bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy of transcutaneous auricular vagus nerve stimulation on radiotherapy-related neuropathic pain in patients with head and neck cancers (RELAX): protocol for a multicentre, randomised, double-blind, sham-controlled trial
Authors: Zuo Xuzheng , Li Yi , Rong Xiaoming , Yang Xinguang , Zhu Yingying , Pan Dong , Li Honghong , Shen Qing-Yu , Tang Yamei 
Published: September 2023

IntroductionRadiotherapy-related neuropathic pain (RRNP) is one of the most distressing complications after radiotherapy for head and neck cancers. Drug therapy is not sufficiently effective and has limitations in terms of dose titration period and side effects. Transcutaneous auricular vagus nerve stimulation (taVNS), which stimulates the auricular branches of the vagus nerve through electrical impulses, has been proven to have analgesic effects in certain diseases. However, it is unknown whether taVNS can relieve RRNP.Methods and analysisThis is a multicentre, randomised, double-blind, parallel, sham-controlled trial. We will include adult patients newly diagnosed with neuropathic pain after radiotherapy for head and neck cancers. One hundred and sixteen individuals will be recruited and randomly assigned in a 1:1 ratio to receive taVNS or sham stimulation. The interventions will last for 7 days, twice daily for 30 min each. The primary efficacy outcome is pain reduction on day 7. The secondary outcomes are changes in functional interference, psychological distress, fatigue, quality of life and serum inflammatory factors. The study may provide a new early intervention strategy for RRNP among patients with head and neck cancers.Ethics and disseminationThis study has been approved by the Medical Research Ethics Committee of Sun Yat-sen University (SYSKY-2022-109-01) and will be conducted in strict accordance with the Declaration of Helsinki. Ethical approvals will be obtained separately for all centres involved in the study. Study results will be published in peer-reviewed academic journals. The database of the study will be available from the corresponding author on reasonable request.Trial registration numberNCT05543239
Effects of the Education and Training Programme for Excellent Physicians in China on medical students’ academic performance: a cross-sectional study
Authors: Shi Zehua , Li Chunqing , Wu Hongbin 
Published: September 2023

ObjectivesTo evaluate the effect of the Education and Training Programme for Excellent Physicians in China on medical students’ academic performance.DesignThis study is a secondary analysis of data from a cross-sectional survey of China Medical Student Survey (CMSS, 2021) and administrative data of the first-stage Medical Licensing Examination—the Standardised Competence Test for Clinical Medicine Undergraduates (the Test, 2021). CMSS used a stratified sampling process, with all undergraduate clinical medicine students participating voluntarily.SettingThis programme is implemented at the class level within reformed medical schools, targeting undergraduate students in 5-year clinical medicine in China. The reformed medical schools run pilot classes and traditional classes simultaneously. The analytic sample was a total of 12 243 observations from pilot and traditional classes in 34 medical schools which implemented the reform across 19 provinces in China.MethodsThis study applied the propensity score matching method to estimate the effect of the reform by comparing the scores of the Test between pilot and traditional classes within the same medical schools. We further explored the potential mechanisms driving the effect from two facets of the Test: medical knowledge modules and cognitive levels.ResultsPilot classes outperformed traditional classes by 0.104 SD on the Test (95% CI 0.037 to 0.171). Improvements were seen in basic medicine and clinical medicine modules (0.109 and 0.101 SD, respectively) and cognitive levels of memorisation and application (0.116 and 0.111 SD, respectively).ConclusionThese results suggest that the reform had a significant positive impact on medical students’ academic performance. Based on the components of this reform and the potential mechanism analysis of the two facets, this study indicates that curriculum reform in integrated learning and teaching methods reform in the adoption of problem-based learning may have been the possible drivers of this positive impact.
Occurrence of sensitive topics during ward round: an ancillary analysis of the BEDSIDE-OUTSIDE trial
Authors: Gross Sebastian , Becker Christoph , Beck Katharina , Memma Valentina , Gaab Jens , Schütz Philipp , Leuppi Jörg D , Schaefert Rainer , Langewitz Wolf , Trendelenburg Marten , Breidthardt Tobias , Eckstein Jens , Osthoff Michael , Bassetti Stefano , Hunziker Sabina 
Published: September 2023

ObjectiveDiscussing sensitive topics (eg, medical uncertainty, social issues, non-adherence) during ward rounds is challenging and may negatively impact patient satisfaction with the healthcare they are receiving. In the previous multicentre randomised BEDSIDE-OUTSIDE trial focusing on communication during ward rounds, we investigated the interplay between sensitive topics and low reported satisfaction with care.DesignPre-planned secondary analysis of a randomised controlled trial. For this analysis data of the original trial was pooled across intervention groups.SettingThree Swiss teaching hospitals.ParticipantsAdult patients hospitalised for medical care.InterventionsWe analysed predefined sensitive health topics and specific elements of communication from audiotapes recorded during ward rounds, for both patients dealing with and without sensitive topics.Primary and secondary outcome measuresThe primary endpoint was overall patient satisfaction with care; measured on a Visual Analogue Scale from 0 to 100. Secondary endpoints included duration of ward rounds and further satisfaction outcomes.ResultsOf the 919 included patients, 474 had at least one sensitive topic including medical uncertainty (n=251), psychiatric comorbidities (n=161), tumour diagnosis (n=137) and social issues (n=125). Compared with patients without sensitive topics, patients with sensitive topics reported lower satisfaction with care (mean (SD), 87.7 (±14.6) vs 90.2 (±12.1), adjusted difference −2.5 (95% CI −4.28 to −0.72), p=0.006. Among patients with sensitive topics, risk factors for low satisfaction included several parameters concerning patient–physician interaction such as disagreements during ward rounds (mean (SD), 14/212 (6.6%) vs 41/254 (16.1%), adjusted OR 2.78 (95% CI 1.47 to 5.27), p=0.002).ConclusionsA large proportion of medical inpatients must deal with sensitive health topics. This is associated with lower satisfaction with care, particularly if the patient perceives the interaction with doctors during ward rounds as unsatisfactory. Educating physicians on specific communication techniques may help improve care for these patients.Trial registration numberNCT03210987.
Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE): study protocol for a partially randomised patient preference study
Authors: Philipps Lara , Foster Stephanie , Gardiner Deborah , Gath Jacqui , Gillman Alexa , Haviland Joanne , Hill Elizabeth , King Diana , Manning Georgina , Stiles Morgaine , Hall Emma , Lewis Rebecca 
Published: September 2023

IntroductionPatient-reported outcomes (PRO) are currently collected from trial participants using paper questionnaires by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU). Streamlining PRO collection using electronic questionnaires (ePRO) may improve data collection and patient experience. Here, we outline our protocol for a Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE), which investigates the acceptability of ePRO in oncology clinical trials.Methods and analysisSPRUCE was developed alongside patient and public contributors. SPRUCE runs in multiple host trials with a partially randomised patient preference design, allowing participants to be randomised or choose their preference of electronic or paper questionnaires. Questionnaires are scheduled in accordance with host trial follow-up. The primary objective will assess differences in return rates (compliance) between ePRO and paper PROs at the first timepoint post-host trial intervention in the randomised group. Paper PRO compliance is expected to be 90%. 244 randomised participants are required to exclude ≤80% compliance rates with ePRO (10% non-inferiority margin, with 80% power and one-sided alpha=0.05). SPRUCE aims to assess acceptability of ePRO in oncology clinical trials, establish whether ePRO is acceptable to ICR-CTSU trial participants and can capture complete PRO data, consistent with paper PROs.Ethics and disseminationThe SPRUCE protocol (ICR-CTSU/2021/10074) was approved by the Coventry and Warwick Central Research Ethics Committee (21/WM/0223) on 21 October 2021. Results will be disseminated via presentations, publications and lay summaries. No participant identifiable data will be included.Trial registrationSWAT169.
Prevalence of psychological distress and associated factors among Omani women diagnosed with breast cancer: a single-centre, cross-sectional study
Authors: Al-Fahdi Amal , Chan Moon Fai , Al-Siyabi Wedad , Al-Yafai Entesar , Al-Khatri Mariya , Al-Azri Mohammed 
Published: September 2023

ObjectivesTo determine the prevalence of psychological distress (ie, anxiety and depressive symptoms) among Omani women diagnosed with breast cancer (BC) and to investigate associations with socio-demographic factors.DesignA cross-sectional, self-administered survey was conducted between September 2021 and June 2022.SettingSultan Qaboos Comprehensive Cancer Care and Research Centre (Muscat, Oman).ParticipantsAdult Omani women diagnosed with BC during the study period.Outcome measuresData regarding anxiety and depressive symptoms were collected using an Arabic version of the Hospital Anxiety and Depression Scale (HADS). Socio-demographic and clinical information was obtained from the participants and their hospital medical records.Results190 Omani women diagnosed with BC were invited to participate in the study, of whom 171 participated (response rate: 90.0%). The mean age was 50.3±10.9 years. 52.3% of participants had been diagnosed with BC at stages III or IV and 28.9% had metastasis. 29 women (17.0%) exhibited depressive symptoms (HADS-D score: ≥8), while 37 (21.6%) exhibited anxiety symptoms (HADS-A score: ≥8). Women with anxiety symptoms were almost 15-times more likely to have depressive symptoms than those without anxiety symptoms (OR: 14.87, p<0.001). Younger women were less likely to exhibit depressive symptoms than older women (≤39 vs ≥60 years, p=0.050; 40–59 vs ≥60 years, p=0.005). Women at the school/diploma education level were less likely to have depressive symptoms than those at college/university level (OR: 0.19, p=0.017).ConclusionsMore than half of the women surveyed had been diagnosed at an advanced stage, with up to 21.6% presenting with symptoms of anxiety and depression. Healthcare professionals in Oman should consider additional screening for anxiety and depressive symptoms in this group and encourage patients with BC to disclose emotional information during consultations, particularly for those aged ≥60 years.
Protocol for development and validation of a prediction model for post-induction hypotension in elderly patients undergoing non-cardiac surgery: a prospective cohort study
Authors: Hu Jing-Hui , Xu Ning , Bian Zhen , Shi Hai-Jing , Ji Fu-Hai , Peng Ke 
Published: September 2023

IntroductionPost-induction hypotension (PIH) is a common event in elderly surgical patients and is associated with increased postoperative morbidity and mortality. This study aims to develop and validate a PIH prediction model for elderly patients undergoing elective non-cardiac surgery to identify potential PIH in advance and help to take preventive measures.Methods and analysisA total of 938 elderly surgical patients (n=657 for development and internal validation, n=281 for temporal validation) will be continuously recruited at The First Affiliated Hospital of Soochow University in Suzhou, China. The main outcome is PIH during the first 15 min after anaesthesia induction or before skin incision (whichever occurs first). We select candidate predictors based on published literature, professional knowledge and clinical expertise. For model development, we will use the least absolute shrinkage and selection operator regression analysis and multivariable logistic regression. For internal validation, we will apply the bootstrapping technique. After model development and internal validation, temporal validation will be conducted in patients recruited in another time period. We will use the discrimination, calibration and max-rescaled Brier score in the temporal validation cohort. Furthermore, the clinical utility of the prediction model will be assessed using the decision curve analysis, and the results will be presented in a nomogram and a web-based risk calculator.Ethics and disseminationEthical approval was obtained from the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2023-012). This PIH risk prediction model will be published in a peer-reviewed journal.Trial registration numberChiCTR2200066201.
Learning machines or the key to care: a qualitative study exploring the impact of the hidden curriculum on medical students’ longitudinal experiences in primary care
Authors: Brown Megan E L , Parekh Ravi , Collin Victoria , Sivam Vanessa , Ahuja Neha , Kumar Sonia 
Published: September 2023

ObjectiveLongitudinal learning often faces implementation challenges within UK medical schools. Some have suggested that the hidden curriculum may be implicated, but there is little evidence regarding how the hidden curriculum influences student experiences of, and engagement with longitudinal learning. Given this, our objective was to explore the impact of the hidden curriculum on student experiences of a longitudinal curriculum based in primary care at a research-intensive medical school.DesignWe conducted a longitudinal qualitative study. Students participated in three serial, in-depth semistructured interviews. We conducted a longitudinal thematic analysis.SettingOne research-intensive medical school based in the UK. Data collection occurred in 2021–2022.Participants12 penultimate year medical students taking part in a longitudinal primary care placement for 1 day a week over the course of one academic year.ResultsWe constructed four themes capturing insights on how hidden curricula influenced students’ experiences: (1) A culture which stresses assessment influences student engagement with longitudinal learning; (2) Longitudinal relationships can challenge the hidden curriculum; (3) Support and continuity within primary care improves skills and can influence belonging and (4) Logistical issues influence engagement with longitudinal learning.ConclusionsThe hidden curriculum, particularly related to assessment, plays a large role in student perceptions of educational value and subsequent engagement with curricula. In a research-intensive institution, longitudinal learning, particularly within primary care, was perceived as at odds with what was important for assessments. Where longitudinal relationships were successfully established, students became more aware of the benefits of person-centred practice. For primary care longitudinal education to succeed in more research-intensive institutions, there must first be advocacy for greater representation of primary care and person-centred values within organisational structures to ensure meaningful curricular alignment.
Exploring experiences of times without care and encounters in dementia: protocol for a living and adaptive evidence map
Authors: Hirt Julian , Adlbrecht Laura , Maurer Carola , Beer Thomas 
Published: September 2023

IntroductionIndividuals with dementia spend most of the day without care, without encounters, and usually without activity. Although this has been proven in studies, there is a knowledge gap on how individuals with dementia experience these periods of time. Such knowledge would be highly relevant for health professionals and relatives to develop adequate strategies for dealing with these periods of time. TheFreiZeitstudy aims to reconstruct periods of time without care and encounters from the perspective of individuals with dementia and formal and informal carers. The specific objective of this review is to provide a continuously updated overview of the topical evidence that may be used to guide data synthesis and interpretation within theFreiZeitstudy.Methods and analysisWe conduct a living evidence map, based on a comprehensive systematic literature search in MEDLINE/PubMed, CINAHL, PsycINFO/Ovid and Web of Science Core Collection, citation-based searches and web searches. We include studies on times without care and encounters of individuals with dementia from the perspective of individuals with dementia themselves and formal or informal caregivers of any observational study design that were conducted in the institutional and domestic long-term care setting and published as journal article in English, French or German language without any restriction of the publication year. One reviewer screens titles, abstracts and full texts and extracts data. Key characteristics and results of the included studies are charted in a tabular format. The searches will be run and continuously updated throughout the duration of the overarchingFreiZeitstudy (every 6 months for 2 years from 2023 to 2025).Ethics and disseminationEthics approval is not required for this evidence map. We disseminate our findings via journal articles and conference proceedings as well as other formats.Registration detailsThis review protocol is uploaded on Open Science Framework (OSF; DOI 10.17605/OSF.IO/GDYZ9).
Psychosocial patient perspectives following major lower-limb amputation due to vascular aetiology: a protocol for a systematic meta-aggregation study
Authors: Laursen Sisse Heiden , Rasmussen Helle Lund , Seidelin Dinnie , Pedersen Peter Hørslev , Chræmmer Tanja Mortensen 
Published: September 2023

IntroductionPersistent psychosocial problems in people with lower-limb amputation due to vascular aetiology indicate a great need for long-lasting holistic rehabilitation. An in-depth understanding of the psychosocial problems is essential for the guidance of health professionals in meeting and normalising patients’ experiences and emotions. Furthermore, identifying the psychological problems may help develop effective rehabilitation and counselling programmes. This meta-aggregation study aims to explore the psychosocial perspectives of individuals who have undergone a major lower-limb amputation due to vascular aetiology during the post-discharge rehabilitation phase.Methods and analysisA systematic meta-aggregation study will be performed to identify full-text, peer-reviewed journal articles reporting on patients’ psychosocial perspectives on major lower-limb amputation due to vascular aetiology from post-discharge to several years afterward. The databases Embase, CINAHL Ultimate, APA PsycInfo, PubMed and Scopus will be searched with no limitations regarding the publication year. Studies that satisfy the eligibility criteria will be critically appraised using an acknowledged checklist and synthesised using the Joanna Briggs Institute three-phase approach for the synthesis of meta-aggregation studies. The GRADE-CERQual (Grading of Recommendations Assessment, Development and Evaluation- Confidence in Evidence from Reviews of Qualitative research) tool will be used to determine the level of confidence in the qualitative evidence, and the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analysis) reporting guidelines will be followed throughout the review process.Ethics and disseminationEthical approval is not required for the study, as the review is built on pre-existing available data in the literature. Findings from the review will be disseminated through publication in a peer-review journal.PROSPERO registration numberCRD42022377114.
Reduced long-term mortality after successful resective epilepsy surgery: a population-based study
Authors: Granthon Cecilia , Tranberg Anna Edelvik , Malmgren Kristina , Strandberg Maria Compagno , Kumlien Eva , Redfors Petra 
Published: September 2023

BackgroundWe investigated all-cause and epilepsy-related mortality in patients operated with resective epilepsy surgery and in non-operated patients with drug-resistant epilepsy. Our hypothesis was that patients who proceed to surgery have lower mortality over time compared with non-operated patients.MethodData from 1329 adults and children from the Swedish National Epilepsy Surgery Register and 666 patients with drug-resistant epilepsy who had undergone presurgical work-up but not been operated were analysed. The operated patients had follow-ups between 2 and 20 years. We used the Swedish Cause of Death Register to identify deaths. Autopsy reports were collected for patients with suspected sudden unexpected death in epilepsy (SUDEP). Kaplan-Meier and Cox regression analyses were performed to identify predictors for mortality and SUDEP.ResultsSUDEP accounted for 30% of all deaths. Surgery was associated with lower all-cause mortality (HR 0.7, 95% CI 0.5 to 0.9), also when adjusted for age, sex and tonic–clonic seizures at inclusion. The benefit of surgery seemed to persist and possibly even increase after 15 years of follow-up. Risk factors of mortality for operated patients were persisting seizures and living alone. Of the operated patients, 37% had seizures, and these had a higher risk of mortality (HR 2.1, 95% CI 1.4 to 3.0) and SUDEP (HR 3.5, 95% CI 1.7 to 7.3) compared with patients with seizure freedom at last follow-up.ConclusionsIn this large population-based epilepsy surgery cohort, operated patients had a lower all-cause mortality compared with non-operated patients with drug-resistant epilepsy. Seizure freedom was the most important beneficial factor for both all-cause mortality and SUDEP among operated patients.