BMJ Surgery Interventions Health Technologies最新文献

{"title":"Addressing the reporting chasm of artificial intelligence research: the DECIDE-AI reporting guidelines.","authors":"John Gerrard Hanrahan, Danyal Zaman Khan, Hani J Marcus","doi":"10.1136/bmjsit-2022-000154","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000154","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. EDITORIAL The meteoric rise of artificial intelligence (AI) to the forefront of healthcare innovation has unearthed an array of avenues for surgical researchers to pursue. Applications found throughout the surgical patient pathway mean AI offers newfound support systems for clinical decisionmaking. Indeed, a growing number of technologies are entering clinical practice, with a recent review evaluating randomised controlled trials of diagnostic prediction tools suggests that potential benefits of AI that contemporary healthcare stands to realise. However, the pathway to translation to the bedside for these technologies is variable. Captured aptly in a recent editorial, there are clear examples of AI technologies already approved for clinical use in the USA, both with and without evaluation through randomised controlled trials. This speaks to a wider problem of evaluation in AI innovation, where insufficient reporting in randomised controlled trials prompted the development of several reporting guidelines, examples including the Consolidated Standards of Reporting TrialsAI and Standard Protocol Items: Recommendations for Interventional TrialsAI guidelines advising the minimum reporting standards for clinical trials and protocols, respectively. Similarly, guidance for the initial stages of AI development has been developed, namely, the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPODAI) guidelines for machine learning (ML) prediction models. Yet, when one looks at the process of AI translation, from in silico to clinical trial, an evaluation chasm becomes obvious, with guidance lacking on studies reflecting stages 2a and 2b of the IDEAL (Idea, Development, Exploration, Assessment, Longterm study) collaborative. These stages reflect the refinement and preparation for larger clinical studies, which are influenced by factors from the operator including learning curves or training; the health system the technologies enter into or organisational factors such as integration into clinical workflows. Study design features such as patient selection for both training and testing an intervention, and even the AI model itself, are crucial factors to consider prior to largescale testing. Vasey and colleagues have identified a gap in the reporting guidelines for evaluating AIdriven decision support systems, producing reporting guidelines to support the evaluation of their early stages. This was achieved through an international, tworound modified Delphi consensus process producing a 17 AIspecific item and 10 generic item reporting guidelines (DECIDEAI), informing the reporting of earlystage clinical studies of AIbased decision support systems in healthcare. The systems perspective taken by Vasey et al frame AI decisionsupport systems as complex interventions. This perspect","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000154"},"PeriodicalIF":0.0,"publicationDate":"2022-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/51/52/bmjsit-2022-000154.PMC9345081.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40644442","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":"Endovascular versus open repair in patients with abdominal aortic aneurysm: a claims-based data analysis in Japan.","authors":"Yuki Kimura,&nbsp;Hiroshi Ohtsu,&nbsp;Naohiro Yonemoto,&nbsp;Nobuyoshi Azuma,&nbsp;Kazuhiro Sase","doi":"10.1136/bmjsit-2022-000131","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000131","url":null,"abstract":"<p><strong>Objectives: </strong>Endovascular aortic repair (EVAR) evolved through competition with open aortic repair (OAR) as a safe and effective treatment option for appropriately selected patients with abdominal aortic aneurysm (AAA). Although endoleaks are the most common reason for post-EVAR reintervention, compliance with lifelong regular follow-up imaging remains a challenge.</p><p><strong>Design: </strong>Retrospective data analysis.</p><p><strong>Setting: </strong>The Japan Medical Data Center (JMDC), a claims database with anonymous data linkage across hospitals, consists of corporate employees and their families of ≤75 years of age.</p><p><strong>Participants: </strong>The analysis included participants in the JMDC who underwent EVAR or OAR for intact (iAAA) or ruptured (rAAA) AAA. Patients with less than 6 months of records before the aortic repair were excluded.</p><p><strong>Main outcome measures: </strong>Overall survival and reintervention rates.</p><p><strong>Results: </strong>We identified 986 cases (837 iAAA and 149 rAAA) from JMDC with first aortic repairs between January 2015 and December 2020. The number of patients, median age (years (IQR)), follow-up (months) and post-procedure CT scan (times per year) were as follows: iAAA (OAR: n=593, 62.0 (57.0-67.0), 26.0, 1.6, EVAR: n=244, 65.0 (31.0-69.0), 17.0, 2.2), rAAA (OAR: n=110, 59.0 (53.0-59.0), 16.0, 2.1, EVAR: n=39, 62.0 (31.0-67.0), 18.0, 2.4). Reintervention rate was significantly higher among EVAR than OAR in rAAA (15.4% vs 8.2%, p=0.04). In iAAA, there were no group difference after 5 years (7.8% vs 11.0%, p=0.28), even though EVAR had initial advantage. There were no differences in mortality rate between EVAR and OAR for either rAAA or iAAA.</p><p><strong>Conclusions: </strong>Claims-based analysis in Japan showed no statistically significant difference in 5-year survival rates of the OAR and EVAR groups. However, the reintervention rate of EVAR in rAAA was significantly higher, suggesting the need for regular post-EVAR follow-up with imaging. Therefore, international collaborations for long-term outcome studies with real-world data are warranted.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000131"},"PeriodicalIF":0.0,"publicationDate":"2022-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/31/5d/bmjsit-2022-000131.PMC9345055.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40644444","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":"Impact of prostate biopsy technique on outcomes of the precision prostatectomy procedure.","authors":"Ralph Grauer,&nbsp;Michael A Gorin,&nbsp;Akshay Sood,&nbsp;Mohit Butaney,&nbsp;Phil Olson,&nbsp;Guillaume Farah,&nbsp;Renee Hanna Cole,&nbsp;Wooju Jeong,&nbsp;Firas Abdollah,&nbsp;Mani Menon","doi":"10.1136/bmjsit-2021-000122","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000122","url":null,"abstract":"<p><strong>Objective: </strong>To assess the impact of iterative changes in preoperative and postoperative biopsy techniques on the outcomes of men undergoing the precision prostatectomy procedure. Precision prostatectomy is a novel surgical treatment for prostate cancer that aims to maximally preserve erectogenic nerves via partial preservation of the prostate capsule.</p><p><strong>Design: </strong>Retrospective.</p><p><strong>Setting: </strong>Single tertiary care center.</p><p><strong>Participants: </strong>This study included 120 patients who consented to undergo prostate cancer treatment with the precision prostatectomy procedure. Patients were originally enrolled in one of two separate prospective protocols studying precision prostatectomy.</p><p><strong>Interventions: </strong>Preoperatively, 60 patients were screened with transrectal (TR) biopsy and 60 were screened by transperineal (TP) biopsy. Ultimately, 117 patients underwent precision prostatectomy. Of the 43 postoperative biopsies, 19 were TR; 17 were TP with ultrasound; and 7 were TP with microultrasound (mUS).</p><p><strong>Main outcome measures: </strong>Preoperatively, we evaluated whether the transition to TP biopsy was associated with differences in postoperative treatment failure defined as a neoplasm-positive postoperative biopsy. Postoperative biopsies were compared with respect to their ability to sample the remnant tissue, specifically percentage of cores positive for prostate tissue.</p><p><strong>Results: </strong>Preoperatively, 9/60 (15%) positive postoperative biopsies occurred in the TR group and 6/60 (10%) in the TP group; Kaplan-Meier survival estimates did not differ between groups (p=0.69 by log rank). Postoperatively, the numbers of cores positive for prostate tissue were 99/160 (62%), 63/107 (59%), and 36/39 (92%) in the TR biopsy, TP with ultrasound, and TP with mUS groups, respectively; this difference was statistically significant versus the rate in the TR and standard TP groups (p=0.0003 and 0.0002).</p><p><strong>Conclusion: </strong>We found no significant improvement in patient screening, preoperatively-though limited by small sample size and relatively short follow-up. The incorporation of high-frequency mUS for postoperative biopsies improved the ability to sample the remnant tissue with a higher efficiency.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000122"},"PeriodicalIF":0.0,"publicationDate":"2022-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/25/da/bmjsit-2021-000122.PMC9260793.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40548336","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":"First in-human trial and prospective case series of an articulated laparoscopic camera system in minimally invasive surgery in gynecology: an IDEAL stage 1 and 2a study.","authors":"Tong Yow Ng,&nbsp;Siew Fei Ngu,&nbsp;Tat Yan Deyoung Kam,&nbsp;Sai Yan Ng,&nbsp;Ping Lai Benny Lo","doi":"10.1136/bmjsit-2021-000117","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000117","url":null,"abstract":"<p><strong>Objectives: </strong>Precision Robotics' Sirius Robotic Flexible Endoscopic System is a new, fully integrated, compact three-dimensional laparoscopic camera system with a disposable single-use flexible tip that can change its viewing direction. This IDEAL Stage 1 and 2a study assessed its safety, reliability and potential efficacy particularly for single incision laparoscopic surgery and vaginal natural orifice transluminal endoscopic surgery.</p><p><strong>Design: </strong>Prospective single-institution, single-surgeon study.</p><p><strong>Setting: </strong>The study was conducted in a multispecialty hospital.</p><p><strong>Participants: </strong>Women aged 18-70 years scheduled for gynecological laparoscopic surgery were invited to participate. An information sheet and consent was available for the women and an informed consent was obtained. Thirteen participants completed this study.</p><p><strong>Interventions: </strong>The laparoscopic procedures were done in the usual manner. The only difference was the Sirius System was used in place of the conventional laparoscope. All other procedures and instruments remained the same.</p><p><strong>Main outcome measures: </strong>Primary outcome was the proportion of women who successfully completed the intended procedure using the Sirius System without conversion to another camera system, camera users and surgeon's view and experience, and iterations and modifications to the system. Secondary outcomes were the incidence of intraoperative and postoperative complications during the first 6 weeks following surgery, and duration of surgery.</p><p><strong>Results: </strong>85% (11/13) of women had their procedure completed successfully using the Sirius System. Two women required immediate conversion to the conventional laparoscope due to technical issues. There were no intraoperative complications. Users agreed that the improved field of view was beneficial for laparoscopic surgery. Iterative improvements were made in the imaging quality, user interface and manufacturing quality.</p><p><strong>Conclusions: </strong>Sirius System has early indications for safety and efficacy for intermediate and major minimally invasive laparoscopic procedures in gynecology. Further studies are needed to confirm it can replace a conventional laparoscope in the surgical workflow.</p><p><strong>Trial registration number: </strong>NCT05048407.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000117"},"PeriodicalIF":0.0,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/55/f3/bmjsit-2021-000117.PMC8900025.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40314584","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 stage of novel digital health interventions for postoperative monitoring: protocol of a systematic review.","authors":"Kenneth A McLean,&nbsp;Stephen R Knight,&nbsp;Thomas M Diehl,&nbsp;Syed Nabeel Zafar,&nbsp;Matt Bouamrane,&nbsp;Ewen M Harrison","doi":"10.1136/bmjsit-2021-000104","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000104","url":null,"abstract":"<p><strong>Introduction: </strong>The postoperative period represents a time where patients are at a high-risk of morbidity, which warrants effective surveillance. While digital health interventions (DHIs) for postoperative monitoring are promising, a coordinated, standardized and evidence-based approach regarding their implementation and evaluation is currently lacking. This study aimed to identify DHIs implemented and evaluated in postoperative care to highlight research gaps and assess the readiness for routine implementation.</p><p><strong>Methods: </strong>A systematic review will be conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify studies describing the implementation and evaluation of DHIs for postoperative monitoring published since 2000 (PROSPERO ID: CRD42021264289). This will encompass the Embase, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Web of Science and ClinicalTrials.gov databases, and manual search of bibliographies for relevant studies and gray literature. Methodological reporting quality will be evaluated using the Idea, Development, Exploration, Assessment and Long-term Follow-up (IDEAL) reporting guideline relevant to the IDEAL stage of the study, and risk of bias will be assessed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) framework. Data will be extracted according to the WHO framework for monitoring and evaluating DHIs, and a narrative synthesis will be performed.</p><p><strong>Discussion: </strong>This review will assess the readiness for implementation of DHIs for routine postoperative monitoring and will include studies describing best practice from service changes already being piloted out of necessity during the COVID-19 pandemic. This will identify interventions with sufficient evidence to progress to the next IDEAL stage, and promote standardized and comprehensive evaluation of future implementational studies.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000104"},"PeriodicalIF":0.0,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8900039/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40314586","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":"Transesophageal echocardiography and risk of respiratory failure in patients who had ischemic stroke or transient ischemic attack: an IDEAL phase 4 study.","authors":"Samuel S Bruce,&nbsp;Babak B Navi,&nbsp;Cenai Zhang,&nbsp;Jiwon Kim,&nbsp;Richard B Devereux,&nbsp;Edward J Schenck,&nbsp;Art Sedrakyan,&nbsp;Iván Díaz,&nbsp;Hooman Kamel","doi":"10.1136/bmjsit-2021-000116","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000116","url":null,"abstract":"<p><strong>Objective: </strong>Transesophageal echocardiography (TEE) is sometimes used to search for cardioembolic sources after ischemic stroke or transient ischemic attack (TIA). TEE visualizes some sources better than transthoracic echocardiography, but TEE is invasive and may cause aspiration. Few data exist on the risk of respiratory complications after TEE in patients who had stroke or TIA. Our objective was to determine whether TEE was associated with increased risk of respiratory failure in patients who had ischemic stroke or TIA.</p><p><strong>Design: </strong>This is a retrospective cohort study using administrative data from inpatient and outpatient insurance claims collected by the US federal government's Centers for Medicare and Medicaid Services.</p><p><strong>Setting: </strong>Hospitals and outpatient clinics throughout the USA.</p><p><strong>Participants: </strong>99 081 patients ≥65 years old hospitalized for out-of-hospital ischemic stroke or TIA, defined by validated International Classification of Disease-9/10 diagnosis codes and present-on-admission codes, using claims data from 2008 to 2018 in a random 5% sample of Medicare beneficiaries.</p><p><strong>Main outcome measures: </strong>Acute respiratory failure, defined as endotracheal intubation and/or mechanical ventilation, starting on the first day after admission through 28 days afterward.</p><p><strong>Results: </strong>Of 99 081 patients included in this analysis, 73 733 (74.4%) had an ischemic stroke and 25 348 (25.6%) a TIA. TEE was performed in 4677 (4.7%) patients and intubation and/or mechanical ventilation in 1403 (1.4%) patients. The 28-day cumulative risk of respiratory failure after TEE (1.4%; 95% CI 0.8% to 2.7%) was similar to that seen in those without TEE (1.4%; 95% CI 1.4% to 1.5%) (p=0.84). After adjustment for age, sex, race, Charlson comorbidities, diagnosis of stroke versus TIA, intravenous thrombolysis, and mechanical thrombectomy, TEE was not associated with an increased risk of respiratory failure (HR, 0.9; 95% CI 0.6 to 1.2).</p><p><strong>Conclusions: </strong>In a cohort of older patients who had ischemic stroke or TIA, TEE was not associated with an increased risk of subsequent respiratory failure.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000116"},"PeriodicalIF":0.0,"publicationDate":"2022-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/94/18/bmjsit-2021-000116.PMC8823208.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39637358","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":"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}