bluuebunny/crossref_metadata_2025_split huggingface dataset:
Disparities in availability of new cancer drugs worldwide: 1990-2022
Authors: Li Meng , Ka DukHee , Chen Qiushi 
Published: October 2024

IntroductionDespite progress in the development of new cancer drugs, concerns about equity of access remain. This study aimed to examine the availability and timeliness of availability of new cancer drugs around the globe over the past three decades and their associations with country characteristics.MethodsFrom a pharmaceutical intelligence database we identified new cancer drugs launched between 1990 and 2022. We calculated the number of new drugs launched in each country and the delay in launches. Using a multivariable linear regression and a Cox regression model with shared frailty, we examined the associations of the country’s Gross National Income (GNI) per capita, cancer incidence, number of physicians per population, and Gini index with the number of new cancer drug launches and launch delay in a country, respectively.ResultsA total of 568 cancer drugs were launched for the first time globally between 1990 and 2022. Among these, 35% had been launched in only one country by 2022, 22% in 2–5 countries, 15% in 6–10 countries, and 28% in more than 10 countries. The number of new cancer drugs launched in a country in this period ranged from 0 to 345. The average delays from the first global launch to the second, third, fourth, and fifth launch were 18.0 months, 24.3 months, 32.5 months, and 39.4 months, respectively. Our multivariate models showed that higher GNI per capita and cancer incidence in a country were associated with more launches and shorter delays.ConclusionThis research reveals significant disparities in the availability and timeliness of availability of new cancer drugs across countries. These disparities are likely to have contributed to the poor cancer outcomes observed in many countries.
Is cardiovascular risk profiling from UK Biobank retinal images using explicit deep learning estimates of traditional risk factors equivalent to actual risk measurements? A prospective cohort study design
Authors: Qian Yiming , Li Liangzhi , Nakashima Yuta , Nagahara Hajime , Nishida Kohji , Kawasaki Ryo 
Published: October 2024

ObjectiveDespite extensive exploration of potential biomarkers of cardiovascular diseases (CVDs) derived from retinal images, it remains unclear how retinal images contribute to CVD risk profiling and how the results can inform lifestyle modifications. Therefore, we aimed to determine the performance of cardiovascular risk prediction model from retinal images via explicitly estimating 10 traditional CVD risk factors and compared with the model based on actual risk measurements.DesignA prospective cohort study design.SettingThe UK Biobank (UKBB), a prospective cohort study, following the health conditions including CVD outcomes of adults recruited between 2006 and 2010.ParticipantsA subset of data from the UKBB which contains 52 297 entries with retinal images and 5-year cumulative incidence of major adverse cardiovascular events (MACE) was used. Our dataset is split into 3:1:1 as training set (n=31 403), validation set (n=10 420) and testing set (n=10 474). We developed a deep learning (DL) model to predict 5-year MACE using a two-stage DL neural network.Primary and secondary outcome measuresWe computed accuracy, area under the receiver operating characteristic curve (AUC) and compared variations in the risk prediction models combining CVD risk factors and retinal images.ResultsThe first-stage DL model demonstrated that the 10 CVD risk factors can be estimated from a given retinal image with an accuracy ranging between 65.2% and 89.8% (overall AUC of 0.738 with 95% CI: 0.710 to 0.766). In MACE prediction, our model outperformed the traditional score-based models, with 8.2% higher AUC than Systematic COronary Risk Evaluation (SCORE), 3.5% for SCORE 2 and 7.1% for the Framingham Risk Score (with p value<0.05 for all three comparisons).ConclusionsOur algorithm estimates the 5-year risk of MACE based on retinal images, while explicitly presenting which risk factors should be checked and intervened. This two-stage approach provides human interpretable information between stages, which helps clinicians gain insights into the screening process copiloting with the DL model.
Influence of a structured, 1-year-long dietary intervention regarding body composition and cardiovascular risk (ARCTIC) in coeliac disease: a protocol of a multicentre randomised controlled trial
Authors: Vereczkei Zsófia , Szakács Zsolt , Peresztegi Míra Zsófia , Lemes Klára , Hagymási Krisztina , Dakó Sarolta , Dakó Eszter , Lada Szilvia , Faluhelyi Nándor , Szekeres Gábor , Pásztor Gyula , Farkas Nelli , Pár Gabriella , Mezősi Emese , Bajor Judit 
Published: October 2024

IntroductionCoeliac disease (CD) affects 1% of the population worldwide. The only available evidence-based treatment is a strict gluten-free diet (GFD), which can readily lead to weight gain and unfavourable metabolic changes (eg, dyslipidaemia, fatty liver disease and insulin resistance) if followed without adequate dietary control. That can lead to increased cardiovascular risk (CV). We planned a randomised controlled trial to test the effect of a group-based, structured, 1-year, advanced dietary education, per the proposal of a Mediterranean diet vs standard of care, regarding the most relevant CV risk factors (eg, metabolic parameters and body composition) in CD patients.Methods and analysisRandomisation will occur after the baseline dietary education and interview in a 1:1 allocation ratio. Outcomes include anthropometric parameters (body composition analysis including weight, Body Mass Index, fat mass, per cent body fat, skeletal muscle mass, visceral fat area and total body water) and CV risk-related metabolic parameters (eg, lipid profile, homocysteine, fasting glucose, haemoglobin A1c, Homeostatic Model Assessment Index, metabolic hormones, waist circumference, blood pressure, liver function tests, liver steatosis rate and diet composition). In this study, we aim to draw attention to a new aspect regarding managing CD: dietary education can lead to a better quality of the GFD, thereby reducing the risk of potential metabolic and CV complications.Ethics and disseminationThe study was approved by the Scientific and Research Ethics Committee of the Hungarian Medical Research Council (27521-5/2022/EÜIG). Findings will be disseminated at research conferences and in peer-reviewed journals.Trial registration numberNCT05530070
Physician perspectives on statin continuation and discontinuation in older adults in primary cardiovascular prevention: a qualitative methods study
Authors: Marti Andreas , Zbinden Samuel , Brunner Laureline , Rodondi Nicolas , Schneider Claudio , Aubert Carole Elodie 
Published: October 2024

ObjectivesIn the context of limited evidence on statin use in primary cardiovascular prevention in older adults, we assessed physician perspectives on decision-making about statin continuation or discontinuation in this population.DesignQualitative descriptive approach including four focus groups. Inductive and deductive thematic analysis.Setting and participants18 physicians including two neurologists, three cardiologists, seven hospital internists and six primary care providers (PCPs) recruited at a hospital and primary care practices in the area of Bern in Switzerland.ResultsConcerning knowledge about statins in older adults, physicians reported defining if a patient is treated for primary or secondary prevention as challenging and that lack of evidence makes the decision to continue or discontinue the statin difficult. In terms of beliefs, fear of a possible rebound effect after statin discontinuation was reported. Regarding decision-making, physicians mentioned that statin discontinuation or continuation should be a shared decision between the patient and the physician. Concerning the professional role, environmental context and resources, the PCP office was identified as the ideal setting to discuss discontinuation, as all necessary information is available and PCPs have a longer relationship with the patients, thus facilitating a shared decision. Discontinuation of a chronic medication was perceived as difficult in general. Furthermore, PCPs noticed a possible negative impact on patient–physician relationship as some patients felt not being worth it, given up or undertreated if the statin was discontinued.ConclusionsThis study highlights the challenges of statin continuation and discontinuation in older patients and the crucial role of PCPs in situations with unclear evidence for a medication, where shared decision-making between physicians and patients is important. More evidence forming the background for a decision aid would be helpful.
Reasons for encounter in video contacts at a Danish out-of-hours primary care service: a questionnaire study
Authors: Nebsbjerg Mette Amalie , Bomholt Katrine Bjørnshave , Vestergaard Claus Høstrup , Christensen Morten Bondo , Huibers Linda 
Published: October 2024

ObjectiveTo investigate reasons for encounter in telephone triage contacts to an out-of-hours primary care service for which general practitioners (GPs) use video consultations (video contact), overall and stratified for patient age and time of day.DesignA cross-sectional questionnaire study among GPs doing telephone triage in an out-of-hours primary care service. The questionnaire was integrated into the electronic patient registration system, popping up after every third video contact. This setup automatically linked patient register data, including age and sex, with the questionnaire data.SettingThe study was conducted from 5 September 2022 to 21 December 2022 at the out-of-hours primary care service in the Central Denmark Region.Participants649 volunteer GPs who answered 2452 questionnaires.Main outcome measuresReasons for encounter in video contacts registered with codes from International Classification of Primary Care (ICPC) coding system, V.2 (ICPC-2).ResultsGPs doing telephone triage in out-of-hours primary care used video contacts for a broad range of ICPC-2 codes within few ICPC-2 chapters. 83% of all reasons for encounter were due to symptoms in chapters S ‘Skin’ (34.5%), R ‘Respiratory’ (21.8%), A ‘General and unspecified’ (14.7%) and L ‘Musculoskeletal’ (12.0%) in the ICPC-2 classification system. Video contacts concerning skin and musculoskeletal symptoms were more frequent among older children and adults compared with young children. Respiratory symptoms and general and unspecified symptoms dominated by fever were more frequent among video contacts for young children compared with older children and adults.ConclusionOur study suggests a focused use of video contacts in an out-of-hours primary care setting; the majority of registered ICPC-2 codes were within few ICPC-2 chapters.
Assessing the safety and pharmacokinetics of casirivimab and imdevimab (CAS+IMD) in a cohort of pregnant outpatients with COVID-19: results from an adaptive, multicentre, randomised, double-blind, phase 1/2/3 study
Authors: Norton Thomas D , Thakur Mazhar , Ganguly Samit , Ali Shazia , Chao Jesse , Waldron Alpana , Xiao Jing , Patel Yogesh , Turner Kenneth C , Davis John D , Irvin Susan C , Pan Cynthia , Atmodjo-Watkins Dominique , Hooper Andrea T , Hamilton Jennifer D , Subramaniam Danise , Bocchini Joseph A , Kowal Bari , DiCioccio A. Thomas , Bhore Rafia , Geba Gregory P , Cox Edward , Braunstein Ned , Dakin Paula , Herman Gary A 
Published: October 2024

ObjectivePregnant women with COVID-19 are at elevated risk for severe outcomes, but clinical data on management of these patients are limited. Monoclonal antibodies, such as casirivimab plus imdevimab (CAS+IMD), have proven effective in treating non-pregnant adults with COVID-19, prompting further evaluation in pregnant women.MethodsA phase 3 portion of an adaptive, multicentre, randomised, double-blind, placebo-controlled trial evaluated the safety, clinical outcomes, pharmacokinetics and immunogenicity of CAS+IMD (1200 mg or 2400 mg) in the treatment of pregnant outpatients with COVID-19 (NCT04425629). Participants were enrolled between December 2020 and November 2021, prior to the emergence of Omicron-lineage variants against which CAS+IMD is not active. Safety was evaluated in randomised participants who received study drug (n=80); clinical outcomes were evaluated in all randomised participants (n=82). Only two pregnant participants received placebo, limiting conclusions regarding treatment effect. Infants born to pregnant participants were followed for developmental outcomes ≤1 year of age.ResultsIn pregnant participants, CAS+IMD was well tolerated, with no grade ≥2 hypersensitivity or infusion-related reactions reported. There were no participant deaths, and only one COVID-19–related medically attended visit. Although two pregnancies (3%) reported issues in the fetus/neonate, they were confounded by maternal history or considered to be due to an alternate aetiology. No adverse developmental outcomes in infants ≤1 year of age were considered related to in utero exposure to the study drug. CAS+IMD 1200 mg and 2400 mg rapidly and similarly reduced viral loads, with a dose-proportional increase in concentrations of CAS+IMD in serum. Pharmacokinetics were consistent with that reported in the general population. Immunogenicity incidence was low.ConclusionCAS+IMD treatment of pregnant outpatients with COVID-19 showed similar safety, clinical outcomes and pharmacokinetic profiles to that observed in non-pregnant adults. There was no evidence of an impact on developmental outcomes in infants ≤1 year of age.Trial registration numberNCT04425629.
Hybrid versus catheter ablation for Hypertrophic CardioMyopathy with Atrial Fibrillation (HCM-AF): study protocol for a randomised controlled trial
Authors: Tang Yajie , Li Le , Chen Sipeng , Xue Yumei , Guo Huiming , Song Lei , Tang Min , Yao Yan , Zheng Zhe 
Published: October 2024

IntroductionAtrial fibrillation (AF) is an independent predictor of adverse outcomes in patients with hypertrophic cardiomyopathy (HCM). Although catheter ablation is highly recommended for general AF populations, it is less effective in maintaining sinus rhythm in patients with HCM associated with AF. Hybrid ablation, combining a cosmetic approach with a lower rate of AF relapse, lacks comparative studies to verify its efficacy against CA in HCM. This study aims to assess the rhythm control effectiveness of hybrid versus CA in non-obstructive HCM (non-oHCM) patients with AF.Methods/analysisThis prospective, multicentre, randomised trial involves a blinded assessment of outcomes in non-oHCM patients with non-paroxysmal AF. Sixty-six candidates from three centres will be randomised 1:1 to either hybrid or CA, including isthmus addressed lesion sets. Participants will be stratified by left atrial (LA) size (LA diameter ≤50 mm or >50 mm). Follow-ups at the 3rd, 6th and 12th months will evaluate the primary endpoint of freedom from documented atrial tachycardia lasting over 30 s within 12 months post-procedure without antiarrhythmic drugs, along with secondary endpoints of all-cause mortality, cardiovascular-related mortality, cerebral stroke, peripheral vascular embolism, heart failure-related rehospitalisation, all-cause rehospitalisation and quality of life assessments.Ethics and disseminationapprovalThe central ethics committee at Fuwai Hospital has approved the Hypertrophic CardioMyopathy with Atrial Fibrillation trial (approval number: 2022-1736). Results will be disseminated through publications in peer-reviewed journals and presentations at conferences.Trial registration numberNCT05610215.
Investigation of factors associated with delayed initiation of breastfeeding in Papua New Guinea: a cross-sectional study
Authors: Maviso McKenzie , Pulsan Francis , Vallely Lisa M 
Published: October 2024

BackgroundBreastfeeding within the first hour of birth is critical for newborn survival. However, in Papua New Guinea (PNG), about 40% of newborns are not breastfed within the first hour of birth. This study aimed to determine the prevalence and factors associated with delayed initiation of breastfeeding in PNG.MethodsThis study used secondary data from the 2016–2018 PNG Demographic and Health Survey, a nationally representative cross-sectional study. A total weighted sample of 4748 women aged 15–49 were included. Complex samples analysis was performed to determine the direction of association between the independent variables and delayed initiation of breastfeeding.ResultsAbout a quarter (24.6%) of women delayed initiation of breastfeeding. Women with an unplanned pregnancy (adjusted OR (AOR) 1.32; 95% CI 1.03 to 1.68), those who had a caesarean section (AOR 3.16; 95% CI 1.39 to 7.17), those who did not initiate newborn skin-to-skin contact immediately after birth (AOR 1.83; 95% CI 1.41 to 2.38) and those who watched television (AOR 1.39; 95% CI 1.11 to 1.75), and were from the Momase region (AOR 1.31; 95% CI 1.00 to 1.93) had higher odds of delayed breastfeeding initiation. Conversely, the odds of delayed initiation of breastfeeding was lower among women who read a newspaper or magazine (AOR 0.76; 95% CI 0.61 to 0.95), were from the Southern (AOR 0.81; 95% CI 0.56 to 1.15) and Highlands (AOR 0.86; 95% CI 0.58 to 1.29) regions, and gave birth at home or in the village (AOR 0.69; 95% CI 0.49 to 0.96).ConclusionOne in four women in this study delayed initiation of breastfeeding until after 1 hour after birth. Interventions to promote optimal breastfeeding require a multi-sectoral approach, as well as bolstering health workers’ capacity to encourage and support early initiation of breastfeeding during the antenatal and early postnatal periods.
Survey of the endoscopy workforce’s perception of sustainability
Authors: Poo Stephanie Xiu Wern , Kader Rawen , Shakweh Eathar , Kronsten Victoria T , Baddeley Robin ,   Gastroenterology London Investigative Network for Trainees Study Group (GLINT), Siddhi Sandeep , Hayee Bu'Hussain 
Published: October 2024

ObjectiveThe National Health Service is a significant contributor to greenhouse gas emissions, with endoscopy ranking as the third highest contributor of waste in healthcare. We aimed to ascertain the endoscopy workforce attitudes towards sustainable practices, barriers to change and potential solutions towards achieving a more sustainable endoscopy practice.MethodsA prospective cross-sectional online survey was distributed to endoscopy staff through the Joint Advisory Group on Gastrointestinal Endoscopy, the British Society of Gastroenterology (BSG), the Green Endoscopy Centre for Sustainable Healthcare Network and trainee research networks. The survey used a 5-point Likert scale to include:(1) perceived importance of sustainability in endoscopy, (2) factors contributing to waste generation in endoscopy, (3) barriers to sustainability in endoscopy and (4) strategies for sustainable changeResultsOf 202 participants, 83% were highly concerned about climate change and 71% recognised the significant carbon footprint generation within endoscopy. Lack of environmental consideration (77%), personal protective equipment and decontamination (76%), and packaging of single-use items (74%) were considered the most significant factors impacting waste generation in endoscopy. Participants ranked poor access to recyclable equipment (55%), poor awareness (52%) and poor attitudes (47%) as the main barriers to sustainable change. Concerningly, only a third would inform others if they noticed the wasting of resources.An overwhelming majority agreed with the BSG prioritising sustainability highly (84%), with 88.6% supporting policy and guideline development on sustainable endoscopy practice.ConclusionWe identified a strong consensus supporting the BSG’s prioritisation of activities relating to sustainability and climate change, with endoscopy being a key area of focus for improvement.
Proactive assessment of patient reported outcomes in ovarian cancer studies: a systematic review and call for action in future studies
Authors: Madariaga Ainhoa , Sánchez-Bayona Rodrigo , Kasherman Lawrence , Estrada-Lorenzo Jose Manuel , Manso Luis , Tolosa Pablo , Alva Manuel , Lema Laura , González-Deza Cristina , Ciruelos Eva , Valcarcel David , Lheureux Stephanie , Oza Amit M 
Published: October 2024

ObjectiveThis systematic review aims to evaluate the proactive or real-time assessment of patient reported outcomes in studies involving patients with ovarian cancer undergoing systemic therapy.MethodsPubMed, Embase, and Cochrane databases were searched (from database inception until February 2022), and prospective ovarian cancer studies (experimental or observational) that incorporated patient reported outcomes, including quality of life, were included. The primary objective was to assess the ratio of studies incorporating real-time use of patient reported outcomes among those studies performing patient reported outcomes. A secondary objective was to describe the patient reported outcome reporting. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) 2020 checklist was followed. Descriptive statistics were used.Results3071 articles were screened, with 117 included in the final analysis. Studies were published between 1990 and 2022, and consisted of 35 735 patients (median 140 patients per study; interquartile range 58–415). Median time from patient enrollment initiation to study publication was 7 years (range 1–15). Most studies were experimental/clinical trials (n=93, 79%) followed by observational (n=23, 20%). Therapeutic strategies were assessed in 98% (91/93) of experimental studies, most frequently chemotherapy (n=53, 58%), followed by antiangiogenics or poly-ADP ribose polymerase (PARP) inhibitors (n=8, 9%, each). Patient reported outcomes were the primary endpoint in 7.5% (7/93) and 83% (19/23) of experimental and observational studies, respectively. The ratio of real-time patient reported outcomes assessment/evaluation was 0.9% (1/117).ConclusionsCompletion of patient reported outcome questionnaires involves time and effort for patients with ovarian cancer. Responses to these questionnaires were only assessed in real time in <1% of analyzed studies. Efforts should be made to incorporate proactive assessment of patient reported outcomes to optimize patient care and safety.