bluuebunny/crossref_metadata_2025_split huggingface dataset:
Effectiveness of an evidence-based swallowing facilitation strategy for patients undergoing radiotherapy for head and neck cancer: a study protocol for a randomised controlled trial
Authors: Zhang Yu , Zhu Yu , Wan Hongwei 
Published: January 2024

IntroductionDysphagia emerges as a frequent, persistent and enduring aftermath in individuals undergoing radiotherapy for head and neck cancer (HNC). Timely intervention becomes imperative to ameliorate prolonged dysphagia and curtail related complications. Among the evidence-grounded tactics, preventive swallowing training and proficient feeding management stand out as pivotal measures for precluding and mitigating dysphagia. However, past inquiries that amalgamated these dual interventions exhibited heterogeneous quality due to their restricted participant cohorts and a dearth of uniform, systematic and practicable procedural benchmarks.Method/designThis randomised, parallel-controlled study enrols 94 patients diagnosed with HNC, who are undergoing radiotherapy either with or without concurrent chemotherapy. The patients will be randomly assigned to either the intervention group, which will receive a facilitation strategy to enhance swallowing function in conjunction with standard care, or the control group, which will receive typical radiotherapy care. Patient assessments will be conducted at three distinct time points: at the onset of radiotherapy (baseline), at the conclusion of radiotherapy and 3 months postradiotherapy. The primary outcome will revolve around measuring swallowing function, while secondary outcomes will encompass swallowing-related quality of life and nutritional status.Ethics and disseminationThis research initiative received endorsement from the Shanghai Proton Heavy Ion Hospital Ethics Committee on 2 December 2 (Approval Number 2210-59-01). Throughout the recruitment process, patients will be acquainted with the primary aims and scope of the study. Their participation will be a voluntary choice, demonstrated by their informed consent form signatures. The outcomes of this study will be disseminated through publication in a peer-reviewed journal.Trial registration numberClinical Trials.gov, ChiCTR2300067550, registered 11 January 2023.
Older adults’ attitudes towards deprescribing and medication changes: a longitudinal sub-study of a cluster randomised controlled trial
Authors: Jungo Katharina Tabea , Weir Kristie Rebecca , Cateau Damien , Streit Sven 
Published: January 2024

ObjectiveTo investigate the association between older patients’ willingness to have one or more medications deprescribed and: (1) change in medications, (2) change in the appropriateness of medications and (3) implementation of prescribing recommendations generated by the electronic decision support system tested in the ‘Optimising PharmacoTherapy In the Multimorbid Elderly in Primary CAre’ (OPTICA) trial.DesignA longitudinal sub-study of the OPTICA trial, a cluster randomised controlled trial.SettingSwiss primary care settings.ParticipantsParticipants were aged ≥65 years, with ≥3 chronic conditions and ≥5 regular medications recruited from 43 general practitioner (GP) practices.ExposuresPatients’ willingness to have medications deprescribed was assessed using three questions from the ‘revised Patient Attitudes Towards Deprescribing’ (rPATD) questionnaire and its concerns about stopping score.Measures/analysesMedication-related outcomes were collected at 1 year follow-up. Aim 1 outcome: change in the number of long-term medications between baseline and 12 month follow-up. Aim 2 outcome: change in medication appropriateness (Medication Appropriateness Index). Aim 3 outcome: binary variable on whether any prescribing recommendation generated during the OPTICA medication review was implemented. We used multilevel linear regression analyses (aim 1 and aim 2) and multilevel logistic regression analyses (aim 3). Models were adjusted for sociodemographic variables and the clustering effect at GP level.Results298 patients completed the rPATD, 45% were women and 78 years was the median age. A statistically significant association was found between the concerns about stopping score and the change in the number of medications over time (per 1-unit increase in the score the average number of medications use was 0.65 higher; 95% CI: 0.08 to 1.22). Other than that we did not find evidence for statistically significant associations between patients’ agreement with deprescribing and medication-related outcomes.ConclusionsWe did not find evidence for an association between most measures of patient agreement with deprescribing and medication-related outcomes over 1 year.Trial registration numberNCT03724539.
Multicentre external validation of the prognostic model kidney failure risk equation in patients with CKD stages 3 and 4 in Peru: a retrospective cohort study
Authors: Bravo-Zúñiga Jessica , Chávez-Gómez Ricardo , Soto-Becerra Percy 
Published: January 2024

ObjectivesTo externally validate the four-variable kidney failure risk equation (KFRE) in the Peruvian population for predicting kidney failure at 2 and 5 years.DesignA retrospective cohort study.Setting17 primary care centres from the Health’s Social Security of Peru.ParticipantsPatients older than 18 years, diagnosed with chronic kidney disease stage 3a–3b–4 and 3b–4, between January 2013 and December 2017. Patients were followed until they developed kidney failure, died, were lost, or ended the study (31 December 2019), whichever came first.Primary and secondary outcome measuresPerformance of the KFRE model was assessed based on discrimination and calibration measures considering the competing risk of death.ResultsWe included 7519 patients in stages 3a–4 and 2798 patients in stages 3b–4. The estimated cumulative incidence of kidney failure, accounting for competing event of death, at 2 years and 5 years, was 1.52% and 3.37% in stages 3a–4 and 3.15% and 6.86% in stages 3b–4. KFRE discrimination at 2 and 5 years was high, with time-dependent area under the curve and C-index >0.8 for all populations. Regarding calibration in-the-large, the observed to expected ratio and the calibration intercept indicated that KFRE underestimates the overall risk at 2 years and overestimates it at 5 years in all populations.ConclusionsThe four-variable KFRE models have good discrimination but poor calibration in the Peruvian population. The model underestimates the risk of kidney failure in the short term and overestimates it in the long term. Further research should focus on updating or recalibrating the KFRE model to better predict kidney failure in the Peruvian context before recommending its use in clinical practice.
NSAID prescribing and adverse outcomes in common infections: a population-based cohort study
Authors: Stuart Beth , Venekamp Roderick , Hounkpatin Hilda , Wilding Sam , Moore Michael , Little Paul , Gulliford Martin C 
Published: January 2024

ObjectivesInfections in primary care are often treated with non-steroidal anti-inflammatory drugs (NSAIDs). This study evaluates whether NSAID prescribing is associated with adverse outcomes for respiratory (RTIs) or urinary track (UTI) infections.ObjectivesTo determine whether there is an association between NSAID prescribing and the rate of adverse outcomes for infections for individual consulting in primary care.DesignCohort study of electronic health records.Setting87 general practices in the UK Clinical Practice Research Datalink GOLD.Participants142 925 patients consulting with RTI or UTI.Primary and secondary outcome measuresRepeat consultations, hospitalisation or death within 30 days of the initial consultation for RTI or UTI. Poisson models estimated the associations between NSAID exposure and outcome. Rate ratios were adjusted for gender, age, ethnicity, deprivation, antibiotic use, seasonal influenza vaccination status, comorbidities and general practice. Since prescribing variations by practice are not explained by case mix—hence, less impacted by confounding by indication—both individual-level and practice-level analyses are included.ResultsThere was an increase in hospital admission/death for acute NSAID prescriptions (RR 2.73, 95% CI 2.10 to 3.56) and repeated NSAID prescriptions (6.47, 4.46–9.39) in RTI patients, and for acute NSAID prescriptions for UTI (RR 3.03; 1.92 to 4.76). Practice-level analysis, controlling for practice population characteristics, found that for each percentage point increase in NSAID prescription, the percentages of hospital admission/death within 30 days increased by 0.32 percentage points (95% CI 0.16 to 0.47).ConclusionsIn this non-randomised study, prescription of NSAIDs at consultations for RTI or UTIs in primary care is infrequent but may be associated with increased risk of hospital admission. This supports other observational and limited trial data that NSAID prescribing might be associated with worse outcomes following acute infection and should be prescribed with caution.
Association between the triglyceride glucose index and low skeletal muscle mass: a cross-sectional study
Authors: Li Zhenzhen , Tong Xiang , Ma Yao , Bao Ting , Yue Jirong 
Published: January 2024

ObjectivesTriglyceride glucose (TyG) represents a consistent surrogate biomarker and index of insulin resistance (IR), IR has also been linked to skeletal muscle mass loss (SMM-L). Here, we evaluated the association between SMM-L and the TyG index (TyGi).DesignAn analytical cross-sectional study.SettingTertiary care hospitals.Participants36 275 participants who underwent health checks between 1 January 2013 and 31 December 2020.Primary and secondary outcome measuresA bioelectrical impedance analysis was used to assess the body composition, SMM-L was defined as low ASMI (total limb lean mass/height2) and TyGi was calculated as ln(triglycerides (mg/dL)×fasting blood glucose (mg/dL)/2).ResultsA total of 36 275 subjects were included in the study, of which 58.46% were male, with a mean age of 43.74±12.33 years. The prevalence of low skeletal muscle mass (SMM) was 17.7% and the mean TyGi was 8.56±0.64. TyGi was found to be significantly correlated with low SMM in all subjects (OR 1.87, 95% CI 1.75 to 2.00, p<0.001), with higher correlations seen in younger subjects (OR 1.97, 95% CI 1.77 to 2.20, p<0.001), and remaining significant in middle age (OR 1.95, 95% CI 1.77 to 2.14, p<0.001), old age (OR 1.73, 95% CI 1.38 to 1.16, p<0.001), men (OR 1.60, 95% CI 1.46 to 1.76, p<0.001) and women (OR 2.59, 95% CI 2.39 to 2.87, p<0.001).ConclusionsThese data demonstrated a significant independent interaction between TyGi and low SMM in all subjects regardless of sex and age subgroups in the general population.
Hospitals’ financial performance across European countries: a scoping review protocol
Authors: Dubas‐Jakóbczyk Katarzyna , Ndayishimiye Costase , Szetela Przemysław , Sowada Christoph 
Published: January 2024

IntroductionHospitals remain the cornerstone of health systems in European countries. Therefore, the financial sustainability of hospitals constitutes an important determinant of healthcare provision security. The fragmentary data available indicate that hospitals in many European countries are continuously facing financial deficits and/or insolvency problems. Yet a comparative analysis of hospital financial performance across European countries has been lacking. The proposed review will, therefore, fill in an important research gap and build a knowledge base on the topic of assessing and monitoring the financial sustainability of hospitals in Europe. The general objective is to identify, synthetise and map existing evidence on hospital financial performance across European countries.Methods and analysisThis scoping review will follow six stages: (1) defining the research question, (2) identifying relevant literature, (3) studies selection, (4) data extraction, (5) collating, summarising and reporting of results and (6) consultation process and involvement of knowledge users. The following databases will be searched:(1) Medline via PubMed, (2) Web of Science Core Collection, (3) Scopus and (4) ProQuest Central. In addition, a Google Engine search will also be performed. Furthermore, reference lists of relevant papers will be visually scanned to identify further studies of interest. The review will include both quantitative and qualitative empirical studies as well as theoretical papers and technical reports. The PRISMA extension for a Scoping Review checklist will be used for reporting.Ethics and disseminationFormal ethical approval is not required because no primary data will be collected in this study. Results will be published in a peer-reviewed journal. The findings will also be disseminated through conference presentations and summaries to key stakeholders.
RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands
Authors: van Eijk Jorna , Luijken Kim , Jaarsma Tiny , Reitsma Johannes B , Schuit Ewoud , Frederix Geert W J , Derks Lineke , Schaap Jeroen , Rutten Frans H , Brugts Jasper , de Boer Rudolf A , Asselbergs Folkert W , Trappenburg Jaap C A 
Published: January 2024

IntroductionMeta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-)effective.Methods and analysisThe RELEASE-HF (‘REsponsible roLl-out of E-heAlth through Systematic Evaluation – Heart Failure’) study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts.Ethics and disseminationThe study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible.Trial registration numberNCT05654961.
Amantadine and/or transcranial magnetic stimulation for fatigue associated with multiple sclerosis (FETEM): study protocol for a phase 3 randomised, double-blind, cross-over, controlled clinical trial
Authors: Matias-Guiu Jordi A , González-Rosa Javier , Hernández Miguel Ángel , Martínez-Ginés Maria Luisa , Portolés Antonio , Pérez-Macías Natalia , Benito-León Julián , Padrón Iván , Prieto Julio , Matias-Guiu Jorge 
Published: January 2024

IntroductionFatigue is one of the most disabling symptoms of multiple sclerosis (MS), and effective treatments are lacking. Amantadine is one of the most used treatments, although its efficacy is under debate. Transcranial magnetic stimulation (TMS) is a promising intervention that has shown positive effects in some preliminary investigations. We aim to investigate the effect of 6 weeks of amantadine and/or TMS in fatigue due to MS.Methods and analysisThe study is a national, multicentre, phase 3, randomised, double-blind, cross-over, placebo-controlled and sham-controlled clinical trial. Adult patients with relapsing-remitting MS, Expanded Disability Status Scale score of 1.5–4.5 and Fatigue Severity Score>4 are eligible for the trial. Participants will be randomised to one of the sequences of the study. Each sequence consists of four periods of 6 weeks of treatment and three washout periods of 12–18 weeks. All patients will receive all the combinations of therapies. The primary outcome is the Modified Fatigue Impact Scale. The secondary outcomes are the Symbol Digit Modalities Test (cognition), Beck Depression Inventory-II (depressive symptoms) and Short-Survey 12 (quality of life). Safety and cost-effectiveness will also be evaluated. An exploratory substudy including MRI and blood biomarkers will be conducted.Ethics and disseminationThe study is approved by the Ethics Committee of the Hospital Clinico San Carlos and the Spanish Agency of Medications and Medical Devices. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.Trial registration numberEudraCT 2021-004868-95;NCT05809414.
The Tuberculosis Sentinel Research Network (TB-SRN) of the International epidemiology Databases to Evaluate AIDS (IeDEA): protocol for a prospective cohort study in Africa, Southeast Asia and Latin America
Authors: Enane Leslie A , Duda Stephany N , Chanyachukul Thida , Bolton-Moore Carolyn , Navuluri Neelima , Messou Eugène , Mbonze Nana , McDade LaQuita R , Figueiredo Marina Cruvinel , Ross Jeremy , Evans Denise , Diero Lameck , Akpata Robert , Zotova Natalia , Freeman Aimee , Pierre Marie Flore , Rupasinghe Dhanushi , Ballif Marie , Byakwaga Helen , de Castro Nathalie , Tabala Martine , Sterling Timothy R , Sohn Annette H , Fenner Lukas , Wools-Kaloustian Kara , Poda Armel , Yotebieng Marcel , Huebner Robin , Marcy Olivier 
Published: January 2024

IntroductionTuberculosis (TB) is a leading infectious cause of death globally. It is the most common opportunistic infection in people living with HIV, and the most common cause of their morbidity and mortality. Following TB treatment, surviving individuals may be at risk for post-TB lung disease. The TB Sentinel Research Network (TB-SRN) provides a platform for coordinated observational TB research within the International epidemiology Databases to Evaluate AIDS (IeDEA) consortium.Methods and analysisThis prospective, observational cohort study will assess treatment and post-treatment outcomes of pulmonary TB (microbiologically confirmed or clinically diagnosed) among 2600 people aged ≥15 years, with and without HIV coinfection, consecutively enrolled at 16 sites in 11 countries, across 6 of IeDEA’s global regions. Data regarding clinical and sociodemographic factors, mental health, health-related quality of life, pulmonary function, and laboratory and radiographic findings will be collected using standardised questionnaires and data collection tools, beginning from the initiation of TB treatment and through 12 months after the end of treatment. Data will be aggregated for proposed analyses.Ethics and disseminationEthics approval was obtained at all implementing study sites, including the Vanderbilt University Medical Center Human Research Protections Programme. Participants will provide informed consent; for minors, this includes both adolescent assent and the consent of their parent or primary caregiver. Protections for vulnerable groups are included, in alignment with local standards and considerations at sites. Procedures for requesting use and analysis of TB-SRN data are publicly available. Findings from TB-SRN analyses will be shared with national TB programmes to inform TB programming and policy, and disseminated at regional and global conferences and other venues.
Study of postoperative laryngopharyngeal discomfort: protocol for a single-centre cohort study
Authors: Wang Li Fang , Zheng Meng-Tao , Liang Nan , Ma Hao Ning , Li Wei Xia 
Published: January 2024

IntroductionPostoperative laryngopharyngeal discomfort after extubation can lead to severe throat pain, dysphagia, or postoperative tongue oedema. Possible mechanisms include increased oral pressure, obstruction of venous and lymphatic return in the neck, and increased capillary hydrostatic pressure, which leads to oedema of the tongue and upper airway. However, real-time monitoring indicators of anaesthesia are lacking. Therefore, we designed this study to accurately measure the contact force of the tracheal tube on the tongue in different surgical positions during general anaesthesia.Methods and analysisThis prospective single-centre observational study will enrol 54 patients undergoing elective surgery under general anaesthesia for>2 hours with endotracheal tube application from 1 July 2023 to 30 June 2024. Patients will be divided into the supine (Supine group) and high-risk (Flexion group) groups. Dynamic changes in the contact force between the tracheal tube and tongue will be measured using T-Scan technology. All patients will be followed up for 7 days postoperatively. The primary endpoint is postoperative laryngopharyngeal discomfort. Secondary outcomes include the time to the first successful recovery of oral intake of fluids and solid food, and airway-related events.Ethics and disseminationEthical approval was obtained from the Ethics Committee of Clinical Research of China-Japan Friendship Hospital (2023-KY-219, approved on 14 September 2023). Informed consent will be obtained during anaesthesia evaluation. This study aims to explore the characteristics of the contact force on the tongue caused by endotracheal intubation in different surgical positions and to provide a better understanding of the risk factors and prevention of postoperative laryngopharyngeal discomfort. The findings of this study will be presented at our hospital, reported on ClinicalTrials.gov, and published in peer-reviewed journals.Trial registration numberNCT05987293.
Excess mortality during the COVID-19 pandemic in low-income and lower middle-income countries: protocol for a systematic review and meta-analysis
Authors: Gmanyami Jonathan Mawutor , Jarynowski Andrzej , Belik Vitaly , Lambert Oscar , Amuasi John , Quentin Wilm 
Published: January 2024

IntroductionThe COVID-19 pandemic has been marked by a massive death toll. However, the overall effect of the pandemic, including potential unintended negative impacts of some control measures, on mortality remains poorly understood in low-income and lower middle-income countries (LLMICs). This review aims to summarise the available literature on excess mortality in LLMICs, focusing on the methods and data sources used in estimating excess mortality and the drivers of excess mortality.Methods and analysisWe will review the available literature and report results in line with the Preferred Reporting Items for Systematic Review and Meta-Analysis. Searches will be conducted in PubMed, Embase, Web of Science, Cochrane Library, Google Scholar and Scopus. All published studies that report on the estimates of excess mortality in populations of LLMICs will be included. This will include those with a publication date from 2019 onwards and those with at least a 1-year non-COVID-19 period as the comparator in the estimation of excess mortality during the pandemic. There will be no language restrictions on the search. The meta-analysis will include studies with extractable data on excess mortality, methods, population size, and observed and expected deaths. We will use the Mantel-Haenszel method to estimate the pooled risk ratio with 95% CIs.Ethics and disseminationAs there is no primary data collection, there is no requirement for ethical review. The results will be disseminated through peer-reviewed journal publication and conference presentations.PROSPERO registration numberCRD42022378267.