bluuebunny/crossref_metadata_2025_split huggingface dataset:
Financial burden of complications following lung resection: a scoping review protocol
Authors: Flinkier Ariane , Chu Fabien , Berman Jordan , Slifirski Hugh , Barnett Stephen , Caragata Rebecca , Weinberg Laurence 
Published: December 2024

IntroductionGlobal healthcare expenditures are rising, driven largely by increased spending in both high- and low-income countries with hospitalisation as a primary contributor. Respiratory diseases, particularly lung cancer, pose significant public health and economic challenges with thoracic surgery as the standard curative treatment. Complications post resection, such as arrhythmias, infections and respiratory failure, result in substantial healthcare costs and resource demands. Although studies have explored the economic impact of surgeries, there is a limited comprehensive analysis of the financial burden of postoperative complications after lung resection surgery. To address this gap, this scoping review aims to map existing literature on lung resection complications and associated costs, providing insights for future research and healthcare policy.Methods and analysisThis scoping review will be conducting according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Reviews standards. Eligible peer-reviewed articles and grey literature will be identified across Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database and Cochrane Central Register of Controlled Trials. Cost data will be converted into US dollars as per the Federal Reserve Bank of St Louis and adjusted for inflation as per the US Bureau of Labor Statistics Consumer Price Index inflation calculator.Ethics and disseminationEthics approval was not required. The results will be communicated through established professional networks, conference presentations and publication in peer-reviewed journals.
Uptake of HIV pre-exposure prophylaxis and contraception in South African hair salons: a study protocol for a pilot cluster randomised controlled trial
Authors: Govere Sabina Medal , Jarolimova Jana , Yan Joyce , Shezi Sthabile , Ngcobo Lungile M , Sagar Shruti , Zionts Dani , Dube Nduduzo , Parker RA , Psaros Christina , Bassett Ingrid 
Published: December 2024

IntroductionYoung women are disproportionately affected by HIV in South Africa and have a high incidence of unintended pregnancies. Access to sexual and reproductive health (SRH) services, including HIV pre-exposure prophylaxis (PrEP), contraception and screening for seally transmitted infections (STIs), remains limited in South Africa, in part due to inadequate infrastructure and individual barriers to care. Integrated, community-based SRH services have the potential to overcome barriers to clinic-based care for women at risk of HIV, unintended pregnancy and STIs. We are evaluating the feasibility, acceptability and preliminary effectiveness of a novel intervention offering PrEP, contraception and STI screening in hair salons.Methods and analysisWe will conduct a pilot cluster randomised controlled trial in hair salons in urban KwaZulu-Natal, South Africa. Salons serving primarily female clients will be randomised either to an SRH service package (offer of PrEP, contraception, STI screening and health education) or to health education only. Interested female salon clients≥18 years old will be referred by trained stylists. In intervention salons, women who meet inclusion criteria will be offered HIV and pregnancy testing; if eligible, they will be offered oral PrEP, contraception (oral or injectable) and STI screening. Follow-up visits including monitoring side effects will be conducted at baseline and 3, 6, 9 and 12 months. We will measure intervention uptake as the proportion of eligible women who agree to salon-based PrEP and separately to salon-based contraception. We will assess feasibility by collecting process measures and evaluate retention as continued use of PrEP and contraception separately, defined as one additional visit within 6 months with continued use of PrEP and/or contraception.Ethics and disseminationThe study has been approved by the University of KwaZulu-Natal Biomedical Research Ethics Committee and the Massachusetts General Brigham Institutional Review Board. The results will be disseminated to local and provincial Departments of Health, at scientific conferences and in peer-reviewed scientific journals.Trial registration numberNCT04222504. Registered January 2020.
A phase II double-blind multicentre, placebo-controlled trial to assess the efficacy and safety of alpelisib (BYL719) in paediatric and adult patients with Megalencephaly-CApillary malformation Polymicrogyria syndrome (MCAP): the SESAM study protocol
Authors: Luu Maxime , Vabres Pierre , Espitalier Aurélie , Maurer Agnès , Garde Aurore , Racine Caroline , Carpentier Maud , Rega Adélaide , Loffroy Romaric , Hadouiri Nawale , Boddaert Nathalie , Curie Aurore , Guibaud Laurent , Chebbi Mouna , Charligny Julie , Kuentz Paul , Canaud Guillaume , Bahi-Buisson Nadia , Fleck Camille , Cransac Amelie , Bardou Marc , Faivre Laurence 
Published: December 2024

Introduction

The megalencephaly capillary malformation polymicrogyria (MCAP syndrome) results from mosaic gain-of-function
PIK3CA
variants. The main clinical features are macrocephaly, somatic overgrowth, neurodevelopmental delay and brain anomalies. Alpelisib (Vijoice) is a recently FDA-approved PI3Kα-specific inhibitor for patients with PIK3CA-related overgrowth spectrum (PROS). During its development, in patients with the MCAP subgroup of PROS, there was no specific, standardised evaluation of the effect on neuro-cognitive functioning. Moreover, it remains unknown if the molecule crosses the blood-brain barrier. Our objective is to evaluate the efficacy of a 24 month treatment with alpelisib on adaptive behaviour in patients with MCAP syndrome.

Methods and analysis
SESAM is an industry-sponsored two-period multicentre French academic phase II trial, with a 6-month double-blind, placebo-controlled period followed by an open-label period. The primary endpoint is a ≥4-point improvement in the Vineland II Adaptive Behaviour Scale (VABS), 24 months after treatment initiation. Secondary objectives are safety, VABS improvement at 6 months, impact on the quality of life, epilepsy and hypotonia. 20 patients aged 2 to 40 years with an MCAP diagnosis and neurodevelopmental disorders of various degrees, will be followed monthly in local centres, centrally assessed (clinical, biological, neuropsychological and functional evaluation) at baseline and every 6 months. Patients will be evaluated by volumetric MRI at baseline and at 24 months. An optional lumbar puncture will be performed to investigate blood-brain barrier crossing. Inclusions were completed by April 2024, with the end of follow-up in November 2026.
Given the efficacy of alpelisib in patients with PROS, if the drug crosses the blood-brain barrier, we can expect a clinical benefit for patients with neurocognitive disorders.

Ethics and dissemination
Ethical approval was given by CPP Sud-Ouest et Outre-Mer I (reference: 2022-500197-34-01). Findings from this study will be disseminated via publication, reports and conference presentations.

Trial registration number

NCT05577754
Effects of high-intensity interval and moderate-intensity continuous training on ambulatory blood pressure and cardiovascular outcomes in older adults with hypertension (HEXA Study): study protocol for a randomised trial
Authors: Dalton-Alves Francisco , Araújo Maria Beatriz F , Lucena Bruno Erick B , Souto Gabriel C , Lopes Daniele Samara D , Lucena Maria Isabel S , de Melo Silva Raíssa , Cabral Ludmila L P , Freire Yuri A , Golveia Fabíola L , Lemos Telma Maria Araújo , Browne Rodrigo A V , Costa Eduardo Caldas 
Published: December 2024

IntroductionApproximately two-thirds of Brazilian older adults have hypertension. Aerobic training is the first-line non-pharmacological therapy for hypertension. However, the effects of different aerobic training approaches on ambulatory blood pressure in older adults are uncertain. Here, we present the study protocol for the HEXA Study, which aims to investigate the effects of high-intensity interval (HIIT) and moderate-intensity continuous training (MICT) on 24-hour ambulatory blood pressure and cardiovascular outcomes in older adults with hypertension.Methods and analysisThis is a single-centre, randomised, three-arm, parallel superiority trial with a 1:1:1 ratio. The trial is conducted with blinded outcome assessors and statistical analysts. 66 inactive older adults with hypertension aged 60–80 years without a history of major adverse cardiovascular events will be randomly assigned to one of the following groups: (1) HIIT (3 months; 3× week); (2) MICT (3 months; 3× week); (3) health education programme (control; 3 months; 1× week). Exercise training sessions involve rating of perceived exertion-based outdoor moderate walking, brisk walking and/or jogging. The primary outcome is 24-hour ambulatory blood pressure. Secondary cardiovascular outcomes are resting blood pressure, cardiorespiratory fitness, pulse wave velocity, carotid intima-media thickness, heart rate variability and cardiac function/structure. All outcomes are measured at baseline and after a 3-month period. In addition, feelings of pleasure/displeasure, adherence and safety are reported.Ethics and disseminationAll procedures were approved by the Research Ethics Committee of the Onofre Lopes University Hospital (protocol, CAAE 07191019.8.0000.5292) and are executed in compliance with the Declaration of Helsinki. Additionally, the procedures adhered to Resolution 466/2012 issued by the Brazilian National Health Council for research involving human subjects.Trial registration numberBrazilian Registry of Clinical Trials (ID: RBR-4ntszb).
Frequency, demographics, diagnoses and consultation patterns associated with low-acuity attendances in German emergency departments: a retrospective routine healthcare data analysis from the INDEED project
Authors: Fischer-Rosinský Antje , Slagman Anna , Legg David , Wu Yves-Noel , King Ryan , Roll Stephanie , Keil Thomas , Möckel Martin 
Published: December 2024

ObjectiveEvidence suggests interventions targeting low-acuity attendances have been hampered by insufficient characterisation of potential target groups. This study aimed to estimate the frequency of low-acuity emergency department (ED) attendances and to provide an overview of their demographic, diagnosis and consultation patterns.DesignObservational analyses of routine healthcare data.SettingGerman EDs.ParticipantsAdult patients with statutory health insurance who visited the ED of 16 participating hospitals in 2016.Main outcome measuresFrequency, demographics, diagnoses and consultation patterns of low-acuity and high-acuity attendees.Main resultsOf the 454 747 ED visits, 370 756 visits (50.1% female) were included for analysis. Four participating hospitals had to be excluded due to the lack of data that were necessary for the stepwise approach to define low and high acuity. We identified 101 337 visits as low acuity (27.3%) and 256 876 as high acuity (69.3%), whereas 12 543 (3.4%) could not be classified. The proportion of attendees classified as low acuity decreased with age (highest at 40.6% in the age group <35 years). The proportion of women and men was 50% in both acuity categories, respectively (50 654 of all low-acuity and 128 427 of all high-acuity contacts). The highest proportion of low-acuity presentations was observed during the weekend (average of 18.6% per day), compared with an average of 12.5% on weekdays. The most common diagnoses (back pain, abdominal and pelvic pain) were similar in both low-acuity and high-acuity groups.ConclusionOur study provides further evidence that younger age is associated with low-acuity presentation in German EDs. Age-specific intervention strategies are needed to ease the burden on urgent care facilities. The similar spectrum of diagnoses between low-acuity and high-acuity patients suggests a so far under-recognised higher importance of severity.Trial registration numberDRKS00022969.
Vestibular Infant Screening-Rehabilitation (VIS-REHAB): protocol for a randomised controlled trial on Vestibular Rehabilitation Therapy (VRT) in vestibular-impaired children
Authors: Fontaine Marieke , Dhooge Ingeborg , Dhondt Cleo , Van Hecke Ruth , Acke Frederic , Van den Bossche Lena , Van Hoecke Helen , De Leenheer Els , Maes Leen 
Published: December 2024

IntroductionA vestibular deficit can have a substantial impact on the overall development of children. Therefore, it is of utmost importance that vestibular-impaired problems are treated early and effectively through Vestibular Rehabilitation Therapy (VRT). Although VRT is sufficiently proven and standardised in adults, there remains a lack of research examining its efficacy in children. To assess the effectiveness of VRT in vestibular-impaired children, the Vestibular Infant Screening-Rehabilitation (VIS-REHAB) protocol was developed with the following objectives: (1) to investigate the short-term effect of a combined postural control and gaze stabilisation protocol, compared with receiving no therapy and (2) to investigate the most important factors that may influence the effect of and outcome after application of the VIS-REHAB protocol in a group of vestibular-impaired children. This study aims to address lingering questions in the existing literature in a standardised manner, with the ultimate objective to establish evidence-based rehabilitation guidelines.Methods and analysisThe VIS-REHAB study is a two-parallel group, superiority, randomised controlled crossover trial with 1:1 allocation ratio. The study includes patients aged 3–17 years old with identified peripheral vestibular dysfunction. Primary and secondary outcome measures assess gaze stability, postural stability, motor performance and quality of life. The effectiveness of the VIS-REHAB protocol will be evaluated through parallel group and crossover analyses using analysis of covariance (ANCOVA). Additionally, prespecified subgroup analyses will be conducted to assess influencing factors that may impact the outcome and effect of VIS-REHAB.Ethics and disseminationAt the start of the VIS-REHAB study, an amendment will be submitted to the ethics committee of Ghent University Hospital for the following applications: (EC2018/0435), (EC2018/0959), (EC2015/1441) and (EC2015/1442). The trial is registered at Clinical Trials (clinicaltrials.gov) with registry name VIS-REHAB and identifierNCT06177132. All research findings will be disseminated in peer-reviewed journals.Trial registration numberNCT06177132.
Heavy slow resistance training, radial extracorporeal shock wave therapy or advice for patients with tennis elbow in the Norwegian secondary care: a randomised controlled feasibility trial
Authors: Sveinall Håkon , Brox Jens Ivar , Engebretsen Kaia B , Hoksrud Aasne Fenne , Røe Cecilie , Johnsen Marianne Bakke 
Published: December 2024

ObjectivesTo evaluate the feasibility of recruitment, appointment adherence, intervention compliance, acceptance and comprehensibility, in addition to retention rate and data completeness. An ancillary aim was to describe within-group changes in the secondary outcome measures (patient-reported and performance-based).DesignA single-centre, three-armed, randomised controlled feasibility trial with a parallel design, with follow-up after 3 and 6 months.SettingParticipants were recruited from the outpatient clinic at Oslo University Hospital.ParticipantsPatients with lateral epicondylalgia, commonly known as tennis elbow.InterventionsParticipants were randomised in a 1:1:1 ratio to heavy slow resistance training, radial extracorporeal shock wave therapy or information and advice.Main outcome measuresFeasibility was assessed according to a priori criteria for success.ResultsIn total, 89 patients were screened for eligibility, and 69 (78%) patients were eligible for randomisation. 60 (92%) participants were randomised which gave a recruitment rate of 3.4 per month (against an a priori success cut-off of 3.75). The participants rated all the interventions as acceptable and comprehensive. Only 6 of 19 (32%) did comply with heavy slow resistance training. Retention rate and completeness of data were successful at 3 months. At 6 months, the retention rate was below the criteria for success. Patient-reported and performance-based outcomes improved in all groups.ConclusionThe current study shows that the process of recruitment and the retention rate at follow-up can be feasible with minor amendments. Participants had low compliance with heavy slow resistance training mainly due to pain aggravation, which suggests that this intervention was not suitable for patients with tennis elbow. Shock wave therapy and information and advice should be investigated further in a full-scale randomised controlled trial including sham shock wave therapy.Trial registration numberNCT04803825.
Incremental cost of treating antimicrobial-resistant infections among hospitalised patients in India: a cohort study
Authors: Kadam Abhijit , Mamulwar Megha , Bhambure Gayatri , Bembalkar Shilpa , Bapat Shraddha , Mane Arati , Rajure Shobha , Mathaiyan Jayanthi , Shafiq Nusrat , Prinja Shankar , Ramanathan Yamunadevi , Mehendale Sanjay M , Deotale Vijayshri Suresh , Khadanga Sagar , Bhattacharya Sanjay , Gogoi Gourangie , Walia Kamini , Panda Samiran , Gangakhedkar Raman , Attal Ruchita , Mandal Jharna , Ramanathan Venkateswaran , Ray Pallab , Chatterjee Susmita 
Published: December 2024

BackgroundAccurate estimates of incremental cost (IC) attributable to antimicrobial resistance (AMR) provide information of immense public health importance to the policy makers. Here, we present the IC from patient perspective for treating antimicrobial-resistant pathogens in India.MethodsThis cohort study was conducted in eight hospitals including government (GH), private (PH) and trust hospitals (TH), considering their ownership, geographical location and categories of cities. This study had a retrospective component, which calculated the direct cost of treating resistant and susceptible blood stream infections caused by selected WHO priority pathogens. The prospective component estimated indirect cost and financial coping strategies for the treatment of AMR. In the retrospective component, 1723 records were included and 170 patients were recruited in the prospective component.ResultsThe median total cost for management of antimicrobial-resistant infections was US$199 (IQR 89, 377) as opposed to US$109 (IQR 55, 229) for susceptible infection in GH. Our study has revealed that the ICs forEnterobacteriaceae(53.9%),Acinetobacter(43.8%) andStaphylococcus(49.7%) at GHs were higher for resistant pathogens. Pharmaceutical cost was the major contributor to IC at GHs (61.5%) and PHs (27.1%). In the prospective component, 46.5% of patients resorted to borrowing money for hospitalisation expenses and the per day median total cost for resistant and sensitive infection was estimated to be US$65 and US$35, respectively.ConclusionsThe current study concluded that the presence of any critical or high priority pathogens led to an increase in the direct and indirect medical costs. The IC varied with hospital type, length of stay, pathogen, comorbidities and diagnosis. Prospective studies are needed for precise understanding of variations in the costs of treating AMR infections.
Exploring the relationship between personal and cohabiting family members’ COVID-19 infection experiences and fear of COVID-19: a longitudinal study based on the Japan COVID-19 and Society Internet Survey (JACSIS)
Authors: Ishikawa Akira , Tachikawa Hirokazu , Midorikawa Haruhiko , Tabuchi Takahiro 
Published: December 2024

ObjectivesThis study aims to explore the relationship between the combined experiences of COVID-19 infection in individuals and their family members and the resulting fear of COVID-19, with a focus on the severity of symptoms and various sociodemographic factors.DesignLongitudinal survey study.SettingThe Japan COVID-19 and Society Internet Survey (JACSIS), a large-scale web panel survey administered in Japan.ParticipantsAnalysis was based on responses from 15 542 individuals who participated in all three waves of JACSIS conducted between 2020 and 2022.Main outcome measuresThe primary measure was the fear of COVID-19, assessed using the Fear of COVID-19 Scale. The study employed a two-way analysis of variance without repetition, Games-Howell post hoc tests and ordinary least-squares linear regression analysis, with time points treated as fixed effects.ResultsThe study revealed significant differences in fear levels based on the combined COVID-19 infection experiences of respondents and their family members, with variations observed across different time points. Mild symptoms in either the respondents or their family members correlated with reduced fear (β=−0.584, SE=0.181, p=0.001), while severe symptoms were associated with increased fear (β=1.244, SE=0.217, p<0.001). Gender, age, marital status and a history of respiratory disease or mental illness were also significant factors. For instance, females reported higher fear levels compared with males (β=0.707, SE=0.049, p<0.001), and those with a history of respiratory diseases showed increased fear (β=1.632, SE=0.286, p<0.001). Over time, the general fear of COVID-19 decreased, with the sharpest decline observed at T3 compared with T1 (β=−1.399, SE=0.061, p<0.001).ConclusionThe study highlights the significant influence of the combined COVID-19 infection experiences of individuals and their family members (the severity of symptoms, in particular) on the fear of COVID-19. These results underscore the need for tailored mental health interventions that consider both personal and familial infection experiences, as well as other sociodemographic factors. The findings also reflect the evolving public response to the changing dynamics of the pandemic.
Development of evidence-based standards for inpatient physiotherapy services: a systematic review and content analysis of clinical practice guidelines
Authors: Plater Jacqueline Claire , Baxter G David , Wood Lincoln C , Mueller Janice , Fisher Thelma 
Published: December 2024

ObjectivePerformance standards are critical to service design and quality improvement. There are no published standards defining the care inpatients should receive from physiotherapists in Aotearoa New Zealand. This study aims to explore the potential of using clinical practice guidelines (CPGs) to develop a set of evidence-based standards for physiotherapy in inpatient settings.DesignA systematic review and content analysis of CPGs.Data sourcesScholarly databases (Web of Science, CINAHL and Scopus, PEDro) and grey literature (guideline databases – NICE, SIGN, ECRI guideline trust, Guidelines International Network (GIN)) were searched between July and September 2021.Eligibility criteriaCPGs related to conditions and treatments common to physiotherapy in a secondary care setting were included. Mental health conditions, paediatrics, COVID-19 and conditions common to tertiary care were excluded.Data extraction and synthesisA pragmatic approach was taken to group guidelines aligned with common physiotherapy services and select only the most recent and comprehensive guidelines for final analysis. The quality of CPGs was assessed using the Appraisal of Guidelines for Research and Evaluation Instrument (AGREE II). Data from guideline recommendations of relevance to inpatient physiotherapy were grouped into themes. Summative ‘statements’ were drafted to represent the content of each theme; these were given a confidence rating based on the number of supporting guidelines and the strength or grade of evidence awarded by the guideline group.ResultsThe recommendations of 32 CPGs yielded 27 statements.ConclusionTwenty-seven statements represent a distillation of the best evidence-based practice recommendations from CPGs in inpatient physiotherapy. Statements of physiotherapy dosage (frequency, intensity and duration) are not available for many areas of practice; researchers and CPG groups should consider the importance of these data for service commissioning.