bluuebunny/crossref_metadata_2025_split huggingface dataset:
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

IntroductionVeterans 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 analysisTo 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 disseminationThe 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

ObjectivesThe 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 settingA 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).ParticipantsThe 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).ResultsThe 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.ConclusionsDuring 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

ObjectivesInvestigate 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).DesignProspective observational study.SettingClinical settings in Xiangya Hospital, Central South University, Hunan, China.ParticipantsFrom 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.ResultsDuring 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).ConclusionsLower 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 numberChiCTR2100048120.
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

IntroductionObstructive 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 analysisThis 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 disseminationThe 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 numberNCT03868618.
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

IntroductionIn 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 analysisAs 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 disseminationResults 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

ObjectivesThe 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.MethodsA 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.ResultsIn 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.ConclusionsResults 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

IntroductionAge-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 analysisThis 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 disseminationThis 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 numberNCT05675150, 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

IntroductionIn 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 analysisA 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 disseminationEthical 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 numberCRD42023459903.
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

IntroductionCompared 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 analysisThis 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 disseminationThis 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 numberChinese Clinical Trial Registry (ChiCTR) 2300078535.
Combined collaterals and hemodynamic features to predict the prognosis in acute ischemic stroke patients undergoing mechanical thrombectomy
Authors: Song Zhiruo , Fang Xiang , Jia Xuerong , Liu Rui , Yang Dong , Liao Anyu , Kasaer Feiluola , Xu Yan , Zhang Zhiguo , Zhu Wusheng , Huang Kangmo , Liu Xinfeng 
Published: December 2024

BackgroundDespite successful recanalization via mechanical thrombectomy (MT), only half of acute ischemic stroke (AIS) patients achieve functional independence. Post-MT hemodynamic features are insufficiently investigated, and the lack of bilateral comparisons limits individual assessment. Therefore, we aimed to explore how individualized hemodynamic features affect functional outcomes using quantitative digital subtraction angiography (Q-DSA).MethodsWe screened three prospective databases for anterior circulation AIS participants with successful recanalization via MT. Hemodynamic features, including time to peak (TTP), were measured for four regions of interest (ROIs) on each side with Q-DSA. ROIC2served as a reference for correcting TTP values. We defined TTP variation (TTPV), as the degree of difference in TTP between the symptomatic and the healthy sides. A composite indicator, integrating TTPV and collateral status, was developed to reflect comprehensive perfusion capacity. Multivariable logistic regression was employed to investigate the association between TTPV, or the composite indicator, and functional outcomes (90-day modified Rankin Scale <2).ResultFinally, 201 participants (median (interquartile range (IQR) age 68 (57, 75] years, 64.2% males) were enrolled, and 97 (48.3%) patients achieved favourable functional outcomes. TTPVC2-M1was significantly related to favorable functional outcome (adjusted OR (aOR) = 0.627; 95% confidence interval (0.407, 0.966); p=0.034). Additionally, the composite indicator of good collaterals and low TTPVC2-M1was a powerful predictor for the favorable outcome (aOR=6.693; 95% confidence interval (2.652, 16.896); P<0.001).ConclusionTTPVC2-M1and the composite perfusion indicator showed significant predictive value in prognosis and potentially guided intra-procedure interventions and subsequent management among AIS patients.