Evaluation of the Prime Diet Quality Score from Early Childhood Through Mid-Adolescence.

BACKGROUND: Few diet quality indices have been developed and validated for use among children and adolescents. Additionally, many available indices require completion of burdensome dietary assessments. OBJECTIVES: We aimed to calculate and evaluate the performance of a modified version of the food-based Prime Diet Quality Score (PDQS) derived from different diet assessment methods conducted at 4 time points in a single study population from childhood through adolescence. METHODS: Among 1460 child participants in the Project Viva cohort, we calculated the PDQS in early and mid-childhood and early and mid-adolescence using dietary data obtained from food frequency questionnaire (early childhood: parent report), PrimeScreen (mid-childhood: parent report; early adolescence: self-report) and 24-h recall (mid-adolescence: self-report). We evaluated construct and relative validity and internal reliability of the score in each life stage. RESULTS: The PDQS showed a range of scores at all life stages and higher scores were associated with intake of many health-promoting macronutrients and micronutrients (e.g., protein, fiber, and vitamins) in early childhood and mid-adolescence. The PDQS performed similarly to the Youth Healthy Eating Index/Healthy Eating Index (Spearman r = 0.63-0.85) in various assessments. Higher PDQS was associated with expected characteristics including more frequent breakfast eating, family dinners, and vigorous physical activity; with less frequent TV viewing and fast food intake; and with more sleep and higher maternal diet scores during pregnancy. Cross-sectional associations of the PDQS with various anthropometric measurements and biomarkers were inconsistent but generally in the expected directions (e.g., higher PDQS associated with lower triglycerides and insulin and higher HDL cholesterol). Internal reliability was consistent with what has been found for other diet quality indices. CONCLUSIONS: The PDQS can be calculated from data collected using different and brief dietary assessment methods and appears to be a valid and useful measure of overall diet quality in children and adolescents. Project Viva was registered at clinicaltrials.gov as NCT02820402.

The 2022 top 10 list of endoscopy topics in medical publishing: an annual review by the American Society for Gastrointestinal Endoscopy Editorial Board.

Using a systematic literature search of original articles published during 2022 in Gastrointestinal Endoscopy and other high-impact medical and gastroenterology journals, the 10-member Editorial Board of the American Society for Gastrointestinal Endoscopy composed a list of the 10 most significant topic areas in GI endoscopy during the study year. Each Editorial Board member was directed to consider 3 criteria in generating candidate lists-significance, novelty, and global impact on clinical practice-and subject matter consensus was facilitated by the Chair through electronic voting. The 10 identified areas collectively represent advances in the following endoscopic spheres: artificial intelligence, endoscopic submucosal dissection, Barrett's esophagus, interventional EUS, endoscopic resection techniques, pancreaticobiliary endoscopy, management of acute pancreatitis, endoscopic environmental sustainability, the NordICC trial, and spiral enteroscopy. Each board member was assigned a consensus topic area around which to summarize relevant important articles, thereby generating this précis of the "top 10" endoscopic advances of 2022.

Promoting Research that Supports High-Quality Gastrointestinal Endoscopy in Children.

PURPOSE OF REVIEW: Defining and measuring the quality of endoscopic care is a key component of performing gastrointestinal endoscopy in children. The purpose of this review is to discuss quality metrics for pediatric gastrointestinal endoscopy and identify where additional research is needed. RECENT FINDINGS: Pediatric-specific standards and indicators were recently defined by the international Pediatric Endoscopy Quality Improvement Network (PEnQuIN) working group through a rigorous guideline consensus process. Although the aim of these guidelines is to facilitate best practices for safe and high-quality gastrointestinal endoscopy in children, they highlight the pressing need to expand upon the body of evidence supporting these standards and indicators as predictors of clinically relevant outcomes. In this review, we propose and discuss ideas for several high-yield research topics to engage pediatric endoscopists and promote best practices in pediatric endoscopy.

Pediatric Endoscopy Quality Improvement Network (PEnQuIN) quality standards and indicators for pediatric endoscopy: an ASGE-endorsed guideline.

BACKGROUND AND AIMS: Current endoscopy quality guidelines largely focus on cancer screening-related metrics that are not applicable to pediatric populations. Through an international Pediatric Endoscopy Quality Improvement Network (PEnQuIN), quality standards and indicators for pediatric endoscopic procedures were developed and endorsed by the American Society for Gastrointestinal Endoscopy (ASGE). METHODS: The Appraisal of Guidelines for REsearch and Evaluation II instrument guided PEnQuIN members, from 31 centers representing 11 countries, in generating and refining proposed quality standards and indicators. Quality of evidence and strength of recommendations were rated according to the Grading of Recommendation Assessment, Development, and Evaluation approach. Consensus on reporting elements was sought with an iterative online Delphi process. RESULTS: Forty-nine quality standards and 47 indicators, encompassing pediatric endoscopy facilities, procedures, and endoscopists, as well as 30 reporting elements essential for inclusion within a pediatric endoscopy report reached consensus. Minimal acceptable standards were defined for 3 key indicators related to pediatric lower endoscopy: terminal ileal intubation rate ≥85%, cecal intubation rate ≥90%, and rate of adequate bowel preparation ≥80%. There was strong consensus that terminal ileal intubation, rather than cecal intubation, is integral to ensuring high-quality endoscopic care in children. CONCLUSIONS: The PEnQuIN guidelines establish international agreement on clinically meaningful metrics tailored to pediatric endoscopy that can be used to promote safe, high-quality, patient- and family-centered endoscopic care. Moving forward, it is recommended that all providers and facilities involved in endoscopy service for children adopt the PEnQuIN standards, indicators, and key reporting elements outlined in these ASGE-endorsed guidelines.

GIE Editorial Board Top 10: advances in GI endoscopy in 2021.

The 9-member Editorial Board of the American Society for Gastrointestinal Endoscopy performed a systematic literature search of original articles published during 2021 in Gastrointestinal Endoscopy and 10 other high-impact medical and gastroenterology journals on endoscopy-related topics. Votes from each editorial board member were tallied to identify a consensus list of the 10 most significant topic areas in GI endoscopy over the calendar year of study, with a focus on 3 criteria: significance, novelty, and global impact on clinical practice. The 10 areas identified collectively represent advances in the following endoscopic topics: colonoscopy optimization, bariatric endoscopy, endoscopic needle sampling and drainage, peroral endoscopic myotomy, endoscopic defect closure, meeting systemic challenges in endoscopic training and practice, endohepatology, FNA versus fine-needle biopsy sampling, endoscopic mucosal and submucosal procedures, and cold snare polypectomy. Each board member contributed a summary of important articles relevant to 1 to 2 of the consensus topic areas, leading to a collective summary that is presented in this document of the "top 10" endoscopic advances of 2021.

Overview of the Pediatric Endoscopy Quality Improvement Network Quality Standards and Indicators for Pediatric Endoscopy: A Joint NASPGHAN/ESPGHAN Guideline.

INTRODUCTION: Pediatric-specific quality standards for endoscopy are needed to define best practices, while measurement of associated indicators is critical to guide quality improvement. The international Pediatric Endoscopy Quality Improvement Network (PEnQuIN) working group was assembled to develop and define quality standards and indicators for pediatric gastrointestinal endoscopic procedures through a rigorous guideline consensus process. METHODS: The Appraisal of Guidelines for REsearch and Evaluation (AGREE) II instrument guided PEnQuIN members, recruited from 31 centers of various practice types representing 11 countries, in generating and refining proposed quality standards and indicators. Consensus was sought via an iterative online Delphi process, and finalized at an in-person conference. Quality of evidence and strength of recommendations were rated according to the GRADE (Grading of Recommendation Assessment, Development, and Evaluation) approach. RESULTS: Forty-nine quality standards and 47 indicators reached consensus, encompassing pediatric endoscopy facilities, procedures, endoscopists, and the patient experience. The evidence base for PEnQuIN standards and indicators was largely adult-based and observational, and downgraded for indirectness, imprecision, and study limitations to "very low" quality, resulting in "conditional" recommendations for most standards (45/49). CONCLUSIONS: The PEnQuIN guideline development process establishes international agreement on clinically meaningful metrics that can be used to promote safety and quality in endoscopic care for children. Through PEnQuIN, pediatric endoscopists and endoscopy services now have a framework for auditing, providing feedback, and ultimately, benchmarking performance. Expansion of evidence and prospective validation of PEnQuIN standards and indicators as predictors of clinically relevant outcomes and high-quality pediatric endoscopic care is now a research priority.

Pediatric Endoscopy Quality Improvement Network Quality Standards and Indicators for Pediatric Endoscopy Facilities: A Joint NASPGHAN/ESPGHAN Guideline.

INTRODUCTION: There is increasing international recognition of the impact of variability in endoscopy facilities on procedural quality and outcomes. There is also growing precedent for assessing the quality of endoscopy facilities at regional and national levels by using standardized rating scales to identify opportunities for improvement. METHODS: With support from the North American and European Societies of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN and ESPGHAN), an international working group of the Pediatric Endoscopy Quality Improvement Network (PEnQuIN) used the methodological strategy of the Appraisal of Guidelines for REsearch and Evaluation (AGREE) II instrument to develop standards and indicators relevant for assessing the quality of facilities where endoscopic care is provided to children. Consensus was reached via an iterative online Delphi process and subsequent in-person meeting. The quality of evidence and strength of recommendations were rated according to the GRADE (Grading of Recommendation Assessment, Development and Evaluation) approach. RESULTS: The PEnQuIN working group achieved consensus on 27 standards for facilities supporting pediatric endoscopy, as well 10 indicators that can be used to identify high-quality endoscopic care in children. These standards were subcategorized into three subdomains: Quality of Clinical Operations (15 standards, 5 indicators); Patient and Caregiver Experience (9 standards, 5 indicators); and Workforce (3 standards). DISCUSSION: The rigorous PEnQuIN process successfully yielded standards and indicators that can be used to universally guide and measure high-quality facilities for procedures around the world where endoscopy is performed in children. It also underscores the current paucity of evidence for pediatric endoscopic care processes, and the need for research into this clinical area.

Pediatric Endoscopy Quality Improvement Network Quality Standards and Indicators for Pediatric Endoscopic Procedures: A Joint NASPGHAN/ESPGHAN Guideline.

INTRODUCTION: High-quality pediatric gastrointestinal procedures are performed when clinically indicated and defined by their successful performance by skilled providers in a safe, comfortable, child-oriented, and expeditious manner. The process of pediatric endoscopy begins when a plan to perform the procedure is first made and ends when all appropriate patient follow-up has occurred. Procedure-related standards and indicators developed to date for endoscopy in adults emphasize cancer screening and are thus unsuitable for pediatric medicine. METHODS: With support from the North American and European Societies of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN and ESPGHAN), an international working group of the Pediatric Endoscopy Quality Improvement Network (PEnQuIN) used the methodological strategy of the Appraisal of Guidelines for REsearch and Evaluation (AGREE) II instrument to develop standards and indicators relevant for assessing the quality of endoscopic procedures. Consensus was sought via an iterative online Delphi process and finalized at an in-person conference. The quality of evidence and strength of recommendations were rated according to the GRADE (Grading of Recommendation Assessment, Development, and Evaluation) approach. RESULTS: The PEnQuIN working group achieved consensus on 14 standards for pediatric endoscopic procedures, as well as 30 indicators that can be used to identify high-quality procedures. These were subcategorized into three subdomains: Preprocedural (3 standards, 7 indicators), Intraprocedural (8 standards, 18 indicators), and Postprocedural (3 standards, 5 indicators). A minimum target for the key indicator, "rate of adequate bowel preparation," was set at ≥80%. DISCUSSION: It is recommended that all facilities and individual providers performing pediatric endoscopy worldwide initiate and engage with the procedure-related standards and indicators developed by PEnQuIN to identify gaps in quality and drive improvement.

Pediatric Endoscopy Quality Improvement Network Quality Standards and Indicators for Pediatric Endoscopists and Endoscopists in Training: A Joint NASPGHAN/ESPGHAN Guideline.

INTRODUCTION: High-quality pediatric endoscopy requires reliable performance of procedures by competent individual providers who consistently uphold all standards determined to assure optimal patient outcomes. Establishing consensus expectations for ongoing monitoring and assessment of individual pediatric endoscopists is a method for confirming the highest possible quality of care for such procedures worldwide. We aim to provide guidance to define and measure quality of endoscopic care for children. METHODS: With support from the North American and European Societies of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN and ESPGHAN), an international working group of the Pediatric Endoscopy Quality Improvement Network (PEnQuIN) used the methodological strategy of the Appraisal of Guidelines for REsearch and Evaluation (AGREE) II instrument to develop standards and indicators relevant for assessing the quality of endoscopists. Consensus was sought via an iterative online Delphi process and finalized at an in-person conference. The quality of evidence and strength of recommendations were rated according to the GRADE (Grading of Recommendation Assessment, Development, and Evaluation) approach. RESULTS: The PEnQuIN working group achieved consensus on 6 standards that all providers who perform pediatric endoscopy should uphold and 2 standards for pediatric endoscopists in training, with 7 corresponding indicators that can be used to identify high-quality endoscopists. Additionally, these can inform continuous quality improvement at the provider level. Minimum targets for defining high-quality pediatric ileocolonoscopy were set for 2 key indicators: cecal intubation rate (≥90%) and terminal ileal intubation rate (≥85%). DISCUSSION: It is recommended that all individual providers performing or training to perform pediatric endoscopy initiate and engage with these international endoscopist-related standards and indicators developed by PEnQuIN.

Pediatric Endoscopy Quality Improvement Network Pediatric Endoscopy Reporting Elements: A Joint NASPGHAN/ESPGHAN Guideline.

INTRODUCTION: High-quality procedure reports are a cornerstone of high-quality pediatric endoscopy as they ensure the clear communication of procedural events and outcomes, guide patient care and facilitate continuous quality improvement. The aim of this document is to outline standardized reporting elements that achieved international consensus as requirements for high-quality pediatric endoscopy procedure reports. METHODS: With support from the North American and European Societies of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN and ESPGHAN), an international working group of the Pediatric Endoscopy Quality Improvement Network (PEnQuIN) used Delphi methodology to identify key elements that should be found in all pediatric endoscopy reports. Item reduction was attained through iterative rounds of anonymized online voting using a 6-point scale. Responses were analyzed after each round and items were excluded from subsequent rounds if ≤50% of panelists rated them as 5 ("agree moderately") or 6 ("agree strongly"). Reporting elements that ≥70% of panelists rated as "agree moderately" or "agree strongly" were considered to have achieved consensus. RESULTS: Twenty-six PEnQuIN group members from 25 centers internationally rated 63 potential reporting elements that were generated from a systematic literature review and the Delphi panelists. The response rates were 100% for all three survey rounds. Thirty reporting elements reached consensus as essential for inclusion within a pediatric endoscopy report. DISCUSSION: It is recommended that the PEnQuIN Reporting Elements for pediatric endoscopy be universally employed across all endoscopists, procedures and facilities as a foundational means of ensuring high-quality endoscopy services, while facilitating quality improvement activities in pediatric endoscopy.

GIE Editorial Board top 10 topics: advances in GI endoscopy in 2020.

The American Society for Gastrointestinal Endoscopy's Gastrointestinal Endoscopy Editorial Board reviewed a systematic literature search of original endoscopy-related articles published during 2020 in Gastrointestinal Endoscopy and 10 other high-impact medical and gastroenterology journals. Votes from each individual board member were tallied to identify a consensus list of the 10 most significant topic areas in GI endoscopy over the calendar year of study using 4 criteria: significance, novelty, impact on national health, and impact on global health. The 10 areas identified were as follows: artificial intelligence in endoscopy, coronavirus disease 2019 and GI practice, third-space endoscopy, lumen-apposing metal stents, single-use duodenoscopes and other disposable equipment, endosonographic needle technology and techniques, endoscopic closure devices, advances in GI bleeding management, improvements in polypectomy techniques, and bariatric endoscopy. Each board member contributed a summary of important articles relevant to 1 to 2 topic areas, leading to a collective summary that is presented in this document of the "top 10" endoscopic advances of 2020.

Physician Perspectives about Telemedicine: Considering the Usability of Telemedicine in Response to Coronavirus Disease 2019.

OBJECTIVE: Use of telemedicine in pediatric gastroenterology has increased dramatically in response to the coronavirus disease 2019 (COVID-19) pandemic. The goal of this study was to systematically assess the usability of telemedicine in the field of pediatric gastroenterology. METHODS: The previously validated Telehealth Usability Questionnaire was distributed to physician pediatric gastroenterologist members of North American Society for Pediatric Gastroenterology Hepatology and Nutrition. Physician demographic and practice characteristics were collected. Data were analyzed using descriptive, linear mixed-effect, and ordinary least squares regression methods. RESULTS: One hundred sixty pediatric gastroenterologists completed the survey. The majority were from academic practice (77%) with experience ranging from trainee (11%) to over 20 years of clinical practice (34%). Most (82%) had no experience with telemedicine before the pandemic. The average usability score (scale 1-5) was 3.87 (σ = 0.67) with the highest domain in the usefulness of telemedicine (µâ€Š= 4.29, σ = 0.69) and physician satisfaction (µâ€Š= 4.13, σ = 0.79) and the lowest domain in reliability (µâ€Š= 3.02, σ = 0.87). When comparing trainees to attending physicians, trainees' responses were almost one point lower on satisfaction with telemedicine (trainee effect = -0.97, Bonferroni adjusted 95% confidence interval = -1.71 to -0.23). CONCLUSION: Pediatric gastroenterologists who responded to the survey reported that the technology for telemedicine was usable, but trainees indicated lower levels of satisfaction when compared to attending physicians. Future study is needed to better understand user needs and the impacts of telemedicine on providers with different levels are experience to inform efforts to promote implementation and use of telemedicine beyond the pandemic.

Socioeconomic disparities in the comorbidities and surgical management of pediatric Crohn's disease.

BACKGROUND: To examine differences in comorbidities and surgical management based on socioeconomics in hospitalized children with Crohn's disease (CD). METHODS: Using the Kids' Inpatient Database for 2006-2012, we identified patients (<21 years) with a CD diagnosis. Cases were analyzed and stratified by median parental income by zip code. Multivariable logistic regression was performed. RESULTS: Of the 28,337 pediatric CD hospitalizations identified, patients were more likely male (51.1%), non-Hispanic white (71.3%), and had a mean age of 15.9 years. The proportion of minority patients increased as income quartile declined. Higher income quartile patients were more likely to be coded with anxiety and less likely with anemia. The highest income quartile was more likely to have a bowel obstruction, and peritoneal/intestinal abscess and was also 28% more likely to undergo a major surgical procedure. CONCLUSIONS: Significant variability exists in the reported comorbidities and surgical interventions associated with CD by income quartile. Lower income quartile patients are more likely to be of minority ethnicity and anemic, but less likely to undergo a major surgical procedure. Further investigation is warranted to determine whether these differences represent disease variability, differences in healthcare resource allocation, or implicit bias in management. IMPACT: There is a disparity in the care of children and young adults with Crohn's disease based on parental income. Links between parental income and the treatment of Crohn's disease in children and young adults has not been assessed in national datasets in the United States. Children in the highest income quartile were more likely to undergo a major surgical procedure. The variations in healthcare for hospitalized children and young adults with CD found in this study may represent variability in patient disease, implicit bias, or a disparity in healthcare delivery across the United States.

Mitigating Risks of Swallowed Button Batteries: New Strategies Before and After Removal.

Despite ongoing efforts of the national Button Battery Task Force (BBTF), cases of major morbidity and mortality continue to be reported at a higher rate after ingestion of higher voltage and larger button batteries. Initiation of sucralfate or honey shortly after some button battery ingestions is crucial to prevent further injury while awaiting emergent removal. Endoscopic acetic acid irrigation post removal of button battery may halt deeper injury. Gastroenterologists need to be aware of the updates to the National Capital Poison Center algorithm for button battery ingestion.

Sedation and the Food and Drug Administration Warning: What a Pediatric Gastroenterologist, Hepatologist, and Pancreatologist Should Know.

Pediatric gastroenterologists recommend and perform a range of procedures requiring sedation and anesthesia in young children. A recent warning from the US Food and Drug Administration (FDA) states that "repeated or lengthy use of general anesthetics and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children's brains." 1 As it relates to time, the FDA warning details risks of "procedures lasting longer than 3 hours or if multiple procedures are required." Pediatric gastroenterologists and related specialists should be aware of the warning and its relevance to their patients.

Pediatric Endoscopy and High-risk Patients: A Clinical Report From the NASPGHAN Endoscopy Committee.

Pediatric gastrointestinal endoscopy has been established as safe and effective for diagnosis and management of many pediatric gastrointestinal diseases. Nevertheless, certain patient and procedure factors should be recognized that increase the risk of intra- and/or postprocedural adverse events (AEs). AEs associated with endoscopic procedures can broadly be categorized as involving sedation-related physiological changes, bleeding, perforation, and infection. Factors which may increase patient risk for such AEs include but are not limited to, cardiopulmonary diseases, anatomical airway or craniofacial abnormalities, compromised intestinal luminal wall integrity, coagulopathies, and compromised immune systems. Examples of high-risk patients include patients with congenital heart disease, craniofacial abnormalities, connective tissues diseases, inflammatory bowel disease, and children undergoing treatment for cancer. This clinical report is intended to help guide clinicians stratify patient risks and employ clinical practices that may minimize AEs during and after endoscopy. These include use of CO2 insufflation, endoscopic techniques for maneuvers such as biopsies, and endoscope loop-reduction to mitigate the risk of such complications such as bleeding and intestinal perforation. Endoscopic infection risk and guidance regarding periprocedural antibiotics are also discussed.

Can Pediatric Endoscopists Accurately Assess Their Clinical Competency? A Comparison Across Skill Levels.

BACKGROUND: Assessment is critical to support pediatric endoscopy training. Although trainee engagement in assessment is encouraged, the use of self-assessment and its accuracy among pediatric endoscopists is not well described. We aimed to determine the self-assessment accuracy of novice, intermediate, and experienced pediatric endoscopists. METHODS: Novice (performed <50 previous colonoscopies), intermediate (50-500), and experienced (>1000) pediatric endoscopists from 3 North American academic teaching hospitals each performed a clinical colonoscopy. Endoscopists were assessed in real-time by 2 experienced endoscopists using the Gastrointestinal Endoscopy Competency Assessment Tool for Pediatric Colonoscopy (GiECATKIDS). In addition, participants self-assessed their performance using the same instrument. Self-assessment accuracy between the externally assessed and self-assessed scores was evaluated using absolute difference scores, intraclass correlation coefficients, and Bland-Altman analyses. RESULTS: Forty-seven endoscopists participated (21 novices, 16 intermediates, and 10 experienced). Overall, there was moderate agreement of externally assessed and self-assessed GiECATKIDS total scores with an intraclass correlation coefficient of 0.72 (95% confidence interval, 0.55-0.83). The absolute difference scores among the 3 groups were significantly different (P = 0.005), with experienced endoscopists demonstrating a more accurate self-assessment compared to novices (P = 0.003). Bland-Altman plots revealed that novice endoscopists' self-assessed scores tended to be higher than their externally assessed scores, indicating they overestimated their performance. CONCLUSIONS: We found that endoscopic experience was positively associated with self-assessment accuracy among pediatric endoscopists. Novices were inaccurate in assessing their endoscopic competence and were prone to overestimation of their performances. Our findings suggest novices may benefit from targeted interventions aimed at improving their insight and self-awareness.

Evaluating Patient-Centered Outcomes in Clinical Trials of Procedural Sedation, Part 2 Safety: Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations.

The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.