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J Scott Andrews,1 David Kudrow,2 Mallikarjuna Rettiganti,1 Tina Oakes,1 Jennifer N Bardos,1 Richard Wenzel,1 Dulanji K Kuruppu,1 Charly Gaul,3 James M Martinez1 1Eli Lilly and Company, Indianapolis, IN, USA; 2California Medical Clinic for Headache, Santa Monica, CA, USA; 3Headache Center, Frankfurt, GermanyCorrespondence: Mallikarjuna RettigantiEli Lilly and Company, Lilly Corporate Center, 893 Delaware St., Indianapolis, IN, 46285, USATel +1 3176519378Email rettiganti_mallikarjuna@lilly.comPurpose: In a phase 3 study, galcanezumab significantly reduced the frequency of episodic cluster headache attacks across weeks 1– 3 (primary endpoint) compared with placebo. However, multiple pain dimensions may contribute to the total burden of episodic cluster headache pain. This post hoc analysis assessed the impact of galcanezumab on the total pain burden of episodic cluster headache using a composite measure.Patients and Methods: Patients with episodic cluster headache were randomized 1:1 to galcanezumab 300 mg or placebo once monthly for 8 weeks. Mean weekly total pain burden was calculated (daily cluster headache attack frequency × average duration × average pain severity summed over 7 days) using data collected in an electronic patient-reported outcomes diary. Change from baseline in weekly total pain burden across weeks 1– 3 was compared between galcanezumab and placebo. To explore construct validity, mean weekly total pain burden scores were stratified by Patient Global Impression of Improvement (PGI-I) responses at the week 4 clinic visit.Results: The reduction from baseline in mean weekly total pain burden was significantly greater with galcanezumab (N=49) than with placebo (N=57): the least squares mean difference was − 11.18 severity-weighted hours (p=0.035). Median weekly total pain burden decreased as PGI-I ratings improved, from 33.6 to 5.0 severity-weighted hours for patients who felt “very much worse” and “very much better,” respectively.Conclusion: Galcanezumab significantly reduced mean weekly total pain burden compared with placebo in patients with episodic cluster headache. The composite pain measure demonstrated construct validity. Total pain burden may provide a holistic measure of the pain of episodic cluster headache.Clinical Trials: ClinicalTrials.gov, NCT02397473.Keywords: composite pain, frequency, severity, duration, CGRP

Introduction: In evaluating therapies for migraine prevention, emphasis is placed on frequency and less attention is paid to duration or severity. Total pain burden (TPB) combines frequency, duration, and severity of migraine headache, and has the potential to further characterize the benefit of preventive treatment using a single composite measure. TPB was previously used to characterize response to galcanezumab (GMB) in patients with migraine. In this post hoc analysis we assessed the impact of GMB in lowering TPB in patients who had previously not benefited from two to four categories of migraine preventive medication., Methods: CONQUER trial patients (N = 462), 18-75 years old who had previously not benefited from two to four categories of migraine preventive medication, were randomized (1:1) to monthly placebo or GMB 120 mg with 240 mg loading dose. For each patient, monthly TPB in severity-weighted hours was calculated by multiplying migraine headache duration (hours) by maximum severity for each migraine headache day, then summing these daily scores over the month for the monthly score. Changes from baseline in monthly TPB across months 1-3 were analyzed. Spearman correlations between TPB and scores on the Migraine-Specific Quality-of-Life Questionnaire (MSQ) total and Migraine Disability Assessment Scale (MIDAS) were assessed at baseline., Results: Mean (SD) baseline monthly TPB was 192.1 (158.3) and 188.2 (197.4) severity-weighted hours for GMB-treated and placebo-treated patients, respectively. Across the 3-month double-blind period, GMB-treated patients experienced significantly greater mean reductions from baseline in monthly TPB compared with placebo-treated patients, both for mean change (GMB - 82.7, placebo - 15.8, p < 0.001) and percentage change (GMB - 38.6%, placebo 9.4%, p < 0.001). Furthermore, baseline TPB correlated with MSQ score (r = - 0.39) and MIDAS score (r = 0.40), suggesting good association of TPB with functional and disability outcomes., Conclusion: GMB reduced mean TPB in patients who had previously not benefited from two to four categories of migraine preventive medication., Trial Registration: NCT03559257., (© 2022. The Author(s).)

BACKGROUND: Patients with migraine, particularly with multiple prior preventive treatment failures, often have high rates of acute headache medication use and are at risk for overuse (acute or symptomatic headache medication use between 10 and 15 days per month [depending on the medication] for > 3 months). Furthermore, these patients have greater health care resource utilization (HCRU). OBJECTIVE: To examine acute headache medication use and HCRU with galcanezumab compared with placebo in a population with multiple prior migraine preventive treatment failures. METHODS: In the 3-month double-blind phase, patients with episodic or chronic migraine and treatment failures to 2 to 4 standard-of-care migraine preventive categories (lack of effectiveness or safety/tolerability) received galcanezumab 120 mg/month (following a 240-mg loading dose) or placebo; an optional 3 month open-label phase followed. Acute headache medication use (monthly days with acute headache medication utilization) was self-reported daily. The change from baseline in monthly days with acute headache medication used a mixed-model repeated measures analysis. HCRU was reported at baseline (for the previous 6 months) and at monthly visits. Migraine-related HCRU rates were evaluated in the total population per 100 patient-years. RESULTS: Of the 462 patients (galcanezumab n=232, placebo n=230), baseline mean days/month of acute headache medication was 12.3; 44.8% had acute headache medication overuse. Across months 1-3, least squares (LS) mean reductions in acute headache medication use were greater for the galcanezumab group (4.2) compared with placebo (0.9); the LS mean difference was 3.4 (95% CI = 2.7-4.1; P < 0.0001). Greater reductions in the galcanezumab group were observed as early as month 1; statistical separation continued at months 2 and 3 (all P < 0.0001). During the open-label phase, reductions from baseline ranged from 4.7 to 5.3 days and were similar in patients who transitioned from placebo to patients continuing galcanezumab. Reductions from baseline of migraine-specific health care visits (double-blind phase) were numerically greater with galcanezumab than placebo (215.5 vs 155.3). Patients switching to galcanezumab had reductions (212.9 days) similar to patients continuing galcanezumab (222.6 days). Migraine-specific emergency department visits decreased by two-thirds at month 3 in the galcanezumab group compared with nearly no reduction in the placebo group that experienced a similar reduction during the open-label phase. For both groups, migraine-specific hospitalizations were less than 2 per 100 patient-years. CONCLUSIONS: These results demonstrate that galcanezumab has the potential to reduce acute headache medication use and overuse and HCRU in patients with prior migraine preventive treatment failures. DISCLOSURES: Data were presented in part as a poster presentation at the 14th European Headache Congress (European Headache Federation), Virtual Meeting, July 3-5, 2020. Dr Ambrosini is on the advisory board for Eli Lilly and Company and received honorarium from Teva, Novartis, and Eli Lilly and Company. Dr Estemalik is on the advisory boards for Eli Lilly and Company, Lundbeck, and Allergan and the speakers' bureau for Teva, Lundbeck, Eli Lilly and Company, Allergan, and Biohaven. He received consulting fees from Eli Lilly and Company, Teva, Lundbeck, and Allergan and support for attending meetings and/or travel from Eli Lilly and Company, Allergan, Biohaven, Teva, and Lundbeck. Dr Pascual received research support from Instituto de Salud Carlos III, Ministry of Economy, Spain. He was also on advisory boards for Allergan, Amgen-Novartis, Eli Lilly and Company, and Stendhal and received consulting fees or honoraria from Allegan, Eli Lilly and Company, Novartis-Amgen, and Teva. Dr Rettiganti is an employee of Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN. She is also a minor stock and restricted stockholder of Eli Lilly and Company. Mr. Stroud and Ms. Day are employees of Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN. Dr Ford is an employee of and holds stock of Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN. She also received support for attending meetings and/or travel from Eli Lilly and Company.

Objective: The purpose of this study was to propose a definition of "wearing off" at the individual patient-level and determine the percentage of patients with migraine who experience "wearing off" of efficacy of galcanezumab at the end of a treatment cycle using this predefined threshold., Background: Anecdotal reports suggest that some patients may experience "wearing off" of efficacy during the last week of their calcitonin gene-related peptide monoclonal antibody treatment cycle. A previous post hoc analysis of galcanezumab demonstrated consistent efficacy at each week throughout all monthly dosing intervals at the population-level, but "wearing off" has not been assessed at the individual patient-level., Methods: Post hoc analyses of clinical trial data from four galcanezumab phase III, randomized, placebo-controlled studies in a total of 2680 patients with high-frequency episodic migraine (EVOLVE-1, EVOLVE-2, and CONQUER studies) or chronic migraine (CM; REGAIN and CONQUER studies) were conducted. "Wearing off" was defined as an increase of greater than or equal to 2 weekly migraine headache days in the last week of the treatment cycle compared to the second week for at least 2 months. The analyses were conducted (1) in all patients and (2) in patients with a clinically meaningful response to treatment., Results: The percentage of patients meeting the threshold of "wearing off" was not statistically significantly different among the placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups, both in the total population and in patients with a clinically meaningful response (all ≤9.0%). Although the frequency of "wearing off" in patients with CM and prior preventive failures was numerically greater in the galcanezumab groups (8/89 or 9.0%) compared to placebo (3/95 or 3.2%), these differences were not statistically significant., Conclusions: Consistent with previous analyses at the population-level that showed no evidence of decreased efficacy at the end of a treatment cycle, rates of individual patients meeting the threshold of "wearing off" in this analysis were low and similar among placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups., (© 2022 Eli Lilly and Company. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.)

Introduction: The consistency of the treatment effect of galcanezumab throughout the dosing interval is examined in patients with episodic and chronic migraine., Methods: This study was a post hoc analysis of clinical trial data from episodic (EVOLVE-1; EVOLVE-2; both 6-month duration) and chronic (REGAIN; 3-month duration) migraine double-blind trials evaluating the efficacy of a once-monthly injection of galcanezumab 120 mg relative to placebo. Adults with episodic (placebo, n = 894; galcanezumab, n = 444) or chronic migraine (placebo, n = 558; galcanezumab, n = 278) were included. Mean change from baseline in weekly migraine headache days, averaged across all months for each week of the dosing interval, was compared between groups and within the galcanezumab group during weeks 1 and 4. Additional analyses examined the mean difference from placebo in weekly migraine headache days and a day-by-day analysis., Results: Weekly migraine headache day reduction was significantly greater with galcanezumab relative to placebo every week (P < 0.001) and did not differ during weeks 1 and 4 for those with episodic (P = 0.740) or chronic migraine (P = 0.231) taking galcanezumab. Estimated probabilities of migraine on day 2 and day 30 did not differ for those with episodic (P = 0.61) or chronic migraine (P = 0.616) taking galcanezumab., Conclusion: This analysis demonstrates once monthly galcanezumab exhibits consistent efficacy throughout the dosing interval among the population of patients with migraine in three clinical trials evaluating the efficacy of galcanezumab. There is no evidence from these trials that the effect of galcanezumab "wears off" at the end of the dosing interval., Trial Registration: ClinicalTrials.gov identifier: EVOLVE-1 (NCT02614183); EVOLVE-2 (NCT02614196); REGAIN (NCT02614261).

Background: Patients with episodic migraine (EM) with a higher-frequency of migraine headache days (HFEM: 8-14 migraine headache days/month) have a greater disease burden and a higher risk of progressing to chronic migraine (CM) with associated acute treatment overuse versus those with low-frequency EM (LFEM: 4-7 migraine headache days/month). In this post hoc analysis, we assessed the proportions of patients who shifted from HFEM to LFEM and to very low-frequency EM (VLFEM: 0-3 migraine headache days/month) status following treatment with galcanezumab versus placebo., Methods: EVOLVE-1 and EVOLVE-2 were double-blind, Phase 3 studies in patients with EM. Patients (18-65 years) were randomized (2:1:1) to subcutaneous monthly injections of placebo, galcanezumab 120 mg (240 mg loading dose) or 240 mg, for up to 6 months. Data were pooled and endpoints were change from baseline in number of migraine headache days/month and patients who shifted from HFEM to LFEM or VLFEM status. Impact of change in HFEM status on migraine headache days/month, quality of life and disability was also assessed., Results: A total of 66% (1176/1773) patients from EVOLVE studies had HFEM status at baseline and were included in this analysis; placebo: 592, galcanezumab 120 mg: 294 and galcanezumab 240 mg: 290. At each month, both doses of galcanezumab resulted in a higher proportion of patients who shifted to 0-7 monthly headache days/month (VLFEM or LFEM status). Patients who shifted from HFEM at baseline to VLFEM status at Month 3, a relatively larger proportion of patients on galcanezumab 120 mg versus placebo remained at VLFEM status at Months 4-6; Months 4-5 for galcanezumab 240 mg versus placebo. Among the galcanezumab-treated patients who did-not-shift or shifted to LFEM or VLFEM status for ≥3 consecutive months until the end of the study, patients who shifted from HFEM to VLFEM status experienced the largest reduction in migraine headache days/month and the largest clinically meaningful improvements in daily functioning (MSQ-RFR) and disability (MIDAS)., Conclusions: In patients with HFEM, treatment with galcanezumab (120 mg and 240 mg) significantly reduced migraine headache days/month, maintained remission status at subsequent months until the end of the study, and improved patients' quality of life versus placebo., Trial Registration: ClinicalTrials.gov Identifier: EVOLVE-1, NCT02614183 ; EVOLVE-2, NCT02614196 .

Background: Galcanezumab, a humanized monoclonal antibody that binds calcitonin gene-related peptide, has demonstrated a significant reduction in monthly migraine headache days compared with placebo. Here, we analyze data from 3 randomized clinical trials (2 episodic trials [EVOLVE-1, EVOLVE-2] and 1 chronic trial [REGAIN]), to examine if galcanezumab also alleviates the severity and symptoms of migraine., Methods: The episodic migraine trials were 6-month, double-blind studies in patients with episodic migraine (4-14 monthly migraine headache days). The chronic migraine trial was a 3-month, double-blind study in patients with chronic migraine (≥ 15 headache days per month, where ≥ 8 met criteria for migraine). Patients (18-65 years) were randomized to placebo or galcanezumab 120 mg with a 240-mg loading dose or 240 mg. Patients recorded headache characteristics, duration, severity, and presence of associated symptoms with each headache. The outcomes analyzed were changes from baseline in number of monthly migraine headache days with nausea and/or vomiting, photophobia and phonophobia, aura, and prodromal symptoms other than aura. Additional outcomes analyzed included the number of moderate-to-severe monthly migraine headache days, number of severe migraine headache days, and mean severity of remaining migraine headache days. Change from baseline in the proportion of days with nausea and/or vomiting and the proportion of days with photophobia and phonophobia among the remaining monthly migraine headache days were also analyzed., Results: Galcanezumab was superior to placebo in reducing the frequency of migraine headache days with associated symptoms of migraine such as nausea and/or vomiting, photophobia and phonophobia, and prodromal symptoms. Galcanezumab reduced the frequency of migraine headache days with aura in the episodic migraine studies. There was a significant reduction in the proportion of remaining migraine headache days with nausea and/or vomiting for the episodic and chronic migraine studies, and with photophobia and phonophobia for the episodic migraine studies. Galcanezumab was superior to placebo in reducing the number of monthly moderate-to-severe migraine headache days and the overall and monthly severe migraine headache days., Conclusions: Galcanezumab reduces the frequency of migraine headache days and can alleviate potentially disabling non-pain symptoms on days when migraine is present in patients with episodic or chronic migraine., Trial Registration: NCT, NCT02614183 (EVOLVE-1), registered 25 November 2015; NCT, NCT02614196 , (EVOLVE-2), registered 25 November 2015; NCT, NCT02614261 (REGAIN), registered 25 November 2015.

Objective: This post hoc study investigated the relationship between patient response in terms of migraine headache day reduction and patient-reported outcomes of health-related quality of life (HRQoL) and disability categories., Background: Migraine causes considerable disease-related disability and negatively impacts HRQoL of patients. Calcitonin gene-related peptide inhibitors improve these outcomes and may eliminate disability due to migraine in some patients., Methods: Analyses used data from 3 double-blind, placebo (PBO)-controlled, phase 3 studies in adults with episodic migraine (EM) (EVOLVE-1: N = 858 and EVOLVE-2: N = 915) or chronic migraine (CM) (REGAIN: N = 1113). Patients were randomized 2:1:1 to subcutaneous injection of PBO, galcanezumab (GMB) 120 mg, or GMB 240 mg once monthly for 6 months in EVOLVE-1 and -2 and for 3 months in REGAIN. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Patients were divided into 4 response-level groups based on percent change from baseline (<30%, ≥30% to <50%, ≥50% to <75%, ≥75%). Patient-reported outcomes included the 14-item Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) and Migraine Disability Assessment (MIDAS) questionnaire., Results: Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response. On a 100-pt scale, increases in Role Function-Restrictive score in EM were 16.8 and 36.0 at the <30% and ≥75% response levels, respectively, and for CM were 10.7 and 46.5. Similar patterns in scores were observed for the Role Function-Preventive and Emotional Function domains. Examination of improvement in MSQ item score by treatment group showed that, in patients with EM, approximately 10 to 20% more GMB-treated patients (N = 796 for GMB 120 mg and GMB 240 mg) had improvements in all 14 MSQ items compared with PBO-treated patients (N = 773) (all P < .001). In patients with CM, 3 to 16% more GMB-treated patients (N = 507) had improvements in the 14 MSQ items compared with PBO (N = 494), though differences were statistically significant in only 19 of 28 comparisons. At baseline, mean MIDAS scores (EM, 33.1; CM, 67.2) indicated severe mean disability for patients with EM and very severe disability for patients with CM. Among patients with EM, 215 of 425 (50.6%) of those treated with GMB 120 mg and 212 of 413 (51.3%) treated with 240 mg had little/no disability due to migraine after 6 months (PBO: 277 of 832 (33.3%), P < .001 for both). Among patients with CM, 50 of 254 (19.7%) of those treated with GMB 120 mg and 54 of 258 (20.9%) treated with 240 mg reached the level of little/no disability after 3 months of treatment (PBO: 70 of 504 (13.9%), P = .045 for 120 mg, P = .017 for 240 mg)., Conclusions: Because migraine greatly impairs an individual's ability to participate in activities of daily living, measurements of HRQoL are essential in clinical research. This study showed that function in daily life, as measured by MSQ score, improved as migraine headache days were reduced and that GMB-treated patients were more likely to see improvement in MSQ item scores compared with PBO-treated patients. Elimination of migraine-related disability was also more frequent in GMB-treated patients compared with placebo-treated patients., (© 2020 Eli Lilly and Company. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC, on behalf of American Headache Society.)

Background: Cluster headache (CH) is a highly disabling primary headache disorder. To date, characterization of outcomes in the preventive treatment of episodic CH, including precise definitions of clinically meaningful attack frequency reduction and impact on acute treatment management, is lacking., Methods: This was a Phase 3, randomized, double-blind, placebo-controlled study in patients (men or women aged 18-65 years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders-3 beta criteria. In this post hoc analysis, we evaluated the median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attack frequency, and impact on acute medication use. An anchor-based assessment of clinically relevant attack frequency reduction using the Patient Global Impression of Improvement (PGI-I) scores at Week 4 was also assessed., Results: The median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attacks was consistently shorter (9-10 days sooner) with galcanezumab vs placebo (median [95% confidence interval, 95% CI]: ≥50%, 5 days [4.0 to 7.0] vs 14 days [6.0 to 19.0]; ≥75%, 11 days [7.0 to 16.0] vs 21 days [13.0 to 26.0]; 100%, 22 days [16.0 to 37.0] vs 32 days [23.0 to 34.0]). Mean reduction from baseline in the overall frequency of weekly pooled acute medication use across Weeks 1-3 was significantly greater with galcanezumab vs placebo (11.0 vs 5.5; odds ratio, OR [95% CI]: 5.52 [1.02, 10.01]; P value = .017). Patients reporting "much better" on the PGI-I experienced a median weekly CH attack reduction of approximately 43% from baseline across Weeks 1-3. The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3])., Conclusions: Faster median time-to-first occurrence of response rates, lower frequency of pooled acute medications use, and a greater proportion of patients achieving a response anchored by patient-reported improvement were observed for galcanezumab vs placebo., (© 2020 Eli Lilly and Company. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC, on behalf of American Headache Society.)

Background: Focus on the frequency of migraine pain may undervalue the total burden of migraine as pain duration and severity may present unique, additive burden. A composite measure of total pain burden (TPB; frequency, severity, and duration) may provide a more comprehensive characterization of pain burden and treatment response in patients with episodic migraine (EM) or chronic migraine (CM). The impact of galcanezumab versus placebo on TPB among patients with EM or CM was analyzed., Methods: Patients from randomized, double-blind, placebo-controlled episodic (two 6-month studies pooled) and chronic migraine (3-month) studies received once-monthly subcutaneous injection of galcanezumab 120 mg or placebo. A post hoc analysis of TPB for a given month was calculated as severity-weighted duration by multiplying duration (hours) and maximum pain severity (0 = none, 1 = mild, 2 = moderate, 3 = severe) of migraine for each day and summing these over the days in a month. Least square mean change from baseline in monthly TPB across Months 1-6 (EM, N = 444 galcanezumab, N = 894 placebo) and Months 1-3 (CM, N = 278 galcanezumab, N = 558 placebo) were compared using a mixed-model repeated measures model. Correlation of the Migraine Specific Quality of Life Questionnaire (MSQ) and Migraine Disability Assessment Scale (MIDAS) to TPB at baseline was assessed., Results: At baseline, the duration of migraine on a given migraine headache day accounted for the greatest unique proportion of variability (EM, 57.4% and CM, 61.1%) to TPB after adjusting for frequency of migraine headache days and maximum pain severity. The decrease from baseline in monthly TPB was greater with galcanezumab than placebo for patients with EM (68.6 versus 36.2) and CM (102.6 versus 44.4). The average percent reduction of TPB from baseline was significantly greater with galcanezumab compared with placebo in patients with EM (50.8% versus 17.2%) and CM (29.7% versus 11.0%). In patients with EM and CM, TPB correlated with MSQ total score (r = - 0.35 and r = - 0.37) and MIDAS (r = 0.34 and r = 0.32)., Conclusions: Greater reduction in TPB was seen in patients with EM and CM treated with galcanezumab 120 mg once-monthly injection relative to placebo. Discussing TPB supports patient-centric conversations regarding treatment expectations when clinicians are evaluating options for migraine prevention., Trial Registration: ClinicalTrials.gov : # NCT02614183 (I5Q-MC-CGAG; EVOLVE-1), # NCT02614196 (I5Q-MC-CGAH; EVOLVE-2), and # NCT02614261 (I5Q-MC-CGAI; REGAIN) - all 3 trials were registered on 23 November 2015.

Objectives: To explore relationships between the training background of cardiac critical care attending physicians and self-reported perceived strengths and weaknesses in their ability to provide clinical care., Design: Cross-sectional observational survey sent worldwide to ~550 practicing cardiac ICU attending physicians., Setting: Hospitals providing cardiac critical care., Subjects: Practicing cardiac critical care physicians., Interventions: None., Measurements and Main Results: We received responses from 243 ICU attending physicians from 82 centers (14 countries). The primary training background of the respondents included critical care (62%), dual training in critical care and cardiology (16%), cardiology (14%), and other (8%). We received 49 responses from medical directors in nine countries, who reported that the predominant training background for attending physicians who provide cardiac intensive care at their institutions were critical care (58%), dual trained (18%), cardiology (12%), and other (11%). A greater proportion of physicians trained in either critical care or dual-training reported feeling confident managing multiple organ failure, neurologic conditions, brain death, cardiac arrest, and performing procedures like advanced airway placement and inserting chest- and abdominal-drains. In contrast, physicians with cardiology and dual-training reported feeling more confident managing intractable arrhythmias, understanding cardiopulmonary interactions, and interpreting echocardiogram, electrocardiogram, and cardiac catheterization. Overall, only 57% of the respondents felt comfortable based on their current training background to manage patients with complex cardiac issues without collaboration with other specialists., Conclusions: Our survey demonstrates that intensivists trained in critical care are more comfortable with critical care skills, cardiology-trained intensivists are more comfortable with cardiology skills, and dual-trained physicians are comfortable with both critical care skills and cardiology skills. These findings may help inform future efforts to optimize the educational curriculum and training pathways for future cardiac intensivists. These data may also be used to shape continuing medical education activities for cardiac intensivists who have already completed their training.

Objectives: To evaluate risk factors associated with eye injuries related to motor vehicle accidents (MVA) using a multicentre national database from the US emergency departments., Patients and Methods: A post hoc analysis from the Nationwide Emergency Department Sample database (2006-2013) was performed. Patients presenting to the emergency department (ED) with MVA-related trauma were included. We then evaluated patient- and centre-level risk factors associated with the presence of ocular trauma using a multivariable logistic regression model., Results: A total of 2,745,152 patients from 2080 ED were identified for inclusion. Of these, 31,493 patients (1.14%) were associated with ocular trauma. The most common ocular injuries reported in our study were injury to ocular adnexa, orbital fractures, subconjunctival haemorrhage, foreign body on eye, and open wound of the eyeball. In univariate analysis, the other patient factors associated with ocular trauma included male gender, >1 chronic condition, admission during weekend, >1 bodily injury, higher injury severity score (ISS), presence of skull fractures and other bodily fractures, seizures, and initiation of mechanical ventilation after MVA. The hospital characteristics associated with highest incidence of ocular trauma included ED visit to a level I trauma centre and metropolitan teaching hospital. The independent factors associated with ocular trauma included younger age groups, male gender, weekend injury, presence of chronic conditions, >1 bodily injury, higher ISS, presence of skull fractures, ED admission to level-1 trauma centre, and ED admission to a teaching hospital., Conclusions: This multicentre study establishes that both patient- and centre-level factors are associated with MVA-related eye injuries.

Objective: Nitric oxide is utilized after pediatric cardiac surgery as an off-label medication without much evidence, is expensive, and varies among centers of varying surgical volume. The objective of our study was to describe the spectrum of nitric oxide utilization and to evaluate the effect of nitric oxide utilization on outcomes among patients cared for in centers of varying surgical volume using Pediatric Health Information system., Methods: Patients aged ≤18 years undergoing heart surgery were included (2004-2015). Multivariable mixed-effects logistic regression models were fitted to evaluate association of center volume with odds of nitric oxide utilization among patients undergoing heart operations. Centers were classified into 3 volume categories based on tertiles of number of cardiopulmonary bypass cases performed (low volume: 34 792 patients, 21 centers; medium volume: 38 362 patients, 13 centers; high volume: 30 560 patients, 7 centers)., Results: A total of 103 714 patients from 41 hospitals were included. Of these, 15 708 (15.1%) patients received nitric oxide after cardiac surgery. Of the patients receiving nitric oxide, only 3936 (25.1%) patients were associated with a diagnosis of pulmonary hypertension. In adjusted models, low- and medium-volume centers were associated with higher nitric oxide utilization after heart operations as compared to high-volume centers (low vs high, odds ratio [OR]: 1.48, 95% confidence interval [CI]: 1.38-1.60; medium vs high, OR: 1.33, 95% CI: 1.26-1.41). Despite higher nitric oxide utilization, the mortality was worse among patients treated in low- and medium-volume centers, as compared to high-volume centers (low vs high, OR: 1.42, 95% CI: 1.26-1.60; medium vs high, OR: 1.14, 95% CI: 1.04-1.25)., Conclusions: This study demonstrates variation in nitric oxide utilization after heart operations among centers of varying surgical volume. Further, it raises questions on the benefit of nitric oxide administration after pediatric cardiac surgery.

Objectives: To evaluate the prevalence of do-not-resuscitate status, assess the epidemiologic trends of do-not-resuscitate status, and assess the factors associated with do-not-resuscitate status in children after in-hospital cardiac arrest using large, multi-institutional data., Design: Generalized estimating equations logistic regression model was used to evaluate the trends of do-not-resuscitate status and evaluate the factors associated with do-not-resuscitate status after cardiac arrest., Setting: American Heart Association's Get With the Guidelines-Resuscitation Registry., Patients: Children (< 18 yr old) with an index in-hospital cardiac arrest and greater than or equal to 1 minute of documented chest compressions were included (2006-2015). Patients with no return of spontaneous circulation after cardiac arrest were excluded., Interventions: None., Measurements and Main Results: In total, 8,062 patients qualified for inclusion. Of these, 1,160 patients (14.4%) adopted do-not-resuscitate status after cardiac arrest. We found low rates of survival to hospital discharge among children with do-not-resuscitate status (do-not-resuscitate vs no do-not-resuscitate: 6.0% vs 69.7%). Our study found that rates of do-not-resuscitate status after cardiac arrest are highest in children with Hispanic ethnicity (16.4%), white race (15.0%), and treatment at institutions with larger PICUs (> 50 PICU beds: 17.8%) and at institutions located in North Central (17.6%) and South Atlantic/Puerto Rico (17.1%) regions of the United States. Do-not-resuscitate status was more common among patients with more preexisting conditions, longer duration of cardiac arrest, greater than 1 cardiac arrest, and among patients requiring extracorporeal cardiopulmonary resuscitation. We also found that trends of do-not-resuscitate status after cardiac arrest in children are decreasing in recent years (2013-2015: 13.8%), compared with previous years (2006-2009: 16.0%)., Conclusions: Patient-, hospital-, and regional-level factors are associated with do-not-resuscitate status after pediatric cardiac arrest. As cardiac arrest might be a signal of terminal chronic illness, a timely discussion of do-not-resuscitate status after cardiac arrest might help families prioritize quality of end-of-life care.

Background: Food insecurity (FI), limited availability of or access to nutritional foods, is linked to poor child/caregiver health. We examined FI in food-allergic and non-food-allergic children to determine whether dietary limitations associated with food allergy increases risk of FI., Methods: Food-allergic and non-food-allergic children (1-17 years) were recruited from Arkansas Children's Hospital allergy/asthma clinics. The USDA Food Security Survey, the Newest Vital Sign Health Literacy (HL) questionnaire, and the Food Allergy Impact Scale QOL survey were administered. Logistic regression and analysis of covariance models were utilized for data analysis., Results: Subjects (n = 650) included 325 food-allergic and 325 non-food-allergic children. Overall rate of FI was 21.5% (food allergic 22.2% and non-food allergic 20.9%) with no significant difference in the prevalence of FI between groups (OR = 1.30; 95% CI 0.86-1.96; P = 0.21). FI was increased in households of children with both milk and egg allergy when compared to those without food allergy and those with single food allergy (OR = 2.5; 95% CI 1.4-4.6; P = 0.003). Mean HL rates were higher in the food-secure vs food-insecure groups (mean diff = 0.31; 95% CI 0.03-0.59; P = 0.03). Among food-allergic children, QOL was better in the food-secure vs food-insecure group (mean diff = 0.61; 95% CI 0.002-1.23; P = 0.049)., Conclusion: Food allergy to milk and egg was associated with increased risk of household FI. Food-insecure participants had lower HL than their food-secure counterparts. Further work is needed to define risks associated with FI among food-allergic children to improve screening and management strategies., (© 2019 EAACI and John Wiley and Sons A/S. Published by John Wiley & Sons Ltd.)

Objectives: To evaluate the impact of regional cerebral perfusion (RCP) during heart operation on outcomes in neonates undergoing Norwood operation., Methods: We performed a retrospective cohort study using data from the Single Ventricle Reconstruction trial data set. The adjusted effect of RCP use on each outcome was studied using a penalized logistic regression model with bootstrap validation., Results: Of 549 patients included in the study, 252 patients (45.9%) received RCP during their heart operation. In univariate comparisons, the majority of the baseline characteristics and preoperative risk factors were similar in the RCP and No RCP group. The total cardiopulmonary bypass (CPB) time and the total cross-clamp (CC) time were longer in the RCP group (RCP vs No RCP, median CPB time: 161 minutes vs 109 minutes; median CC time: 63 minutes vs 43 minutes). In adjusted models, the use of RCP was not associated with decreased mortality and/or need for heart transplant at hospital discharge (odds ratio [OR]: 0.73; 95% confidence interval [CI]: 0.43-1.25) or prolonged mechanical ventilation (OR: 1.20, 95% CI: 0.62-2.28) or prolonged hospital length of stay (OR: 1.30, 95% CI: 0.73-2.30). We demonstrated that use of RCP was associated with longer CPB times, increased use of ultrafiltration, and higher probability of open chest after Norwood operation., Conclusions: This study did not demonstrate any impact of RCP on in-hospital mortality and/or heart transplantation, prolonged mechanical ventilation, and prolonged hospital length of stay among neonates undergoing Norwood operation.

Background: We examined prevalence, incidence, and trajectory of obesity from kindergarten through grade 8 in one of the first states to implement annual surveillance., Methods: Participants included 16,414 children enrolled in kindergarten in Arkansas in 2004 with complete body mass index (BMI) measurements in kindergarten and eighth grade. Repeated measures of weight status were entered in multiple linear and logistic regression models with demographics and family poverty status., Results: The prevalence of obesity (BMI ≥ 95th percentile) was lowest in kindergarten (14.9%), with subsequent incidence rates consistent at 4%. Prevalence and incidence peaked in eighth grade (24.5% and 4.9%, respectively), with 33.8% of children measuring obese at least once by eighth grade. Kindergarten obesity was a significant predictor of eighth grade obesity (odds ratio, 17.5; 95% confidence interval, 15.8-19.3). We found statistically significant 3-way interactions for sex, race, and time, suggesting unique patterns for Hispanic boys and black girls., Conclusions: Our study documents unique longitudinal patterns of obesity from kindergarten through eighth grade that expand our understanding of risk. It demonstrates the value of public school health systems that collect routine administrative data about student BMI that is integrated with education records to foster program and policy discussions., (© 2019, American School Health Association.)

Purpose: To create a real-time prediction tool to predict probability of ECMO deployment in children with cardiac or pulmonary failure., Materials and Methods: Patients ≤18 years old admitted to an ICU that participated in the Virtual Pediatric Systems database (2009-2015) were included. Logistic regression models using adaptive lasso methodology were used to identify independent factors associated with ECMO use., Results: A total of 538,202 ICU patients from 140 ICUs qualified for inclusion. ECMO was deployed in 3484 patients (0.6%) with a mortality of 1450 patients (41.6%). The factors associated with increased probability of ECMO use included: younger age, pulmonary hypertension, congenital heart disease, high-complexity cardiac surgery, cardiomyopathy, acute lung injury, shock, renal failure, cardiac arrest, use of nitric oxide, use of either conventional mechanical ventilation or high frequency oscillatory ventilation, and higher annual ECMO center volume. The area under the receiver operating curve for this model was 0.90 (95% CI: 0.85-0.93). This tool can be accessed at https://soipredictiontool.shinyapps.io/ECMORisk/., Conclusions: Here, we present a tool to predict ECMO deployment among critically ill children; this tool will help create real-time risk stratification among critically ill children, and it will help with benchmarking, family counseling, and research., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Purpose: The purpose of this study is to evaluate the characteristics and publication outcomes of abstracts presented in American Academy of Ophthalmology (AAO) meetings., Subject and Methods: Abstracts from AAO meetings for the years 2012 and 2013 were evaluated from the meeting archives. The study characteristics were recorded for each abstract. Each abstract was assessed for publication in a peer-reviewed scientific journal using three search engines (PubMed, Medline, and Google Scholar). Time to publication was also calculated., Results: A total of 929 abstracts presented to 2 AAO meetings were analyzed. Among subspecialty areas, retina represented the largest percentage of accepted meeting abstracts (33.3%) followed by cornea (21.9%), cataract (14.9%), and glaucoma (14.4%). A total of 304 abstracts (32.7%) were published in peer-reviewed journals as full-length articles. The median time to publication was 40 months, and the median impact factor of the journal for the published manuscript was 1.9. In multivariable models, topics related to glaucoma were most likely to be published followed by retina. The odds for publication were higher if the first author was affiliated with a residency program, and if the first author originated from South Korea and the United States., Conclusions: Our study presents the landscape of publication outcomes for abstracts presented in national AAO meetings with ~1/3 of presented abstracts culminated in publication in a peer-reviewed journal.

Adoption of electronic personal health records by older adults offers multiple advantages to healthcare and is being encouraged by federal agencies and health associations. However, obstacles have limited older adults' rates of adoption to approximately 10%. This study examined the initial proficiency of older adults at entering 21 standard health elements into an electronic personal health record. Entry completeness, accuracy, elapsed time, and help requests were measured. A combination of standard technology adoption model and older adult characteristics accounted for 52% of variability in proficiency at entering electronic personal health record data. Automatic linear modeling identified three variables as primarily related to proficiency with electronic personal health record use: age, computer competency, and mental status. Interventions to increase electronic personal health record adoption and proficiency of use will require the consideration of variables specific to older adults, and may best focus on younger seniors with good mental status and computer competency. Efforts for older seniors with decreased mental status might better center on delegation to a primary caregiver.

Objectives: To use two national databases to quantify the pace and magnitude of improvement in hospital performance (as measured by mortality) across hospitals caring for critically ill children in the United States., Design: We used empirical Bayes shrinkage estimators to obtain shrinkage estimators of observed/expected mortality ratios for each hospital assuming a Gamma Poisson posterior distribution. Revised mortality rates for each hospital were obtained from the shrunken incidence ratios., Setting: Pediatric Health Information System participating hospital and Kids' Inpatient Database participating hospital., Patients: Patients less than or equal to 18 years old who received invasive mechanical ventilation during their hospital stay at a Pediatric Health Information System participating hospital (2005-2015) or a Kids' Inpatient Database participating hospital (1997-2012) were included., Interventions: None., Measurements and Main Results: A total of 486,838 patients from 48 Pediatric Health Information System hospitals and 798,840 patients from 947 Kids' Inpatient Database hospitals were included. For the Pediatric Health Information System hospitals, the median shrunken adjusted mortality decreased from 11.66% in 2005 to 7.11% in 2015; for the Kids' Inpatient Database hospitals, it decreased from 5.79% in 1997 to 3.86% in 2012. By 2015, more than 95% of the Pediatric Health Information System hospitals performed better than or as well as the best 25% of the hospitals in 2005. By 2012, 33.7% of Kids' Inpatient Database hospitals performed better than or as well as the best 25% of the hospitals in 1997., Conclusions: This study provides insight into the magnitude of improvement in patient mortality in hospitals caring for critically ill children in the United States. This study quantifies hospital performance in pediatric critical care over time, and it provides benchmarks against which individual hospitals can assess their own performance. In future pediatric epidemiologic studies, we should identify outcomes other than mortality to quantify improvement in hospital performance.

Objective: To evaluate whether the presence of patent ductus arteriosus (PDA) in preterm infants worsens long-term neurodevelopmental outcomes., Study Design: This was a secondary observational analysis of data from 1090 preterm low-birthweight infants in the Infant Health and Development Program (IHDP), a multicenter longitudinal cohort study of outcomes assessed from 3 to 18 years of age. Multivariable analysis was adjusted for IHDP treatment group (intervention or follow-up), birth weight, maternal race, maternal education, infant sex, maternal preconception weight, Home Observation Measurement of the Environment (HOME) total score at 12 months, neonatal health index, and gestational age., Results: Of the 1090 patients (49% male) included in the analysis, 135 had a PDA. Mean birth weight (1322 g vs 1871 g; P < .0001) and gestational age (30.2 weeks vs 33.4 weeks, P < .0001) were lower and mean ventilator days (11.8 vs 1.3; P < .0001), vasopressor use (12.6% vs 1.2%; P < .0001), and congestive heart failure (8.9% vs 0.1%; P < .0001) were higher in the PDA group. There were no differences between the PDA and no-PDA groups in maternal education level and HOME total score at age 12 months. Multivariable analysis demonstrated no between-group differences in cognitive development or behavioral competence at age 3, 8, and 18 years., Conclusions: The presence of a PDA in moderately preterm, low-birthweight infants does not impact long-term neurodevelopmental outcomes., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: To evaluate the effect on mortality of reclassifying patients undergoing pediatric heart reoperations of varying complexity by operation of highest complexity instead of by first operation., Methods: Data from the Virtual Pediatric Systems Database on children aged < 18 years who underwent heart surgery (with or without cardiopulmonary bypass) were included (2009-2015). Only patients who underwent reoperations during the same hospitalization were included. Patients were classified based on the first cardiovascular operation (the index operation), and on the complexity of the operation (the operation with the highest Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery [STAT] mortality category of each hospital admission) performed., Results: Of 51,047 patients (73 centers), 22,393 met inclusion criteria. Using index operation as the classifying operation, the number of patients classified in the STAT 1 category increased by approximately 2.5 times compared with the highest-complexity operation (index, 7,077 and highest complexity, 2,654). In contrast, when the highest-complexity classification was used, we noted an increase in the number of patients in other STAT categories. We also noted higher mortality in all STAT categories when patients were classified by index operation instead of by highest complexity (index vs highest STAT category 1, 0.6% vs 0.2%; category 2, 2.4% vs 0.8%; category 3, 3.1% vs 2.1%; category 4, 5.8% vs 5.6%; and category 5, 16.7% vs 16.5%)., Conclusions: This study demonstrates differences in the reported number of patients and reported mortality in each STAT category among children undergoing various heart reoperations during the same hospitalization by classifying patients based on index operation compared with the operation of highest complexity., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Right ventricular (RV) end-diastolic volume measured by cardiovascular magnetic resonance imaging (CMR) is a criterion for pulmonary valve replacement in patients with tetralogy of Fallot (TOF). We sought to determine if the ratio of echocardiographic, short-axis RV-to-left ventricular (LV) end-diastolic areas (EDA) could be used to predict RV volume on CMR. We retrospectively reviewed the echocardiograms of all patients with repaired TOF who underwent CMR at our institution from 2011 to 2015 and also had an echocardiogram within 6 months of the CMR. The short-axis RV and LV EDAs were measured and the ratio of the two was calculated. Results were compared with CMR RV end-diastolic volume index (RVEDVi) and RV:LV end-diastolic volume ratio. The sensitivity and specificity values predicting RV volumes > 150 ml/m 2 were calculated. Fifty-eight studies met inclusion criteria. There were 47 studies with RVEDVi < 150 ml/m 2 and 11 with RVEDVi > 150 ml/m 2 . RV:LV EDA and CMR RV:LV end-diastolic volume ratio correlated strongly (r = 0.76, p < 0.0001). An RV:LV EDA ≥ 1.57 had a 90% sensitivity to predict RVEDVi > 150 ml/m 2 (area under the curve = 0.74, 95% CI 1.5-27.9; p = 0.012). An RV:LV EDA ≥ 1.88 had an 81% specificity to detect RV volume index > 150 ml/m 2 . Short-axis RV:LV EDA correlates well with an increased RVEDVi as measured by CMR. This new and simple measure can be used to predict optimal timing for CMR in anticipation of pulmonary valve replacement in repaired TOF.

Purpose: To study the effect of cycloplegia on astigmatism measurements in pediatric patients with amblyopia., Methods: This was a prospective comparative clinical study. Participants 4 to 17 years old were recruited from the patient population at the Arkansas Children's Hospital eye clinic after informed consent was obtained. Autorefractor measurements were used to obtain values of refractive error in amblyopic and non-amblyopic patients before and after cycloplegia. The groups were subdivided into myopia and hyperopia and with and without underlying amblyopia. The refractive error was expressed as sphere, cylinder, axis of astigmatism, and spherical equivalent. The treatment effect was summarized as the mean difference (95% confidence interval) for each outcome., Results: No statistically significant difference was found on the axis and power of astigmatism before and after cycloplegia in the patients with amblyopia (P = .28 and .99, respectively)., Conclusions: Non-cycloplegic autorefraction measurements may be considered safe for refining astigmatism power and axis in pediatric patients with amblyopia. [J Pediatr Ophthalmol Strabismus. 2018;55(5):293-298.]., (Copyright 2018, SLACK Incorporated.)

Introduction: Helicopter emergency medical services (HEMS) have provided benefit for severely injured patients. However, HEMS are likely overused for the transportation of both adult and pediatric trauma patients. In this study, we aim to evaluate the degree of overuse of helicopter as a mode of transport for head-injured children. In addition, we propose criteria that can be used to determine if a particular patient is suitable for air versus ground transport., Materials and Methods: We identified patients who were transported to our facility for head injuries. We included only those patients who were transported from another facility and who were seen by the neurosurgical service. We recorded a number of data points including age, gender, race, Glasgow Coma Score (GCS), and intubation status. We also collected data on a number of imaging findings such as mass effect, edema, intracranial hemorrhage, and skull fractures. Patients undergoing emergent nonneurosurgical intervention were excluded., Results: Of the 373 patients meeting inclusion criteria, 116 (31.1%) underwent a neurosurgical procedure or died and were deemed appropriate for helicopter transport. The remaining 68.9% of patients survived their injuries without neurosurgical intervention and were deemed nonappropriate for helicopter transport. Multivariable logistic regression identified GCS 3-8 and/or presence of mass effect, edema, epidural hematoma (EDH), and open-depressed skull fracture as appropriate indications for helicopter transport., Conclusions: The majority of patients transported to our facility by helicopter survived their head injury without need for neurosurgical intervention. Only those patients meeting clinical (GCS 3-8) or radiographic (mass effect, edema, EDH, open-depressed skull fracture) criteria should be transported by air., Level of Evidence: Level III (Diagnostic Study)., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: This study evaluated the characteristics and publication outcomes of pediatric heart disease abstracts presented in national meetings., Methods: Three years of abstracts (2012-2014) were evaluated from five national meetings: Society of Thoracic Surgeons (STS), American Association of Thoracic Surgeons (AATS), American College of Cardiology (ACC), American Academy of Pediatrics (AAP), and American Heart Association (AHA). Each abstract was assessed for publication in a peer-reviewed scientific journal, time to publication, impact factor of the journal, and number of citations associated with the publication., Results: A total of 1145 abstracts qualified for inclusion. The majority of the abstracts originated from North America (80.8%) and were single institutional (85.7%), clinical (92.5%), and retrospective (77.9%) studies. A total of 767 abstracts (66.9%) were published in peer-reviewed journals as full-length articles. More than 90% of the abstracts presented at the surgical meetings were published as manuscripts in peer-reviewed journals. In contrast, 68.8% of ACC abstracts 53.7% AAP abstracts and 61.4% of AHA abstracts were published as manuscripts in a peer-reviewed journal. The median time to publication was shortest for STS abstracts (10 months) and longest for AHA abstracts (29 months). The median impact factor for published manuscripts varied between 3.0 and 3.5 for AATS abstracts, STS abstracts, ACC abstracts, and AHA abstracts. Manuscripts from AATS abstracts had the highest number of citations., Conclusions: Our data indicate that the national cardiology and cardiac surgery meetings have become a forum for presenting high-quality research, with >90% of the abstracts presented in these meetings culminating in publication., (Copyright © 2018. Published by Elsevier Inc.)

Background and Purpose: A valid and reliable Authentic Leadership (AL) measurement instrument is paramount as nursing leadership research grows. The purpose of this study was to analyze the reliability and construct validity of the Authentic Leadership Inventory (ALI) among nurses., Methods: This study was a cross-sectional, prospective design that explored the relationship between registered nurses' (RNs) perceptions of AL qualities in nurse managers in a random sample of RNs working in an acute care setting., Results: A Cronbach α 0.96 confirmed reliability. Exploratory factor analysis determined a one-factor structure. Confirmatory factor analysis utilized the one-factor structure for a final best-fit model (χ 2 = 107.3, df = 70, p = .003; TLI = 0.95, CFI = 0.96, RMSEA = 0.08)., Conclusions: This study gives support to using the ALI with the nursing profession., (© 2018 Springer Publishing Company, LLC.)

Background: Asthma morbidity is high in low-income children living in rural US regions, yet few interventions have been designed to decrease the asthma burden in rural populations., Objective: To examine the effect of a school-based asthma education program delivered by telemedicine in children living in an impoverished rural region., Methods: We conducted a cluster randomized trial with rural children 7 to 14 years old by comparing a school-based telemedicine asthma education intervention with usual care. The intervention provided comprehensive asthma education by telemedicine to participants and provided evidence-based treatment recommendations to primary care providers., Results: Of the 393 enrolled children, median age was 9.6 years, 81% were African American, and 47% lived in households with an annual income less than $14,999. At enrollment, 88% of children reported uncontrolled asthma symptoms. At the end of the intervention, there were no statistically significant differences in reported symptom-free days (primary outcome) for the intervention or usual-care group. Participants in the intervention group reported significantly higher use of peak flow meters to monitor asthma and reported taking their asthma medications as prescribed more frequently compared with the usual-care group. There were no changes in other outcome measures, including quality of life, self-efficacy, asthma knowledge, or lung function, between groups., Conclusion: Although there was some evidence of behavior change among intervention participants, these changes were inadequate to overcome the significant morbidity experienced by this highly symptomatic rural impoverished population. Future interventions should be designed with a multifaceted approach that considers caregiver engagement, distance barriers, and inadequate access to asthma providers in rural regions., Trial Registration: ClinicalTrials.gov Identifier: NCT01167855., (Copyright © 2018 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

This pilot study examined the initial effects and estimated effect size of a computer-based simulation education program on certified nursing assistants' level of assistance when dressing nursing home residents with dementia and on residents' dressing performance. Nine dyads, assigned to either the experimental or control group, completed the study. Both groups received a traditional 1-hour education module delivered by a research assistant. The experimental group was then instructed to undertake an additional 2-hour intervention using a video simulator that enabled nursing assistants to practice level of assistance skills. The appropriateness of dressing assistance from nursing assistants and residents' dressing performance was measured before and 6 weeks after the intervention. The results showed that the two groups did not significantly differ in either appropriate levels of dressing assistance (P = .42) or residents' dressing performance (P = .38). A lack of effort by some assistants to properly assist residents and low statistical power may explain the lack of significance. The effect sizes of the experimental intervention on appropriate levels of dressing assistance and resident dressing performance were 0.69 and 0.89, respectively. Incorporating a strategy to improve motivation should be considered in future studies.

We aimed to empirically derive an inotrope score to predict real-time outcomes using the doses of inotropes after pediatric cardiac surgery. The outcomes evaluated included in-hospital mortality, prolonged hospital length of stay, and composite poor outcome (mortality or prolonged hospital length of stay). The study population included patients <18 years of age undergoing heart operations (with or without cardiopulmonary bypass) of varying complexity. To create this novel pediatric cardiac inotrope score (PCIS), we collected the data on the highest doses of 4 commonly used inotropes (epinephrine, norepinephrine, dopamine, and milrinone) in the first 24 hours after heart operation. We employed a hierarchical framework by representing discrete probability models with continuous latent variables that depended on the dosage of drugs for a particular patient. We used Bayesian conditional probit regression to model the effects of the inotropes on the mean of the latent variables. We then used Markov chain Monte Carlo simulations for simulating posterior samples to create a score function for each of the study outcomes. The training dataset utilized 1030 patients to make the scientific model. An online calculator for the tool can be accessed at https://soipredictiontool.shinyapps.io/InotropeScoreApp. The newly proposed empiric PCIS demonstrated a high degree of discrimination for predicting study outcomes in children undergoing heart operations. The newly proposed empiric PCIS provides a novel measure to predict real-time outcomes using the doses of inotropes among children undergoing heart operations of varying complexity., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Purpose: With increasing emphasis on high-quality care, we designed this study to evaluate the relationship between Magnet® recognition and patient outcomes in pediatric critical care., Materials and Methods: Post hoc analysis of data from an existing administrative national database. We used inverse probability of treatment weighting and multivariate models to compare outcomes between two study groups after adjusting for confounding variables., Results: A total of 823,634 pediatric patients from 41 centers were included. Of these, 454,616 patients (55.2%) were treated in 23 Magnet hospitals. The majority of baseline characteristics did not vary significantly among the two study groups. In adjusted models, there was no difference in mortality between the two groups (Magnet vs. non-Magnet; odds ratio: 0.92, 95% confidence interval: 0.77-1.11). When stratified by various subgroups, such as cardiac, non-cardiac, ECMO, cardiac arrest, respiratory failure, use of nitric oxide, genetic abnormality etc., Magnet status of the hospital did not confer a survival advantage. In a sensitivity analysis on patients from crossover hospitals only, attainment of magnet status was associated with increased hospital charges., Conclusions: This large observational study calls into question the utility of the Magnet Recognition Program among children with critical illness, at least among the freestanding children's hospitals., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The existing training pathways to become a pediatric cardiac intensivist are very variable with physicians coming from varied training backgrounds of pediatric critical care, pediatric cardiology, neonatology, or pediatric anesthesia., Aim: To evaluate the impact of cardiac Intensive Care Unit (ICU) attending physician training background on outcomes in children undergoing heart operations., Setting and Design: Patients in the age group from 1 day to 18 years undergoing heart operation at a Pediatric Health Information System database participating hospital were included (2010-2015)., Patients and Methods: Based on the training background of majority of attending physicians in an ICU, the participating ICUs were divided into three groups: critical care medicine (CCM), cardiology, and indeterminate., Statistical Analysis: Multivariable logistic regression models were fitted to evaluate the association of ICU physician training background with study outcomes., Results: A total of 54,935 patients from 42 ICUs were included. Of these, 31,815 patients (58%) were treated in the CCM group (26 ICUs), 19,340 patients (35%) were treated in the cardiology group (12 ICUs), and 3780 patients (7%) were treated in the indeterminate group (4 ICUs). In adjusted models, no specific group based on ICU attending physician training background was associated with lower mortality (CCM vs. cardiology, odds ratio: 0.75, 95% confidence interval: 0.48-1.18), or lower incidence of cardiac arrest, or prolonged hospital length of stay, or prolonged mechanical ventilation., Conclusions: This large observational study did not demonstrate any impact of ICU attending training background on outcomes in children undergoing heart operations., Competing Interests: There are no conflicts of interest.

Objectives: To create a novel tool to predict favorable neurologic outcomes during ICU stay among children with critical illness., Design: Logistic regression models using adaptive lasso methodology were used to identify independent factors associated with favorable neurologic outcomes. A mixed effects logistic regression model was used to create the final prediction model including all predictors selected from the lasso model. Model validation was performed using a 10-fold internal cross-validation approach., Setting: Virtual Pediatric Systems (VPS, LLC, Los Angeles, CA) database., Patients: Patients less than 18 years old admitted to one of the participating ICUs in the Virtual Pediatric Systems database were included (2009-2015)., Interventions: None., Measurements and Main Results: A total of 160,570 patients from 90 hospitals qualified for inclusion. Of these, 1,675 patients (1.04%) were associated with a decline in Pediatric Cerebral Performance Category scale by at least 2 between ICU admission and ICU discharge (unfavorable neurologic outcome). The independent factors associated with unfavorable neurologic outcome included higher weight at ICU admission, higher Pediatric Index of Morality-2 score at ICU admission, cardiac arrest, stroke, seizures, head/nonhead trauma, use of conventional mechanical ventilation and high-frequency oscillatory ventilation, prolonged hospital length of ICU stay, and prolonged use of mechanical ventilation. The presence of chromosomal anomaly, cardiac surgery, and utilization of nitric oxide were associated with favorable neurologic outcome. The final online prediction tool can be accessed at https://soipredictiontool.shinyapps.io/GNOScore/. Our model predicted 139,688 patients with favorable neurologic outcomes in an internal validation sample when the observed number of patients with favorable neurologic outcomes was among 139,591 patients. The area under the receiver operating curve for the validation model was 0.90., Conclusions: This proposed prediction tool encompasses 20 risk factors into one probability to predict favorable neurologic outcome during ICU stay among children with critical illness. Future studies should seek external validation and improved discrimination of this prediction tool.

Objectives: To create and validate a prediction model to assess outcomes associated with the Norwood operation., Methods: The public-use dataset from a multicenter, prospective, randomized single-ventricle reconstruction trial was used to create this novel prediction tool. A Bayesian lasso logistic regression model was used for variable selection. We used a hierarchical framework by representing discrete probability models with continuous latent variables that depended on the risk factors for a particular patient. Bayesian conditional probit regression and Markov chain Monte Carlo simulations were then used to estimate the effects of the predictors on the means of these latent variables to create a score function for each of the study outcomes. We also devised a method to calculate the risk of outcomes associated with the Norwood operation before the actual heart operation. The 2 study outcomes evaluated were in-hospital mortality and composite poor outcome., Results: The training dataset used 520 patients to generate the prediction model. The model included patient demographics, baseline characteristics, cardiac diagnosis, operation details, site volume, and surgeon experience. An online calculator for the tool can be accessed at https://soipredictiontool.shinyapps.io/NorwoodScoreApp/. Model validation was performed on 520 observations using an internal 10-fold cross-validation approach. The prediction model had an area under the curve of 0.77 for mortality and 0.72 for composite poor outcome on the validation dataset., Conclusions: Our new prognostic tool is a promising first step in creating real-time risk stratification in children undergoing a Norwood operation; this tool will be beneficial for the purposes of benchmarking, family counseling, and research., (Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)