BMJ Open最新文献

{"title":"Development, validation and clinical utility of prognostic models for patients with traumatic brain injury in an Indian setting using machine learning and traditional approaches: a study protocol.","authors":"Vineet Kumar Kamal, Deepak Agrawal, Anil Kumar, Raghavendran Radhakrishnan, Manickam Ponnaiah, Deepana Ramaiya, Arumugam Thiruvalluvan, Aditya Sivaram","doi":"10.1136/bmjopen-2024-096275","DOIUrl":"10.1136/bmjopen-2024-096275","url":null,"abstract":"<p><strong>Introduction: </strong>Traumatic brain injury (TBI) remains a major public health concern in India, with high mortality and long-term disability. Existing prognostic models, mostly developed in high-income countries using traditional methods, lack generalisability to the Indian context and do not use the potential of machine learning or multicentric data. This study primarily aims to develop, compare and validate machine learning methods, including the traditional approach, to predict 30-day mortality and 6-month functional outcomes in patients with moderate or severe TBI. A secondary objective is to describe and compare admission characteristics and outcomes (at discharge, 3 months, 6 months and 1 year) in TBI patients in tertiary care settings using descriptive analyses.</p><p><strong>Methods and analysis: </strong>Data from the neurotrauma registry at Jai Prakash Narayan Apex Trauma Centre, department of neurosurgery, All India Institute of Medical Sciences (AIIMS), New Delhi, including patients admitted between 23 March 2022 and 22 September 2024, will be used for model development and internal validation. For external validation, retrospectively collected data from the same centre (May 2010 to August 2013) and prospectively collected data from AIIMS Patna (1 June 2022 to 30 November 2024) and Rajiv Gandhi Government General Hospital, Madras Medical College (MMC), Chennai (1 May 2022 to 31 October 2024) will be included. Prediction models for 30-day mortality and 6-month functional outcomes will be developed using both machine learning and traditional statistical techniques. Model performance will be evaluated based on discrimination, calibration and clinical utility, with the latter assessed through decision curve analysis (DCA). An online risk calculator will be developed based on the best-performing model to estimate outcome probabilities along with 95% CIs.</p><p><strong>Ethics and dissemination: </strong>The institutional Ethics Review Board of respective data collection centres, that is, AIIMS, New Delhi, AIIMS, Patna, and MMC, Chennai, approved the study. Findings will be published in peer-reviewed journals and disseminated at national and international conferences.</p><p><strong>Discussion: </strong>This study will develop and validate prognostic models using traditional and machine learning methods tailored to the Indian TBI context. Multicentric, prospectively collected data will enhance generalisability, while clinical utility will be evaluated through DCA. Adherence to Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis + Artificial Intelligence (TRIPOD+AI) guidelines ensures methodological transparency. With external validation, these models may improve clinical decision-making, resource planning and patient-family communication in diverse Indian healthcare settings.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e096275"},"PeriodicalIF":2.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496054/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145224909","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"General surgery nurses' views on preoperative spiritual care: a qualitative descriptive study.","authors":"Sevgi Koroglu, Gülgün Durat","doi":"10.1136/bmjopen-2024-097567","DOIUrl":"10.1136/bmjopen-2024-097567","url":null,"abstract":"<p><strong>Objective: </strong>Spiritual care has been shown to assist patients in managing anxiety, fear of death and existential concerns commonly encountered during the preoperative period. Nevertheless, surgical clinics often fail to prioritise this dimension of care. Accordingly, it is essential to gain a thorough understanding of how surgical nurses perceive and implement spiritual care. This study aims to describe the views of nurses working in surgical units regarding the provision of spiritual care in the preoperative phase, the challenges they encounter and the factors that influence this process.</p><p><strong>Design: </strong>A qualitative descriptive study using an inductive thematic analysis approach.</p><p><strong>Setting: </strong>The study was conducted in the general surgery units of a tertiary-level hospital providing healthcare services to a diverse patient population, with the aim of enhancing nurses' views related to spiritual care.</p><p><strong>Participants: </strong>18 nurses with a minimum of 6 months of experience in surgical units were selected using purposive sampling. Head nurses and those on leave during the data collection period were excluded from participation.</p><p><strong>Methods: </strong>Semi-structured interviews were conducted via video conferencing or telephone between September and October 2023, each lasting between 45 and 60 min. Audio-recorded interviews were transcribed verbatim and analysed using Braun and Clarke's six-step thematic analysis method. Data collection ceased at the point of thematic saturation.</p><p><strong>Results: </strong>Three key themes emerged: (1) perceptions of spirituality-nurses viewed spirituality as abstract and subjective, yet recognised religious rituals as visible signs of patients' emotional and spiritual needs. (2) Spiritual care in nursing-though seen as vital to holistic care, spiritual support was limited by privacy concerns and unclear professional boundaries. (3) Dynamics of spiritual care-delivery was shaped by institutional barriers, nurses' personal traits and patients' non-verbal communication of distress.</p><p><strong>Conclusion: </strong>This study revealed the views of general surgical nurses regarding spiritual care. The findings indicate that while nurses acknowledge the importance of spiritual care, they encounter obstacles in its implementation. Consequently, the results suggest that nurses need to be culturally sensitive and receive institutional support-particularly in collectivist and high-context cultures such as Turkey-in order to better understand and meet spiritual needs. Future studies should explore spiritual care models adapted to different cultural contexts.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 10","pages":"e097567"},"PeriodicalIF":2.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496117/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145224959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnostic and therapeutic impact of ultrasound tomography in lower extremity varicose veins: protocol for a paired accuracy study and randomised controlled trial in a tertiary hospital in China.","authors":"Wei Zhang, Feiyin Lan, Sumin Yuan, Jingyi Guo, Yi Li, Ye Pan, Yuanyi Zheng","doi":"10.1136/bmjopen-2025-107744","DOIUrl":"10.1136/bmjopen-2025-107744","url":null,"abstract":"<p><strong>Background: </strong>Chronic venous disease, particularly lower extremity varicose veins (VVs) and incompetent perforating veins (IPVs), is a prevalent condition associated with significant morbidity, including venous ulcers and post-surgical recurrence. Current diagnostic modalities for IPVs-such as digital subtraction angiography, CT venography, magnetic resonance venography and conventional ultrasound-are limited by ionising radiation, operator dependency or inadequate spatial resolution. Ultrasound tomography (UT), an emerging automated 3D imaging technology, offers comparable resolution, wider field of view and reduced operator bias compared with conventional ultrasound. Preliminary studies suggest UT improves IPV detection rates, yet its diagnostic accuracy and clinical utility remain unvalidated in large-scale trials. This study aims to evaluate UT's diagnostic performance and its impact on surgical outcomes in a paired-design and randomised controlled trial (RCT), addressing a critical gap in non-invasive venous assessment.</p><p><strong>Methods: </strong>This study combines a paired diagnostic trial and a prospective, triple-blind RCT. In the paired trial (n=84), patients with VVs (Clinical-Etiological-Anatomical-Pathophysiological C2-C5) receive both conventional ultrasound and UT combined with Doppler examination to compare IPV detection sensitivity against surgical findings. The RCT (n=264) randomises patients to conventional ultrasound group (control group) or conventional ultrasound＋UT group (intervention group). After examination, all patients undergo standardised treatment (radiofrequency ablation with sclerotherapy and selective IPV ligation), with follow-up extending to 5 years. The primary endpoint is 1-year recurrence rates and secondary endpoints, including 3-month, 3-year and 5-year recurrence rates, as well as Venous Clinical Severity Scores, quality of life and Aberdeen Varicose Vein Questionnaire scores.</p><p><strong>Ethics and dissemination: </strong>The study has been approved by the Ethics Committee of Shanghai Sixth People's Hospital (approval number: 2024-132). Written informed consent will be obtained from each participant, and final results will be published in peer-reviewed journals.</p><p><strong>Trial registration number: </strong>The study has been registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn), identifier: ChiCTR2500097289.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 9","pages":"e107744"},"PeriodicalIF":2.3,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigating the use and impact of community Care (Education) and Treatment Reviews (C(E)TRs) in people with intellectual disability and autistic people: protocol for a cohort study using electronic health records.","authors":"Brónagh McCoy, Lauren Bell, Kang Wang, Huajie Jin, Angela Hassiotis, André Strydom, Johnny Downs, Ben Carter, Hitesh Shetty, Robert Stewart, Afia Ali, Rory Sheehan","doi":"10.1136/bmjopen-2025-107889","DOIUrl":"10.1136/bmjopen-2025-107889","url":null,"abstract":"<p><strong>Introduction: </strong>Care (Education) and Treatment Reviews (C(E)TRs) are intended to reduce unnecessary psychiatric hospital admission and length of stay for people with intellectual disability and autistic people. The use and impact of C(E)TRs have not been systematically evaluated since their introduction in England in 2015. The aims of this study are to describe the demographic and clinical profiles of people who receive a community C(E)TR and to investigate their effects on admission, length of hospital stay and clinical and functional change.</p><p><strong>Methods and analysis: </strong>We will conduct a retrospective cohort study using de-identified data from electronic health records derived from two large National Health Service mental health providers in London, England, including one replication site. Data will be extracted using the Clinical Record Interactive Search (CRIS) tool for all people with recorded intellectual disability and/or autism who received mental healthcare from 2015. We will identify community C(E)TR events using keyword searches. Community C(E)TRs will be examined in two ways: (1) In a community cohort, we will capture data in the 6-month periods before and after a community C(E)TR and compare this to a matched control group and (2) In a hospital cohort, we will compare groups who did and did not receive a community C(E)TR prior to their admission. We will describe the socio-demographic and clinical profiles of each group and their health service use, and compare C(E)TR and no C(E)TR groups using t-tests (or a non-parametric equivalent). The primary outcomes are admission to a psychiatric hospital (community cohort) and length of psychiatric hospital admission and clinical change (hospital cohort). Admission to psychiatric hospital will be estimated using propensity score weighting and difference-in-differences methods. Cox's proportional hazard model will be used for length of hospital admission and repeated-measures analysis of variance (ANOVA) will be used to assess clinical change.</p><p><strong>Ethics and dissemination: </strong>Use of CRIS to examine de-identified clinical data for research purposes has overarching ethical approval. This study has been granted local approval by the South London and Maudsley CRIS Oversight Committee. Findings will be disseminated in an open-access peer-reviewed academic publication, at conference presentations, and to service users and carers in accessible formats.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 9","pages":"e107889"},"PeriodicalIF":2.3,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496089/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the correlation between knowledge of multiple sclerosis, medication beliefs, access to care and depression in MS patients: a cross-sectional study.","authors":"Suhaib Muflih, Doaa A Albtoush, Samah F Al-Shatnawi, Osama Y Alshogran, Salma Yasser Abu-Saleh, Ibrahim Alabbadi, Abdel Qader Al Bawab","doi":"10.1136/bmjopen-2025-103299","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-103299","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) is a common autoimmune illness that causes inflammation, demyelination and neurological damage. Symptom relief and immunotherapy are part of the treatment, but several healthcare barriers significantly influence outcomes and quality of life.</p><p><strong>Objectives: </strong>This study aimed to assess different aspects among patients with MS, such as their knowledge of the disease, access to care, medications' beliefs and depression, and to evaluate any correlations between these variables and their impact on the presence of depression.</p><p><strong>Methods: </strong>A cross-sectional study was conducted from May 2024 to October 2024 at Al-Basheer Hospital, King Abdullah University Hospital (KAUH), Princess Basma Teaching Hospital and the Multiple Sclerosis Society of Amman. 200 participants were recruited after confirming consent. Data were collected through face-to-face interviews using validated instruments, covering sociodemographics, beliefs about medicines, knowledge about MS, access to care and levels of depression.</p><p><strong>Results: </strong>This study involved 200 patients with MS with a median age of 36 years, mostly women (70.5%), non-smokers (65%) and insured (77.5%). The majority had high education (58%) but low income (67%), with a mean duration of MS disease of 7.8 years after diagnosis. The majority (79.5%) were unaware of their MS type. Beliefs about medications varied, with 22% accepting, 48.5% ambivalent, 14.5% sceptical and 15% indifferent. Disease knowledge was high, with patients recognising MS as an immune, non-contagious and non-curable disease that affects women more than men. Despite good access to care, a percentage of patients needed to travel long distances for care. Depression affected 58% of participants, and it was influenced by access to care, concerning beliefs, income and education. Other variables such as gender, health insurance, the duration of the disease and the necessity of medications had no significant influence.</p><p><strong>Conclusion: </strong>In conclusion, patients with MS deal with various challenges, such as difficulties in accessing care, associated with psychological factors such as depression. Addressing these barriers by optimising patients' beliefs about medications, enhancing access to care and focusing on the level of knowledge of the disease is crucial for ensuring better and optimal treatment outcomes, as well as decreasing the risk of depression development.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 9","pages":"e103299"},"PeriodicalIF":2.3,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Leveraging emotional intelligence to alleviate mental health: protocol of a cluster randomised controlled trial among parents of children with neurodevelopmental disorders in Bangladesh.","authors":"Marium Salwa, Salim Mahmud Chowdhury, Rumana Rois, Muhammad Kamal Uddin, Shaheen Akhter, Kamrun Nahar, Ashekur Rahman Mullick, Muzharul Mannan, Gopen Kumar Kundu, Kanij Fatema, Md Maruf Haque Khan, M Atiqul Haque","doi":"10.1136/bmjopen-2025-105688","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-105688","url":null,"abstract":"<p><strong>Background: </strong>Parents of children with neurodevelopmental disorders often experience high levels of stress that impact their mental health, yet few interventions focus on their well-being. To address this gap, we developed a mental health intervention based on emotional intelligence (EI), designed for delivery in healthcare settings. We hypothesise that enhancing EI can reduce parenting stress and improve psychological well-being. This study aims to assess the effectiveness, cost-effectiveness and feasibility of this EI-based intervention in Bangladesh.</p><p><strong>Methods and analysis: </strong>This hybrid type 1 effectiveness-implementation study will include a cluster randomised controlled trial, an implementation analysis and an economic evaluation. Eight child development centres will be randomly assigned in a 1:1 ratio to intervention and waitlist control groups. A total of 480 parents (mothers and fathers) will be recruited. The intervention consists of interactive sessions on EI skills, supported by personal diaries and a mobile app. Data will be collected at baseline and 12 weeks postintervention using validated tools to assess EI, parenting stress, psychological well-being and other mental health outcomes. Implementation will be evaluated using mixed methods to assess feasibility, acceptability and fidelity. Cost-effectiveness will be determined through a cost-utility analysis of direct and indirect costs.</p><p><strong>Ethics and dissemination: </strong>Ethical approval was granted by the Institutional Review Board of Bangladesh Medical University (BSMMU/2022/10733). Written informed consent will be obtained at each stage of data collection and intervention. Findings will be disseminated through open-access publications, plain-language summaries, academic conferences, community workshops and policy briefs. Data will be shared in open-access platforms to inform mental health strategies in low-resource settings globally.</p><p><strong>Trial registration number: </strong>NCT06166550.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 9","pages":"e105688"},"PeriodicalIF":2.3,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of actionable quality indicators and an implementation toolkit for perioperative opioid stewardship in colorectal cancer in the UK Yorkshire and Humber region: a modified RAND consensus study.","authors":"Sarah Alderson, Caroline Thomas, Hannah Rossington, Emily Connearn, Simon Howell","doi":"10.1136/bmjopen-2024-092675","DOIUrl":"https://doi.org/10.1136/bmjopen-2024-092675","url":null,"abstract":"<p><strong>Objectives: </strong>There are global concerns about the rise in opioid prescribing. Patients undergoing potentially curative surgery for colorectal cancer (CRC) are at high risk of adverse outcomes from opioid-related complications, including delayed discharge and adjuvant chemotherapy, long-term opioid use and reduced cancer-free survival. We aimed to develop a set of actionable quality indicators for opioid stewardship for patients undergoing CRC surgery, and an implementation toolkit to support professional behaviour change to improve appropriateness of perioperative opioid prescribing.</p><p><strong>Design: </strong>A five-round modified RAND consensus process was conducted in 2021-2024.</p><p><strong>Setting: </strong>14 secondary care trusts across the UK Yorkshire and Humber region.</p><p><strong>Participants: </strong>Consultant anaesthetists and national perioperative opioid stewardship experts (expert panel) and patient and public panel.</p><p><strong>Interventions: </strong>Potential indicators were identified from a literature review, guideline search and expert panel. All potential indicators were rated on relevance and actionability (online survey, expert panel) and importance to patient care (online meeting, patient panel). A hybrid consensus meeting involving a patient representative and the expert panel discussed and rerated the indicators. An online expert survey identified potential barriers to implementation. An actionable toolkit was developed using implementation strategies and supporting resources developed where appropriate.</p><p><strong>Results: </strong>73 potential indicators were identified. All indicators remained in the process through the online survey and patient panel. After the final meeting, four indicators remained: (1) hospital trust presence of an opioid stewardship protocol; (2) inpatient functional post-operative pain assessments; (3) patient education and discharge leaflet; and (4) senior clinician review of 'strong' opioids on discharge (British National Formulary definition). The number of barriers identified ranged from 8 to 22 per indicator. 49 different implementation strategies were identified for the toolkit (range 32-45 per indicator).</p><p><strong>Conclusions: </strong>We identified four actionable quality indicators and developed an implementation toolkit that represents consensus in defining quality of care in opioid stewardship for CRC surgery.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 9","pages":"e092675"},"PeriodicalIF":2.3,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Quadrivalent HPV Vaccine Evaluation Study with Addition of the Nonavalent Vaccine (QUEST-ADVANCE): protocol of an observational cohort study.","authors":"Marit Middeldorp, Robine Donken, Aarthi Nirmal, Brenda Smith, Ana Citlali Marquez, Julie A Bettinger, Marc Brisson, Ann N Burchell, Simon R Dobson, Meena Dawar, Eduardo L Franco, Troy Grennan, Mel Krajden, Marie-Hélène Mayrand, Shelly McNeil, Monika Naus, Chantal Sauvageau, Joel Singer, Laurie W Smith, Gina S Ogilvie, Manish Sadarangani","doi":"10.1136/bmjopen-2025-100560","DOIUrl":"https://doi.org/10.1136/bmjopen-2025-100560","url":null,"abstract":"<p><strong>Introduction: </strong>The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.</p><p><strong>Methods and analysis: </strong>QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1-3 doses of the quadrivalent or nonavalent HPV vaccine at 9-14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9-14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4-5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20-27-year-old females vaccinated at 9-14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16-26 years of age up to 12 years postvaccination.</p><p><strong>Ethics and dissemination: </strong>QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children's and Women's Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 9","pages":"e100560"},"PeriodicalIF":2.3,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of liposomal bupivacaine combined with bupivacaine hydrochloride for transversus thoracic muscle plane block and pectoral nerves block in modified radical mastectomy for breast cancer: protocol for a randomised controlled trial.","authors":"Jie Zhou, Rong Zhou, Su-Hong Tang, Zhichuan Chen, Jianyou Zhang, Dawei Yang","doi":"10.1136/bmjopen-2025-101171","DOIUrl":"10.1136/bmjopen-2025-101171","url":null,"abstract":"<p><strong>Introduction: </strong>The incidence of acute pain subsequent to modified radical mastectomy (MRM) for breast cancer approximates 40%, with more than half of these cases evolving into chronic pain. Currently, the commonly employed analgesic schemes in clinical practice still have inadequacies. Liposomal bupivacaine (LB) is bupivacaine encapsulated in liposomes, and it is reported that its duration of action can extend up to 72 hours. This study will investigate the analgesic efficacy of LB in combination with bupivacaine hydrochloride (BHCl) for transversus thoracic muscle plane (TTP) block and pectoral nerves (PECS) block after MRM for breast cancer.</p><p><strong>Methods and analysis: </strong>In this prospective, randomised, controlled trial, we will enrol 80 female patients aged 30 to 65 years who are scheduled to undergo MRM under general anaesthesia in combination with nerve block. They will be randomly assigned in a 1:1 ratio to the LB+BHCl group (Group A) and the BHCl group (Group B). All patients will undergo ultrasound-guided TTP+PECS block prior to surgery. The primary outcomes are the cumulative pain visual analogue scale (VAS) scores from 6 to 72 hours post-surgery and the quality of recovery, assessed using the QoR-40 score at 72 hours post-surgery. The secondary outcomes include the time to first analgesic rescue, the consumption of analgesic drugs within 72 hours postoperatively, the occurrence of adverse events and the VAS scores at 6 and 12 months postoperatively.</p><p><strong>Ethics and dissemination: </strong>Ethical approval was obtained from the Ethics Committee of the Affiliated Hospital of Yangzhou University (2024 Ke Lun Shen (2024-07-01)). All patients will provide written informed consent. The results of this study will be published in a peer-reviewed journal.</p><p><strong>Trial registration number: </strong>Chinese Clinical Trial Registry (ChiCTR2400089933).</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 9","pages":"e101171"},"PeriodicalIF":2.3,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patients' sense of gain experience and its influencing factors: a cross-sectional study in Foshan, China.","authors":"Ping Xia, Baofang Liang, Qi Zeng, Liang Wang, Lixiang Zhai, Meiying Li, Lieshen Chen, Haofan Yang, Haiyan He, Xingying Xu, Wenjin Gong","doi":"10.1136/bmjopen-2024-097707","DOIUrl":"10.1136/bmjopen-2024-097707","url":null,"abstract":"<p><strong>Objectives: </strong>Patients' sense of gain experience (PSGE) is the comprehensive feeling throughout the treatment process, which is a critical benchmark for evaluating comprehensive medical and health system reform in China. This study aims to assess the current status of PSGE in public hospitals and identify important associated factors, providing evidence-based recommendations for improving healthcare services.</p><p><strong>Design: </strong>This was a cross-sectional study conducted from October to November 2023.</p><p><strong>Setting: </strong>A total of 14 public hospitals in Foshan, Guangdong Province, China.</p><p><strong>Participants: </strong>There were 3223 responses, including 1592 from outpatients and 1631 from inpatients.</p><p><strong>Primary outcome measure: </strong>PSGE was assessed across five domains: time accessibility, service accessibility, cost affordability, patient participation and efficacy predictability. Participants were also asked to provide an overall rating of the PSGE.</p><p><strong>Results: </strong>The overall score for PSGE was 4.47±0.53 (mean±SD), with service accessibility receiving the highest score (4.68±0.50) and affordability the lowest (4.17±0.86). Secondary hospitals scored an overall PSGE of 4.55±0.50, while tertiary hospitals scored 4.42±0.54. Key factors associated with PSGE were overall satisfaction (β=0.164, p<0.001), treatment satisfaction (β=0.187, p<0.001), satisfaction with medical reforms (β=0.149, p<0.001), patient loyalty (β=0.072, p=0.001) and hospital reputation (β=0.223, p<0.001).</p><p><strong>Conclusions: </strong>This study found that patients reported a positive PSGE with service accessibility but reported a less positive PSGE with cost affordability. A tier-based disparity was evident, with secondary hospitals outperforming tertiary hospitals in overall PSGE outcome. Stronger PSGE was positively associated with higher scores in overall satisfaction, treatment satisfaction, satisfaction with medical reforms, patient loyalty and hospital reputation. Demographic and institutional factors, such as hospital level, patient type and household registration, were associated with the PSGE. Efforts can be focused on enhancing clinicians' willingness and competence in discussing treatment costs during clinical encounters. It is essential for policymakers to address disparities in healthcare experiences among patient groups across hospital tiers to advance equitable, patient-centred systems.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"15 9","pages":"e097707"},"PeriodicalIF":2.3,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12496085/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}