BMJ Surgery Interventions Health Technologies最新文献

{"title":"Integration of a personalised mobile health (mHealth) application into the care of patients with brain tumours: proof-of-concept study (IDEAL stage 1).","authors":"Andrew Gvozdanovic,&nbsp;Felix Jozsa,&nbsp;Naomi Fersht,&nbsp;Patrick James Grover,&nbsp;Georgina Kirby,&nbsp;Neil Kitchen,&nbsp;Riccardo Mangiapelo,&nbsp;Andrew McEvoy,&nbsp;Anna Miserocchi,&nbsp;Rayna Patel,&nbsp;Lewis Thorne,&nbsp;Norman Williams,&nbsp;Michael Kosmin,&nbsp;Hani J Marcus","doi":"10.1136/bmjsit-2021-000130","DOIUrl":"10.1136/bmjsit-2021-000130","url":null,"abstract":"<p><strong>Objectives: </strong>Brain tumours lead to significant morbidity including a neurocognitive, physical and psychological burden of disease. The extent to which they impact the multiple domains of health is difficult to capture leading to a significant degree of unmet needs. Mobile health tools such as Vinehealth have the potential to identify and address these needs through real-world data generation and delivery of personalised educational material and therapies. We aimed to establish the feasibility of Vinehealth integration into brain tumour care, its ability to collect real-world and (electronic) patient-recorded outcome (ePRO) data, and subjective improvement in care.</p><p><strong>Design: </strong>A mixed-methodology IDEAL stage 1 study.</p><p><strong>Setting: </strong>A single tertiary care centre.</p><p><strong>Participants: </strong>Six patients consented and four downloaded and engaged with the mHealth application throughout the 12 weeks of the study.</p><p><strong>Main outcome measures: </strong>Over a 12-week period, we collected real-world and ePRO data via Vinehealth. We assessed qualitative feedback from mixed-methodology surveys and semistructured interviews at recruitment and after 2 weeks.</p><p><strong>Results: </strong>565 data points were captured including, but not limited to: symptoms, activity, well-being and medication. EORTC QLQ-BN20 and EQ-5D-5L completion rates (54% and 46%) were impacted by technical issues; 100% completion rates were seen when ePROs were received. More brain cancer tumour-specific content was requested. All participants recommended the application and felt it improved care.</p><p><strong>Conclusions: </strong>Our findings indicate value in an application to holistically support patients living with brain cancer tumours and established the feasibility and safety of further studies to more rigorously assess this.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"4 1","pages":"e000130"},"PeriodicalIF":0.0,"publicationDate":"2022-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/62/76/bmjsit-2021-000130.PMC9791405.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10457903","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":"Building Blocks for the Long-acting and Permanent Contraceptives Coordinated Registry Network.","authors":"Courtney E Baird, Maryam Guiahi, Scott Chudnoff, Nilsa Loyo-Berrios, Stephanie Garcia, Mary Jung, Laura Elisabeth Gressler, Jialin Mao, Beth Hodshon, Art Sedrakyan, Sharon Andrews, Kelly Colden, Jason Roberts, Abby Anderson, Catherine Sewell, Danica Marinac-Dabic","doi":"10.1136/bmjsit-2020-000075","DOIUrl":"10.1136/bmjsit-2020-000075","url":null,"abstract":"<p><strong>Objectives: </strong>A multistakeholder expert group under the Women's Health Technology Coordinated Registry Network (WHT-CRN) was organized to develop the foundation for national infrastructure capturing the performance of long-acting and permanent contraceptives. The group, consisting of representatives from professional societies, the US Food and Drug Administration, academia, industry and the patient community, was assembled to discuss the role and feasibility of the CRN and to identify the core data elements needed to assess contraceptive medical product technologies.</p><p><strong>Design: </strong>We applied a Delphi survey method approach to achieve consensus on a core minimum data set for the future 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. After the first survey, questions for subsequent surveys were based on the analysis process and conference call discussions with group members. This process was repeated two times over a 6-month time period until consensus was achieved.</p><p><strong>Results: </strong>Twenty-three experts participated in the Delphi process. Participation rates in the first and second round of the Delphi survey were 83% and 100%, respectively. The working group reached final consensus on 121 core data elements capturing reproductive/gynecological history, surgical history, general medical history, encounter information, long-acting/permanent contraceptive index procedures and follow-up, procedures performed in conjunction with the index procedure, product removal, medications, complications related to the long-acting and/or permanent contraceptive procedure, pregnancy and evaluation of safety and effectiveness outcomes.</p><p><strong>Conclusions: </strong>The WHT-CRN expert group produced a consensus-based core set of data elements that allow the study of current and future contraceptives. These data elements influence patient and provider decisions about treatments and include important outcomes related to safety and effectiveness of these medical devices, which may benefit other women's health stakeholders.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"4 Suppl 1","pages":"e000075"},"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/cb/18/bmjsit-2020-000075.PMC9660629.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9723702","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":"Maturity framework and select approaches for developing Coordinated Registry Networks (CRNs): Medical Device Epidemiology Network (MDEpiNet) supplement.","authors":"Art Sedrakyan, Suvekshya Aryal","doi":"10.1136/bmjsit-2022-000148","DOIUrl":"10.1136/bmjsit-2022-000148","url":null,"abstract":"","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"4 Suppl 1","pages":"e000148"},"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/24/08/bmjsit-2022-000148.PMC9660703.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9723698","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":"Orthopedic Coordinated Registry Network (Ortho-CRN): advanced infrastructure for real-world evidence generation.","authors":"Laura Elisabeth Gressler, Vincent Devlin, Mary Jung, Danica Marinac-Dabic, Art Sedrakyan, Elizabeth W Paxton, Patricia Franklin, Ronald Navarro, Said Ibrahim, Jonathan Forsberg, Paul E Voorhorst, Robbert Zusterzeel, Michael Vitale, Michelle C Marks, Peter O Newton, Raquel Peat","doi":"10.1136/bmjsit-2020-000073","DOIUrl":"10.1136/bmjsit-2020-000073","url":null,"abstract":"","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":"4 Suppl 1","pages":"e000073"},"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/ab/11/bmjsit-2020-000073.PMC9660599.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9708575","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 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}