bluuebunny/crossref_metadata_2025_split huggingface dataset:
An international comparative analysis and roadmap to sustainable biosimilar markets
Authors: Alnaqbi Khalid A. , Bellanger Agnès , Brill Alex , Castañeda-Hernández Gilberto , Clopés Estela Ana , Delgado Sánchez Olga , García-Alfonso Pilar , Gyger Pius , Heinrich Daniel , Hezard Germain , Kakehasi Adriana , Koehn Cheryl , Mariotte Olivier , Mennini Francesco , Mayra Pérez-Tapia Sonia , Pistollato Michele , Saada Rowan , Sasaki Tadanori , Tambassis George , Thill Marc , Werutsky Gustavo , Wilsdon Tim , Simoens Steven 
Published: August 2023

Background: Although biosimilar uptake has increased (at a variable pace) in many countries, there have been recent concerns about the long-term sustainability of biosimilar markets. The aim of this manuscript is to assess the sustainability of policies across the biosimilar life cycle in selected countries with a view to propose recommendations for supporting biosimilar sustainability.Methods: The study conducted a comparative analysis across 17 countries from North America, South America, Asia-Pacific, Europe and the Gulf Cooperation Council. Biosimilar policies were identified and their sustainability was assessed based on country-specific reviews of the scientific and grey literature, validation by industry experts and 23 international and local non-industry experts, and two advisory board meetings with these non-industry experts.Results: Given that European countries tend to have more experience with biosimilars and more developed policy frameworks, they generally have higher sustainability scores than the other selected countries. Existing approaches to biosimilar manufacturing and R&amp;D, policies guaranteeing safe and high-quality biosimilars, exemption from the requirement to apply health technology assessment to biosimilars, and initiatives counteracting biosimilar misconceptions are considered sustainable. However, biosimilar contracting approaches, biosimilar education and understanding can be ameliorated in all selected countries. Also, similar policies are sometimes perceived to be sustainable in some markets, but not in others. More generally, the sustainability of the biosimilar landscape depends on the nature of the healthcare system and existing pharmaceutical market access policies, the experience with biosimilar use and policies. This suggests that a general biosimilar policy toolkit that ensures sustainability does not exist, but varies from country to country.Conclusion: This study proposes a set of elements that should underpin sustainable biosimilar policy development over time in a country. At first, biosimilar policies should guarantee the safety and quality of biosimilars, healthy levels of supply and a level of cost savings. As a country gains experience with biosimilars, policies need to optimise uptake and combat any misconceptions about biosimilars. Finally, a country should implement biosimilar policies that foster competition, expand treatment options and ensure a sustainable market environment.
Prophylactic alpha blockers fail to prevent postoperative urinary retention following orthopaedic procedures: evidence from a meta-analysis and trial sequential analysis of comparative studies
Authors: Shan Lianliang , Sun Ping , Zhang Wenping , Zheng Xuelian , Li Hua , Wang Songling 
Published: August 2023

Objective: The present systematic review and meta-analysis aimed to estimate the prophylactic effect of alpha blockers against postoperative urinary retention (POUR) in orthopaedic patients.Methods: PubMed, Embase, Web of Science and Cochrane Library databases were searched between 1 January 1990 and 1 March 2023. The studies reporting the preventive efficacy of alpha blockers on POUR after orthopaedic procedures were identified. The pooled rates of POUR in the Intervention group (patients receiving alpha blockers) and the Control group (patients not receiving alpha blockers) were estimated and compared. The risk ratios (RRs) were calculated using the random-effects model. Subgroup analysis was performed based on surgical type. Trial sequential analysis (TSA) was conducted to confirm the robustness of pooled results.Results: Seven studies containing 1,607 patients were identified. The rates of POUR were similar between the two groups (Intervention group: 126/748 [16.8%] VS. Control group: 168/859 [19.6%]; RR = 0.75; 95% confidence interval [CI] 0.51 to 1.09; p = 0.130; Heterogeneity: I2 = 67.1%; p = 0.006). No significant difference in the incidence of POUR was observed in either the Arthroplasty subgroup or Spine surgery subgroup. The result of TSA suggested that the total sample size of the existing evidence might be insufficient to draw conclusive results. Administrating alpha blockers was associated with a higher risk of complications (88/651 [13.5%] VS. 56/766 [7.3%]; RR = 1.73; 95% CI 1.27 to 2.37; p = 0.0005; Heterogeneity: I2 = 0%; p = 0.69).Conclusion: Prophylactic alpha blockers do not reduce the risk of POUR in orthopaedic procedures, and administrating these drugs was associated with a higher risk of complications.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=409388.
Muscle strength adaptation between high-load resistance training versus low-load blood flow restriction training with different cuff pressure characteristics: a systematic review and meta-analysis
Authors: Chang Hualong , Yan Jing , Lu Guiwei , Chen Biao , Zhang Jianli 
Published: August 2023

Purpose: In this systematic review and meta-analysis, blood flow restriction (BFR) with low-load resistance training (BFR-RT) was compared with high-load resistance training (HL-RT) on muscle strength in healthy adults. The characteristics of cuff pressure suitable for muscle strength gain were also investigated by analyzing the effects of applying different occlusion pressure prescriptions and cuff inflation patterns on muscle strength gain.Methods: Literature search was conducted using PubMed, Ovid Medline, ProQuest, Cochrane Library, Embase, and Scopus databases to identify literature published until May 2023. Studies reporting the effects of BFR-RT interventions on muscle strength gain were compared with those of HL-RT. The risk of bias in the included trials was assessed using the Cochrane tool, followed by a meta-analysis to calculate the combined effect. Subgroup analysis was performed to explore the beneficial variables.Results: Nineteen articles (42 outcomes), with a total of 458 healthy adults, were included in the meta-analysis. The combined effect showed higher muscle strength gain with HL-RT than with BFR-RT (p = 0.03, SMD = −0.16, 95% CI: −0.30 to −0.01). The results of the subgroup analysis showed that the BFR-RT applied with incremental and individualized pressure achieved muscle strength gain similar to the HL-RT (p = 0.8, SMD = −0.05, 95% CI: −0.44 to 0.34; p = 0.68, SMD = −0.04, 95% CI: −0.23 to 0.15), but muscle strength gain obtained via BFR-RT applied with absolute pressure was lower than that of HL-RT (p &lt; 0.05, SMD = −0.45, 95% CI: −0.71 to −0.19). Furthermore, muscle strength gain obtained by BFR-RT applied with intermittent pressure was similar to that obtained by HL-RT (p = 0.88, SMD = −0.02, 95% CI: −0.27 to 0.23), but muscle strength gain for BFR-RT applied with continuous pressure showed a less prominent increase than that for HL-RT (p &lt; 0.05, SMD = −0.3, 95% CI: −0.48 to −0.11).Conclusion: In general, HL-RT produces superior muscle strength gains than BFR-RT. However, the application of individualized, incremental, and intermittent pressure exercise protocols in BFR-RT elicits comparable muscle strength gains to HL-RT. Our findings indicate that cuff pressure characteristics play a significant role in establishing a BFR-RT intervention program for enhancing muscle strength in healthy adults.Clinical Trial Registration:https://www.crd.york.ac.uk/PROSPERO/#recordDetails; Identifier: PROSPERO (CRD42022364934).
Effects of drought hardening on the carbohydrate dynamics of Quercus acutissima seedlings under successional drought
Authors: Li Qiang , Liu Xiao , Sun Xinke , Zhao Mingming , Liu Lele , Wang Ning , Gao Qun , Fan Peixian , Du Ning , Wang Hui , Wang Renqing 
Published: August 2023

IntroductionAs precipitation patterns are predicted to become increasingly erratic, the functional maintenance of warm-temperate forests constitutes a key challenge for forest managers. In this study, 2-year-old Quercus acutissima seedlings were selected to elucidate the mechanisms whereby they respond to soil water fluctuations and the drought hardening effects on plant carbohydrate dynamics.MethodsSeedlings were trained under different soil water conditions for 2 months: drought (D), well-watered (W), 1-month drought and then 1-month well-watered (D-W), and 1-month well-watered and then 1-month drought (W-D). The functional traits involved in water- and carbon-use strategies were explored at the end of the hardening period. Compared with seedlings in group W, seedlings in groups D, D-W, and W-D had increased potential for carbon uptake (i.e., light saturated point, maximum ribulose-1,5-bisphosphate (RuBP) saturated rate, and electron transport rate) and water uptake (i.e., fine root–to–coarse root ratio) and downregulated growth and mitochondrial respiration to decrease carbon consumption. After water fluctuation hardening, we performed a successional dry-down experiment for 1 month to detect carbohydrate dynamics and explore the acclimation caused by prior hardening.Results and discussionOur results revealed that there were more soluble sugars allocated in the leaves and more starch allocated in the stems and roots of seedlings hardened in the D, W-D, and D-W treatments than that of seedlings hardened in the W treatment. No significant changes in total non-structural carbohydrates were found. In addition, we found near-zero (seedlings trained by D and D-W treatments) or negative (seedlings trained by W-D treatment) growth of structural biomass at the end of the dry-down experiment, which was significantly lower than that of W-hardened seedlings. This suggests that there was a shift in allocation patterns between carbon storage and growth under recurrent soil drought, which can be strengthened by drought memory. We conclude that Q. acutissima seedlings adjusted water- and carbon-use strategies in response to water fluctuations, whereas stress memory can enhance their overall performance in reoccurring drought. Therefore, taking advantage of stress memory is a promising management strategy in forest nurseries, and drought-trained seedlings might be more suitable for afforestation practices in sites characterized by fluctuating soil water content, considering the ongoing global climatic changes.
Resting-state functional connectivity is modulated by cognitive reserve in early Parkinson’s disease
Authors: Di Tella Sonia , De Marco Matteo , Baglio Francesca , Silveri Maria Caterina , Venneri Annalena 
Published: August 2023

BackgroundFronto-striatal disconnection is thought to be at the basis of dysexecutive symptoms in patients with Parkinson’s disease (PD). Multiple reserve-related processes may offer resilience against functional decline. Among these, cognitive reserve (CR) refers to the adaptability of cognitive processes.ObjectiveTo test the hypothesis that functional connectivity of pathways associated with executive dysfunction in PD is modulated by CR.MethodsTwenty-six PD patients and 24 controls underwent resting-state functional magnetic resonance imaging. Functional connectivity was explored with independent component analysis and seed-based approaches. The following networks were selected from the outcome of the independent component analysis: default-mode (DMN), left and right fronto-parietal (l/rFPN), salience (SalN), sensorimotor (SMN), and occipital visual (OVN). Seed regions were selected in the substantia nigra and in the dorsolateral and ventromedial prefrontal cortex for the assessment of seed-based functional connectivity maps. Educational and occupational attainments were used as CR proxies.ResultsCompared with their counterparts with high CR, PD individuals with low CR had reduced posterior DMN functional connectivity in the anterior cingulate and basal ganglia, and bilaterally reduced connectivity in fronto-parietal regions within the networks defined by the dorsolateral and ventrolateral prefrontal seeds. Hyper-connectivity was detected within medial prefrontal regions when comparing low-CR PD with low-CR controls.ConclusionCR may exert a modulatory effect on functional connectivity in basal ganglia and executive-attentional fronto-parietal networks. In PD patients with low CR, attentional control networks seem to be downregulated, whereas higher recruitment of medial frontal regions suggests compensation via an upregulation mechanism. This upregulation might contribute to maintaining efficient cognitive functioning when posterior cortical function is progressively reduced.
Can digital health researchers make a difference during the pandemic? Results of the single-arm, chatbot-led Elena+: Care for COVID-19 interventional study
Authors: Ollier Joseph , Suryapalli Pavani , Fleisch Elgar , Wangenheim Florian von , Mair Jacqueline Louise , Salamanca-Sanabria Alicia , Kowatsch Tobias 
Published: August 2023

BackgroundThe current paper details findings from Elena+: Care for COVID-19, an app developed to tackle the collateral damage of lockdowns and social distancing, by offering pandemic lifestyle coaching across seven health areas: anxiety, loneliness, mental resources, sleep, diet and nutrition, physical activity, and COVID-19 information.MethodsThe Elena+ app functions as a single-arm interventional study, with participants recruited predominantly via social media. We used paired samples T-tests and within subjects ANOVA to examine changes in health outcome assessments and user experience evaluations over time. To investigate the mediating role of behavioral activation (i.e., users setting behavioral intentions and reporting actual behaviors) we use mixed-effect regression models. Free-text entries were analyzed qualitatively.ResultsResults show strong demand for publicly available lifestyle coaching during the pandemic, with total downloads (N = 7′135) and 55.8% of downloaders opening the app (n = 3,928) with 9.8% completing at least one subtopic (n = 698). Greatest areas of health vulnerability as assessed with screening measures were physical activity with 62% (n = 1,000) and anxiety with 46.5% (n = 760). The app was effective in the treatment of mental health; with a significant decrease in depression between first (14 days), second (28 days), and third (42 days) assessments: F2,38 = 7.01, p = 0.003, with a large effect size (η2G = 0.14), and anxiety between first and second assessments: t54 = 3.7, p = &lt;0.001 with a medium effect size (Cohen d = 0.499). Those that followed the coaching program increased in net promoter score between the first and second assessment: t36 = 2.08, p = 0.045 with a small to medium effect size (Cohen d = 0.342). Mediation analyses showed that while increasing number of subtopics completed increased behavioral activation (i.e., match between behavioral intentions and self-reported actual behaviors), behavioral activation did not mediate the relationship to improvements in health outcome assessments.ConclusionsFindings show that: (i) there is public demand for chatbot led digital coaching, (ii) such tools can be effective in delivering treatment success, and (iii) they are highly valued by their long-term user base. As the current intervention was developed at rapid speed to meet the emergency pandemic context, the future looks bright for other public health focused chatbot-led digital health interventions.
Excess mortality among older adults institutionalized in long-term care facilities during the COVID-19 pandemic: a population-based analysis in Catalonia
Authors: Cases Laia , Vela Emili , Santaeugènia Gonzàlez Sebastià J. , Contel Joan Carles , Carot-Sans Gerard , Coca Marc , Pastor Marta , Carrasco Ignasi , Barbeta Conxita , Vila Anna , Amil Paloma , Plaza Aina , Pontes Caridad , Piera-Jiménez Jordi , Amblàs Jordi 
Published: August 2023

ObjectivesTo assess excess mortality among older adults institutionalized in nursing homes within the successive waves of the COVID-19 pandemic in Catalonia (north-east Spain).DesignObservational, retrospective analysis of population-based central healthcare registries.Setting and participantsIndividuals aged &gt;65 years admitted in any nursing home in Catalonia between January 1, 2015, and April 1, 2022.MethodsDeaths reported during the pre-pandemic period (2015–2019) were used to build a reference model for mortality trends (a Poisson model, due to the event counting nature of the variable “mortality”), adjusted by age, sex, and clinical complexity, defined according to the adjusted morbidity groups. Excess mortality was estimated by comparing the observed and model-based expected mortality during the pandemic period (2020–2022). Besides the crude excess mortality, we estimated the standardized mortality rate (SMR) as the ratio of weekly deaths’ number observed to the expected deaths’ number over the same period.ResultsThe analysis included 175,497 older adults institutionalized (mean 262 days, SD 132), yielding a total of 394,134 person-years: 288,948 person-years within the reference period (2015–2019) and 105,186 within the COVID-19 period (2020–2022). Excess number of deaths in this population was 5,403 in the first wave and 1,313, 111, −182, 498, and 329 in the successive waves. The first wave on March 2020 showed the highest SMR (2.50; 95% CI 2.45–2.56). The corresponding SMR for the 2nd to 6th waves were 1.31 (1.27–1.34), 1.03 (1.00–1.07), 0.93 (0.89–0.97), 1.13 (1.10–1.17), and 1.07 (1.04–1.09). The number of excess deaths following the first wave ranged from 1,313 (2nd wave) to −182 (4th wave). Excess mortality showed similar trends for men and women. Older adults and those with higher comorbidity burden account for higher number of deaths, albeit lower SMRs.ConclusionExcess mortality analysis suggest a higher death toll of the COVID-19 crisis in nursing homes than in other settings. Although crude mortality rates were far higher among older adults and those at higher health risk, younger individuals showed persistently higher SMR, indicating an important death toll of the COVID-19 in these groups of people.
Physical fitness, cardiovascular and musculoskeletal health, and occupational performance in firefighters
Authors: Ras Jaron , Smith Denise L. , Kengne Andre P. , Soteriades Elpidoforos S. , Leach Lloyd 
Published: August 2023

IntroductionTo perform their work efficiently and safely, firefighters should maintain all aspects of physical fitness. Cardiac-related incidents are the leading cause of duty-related deaths in firefighters, and many firefighters have poor musculoskeletal health (MSH) that hinder their occupational performance (OP). Establishing the relationship between physical fitness, cardiovascular health (CVH), MSH and OP may add new insight on the most significant factors influencing OP in firefighters, specifically in the City of Cape Town Fire and Rescue Service (CoCTFS), which had not been studied before. Therefore, the purpose of this study was to investigate whether physical fitness, CVH and MSH were associated with OP in firefighters, in the COCTFRS.MethodsThis cross-sectional study included 283 full-time firefighters aged 20–65 years from Cape Town, South Africa. A researcher-generated questionnaire was used to collect data on sociodemographic characteristics, lifestyle factors and MSH. Physical measures were used to collect information on physical fitness, CVH, and OP [using a physical ability test (PAT)]. Linear and binary logistic regressions, adjusted for age, sex, height and weekly metabolic equivalent minutes (WMETM), multivariate analysis of covariance (MANCOVA), adjusted for age, sex, height and body mass index (BMI) and backward stepwise regressions were used to investigate the associations between the various constructs.ResultsFrom multivariable analyses, age, lean body mass, body fat percentage (BF%), estimated absolute oxygen consumption (abV̇O2max), grip strength, leg strength, push-ups, sit-ups, WMETM and heart rate variability were associated with PAT completion times (all p &lt; 0.01). The MANCOVA showed a significant difference between performance categories of the PAT based on physical fitness and CVH (both p &lt; 0.001). WMETM, BF%, abV̇O2max, grip strength, leg strength and sit-ups explained the highest proportion (50.5%) of the variation in PAT completion times.ConclusionYounger, non-obese, fitter and stronger firefighters, with a better CVH status, performed significantly better and were most likely to pass the PAT in firefighters, in Cape Town, South Africa. Firefighters should maintain high levels of physical fitness and a good level of CVH to ensure a satisfactory level of OP.
Association of dietary patterns and sarcopenia in the elderly population: a cross-sectional study
Authors: Wang Boshi , Wei Yanan , Shao Lin , Li Menghan , Zhang Xue , Li Wei , Zhao Shilong , Xia Xin , Liu Peng 
Published: August 2023

Background: Sarcopenia, defined as the loss of muscle mass and strength, has been associated with increased hospitalization and mortality. Dietary pattern analysis is a whole diet approach which in this study was used to investigate the relationship between diet and sarcopenia. This study aims to estimate the prevalence of sarcopenia and explore possible factors associated with it among a large population in Beijing, China.Methods: A cross-sectional study with 1,059 participants aged more than 50 years was performed. Sarcopenia was defined based on the guidelines of the Asian Working Group for Sarcopenia. The total score of the MNA-SF questionnaire was used to analyse nutrition status. The baseline demographic information, diet structure and eating habits were collected by clinicians trained in questionnaire data collection and anthropometric and bioimpedance measurements.Results: The overall prevalence of sarcopenia was 8.8% and increased with age: 5%, 5.8%, 10.3% and 26.2% in the 50–59, 60–69, 70–79, and ≥80 years groups, respectively. Marital status (with or without a spouse) was not an independent factor associated with sarcopenia adjusted by age and sex. However, nutritional risk or malnutrition, vegetable diet, advanced age and spicy eating habits were risk factors for sarcopenia. Meanwhile, daily fruit, dairy and nut consumption were protective factors against sarcopenia adjusted by age, sex, income status and spouse status.Conclusion: Although further studies are required to explore the association between healthy dietary patterns and the risk of sarcopenia, the present study provides basic data for identifying correlates of sarcopenia in elderly Chinese individual.