Two AIS Cases, 2 Surgeons, 1 Operating Room, 1 Day: Faster and Safer Than 1 Case in a Day.

BACKGROUND: To lessen surgical times for patients with adolescent idiopathic scoliosis (AIS) undergoing posterior spinal instrumentation and fusion (PSIF), our department developed a quality improvement initiative where 2 AIS cases were completed in 1 day by the same 2 surgeons operating together in 1 operating room (OR). We describe the results of this initiative, comparing operative times and outcomes to cases of these surgeons operating individually. METHODS: From 2017 to 2023, patients aged 10 to 18 years with AIS undergoing PSIF were prospectively enrolled for "Two Spine Tuesday." Patients were matched by age, sex, curve severity, and number of levels fused to historical AIS controls. Outcomes included surgery time, total OR time, estimated blood loss (EBL), volume of cell saver transfused, allogenic blood transfusion, length of stay, 90-day readmissions, Clavien-Dindo-Sink Complication Classification System complication rates, and percentage who achieved the minimal clinically important difference (MCID) for SRS-22. RESULTS: Fifty-five patients composing the 2-spine group (group 2) were compared with 55 historical sex-matched and age-matched controls (group 1). Major coronal curve and average number of levels fused were similar between groups. Overall surgery time (203 vs. 296 min, P<0.001), total OR time (P<0.001), and EBL (400 vs. 550 mL, P<0.001) were lower for group 2. Group 2 had fewer complications [n=17 (31%) vs. n=28 (51%), P=0.03]. CONCLUSIONS: Performing 2 AIS cases in 1 OR by 2 surgeons the same day resulted in shorter surgery times, less total time in the operating room, lower complication rates, and less blood loss compared with single-surgeon matched controls. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Health-related quality of life in primary immunodeficiencies: Impact of delayed diagnosis and treatment burden.

Accurate and timely diagnosis of primary immunodeficiencies (PID) is an ongoing effort. Individuals with PID can be severely impacted by their disease and many experience chronic complications, treatment burden, and reduced quality of life (QoL). This review focuses on the impact of delayed diagnosis and treatment burden on patient QoL and outcomes. Adults tend to experience longer delays in diagnosis than pediatric populations. The median diagnostic delay has reduced over recent decades, but remains high for some antibody deficiency variants, such as common variable immunodeficiency. The largest burden impacting QoL tends to be poorly controlled disease and persistent chronic conditions rather than treatment burden. Hospitalization, physician/emergency room visits, and bronchiectasis were the most expensive PID complications prior to diagnosis and cost analyses estimate cost reductions once appropriate treatment is initiated. A combination of poor awareness, lack of infrastructure, and resources supporting national registries play a major role in delayed diagnosis.

Genomic answers for children: Dynamic analyses of >1000 pediatric rare disease genomes.

PURPOSE: This study aimed to provide comprehensive diagnostic and candidate analyses in a pediatric rare disease cohort through the Genomic Answers for Kids program. METHODS: Extensive analyses of 960 families with suspected genetic disorders included short-read exome sequencing and short-read genome sequencing (srGS); PacBio HiFi long-read genome sequencing (HiFi-GS); variant calling for single nucleotide variants (SNV), structural variant (SV), and repeat variants; and machine-learning variant prioritization. Structured phenotypes, prioritized variants, and pedigrees were stored in PhenoTips database, with data sharing through controlled access the database of Genotypes and Phenotypes. RESULTS: Diagnostic rates ranged from 11% in patients with prior negative genetic testing to 34.5% in naive patients. Incorporating SVs from genome sequencing added up to 13% of new diagnoses in previously unsolved cases. HiFi-GS yielded increased discovery rate with >4-fold more rare coding SVs compared with srGS. Variants and genes of unknown significance remain the most common finding (58% of nondiagnostic cases). CONCLUSION: Computational prioritization is efficient for diagnostic SNVs. Thorough identification of non-SNVs remains challenging and is partly mitigated using HiFi-GS sequencing. Importantly, community research is supported by sharing real-time data to accelerate gene validation and by providing HiFi variant (SNV/SV) resources from >1000 human alleles to facilitate implementation of new sequencing platforms for rare disease diagnoses.

Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial.

BACKGROUND: Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein in development for the prophylaxis of hereditary angioedema (HAE) attacks. OBJECTIVE: Our aim was to determine the efficacy, safety, and tolerability of berotralstat in patients with HAE over a 24-week treatment period (the phase 3 APeX-2 trial). METHODS: APeX-2 was a double-blind, parallel-group study that randomized patients at 40 sites in 11 countries 1:1:1 to receive once-daily berotralstat in a dose of 110 mg or 150 mg or placebo (Clinicaltrials.gov identifier NCT03485911). Patients aged 12 years or older with HAE due to C1 inhibitor deficiency and at least 2 investigator-confirmed HAE attacks in the first 56 days of a prospective run-in period were eligible. The primary efficacy end point was the rate of investigator-confirmed HAE attacks during the 24-week treatment period. RESULTS: A total of 121 patients were randomized; 120 of them received at least 1 dose of the study drug (n = 41, 40, and 39 in the 110-mg dose of berotralstat, 150-mg of dose berotralstat, and placebo groups, respectively). Berotralstat demonstrated a significant reduction in attack rate at both 110 mg (1.65 attacks per month; P = .024) and 150 mg (1.31 attacks per month; P < .001) relative to placebo (2.35 attacks per month). The most frequent treatment-emergent adverse events that occurred more with berotralstat than with placebo were abdominal pain, vomiting, diarrhea, and back pain. No drug-related serious treatment-emergent adverse events occurred. CONCLUSION: Both the 110-mg and 150-mg doses of berotralstat reduced HAE attack rates compared with placebo and were safe and generally well tolerated. The most favorable benefit-to-risk profile was observed at a dose of 150 mg per day.

Safety and Tolerability of Subcutaneous IgPro20 at High Infusion Parameters in Patients with Primary Immunodeficiency: Findings from the Pump-Assisted Administration Cohorts of the HILO Study.

PURPOSE: To evaluate the safety and tolerability of subcutaneous IgPro20 (Hizentra®, CSL Behring, King of Prussia, PA, USA) administered at high infusion parameters (> 25 mL and > 25 mL/h per injection site) in patients with primary immunodeficiency. METHODS: The Hizentra® Label Optimization (HILO) study was an open-label, parallel-arm, non-randomized study (NCT03033745) of IgPro20 using a forced upward titration design for infusion parameters. Patients experienced with pump-assisted IgPro20 infusions received weekly IgPro20 infusions at a stable dose in the Pump-Assisted Volume Cohort (N = 15; 25-50 mL per injection site) and in the Pump-Assisted Flow Rate Cohort (N = 18; 25-100 mL/h per injection site). Responder rates (percentage of patients who successfully completed ≥ 75% of planned infusions), safety outcomes, and serum immunoglobulin G (IgG) trough levels were evaluated. RESULTS: Responder rates were 86.7% (13/15, 25 mL) and 73.3% (11/15, 40 and 50 mL) in the Volume Cohort, and 77.8% (14/18, 25 and 50 mL/h), 66.7% (12/18, 75 mL/h), and 61.1% (11/18, 100 mL/h) in the Flow Rate Cohort. Infusion compliance was ≥ 90% in all patients in the Volume Cohort and in 83.3% of patients in the Flow Rate Cohort. The number of injection sites (Volume Cohort) and the infusion duration (Flow Rate Cohort) decreased with increasing infusion parameters. The rate of treatment-emergent adverse events per infusion was low (0.138 [Volume Cohort] and 0.216 [Flow Rate Cohort]). Serum IgG levels remained stable during the study. CONCLUSION: Pump-assisted IgPro20 infusions are feasible at 50 mL and 100 mL/h per injection site in treatment-experienced patients, which may result in fewer injection sites and shorter infusion times. TRIAL REGISTRATION: NCT03033745 ; registered January 27, 2017.

Development and validation of a patient-reported scale for tolerability of endoscopic procedures using conscious sedation.

BACKGROUND AND AIMS: Patient-reported experience measures (PREMs) assessing the tolerability of endoscopic procedures are scarce. In this study, we designed and validated a PREM to assess tolerability of endoscopy using conscious sedation. METHODS: The patient-reported scale for tolerability of endoscopic procedures (PRO-STEP) consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas domain 2 (postprocedural) consists of 4 questions on pain, nausea, distention, and either throat or anal pain. All questions are scored on a Likert scale from 0 to 10. Cronbach's alpha was used to measure internal consistency of the questions. Multivariable logistic regression was performed to assess predictors of higher scores, reported using adjusted odds ratios and confidence intervals. RESULTS: Two hundred fifty-five patients (91 colonoscopy, 73 gastroscopy, and 91 ERCP) were included. Colonoscopy was the least tolerable procedure by recall, with mean intraprocedural awareness and discomfort scores of 5.1 ± 3.8, and 2.6 ± 2.7, respectively. Consistency between intraprocedural awareness and discomfort/pain yielded an acceptable Cronbach's alpha of .71 (95% confidence interval, .62-.78). Higher use of midazolam during colonoscopy was inversely associated with an intraprocedural awareness score of 7 or higher (per additional mg: adjusted odds ratio, .23; 95% confidence interval, .09-.54). CONCLUSIONS: PRO-STEP is a simple PREM that can be administered after multiple endoscopic procedures using conscious sedation. Future work should focus on its performance characteristics in adverse event prediction.

Colonoscopy competence assessment tools: a systematic review of validity evidence.

BACKGROUND: Assessment tools are essential for endoscopy training, being required to support feedback provision, optimize learner capabilities, and document competence. We aimed to evaluate the strength of validity evidence that supports the available colonoscopy direct observation assessment tools using the unified framework of validity. METHODS: We systematically searched five databases for studies investigating colonoscopy direct observation assessment tools from inception until 8 April 2020. We extracted data outlining validity evidence (content, response process, internal structure, relations to other variables, and consequences) from the five sources and graded the degree of evidence, with a maximum score of 15. We assessed educational utility using an Accreditation Council for Graduate Medical Education framework and methodological quality using the Medical Education Research Quality Instrument (MERSQI). RESULTS: From 10 841 records, we identified 27 studies representing 13 assessment tools (10 adult, 2 pediatric, 1 both). All tools assessed technical skills, while 10 each assessed cognitive and integrative skills. Validity evidence scores ranged from 1-15. The Assessment of Competency in Endoscopy (ACE) tool, the Direct Observation of Procedural Skills (DOPS) tool, and the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT) had the strongest validity evidence, with scores of 13, 15, and 14, respectively. Most tools were easy to use and interpret, and required minimal resources. MERSQI scores ranged from 9.5-11.5 (maximum score 14.5). CONCLUSIONS: The ACE, DOPS, and GiECAT have strong validity evidence compared with other assessments. Future studies should identify barriers to widespread implementation and report on the use of these tools in credentialing examinations.

Hemostatic spray powder TC-325 in the primary endoscopic treatment of peptic ulcer-related bleeding: multicenter international registry.

BACKGROUND: Upper gastrointestinal bleeding (UGIB) is a leading cause of morbidity and is associated with a 2 % - 17 % mortality rate in the UK and USA. Bleeding peptic ulcers account for 50 % of UGIB cases. Endoscopic intervention in a timely manner can improve outcomes. Hemostatic spray is an endoscopic hemostatic powder for GI bleeding. This multicenter registry was created to collect data prospectively on the immediate endoscopic hemostasis of GI bleeding in patients with peptic ulcer disease when hemostatic spray is applied as endoscopic monotherapy, dual therapy, or rescue therapy. METHODS: Data were collected prospectively (January 2016 - March 2019) from 14 centers in the UK, France, Germany, and the USA. The application of hemostatic spray was decided upon at the endoscopist's discretion. RESULTS: 202 patients with UGIB secondary to peptic ulcers were recruited. Immediate hemostasis was achieved in 178/202 patients (88 %), 26/154 (17 %) experienced rebleeding, 21/175 (12 %) died within 7 days, and 38/175 (22 %) died within 30 days (all-cause mortality). Combination therapy of hemostatic spray with other endoscopic modalities had an associated lower 30-day mortality (16 %, P < 0.05) compared with monotherapy or rescue therapy. There were high immediate hemostasis rates across all peptic ulcer disease Forrest classifications. CONCLUSIONS: This is the largest case series of outcomes of peptic ulcer bleeding treated with hemostatic spray, with high immediate hemostasis rates for bleeding peptic ulcers.

Establishing key research questions for the implementation of artificial intelligence in colonoscopy: a modified Delphi method.

BACKGROUND : Artificial intelligence (AI) research in colonoscopy is progressing rapidly but widespread clinical implementation is not yet a reality. We aimed to identify the top implementation research priorities. METHODS : An established modified Delphi approach for research priority setting was used. Fifteen international experts, including endoscopists and translational computer scientists/engineers, from nine countries participated in an online survey over 9 months. Questions related to AI implementation in colonoscopy were generated as a long-list in the first round, and then scored in two subsequent rounds to identify the top 10 research questions. RESULTS : The top 10 ranked questions were categorized into five themes. Theme 1: clinical trial design/end points (4 questions), related to optimum trial designs for polyp detection and characterization, determining the optimal end points for evaluation of AI, and demonstrating impact on interval cancer rates. Theme 2: technological developments (3 questions), including improving detection of more challenging and advanced lesions, reduction of false-positive rates, and minimizing latency. Theme 3: clinical adoption/integration (1 question), concerning the effective combination of detection and characterization into one workflow. Theme 4: data access/annotation (1 question), concerning more efficient or automated data annotation methods to reduce the burden on human experts. Theme 5: regulatory approval (1 question), related to making regulatory approval processes more efficient. CONCLUSIONS : This is the first reported international research priority setting exercise for AI in colonoscopy. The study findings should be used as a framework to guide future research with key stakeholders to accelerate the clinical implementation of AI in endoscopy.

Colonoscopy Direct Observation of Procedural Skills Assessment Tool for Evaluating Competency Development During Training.

INTRODUCTION: Formative colonoscopy direct observation of procedural skills (DOPS) assessments were updated in 2016 and incorporated into UK training but lack validity evidence. We aimed to appraise the validity of DOPS assessments, benchmark performance, and evaluate competency development during training in diagnostic colonoscopy. METHODS: This prospective national study identified colonoscopy DOPS submitted over an 18-month period to the UK training e-portfolio. Generalizability analyses were conducted to evaluate internal structure validity and reliability. Benchmarking was performed using receiver operator characteristic analyses. Learning curves for DOPS items and domains were studied, and multivariable analyses were performed to identify predictors of DOPS competency. RESULTS: Across 279 training units, 10,749 DOPS submitted for 1,199 trainees were analyzed. The acceptable reliability threshold (G > 0.70) was achieved with 3 assessors performing 2 DOPS each. DOPS competency rates correlated with the unassisted caecal intubation rate (rho 0.404, P < 0.001). Demonstrating competency in 90% of assessed items provided optimal sensitivity (90.2%) and specificity (87.2%) for benchmarking overall DOPS competence. This threshold was attained in the following order: "preprocedure" (50-99 procedures), "endoscopic nontechnical skills" and "postprocedure" (150-199), "management" (200-249), and "procedure" (250-299) domain. At item level, competency in "proactive problem solving" (rho 0.787) and "loop management" (rho 0.780) correlated strongest with the overall DOPS rating (P < 0.001) and was the last to develop. Lifetime procedure count, DOPS count, trainer specialty, easier case difficulty, and higher cecal intubation rate were significant multivariable predictors of DOPS competence. DISCUSSION: This study establishes milestones for competency acquisition during colonoscopy training and provides novel validity and reliability evidence to support colonoscopy DOPS as a competency assessment tool.

Associations between endoscopist feedback and improvements in colonoscopy quality indicators: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Colonoscopy quality indicators such as adenoma detection rate (ADR) are surrogates for the effectiveness of screening-related colonoscopy. It is unclear whether endoscopist feedback on these indicators improves performance. We performed a meta-analysis to determine whether associations exist between endoscopist feedback and colonoscopy performance. METHODS: We conducted a search through May 2019 for studies reporting on endoscopist feedback and associations with ADR or other colonoscopy quality indicators. Pooled rate ratios (RRs) and weighted mean differences were calculated using DerSimonian and Laird random effects models. Subgroup, sensitivity, and meta-regression analyses were performed to assess for potential methodological or clinical factors associated with outcomes. RESULTS: From 1326 initial studies, 12 studies were included in the meta-analysis for ADR, representing 33,184 colonoscopies. Endoscopist feedback was associated with an improvement in ADR (RR, 1.21; 95% confidence interval [CI], 1.09-1.34). Low performers derived a greater benefit from feedback (RR, 1.62; 95% CI, 1.18-2.23) compared with moderate performers (RR, 1.19; 95% CI, 1.11-1.29), whereas high performers did not derive a significant benefit (RR, 1.06; 95% CI, 0.99-1.13). Feedback was not associated with increases in withdrawal time (weighted mean difference, +0.43 minutes; 95% CI, -0.50 to +1.36 minutes) or improvements in cecal intubation rate (RR, 1.00; 95% CI, 0.99-1.01). CONCLUSION: Endoscopist feedback is associated with modest improvements in ADR. The implementation of routine endoscopist audit and feedback should be considered alongside other quality improvement interventions in institutions dedicated to the provision of high-quality screening-related colonoscopy.

Hereditary angioedema: Comprehensive management plans and patient support.

Hereditary angioedema (HAE) is a rare disease. Regardless, patients with HAE have access to multiple state-of-the-art medications available for on-demand use and prevention that reduce the frequency and burden of HAE attacks. These treatments have greatly reduced the burden of disease and helped patients achieve improved quality of life. However, with greater numbers of therapeutic options, HAE care has become more complex. In this review, we addressed essential elements of an individualized comprehensive management plan for a patient with HAE. We focused on access to an expert physician, ongoing patient education, access to effective treatment options, coordination of care and management of treatment logistics, ongoing monitoring of attacks and treatments, and other resources for patient support. This plan will need to be communicated with the patient and other care providers, especially during emergent conditions, and accommodate the patient's lifestyle with consideration for work, school, travel, etc. Periodically, the physician and the patient will need to review information about attacks, triggers, and treatments to identify areas for improvement and update the plan.

Why Irrigate for the Same Contamination Rate: Wound Contamination in Pediatric Spinal Surgery Using Betadine Versus Saline.

BACKGROUND: The risk of surgical site infection in pediatric posterior spine fusion (PSF) is up to 4.3% in idiopathic populations and 24% in patients with neuromuscular disease. Twenty-three percent of pediatric PSF tissue cultures are positive before closure, with a higher rate in neuromuscular patients. Our primary aim was to evaluate the feasibility of a complete randomized controlled trial to study the efficacy of surgical site irrigation with povidone-iodine (PVP-I) compared with sterile saline (SS) to reduce the bacterial contamination rate before closure in children undergoing PSF. METHODS: One hundred seventy-five subjects undergoing PSF were enrolled in a multicenter, single-blind, pilot randomized controlled trial. We recruited patients at low-risk (LR) and high-risk (HR) for infection 3:1, respectively. Before closure, a wound culture was collected. Nonviable tissues were debrided and the wound was soaked with 0.35% PVP-I or SS for 3 minutes. The wound was then irrigated with 2 L of saline and a second sample was collected. RESULTS: One hundred fifty-three subjects completed the protocol. Seventy-seven subjects were allocated to PVP-I (18 HR, 59 LR) and 76 to SS (19 HR, 57 LR). Cultures were positive in 18% (14/77) of PVP-I samples (2 HR, 12 LR) and in 17% (13/76) of SS samples (3 HR, 10 LR) preirrigation and in 16% (12/77) of PVP-I samples (5 HR, 7 LR) and in 18% (14/76) of SS samples (4 HR, 10 LR) postirrigation. Eight percent (3/37) HR subjects (1 PVP-I, 2 SS) experienced infection at 30 days postoperative. No LR subjects experienced infection. CONCLUSIONS: Positive cultures were similar across treatment and risk groups. The bacterial contamination of wounds before closure remains high regardless of irrigation type. A complete randomized controlled trial would be challenging to adequately power given the similarity of tissue positivity across groups. LEVEL OF EVIDENCE: Level II-pilot randomized controlled trial.

Paediatric Colonoscopy Direct Observation of Procedural Skills: Evidence of Validity and Competency Development.

INTRODUCTION: The paediatric series of direct observation of procedural skills (DOPS) were introduced into the UK national endoscopy training curriculum in 2016, but lack validity evidence. We aimed to present validity evidence for paediatric colonoscopy DOPS and study competency development in a national trainee cohort. METHODS: This prospective UK-wide study analysed formative paediatric colonoscopy DOPS which were submitted to the e-Portfolio between 2016 and 2018. Item, domain, and average DOPS scores were correlated with the overall DOPS rating to evidence internal structure validity. Overall DOPS ratings were compared over lifetime procedure count to demonstrate learning curves (discriminant validity). Consequential validity was founded on receiver operating characteristic curve analyses. RESULTS: A total of 203 DOPS assessments were completed for 29 trainees from 11 UK training centres. Internal structure validity was provided through item-total correlation analyses. DOPS scores positively correlated with trainee seniority (P < 0.001) and lifetime procedure count (P < 0.001). Competency acquisition followed the order of: "preprocedure," "postprocedure," "endoscopic nontechnical skills," "management," "procedure" domains, followed by overall DOPS competency, which was achieved in 81% of the cohort after 125 to 149 procedures. Mean DOPS scores could be used to predict overall procedure competence (area under receiver operating characteristic curve 0.969, P < 0.001), with a mean score of 3.9 demonstrating optimal sensitivity (93.5%) and specificity (87.6%). CONCLUSIONS: This study provides validity evidence supporting the use of paediatric colonoscopy DOPS as an in-training competence assessment tool. DOPS may also be used to measure competency development and benchmark performance during training, which may be of value to trainees, trainers, and training programmes.

A new composite measure of colonoscopy: the Performance Indicator of Colonic Intubation (PICI).

BACKGROUND AND STUDY AIM: Cecal intubation rate (CIR) is an established performance indicator of colonoscopy. In some patients, cecal intubation with acceptable tolerance is only achieved with additional sedation. This study proposes a composite Performance Indicator of Colonic Intubation (PICI), which combines CIR, comfort, and sedation. METHODS : Data from 20 085 colonoscopies reported in the 2011 UK national audit were analyzed. PICI was defined as the percentage of procedures achieving cecal intubation with median dose (2 mg) of midazolam or less, and nurse-assessed comfort score of 1 - 3/5. Multivariate logistic regression analysis evaluated possible associations between PICI and patient, unit, colonoscopist, and diagnostic factors. RESULTS : PICI was achieved in 54.1 % of procedures. PICI identified factors affecting performance more frequently than single measures such as CIR and polyp detection, or CIR + comfort alone. Older age, male sex, adequate bowel preparation, and a positive fecal occult blood test as indication were associated with a higher PICI. Unit accreditation, the presence of magnetic imagers in the unit, greater annual volume, fewer years' experience, and higher training/trainer status were associated with higher PICI rates. Procedures in which PICI was achieved were associated with significantly higher polyp detection rates than when PICI was not achieved. CONCLUSIONS : PICI provides a simpler picture of performance of colonoscopic intubation than separate measures of CIR, comfort, and sedation. It is associated with more factors that are amenable to change that might improve performance and with higher likelihood of polyp detection. It is proposed that PICI becomes the key performance indicator for intubation of the colon in colonoscopy quality improvement initiatives.

Changes in scoring of Direct Observation of Procedural Skills (DOPS) forms and the impact on competence assessment.

BACKGROUND: Direct Observation of Procedural Skills (DOPS) is an established competence assessment tool in endoscopy. In July 2016, the DOPS scoring format changed from a performance-based scale to a supervision-based scale. We aimed to evaluate the impact of changes to the DOPS scale format on the distribution of scores in novice trainees and on competence assessment. METHODS: We performed a prospective, multicenter (n = 276), observational study of formative DOPS assessments in endoscopy trainees with ≤ 100 lifetime procedures. DOPS were submitted in the 6-months before July 2016 (old scale) and after (new scale) for gastroscopy (n = 2998), sigmoidoscopy (n = 1310), colonoscopy (n = 3280), and polypectomy (n = 631). Scores for old and new DOPS were aligned to a 4-point scale and compared. RESULTS: 8219 DOPS (43 % new and 57 % old) submitted for 1300 trainees were analyzed. Compared with old DOPS, the use of the new DOPS was associated with greater utilization of the lowest score (2.4 % vs. 0.9 %; P < 0.001), broader range of scores, and a reduction in competent scores (60.8 % vs. 86.9 %; P < 0.001). The reduction in competent scores was evident on subgroup analysis across all procedure types (P < 0.001) and for each quartile of endoscopy experience. The new DOPS was superior in characterizing the endoscopy learning curve by demonstrating progression of competent scores across quartiles of procedural experience. CONCLUSIONS: Endoscopy assessors applied a greater range of scores using the new DOPS scale based on degree of supervision in two cohorts of trainees matched for experience. Our study provides construct validity evidence in support of the new scale format.

Evidence-based Approach to Training Pediatric Gastrointestinal Endoscopy Trainers.

Endoscopy training has evolved in recent years from the traditional model of "learning by doing" to the current skillful application of evidence-based educational principles. Endoscopy training should ideally be provided by individuals with the requisite skills and behaviors to teach endoscopy effectively and efficiently, including an awareness of principles of adult education, best practices in procedural skills education, and appropriate use of beneficial educational strategies such as feedback. The aim of this article is to outline principles that underlie successful endoscopy training and describe the "Preparation-Training-Wrap-up" framework that can be used by pediatric endoscopy trainers to help guide an effective endoscopy training session. Looking to the future, application of content from well-developed "train the trainer" courses to pediatric endoscopy practice would help to improve the quality of endoscopy training and facilitate the development of conscious competences among pediatric endoscopy trainers.

Subsets of airway myeloid-derived regulatory cells distinguish mild asthma from chronic obstructive pulmonary disease.

BACKGROUND: Subsets of myeloid-derived regulatory cells (MDRCs), which are phenotypically similar to the myeloid-derived suppressor cells found in patients with cancer, have recently been appreciated as critical regulators of airway inflammation in mouse models of asthma. OBJECTIVE: We test the hypothesis that subsets of airway MDRCs contribute differentially to the inflammatory milieu in human asthma and chronic obstructive pulmonary disease (COPD). METHODS: We used bronchoalveolar lavage to identify and characterize human airway MDRCs from 10 healthy subjects, 9 patients with mild asthma, and 8 patients with COPD, none of whom were treated with inhaled or systemic corticosteroids. We defined subsets of airway MDRCs using flow cytometry, the molecular mediators they produce, and their abilities to regulate proliferation of polyclonally activated autologous T lymphocytes. RESULTS: We found substantial differences in the functional potential of MDRC subsets in healthy subjects, patients with asthma, and patients with COPD, with these differences regulated by the nitrosative and oxidative free radicals and cytokines they produced. Nitric oxide-producing MDRCs suppressed and superoxide-producing MDRCs enhanced proliferation of polyclonally activated autologous CD4 T cells. HLA-DR(+)CD11b(+)CD11c(+)CD163(-) superoxide-producing MDRCs, which stimulated proliferation of autologous T cells, comprised a high fraction of MDRCs in the airways of patients with mild asthma or COPD but not those of healthy control subjects. CD11b(+)CD14(+)CD16(-)HLA-DR(-) nitric oxide-producing MDRCs, which suppressed T-cell proliferation, were present in high numbers in airways of patients with mild asthma but not patients with COPD or healthy control subjects. CONCLUSION: Subsets of airway MDRCs conclusively discriminate patients with mild asthma, patients with COPD, and healthy subjects from each other. The distinctive activities of these MDRCs in patients with asthma or COPD might provide novel targets for new therapeutics for these common disorders. [Corrected]

The national colonoscopy audit: a nationwide assessment of the quality and safety of colonoscopy in the UK.

OBJECTIVE: To perform a comprehensive audit of all colonoscopy undertaken in the UK over a 2-week period. DESIGN: Multi-centre survey. All adult (≥16 years of age) colonoscopies that took place in participating National Health Service hospitals between 28 February 2011 and 11 March 2011 were included. RESULTS: Data on 20,085 colonoscopies and 2681 colonoscopists were collected from 302 units. A validation exercise indicated that data were collected on over 94% of all procedures performed nationally. The unadjusted caecal intubation rate (CIR) was 92.3%. When adjusted for impassable strictures and poor bowel preparation the CIR was 95.8%. The polyp detection rate was 32.1%. The polyp detection rate for larger polyps (≥10 mm diameter) was 11.7%. 92.3% of resected polyps were retrieved. 90.2% of procedures achieved acceptable levels of patient comfort. A total of eight perforations and 52 significant haemorrhages were reported. Eight patients underwent surgery as a consequence of a complication. CONCLUSIONS: This is the first national audit of colonoscopy that has successfully captured the majority of adult colonoscopies performed across an entire nation during a defined time period. The data confirm that there has been a significant improvement in the performance of colonoscopy in the UK since the last study reported seven years ago (CIR 76.9%) and that performance is above the required national standards.