Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience.

BACKGROUND: Timely trial start-up is a key determinant of trial success; however, delays during start-up are common and costly. Moreover, data on start-up metrics in pediatric clinical trials are sparse. To expedite trial start-up, the Trial Innovation Network piloted three novel mechanisms in the trial titled Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multi-site, randomized, double-blind, placebo-controlled trial in the pediatric intensive care setting. METHODS: The three novel start-up mechanisms included: 1) competitive activation; 2) use of trial start-up experts, called site navigators; and 3) supplemental funds earned for achieving pre-determined milestones. After sites were activated, they received a web-based survey to report perceptions of the DOSE start-up process. In addition to perceptions, metrics analyzed included milestones met, time to start-up, and subsequent enrollment of subjects. RESULTS: Twenty sites were selected for participation, with 19 sites being fully activated. Across activated sites, the median (quartile 1, quartile 3) time from receipt of regulatory documents to site activation was 82 days (68, 113). Sites reported that of the three novel mechanisms, the most motivating factor for expeditious activation was additional funding available for achieving start-up milestones, followed by site navigator assistance and then competitive site activation. CONCLUSION: Study start-up is a critical time for the success of clinical trials, and innovative methods to minimize delays during start-up are needed. Milestone-based funds and site navigators were preferred mechanisms by sites participating in the DOSE study and may have contributed to the expeditious start-up timeline achieved. CLINICALTRIALS: gov #: NCT03938857.

Using Multisource Feedback to Assess Resident Communication Skills: Adding a New Dimension to Milestone Data.

Background: The Accreditation Council for Graduate Medical Education (ACGME) requires evaluation of residents' communication skills. These evaluations should involve assessments from a variety of persons with different perspectives and opportunities to observe resident behavior. Our objectives with this study were to determine if parents, nurses, and physicians significantly differed in their ratings of residents' communication skills; to ascertain the degree of association between these evaluations and ACGME milestone data; and to elicit feedback from residents about the specificity and usefulness of this type of evaluation compared to the evaluations they were typically provided. Methods: During the 2016-2017 academic year, parents of patients ready for discharge, nurses, and attending physicians completed evaluations of resident communication skills. A repeated measures multivariate analysis of variance compared communication skills scores across the 3 groups of raters. Resident ACGME milestone ratings for interpersonal and communication skills were correlated with the communication skills evaluations. Residents rated the specificity and usefulness of the 360-degree evaluations. Results: Parents rated residents' communication skills significantly higher than nurses and physicians rated them. We found no significant difference between the nurse and physician ratings. A significant correlation was found between resident ratings by physicians and ACGME milestone data. Residents found the feedback from these evaluations to be more specific and useful in delineating their communication strengths and weaknesses than typical milestone feedback. Conclusion: Parents added a unique perspective about residents' communication and should be included in resident evaluation when feasible. Residents appreciated the specificity and usefulness of the evaluation instrument.

Emergency contraception: are pediatric residents counseling and prescribing to teens?

STUDY OBJECTIVES: (1) To assess pediatric residents' attitudes and practices related to counseling about and prescribing emergency contraceptive pills (ECPs) for teens. (2) To determine whether attitudes, counseling, and prescribing practices vary among different levels of residency training. DESIGN: Questionnaire. SETTING: Two large inner-city academic medical centers in New York City. PARTICIPANTS: Pediatric residents (PGY 1-3). MAIN OUTCOME MEASURES: Attitudes, counseling and prescribing patterns of ECPs by the pediatric residents RESULTS: 101/120 residents participated in the survey; 35% PGY1, 38% PGY2, 28% PGY3. Less than a third (26%) reported counseling teens about the availability of ECPs during routine non-acute care visits and just over half (56%) provided ECP counseling during visits for contraception. Only 6% of pediatric residents reported that they prescribed ECPs often, while 42% never prescribed ECPs. The majority of the residents did not think that prescribing ECPs would encourage teens to practice unsafe sex or would discourage compliance with other contraceptive methods (70% and 68%, respectively). However, the majority (67%) also reported that they did not think that ECPs should be available over the counter, without prescription. Further analysis by year of training showed that more junior and senior residents than interns counseled adolescents about ECPs at both routine health care maintenance visits and at visits for contraception (32% vs 15%; 62% vs 42%, respectively), would provide adolescent girls with ECPs to have on hand prior to an episode of unprotected sex (52% vs 31%), and thought that ECPs should be available over the counter (39% vs 20%), P < 0.05. CONCLUSIONS: Pediatric residents are missing opportunities to prevent unintended teenage pregnancy but they become more likely to counsel about and prescribe ECPs as they progress through residency training.

Myocardial cytochrome oxidase activity is decreased following carbon monoxide exposure.

Carbon monoxide (CO) inhalation often leads to cardiac dysfunction, dysrhythmias, ischemia, infarction, and death. However, the underlying mechanism of CO toxicity is poorly understood. We hypothesize that inhaled CO interrupts myocardial oxidative phosphorylation by decreasing the activity of myocardial cytochrome oxidase (CcOX), the terminal oxidase of the electron transport chain. Male C57Bl6 mice were exposed to either 1000 ppm (0.1%) CO or air for 3 h. Cardiac ventricles were harvested and mitochondria were isolated. CcOX kinetics and heme aa(3) content were measured. V(max), K(m), and turnover number were determined. Levels of CcOX subunit I message and protein were evaluated. Carboxyhemoglobin (COHb) levels were measured and tissue hypoxia was assessed with immunohistochemistry for pimonidazole hydrochloride. CO significantly decreased myocardial CcOX activity and V(max) without altering K(m). Heme aa(3) content and CcOX I protein levels significantly decreased following CO exposure while enzyme turnover number and CcOX I mRNA levels remained unchanged. CO exposure increased COHb levels without evidence of tissue hypoxia as compared to sham and hypoxic controls. Decreased CcOX activity following CO inhalation was likely due to decreased heme aa(3) and CcOX subunit I content. Importantly, myocardial CcOX impairment could underlie CO induced cardiac dysfunction.

Evaluation of asthma management policies in New York City public schools.

The aim of this study was to investigate asthma management policies and protocols in Bronx, New York, public elementary schools in light of the National Heart, Lung, and Blood Institute (NHLBI) Resolution on Asthma Management in Schools. An anonymous survey was conducted in November 2001 of principals, teachers, counselors, and nurses at five Bronx elementary schools. The response rate was 62%, and the majority of respondents (84%) were teachers; 51% of respondents learned of a student's asthma only through informal conversation with the student or parent, 28% said they were usually not informed of a student's asthma status, and only 10% learned of a child's asthma through existing school protocols; 21% of respondents did not know whom in the school was responsible for supervising the health needs of children with asthma, and 30% did not know how asthma inhalers were supposed to be handled at their school. Only 1.6% of teachers were "very familiar" with Board of Education asthma policies. The results are interpreted as showing poor adherence to the NHLBI recommendations. They also reflect a lack of consistent strategies for communication of a child's asthma diagnosis and for management of the disease in the schools. Ongoing efforts to improve asthma management in public schools through teacher education and policy development should be supported and evaluated for outcomes in teacher knowledge and student health.

Do pediatric healthcare providers know how to use metered dose inhaler plus spacer devices?

We tested whether health practitioners correctly used MDI-spacer devices. Of 122 subjects, 89% had instructed a patient on using a spacer. Whilst performance with the Aerochamber was the best, only 3% correctly demonstrated all the steps for that device.