Establishing a Risk Assessment Framework for Point-of-Care Ultrasound

Point of Care Ultrasound (POCUS) refers to the use of portable ultrasound (US) applications at the bedside, performed directly by the treating physician, for either diagnostic or procedure guidance purposes. It is being rapidly adopted by traditionally non-imaging medical specialties across the globe. Recent international evidence-based guidelines on POCUS for critically ill neonates and children were issued by the POCUS Working Group of the European Society of Pediatric and Neonatal Intensive Care (ESPNIC). Currently there are no standardized national or international guidelines for its implementation into clinical practice or even the training curriculum to monitor quality assurance. Further, there are no definitions or methods of POCUS competency measurement across its varied clinical applications.The Hippocratic Oath suggests medical providers do no harm to their patients. In our continued quest to uphold this value, providers seeking solutions to clinical problems must often weigh the benefit of an intervention with the risk of harm to the patient. Technologies to guide diagnosis and medical management present unique considerations when assessing possible risk to the patient. Frequently risk extends beyond the patient and impacts providers and the institutions in which they practice. Point-of-care ultrasound (POCUS) is an emerging technology increasingly incorporated in the care of children across varied clinical specialties. Concerns have been raised by clinical colleagues and regulatory agencies regarding appropriate POCUS use and oversight. We present a framework for assessing the risk of POCUS use in pediatrics and suggest methods of mitigating risk to optimize safety and outcomes for patients, providers and institutions.

Image-guided Sports Medicine and Musculoskeletal Tumor Interventions: A Patient-Centered Model

The spectrum of effective musculoskeletal (MSK) interventions is broadening and rapidly evolving. Increasing demands incite a perpetual need to optimize services and interventions by maximizing the diagnostic and therapeutic yield, reducing exposure to ionizing radiation, increasing cost efficiency, as well as identifying and promoting effective procedures to excel in patient satisfaction ratings and outcomes. MSK interventions for the treatment of oncological conditions, and conditions related to sports injury can be performed with different imaging modalities; however, there is usually one optimal image guidance modality for each procedure and individual patient. We describe our patient-centered workflow as a model of care that incorporates state-of-the-art imaging techniques, up-to-date evidence, and value-based practices with the intent of optimizing procedural success and outcomes at a patient-specific level. This model contrasts interventionalist- and imaging modality-centered practices, where procedures are performed based on local preference and selective availability of imaging modality or interventionalists. We discuss rationales, benefits, and limitations of fluoroscopy, ultrasound, computed tomography, and magnetic resonance imaging procedure guidance for a broad range of image-guided MSK interventions to diagnose and treat sports and tumor-related conditions.

Devices for image-guided lung interventions: State-of-the-art review

Lung cancer is the leading cause of cancer-related death. According to the American Cancer Society, there were an estimated 222,500 new cases of lung cancer and 155,870 deaths from lung cancer in the United States in 2017. Accurate localization in lung interventions is one of the keys to reducing the death rate from lung cancer. In this study, a total of 217 publications from 2006 to 2017 about designs of medical devices for localization in lung interventions were screened, shortlisted, and categorized by localization principle and reviewed for functionality. Each study was analyzed for engineering characteristics and clinical significance. Research regarding interventional imaging equipment, navigation systems, and surgical devices was reviewed, and both research prototypes and commercial products were discussed. Finally, the future directions and existing challenges were summarized, including real-time intra-procedure guidance, accuracy of localization, clinical application, clinical adoptability, and clinical regulatory issues.

VP22 Applying The IDEAL Framework To NICE Interventional Procedure Guidance

IntroductionThe IDEAL (Idea, Development, Exploration, Assessment, Learning) Framework measures the maturity of evidence base behind surgical innovation. The NICE Interventional Procedures (IP) programme issues guidance for the United Kingdom National Health Service (NHS) on use of surgical innovation. One of four recommendations can be made: (a) standard arrangements, (b) special arrangements, (c) research only, and (d) do not use. This study aimed to investigate whether the recommendation of NICE IP guidance corresponded with the stage of innovation as determined by IDEAL, thus IDEAL's role in informing future guidance production.MethodsA retrospective sample of 103 pieces of guidance issued between 2015 and 2018 was analysed. One researcher examined the evidence base and determined the corresponding stage of the IDEAL framework, numbered 1, 2, 2a, 3 and 4. The primary outcome measure was the association between stage of evidence on IDEAL framework and the recommendation of published NICE IP guidance.ResultsThere were twenty-one (20 percent), thirty-three (32 percent), three (3 percent), forty (39 percent) and six (6 percent) procedures at IDEAL stages 1, 2, 2a, 3 and 4, respectively. Of those at stage 1 (idea), 48 percent were given research only arrangements, 43 percent special arrangements, and 10 percent standard. Many of the procedures at stages 2 (development) and 2a (exploration) were given standard arrangements (39 percent and 67 percent respectively). Forty-three percent of stage 3 (assessment) and 67 percent of stage 4 (learning) guidance were identified standard. At stage 4 none were given a ‘research only’ recommendation.ConclusionsProcedures given ‘standard’ arrangements guidance are more likely have a mature and robust evidence base as determined by IDEAL. Those with limited evidence are more likely to be given a more cautious ‘research only’ guidance. Routine use of this framework could help inform future guidance production however cannot replace the decision-making function of the NICE committee which also involves patient experiences, population characteristics, risk of serious safety events, and equity issues.

VP41 NICE Interventional Procedures Advisory Committee Recommendations

IntroductionThis study explores the factors (principally evidential) that predict guidance recommendations by this NICE committee. There are three main types of recommendations: Standard/normal arrangements (can be done without restriction in the NHS); Special arrangements (can be done under certain conditions); and Research only.MethodsThe following data were extracted from all published pieces of Interventional Procedure Guidance (IPGs) produced by this committee: year, IPG number, recommendations, evidence base (numbers and types of included studies, numbers of included patients etc.). All data were extracted independently by two researchers, and any disagreements clarified by consensus. Data were tabulated and descriptive statistics produced. Regression analyses will be performed using these data to identify any statistically significant predictors of recommendations.ResultsIPG recommendations (n = 496); year range: 2003-2018. Proportion of IPGs by each recommendation: 50% Standard; 38% Special; 11% Research Only; 2% Do Not Do. Proportion of IPGs with highest level evidence (i.e. systematic review and/or RCT) by recommendation type: Standard = 64% (152/239); Special = 43% (77/180); Research Only = 48% (26/54); Do Not Do = 75% (6/8). Mean numbers of patients by recommendation type: Standard = 7,838; Special = 3,935; Research Only = 2,423. There is also a clear trend over time: Standard recommendations decrease for all IPGs from 63% in 2003-2009 to 40% in 2014-2018; and the evidence threshold for Standard recommendations increases over time from 56% based on systematic reviews and/or RCTs in 2003-2009 to 85% in 2014-2018; mean numbers of patients per Standard recommendation also increase from 2,002 to 6,098 over this period.ConclusionsHigher levels evidence and numbers of patients increase the likelihood of the most positive recommendation. However, this evidence might still lack sufficient quality or certainty to answer a policy question. The evidence threshold to achieve a Standard recommendation has also increased markedly over time. As with other NICE committees, factors other than cost and perceived hierarchies of evidence clearly act as drivers of decisions.