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A systematic review and meta-analysis assessed renal denervation randomized trials for uncontrolled hypertension using the revised Cochrane RoB tool by two reviewers. Results showed rating disparities, with sham-controlled trials marked “some concerns” and open-label trials rated low, and the tool struggled to distinguish designs. Findings support context-sensitive RoB interpretation and motivate development of device-focused tools.",{"@graph":69,"@context":126},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/the-problem-of-applying-risk-of-bias-tools-in-studies-of-medical-devices-a-case-study-in-hypertension/445742/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/the-problem-of-applying-risk-of-bias-tools-in-studies-of-medical-devices-a-case-study-in-hypertension/445742.png","ImageObject",300,407,{"name":92,"@type":93},"Riley","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-30","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":34},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118,122],{"name":109,"@type":110,"acceptedAnswer":111},"Why do standard risk-of-bias tools may be problematic for medical device trials?","Question",{"text":112,"@type":113},"Many RoB tools were designed with pharmaceuticals in mind, while medical device trials can face different methodological challenges. This mismatch can affect how evidence is perceived in health technology assessment.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"Which device and condition were analyzed in the study?",{"text":117,"@type":113},"The review focused on renal denervation devices used to treat uncontrolled hypertension, including only randomized controlled trials.",{"name":119,"@type":110,"acceptedAnswer":120},"What main pattern of RoB ratings did the revised Cochrane tool produce?",{"text":121,"@type":113},"Some sham-controlled RCTs received an overall RoB rating of “some concerns,” while some open-label RCTs had low RoB ratings, and the tool appeared unable to distinguish between the designs.",{"name":123,"@type":110,"acceptedAnswer":124},"What is the study’s implication for future risk-of-bias assessment of medical devices?",{"text":125,"@type":113},"RoB assessment requires careful, contextual interpretation, and the paper supports the need for a potential new RoB tool tailored to medical device studies.","https://schema.org",{"og:url":83,"og:type":128,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":130,"canonical":83},"index,follow",{"doc_id":132,"site_id":62},445742,1790896635,{"code":4,"msg":5,"data":135},{"doc_id":132,"user_id":136,"nickname":92,"user_avatar":137,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":138,"file_id":139,"file_url":140,"file_type":141,"file_size":142,"view_count":34,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":8,"language":143,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":144,"faqs":145,"seo_title":146,"seo_description":67,"update_tm":147,"read_time":81,"preview_page_count":4},1374391975076,"https://ap-avatar.wpscdn.com/avatar/14000253ca4ec9f6853?x-image-process=image/resize,m_fixed,w_180,h_180&k=1783305029341752051","PP63 Predictive Value Of Intermediate Endpoints For Overall Survival In High-Risk Localized And Locally Advanced Prostate Cancer  \nUwe Siebert ([uwe.siebert@umit-tirol.at](uwe.siebert@umit-tirol.at)),  \nFrancesco De Solda, Kimberly Hofer, James McCallion, Sharon A. McCarthy, Suneel D. Mundle,  \nMir-Masoud Pourrahmat, Victoria Wan and Beate Jahn  \nIntroduction: Demonstrating meaningful overall survival (OS) treatment benefit in high-risk localized or locally advanced prostate cancer (HR-LPC/LAPC) remains challenging due to the prolonged natural disease evolution. There is growing interest invalidating intermediate clinical endpoints (ICEs) for OS. We evaluated the predictive value of ICEs for OS in HR-LPC/LAPC using data from randomized controlled trials (RCTs) and non-randomized comparative studies (non-RCTs) .  \nMethods: We conducted a systematic literature review using Embase, MEDLINE, CENTRAL, and grayliterature(22March2024)to identify RCTs and non-RCTs investigating therapeutic options for adults (≥ 18 years) with HR-LPC/LAPC. Eligible studies reporting treatment effects (hazard ratios [HR]) for OS (HROS) or ICEs were included. Event-free survival (EFS), metastasis-free survival (MFS), no evidence of disease (NED), and pathological complete response (pCR) were ICEs of interest. Correlation of each ICE with OS was evaluated using Bayesian bivariate random-effects meta-analysis (BRMA) with an uninformative prior distribution. The predictive value of each ICE was determined by assessing observed versus predicted treatment effects of OS via leave-one-out cross validation (LOOCV).  \nResults: We selected 137 unique studies (89 RCTs and 48 non-RCTs) for meta-analysis: EFS-OS, k=85 studies (n=53,965 patients); MFSOS, k=79 (n=51,746); NED-OS, k=100 (n=56,187); pCR-OS, k=112 (n=70,228) . We observed moderate correlation estimates of 0 .53 (95% credible interval [Crl]: 􀀁0 .23, 0 .96), 0 .69 (95% CrI: 􀀁0 .35, 0.98), and 􀀁0 .53 (95% CrI: 􀀁0 .95, 0 .39) for EFS-OS, MFS-OS, and NED-OS, respectively. pCR-OS showed a weak correlation (0.06, 95%Crl: 􀀁0 .89, 0 .94) . None of the correlation estimates were statistically significant. An RCT-only sensitivity analysis showed consistent results. The LOOCV had good predictive accuracy, with 95 percent prediction intervals capturing the observed HROS for 89.5, 87.5, 100, and 83.3 percent of studies, for respective ICEs. No ICEs met the Institute for Quality and Efficiency in Health Care (IQWiG) criteria for strong correlation.  \nConclusions: Despite consistent direction of associations between ICEs and OS using rigorous BRMA, we could not meet the stringent surrogacy thresholds used by health technology assessment (HTA) agencies. Our findings highlight a need for further analysis to prove correlations, including analyses using real-world data and consideration of how surrogacy evidence is assessed by HTA agencies in earlystage prostate cancer.  \nPP64 The Problem Of Applying Risk-Of-Bias Tools In Studies Of Medical Devices: A Case Study In Hypertension  \nAlice Sanderson, Liesl Strachan  \n( [liesl.strachan@medtronic.com](liesl.strachan@medtronic.com)),  \nSilke Walleser Autiero and Rachael McCool  \nIntroduction: Assessing the risk of bias (RoB) using validated tools isan important aspect of any health technology assessment (HTA) . However, many of these tools were designed with pharmaceuticals in mind. Well conducted trials of medical devices often face different challenges. Consequently, choosing the RoB tool to use in any assessment may playa large role in how evidence ofsuch technologies is perceived.  \nMethods: A systematic review and meta-analysis was conducted on renal denervation devices for treating uncontrolled hypertension. Only randomized controlled trials (RCTs) were included, so the revised Cochrane RoB tool was chosen to assess bias in individual studies. RoB assessments were undertaken by two reviewers. Results: Twenty-five RCTs met the eligibility criteria for the systematic review and","cbCaioF7iVo7INKX","https://ap.wps.com/l/cbCaioF7iVo7INKX","pdf",35879,"English","# Introduction\n# Methods\n# Results\n# Conclusions","[{\"question\":\"Why do standard risk-of-bias tools may be problematic for medical device trials?\",\"answer\":\"Many RoB tools were designed with pharmaceuticals in mind, while medical device trials can face different methodological challenges. This mismatch can affect how evidence is perceived in health technology assessment.\"},{\"question\":\"Which device and condition were analyzed in the study?\",\"answer\":\"The review focused on renal denervation devices used to treat uncontrolled hypertension, including only randomized controlled trials.\"},{\"question\":\"What main pattern of RoB ratings did the revised Cochrane tool produce?\",\"answer\":\"Some sham-controlled RCTs received an overall RoB rating of “some concerns,” while some open-label RCTs had low RoB ratings, and the tool appeared unable to distinguish between the designs.\"},{\"question\":\"What is the study’s implication for future risk-of-bias assessment of medical devices?\",\"answer\":\"RoB assessment requires careful, contextual interpretation, and the paper supports the need for a potential new RoB tool tailored to medical device studies.\"}]","The Problem Of Applying Risk-Of-Bias Tools In Studies Of Medical Devices - A Case Study In Hypertension | PDF",1790712629]