD) is a prevalent eye disease among middle-aged and older adults. AMD leaves the patient with irreversible deteriorating vision, which profoundly impacts their daily lives and psychosocial well-being. Given the limited studies addressing the psychosocial needs of adults with AMD and, in particular, using an expressive arts-based intervention (EXABI) as an intervention, this study aims to investigate the effectiveness of such an intervention in enhancing the psychosocial well-being of adults with AMD.

Methods and analysis

This study will employ a mixed-methods randomised controlled trial design. One hundred fifty-four participants with AMD will be recruited and randomised into either the EXABI or treatment-as-usual waitlist control group. Participants will respond to a battery of measurements regarding their psychosocial condition at four time points: baseline (T0), 2 months after baseline (postintervention, T1), 5 months after baseline (T2) and 8 months after baseline (T3). A subgroup of participants will also share their experiences through in-depth interviews at T1and T3to help further understand the mechanism and effect of the intervention. Quantitative data will be analysed by mixed-effects models and path analysis, whereas qualitative data will be analysed by adopting the thematic analysis approach. The two sets of data will be integrated to provide a comprehensive view of the effectiveness and mechanisms of the intervention.

Ethics and dissemination

This study has obtained ethical approval from the Human Research Ethics Committee of the University of Hong Kong (Ref. no.: EA210606). All research procedures will be conducted upon receiving signed written consent forms from participants. The findings of the study will also be presented at international conferences and published in peer-reviewed academic journals.

Trial registration number

NCT05675150, prospectively registered.
Effect of size of capsulorhexis on the outcome of cataract surgery: a protocol for systematic review and individual participant data meta-analysis
Authors: Wang Songhong , Wu Tiexi , Zhang Yue , Liu Yue , Qin Xuejiao
Published: December 2024

Introduction

In the era of functional intraocular lens (IOL) implantation, it is crucial to investigate the influence of different capsulorhexis sizes (including the diameter of the capsulorhexis, area of the anterior capsule opening, anterior capsule coverage, centration and circularity of the capsulorhexis) on the postoperative outcomes (eg, visual acuity, capsule shrinkage, IOL stability and intraocular pressure) in patients undergoing cataract surgery. This is particularly important in patients with high myopia or diabetes mellitus. The proposed protocol aims to enhance the transparency of our research and offer references for future studies.

Methods and analysis

A comprehensive search of PubMed, Embase, Cochrane Library, Web of Science, SinoMed, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform and China Science and Technology Journal Database is performed from inception to 4 July 2024. Data of individual participants will be collected from relevant clinical trials, both completed and ongoing. The collected data will be analysed using multilevel regression models to examine the association between capsulorhexis size and surgical outcomes. Potential demographic and clinical factors that may influence the results of cataract surgery, including postoperative visual acuity and IOL rotational stability, will also be explored. Any future modification to this protocol will include the date and rationale for the change.

Ethics and dissemination

Ethical approval is not required because the study does not involve individual patients. The study results are to be disseminated via professional journals as well as academic media.

Trial registration number

CRD42023459903.
Efficacy and safety of rivaroxaban in preventing venous thromboembolism in postoperative patients with gynecological malignancies: protocol for a randomised controlled open-label trial (G-alfalfa trial)
Authors: Wei Ting , Zhou Hong , Wu Shuyi , He Fei , Yi Huan , Zhang Jinhua
Published: December 2024

Introduction

Compared with the guideline-recommended use of low-molecular weight heparin (LMWH) for 28 days to prevent venous thromboembolism (VTE) after cytoreductive surgery, oral rivaroxaban avoids the pain and inconvenience of daily injections and reduces medical expenses. The proposed randomised controlled trial (RCT) aims to compare the efficacy and safety of rivaroxaban and enoxaparin in preventing VTE in patients after surgery for gynaecological malignancies and to provide a reference for clinical medication prevention.

Methods and analysis

This is a single-centre, randomised, controlled, open-label and assessor-blind clinical trial. Patients undergoing surgery for gynaecological malignancies will be randomly assigned in a 1:1 ratio to an oral rivaroxaban study group and a subcutaneous injection enoxaparin control group for anticoagulant prophylaxis. The medication administration begins 12–24 hours after surgery and continues for 28 days, with a 30-day follow-up after surgery. Clinical events during the treatment and the follow-up period will be observed. The primary endpoint will be any VTE. Secondary endpoints will be any bleeding event, medication compliance rate, rivaroxaban pharmacokinetics and pharmacogenomics. The sample size required for the G-alfalfa trial is derived based on power calculations of the VTE incidence in the two intervention regimens in previous literature.

Ethics and dissemination

This study was approved by the Ethics Committee of Fujian Maternal and Child Health Hospital on 2 April 2024 (Approval No.:2023KY174-03). The results of the trial will be submitted for publication in a peer-reviewed journal and presented at relevant conferences.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR) 2300078535.