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
{"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}
Cynthia Long, James E Tcheng, Danica Marinac-Dabic, Andrea Iorga, Mitchell Krucoff, Deborah Fisher
{"title":"Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN).","authors":"Cynthia Long, James E Tcheng, Danica Marinac-Dabic, Andrea Iorga, Mitchell Krucoff, Deborah Fisher","doi":"10.1136/bmjsit-2021-000118","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000118","url":null,"abstract":"<p><p>Obesity continues to be a major public health issue, with more than two-thirds of adults in the USA categorized as overweight or obese. Bariatric surgery is effective and yields durable weight loss; however, few qualified candidates choose to undergo surgical treatment. Less-invasive alternatives to bariatric surgery are being developed to bridge the treatment gap. Recognizing the burden of conducting pivotal clinical trials and traditional post-approval studies for medical devices, the Food and Drug Administration (FDA) Center for Devices and Radiological Health has encouraged the development of real-world data content and quality that is sufficient to provide evidence for Total Product Life Cycle medical device evaluation. A key first step is to establish a minimum core data structure that provides a common lexicon for endoscopic obesity devices and its corresponding interoperable data elements. Such a structure would facilitate data capture across existing workflow with a 'coordinated registry network' capability. On July 29, 2016, a workshop entitled, 'GI Coordinated Registry Network: A Case for Obesity Devices' was held at the FDA White Oak Campus by the Medical Device Epidemiology Network public-private partnership and FDA to initiate the work of developing a common lexicon and core data elements in the metabolic device space, which marked the inauguration of the Gastrointestinal Coordinated Registry Network project. Several work groups were subsequently formed to address clinical issues, data quality issues, registry participation, and data sharing.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000118"},"PeriodicalIF":0.0,"publicationDate":"2022-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f3/27/bmjsit-2021-000118.PMC9660582.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40692431","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}
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
{"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}
Courtney E Baird, Bilal Chughtai, Catherine S Bradley, Kathleen Kobashi, Mary Jung, Art Sedrakyan, Sharon Andrews, Ann Ferriter, Terri Cornelison, Danica Marinac-Dabic
{"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}
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
{"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}
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
{"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}
Takeaki Ishizawa, Peter McCulloch, Laurents Stassen, Jacqueline van den Bos, Jean-Marc Regimbeau, Jeanne Dembinski, Sylke Schneider-Koriath, Luigi Boni, Takeshi Aoki, Hiroto Nishino, Kiyoshi Hasegawa, Yasuo Sekine, Toyofumi Chen-Yoshikawa, Trevor Yeung, Eren Berber, Bora Kahramangil, Michael Bouvet, Michele Diana, Norihiro Kokudo, Fernando Dip, Kevin White, Raul J Rosenthal
{"title":"Assessing the development status of intraoperative fluorescence imaging for anatomy visualisation, using the IDEAL framework.","authors":"Takeaki Ishizawa, Peter McCulloch, Laurents Stassen, Jacqueline van den Bos, Jean-Marc Regimbeau, Jeanne Dembinski, Sylke Schneider-Koriath, Luigi Boni, Takeshi Aoki, Hiroto Nishino, Kiyoshi Hasegawa, Yasuo Sekine, Toyofumi Chen-Yoshikawa, Trevor Yeung, Eren Berber, Bora Kahramangil, Michael Bouvet, Michele Diana, Norihiro Kokudo, Fernando Dip, Kevin White, Raul J Rosenthal","doi":"10.1136/bmjsit-2022-000156","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000156","url":null,"abstract":"<p><strong>Objectives: </strong>Intraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: visualising anatomy, assessing tissue perfusion, identifying/localising cancer and mapping lymphatic systems. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging used to visualise anatomical structures using the IDEAL framework, a framework designed to describe the stages of innovation in surgery and other interventional procedures.</p><p><strong>Design: </strong>IDEAL staging based on a thorough literature review.</p><p><strong>Setting: </strong>All publications on intraoperative fluorescence imaging for visualising anatomical structures reported in PubMed through 2020 were identified for five surgical procedures: cholangiography, hepatic segmentation, lung segmentation, ureterography and parathyroid identification.</p><p><strong>Main outcome measures: </strong>The IDEAL stage of research evidence was determined for each of the five procedures using a previously described approach.</p><p><strong>Results: </strong>225 articles (8427 cases) were selected for analysis. Current status of research evidence on fluorescence imaging was rated IDEAL stage 2a for ureterography and lung segmentation, IDEAL 2b for hepatic segmentation and IDEAL stage 3 for cholangiography and parathyroid identification. Enhanced tissue identification rates using fluorescence imaging relative to conventional white-light imaging have been documented for all five procedures by comparative studies including randomised controlled trials for cholangiography and parathyroid identification. Advantages of anatomy visualisation with fluorescence imaging for improving short-term and long-term postoperative outcomes also were demonstrated, especially for hepatobiliary surgery and (para)thyroidectomy. No adverse reactions associated with fluorescent agents were reported.</p><p><strong>Conclusions: </strong>Intraoperative fluorescence imaging can be used safely to enhance the identification of anatomical structures, which may lead to improved postoperative outcomes. Overviewing current research knowledge using the IDEAL framework aids in designing further studies to develop fluorescence imaging techniques into an essential intraoperative navigation tool in each surgical field.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000156"},"PeriodicalIF":0.0,"publicationDate":"2022-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/58/15/bmjsit-2022-000156.PMC9639126.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40454216","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}
Mudathir Ibrahim, Arsenio Paez, Jiajie Yu, Baptiste Vasey, Joel Horovitz, Peter McCulloch
{"title":"Examining the empirical evidence for IDEAL 2b studies: the effects of preceding prospective collaborative cohort studies on the quality and impact of subsequent randomized controlled trials of surgical innovations - protocol for a systematic review and case-control analysis.","authors":"Mudathir Ibrahim, Arsenio Paez, Jiajie Yu, Baptiste Vasey, Joel Horovitz, Peter McCulloch","doi":"10.1136/bmjsit-2021-000120","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000120","url":null,"abstract":"<p><p>Randomized controlled trials (RCTs) in surgery face methodological challenges, which often result in low quality or failed trials. The Idea, Development, Exploration, Assessment and Long-term (IDEAL) framework proposes preliminary prospective collaborative cohort studies with specific properties (IDEAL 2b studies) to increase the quality and feasibility of surgical RCTs. Little empirical evidence exists for this proposition, and specifically designed 2b studies are currently uncommon. Prospective collaborative cohort studies are, however, relatively common, and might provide similar benefits. We will, therefore, assess the association between prior 'IDEAL 2b-like' cohort studies and the quality and impact of surgical RCTs. We propose a systematic review using two parallel case-control analyses, with surgical RCTs as subjects and study quality and journal impact factor (IF) as the outcomes of interest. We will search for surgical RCTs published between 2015 and 2019 and and prior prospective collaborative cohort studies authored by any of the RCT investigators. RCTs will be categorized into cases or controls by (1) journal (IF ≥or <5) and (2) study quality (PEDro score ≥or < 7). The case/control OR of exposure to a prior '2b like' study will be calculated independently for quality and impact. Cases will be matched 1: 1 with controls by year of publication, and confounding by peer-reviewed funding, author academic affiliation and trial protocol registration will be examined using multiple logistic regression analysis. This study will examine whether preparatory IDEAL 2b-like studies are associated with higher quality and impact of subsequent RCTs.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000120"},"PeriodicalIF":0.0,"publicationDate":"2022-11-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3a/9c/bmjsit-2021-000120.PMC9639119.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40454217","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":"Correction: Evaluation of intervertebral body implant performance using active surveillance of electronic health records.","authors":"","doi":"10.1136/bmjsit-2021-000125corr2","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000125corr2","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1136/bmjsit-2021-000125.].</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000125corr2"},"PeriodicalIF":0.0,"publicationDate":"2022-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/71/9e/bmjsit-2021-000125corr2.PMC9582312.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40653007","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}