bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial
Authors: Ahmed Irfan , Hudson Jemma , Innes Karen , Hernández Rodolfo , Gillies Katie , Bruce Rebecca , Bell Victoria , Avenell Alison , Blazeby Jane , Brazzelli Miriam , Cotton Seonaidh , Croal Bernard , Forrest Mark , MacLennan Graeme , Murchie Peter , Wileman Samantha , Ramsay Craig 
Published: December 2023

Abstract

Objective
To assess the clinical and cost effectiveness of conservative management compared with laparoscopic cholecystectomy for the prevention of symptoms and complications in adults with uncomplicated symptomatic gallstone disease.

Design
Parallel group, pragmatic randomised, superiority trial.

Setting
20 secondary care centres in the UK.

Participants
434 adults (>18 years) with uncomplicated symptomatic gallstone disease referred to secondary care, assessed for eligibility between August 2016 and November 2019, and randomly assigned (1:1) to receive conservative management or laparoscopic cholecystectomy.

Interventions
Conservative management or surgical removal of the gallbladder.

Main outcome measures
The primary patient outcome was quality of life, measured by area under the curve, over 18 months using the short form 36 (SF-36) bodily pain domain, with higher scores (range 0-100) indicating better quality of life. Other outcomes included costs to the NHS, quality adjusted life years (QALYs), and incremental cost effectiveness ratio.

Results
Of 2667 patients assessed for eligibility, 434 were randomised: 217 to the conservative management group and 217 to the laparoscopic cholecystectomy group. By 18 months, 54 (25%) participants in the conservative management arm and 146 (67%) in the cholecystectomy arm had received surgery. The mean SF-36 norm based bodily pain score was 49.4 (standard deviation 11.7) in the conservative management arm and 50.4 (11.6) in the cholecystectomy arm. The SF-36 bodily pain area under the curve up to 18 months did not differ (mean difference 0.0, 95% confidence interval −1.7 to 1.7; P=1.00). Conservative management was less costly (mean difference −£1033, (−$1334; −€1205), 95% credible interval −£1413 to −£632) and QALYs did not differ (mean difference −0.019, 95% credible interval −0.06 to 0.02).

Conclusions
In the short term (≤18 months), laparoscopic surgery is no more effective than conservative management for adults with uncomplicated symptomatic gallstone disease, and as such conservative management should be considered as an alternative to surgery. From an NHS perspective, conservative management may be cost effective for uncomplicated symptomatic gallstone disease. As costs, complications, and benefits will continue to be incurred in both groups beyond 18 months, future research should focus on longer term follow-up to establish effectiveness and lifetime cost effectiveness and to identify the cohort of patients who should be routinely offered surgery.

Trial registration

ISRCTN registry
ISRCTN55215960
.
Age at menarche, type 2 diabetes and cardiovascular disease complications in US women aged under 65 years: NHANES 1999–2018
Authors: Santos Maria P , Li Yaling , Bazzano Lydia A , He Jiang , Rexrode Kathryn M , Ley Sylvia H 
Published: December 2023

BackgroundDiabetes and diabetes complications are on the rise in US adults aged <65 years, while onset of menarche at a younger age is also increasing. We examined the associations of age at menarche with type 2 diabetes among women aged <65 years and with cardiovascular disease (CVD) complications among women with diabetes.MethodsUsing the nationally representative cross-sectional National Health and Nutrition Examination Survey 1999–2018, women aged 20–65 years free of cancer were included in the current analysis. Diabetes was defined as a self-reported diabetes diagnosis. CVD was defined as coronary heart disease or stroke. Age at menarche was self-reported age of first menstruation and categorised into ≤10, 11, 12, 13, 14 and ≥15 years.ResultsOf 17 377 women included in the analysis, 1773 (10.2%) reported having type 2 diabetes. Earlier age at menarche was associated with type 2 diabetes compared with median age at menarche of 13 years, after adjustment for age, race/ethnicity, education, parity, menopause status and family history of diabetes, smoking status, physical activity, alcohol consumption and body mass index (p for trend=0.02). Among women with diabetes, earlier age at menarche was associated with stroke with similar adjustment (p for trend=0.03), but not with total CVD. Extremely early age at menarche (≤10 years) was significantly associated with stroke (adjusted OR 2.66 (95% CI 1.07 to 6.64)) among women aged <65 years with diabetes with similar adjustment.ConclusionsEarlier age at menarche was associated with type 2 diabetes among young and middle-aged women in the USA and with stroke complications among these women living with diabetes.
Clinical impacts of an integrated electronic health record-based smoking cessation intervention during hospitalisation
Authors: Banerjee Somalee , Alabaster Amy , Adams Alyce S , Fogelberg Renee , Patel Nihar , Young-Wolff Kelly 
Published: December 2023

ObjectiveTo assess the effects of an electronic health record (EHR) intervention that prompts the clinician to prescribe nicotine replacement therapy (NRT) at hospital admission and discharge in a large integrated health system.DesignRetrospective cohort study using interrupted time series (ITS) analysis leveraging EHR data generated before and after implementation of the 2015 EHR-based intervention.SettingKaiser Permanente Northern California, a large integrated health system with 4.2 million members.ParticipantsCurrent smokers aged ≥18 hospitalised for any reason.ExposureEHR-based clinical decision supports that prompted the clinician to order NRT on hospital admission (implemented February 2015) and discharge (implemented September 2015).Main outcomes and measuresPrimary outcomes included the monthly percentage of admitted smokers with NRT orders during admission and at discharge. A secondary outcome assessed patient quit rates within 30 days of hospital discharge as reported during discharge follow-up outpatient visits.ResultsThe percentage of admissions with NRT orders increased from 29.9% in the year preceding the intervention to 78.1% in the year following (41.8% change, 95% CI 38.6% to 44.9%) after implementation of the admission hard-stop intervention compared with the baseline trend (ITS estimate). The percentage of discharges with NRT orders increased acutely at the time of both interventions (admission intervention ITS estimate 15.5%, 95% CI 11% to 20%; discharge intervention ITS estimate 13.4%, 95% CI 9.1% to 17.7%). Following the implementation of the discharge intervention, there was a small increase in patient-reported quit rates (ITS estimate 5.0%, 95% CI 2.2% to 7.8%).ConclusionsAn EHR-based clinical decision-making support embedded into admission and discharge documentation was associated with an increase in NRT prescriptions and improvement in quit rates. Similar systemic EHR interventions can help improve smoking cessation efforts after hospitalisation.
Effect of synchronous remote-based interventions on suicidal behaviours: protocol for a systematic review and meta-analysis
Authors: Comendador Laura , Jiménez-Villamizar María Paola , Losilla Josep-Maria , Sanabria-Mazo Juan P , Mateo-Canedo Corel , Cebrià Ana Isabel , Sanz Antoni , Palao Diego J 
Published: December 2023

IntroductionSuicide is among the leading causes of preventable death worldwide. The impact of suicide affects the personal, social and economic levels. Therefore, its prevention is a priority for public health systems. Previous studies seem to support the efficacy of providing active contact to people who have made a suicide attempt. The current systematic review and meta-analysis aims to investigate the efficacy of distance suicide prevention strategies implemented through synchronous technology-based interventions.Methods and analysisThis protocol is designed according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. The bibliographical searches were conducted in the databases PubMed, PsycINFO, Scopus and Web of Science in April 2022, with no restrictions on the time of publication and limited to publications in English or Spanish. The search strategy was performed using free-text terms and Medical Subject Headings terms: suicide, follow-up, synchronous, remote, telehealth, telephone, hotline, video-conference and text message. Two reviewers will independently conduct study screening, selection process, data extraction and risk of bias assessment. The analysis and synthesis of the results will be both qualitative and quantitative. A narrative synthesis, presented in a comprehensive table, will be performed and meta-analysis will be conducted, as appropriate, if sufficient data are provided.Ethics and disseminationThe present review and meta-analysis will not require ethical approval, as it will use data collected from previously published primary studies. The findings of this review will be published in peer-reviewed journals and widely disseminated.PROSPERO registration numberCRD42021275044.
Estimating the frequency of inpatient adverse events using a two-step retrospective chart review: a study protocol
Authors: ul Hassan Syed Sabih , Asif Fozia , Haque Ghazal , Ayub Farwa , Munir Tahir , Khan Fauzia , Siddiqi Sameen , Latif Asad 
Published: December 2023

IntroductionAdverse events are a major cause of patient harm in the hospitalised setting. Low-income and middle-income countries account for a disproportionate share of the global burden of adverse events. However, patient safety research is still centred around high-income countries and high-resource health systems. The methods and data produced from these efforts are ill-suited to low-income and middle-income systems due to the social and technical differences between these settings. We aim to use our pilot-tested, locally developed methodology to estimate the frequency and characteristics of adverse events in hospitalised patients in a lower-middle-income country to inform patient safety policies and initiatives.Methods and analysisThis multi-centre study will employ a two-step chart review methodology to identify adverse events in a representative sample of patients admitted at five hospitals between 1 January 2019 and 31 December 2019. The first step will include assessing patient files against a list of triggers to detect adverse events and the second step will involve an in-depth review of the events to capture pertinent characteristics. The triggers have been adapted from validated tools used in other studies. The reviewing team will be trained on the use of research tools and operational definitions to ensure that data are collected uniformly. The main outcome of interest is the rate at which adverse events occur in hospitalised patients. Further analysis will look to identify and quantify associations between the main outcome of interest and a variety of variables such as patient age and gender using tests of independence and regression techniques.Ethics and disseminationThis study protocol has been approved by the Ethics Review Committee at Aga Khan University (Reference number: 2023-6324-24566). The findings of this study will be published in a peer-reviewed journal and disseminated to the public through national and international conferences, workshops, websites and social media.
Efficacy of pharmacological interventions: a systematic review informing the 2023 EULAR recommendations for the management of fatigue in people with inflammatory rheumatic and musculoskeletal diseases
Authors: Farisogullari Bayram , Santos Eduardo José Ferreira , Dures Emma , Geenen Rinie , Machado Pedro M 
Published: December 2023

ObjectiveTo identify the best evidence on the efficacy of pharmacological interventions in reducing fatigue in people with inflammatory rheumatic and musculoskeletal diseases (I-RMDs) and to summarise their safety in the identified studies to inform European Alliance of Associations for Rheumatology recommendations for the management of fatigue in people with I-RMDs.MethodsSystematic review of adults with I-RMDs conducted according to the Cochrane Handbook. Search strategy ran in Medline, Embase, Cochrane Library, CINAHL Complete, PEDro, OTseeker and PsycINFO. Only randomised controlled trials (RCTs) or controlled clinical trials were eligible. Assessment of risk of bias, data extraction and synthesis performed by two reviewers independently and in duplicate. Data pooled in statistical meta-analyses.ResultsFrom 4151 records, 455 were selected for full-text review, 99 fulfilled the inclusion criteria and 19 RCTs were included in meta-analyses. Adalimumab was superior to placebo in reducing fatigue at 12 and 52 weeks in rheumatoid arthritis (RA) (n=3 and 2 RCTs; mean difference (MD)= −3.03, p<0.001; MD=−2.25, p=0.03, respectively). Golimumab (n=2 RCTs; 24 weeks: MD=−5.27, p<0.001), baricitinib (n=2 RCTs; 24 weeks: MD=−4.06, p<0.001), sarilumab (n=2 RCTs; 24 weeks: MD=−3.15, p<0.001), tocilizumab (n=3 RCTs; 24 weeks: MD=−3.69, p<0.001) and tofacitinib (n=3 RCTs; 12 weeks: MD=−4.44, p<0.001) were also superior to placebo in reducing fatigue in RA. A dose/effect relationship was observed for sarilumab, tocilizumab and tofacitinib. In spondyloarthritis (excluding psoriatic arthritis), secukinumab was superior to placebo in reducing fatigue at 16 weeks (n=2 RCTs; MD=−4.15, p<0.001), with a dose/effect relationship also observed. The narrative results of the RCTs not included in the meta-analysis indicated that several other pharmacological interventions were efficacious in reducing fatigue, with reassuring safety results.ConclusionsSeveral pharmacological interventions are efficacious and generally safe for managing fatigue in people with I-RMDs.
Paisaje cultural y sostenibilidad: una mirada en dos ejemplos latinoamericanos de México y Brasil
Authors: Salomao Eugenia Maria Azevedo 
Published: December 2023

Este artículo muestra cómo los conceptos de paisaje cultural y paisaje ur­bano histórico pueden generar mejores actuaciones en la protección de valores culturales, naturales, materiales e inmateriales, de los territo rios culturales y ciudades históricas, bajo la visión de la conservación sostenible. Se presentan ejemplos de dos contextos culturales latinoamericanos: Méx­ico y Brasil. Para el caso mexicano se seleccionó la ciudad de Morelia, en Michoacán, para realizar una lectura desde la mirada de paisaje urbano histórico. En el contexto brasileño, el caso abordado está vinculado al con­cepto de paisaje cultural con el ejemplo de la región del Triângulo Mineiro y Alto Paranaíba. La metodología se fundamenta en la revisión bibliográfica y el trabajo de campo. De los ejemplos seleccionados se observan los cambios sucedidos en el tiempo, diagnosticando los problemas que presentan para una correcta gestión integral ante los riesgos de pérdida de valores cul­turales materiales, inmateriales y naturales. Se concluye con una reflexión sobre la importancia del patrimonio en las sociedades actuales, afirmando la necesidad de visiones holísticas en las políticas de gestión del paisaje cultural y urbano histórico.
Kota Djogo: The Island that Never Was …
Authors: Ramenzoni Victoria C. 
Published: December 2023

Abstract
There is a large corpus of myths and legends about sea creatures in the maritime world, a record that portrays incredible and wondrous feats, wrecks, calamities, and disasters. In this article, I present an account of the mythological cosmology of the Endenese, a group of fearless seafarers that scoured the Eastern Indonesian seas for over four centuries. By discussing the legend of Kota Djogo, an island that disappeared into the sea in time immemorial, I reconstruct Endenese explanations for luck and uncertainty in a world plagued by volcanic eruptions, earthquakes, tsunamis, and typhoons. Going beyond the legend’s veracity, I build on the study of the narrative to show how symbolic accounts of environmental events can provide important clues to the understanding of ecological disasters. I argue that the indigenous rationalizations of uncertainty present in oral legends and myths can function as coping mechanisms that reconcile communities with the unpredictable and the ambiguous.
Imitation Is the Most Sincere Form of Mockery: Mock Jewish English in Online Extremist Communities
Authors: McCullough Rachel 
Published: December 2023

Abstract
This article examines the use of Mock Jewish English (MJE) among members of the modern far right as a means of perpetuating ideologies centered around antisemitic canards originating from the 19th and 20th centuries. In order to investigate MJE as an act of language crossing, I examine the 900+ million token Unicorn Riot subcorpus of the Corpus of Digital Extremism and Conspiracies (CoDEC). Following this analysis, I describe the linguistic features of MJE when it is used as ventriloquation, specifically the lexical and phonological features employed by the white supremacist parody advice show, Dear Rabbi. In my analysis, I find that these two strategies of MJE are used by members of the far right to spread antisemitic ideologies, further the semantic pejoration of Jewish lexical borrowings, and covertly affiliate themselves with one another in public spaces (via language crossing) or distance themselves from Jewishness (via ventriloquation).
National Action Plans on Business and Human Rights and Protecting Displaced Populations through Human Rights Due Diligence
Authors: Ling Bonny 
Published: December 2023

Abstract
In 2020, Taiwan released its National Action Plan on Business and Human Rights (NAP) to implement the UN Guiding Principles on Business and Human Rights, with the government committing to release a revised plan by the end of 2024. In parallel was the release of Taiwan’s first National Human Rights Action Plan (NHRAP) in 2022, where refugee protection was expressed as a priority. In this, the government commits to codify legal mechanisms for asylum and clarify application procedures. These developments on business and human rights, on the one hand, and refugee protection, on the other, are significant for the Asia-Pacific because the region hosts the highest number of displaced persons and is the global manufacturing hub. This article examines the nexus between business, human rights and protection for displaced individuals. It provides recommendations on how Taiwan’s next NAP can address refugee protection in line with its human rights protection commitment.
Comparison of efficacy and safety between PD-1 inhibitors and PD-L1 inhibitors plus platinum-etoposide as first-line treatment for extensive-stage small-cell lung cancer: a multicenter, real-world analysis
Authors: Wang Yanrong , Li Lingling , Hu Jia , Zhao Yan , Yan Huan , Gao Ming , Yang Xuejiao , Zhang Xia , Ma Junxun , Dai Guanghai 
Published: December 2023

Abstract
Background
Immunotherapy in combination with platinum-etoposide (EP) chemotherapy has been approved as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). However, real-world (RW) data regarding the use of immune checkpoint inhibitors (ICIs) in ES-SCLC are lacking. We aimed to assess the differences between programmed death protein 1 (PD-1) inhibitors and programmed death ligand 1 (PD-L1) inhibitors, both in conjunction with EP chemotherapy, as first-line treatment for ES SCLC.

Methods
We conducted a real-world, multicenter, retrospective cohort, controlled study to compare the prognosis, efficacy, and safety of PD-1 and PD-L1 inhibitors in ES-SCLC patients when used along with chemotherapy. Each patient received up to six cycles of etoposide, carboplatin, or cisplatin combined with ICI drugs, including PD-1 and PD-L1 inhibitors. The primary endpoints were investigator-assessed progression-free survival (PFS) and overall survival (OS). The secondary endpoints were the investigator-assessed objective response rate (ORR) and disease control rate (DCR) according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1).

Results
Between January 2017 and December 2021, 194 patients with ES-SCLC from three clinical centers in a PLA general hospital were included in our study, including 93 patients in the PD-1 group and 101 patients in the PD-L1 group. At the time of data cutoff, progression-free survival in the PD-1 group (median PFS, 6.8 months; 95% CI, 5.3–8.1) was similar to that in the PD-L1 group (median PFS, 6.4 months; 95% CI, 5.5–7.5); the stratified hazard ratio for PFS was 1.12 (95% CI, 0.83–1.53; P = 0.452). The median OS was similar in the PD-1 and PD-L1 groups (15.8 m vs. 17.7 m, P = 0.566); the hazard ratio was 0.90 (95% CI, 0.62–1.30, P = 0.566). The two groups had comparable investigator-assessed confirmed objective response rates (ORR) (76.3% vs. 76.2%). Adverse effect (AE)-related discontinuation occurred in 4 (4.3%) patients in the PD-1 group and 2 (2.0%) patients in the PD-L1 group. Deaths due to AEs of any cause occurred in 2 (2.2%) patients in the PD-1 inhibitor group and 1 (1.0%) patient in the PD-L1 inhibitor group.

Conclusions
Our research revealed that there were no significant differences in efficacy or prognosis between PD-1 inhibitor + EP chemotherapy and PD-L1 inhibitor + EP chemotherapy. The two groups seemed to have comparable safety profiles, but the number of discontinuation or death events was too small to draw a firm conclusion.
Association of GAB1 gene with asthma susceptibility and the efficacy of inhaled corticosteroids in children
Authors: Zhang Yuxuan , Liu Jun , Zhi Yanjie , You Xuan , Wei Bing 
Published: December 2023

AbstractAsthma is a polygenic disease that may onset during childhood. Inhaled corticosteroids (ICS) are the main therapy in asthma, although their efficacy varies among individuals. Nuclear factor κB (NF-κB) is an important target of ICS treatment of asthma. Recent research has reported that GRB2 associated binding protein 1 (GAB1) gene may participate in the pathogenesis of asthma by regulating the NF-κB pathway. Therefore, we used the technique of an improved multiplex ligation detection reaction to sequence GAB1 gene and investigated the involvement of Single-nucleotide variants (SNVs) in GAB1 gene in asthma and ICS efficacy in asthmatic children. We found no differences between asthma cases and controls in allele or genotype frequencies of GAB1. Haplotype analysis showed an increased tendency for AGGAGC frequency in asthma patients compared with controls (OR = 2.69, p = 0.018). The percentage of EOS and genotype distribution of rs1397527 were associated (p = 0.007). The EOS percentage was higher in GT genotype when compared to the GG genotype (5.50 vs 3.00, Bonferroni adjusted p = 0.005). After 12-weeks ICS treatment, GAB1 rs1397527 TT and GT genotype carriers had a smaller change in forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) than GG carriers (p = 0.009), and rs3805236 GG and AG genotype carriers also had a smaller change in FEV1/FVC than AA carriers (p = 0.025). For ICS response, the frequency of GG genotype of rs1397527 was significantly higher in good responders (p = 0.038). The generalized multifactor dimensionality reduction (GMDR) analysis showed a best significant four-order model (rs1397527, allergen exposure, environmental tobacco smoke exposure, and pet exposure) involving gene-environment interactions (p = 0.001). In summary, we found that GAB1 SNVs were not associated with asthma susceptibility. Haplotype AGGAGC was a risk factor for asthma. GAB1 variants were associated with eosinophils and ICS response in asthmatics. Furthermore, gene-environment interaction was observed.