BMJ Surgery Interventions Health Technologies最新文献

Objectives: 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.

Design: 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.

Results: 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.

Conclusions: 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.

Objectives: 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.

Design setting and participants: 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.

Main outcome measures: 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.

Results: 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.

Conclusions: 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.

Objectives: 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.

Design: 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.

Results: 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.

Conclusions: 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.

Objectives: 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.

Design: IDEAL staging based on a thorough literature review.

Setting: 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.

Main outcome measures: The IDEAL stage of research evidence was determined for each of the five procedures using a previously described approach.

Results: 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.

Conclusions: 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.

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.

[This corrects the article DOI: 10.1136/bmjsit-2021-000125.].

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.

[This corrects the article DOI: 10.1136/bmjsit-2021-000125.].