bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy of photobiomodulation therapy combined with mobile health education in patients with head and neck cancer suffering from chronic xerostomia after radiotherapy: protocol for a three-arm, randomised, placebo-controlled, double-blinded study
Authors: Lopez-Garzon Maria , López-Fernández María Dolores , Ruíz-Martínez Alba Maria , Galván-Banqueri Pilar , Lozano-Lozano Mario , Tovar-Martín Isabel , Postigo-Martin Paula , Ariza-Vega Patrocinio , Artacho-Cordón Francisco , Fernández-Lao Carolina , Cantarero-Villanueva Irene , Fernández-Gualda Miguel Ángel , Arroyo-Morales Manuel , Ruíz-Villaverde Ricardo , Galiano-Castillo Noelia 
Published: January 2024

IntroductionThe role of photobiomodulation (PBM) therapy for oral tissue damage induced by cancer treatment is currently unclear, and there is low-quality to moderate-quality evidence supporting the use of this approach for treating xerostomia and/or hyposalivation. Consequently, patients with head and neck cancer increasingly turn to basic oral hygiene to alleviate salivary gland dysfunction, and their adherence can be improved by mobile health (mHealth) education. The primary objective of this study will be to analyse the effects of different doses of PBM therapy (7.5 J/cm2vs 3 J/cm2) plus mHealth education on quality of life (QoL), oral health, salivary secretion and salivary gland ultrasound assessment at postintervention and at the 6-month follow-up in patients with head and neck cancer after radiotherapy compared with those in control group.Methods and analysisA prospective, three-arm, randomised, placebo-controlled, double-blinded study will be conducted among patients with head and neck cancer suffering from chronic xerostomia. A total of 20 patients per arm will be included and randomly assigned to receive 7.5 J/cm2of PBM, 3 J/cm2of PBM or placebo therapy. PBM therapy will be applied during 24 sessions at 22 points extra and intraorally two times per week for 3 months, combined with a mobile application (https://www.laxer.es). The assessments will be recorded at the beginning of the study, at postintervention and at the 6-month follow-up. The primary outcomes will be QoL, oral health, salivary secretion and salivary gland ultrasound. The pain pressure threshold, functional performance, mood and sleep quality will be secondary indicators.Ethics and disseminationThis study received ethics approval from the Andalusian Biomedical Research Ethics Portal (2402-N-21 CEIM/CEI Provincial de Granada) according to the Declaration of Helsinki for Biomedical Research. The results of this study will be presented at national and international conferences and published in peer-reviewed journals.Trial registration numberClinicalTrials.govNCT05106608.
Time-restricted eating and supervised exercise for improving hepatic steatosis and cardiometabolic health in adults with obesity: protocol for the TEMPUS randomised controlled trial
Authors: Camacho-Cardenosa Alba , Clavero-Jimeno Antonio , Martin-Olmedo Juan J , Amaro-Gahete Francisco , Cupeiro Rocío , Cejudo María Trinidad González , García Pérez Patricia Virginia , Hernández-Martínez Carlos , Sevilla-Lorente Raquel , De-la-O Alejandro , López-Vázquez Alejandro , Molina-Fernandez Marcos , Carneiro-Barrera Almudena , Garcia Federico , Rodríguez-Nogales Alba , Gálvez Peralta Julio Juan , Cabeza Rafael , Martín-Rodríguez José L , Muñoz-Garach Araceli , Muñoz-Torres Manuel , Labayen Idoia , Ruiz Jonatan R 
Published: January 2024

IntroductionMetabolic dysfunction-associated steatotic liver disease is a major public health problem considering its high prevalence and its strong association with extrahepatic diseases. Implementing strategies based on an intermittent fasting approach and supervised exercise may mitigate the risks. This study aims to investigate the effects of a 12-week time-restricted eating (TRE) intervention combined with a supervised exercise intervention, compared with TRE or supervised exercise alone and with a usual-care control group, on hepatic fat (primary outcome) and cardiometabolic health (secondary outcomes) in adults with obesity.Methods and analysisAn anticipated 184 adults with obesity (50% women) will be recruited from Granada (south of Spain) for this parallel-group, randomised controlled trial (TEMPUS). Participants will be randomly designated to usual care, TRE alone, supervised exercise alone or TRE combined with supervised exercise, using a parallel design with a 1:1:1:1 allocation ratio. The TRE and TRE combined with supervised exercise groups will select an 8-hour eating window before the intervention and will maintain it over the intervention. The exercise alone and TRE combined with exercise groups will perform 24 sessions (2 sessions per week+walking intervention) of supervised exercise combining resistance and aerobic high-intensity interval training. All participants will receive nutritional counselling throughout the intervention. The primary outcome is change from baseline to 12 weeks in hepatic fat; secondary outcomes include measures of cardiometabolic health.Ethics and disseminationThis study was approved by Granada Provincial Research Ethics Committee (CEI Granada—0365-N-23). All participants will be asked to provide written informed consent. The findings will be disseminated in scientific journals and at international scientific conferences.Trial registration numberNCT05897073.
Clinical characteristics and healthcare utilisation associated with undiagnosed cognitive impairment in elderly patients with diabetes in a primary care setting: a population-based cohort study
Authors: Merzon Eugene , Shpigelman Miriam , Vinker Shlomo , Golan Cohen Avivit , Green Ilan , Israel Ariel , Cukierman-Yaffe T , Eldor Roy 
Published: January 2024

ObjectivesThe objective of this study is to report the prevalence, clinical characteristics and healthcare utilisation of patients with type 2 diabetes (T2DM) and previously undiagnosed cognitive impairment who were identified as having a low Montreal Cognitive Assessment (MoCA) score.DesignA population-based cohort study comparing clinical characteristics, medications, outpatient and inpatient care of patients with a MoCA score <19 to MoCA >26 using descriptive statistics, linear regression and multivariate logistic regression.SettingElectronic medical records of a large health maintenance organisation in Israel.Participants350 patients, age >65 with T2DM who participated in a cognitive function screening initiative using MoCA, and had a follow-up visit during the 12 months after screening.Results130 (37.1%) had a MoCA score >26 and 68 (19.4%) <19. Patients with MoCA<19 had more diabetes-related complications, poorer glycaemic and lipid control, fewer visits to their main primary care physician (PCP; 3.9±3.2 vs 7.3±4.2 visits/year p=0.008), shorter duration of PCP visits (8.3±4.5 vs 4.0±3.5 min, p=0.007), fewer nutritionist and endocrinologist visits, and lower participation in diabetes or smoking cessation workshops. They were less likely to be treated with glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl peptidase-4 inhibitor (DPP-4), or sodium-glucose transport protein 2 (SGLT-2) inhibitors and more likely to receive insulin or sulfonylurea. Moreover, they had more emergency room visits (ER; 15 (11.5%) vs 16 (23.5%), p=0.019), hospitalisations (8 (6.2%) vs 22 (32.4%), p=0.001), and longer hospital stays (4.3±3.2 vs 14.5±9.8, p=0.001). Using statistical models, MoCA<19 was identified as a risk factor for fewer and shorter PCP visits and more ER visits and hospitalisations.ConclusionsThis study highlights the high prevalence of undiagnosed severe cognitive impairment in elderly patients with T2DM and its association with poor outpatient care. Appropriate interventions are needed to improve outcomes and prevent hospitalisation in this high-risk population.
Association between travel distance and face-to-face consultations with general practitioners before an incident acute myocardial infarction: a nationwide register-based spatial epidemiological study
Authors: Kjærulff Thora Majlund , Bihrmann Kristine , Søndergaard Jens , Gislason Gunnar , Larsen Mogens Lytken , Ersbøll Annette Kjær 
Published: January 2024

ObjectivesThis study examined the association between travel distance to the general practitioner’s (GP) office andnoface-to-face GP consultation within 1 year before an incident acute myocardial infarction (AMI).DesignA prospective cohort study using multilevel spatial logistic regression analysis of nationwide register data.SettingNationwide study including contacts to GPs in Denmark prior to an incident AMI in 2005–2017.Participants121 232 adults (≥30 years) with incident AMI were included in the study.Primary and secondary outcomes measuresThe primary outcome was odds of not having a face-to-face GP consultation within 1 year before an incident AMI.ResultsIn total, 13 108 (10.8%) of the 121 232 individuals with incident AMI had no face-to-face consultation with the GP within 1 year before the AMI. Population density modified the association between travel distance andnoface-to-face GP consultation. Increased odds ofnoface-to-face GP consultation was observed for medium (25th–75th percentile/1123–5449 m) and long (>75th percentile/5449 m) compared with short travel distance (<25th percentile/1123 m) among individuals living in small cities (OR (95% credible intervals) of 1.19 (1.10 to 1.29) and 1.19 (1.06 to 1.33), respectively) and rural areas (1.46 (1.26 to 1.68) and 1.48 (1.29 to 1.68), respectively). No association was observed for individuals living in large cities and the capital.ConclusionsTravel distance above approximately 1 km was significantly associated withnoface-to-face GP consultation before an incident AMI among individuals living in small cities and rural areas. The structure of the healthcare system should consider the importance of geographical distance between citizens and the GP in remote areas.
Effect of 4 weeks vs 8 weeks of acupuncture for knee osteoarthritis in China: protocol for a randomised controlled trial
Authors: Yu Ying , Liu Cun-Zhi , Wang Xue-Zhou , Xi Ya-Wei , Fu Yi-Ming , Mi Bao-Hong , Tu Jian-Feng 
Published: January 2024

IntroductionKnee osteoarthritis represents the prevalent and incapacitating disease. Acupuncture, a widely used clinical treatment for knee osteoarthritis, has been shown to ameliorate pain and enhance joint function in affected individuals. However, there is a lack of evidence comparing different courses of acupuncture for knee osteoarthritis. In this trial, we will assess the effect of 4 weeks vs 8 weeks of acupuncture in patients with knee osteoarthritis.Methods and analysisThe protocol is a pragmatic, parallel, two-arm randomised controlled trial, with the data analyst and assessor being blinded. 148 eligible patients with knee osteoarthritis will be randomly allocated in a 1:1 ratio to receive 4-week or 8-week acupuncture. Electroacupuncture will be administered three times per week for 4 or 8 weeks, respectively. Patients with knee osteoarthritis in both groups will be followed up to 26 weeks. The primary outcome is the response rate at week 26, and secondary outcomes include knee joint pain, knee joint function, knee joint stiffness, quality of life, patient global assessment, the Osteoarthritis Research Society International response rate and rescue medicine. A cost-effectiveness analysis will be carried out over 26 weeks.Ethics and disseminationThe protocol has been approved by the Medical Ethical Committee of Beijing University of Chinese Medicine (2023BZYL0506). The study findings will be disseminated through presentation in a medical journal. Additionally, we plan to present them at selected conferences and scientific meetings.Trial registration numberChinese Clinical Trials Registry (ChiCTR2300073383;https://www.chictr.org.cn/showproj.html?proj=199310).
What are the observed procedural costs of vascular access surgery? Protocol for a systematic review
Authors: Edgar Ben , Jones Catrin , Aitken Emma , Stevenson Karen , Jackson Andrew , Gaianu Lucian , Thomson Peter , Kasthuri Ram , Stove Callum , Kingsmore David 
Published: January 2024

IntroductionA central component in the introduction of a novel surgical procedure or technique is an evaluation of its cost efficiency when compared with a benchmark standard of care. Accurate assessment of costs is thus essential in ensuring appropriate allocation of resources within a healthcare system. The treatment of kidney failure requires a significant volume of resources, and vascular access provision is the main modifiable cost. The costs of providing this service are obscured by generic NHS reference costs, which lack adequate granularity to allow meaningful comparisons between treatments. The aim of this systematic review will be to assess the reporting of procedural costs in all published economic analyses of vascular access surgery and perform a comparison of the reported procedural costs involved in arteriovenous fistula (AVF) and arteriovenous graft (AVG) creation. This will provide an estimate as to the accuracy of the NHS reference costs in this field.Methods and analysisThe Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines will be followed. A systematic search will be performed of the MEDLINE, Embase and Cochrane databases to identify full-text economic analyses of vascular access for haemodialysis in which the procedural cost of AVF or AVG creation is reported. Publications in English from 1 January 2000 to 30 August 2023, will be eligible for inclusion. Studies will be selected by title and abstract review, followed by a full-text review using inclusion and exclusion criteria. Studies not reporting the procedural costs of surgery will be excluded. Data collected will pertain to procedural costs of AVF and AVG creation. Costs will be adjusted to a common currency using a gross domestic product (GDP) deflator index and conversion rates based on purchasing power parities for GDP. Comparison with NHS reference costs will indicate their reliability for use in future economic analyses in this field.Ethics and disseminationEthical approval is not required for this systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.PROSPERO registration numberCRD42023458779.
Effect of an algorithm for automatic placing of standardised test order sets on low-value appointments and attendance rates at four Spanish teaching hospitals: an interrupted time series analysis
Authors: Álvaro de la Parra Juan Antonio , del Olmo Rodríguez Marta , Caramés Sánchez Cristina , Blanco Ángel , Pfang Bernadette , Mayoralas-Alises Sagrario , Fernandez-Ferro Jose , Calvo Emilio , Gómez Martín Óscar , Fernández Tabera Jesús , Plaza Nohales Carmen , Nieto Carlota , Short Apellaniz Jorge 
Published: January 2024

ObjectiveReducing backlogs for elective care is a priority for healthcare systems. We conducted an interrupted time series analysis demonstrating the effect of an algorithm for placing automatic test order sets prior to first specialist appointment on avoidable follow-up appointments and attendance rates.DesignInterrupted time series analysis.Setting4 academic hospitals from Madrid, Spain.ParticipantsPatients referred from primary care attending 10 033 470 outpatient appointments from 16 clinical specialties during a 6-year period (1 January 2018 to 30 June 2023).InterventionAn algorithm using natural language processing was launched in May 2021. Test order sets developed for 257 presenting complaints from 16 clinical specialties were placed automatically before first specialist appointments to increase rates of diagnosis and initiation of treatment with discharge back to primary care.Primary and secondary outcome measuresPrimary outcomes included rate of diagnosis and discharge to primary care and follow-up to first appointment index. The secondary outcome was trend in ‘did not attend’ rates.ResultsSince May 2021, a total of 1 175 814 automatic test orders have been placed. Significant changes in trend of diagnosis and discharge to primary care at first appointment (p=0.005, 95% CI 0.5 to 2.9) and ‘did not attend’ rates (p=0.006, 95% CI −0.1 to −0.8) and an estimated attributable reduction of 11 306 avoidable follow-up appointments per month were observed.ConclusionAn algorithm for placing automatic standardised test order sets can reduce low-value follow-up appointments by allowing specialists to confirm diagnoses and initiate treatment at first appointment, also leading to early discharge to primary care and a reduction in ‘did not attend’ rates. This initiative points to an improved process for outpatient diagnosis and treatment, delivering healthcare more effectively and efficiently.
The Prehabilitation Radiotherapy Exercise, smoking Habit cessation and Balanced diet Study (PREHABS) protocol to explore the feasibility of embedding behavioural modifications into the clinical pathway for patients undergoing radical radiotherapy for lung cancer
Authors: Burnett Carole , Bestall Janine , Boland Alison , Burke Shaunna , Callister Matthew , Greenwood-Wilson Samuel , Hewison Jenny , Morgan Emma , Murray Rachael L , Pompili Cecilia , Sloss Andy , Williams Gillian , Franks Kevin 
Published: January 2024

Patients with curable non-surgical lung cancer are often current smokers, have co-existing medical comorbidities and are treated with curative radiotherapy. To maximise the benefits of modern radiotherapy, there is an urgent need to optimise the patient’s health to improve survival and quality of life.Methods and analysisThe Yorkshire Cancer Research-funded Prehabilitation Radiotherapy Exercise, smoking Habit cessation and Balanced diet Study (PREHABS) (L426) is a single-centre prospective feasibility study to assess embedding behavioural changes into the radical radiotherapy pathway of patients with lung cancer. Feasibility will be assessed by measuring acceptability, demand and implementation. The duration of the study is 24 months. PREHABS has two workstreams: the intervention study and the theory of change (ToC) study.Intervention study: PREHABS will commence at the R-IDEAL phase 2 trial (exploratory) based on existing evidence and includes support for smoking cessation, increasing activity and dietary well-being. Patients undergoing radical radiotherapy for lung cancer will be recruited from the oncology department at Leeds Teaching Hospitals NHS Trust (LTHT).ToC study: to maximise the acceptability and adherence to the PREHABS, we will use a ToC approach to qualitatively explore the key barriers and enablers of implementing a tailored programme of ‘prehabilitation’. The PREHABS ToC study participants will be recruited from patients with lung cancer undergoing radical radiotherapy and staff from the LTHT oncology department.AnalysisThe primary endpoint analysis will report the number of participants and adherence to the study interventions. Secondary endpoints include continued engagement with study interventions post-treatment. The analysis will focus on descriptive statistics. Thematic analysis of the qualitative data from the ToC study will identify consensus on intervention optimisation and delivery.Ethics and disseminationOn 12 May 2021, the Cambridge East Ethics Committee granted ethical approval (21/EE/0048). The study is registered in the National Institute for Health and Care Research (NIHR) portfolio. The results will be disseminated through publication in peer-reviewed scientific journals and presented at conferences.Trial registration numberNIHR portfolio 48420.
All-cause excess mortality among end-stage renal disease (ESRD) patients during the COVID-19 pandemic in Thailand: a cross-sectional study from a national-level claims database
Authors: Jirapanakorn Sutham , Witthayapipopsakul Woranan , Kusreesakul Khanitta , Lakhotia Divya , Tangcharoensathien Viroj , Suphanchaimat Rapeepong 
Published: January 2024

ObjectivesCOVID-19 infection increased nephrology-related risks and mortality rate among end-stage renal disease (ESRD) patients. The pandemic also disrupted essential healthcare services. We aim to explore all-cause excess mortality among ESRD patients who were members of the Universal Coverage Scheme (UCS), the largest public health insurance scheme in Thailand covering citizens who are not employed in the formal sector, including children and older persons.DesignA cross-sectional study.SettingWe retrieved the dataset from the UCS claims database—electronic health records used for processing healthcare expense claims from medical facilities of all UCS members. This database links mortality outcome to civil registration. We employed the WHO’s excess mortality methodology using pre-pandemic data to estimate expected deaths during the pandemic period (March 2020 to August 2022).ParticipantsThis study included ESRD patients from across Thailand, covered by the UCS.Primary outcome measureExcess deaths are the difference between predicted and reported deaths.ResultsOver a 30-month period of the pandemic, the total number of all-cause excess deaths among ESRD patients was 4966 (male 1284; female 3682). The excess death per 100 000 ESRD patients was 3601 (male 2012; female 4969). The relative excess death was 5.7% of expected deaths (95% CI 1.7%, 10.0%). The excess deaths were highly concentrated among patients aged 65 and older.ConclusionESRD patients are significantly more vulnerable to pandemic-related mortality than the general population. Health systems’ capacity to contain the pandemic at varying virulence and maintain essential health services for ESRD patients might be related to the size of excess deaths at different periods. The observed excess deaths highlight the importance of established strategies to reduce all-cause mortality such as rapid vaccine rollout for ESRD patients and sustaining dialysis and other essential services for older patients and other high-risk groups.