BMJ Open最新文献

{"title":"Machine learning algorithms for prediction of measles one vaccination dropout among 12-23 months children in Ethiopia.","authors":"Meron Asmamaw Alemayehu","doi":"10.1136/bmjopen-2024-089764","DOIUrl":"10.1136/bmjopen-2024-089764","url":null,"abstract":"<p><strong>Introduction: </strong>Despite the availability of a safe and effective measles vaccine in Ethiopia, the country has experienced recurrent and significant measles outbreaks, with a nearly fivefold increase in confirmed cases from 2021 to 2023. The WHO has identified being unvaccinated against measles as a major factor driving this resurgence of cases and deaths. Consequently, this study aimed to apply robust machine learning algorithms to predict the key factors contributing to measles vaccination dropout.</p><p><strong>Methods: </strong>This study utilised data from the 2016 Ethiopian Demographic and Health Survey to evaluate measles vaccination dropout. Eight supervised machine learning algorithms were implemented: eXtreme Gradient Boosting (XGBoost), Random Forest, Gradient Boosting, Support Vector Machine, Decision Tree, Naïve Bayes, K-Nearest Neighbours and Logistic Regression. Data preprocessing and model development were performed using R language V.4.2.1. The predictive models were evaluated using accuracy, precision, recall, F1-score and area under the curve (AUC). Unlike previous studies, this research utilised Shapley values to interpret individual predictions made by the top-performing machine learning model.</p><p><strong>Results: </strong>The XGBoost algorithm surpassed all classifiers in predicting measles vaccination dropout (Accuracy and AUC values of 73.9% and 0.813, respectively). The Shapley Beeswarm plot displayed how each feature influenced the best model's predictions. The model predicted that the younger mother's age, religion-Jehovah/Adventist, husband with no and mother with primary education, unemployment of the mother, residence in the Oromia and Somali regions, large family size and older paternal age have a strong positive impact on the measles vaccination dropout.</p><p><strong>Conclusion: </strong>The measles dropout rate in the country exceeded the recommended threshold of <10%. To tackle this issue, targeted interventions are crucial. Public awareness campaigns, regular health education and partnerships with religious institutions and health extension workers should be implemented, particularly in the identified underprivileged regions. These measures can help reduce measles vaccination dropout rates and enhance overall coverage.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e089764"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614757","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":"Clinical impact of customised positive airway pressure (PAP) therapy interfaces versus usual care in the treatment of patients with sleep-disordered breathing (3DPiPPIn): a randomised controlled trial protocol.","authors":"Stephanie K Mansell, Swapna Mandal, Deborah Ridout, Oliver Olsen, Francesca Gowing, Cherry Kilbride, Stephen T Hilton, Eleanor Main, Silvia Schievano","doi":"10.1136/bmjopen-2024-087234","DOIUrl":"10.1136/bmjopen-2024-087234","url":null,"abstract":"<p><strong>Introduction: </strong>Sleep-disordered breathing affects 1.6 million people in the UK. The recognised treatment is positive airway pressure (PAP) therapy, delivered via a generic conventional interface (mask). PAP therapy improves morbidity, mortality and quality of life, but treatment effectiveness depends on interface fit and tolerance. Interface side effects include pressure ulcers, skin reactions and interface leak. Three-dimensional (3D) printing is an innovative technology that can produce customised interfaces.</p><p><strong>Aims: </strong>The primary aim is to assess the impact of customised versus conventional interfaces on residual Apnoea Hypopnea Index at 6 months.</p><p><strong>Methods and analysis: </strong>This is a randomised control trial via block randomisation, minimised by age >65 and ethnicity, using a computerised random number generator. Patients with sleep-disordered breathing under the care of the Royal Free London NHS Foundation Trust will be recruited. Patients new to therapy will be randomised to customised interface or conventional interface for 6 months. A sample size of 160 is required for 80% power with a significance of 5%, accounting for a 20% dropout rate. Descriptive statistics will report demographics. The primary and secondary outcomes will be compared using linear regression adjusted for baseline score.</p><p><strong>Ethics and dissemination: </strong>This protocol has been approved by the Hampshire B Research Ethics Committee (REC reference: 22/SC/0405). Results will be disseminated to healthcare professionals and patients through conferences, open-access journals, newsletters, a study webpage, infographics, animations, social media and healthcare awards.</p><p><strong>Isrctn registration number: </strong>74082423.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e087234"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614700","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 goal-directed mobilisation versus standard care on physical functioning among medical inpatients: the GoMob-in randomised, controlled trial.","authors":"Fabian D Liechti, Jeannelle Heinzmann, Nina A Schmutz, Michael L Rossen, Jean-Benoît Rossel, Andreas Limacher, Joachim M Schmidt Leuenberger, Christine Baumgartner, Maria M Wertli, Drahomir Aujesky, Martin Verra, Carole E Aubert","doi":"10.1136/bmjopen-2024-086921","DOIUrl":"10.1136/bmjopen-2024-086921","url":null,"abstract":"<p><strong>Objective: </strong>To assess the effect of goal-directed mobilisation (GDM) on physical functioning in medical inpatients.</p><p><strong>Design: </strong>Randomised, controlled, single-centre, parallel, superiority trial with a 3-month follow-up and blinded outcome assessment.</p><p><strong>Setting: </strong>General internal medicine wards of a Swiss tertiary acute hospital, September 2021 to April 2023.</p><p><strong>Participants: </strong>Adults with expected hospitalisation of ≥5 days, physiotherapy prescription and ability to follow study procedures.</p><p><strong>Intervention: </strong>GDM during hospitalisation, which includes personal goal setting and a short session of patient education through a physiotherapist (experimental group), versus standard care (control group).</p><p><strong>Outcome measures: </strong>The primary outcome was the change in physical activity between baseline and day 5 (De Morton Mobility Index (DEMMI)). Secondary outcomes included in-hospital accelerometer-measured mobilisation time; in-hospital falls; delirium; length of stay; change in independence in activities of daily living, concerns of falling and quality of life; falls, readmission and mortality within 3 months.</p><p><strong>Results: </strong>The study was completed by 123 of 162 (76%) patients enrolled, with the primary outcome collected at day 5 in 126 (78%) participants. DEMMI Score improved by 8.2 (SD 15.1) points in the control group and 9.4 (SD 14.2) in the intervention group, with a mean difference of 0.3 (adjusted for the stratification factors age and initial DEMMI Score, 95% CI -4.1 to 4.8, p=0.88). We did not observe a statistically significant difference in effects of the interventions on any secondary outcome.</p><p><strong>Conclusions: </strong>The patient's physical functioning improved during hospitalisation, but the improvement was similar for GDM and standard of care. Improving physical activity during an acute medical hospitalisation remains challenging. Future interventions should target additional barriers that can be implemented without augmenting resources.</p><p><strong>Trial registration number: </strong>NCT04760392.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e086921"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614873","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":"Descriptive qualitative study of breathlessness and its management of Turkish individuals with self-reported heart failure.","authors":"Muzeyyen Seckin, Mark C Petrie, Simon Stewart, Bridget Margaret Johnston","doi":"10.1136/bmjopen-2024-088335","DOIUrl":"10.1136/bmjopen-2024-088335","url":null,"abstract":"<p><strong>Aims: </strong>To explore the experiences of individuals with heart failure, with a specific focus on elucidating the full spectrum of symptoms experienced and their subjective descriptions of breathlessness and self-management strategies regarding socio-cultural-behavioural context.</p><p><strong>Design: </strong>Qualitative descriptive study underpinned by critical realism and situation-specific theory of heart failure self-care.</p><p><strong>Setting: </strong>Participants from various settings (hospitals and community) in Southeastern Türkiye.</p><p><strong>Participants: </strong>Adults reporting heart failure and breathlessness.</p><p><strong>Methods: </strong>Semi-structured interviews were carried out with 20 individuals (11 women and 9 men). Data were audio-recorded and transcribed. Participants were asked to describe their symptoms, experiences with breathlessness, self-management strategies and health needs from their perspectives. The interview data were analysed using reflexive thematic analysis.</p><p><strong>Results: </strong>There were a range (31 physical and 7 psycho-social behavioural) of symptoms experienced by participants. This included fatigue, difficulty sleeping, pain (not including chest pain) and fear about death and dying. Based on reflexive thematic analysis of semi-structured interviews, six main themes were identified. First two themes (knowledge and misconception, and experience of breathlessness) were related to breathlessness experience and knowledge. The third theme (culture and religious consideration) highlighted the importance of cultural and religious perspectives in breathlessness regarding Turkish socio-cultural-behavioural context. Themes four (breathlessness self-management/physical) and five (breathlessness self-management/psychological) were identified as self-management strategies for breathlessness. The need for improved health behaviours (improved health behaviours) was also identified.</p><p><strong>Conclusion: </strong>Breathlessness and self-management strategies are affected by individual perspectives in relation to their socio-cultural-behavioural context. Understanding individuals' unique breathlessness experiences regarding their socio-cultural-behavioural context assists in the identification of possible individualised-care strategies to improve their life and care quality in heart failure. We recommend creating a person-centred symptom assessment strategy with reference to culture or transculture guided by nurses. This will help to understand individuals' unique symptom profiles and tailor responses to their needs.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e088335"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614812","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":"Exploring the lived experiences of deep vein thrombosis patients in Lahore, Pakistan: a qualitative phenomenological study on healthcare challenges, resilience and social support.","authors":"Ahtasham Zameer, Javeria Saleem, Naveed Yazdani, Rabia Fatima, Ruhma Binte Shahzad, Afia Zafar, Muhammad Ishaq, Muhammad Salman Butt","doi":"10.1136/bmjopen-2023-081741","DOIUrl":"10.1136/bmjopen-2023-081741","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to explore and describe the lived psychological and emotional experiences of sufferers of deep vein thrombosis (DVT) and to narrate the effect of those experiences on their daily lives.</p><p><strong>Design, setting and participants: </strong>For data collection, a phenomenological qualitative design was used using semistructured, in-depth interviews of patients with DVT aged 18-70 years. Data were transcribed and analysed using the interpretative inductive approach to identify emergent themes.</p><p><strong>Results: </strong>The five major themes emerged were as follows: (1) experiences and challenges of managing pain and physical limitations in patients; (2) the high out-of-pocket cost of care as a financial challenge to access healthcare; (3) the struggle of patients with social isolation and lack of emotional support; (4) resilience and self-reliance in the face of illness for navigation through life and (5) inadequate healthcare system and challenges in accessing proper treatment.</p><p><strong>Conclusions: </strong>Conclusively, chronic disease such as, DVT, negatively impacts the life of its sufferers in terms of their physical health, lifestyle and psychological behaviour. There is a high need to introduce rehabilitative services as a regular part of healthcare system, so that self-management strategies are promoted and the burden of long-term psychological, emotional and behaviour problems can be avoided.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e081741"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614933","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":"Efficacy and safety of remimazolam tosylate for patients undergoing off-pump coronary artery bypass grafting: a study protocol for a non-inferiority randomised controlled trial in China.","authors":"Dan Wang, Min Cui, Xue Wu, Min Niu, Tianhao Yu, Yuzhu Zhang, Yifeng Yue, Qingting Wang, Boxuan Xu, Nianhai Feng, Jiguo Si","doi":"10.1136/bmjopen-2024-085519","DOIUrl":"10.1136/bmjopen-2024-085519","url":null,"abstract":"<p><strong>Introduction: </strong>Maintaining haemodynamic stability is crucial but challenging during the induction and maintenance of general anaesthesia (GA) in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Remimazolam tosylate is a novel ultra-short-acting benzodiazepine with minimal cardiovascular depression. Currently, non-inferior studies comparing the haemodynamic changes induced by remimazolam and etomidate are limited. This study aims to assess the efficacy and safety of remimazolam tosylate for the induction and maintenance of GA in patients undergoing OPCABG.</p><p><strong>Method and analysis: </strong>This two-armed non-inferiority randomised controlled trial will include 88 patients aged 18-75 years who are scheduled for OPCABG. Patients will be randomly assigned in a 1:1 ratio to receive either remimazolam tosylate or etomidate and propofol for anaesthesia induction and maintenance. The primary outcome will be the fluctuation of mean artery pressure during anaesthesia induction. Secondary outcomes will include adverse events, adverse drug reactions, the cumulative dosage of vasoactive drugs, vital signs and bispectral index values at different time points, lengths of postoperative mechanical ventilation and tracheal intubation, lengths of intensive care unit stay and hospital stay and hospital mortality. Analyses will be conducted using both the intention-to-treat approach and the per-protocol approach.</p><p><strong>Ethics and dissemination: </strong>This study was approved by the Ethics Committee of Zibo Central Hospital (No. 2024001). The trial results will be submitted to an international peer-reviewed journal.</p><p><strong>Trial registration number: </strong>ChiCTR.gov.cn: ChiCTR2400079615.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e085519"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614865","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":"Coping with cancer pain: a qualitative study to explore pain perception and self-coping strategies of patients with cancer in Sri Lanka.","authors":"N P Edirisinghe, P T R Makuloluwa, Thamara Amarasekara, C S E Goonewardena","doi":"10.1136/bmjopen-2024-085510","DOIUrl":"10.1136/bmjopen-2024-085510","url":null,"abstract":"<p><p>Pain is one of the most debilitating symptoms of cancer, substantially diminishing one's quality of life. The level of pain experienced is eventually determined by the pain coping strategies adopted by patients individually. The awareness of the 'self-coping methods of pain' of individual patients would be beneficial for the multidisciplinary pain team to consider such methods when planning future interventions to manage pain.</p><p><strong>Objectives: </strong>This study explores the pain perception and coping strategies used by patients with cancer pain in Sri Lanka.</p><p><strong>Design: </strong>A descriptive qualitative study.</p><p><strong>Setting: </strong>Pain management unit, Apeksha Hospital, Maharagama, Sri Lanka.</p><p><strong>Participants: </strong>The study was conducted among purposively selected patients with cancer and registered at the pain management unit. 21 semi-structured interviews were conducted until data saturation. Data were analysed using Graneheim and Lundman's content analysis method.</p><p><strong>Results: </strong>Most participants were between 51 and 60 years old and identified as Sinhalese Buddhists. The study's findings revealed two subthemes under 'Understanding pain', namely 'Physical and emotional impact' and 'Cultural and spiritual interpretations', and five subthemes under 'Coping strategies for living with pain', namely 'Medication and self-control', 'Seeking spiritual support', 'Receiving social support', 'Exploring alternative treatments' and 'Adapting daily life'.</p><p><strong>Conclusion: </strong>Coping strategies were adopted especially in achieving essential life aspirations and participating in preferred activities. Goals or activities were often adjusted to fall within their health limits. Acceptance and progress in life were considered more important than pain control. We recommend giving due consideration to the 'self-coping strategies' of individual patients in designing interventions to mitigate cancer pain.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e085510"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614714","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":"Efficacy and safety of electroacupuncture for metabolic dysfunction-associated fatty liver disease: a study protocol for a multicentre, randomised, sham acupuncture-controlled, patient-blinded clinical trial.","authors":"Jingjie Zhao, Xinyu Zhao, Qianyi Wang, Hao Ren, D I Cao, Xiangdong Hu, Lei Yang, Wei Chen, Jing-Wen Yang, Hong You","doi":"10.1136/bmjopen-2024-084768","DOIUrl":"10.1136/bmjopen-2024-084768","url":null,"abstract":"<p><strong>Background: </strong>Metabolic dysfunction-associated fatty liver disease (MAFLD) is the most common chronic liver disease in the world and carries an increased risk of liver-related events, but no approved medicine. Electroacupuncture has been used to treat non-alcoholic fatty liver disease, but its effect was uncertain because of the poor quality of prior studies. We designed this trial to evaluate the efficacy and safety of electroacupuncture for MAFLD.</p><p><strong>Methods/design: </strong>This is a multicentre, randomised, sham acupuncture-controlled, patient-blinded clinical trial. Participants will take part in a total of 20 weeks of study, containing three phases: a 4-week run-in period, 12-week treatment (36 sessions of acupuncture) and 4-week follow-up. A total of 144 eligible patients diagnosed with MAFLD will be randomly allocated to the electroacupuncture or sham acupuncture groups. The primary outcome is the percentage of relative liver fat reduction on the MRI proton density fat fraction from baseline to 12 weeks. Secondary outcomes include magnetic resonance elastography, liver and metabolic biomarkers, anthropometry parameters, blinding assessment, credibility and expectancy, and adverse events. All patients who receive randomisation will be included in the intent-to-treat analysis.</p><p><strong>Discussion: </strong>The finding of this trial will provide evidence of the efficacy and safety of electroacupuncture for the treatment of MAFLD. The results of this study will be published in peer-reviewed journals.</p><p><strong>Trial registration number: </strong>www.chictr.org.cn, ChiCTR2200060353. It was registered on 29 May 2022.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e084768"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614920","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 acupuncture on quality of life in atrial fibrillation: study protocol for a randomised controlled trial.","authors":"Meng-Tong Li, Guang-Xia Shi, Yu Wang, Bang-Qi Wu, Zhao-Hui Zhang, Qing-Yan Zhao, Xian Wang, Xue-Bin Li, Wei-Hua Guo, Li He, Hao-Lin Zhang, Lin Wang, Xue-Wen Wang, Jian-Feng Tu, Hai-Ying Wang, Shi-Yan Yan, Ying Lin, He-Wen Li, Cun-Zhi Liu, Li-Qiong Wang","doi":"10.1136/bmjopen-2024-087460","DOIUrl":"10.1136/bmjopen-2024-087460","url":null,"abstract":"<p><strong>Introduction: </strong>Atrial fibrillation (AF) is the prevalent cardiac arrhythmia and can significantly impair the quality of life (QoL). Although catheter ablation (CA) is an established treatment for AF,post-procedural complications or perceived inadequate control of AF may diminish the QoL for some patients, potentially even to levels lower than pre-procedure. Preliminary findings from our previous pilot trial indicate that acupuncture may positively influence QoL in AF patients post-CA. This study aims to increase the sample size to evaluate the efficacy of acupuncture as an adjunctive treatment to conventional medical therapy in improving QoL of patients with AF after CA.</p><p><strong>Methods and design: </strong>This multicentre randomised clinical trial will be conducted in China. A total of 146 eligible patients will be randomly assigned in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. All patients will receive standard postablation care and undergo 18 sessions of acupuncture/sham acupuncture within 12 weeks following CA, followed by a 9-month follow-up period. The primary outcome is the change in the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) summary score from baseline to months 6 after CA. Secondary outcomes include the changes in the AFEQT subscale scores at months 6, the AFEQT summary and subscale score at months 3 and 12, AF burden, AF recurrence, heart rate variability, number of cardioversions, repeat CA procedures, European Heart Rhythm Association score, number of arrhythmia-related hospitalisations, average heart rate, use of Six-Dimensional Health State Short Form to assess health status, costs incurred by disease treatment, Credibility/Expectancy Questionnaire and blinded assessments. Adverse events will also be meticulously recorded throughout the trial.</p><p><strong>Ethics and dissemination: </strong>Ethics approval has been granted by the Ethics Committee of Beijing University of Traditional Chinese Medicine (approval no: 2020BZYLL0802) and seven other subcentres. The findings of the study results will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.</p><p><strong>Trial registration number: </strong>ChiCTR2100049323.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e087460"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614855","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":"Multicentre randomised controlled trial comparing Bankart repair with remplissage and Latarjet procedure in shoulder instability with subcritical bone loss (STABLE): study protocol.","authors":"Moin Khan, Asheesh Bedi, Ryan Degen, Jon Warner, Mohit Bhandari","doi":"10.1136/bmjopen-2024-089831","DOIUrl":"10.1136/bmjopen-2024-089831","url":null,"abstract":"<p><strong>Introduction: </strong>Recurrent shoulder dislocations often cause attrition of the labrum and progressive loss of the anterior bony contour of the glenoid. Treatment options for this pathology involve either soft tissue repair or bony augmentation procedure. The optimal management for patients with shoulder instability with subcritical bone loss remains unknown and current clinical practice is highly varied.</p><p><strong>Methods and analysis: </strong>The Shoulder instability Trial comparing Arthroscopic stabilisation Benefits compared with Latarjet procedure Evaluation (STABLE) is an ongoing multicentre, randomised controlled trial of 114 patients diagnosed with recurrent anterior shoulder instability and subcritical glenoid bone loss (10%-20%, measured on 3D CT using circle of best fit technique). Patients are randomised either arthroscopic capsuloligamentous repair (Bankart repair+remplissage) or open or arthroscopic coracoid transfer (Latarjet procedure). The primary outcome of this trial will be the between-group difference in the change from baseline to 24 months postintervention in Western Ontario Shoulder Instability Index scores. Secondary outcomes include: (1) rates of recurrent shoulder dislocations and symptoms of instability up to 24 months' postsurgery; (2) clinical outcomes measured by American Shoulder and Elbow Society score, Shoulder Activity Scale, EQ-5D and Patient Satisfaction Scale; (3) physical examination (range of motion, stability); (4) return to previous level of activity/sport; (5) rate of shoulder-related complications and serious adverse events.</p><p><strong>Ethics and dissemination: </strong>This protocol has been reviewed and approved by the Hamilton Integrated Research Ethics Board (HiREB; project number 15998) prior to commencement of the trial. Results from the study will be submitted for publication in a peer-reviewed journal regardless of whether there are statistically significant findings.</p><p><strong>Trial registration number: </strong>NCT05705479; this study was prospectively registered on clinicaltrials.gov.</p>","PeriodicalId":9158,"journal":{"name":"BMJ Open","volume":"14 11","pages":"e089831"},"PeriodicalIF":2.4,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142614816","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}