Teresa Atz

Reporting adverse events in a surgical trial for complex congenital heart disease: The Pediatric Heart Network experience

OBJECTIVE The purpose of this analysis was to evaluate a novel strategy for reporting adverse events in the Pediatric Heart Networks randomized surgical trial of systemic-pulmonary artery shunt versus right ventricle-pulmonary artery conduit in infants with hypoplastic left heart syndrome. The strategy was developed to align the reporting process with the needs of a surgical trial while maintaining participant safety. METHODS Adverse event reporting was analyzed for 2 groups of study subjects: those randomized to a trial arm during a period in which a standard adverse event reporting system was used (period 1) and those randomized after institution of a system that focused serious adverse event reporting on 6 sentinel events (period 2). The analysis encompassed the period from randomization (Norwood surgery) to hospital discharge from stage II surgery. Adverse event rates were compared using a Poisson regression model for the number of events per subject. RESULTS From period 1 to period 2, the rate of serious adverse events requiring expedited reporting decreased as expected (0.42 vs 0.14/subject/month of follow-up; P < .001). Subjects with a serious (sentinel) adverse event in period 2 had a significantly higher rate of death and cardiac transplantation. CONCLUSIONS The new adverse event reporting system successfully targeted subjects at highest risk, while decreasing the administrative burden associated with adverse event reports. This methodology may be of benefit in trials evaluating surgical or device-based interventions and in critically ill populations where many common clinical events would qualify as serious adverse events in the context of a drug trial.

Challenges and successes of recruitment in the "angiotensin-converting enzyme inhibition in infants with single ventricle trial" of the Pediatric Heart Network.

OBJECTIVES Identify trends of enrolment and key challenges when recruiting infants with complex cardiac diseases into a multi-centre, randomised, placebo-controlled drug trial and assess the impact of efforts to share successful strategies on enrolment of subjects. METHODS Rates of screening, eligibility, consent, and randomisation were determined for three consecutive periods of time. Sites collectively addressed barriers to recruitment and shared successful strategies resulting in the Inventory of Best Recruiting Practices. Study teams detailed institutional practices of recruitment in post-trial surveys that were compared with strategies of enrolment initially proposed in the Inventory. RESULTS The number of screened patients increased by 30% between the Initial Period and the Intermediate Period (p = 0.007), whereas eligibility decreased slightly by 7%. Of those eligible for entry into the study, the rate of consent increased by 42% (p = 0.025) and randomisation increased by 71% (p = 0.10). During the Final Period, after launch of a competing trial, fewer patients were screened (−14%, p = 0.06), consented (−19%, p = 0.12), and randomised (−34%, p = 0.012). Practices of recruitment in the post-trial survey closely mirrored those in the Inventory. CONCLUSIONS Early identification and sharing of best strategies of recruitment among all recruiting sites can be effective in increasing recruitment of critically ill infants with congenital cardiac disease and possibly other populations. Strategies of recruitment should focus on those that build relationships with families and create partnerships with the medical providers who care for them. Competing studies pose challenges for enrolment in trials, but fostering trusting relationships with families can result in successful enrolment into multiple studies.

Integrative Review of Interventions to Promote Breastfeeding in the Late Preterm Infant

Objective: To define the different breastfeeding interventions that promote breastfeeding exclusivity and duration in the late preterm infant and to synthesize findings from the published empirical literature on late preterm infant breastfeeding interventions. Data Sources: The databases CINAHL, Scopus, and PubMed were searched for primary research articles on breastfeeding interventions for late preterm infants. Inclusion criteria included original research studies in which authors examined a breastfeeding intervention or second‐line strategy in a sample inclusive of but not necessarily limited to the gestational age range of 34 to 36Symbol weeks gestation, written in English, and published between 2005 and 2015. Symbol. No caption available. Study Selection: Thirteen articles were identified, including five randomized controlled trials, three quasi‐experimental studies, four descriptive studies, and one case study. Data Extraction: Whittemore and Knafls methodology guided this integrative review. Data extraction and organization occurred under the following headings: author and year, study design, level of evidence, purpose, sample, setting, results, limitations, recommendations, and intervention. Data Synthesis: Studies on breastfeeding interventions were synthesized under four concepts within the Late Preterm Conceptual Framework: Physiologic Functional Status, Care Practices, Family Role, and Care Environment. Conclusion: Most breastfeeding interventions within this integrative review had positive effects on exclusivity and duration of breastfeeding in the late preterm infant. However, second‐line strategies had equivocal effects on exclusivity but had positive effects on duration. The positive effects of breastfeeding interventions on breastfeeding exclusivity and duration are highlighted in our results, and we point to the need for a focus on breastfeeding after the transition home for late preterm infants.

Streamlining Appointment, Promotion, and Tenure Procedures to Promote Early-Career Faculty Success

A critical component of the progression of a successful academic career is being promoted in rank. Early-career faculty are required to have an understanding of appointment, promotion, and tenure (APT) guidelines, but many factors often impede this understanding, thwarting a smooth and planned promotion pathway for professional advancement. This article outlines the steps taken by an APT committee to improve the promotion process from instructor to assistant professor. Six sigmas DMAIC improvement model was selected as the guiding operational framework to remove variation in the promotion process. After faculty handbook revisions were made, several checklists developed, and a process review rubric was implemented; recently promoted faculty were surveyed on satisfaction with the process. Faculty opinions captured in the survey suggest increased transparency in the process and perceived support offered by the APT committee. Positive outcomes include a strengthened faculty support framework, streamlined promotion processes, and improved faculty satisfaction. Changes to the APT processes resulted in an unambiguous and standardized pathway for successful promotion.