Xavier Philip Fowler, Barbara Gladders, Kayla Moore, Jialin Mao, Art Sedrakyan, Philip Goodney
{"title":"Survival, reintervention and surveillance reports: long-term, centre-level evaluation and feedback of vascular interventions.","authors":"Xavier Philip Fowler, Barbara Gladders, Kayla Moore, Jialin Mao, Art Sedrakyan, Philip Goodney","doi":"10.1136/bmjsit-2022-000140","DOIUrl":"https://doi.org/10.1136/bmjsit-2022-000140","url":null,"abstract":"<p><p>The combination of registry and administrative claims data have facilitated research and quality improvement efforts. Using Vascular Quality Initiative (VQI) registry data and Medicare claims we have generated centre-specific survival, reintervention and surveillance reports which benchmark participating centres' performance to the VQI as a whole and to published guidelines. In 2021, we distributed these reports to 303 participating centres. These reports offer an opportunity for centres to evaluate their performance and identify focus areas for quality improvement work.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000140"},"PeriodicalIF":0.0,"publicationDate":"2022-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1a/46/bmjsit-2022-000140.PMC9557801.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33515268","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-2021-000125corr1","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000125corr1","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":"e000125corr1"},"PeriodicalIF":0.0,"publicationDate":"2022-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e7/51/bmjsit-2021-000125corr1.PMC9362785.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40634650","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, Danica Marinac-Dabic, Susan dosReis, Philip Goodney, C Daniel Mullins, Fadia Shaya
{"title":"Creation of objective performance criteria among medical devices.","authors":"Laura Elisabeth Gressler, Danica Marinac-Dabic, Susan dosReis, Philip Goodney, C Daniel Mullins, Fadia Shaya","doi":"10.1136/bmjsit-2021-000106","DOIUrl":"https://doi.org/10.1136/bmjsit-2021-000106","url":null,"abstract":"<p><strong>Objectives: </strong>Objective performance criteria (OPC) may serve as a tool to expedite the approval process and continue active surveillance of class III medical devices. Thus far, published guidance on the creation of OPC has been clinical area-specific. This study aimed to capture reflections from key stakeholders on the creation of OPC that may serve as a precursor for a formalized conceptual framework within the USA.</p><p><strong>Design: </strong>Reflections from key stakeholders and guidance from an advisory committee were captured to gain an understanding of the elements that are crucial to the generation of OPC.</p><p><strong>Setting: </strong>A non-probability sampling method using the purposive sampling strategy was employed to identify relevant stakeholders for engagement in semi-structured, open-ended, concept elicitation discussions.</p><p><strong>Participants: </strong>Stakeholders involved in the generation of OPC.</p><p><strong>Main outcome measures: </strong>Elements and themes regarding the priorities of, experiences with, roles within and perceived challenges associated with OPC creation captured through a phenomenological approach.</p><p><strong>Results: </strong>A total of 27 participants were engaged to represent the following contributors: representatives of registries, health systems, health technology assessment bodies, clinicians, device application reviewers, payers, patients, patient representatives, patient caregivers, device manufacturers, data coordinators, data analysts and data informaticians. Consensus was achieved on the five core elements: (1) identification of medical devices, (2) engagement of key stakeholders, (3) selection of data source, (4) performance of appropriate statistical analyses and (5) reporting of findings. The engagement of key stakeholders (38%) was cited most frequently as the most important core element. Access to meaningful and high-quality data sources (47%) was the most frequently mentioned challenge.</p><p><strong>Conclusions: </strong>The reflections from the participants identified five elements to be considered when generating an OPC within class III medical devices and may provide the needed foundation for the development of official guidance on OPC generation.</p>","PeriodicalId":33349,"journal":{"name":"BMJ Surgery Interventions Health Technologies","volume":" ","pages":"e000106"},"PeriodicalIF":0.0,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/db/7c/bmjsit-2021-000106.PMC9345051.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40644443","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, Hiroshi Ohtsu, Naohiro Yonemoto, Nobuyoshi Azuma, 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}
Ralph Grauer, Michael A Gorin, Akshay Sood, Mohit Butaney, Phil Olson, Guillaume Farah, Renee Hanna Cole, Wooju Jeong, Firas Abdollah, Mani Menon
{"title":"Impact of prostate biopsy technique on outcomes of the precision prostatectomy procedure.","authors":"Ralph Grauer, Michael A Gorin, Akshay Sood, Mohit Butaney, Phil Olson, Guillaume Farah, Renee Hanna Cole, Wooju Jeong, Firas Abdollah, 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}
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
{"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}
Tong Yow Ng, Siew Fei Ngu, Tat Yan Deyoung Kam, Sai Yan Ng, Ping Lai Benny Lo
{"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, Siew Fei Ngu, Tat Yan Deyoung Kam, Sai Yan Ng, 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}
Kenneth A McLean, Stephen R Knight, Thomas M Diehl, Syed Nabeel Zafar, Matt Bouamrane, Ewen M Harrison
{"title":"Development stage of novel digital health interventions for postoperative monitoring: protocol of a systematic review.","authors":"Kenneth A McLean, Stephen R Knight, Thomas M Diehl, Syed Nabeel Zafar, Matt Bouamrane, 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}