4 research outputs found
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Change in Patient Enrollment After Site Principal Investigator Turnover in Surgical Clinical Trials
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Timing of pediatric pyloromyotomy on hospital length of stay
Introduction: Pyloromyotomy timing is predicated upon correction of electrolyte abnormalities. Among infants who presented with normal electrolytes, we hypothesized that pyloromyotomy the evening of presentation, rather than waiting until morning, would confer shorter length of stay (LOS). Methods: This single-center retrospective cohort study included patients who underwent pyloromyotomy from 2012 to 2021. Exposure was time of operation with nighttime considered between the times of 17:00 and 06:59 and daytime between 07:00 and 16:59. A 2:1 daytime to nighttime match was performed among patients who presented with normal electrolytes with Fisher's Exact and Student's t-test for comparisons. Results: Of 520 patients, 15 (3%) underwent pyloromyotomy overnight and were matched to 30 daytime patients. There were no differences in median age (33 days (interquartile range [IQR] 29–44) vs 32 days (IQR 25–44)), male sex (15 (100%) vs 28 (93.3%), or history of prematurity (0 (0%) vs 2 (6.7%)) for nighttime compared to daytime, respectively. Operative outcomes including conversion to open, duodenal perforation, incomplete myotomy, or surgical site infection did not differ between the groups. While the nighttime group had a significantly shorter time from presentation to operating room (OR) than the daytime group (5.3 vs 15.9 h), there were no significant differences in total LOS (45.7 vs 57.3 h, p = 0.13). Conclusion: For infants with hypertrophic pyloric stenosis who present with normal electrolytes, it is safe to offer operation same-day or following a night of hydration. There was no evidence of improved hospital utilization for patients undergoing pyloromyotomy the night of presentation
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A mixed-method approach to generate and deliver rapid-cycle evaluation feedback: Lessons learned from a multicenter implementation trial in pediatric surgery
Background: Rapid-cycle feedback loops provide timely information and actionable feedback to healthcare organizations to accelerate implementation of interventions. We aimed to (1) describe a mixed-method approach for generating and delivering rapid-cycle feedback and (2) explore key lessons learned while implementing an enhanced recovery protocol (ERP) across 18 pediatric surgery centers. Methods: All centers are members of the Pediatric Surgery Research Collaborative (PedSRC, www.pedsrc.org), participating in the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) trial. To assess implementation efforts, we conducted a mixed-method sequential explanatory study, administering surveys and follow-up interviews with each center's implementation team 6 and 12 months following implementation. Along with detailed notetaking and iterative discussion within our team, we used these data to generate and deliver a center-specific implementation report card to each center. Report cards used a traffic light approach to quickly visualize implementation status (green = excellent; yellow = needs improvement; red = needs significant improvement) and summarized strengths and opportunities at each timepoint. Results: We identified several benefits, challenges, and practical considerations for assessing implementation and using rapid-cycle feedback among pediatric surgery centers. Regarding potential benefits, this approach enabled us to quickly understand variation in implementation and corresponding needs across centers. It allowed us to efficiently provide actionable feedback to centers about implementation. Engaging consistently with center-specific implementation teams also helped facilitate partnerships between centers and the research team. Regarding potential challenges, research teams must still allocate substantial resources to provide feedback rapidly. Additionally, discussions and consensus are needed across team members about the content of center-specific feedback. Practical considerations include carefully balancing timeliness and comprehensiveness when delivering rapid-cycle feedback. In pediatric surgery, moreover, it is essential to actively engage all key stakeholders (including physicians, nurses, patients, caregivers, etc.) and adopt an iterative, reflexive approach in providing feedback. Conclusion: From a methodological perspective, we identified three key lessons: (1) using a rapid, mixed method evaluation approach is feasible in pediatric surgery and (2) can be beneficial, particularly in quickly understanding variation in implementation across centers; however, (3) there is a need to address several methodological challenges and considerations, particularly in balancing the timeliness and comprehensiveness of feedback. Trial registration: NIH National Library of Medicine Clinical Trials. Clinicaltrials.gov Identifier: NCT04060303. Registered August 7, 2019, https://clinicaltrials.gov/ct2/show/NCT04060303</p