OBJECTIVETo investigate whether the reliability of telesurgery is non-inferior to that of standard local surgery in patients undergoing urological robotic operations.DESIGNMulticentre, non-inferiority, randomised controlled trial.SETTINGFive hospitals in China from December 2023 to June 2024.PARTICIPANTSPatients scheduled to undergo radical prostatectomy or partial nephrectomy.INTERVENTIONSPatients were randomly assigned 1:1 to undergo telesurgery or local surgery.MAIN OUTCOME MEASURESThe primary outcome was the probability of success of surgery, determined by the medical team on the basis of pre-established criteria. The pre-specified non-inferiority margin was an absolute reduction in probability of 0.1. Thirteen clinical secondary outcomes were associated with the operation and early recovery, and one secondary outcome related to the workload of the medical team. Four technical secondary outcomes for the surgical system were also explored, including network latency, display latency, frame loss during telesurgery, and system malfunction. The participants were followed up at four and six weeks postoperatively for the secondary outcomes of recovery and complications.RESULTSA total of 72 participants were enrolled in the study and randomised 1:1 to the telesurgery group and the local surgery group for the intention-to-treat set. The median age of patients was 61.0 (interquartile range 57.5-68.0) years in the telesurgery group and 65.0 (56.5-70.0) years in the local surgery group. Telesurgery was not inferior to local surgery in terms of the probability of surgical success in the intention-to-treat population, accounting for clustering by surgeon (success probability difference 0.02 (95% credible interval -0.03 to 0.15) with bayesian posterior probability of 0.99 for non-inferiority). The telesurgery system was stable with a distance from 1000 km to 2800 km, a mean round trip network latency of 20.1-47.5 ms, and frame loss of 0-1.5 per telesurgery. Secondary outcomes, including operative basic data, complications, early recovery, oncological outcome, and medical team workload, did not differ substantially between the two groups.CONCLUSIONSThe reliability of telesurgery was non-inferior to that of local robotic surgery according to the non-inferiority margin of a 0.1 reduction in success probability.TRIAL REGISTRATIONChiCTR.org ChiCTR2300077721.
{"title":"Reliability of urological telesurgery compared with local surgery: multicentre randomised controlled trial.","authors":"Ye Wang,Dan Xia,Wanhai Xu,Mulati Rexiati,Wuyi Zhao,Qingbo Huang,Taoping Shi,Baojun Wang,Shuo Wang,Sheng Tai,Bingzhang Qiao,Yubai Zhang,Sunyi Ye,Xiangping Zhang,Jianle Mao,Yi Zhu,Honglei Wang,Shuangyu Ma,Cheng Yang,Weijun Fu,Tao Song,Qing Ai,Yong Song,Longhe Xu,Guoqiang Yang,Yu Gao,Shaoxi Niu,Jing Guo,Guojun Liu,Xueyuan Xiang,Chaozhao Liang,Xin Ma,Hongzhao Li,Xu Zhang, ","doi":"10.1136/bmj-2024-083588","DOIUrl":"https://doi.org/10.1136/bmj-2024-083588","url":null,"abstract":"OBJECTIVETo investigate whether the reliability of telesurgery is non-inferior to that of standard local surgery in patients undergoing urological robotic operations.DESIGNMulticentre, non-inferiority, randomised controlled trial.SETTINGFive hospitals in China from December 2023 to June 2024.PARTICIPANTSPatients scheduled to undergo radical prostatectomy or partial nephrectomy.INTERVENTIONSPatients were randomly assigned 1:1 to undergo telesurgery or local surgery.MAIN OUTCOME MEASURESThe primary outcome was the probability of success of surgery, determined by the medical team on the basis of pre-established criteria. The pre-specified non-inferiority margin was an absolute reduction in probability of 0.1. Thirteen clinical secondary outcomes were associated with the operation and early recovery, and one secondary outcome related to the workload of the medical team. Four technical secondary outcomes for the surgical system were also explored, including network latency, display latency, frame loss during telesurgery, and system malfunction. The participants were followed up at four and six weeks postoperatively for the secondary outcomes of recovery and complications.RESULTSA total of 72 participants were enrolled in the study and randomised 1:1 to the telesurgery group and the local surgery group for the intention-to-treat set. The median age of patients was 61.0 (interquartile range 57.5-68.0) years in the telesurgery group and 65.0 (56.5-70.0) years in the local surgery group. Telesurgery was not inferior to local surgery in terms of the probability of surgical success in the intention-to-treat population, accounting for clustering by surgeon (success probability difference 0.02 (95% credible interval -0.03 to 0.15) with bayesian posterior probability of 0.99 for non-inferiority). The telesurgery system was stable with a distance from 1000 km to 2800 km, a mean round trip network latency of 20.1-47.5 ms, and frame loss of 0-1.5 per telesurgery. Secondary outcomes, including operative basic data, complications, early recovery, oncological outcome, and medical team workload, did not differ substantially between the two groups.CONCLUSIONSThe reliability of telesurgery was non-inferior to that of local robotic surgery according to the non-inferiority margin of a 0.1 reduction in success probability.TRIAL REGISTRATIONChiCTR.org ChiCTR2300077721.","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"143 1","pages":"e083588"},"PeriodicalIF":0.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Dire state of neurological care in the Gaza Strip.","authors":"Racheed M Mani","doi":"10.1136/bmj.s142","DOIUrl":"https://doi.org/10.1136/bmj.s142","url":null,"abstract":"","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"296 1","pages":"s142"},"PeriodicalIF":0.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
OBJECTIVETo investigate the accuracy of risk prediction models and scores for diagnosing ovarian cancer in premenopausal women presenting to secondary care with symptoms and abnormal test results.DESIGNProspective cohort study.SETTINGSecondary care in 23 hospitals in the UK between June 2015 and March 2023.PARTICIPANTSPremenopausal women presenting with non-specific symptoms, and raised serum levels of cancer antigen 125 or abnormal imaging results, were prospectively recruited, predominantly referred through the NHS urgent suspected cancer pathway from primary care. A head-to-head comparison of the accuracy of the six risk prediction models and scores was conducted using donated blood and ultrasound scans performed by NHS staff trained in the use of International Ovarian Tumour Analysis (IOTA) imaging terminology. The index tests used were Risk of Malignancy Index 1 (with pre-stated thresholds of 200, 250), Risk of Malignancy Algorithm (7.4%, 11.4%, 12.5%, 13.1%), IOTA Assessment of Different Neoplasias in the adnEXa (ADNEX) (3%, 10%), IOTA simple rules risk model (3%, 10%), IOTA simple rules, and cancer antigen 125 (CA 125, 87 IU/mL). Participants were classified as having primary invasive ovarian cancer versus having benign or normal pathology according to the reference standard determined from surgical specimens or biopsies by histology or cytology, if undertaken, or else at 12 month follow-up. After June 2018, because of covid restrictions and concerns about sample size, recruitment was restricted to only women undergoing surgery within three months of presentation to clinic (in whom ovarian cancer was more likely).MAIN OUTCOME MEASURESDiagnostic accuracy at predicting primary invasive ovarian cancer versus benign or normal histology, assessed by analysing the sensitivity, specificity, C index, area under receiver operating characteristic curve, positive and negative predictive values, and calibration plots in participants with conclusive reference standard results and available index test data.RESULTS88 of 1211 premenopausal women received diagnoses of primary ovarian cancer: 49 of 857 women in the pre-June 2018 cohort (prevalence of 5.7%) and 39 of 354 women in the post-June 2018 cohort (11.0%). For the diagnosis of primary ovarian cancer (n=799 women, after exclusion of 58 other diagnoses), Risk of Malignancy Index 1 at the 250 threshold had a sensitivity of 42.6% (95% confidence interval (CI) 28.3 to 57.8; specificity 96.5%, 94.7 to 97.8). Compared with Risk of Malignancy Index 1 at the 250 threshold, CA 125 and all other tests had higher sensitivity (CA 125 at 87 IU/mL threshold: 55.1%, 40.2 to 69.3, P=0.06; Risk of Malignancy Algorithm at 11.4% threshold: 79.2%, 65.0 to 89.5, P<0.001; IOTA ADNEX at 10% threshold: 89.1%, 76.4 to 96.4, P<0.001; IOTA simple rules risk at 10% threshold: 83.0%, 69.2 to 92.4, P<0.001; IOTA simple rules: 75.0%, 56.6 to 88.5, P=0.01) and lower specificity (CA 125 at 87 IU/mL threshold: 89.0%, 86.5 to 91.2, P<0
目的探讨有症状且检查结果异常的绝经前二级保健妇女卵巢癌风险预测模型和评分诊断的准确性。前瞻性队列研究。2015年6月至2023年3月期间，英国23家医院的二级护理。前瞻性招募出现非特异性症状、血清癌抗原125水平升高或影像学结果异常的绝经前妇女，主要通过NHS紧急疑似癌症途径从初级保健转诊。通过接受过国际卵巢肿瘤分析（IOTA）成像术语培训的NHS工作人员进行的捐献血液和超声扫描，对六种风险预测模型和评分的准确性进行了正面比较。所采用的指标试验为：Risk of malignant index 1（预设定阈值200、250）、Risk of malignant Algorithm（7.4%、11.4%、12.5%、13.1%）、IOTA Assessment of Different Neoplasias in adnEXa (ADNEX)（3%、10%）、IOTA simple rules Risk model（3%、10%）、IOTA simple rules、cancer antigen 125 （CA 125、87 IU/mL）。根据参考标准，将参与者分为原发性浸润性卵巢癌和良性或正常病理，这些标准是通过手术标本或组织学或细胞学活检确定的，如果进行了，或在12个月的随访中进行的。2018年6月之后，由于对covid的限制和对样本量的担忧，招募仅限于在就诊后三个月内接受手术的女性（她们更有可能患卵巢癌）。主要结局指标预测原发性浸润性卵巢癌与良性或正常组织学的诊断准确性，通过分析具有决定性参考标准结果和可用指标试验数据的参与者的敏感性、特异性、C指数、受试者工作特征曲线下面积、阳性和阴性预测值以及校准图来评估。结果1211名绝经前妇女中有88名被诊断为原发性卵巢癌：2018年6月前队列中857名妇女中有49名（患病率5.7%），2018年6月后队列中354名妇女中有39名（患病率11.0%）。对于原发性卵巢癌的诊断（n=799名妇女，在排除了58名其他诊断后），250阈值处的恶性肿瘤风险指数1的敏感性为42.6%(95%置信区间（CI） 28.3至57.8；特异性96.5%,94.7 ~ 97.8)。与250阈值下的风险指数1相比，CA 125和其他所有试验的敏感性更高(CA 125在87 IU/mL阈值时：55.1%,40.2 ~ 69.3，P=0.06； CA 125在11.4%阈值时的风险算法：79.2%,65.0 ~ 89.5，P<0.001； IOTA ADNEX在10%阈值时的风险：89.1%,76.4 ~ 96.4，P<0.001；IOTA简单规则：75.0%,56.6 ~ 88.5，P=0.01)和较低的特异性（CA 125在87 IU/mL阈值：89.0%,86.5 ~ 91.2，P<0.001；恶性肿瘤算法在11.4%阈值：73.1%,69.6 ~ 76.3，P<0.001； IOTA ADNEX在10%阈值：75.1%,71.4 ~ 78.6，P<0.001； IOTA简单规则在10%阈值：76.0%,72.4 ~ 79.3，P<0.001； IOTA简单规则：95.2%,93.0 ~ 96.9，P=0.06）。799名参与者中有120人对IOTA简单规则的结果不确定。对整个队列（n=1211）的分析，包括354名患卵巢癌可能性较高的绝经前妇女，得出了类似的结果。结论：与250阈值的恶性肿瘤风险指数（Risk of malignant Index 1）相比，大多数检测提高了敏感性，但降低了特异性。在二级医疗中，使用IOTA ADNEX模型进行10%的超声分诊显示出最高的灵敏度增益，与其他比较试验相比，特异性下降相当。超声与IOTA ADNEX模型在10%应被认为是新的标准护理试验，为绝经前妇女的二级护理分诊。实施应包括工作人员培训和质量保证。REGISTRATIONISRCTN17160843审判。
{"title":"Diagnostic tests for ovarian cancer in premenopausal women with non-specific symptoms (ROCkeTS): prospective, multicentre, cohort study.","authors":"Sudha Sundar,Ridhi Agarwal,Katie Scandrett,Clare Davenport,Ben Van Calster,Susanne Johnson,Partha Sengupta,Radhika Selvi-Vikram,Fong Lien Kwong,Sue Mallett,Caroline Rick,Sean Kehoe,Dirk Timmerman,Tom Bourne,Hilary Stobart,Richard D Neal,Usha Menon,Aleksandra Gentry-Maharaj,Lauren Sturdy,Ryan Ottridge,Jonathan J Deeks, ","doi":"10.1136/bmj-2024-083912","DOIUrl":"https://doi.org/10.1136/bmj-2024-083912","url":null,"abstract":"OBJECTIVETo investigate the accuracy of risk prediction models and scores for diagnosing ovarian cancer in premenopausal women presenting to secondary care with symptoms and abnormal test results.DESIGNProspective cohort study.SETTINGSecondary care in 23 hospitals in the UK between June 2015 and March 2023.PARTICIPANTSPremenopausal women presenting with non-specific symptoms, and raised serum levels of cancer antigen 125 or abnormal imaging results, were prospectively recruited, predominantly referred through the NHS urgent suspected cancer pathway from primary care. A head-to-head comparison of the accuracy of the six risk prediction models and scores was conducted using donated blood and ultrasound scans performed by NHS staff trained in the use of International Ovarian Tumour Analysis (IOTA) imaging terminology. The index tests used were Risk of Malignancy Index 1 (with pre-stated thresholds of 200, 250), Risk of Malignancy Algorithm (7.4%, 11.4%, 12.5%, 13.1%), IOTA Assessment of Different Neoplasias in the adnEXa (ADNEX) (3%, 10%), IOTA simple rules risk model (3%, 10%), IOTA simple rules, and cancer antigen 125 (CA 125, 87 IU/mL). Participants were classified as having primary invasive ovarian cancer versus having benign or normal pathology according to the reference standard determined from surgical specimens or biopsies by histology or cytology, if undertaken, or else at 12 month follow-up. After June 2018, because of covid restrictions and concerns about sample size, recruitment was restricted to only women undergoing surgery within three months of presentation to clinic (in whom ovarian cancer was more likely).MAIN OUTCOME MEASURESDiagnostic accuracy at predicting primary invasive ovarian cancer versus benign or normal histology, assessed by analysing the sensitivity, specificity, C index, area under receiver operating characteristic curve, positive and negative predictive values, and calibration plots in participants with conclusive reference standard results and available index test data.RESULTS88 of 1211 premenopausal women received diagnoses of primary ovarian cancer: 49 of 857 women in the pre-June 2018 cohort (prevalence of 5.7%) and 39 of 354 women in the post-June 2018 cohort (11.0%). For the diagnosis of primary ovarian cancer (n=799 women, after exclusion of 58 other diagnoses), Risk of Malignancy Index 1 at the 250 threshold had a sensitivity of 42.6% (95% confidence interval (CI) 28.3 to 57.8; specificity 96.5%, 94.7 to 97.8). Compared with Risk of Malignancy Index 1 at the 250 threshold, CA 125 and all other tests had higher sensitivity (CA 125 at 87 IU/mL threshold: 55.1%, 40.2 to 69.3, P=0.06; Risk of Malignancy Algorithm at 11.4% threshold: 79.2%, 65.0 to 89.5, P<0.001; IOTA ADNEX at 10% threshold: 89.1%, 76.4 to 96.4, P<0.001; IOTA simple rules risk at 10% threshold: 83.0%, 69.2 to 92.4, P<0.001; IOTA simple rules: 75.0%, 56.6 to 88.5, P=0.01) and lower specificity (CA 125 at 87 IU/mL threshold: 89.0%, 86.5 to 91.2, P<0","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"42 1","pages":"e083912"},"PeriodicalIF":0.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"FDA is now \"open to bayesian statistics\": transformational change or new Pandora's box?","authors":"Peter Doshi","doi":"10.1136/bmj.s180","DOIUrl":"https://doi.org/10.1136/bmj.s180","url":null,"abstract":"","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"86 1","pages":"s180"},"PeriodicalIF":0.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069884","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Royal colleges leave X because of \"harmful content and abusive behaviour\".","authors":"Chris Stokel-Walker","doi":"10.1136/bmj.s185","DOIUrl":"https://doi.org/10.1136/bmj.s185","url":null,"abstract":"","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"296 1","pages":"s185"},"PeriodicalIF":0.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Children's environmental health under siege: the hidden burden of war toxicity in Gaza.","authors":"Giovanni Ghirga","doi":"10.1136/bmj.s148","DOIUrl":"https://doi.org/10.1136/bmj.s148","url":null,"abstract":"","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"296 1","pages":"s148"},"PeriodicalIF":0.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"COPD: New targeted treatment is approved by NICE.","authors":"Jacqui Wise","doi":"10.1136/bmj.s183","DOIUrl":"https://doi.org/10.1136/bmj.s183","url":null,"abstract":"","PeriodicalId":22388,"journal":{"name":"The BMJ","volume":"7 1","pages":"s183"},"PeriodicalIF":0.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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