bluuebunny/crossref_metadata_2025_split huggingface dataset:
Alternative to prophylactic antibiotics for the treatment of recurrent urinary tract infections in women: multicentre, open label, randomised, non-inferiority trial
Authors: Harding Chris , Mossop Helen , Homer Tara , Chadwick Thomas , King William , Carnell Sonya , Lecouturier Jan , Abouhajar Alaa , Vale Luke , Watson Gillian , Forbes Rebecca , Currer Stephanie , Pickard Robert , Eardley Ian , Pearce Ian , Thiruchelvam Nikesh , Guerrero Karen , Walton Katherine , Hussain Zahid , Lazarowicz Henry , Ali Ased 
Published: March 2022

Abstract

Objective
To test and compare the efficacy of methenamine hippurate for prevention of recurrent urinary tract infections with the current standard prophylaxis of daily low dose antibiotics.

Design
Multicentre, open label, randomised, non-inferiority trial.

Setting
Eight centres in the UK, recruiting from June 2016 to June 2018.

Participants
Women aged ≥18 years with recurrent urinary tract infections, requiring prophylactic treatment.

Interventions
Random assignment (1:1, using permuted blocks of variable length via a web based system) to receive antibiotic prophylaxis or methenamine hippurate for 12 months. Treatment allocation was not masked and crossover between arms was allowed.

Main outcome measure
Absolute difference in incidence of symptomatic, antibiotic treated, urinary tract infections during treatment. A patient and public involvement group predefined the non-inferiority margin as one episode of urinary tract infection per person year. Analyses performed in a modified intention-to-treat population comprised all participants observed for at least six months.

Results
Participants were randomly assigned to antibiotic prophylaxis (n=120) or methenamine hippurate (n=120). The modified intention-to-treat analysis comprised 205 (85%) participants (antibiotics, n=102 (85%); methenamine hippurate, n=103 (86%)). Incidence of antibiotic treated urinary tract infections during the 12 month treatment period was 0.89 episodes per person year (95% confidence interval 0.65 to 1.12) in the antibiotics group and 1.38 (1.05 to 1.72) in the methenamine hippurate group, with an absolute difference of 0.49 (90% confidence interval 0.15 to 0.84) confirming non-inferiority. Adverse reactions were reported by 34/142 (24%) in the antibiotic group and 35/127 (28%) in the methenamine group and most reactions were mild.

Conclusion
Non-antibiotic prophylactic treatment with methenamine hippurate might be appropriate for women with a history of recurrent episodes of urinary tract infections, informed by patient preferences and antibiotic stewardship initiatives, given the demonstration of non-inferiority to daily antibiotic prophylaxis seen in this trial.

Trial registration

ISRCTN70219762
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Outcome of lifestyle intervention in relation to duration of pre-diabetes: the Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC) study
Authors: Dagogo-Jack Samuel , Umekwe Nkiru , Brewer Amy A , Owei Ibiye , Mupparaju Vamsee , Rosenthal Renate , Wan Jim 
Published: March 2022

IntroductionIn studies that enrolled people with prevalent pre-diabetes of unknown duration, lifestyle intervention (LI) delayed progression to type 2 diabetes (T2D) but did not reverse pre-diabetes in most participants. Here, we assessed the effects of LI among individuals with pre-diabetes of known duration to determine whether outcomes are related to duration of pre-diabetes.Research design and methodsThe Pathobiology and Reversibility of Prediabetes in a Biracial Cohort study initiated LI in subjects with incident pre-diabetes during follow-up of initially normoglycemic African Americans and European Americans with parental T2D. Participants were stratified into those initiating LI after <3, 3–5, or >5 years of pre-diabetes diagnosis. Assessments included anthropometry, body fat, fasting and 2-hour plasma glucose (FPG, 2hPG), and insulin sensitivity and secretion. The outcomes were normal glucose regulation (NGR; ie, normal FPG and 2hPG), persistent pre-diabetes, or T2D. Participants who maintained normal FPG and normal 2hPG levels during follow-up served as the control. The control subjects did not receive lifestyle or other intervention to alter the course of glycemia or body weight.ResultsOf 223 participants (age 53.3±9.28 years, body mass index 30.6±6.70 kg/m2), 72 (control) maintained normoglycemia during follow-up and 138 subjects with incident pre-diabetes initiated LI after 4.08±2.02 years (range 3 months–8.3 years) of diagnosis. Compared with control, LI participants showed decrease in glucose, weight, and body fat; 42.8% reverted to NGR, 50% had persistent pre-diabetes, and 7.2% developed T2D after 5 years. These outcomes were similar across race and pre-diabetes duration strata, but greater glycemic decrease occurred when LI was initiated within 5 years of pre-diabetes diagnosis.ConclusionsNinety-three per cent of adults with parental T2D who initiated LI within 3 months to 8.3 years of developing pre-diabetes did not progress to T2D; nearly half reverted to NGR.Trial registration numberNCT02027571.
Comprehensive compartmental model and calibration algorithm for the study of clinical implications of the population-level spread of COVID-19: a study protocol
Authors: Robinson Brandon , Edwards Jodi D , Kendzerska Tetyana , Pettit Chris L , Poirel Dominique , Daly John M , Ammi Mehdi , Khalil Mohammad , Taillon Peter J , Sandhu Rimple , Mills Shirley , Mulpuru Sunita , Walker Thomas , Percival Valerie , Dolean Victorita , Sarkar Abhijit 
Published: March 2022

IntroductionThe complex dynamics of the coronavirus disease 2019 (COVID-19) pandemic has made obtaining reliable long-term forecasts of the disease progression difficult. Simple mechanistic models with deterministic parameters are useful for short-term predictions but have ultimately been unsuccessful in extrapolating the trajectory of the pandemic because of unmodelled dynamics and the unrealistic level of certainty that is assumed in the predictions.Methods and analysisWe propose a 22-compartment epidemiological model that includes compartments not previously considered concurrently, to account for the effects of vaccination, asymptomatic individuals, inadequate access to hospital care, post-acute COVID-19 and recovery with long-term health complications. Additionally, new connections between compartments introduce new dynamics to the system and provide a framework to study the sensitivity of model outputs to several concurrent effects, including temporary immunity, vaccination rate and vaccine effectiveness. Subject to data availability for a given region, we discuss a means by which population demographics (age, comorbidity, socioeconomic status, sex and geographical location) and clinically relevant information (different variants, different vaccines) can be incorporated within the 22-compartment framework. Considering a probabilistic interpretation of the parameters allows the model’s predictions to reflect the current state of uncertainty about the model parameters and model states. We propose the use of a sparse Bayesian learning algorithm for parameter calibration and model selection. This methodology considers a combination of prescribed parameter prior distributions for parameters that are known to be essential to the modelled dynamics and automatic relevance determination priors for parameters whose relevance is questionable. This is useful as it helps prevent overfitting the available epidemiological data when calibrating the parameters of the proposed model. Population-level administrative health data will serve as partial observations of the model states.Ethics and disseminationApproved by Carleton University’s Research Ethics Board-B (clearance ID: 114596). Results will be made available through future publication.
Complementary feeding practices and the associated risk of childhood obesity among ethnic minority groups living in high-income countries: protocol for a systematic review and meta-analysis
Authors: Tsenoli Maido , Khan Moien A B , Östlundh Linda , Arora Teresa , Omar Omar 
Published: March 2022

IntroductionComplementary feeding (CF) is defined as the period from when exclusive breast milk and formula are no longer sufficient for meeting the infant’s nutritional needs. The CF period occurs from birth to 23 months of age. Though the recommended guidelines for introducing CF is from around 6 months of age, data indicates that some infants are introduced to food earlier than 6 months which can predispose children to obesity and overweight. Obesity in ethnic minority groups (EMG) is higher than their native counterparts and often tracks into adulthood. Hence, our aim was to conduct a systematic review and meta-analysis on the available literature to identify the risk of childhood overweight/obesity associated with CF practices concerning their timing, as well as the frequency and type of CF food introduced. We focused specifically on EMG children living in high-income countries.Methods and analysisA methodological literature search surrounding childhood obesity and overweight (COO) risk associated with CF practices will be conducted in May 2021 following Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. The following academic databases will be methodologically searched: PubMed, EMBASE, PsycINFO, CINAHL, SCOPUS, Cochrane Library and the WHO Global Index Medicus. Three independent researchers will be involved in independent screening and review the included articles based on the predefined inclusion and exclusion criteria. Where conflicts arise during the screening process, it will be resolved through discourse until a consensus is reached. Information on CF practices and anthropometric measurements will be extracted to ascertain the risk of COO. For this study, WHO body mass index for age and sex percentiles, Centers for Disease Control and Prevention classification and other recognised country-specific classifications will be utilised for the outcome.Ethics and disseminationFormal ethical approval is not needed as the results will be drawn from currently available published literature. Outcomes of the review will be shared through peer-reviewed publications.PROSPERO registration numberCRD42021246029.
Assessing the reliability of phone surveys to measure reproductive, maternal and child health knowledge among pregnant women in rural India: a feasibility study
Authors: Ng Angela , Mohan Diwakar , Shah Neha , Scott Kerry , Ummer Osama , Chamberlain Sara , Bhatnagar Aarushi , Dhar Diva , Agarwal Smisha , Ved Rajani , LeFevre Amnesty Elizabeth 
Published: March 2022

ObjectivesEfforts to understand the factors influencing the uptake of reproductive, maternal, newborn, child health and nutrition (RMNCH&N) services in high disease burden low-resource settings have often focused on face-to-face surveys or direct observations of service delivery. Increasing access to mobile phones has led to growing interest in phone surveys as a rapid, low-cost alternatives to face-to-face surveys. We assess determinants of RMNCH&N knowledge among pregnant women with access to phones and examine the reliability of alternative modalities of survey delivery.ParticipantsWomen 5–7 months pregnant with access to a phone.SettingFour districts of Madhya Pradesh, India.DesignCross-sectional surveys administered face-to-face and within 2 weeks, the same surveys were repeated among two random subsamples of the original sample: face-to-face (n=205) and caller-attended telephone interviews (n=375). Bivariate analyses, multivariable linear regression, and prevalence and bias-adjusted kappa scores are presented.ResultsKnowledge scores were low across domains: 52% for maternal nutrition and pregnancy danger signs, 58% for family planning, 47% for essential newborn care, 56% infant and young child feeding, and 58% for infant and young child care. Higher knowledge (≥1 composite score) was associated with older age; higher levels of education and literacy; living in a nuclear family; primary health decision-making; greater attendance in antenatal care and satisfaction with accredited social health activist services. Survey questions had low inter-rater and intermodal reliability (kappa<0.70) with a few exceptions. Questions with the lowest reliability included true/false questions and those with unprompted, multiple response options. Reliability may have been hampered by the sensitivity of the content, lack of privacy, enumerators’ and respondents’ profile differences, rapport, social desirability bias, and/or enumerator’s ability to adequately convey concepts or probe.ConclusionsPhone surveys are a reliable modality for generating population-level estimates data about pregnant women’s knowledge, however, should not be used for individual-level tracking.Trial registration numberNCT03576157.
Brain Oxygen Optimization in Severe Traumatic Brain Injury (BOOST-3): a multicentre, randomised, blinded-endpoint, comparative effectiveness study of brain tissue oxygen and intracranial pressure monitoring versus intracranial pressure alone
Authors: Bernard Francis , Barsan William , Diaz-Arrastia Ramon , Merck Lisa H , Yeatts Sharon , Shutter Lori A 
Published: March 2022

IntroductionManagement of traumatic brain injury (TBI) includes invasive monitoring to prevent secondary brain injuries. Intracranial pressure (ICP) monitor is the main measurement used to that intent but cerebral hypoxia can occur despite normal ICP. This study will assess whether the addition of a brain tissue oxygenation (PbtO2) monitor prevents more secondary injuries that will translate into improved functional outcome.Methods and analysisMulticentre, randomised, blinded-endpoint comparative effectiveness study enrolling 1094 patients with severe TBI monitored with both ICP and PbtO2. Patients will be randomised to medical management guided by ICP alone (treating team blinded to PbtO2values) or both ICP and PbtO2. Management is protocolised according to international guidelines in a tiered approach fashion to maintain ICP <22 mm Hg and PbtO2>20 mm Hg. ICP and PbtO2will be continuously recorded for a minimum of 5 days. The primary outcome measure is the Glasgow Outcome Scale-Extended performed at 180 (±30) days by a blinded central examiner. Favourable outcome is defined according to a sliding dichotomy where the definition of favourable outcome varies according to baseline severity. Severity will be defined according to the probability of poor outcome predicted by the IMPACT core model. A large battery of secondary outcomes including granular neuropsychological and quality of life measures will be performed.Ethics and disseminationThis has been approved by Advarra Ethics Committee (Pro00030585). Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberClinicalTrials.gov Registry (NCT03754114).
Increasing the uptake in a general practice prostate cancer screening programme
Authors: Limaye Neil , Zorzato Daniele , Nadarajasundaram Aaruran , Ong Sabrina B Y 
Published: March 2022

BackgroundProstate cancer (PC) is the second most common cause of cancer deaths among males worldwide. Prostate-specific antigen (PSA) is a predictive indicator of prostate pathology. Men with elevated PSA levels are at increased risk of developing PC. There is currently no UK national PC screening programme, therefore patients often present to general practices (GPs) at later stages of pathology, worsening patient prognosis and outcomes.Local problemThe location of the GP surgery had a large patient population at increased risk of PC, namely Afro-Caribbean/Asian males.MethodsWe conducted baseline measurements to identify male patients over the age of 65 and/or male patients who were at high risk of developing PC. These included previous referred patients or patients with a PSA over 10.0. We then implemented three plan-do-study-act (PDSA) cycles and measured their effect after 2 weeks of starting the respective intervention.InterventionsPDSA1: Generating a list of target patients who have not had repeat/follow-up/referral and directly contacting by telephone to invite them for a blood test.PDSA2: Creating patient-specific electronic pop-up reminders on the electronic-patient-record system for PSA follow-up/referral/repeat test.Planned PDSA3: Patient education of prostate health and general self-checking, as well as benefits/risks of undergoing PSA screening in the form of patient focus groups and informative leaflets.ResultsWe identified 220 male patients over 65 registered at a large South London GP surgery. 77.7% of eligible patients had a PSA measurement since 1 April 2019. Our results showed an overall increase in screening of 13.5% from baseline.ConclusionsOur project identified patients that may potentially have undiagnosed prostate pathology. However, a key factor for not reaching our goal was blood test refusal. This was further exacerbated by the COVID-19 pandemic, impacting the capacity to disseminate appropriate information to the local population on the importance of PSA screening.
Tendency to call an ambulance or attend an emergency department for minor or non-urgent problems: a vignette-based population survey in Britain
Authors: O'Cathain Alicia , Simpson Rebecca , Phillips Miranda , Knowles Emma 
Published: March 2022

BackgroundThere are concerns about high levels of demand for emergency health services. The aim was to identify the characteristics of the British population with a tendency to contact emergency medical services and EDs for minor or non-urgent problems.MethodsA survey of the British adult population in 2018. Six vignettes were constructed about illness in adults (cough/sore throat or diarrhoea/vomiting), injury in adults (sore rib or back pain) and fever in children (occurring weekday or weekend).ResultsThe response rate was 42%, with 2906 respondents. 11% (319/2716) of respondents selected to contact an ambulance and 43% ED, mainly for the vignettes about fever in children and sore rib. Males, people from ethnic minority communities and older people had a tendency to contact emergency services for minor problems. Tendency to call an ambulance was also characterised by ‘low resources’ (manual or unskilled occupations, no car, low health literacy), worry that a symptom might be serious, distress (feeling overwhelmed by health problems) and frequent use of EDs. For EDs, there was an attraction to EDs because of availability of tests.ConclusionWhereas use of emergency ambulances for minor or non-urgent problems appeared to be driven by people’s lack of resources, including lack of transport, use of EDs appeared to be driven by their attractive characteristic of offering tests quickly.
Evaluation of antithrombotic use and COVID-19 outcomes in a nationwide atrial fibrillation cohort
Authors: Handy Alex , Banerjee Amitava , Wood Angela M , Dale Caroline , Sudlow Cathie L M , Tomlinson Christopher , Bean Daniel , Thygesen Johan H , Mizani Mehrdad A , Katsoulis Michail , Takhar Rohan , Hollings Sam , Denaxas Spiros , Walker Venexia , Dobson Richard , Sofat Reecha 
Published: March 2022

ObjectiveTo evaluate antithrombotic (AT) use in individuals with atrial fibrillation (AF) and at high risk of stroke (CHA2DS2-VASc score ≥2) and investigate whether pre-existing AT use may improve COVID-19 outcomes.MethodsIndividuals with AF and CHA2DS2-VASc score ≥2 on 1 January 2020 were identified using electronic health records for 56 million people in England and were followed up until 1 May 2021. Factors associated with pre-existing AT use were analysed using logistic regression. Differences in COVID-19-related hospitalisation and death were analysed using logistic and Cox regression in individuals with pre-existing AT use versus no AT use, anticoagulants (AC) versus antiplatelets (AP), and direct oral anticoagulants (DOACs) versus warfarin.ResultsFrom 972 971 individuals with AF (age 79 (±9.3), female 46.2%) and CHA2DS2-VASc score ≥2, 88.0% (n=856 336) had pre-existing AT use, 3.8% (n=37 418) had a COVID-19 hospitalisation and 2.2% (n=21 116) died, followed up to 1 May 2021. Factors associated with no AT use included comorbidities that may contraindicate AT use (liver disease and history of falls) and demographics (socioeconomic status and ethnicity). Pre-existing AT use was associated with lower odds of death (OR=0.92, 95% CI 0.87 to 0.96), but higher odds of hospitalisation (OR=1.20, 95% CI 1.15 to 1.26). AC versus AP was associated with lower odds of death (OR=0.93, 95% CI 0.87 to 0.98) and higher hospitalisation (OR=1.17, 95% CI 1.11 to 1.24). For DOACs versus warfarin, lower odds were observed for hospitalisation (OR=0.86, 95% CI 0.82 to 0.89) but not for death (OR=1.00, 95% CI 0.95 to 1.05).ConclusionsPre-existing AT use may be associated with lower odds of COVID-19 death and, while not evidence of causality, provides further incentive to improve AT coverage for eligible individuals with AF.
Exercise oxygen pulse kinetics in patients with hypertrophic cardiomyopathy
Authors: Mapelli Massimo , Romani Simona , Magrì Damiano , Merlo Marco , Cittar Marco , Masè Marco , Muratori Manuela , Gallo Giovanna , Sclafani Matteo , Carriere Cosimo , Zaffalon Denise , Salvioni Elisabetta , Mattavelli Irene , Vignati Carlo , De Martino Fabiana , Rovai Sara , Autore Camillo , Sinagra Gianfranco , Agostoni Piergiuseppe 
Published: March 2022

ObjectivesReduced cardiac output (CO) has been considered crucial in symptoms’ genesis in hypertrophic cardiomyopathy (HCM). Absolute value and temporal behaviour of O2-pulse (oxygen uptake/heart rate (VO2/HR)), and the VO2/work relationship during exercise reflect closely stroke volume (SV) and CO changes, respectively. We hypothesise that adding O2-pulse absolute value and kinetics, and VO2/work relationship to standard cardiopulmonary exercise testing (CPET) could help identify more exercise-limited patients with HCM.MethodsCPETs were performed in 3 HCM dedicated clinical units. We retrospectively enrolled non-end-stage consecutive patients with HCM, grouped according to left ventricle outflow tract obstruction (LVOTO) at rest or during Valsalva manoeuvre (72% of patients with LVOTO <30; 10% between 30 and 49 and 18% ≥50 mm Hg). We evaluated the CPET response in HCM focusing on parameters strongly associated with SV and CO, such as O2-pulse and VO2, respectively, considering their absolute values and temporal behaviour during exercise.ResultsWe included 312 patients (70% males, age 49±18 years). Peak VO2(percentage of predicted), O2-pulse and ventilation to carbon dioxide production (VE/VCO2) slope did not change across LVOTO groups. Ninety-six (31%) patients with HCM presented an abnormal O2-pulse temporal behaviour, irrespective of LVOTO values. These patients showed lower peak systolic pressure, workload (106±45 vs 130±49 W), VO2(21.3±6.6 vs 24.1±7.7 mL/min/kg; 74%±17% vs 80%±20%) and O2-pulse (12 (9–14) vs 14 (11–17) mL/beat), with higher VE/VCO2slope (28 (25–31) vs 27 (24–31)) (p<0.005 for all). Only 2 patients had an abnormal VO2/work slope.ConclusionNone of the frequently used CPET parameters, either as absolute values or dynamic relationships, were associated with LVOTO. Differently, an abnormal temporal behaviour of O2-pulse during exercise, which is strongly related to inadequate SV increase, correlates with reduced functional capacity (peak and anaerobic threshold VO2and workload) and increased VE/VCO2slope, identifying more advanced disease irrespectively of LVOTO.