bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial
Authors: Drake Marcus J , Worthington Jo , Frost Jessica , Sanderson Emily , Cochrane Madeleine , Cotterill Nikki , Fader Mandy , McGeagh Lucy , Hashim Hashim , Macaulay Margaret , Rees Jonathan , Robles Luke A , Taylor Gordon , Taylor Jodi , Ridd Matthew J , MacNeill Stephanie J , Noble Sian , Lane J Athene 
Published: November 2023

Abstract

Objective
To determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care.

Design
Cluster randomised controlled trial.

Setting
30 National Health Service general practice sites in England.

Participants
Sites were randomised 1:1 to the intervention and control arms. 1077 men (≥18 years) with bothersome LUTS recruited between June 2018 and August 2019: 524 were assigned to the intervention arm (n=17 sites) and 553 were assigned to the usual care arm (n=13 sites).

Intervention
Standardised information booklet developed with patient and expert input, providing guidance on conservative and lifestyle interventions for LUTS in men. After assessment of urinary symptoms (manualised element), general practice nurses and healthcare assistants or research nurses directed participants to relevant sections of the manual and provided contact over 12 weeks to assist with adherence.

Main outcome measures
The primary outcome was patient reported International Prostate Symptom Score (IPSS) measured 12 months after participants had consented to take part in the study. The target reduction of 2.0 points on which the study was powered reflects the minimal clinically important difference where baseline IPSS is <20. Secondary outcomes were patient reported quality of life, urinary symptoms and perception of LUTS, hospital referrals, and adverse events. The primary intention-to-treat analysis included 887 participants (82% of those recruited) and used a mixed effects multilevel linear regression model adjusted for site level variables used in the randomisation and baseline scores.

Results
Participants in the intervention arm had a lower mean IPSS at 12 months (adjusted mean difference −1.81 points, 95% confidence interval −2.66 to −0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS specific quality of life, incontinence, and perception of LUTS also improved more in the intervention arm than usual care arm at 12 months. The proportion of urology referrals (intervention 7.3%, usual care 7.9%) and adverse events (intervention seven events, usual care eight events) were comparable between the arms.

Conclusions
A standardised and manualised intervention in primary care showed a sustained reduction in LUTS in men at 12 months. The mean difference of −1.81 points (95% confidence interval −0.95 to −2.66) on the IPSS was less than the predefined target reduction of 2.0 points.

Trial registration

ISRCTN Registry
ISRCTN11669964
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The international diffusion of food innovations and the nutrition transition: retrospective longitudinal evidence from country-level data, 1970–2010
Authors: Disdier Anne-Célia , Etilé Fabrice , Rotunno Lorenzo 
Published: November 2023

IntroductionThere is a lack of quantitative evidence on the role of food innovations—new food ingredients and processing techniques—in the nutrition transition.ObjectiveDocument the distribution of food innovations across 67 high-income (HIC) and middle-income (MIC) countries between 1970 and 2010, and its association with the nutritional composition of food supply.MethodsWe used all available data on food patents, as compiled by the European Patent Office, to measure food innovations. We considered innovations directly received by countries from inventors seeking protection in their territories, and those embedded in processed food imports. Food and Agricultural Organization data were used to estimate the associations between international diffusion of food innovations and trends in total food supply and its macronutrient composition, after adjusting for confounding trends in demand-side factors. We identified the role of trade by simulating the changes in average diet due to innovations embedded in food imports.ResultsTrends in food innovations were positively and significantly associated with changes in daily per capita calorie supply available for human consumption in MIC between 1990 and 2010 (elasticity of 0.027, 95% CI 0.019 to 0.036). Food innovations were positively correlated with the share of animal and free fats in total food supply (elasticities of 0.044, 95% CI 0.030 to 0.058 for MIC between 1970 and 1989 and 0.023, 95% CI 0.003 to 0.043 for HIC between 1990 and 2010). Food innovations were associated with substitutions from complex carbohydrates towards sugars in total food supply for MIC after 1990 (elasticities of −0.037, 95% CI −0.045 to −0.029 for complex carbs, 0.082, 95% CI 0.066 to 0.098 for sugars). For these countries, the trade channel capturing access to innovations through imports of processed food played a key role.ConclusionPolicy-makers should consider the impacts of the international diffusion of food innovations in assessing the costs and benefits of international trade regulations.
Estimated impact of the UK soft drinks industry levy on childhood hospital admissions for carious tooth extractions: interrupted time series analysis
Authors: Rogers Nina Trivedy , Conway David I , Mytton Oliver , Roberts Chrissy H , Rutter Harry , Sherriff Andrea , White Martin , Adams Jean 
Published: November 2023

IntroductionTooth extraction due to dental caries is associated with socioeconomic deprivation and is a major reason for elective childhood hospital admissions in England. Consumption of sugar-sweetened beverages is a risk factor for dental caries. We examined whether the soft drinks industry levy (SDIL), announced in March 2016 and implemented in April 2018, was associated with changes in incidence rates of hospital admissions for carious tooth extraction in children, 22 months post-SDIL implementation.MethodsChanges in incidence rates of monthly National Health Service hospital admissions for extraction of teeth due to a primary diagnosis of dental caries (International Classification of Diseases; ICD-10 code: K02) in England, between January 2012 and February 2020, were estimated using interrupted time series and compared with a counterfactual scenario where SDIL was not announced or implemented. Periodical changes in admissions, autocorrelation and population structure were accounted for. Estimates were calculated overall, by Index of Multiple Deprivation (IMD) fifths and by age group (0–4 years, 5–9 years, 10–14 years, 15–18 years).ResultsCompared with the counterfactual scenario, there was a relative reduction of 12.1% (95% CI 17.0% to 7.2%) in hospital admissions for carious tooth extractions in all children (0–18 years). Children aged 0–4 years and 5–9 years had relative reductions of 28.6% (95% CI 35.6% to 21.5%) and 5.5% (95% CI 10.5% to 0.5%), respectively; no change was observed for older children. Reductions were observed in children living in most IMD areas regardless of deprivation.ConclusionThe UK SDIL was associated with reductions in incidence rates of childhood hospital admissions for carious tooth extractions, across most areas regardless of deprivation status and especially in younger children.Trial registration numberISRCTN18042742.
Developing and externally validating a machine learning risk prediction model for 30-day mortality after stroke using national stroke registers in the UK and Sweden
Authors: Wang Wenjuan , Otieno Josline A , Eriksson Marie , Wolfe Charles D , Curcin Vasa , Bray Benjamin D 
Published: November 2023

ObjectivesWe aimed to develop and externally validate a generalisable risk prediction model for 30-day stroke mortality suitable for supporting quality improvement analytics in stroke care using large nationwide stroke registers in the UK and Sweden.DesignRegistry-based cohort study.SettingStroke registries including the Sentinel Stroke National Audit Programme (SSNAP) in England, Wales and Northern Ireland (2013–2019) and the national Swedish stroke register (Riksstroke 2015–2020).Participants and methodsData from SSNAP were used for developing and temporally validating the model, and data from Riksstroke were used for external validation. Models were developed with the variables available in both registries using logistic regression (LR), LR with elastic net and interaction terms and eXtreme Gradient Boosting (XGBoost). Performances were evaluated with discrimination, calibration and decision curves.Outcome measuresThe primary outcome was all-cause 30-day in-hospital mortality after stroke.ResultsIn total, 488 497 patients who had a stroke with 12.4% 30-day in-hospital mortality were used for developing and temporally validating the model in the UK. A total of 128 360 patients who had a stroke with 10.8% 30-day in-hospital mortality and 13.1% all mortality were used for external validation in Sweden. In the SSNAP temporal validation set, the final XGBoost model achieved the highest area under the receiver operating characteristic curve (AUC) (0.852 (95% CI 0.848 to 0.855)) and was well calibrated. The performances on the external validation in Riksstroke were as good and achieved AUC at 0.861 (95% CI 0.858 to 0.865) for in-hospital mortality. For Riksstroke, the models slightly overestimated the risk for in-hospital mortality, while they were better calibrated at the risk for all mortality.ConclusionThe risk prediction model was accurate and externally validated using high quality registry data. This is potentially suitable to be deployed as part of quality improvement analytics in stroke care to enable the fair comparison of stroke mortality outcomes across hospitals and health systems across countries
The risk factors for and the frequency and outcomes of subsyndromal delirium among patients who have undergone cardiac surgery: a protocol for systematic review and meta-analysis
Authors: Gao Yan , Bai Xue , Zhang Huan , Yang Li , Wu Taiqin , Gan Xiuni 
Published: November 2023

IntroductionSeveral key symptoms must be present for the accurate diagnosis of patients with postoperative cardiac delirium. Some patients present with symptoms of delirium but do not meet the diagnostic criteria for delirium; such individuals are considered to have having subsyndromal delirium (SSD). SSD is associated with misdiagnosis and poor outcomes. However, to date, no systematic review (SR) has examined the frequency of, risk factors for, and outcomes of SSD among adults who have undergone cardiac surgery.Methods and analysisThe aim of this SR is to identify those studies that have explored SSD after cardiac surgery. MeSH and free entry terms associated with “subsyndromal delirium” and “subclinical delirium” will be used to search for relevant studies. The PubMed, Web of Science, OVID, Cochrane Library, CINAHL, EMBASE, PsycINFO, China National Knowledge Infrastructure, Wanfang data, VIP database and SinoMed will be searched from inception to the date of retrieval without any restrictions. The primary outcomes will be the frequency of SSD, the risk factors for SSD, and the outcomes of SSD. Analyses will be performed using STATA V.16.0, and descriptive analyses will be performed if the data are not suitable for meta-analysis (ie, data with significant heterogeneity or from different comparisons).Ethics and disseminationThe SR will examine the frequency of, risk factors for and outcomes of SSD in adults who have undergone cardiac surgery. The results will provide guidance for the identification of knowledge gaps in this field, and areas for further research will be highlighted. The review protocol will be submitted for publication in peer-reviewed journals for dissemination of the findings. Individual patient data will not be included in this protocol, so ethical approval will not be needed.PROSPERO registration numberCRD42022379211.
External validation of a cardiovascular risk model for Omani patients with type 2 diabetes mellitus: a retrospective cohort study
Authors: Al Oraimi Fatema , Al Rawahi Amani , Al Harrasi Amira , Albusafi Sarah , Al-Manji Laila Mohammed , Alrawahi Abdul Hakeem , Al Salmani Asma Ali 
Published: November 2023

ObjectivesTo externally validate a recently developed cardiovascular disease (CVD) risk model for Omanis with type 2 diabetes mellitus (T2DM).DesignRetrospective cohort study.SettingNine primary care centres in Muscat Governorate, Oman.ParticipantsA total of 809 male and female adult Omani patients with T2DM free of CVD at baseline were selected using a systematic random sampling strategy.Outcome measuresData regarding CVD risk factors and outcomes were collected from the patients’ electronic medical records between 29 August 2020 and 2 May 2021. The ability of the model to discriminate CVD risk was assessed by calculating the area under the curve (AUC) of the receiver-operating characteristic curve. Calibration of the model was evaluated using a Hosmer-Lemeshow χ2test and the Brier score.ResultsThe incidence of CVD events over the 5-year follow-up period was 4.6%, with myocardial infarction being most frequent (48.6%), followed by peripheral arterial disease (27%) and non-fatal stroke (21.6%). A cut-off risk value of 11.8% demonstrated good sensitivity (67.6%) and specificity (66.5%). The area under the curve (AUC) was 0.7 (95% CI 0.60 to 0.78) and the Brier score was 0.01. However, the overall mean predicted risk was greater than the overall observed risk (11.8% vs 4.6%) and the calibration graph showed a relatively significant difference between predicted and observed risk levels in different subgroups.ConclusionsAlthough the model slightly overestimated the CVD risk, it demonstrated good discrimination. Recalibration of the model is required, after which it has the potential to be applied to patients presenting to diabetic care centres elsewhere in Oman.
Health-related quality of life and associated factors among patients with schizophrenia at comprehensive specialised hospitals in the Northwest Ethiopia: a multicentre cross-sectional study
Authors: Tamene Fasil Bayafers , Sema Faisel Dula , Mihiretie Endalamaw Aschale , Siyum Tewodros Solomon , Sendekie Ashenafi Kibret 
Published: November 2023

ObjectivesThe aim of this study was to assess the health-related quality of life (HRQoL) and associated factors among patients with schizophrenia at comprehensive specialised hospitals in Northwest Ethiopia.Design and settingA cross-sectional study was conducted among 422 patients with schizophrenia who were followed at comprehensive specialised hospitals in Northwest Ethiopia from 1 June to 30 August 2022.ParticipantsAll adult patients with schizophrenia who had regular follow-up in the outpatient departments of the selected hospitals were study participants.Main outcome measuresThe main outcome of this study was HRQoL which was measured using the WHO Quality of Life Scale–Bref Version. Data entry and analysis were done using Epi-data version 4.6.1 and SPSS version 24, respectively. Linear regression was used to assess the association between quality of life and independent variables. Variables with a p value <0.05 at a 95% CI were considered statistically significant.ResultsThe mean score of the overall Quality of Life Scale–Brief Version was 22.42±3.60. No formal education (ß=−1.53; 95% CI: −2.80 to –0.27), duration of treatment (ß = –3.08; 95% CI: −4.71 to –1.45), comorbidity (ß=−1.14; 95% CI: −1.99 to –0.29), substance use (ß=−0.89; 95% CI: −1.56 to –0.23), extrapyramidal side effects (ß=−2.02; 95% CI: −2.90 to –1.14), non-adherence (ß=−0.83; 95% CI: −1.44 to –0.23), and antipsychotic polypharmacy (ß=−1.77; CI: −2.57 to –0.96) were negatively associated with quality of life.Conclusion and recommendationIn this study, the social domain was recorded as having the lowest mean score, which may indicate that patients with schizophrenia could need better psychosocial support. Patients with a longer duration of treatment, who had comorbid illnesses, were substance users, developed EPS, were non-adherent to medications and were on antipsychotic polypharmacy, needs critical follow-up to improve HRQoL.
REVISE:Re-Evaluating theInhibition ofStressErosions in the ICU: a randomised trial protocol
Authors: Deane Adam M , Alhazzani Waleed , Guyatt Gordon , Finfer Simon , Marshall John C , Myburgh John , Zytaruk Nicole , Hardie Miranda , Saunders Lois , Knowles Serena , Lauzier Francois , Chapman Marianne J , English Shane , Muscedere John , Arabi Yaseen , Ostermann Marlies , Venkatesh Balasubramanian , Young Paul , Thabane Lehana , Billot Laurent , Heels-Ansdell Diane , Al-Fares Abdulrahman A , Hammond Naomi E , Hall R , Rajbhandari Dorrilyn , Poole Alexis , Johnson Daniel , Iqbal Mobeen , Reis Gilmar , Xie Feng , Cook Deborah J 
Published: November 2023

IntroductionTheRe-Evaluating theInhibition ofStressErosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE.Methods and analysisREVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia,Clostridioides difficileinfection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial.Ethics and disseminationAll participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to – Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide.Trial registration numberNCT03374800.
How to extend value-based healthcare to population-based healthcare systems? Defining an outcome-based segmentation model for health authority
Authors: Torkki Paulus , Leskelä Riikka-Leena , Mustonen Pirjo , Linna Miika , Lillrank Paul 
Published: November 2023

ObjectivesValue-based healthcare (VBHC) is considered the most promising guiding principle for a new generation of health service production. Many countries have attempted to apply VBHC to managerial and clinical decision-making. However, implementation remains in its infancy and varies between countries. The objective of the study is to help health systems implement a value-based approach by building an outcome-based population segmentation model for health authorities (HAs).DesignFirst, we define the principles according to which segmentation models in healthcare could be developed. Second, we merge the theoretical characteristics of outcomes with population segmentation dimensions identified in previous literature and design a flow model that establishes population segments from these combinations. We then estimate the size of the segments based on national register data.ResultsThe population can be divided into 10 different segments based on relevant outcomes, goals and the outcome measurement logic. These segments consist of healthy, help, increased risk, mild curable without risk, mild curable with risk, severe curable without risk, severe curable with risk, single chronic, multimorbid and terminal. The representatives of Finnish HAs found the segments meaningful for evaluating and managing the healthcare system towards improved population health.ConclusionsAn outcome-based segmentation model for the entire population is needed if an HA wants to steer the healthcare system employing the principles of VBHC. Segmentation should be based on the outcome measurement logic and outcome measurements relevant to each segment and the number of segments has to be limited.
Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial
Authors: Molina Hidalgo Cristina , Collins Audrey M , Crisafio Mary E , Grove George , Kamarck Thomas W , Kang Chaeryon , Leckie Regina L , MacDonald Madison , Manuck Stephen B , Marsland Anna L , Muldoon Matthew F , Rasero Javier , Scudder Mark R , Velazquez-Diaz Daniel , Verstynen Timothy , Wan Lu , Gianaros Peter J , Erickson Kirk I 
Published: November 2023

IntroductionPhysical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.Methods and analysisIn this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.Ethics and disseminationEthical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.Trial registration numberNCT03841669.