BMJ Surgery Interventions Health Technologies最新文献

{"title":"Development of a coordinated registry network for pelvic organ prolapse technologies.","authors":"Courtney E Baird, Bilal Chughtai, Catherine S Bradley, Kathleen Kobashi, Mary Jung, Art Sedrakyan, Sharon Andrews, Ann Ferriter, Terri Cornelison, Danica Marinac-Dabic","doi":"10.1136/bmjsit-2020-000076","DOIUrl":"10.1136/bmjsit-2020-000076","url":null,"abstract":"<p><strong>Objectives: </strong>The accumulation of data through a prospective, multicenter Coordinated Registry Network (CRN) could be a robust and cost-effective way to gather real-world evidence on the performance of pelvic organ prolapse (POP) technologies for device-based and intervention-based studies. To develop the CRN, a group of POP experts consisting of representatives from professional societies, the Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements important to assess POP technologies.</p><p><strong>Design: </strong>A Delphi method approach was employed to achieve consensus on a core minimum dataset for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by the study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via conference call. This process was repeated twice over a 6-month time period during which consensus was achieved.</p><p><strong>Results: </strong>Twenty-one experts participated in the effort and proposed 120 data elements. Participation rates in the first and second round of the Delphi survey were 95.2% and 71.4%, respectively. The working group reached final consensus among responders on 90 data elements capturing relevant general medical and surgical history, procedure and discharge, short-term and long-term follow-up, device factors, and surgery and surgeon factors.</p><p><strong>Conclusions: </strong>The CRN successfully developed a set of core data elements to support the study of POP technologies through convening an expert panel on POP technologies and using the Delphi method. These standardized data elements have the potential to influence patient and provider decisions about treatments and include important outcomes related to efficacy and safety.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"4 Suppl 1","pages":"e000076"},"PeriodicalIF":2.1,"publicationDate":"2022-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/c7/1e/bmjsit-2020-000076.PMC9660621.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9708577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.","authors":"Art Sedrakyan, Danica Marinac-Dabic, Bruce Campbell, Suvekshya Aryal, Courtney E Baird, Philip Goodney, Jack L Cronenwett, Adam W Beck, Elizabeth W Paxton, Jim Hu, Ralph Brindis, Kevin Baskin, Terrie Cowley, Jeffery Levy, David S Liebeskind, Benjamin K Poulose, Charles R Rardin, Frederic S Resnic, James Tcheng, Benjamin Fisher, Charles Viviano, Vincent Devlin, Murray Sheldon, Jens Eldrup-Jorgensen, Jesse A Berlin, Joseph Drozda, Michael E Matheny, Sanket S Dhruva, Timothy Feeney, Kristi Mitchell, Gregory Pappas","doi":"10.1136/bmjsit-2021-000123","DOIUrl":"10.1136/bmjsit-2021-000123","url":null,"abstract":"<p><strong>Objectives: </strong>Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding.</p><p><strong>Design setting and participants: </strong>We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020.</p><p><strong>Main outcome measures: </strong>Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity.</p><p><strong>Results: </strong>Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains.</p><p><strong>Conclusions: </strong>We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"4 Suppl 1","pages":"e000123"},"PeriodicalIF":2.1,"publicationDate":"2022-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1c/d0/bmjsit-2021-000123.PMC9660584.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9709024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of a core minimum data set to advance real-world evidence generation for uterine fibroids treatment technologies.","authors":"Courtney E Baird, Evan Myers, Vanessa Jacoby, Laura Elisabeth Gressler, Sateria Venable, Allison O'Neill, Veronica Price, Angie Lee, Jason Roberts, Sharon Andrews, Art Sedrakyan, Danica Marinac-Dabic","doi":"10.1136/bmjsit-2021-000094","DOIUrl":"10.1136/bmjsit-2021-000094","url":null,"abstract":"<p><strong>Objectives: </strong>The accumulation of data through a prospective, multicenter coordinated registry network (CRN) is a robust and cost-effective way to gather real-world evidence on the performance of uterine fibroids treatment technologies for device-based and intervention-based studies. To develop the CRN, a group of uterine fibroids experts, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry, and the patient community, was convened to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess uterine fibroid treatment technologies.</p><p><strong>Design: </strong>A Delphi method approach was employed to achieve consensus on a core minimum data set for the CRN. A series of surveys were sent to the panel and answered by each expert anonymously and individually. Results from the surveys were collected, collated, and analyzed by a study design team from Weill Cornell Medicine. Questions for the next round were based on the analysis process and discussed with group members via a conference call. This process was repeated twice over a 3-month time period until consensus was achieved.</p><p><strong>Results: </strong>Twenty-nine experts participated in the Delphi surveys, which began with an initial list of 200 data elements. The working group reached final consensus on 97 data elements capturing patient medical history, imaging data, procedure-related data, post-procedure data, and long-term follow-up data.</p><p><strong>Conclusions: </strong>The CRN successfully convened an expert panel on uterine fibroids treatment technologies and used the Delphi method to produce a consensus-based core set of data elements. These identified data elements include important outcomes related to efficacy and safety and thus, influence patient, provider, and regulatory decision-making about treatments for uterine fibroids. Finally, the core data elements provide the foundation of the infrastructure needed for the CRN that will allow for the comparative study of uterine fibroid treatment devices and technologies.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"4 Suppl 1","pages":"e000094"},"PeriodicalIF":2.1,"publicationDate":"2022-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/de/a6/bmjsit-2021-000094.PMC9660574.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9723703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Surgeon experience of mixed reality headset technology during the COVID-19 pandemic: a multicenter international case series in orthopedic surgery","authors":"T. Gregory, J. Gregory, Charles Dacheux, S. Hurst","doi":"10.1136/bmjsit-2021-000127","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000127","url":null,"abstract":"INTRODUCTION There is interest in using reality technologies within the medical sphere and specific focus within orthopedic surgery. Mixed reality (MR) is a type of reality technology that allows for a digital image to be both superimposed and controlled by the user on top of their normal visual field. Using MR headsets, surgeons can access computerbased solutions in real time; manipulate threedimensional (3D) holograms of patient anatomy, surgical planning, or implant systems; and remotely interact with colleagues. All these functions are achieved without compromising sterility and have been demonstrated successfully. Despite these successes, there has been no significant investigation into its impact on surgeon experience. Evaluating the surgeon experience of MR will be of importance in understanding how it can best be deployed and further optimized for the benefit of patients. We report on surgeon experience following an international case series of orthopedic surgeries performed using MR headset technology during the COVID19 pandemic.","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47900913","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":"User-centered design and agile development of a novel mobile health application and clinician dashboard to support the collection and reporting of patient-reported outcomes for breast cancer care","authors":"E. Tsangaris, M. Edelen, Jessica J. Means, M. Gregorowitsch, Joanna O’Gorman, R. Pattanaik, L. Dominici, Michael Hassett, M. Witkowski, Kristen Schrieber, Elizabeth Frank, Martha Carnie, A. Pusic","doi":"10.1136/bmjsit-2021-000119","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000119","url":null,"abstract":"Objectives There is a need for advancements in health information technology that will transform how patient-reported outcomes (PRO) data are collected, reported, and used in breast cancer care. The objective of this study was to develop an innovative and customizable platform, called imPROVE to support PRO uptake in breast cancer care. Design User-centered design and agile development were employed. Recurrent stakeholder meetings with experts in the field of breast cancer care, in-depth one-on-one qualitative interviews with a clinical sample of patients with breast cancer, and focus groups with Dana-Farber/Harvard Cancer Center (DF/HCC) Breast Cancer Advisory Group members, were used to elicit feedback for the design features and functions of a patient mobile application and clinician dashboard. Setting This study was conducted at two academic hospitals in the USA. Participants Participants included experts in the field of breast cancer care, value-based healthcare, and health information technology, a clinical sample of patients with breast cancer, and members of the DF/HCC Breast Cancer Advisory Group. Main outcome measures imPROVE incorporates the International Consortium for Health Outcomes Measurement (ICHOM) breast cancer standard outcome set as well as the complete BREAST-Q Breast Cancer Module. Results Feedback was elicited from eight stakeholder meetings (n=28 members), interviews with a clinical sample of patients (n=28), and two focus groups with members of the DF/HCC Breast Cancer Advisory Group (n=17 members in each focus group). Participant feedback led to the development of a patient mobile application consisting of five components (myCare, myStory, myResources, myCommunity, and myNotes) and a clinician dashboard that includes an overview table and individual patient profiles with data displays. Conclusions imPROVE has the potential to transform the way we deliver care to patients. Developed from best practices in user-centered design, agile development, and qualitative methods; imPROVE addresses the needs of multiple stakeholders, including patients, clinicians, healthcare administrators, and researchers.","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44760434","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":"Developing the foundation for assessment of Devices used for Acute Ischemic Stroke Interventions (DAISI) using a Coordinated Registry Network.","authors":"Hartley LeRoy,&nbsp;Laura Elisabeth Gressler,&nbsp;David S Liebeskind,&nbsp;Claudette E Brooks,&nbsp;Adnan Siddiqui,&nbsp;Sameer Ansari,&nbsp;Murray Sheldon,&nbsp;Carlos Pena,&nbsp;Art Sedrakyan,&nbsp;Danica Marinac-Dabic","doi":"10.1136/bmjsit-2021-000113","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000113","url":null,"abstract":"© Author(s) (or their employer(s)) 2022. Reuse permitted under CC BYNC. No commercial reuse. See rights and permissions. Published by BMJ. INTRODUCTION Stroke is the leading cause of disability with treatment costs exceeding $46 billion between 2014 and 2015 in the USA alone. 2 Every year, approximately 795 000 Americans suffer a new or recurrent stroke resulting in nearly 140 000 deaths, with 87% being ischemic strokes. Deviceassisted interventions, such as endovascular mechanical thrombectomy, can be used for the emergent treatment of acute ischemic stroke. The comprehensive assessment of safety and effectiveness of deviceassisted treatments is complicated by several factors, including complex and unique neurovascular anatomy, the timing of stroke presentations, and variable tissue tolerability to ischemia. Realworld data (RWD) collected during routine medical care of patients presenting with acute ischemic stroke may be used to develop realworld evidence (RWE) to help evaluate the safety and effectiveness of deviceassisted treatments. The generated RWE may support postmarket surveillance requirements, identify potential adverse events, and perhaps guide regulatory decisions. For these reasons, the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) recognizes the potential value of RWE and its use in the course of clinical and regulatory decisionmaking when appropriate. Coordinated Registry Networks (CRNs) allow for the systematic aggregation of highquality RWD which can in turn be analyzed, potentially leading to relevant and reliable evidence for the evaluation of medical devices. 5 Prompted by participation in two public meetings in late 2015, FDA Public Meeting on Acute Ischemic Stroke and the Stroke Treatment Academic Industry Roundtable, the FDA began to consider initiating a registry to advance acute ischemic stroke clinical trials and, where appropriate, to capture data necessary to support regulatory, reimbursement, coverage, and physician decisionmaking. On February 2, 2017, the FDA held a Public Workshop on a CRN for Devices used for Acute Ischemic Stroke Interventions (DAISICRN). The purpose for this workshop was to obtain initial public stakeholders’ input and plan for future collaboration. On November 9, 2017, a multistakeholder group convened to launch the DAISI initiative. The mission of the DAISI initiative is to establish a CRN using RWE generated in the clinical care domain by patients, physicians, providers, and payers, for the purposes of enhancing regulatory and clinical decisionmaking, improving healthcare, and supporting the development of innovative devices to treat acute ischemic stroke. This CRN will use national and international databases to capture information from patient encounters with medical devices used to treat acute ischemic stroke using common data elements (CDEs) related to patient characteristics, medical history, the procedure, preoperative and postoperative imag","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"4 Suppl 1","pages":"e000113"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7e/3d/bmjsit-2021-000113.PMC9660605.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9708578","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis.","authors":"Jonathan Aaron Barnes,&nbsp;Mark A Eid,&nbsp;Kayla Moore,&nbsp;Suvekshya Aryal,&nbsp;Eden Gebre,&nbsp;Jennifer Nicole Woodard,&nbsp;Napong Kitpanit,&nbsp;Jialin Mao,&nbsp;David P Kuwayama,&nbsp;Bjoern D Suckow,&nbsp;Darren Schneider,&nbsp;Tiffany Abushaikha,&nbsp;Robbert Zusterzeel,&nbsp;Sreekanth Vemulapalli,&nbsp;Elizabeth A Shenkman,&nbsp;James Williams,&nbsp;Art Sedrakyan,&nbsp;Philip Goodney","doi":"10.1136/bmjsit-2021-000085","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000085","url":null,"abstract":"<p><strong>Objective: </strong>To assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (IBE+VBX stent graft).</p><p><strong>Design: </strong>Multicentre retrospective cohort study.</p><p><strong>Setting: </strong>Four real-world data sources were used: a national quality improvement registry, a statewide clinical research network, a regional quaternary health system and two tertiary academic medical centres.</p><p><strong>Participants: </strong>In total, 30 patients with 37 IBE+VBX stent graft were identified. Of those, the mean age was 72±10.2 years and 90% were male. The cohort was 77% white, 10% black, 3% Hispanic and 10% other.</p><p><strong>Main outcome measures: </strong>Outcome measures included: proportion of percutaneous vs open surgical access, intensive care admission, intensive care unit (ICU) length-of-stay (LOS), total LOS, postoperative complications, discharge disposition and 30-day mortality.</p><p><strong>Results: </strong>The majority (89%) of cases were performed percutaneously, 5% required surgical exposure following failed percutaneous access and 6% required open surgical exposure outright. Nearly half (43%) required intensive care admission with a median ICU LOS of 1 day (range: 1-2). Median total LOS was 1 day (IQR: 1-2). There were zero postoperative myocardial infarctions, zero reported leg embolisations and no reported reinterventions. Access site complications were described in 1 of 28 patients, manifesting as a haematoma or pseudoaneurysm. Ultimately, 97% were discharged to home and one patient was discharged to a nursing home or rehabilitation facility. There were no 30-day perioperative deaths.</p><p><strong>Conclusions: </strong>This project demonstrates the feasibility of identifying and integrating real-world evidence, as it pertains to an unapproved combination of endovascular devices (IBE+VBX stent graft), for short-term outcomes analysis. This new paradigm of evidence has potential to be used for device monitoring, submission to regulatory agencies, or consideration in indication expansions and approvals with further efforts to systematise data collection and transmission mechanisms.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"4 1","pages":"e000085"},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5d/a2/bmjsit-2021-000085.PMC9345049.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9346645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center.","authors":"Sanket S Dhruva, Guoqian Jiang, Amit A Doshi, Daniel J Friedman, Eric Brandt, Jiajing Chen, Joseph G Akar, Joseph S Ross, Keondae R Ervin, Kimberly Collison Farr, Nilay D Shah, Paul Coplan, Peter A Noseworthy, Shumin Zhang, Thomas Forsyth, Wade L Schulz, Yue Yu, Joseph P Drozda","doi":"10.1136/bmjsit-2021-000089","DOIUrl":"10.1136/bmjsit-2021-000089","url":null,"abstract":"<p><strong>Objectives: </strong>To determine the feasibility of using real-world data to assess the safety and effectiveness of two cardiac ablation catheters for the treatment of persistent atrial fibrillation and ischaemic ventricular tachycardia.</p><p><strong>Design: </strong>Retrospective cohort.</p><p><strong>Setting: </strong>Three health systems in the USA.</p><p><strong>Participants: </strong>Patients receiving ablation with the two ablation catheters of interest at any of the three health systems.</p><p><strong>Main outcome measures: </strong>Feasibility of identifying the medical devices and participant populations of interest as well as the duration of follow-up and positive predictive values (PPVs) for serious safety (ischaemic stroke, acute heart failure and cardiac tamponade) and effectiveness (arrhythmia-related hospitalisation) clinical outcomes of interest compared with manual chart validation by clinicians.</p><p><strong>Results: </strong>Overall, the catheter of interest for treatment of persistent atrial fibrillation was used for 4280 ablations and the catheter of interest for ischaemic ventricular tachycardia was used 1516 times across the data available within the three health systems. The duration of patient follow-up in the three health systems ranged from 91% to 97% at ≥7 days, 89% to 96% at ≥30 days, 77% to 90% at ≥6 months and 66% to 84% at ≥1 year. PPVs were 63.4% for ischaemic stroke, 96.4% for acute heart failure, 100% at one health system for cardiac tamponade and 55.7% for arrhythmia-related hospitalisation.</p><p><strong>Conclusions: </strong>It is feasible to use real-world health system data to evaluate the safety and effectiveness of cardiac ablation catheters, though evaluations must consider the implications of variation in follow-up and endpoint ascertainment among health systems.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"3 1","pages":"e000089"},"PeriodicalIF":0.0,"publicationDate":"2021-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/ce/79/bmjsit-2021-000089.PMC8749235.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39924493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Surgery versus non-operative treatment for ER-stress unstable Weber-B unimalleolar fractures: a study protocol for a prospective randomized non-inferiority (Super-Fin) trial.","authors":"Tero Kortekangas,&nbsp;Ristomatti Lehtola,&nbsp;Hannu-Ville Leskelä,&nbsp;Simo Taimela,&nbsp;Pasi Ohtonen,&nbsp;Olli Savola,&nbsp;Teppo Järvinen,&nbsp;Harri Pakarinen","doi":"10.1136/bmjsit-2021-000098","DOIUrl":"10.1136/bmjsit-2021-000098","url":null,"abstract":"<p><p>Roughly two-thirds of ankle fractures are unimalleolar injuries, the Weber B-type fibula fracture being by far the most common type. Depending on the trauma and the accompanying soft-tissue injury, these fractures are either stable or unstable. Current clinical practice guidelines recommend surgical treatment for unstable Weber B-type fibula fractures. An ongoing randomized, parallel group, non-inferiority trial comparing surgery and non-operative treatment for unstable Weber B-type ankle fractures with allocation ratio 1:1. The rationale for non-inferiority design is as follows: By being able to prove non-inferiority of non-operative treatment, we would be able to avoid complications related to surgery. However, the primary concern related to non-operative treatment is increased risks of ankle mortise incongruency, leading to secondary surgery, early post-traumatic osteoarthritis and poor function. After providing informed consent, 126 patients aged 16 years or older with an unimalleolar Weber B-type unstable fibula fracture were randomly assigned to surgery (open reduction and internal fixation) or non-operative treatment (6-week cast immobilization). We have completed the patient enrolment and are currently in the final stages of the 2-year follow-up. The primary, non-inferiority outcome is the Olerud-Molander Ankle Score (OMAS) at 2 years (primary time point). The predefined non-inferiority margin is set at 8 OMAS points. Secondary outcomes include the Foot and Ankle Score, a 100 mm Visual Analogue Scale for function and pain, the RAND-36-Item Health Survey for health-related quality-of-life, the range-of-motion of the injured ankle, malunion (ankle joint incongruity) and fracture union. Treatment-related complications and harms; symptomatic non-unions, loss of congruity of the ankle joint, reoperations and wound infections will also be recorded. We hypothesize that non-operative treatment yields non-inferior functional outcome to surgery, the current standard treatment, with no increased risk of harms.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"3 1","pages":"e000098"},"PeriodicalIF":0.0,"publicationDate":"2021-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/13/26/bmjsit-2021-000098.PMC8749309.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39924496","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"1-year cost-utility analysis of prostate artery embolization (PAE) versus transurethral resection of the prostate (TURP) in benign prostatic hyperplasia (BPH).","authors":"Nikisha Patel,&nbsp;Nathan Yung,&nbsp;Ganesh Vigneswaran,&nbsp;Laure de Preux,&nbsp;Drew Maclean,&nbsp;Mark Harris,&nbsp;Bhaskar Somani,&nbsp;Timothy Bryant,&nbsp;Nigel Hacking,&nbsp;Sachin Modi","doi":"10.1136/bmjsit-2020-000071","DOIUrl":"https://doi.org/10.1136/bmjsit-2020-000071","url":null,"abstract":"<p><strong>Objective: </strong>To determine whether prostate artery embolization (PAE) is a cost-effective alternative to transurethral resection of the prostate (TURP) in the management of benign prostate hyperplasia (BPH) after 1-year follow-up.</p><p><strong>Design setting and main outcome measures: </strong>A retrospective cost-utility analysis over a 12-month time period was conducted to compare the two interventions from a National Health Service perspective. Effectiveness was measured as quality-adjusted life years (QALYs) derived from data collected during the observational UK Register of Prostate Embolisation (UK-ROPE) Study. Costs for both PAE and TURP were derived from University Hospital Southampton, a tertiary referral centre for BPH and the largest contributor to the UK-ROPE. An incremental cost-effectiveness ratio (ICER) was derived from cost and QALY values associated with both interventions to assess the cost-effectiveness of PAE versus TURP. Further sensitivity analyses involved a decision tree model to account for the impact of patient-reported complications on the cost-effectiveness of the interventions.</p><p><strong>Results: </strong>The mean patient age for TURP (n=31) and PAE (n=133) was 69 and 65.6 years, respectively. In comparison to TURP, PAE was cheaper due to shorter patient stays and the lack of necessity for an operating theatre. Analysis revealed an ICER of £64 798.10 saved per QALY lost when comparing PAE to TURP after 1-year follow-up.</p><p><strong>Conclusion: </strong>Our findings suggest that PAE is initially a cost-effective alternative to TURP for the management of BPH after 1-year follow-up. Due to a higher reintervention rate in the PAE group, this benefit may be lost in subsequent years.</p><p><strong>Trial registration number: </strong>NCT02434575.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"3 1","pages":"e000071"},"PeriodicalIF":0.0,"publicationDate":"2021-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a6/b0/bmjsit-2020-000071.PMC8749306.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39834977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}