Measurement of Electron-Neutrino Charged-Current Cross Sections on

Using an 185-kg NaI[Tl] array, COHERENT has measured the inclusive electron-neutrino charged-current cross section on ^{127}I with pion decay-at-rest neutrinos produced by the Spallation Neutron Source at Oak Ridge National Laboratory. Iodine is one the heaviest targets for which low-energy (≤50 MeV) inelastic neutrino-nucleus processes have been measured, and this is the first measurement of its inclusive cross section. After a five-year detector exposure, COHERENT reports a flux-averaged cross section for electron neutrinos of 9.2_{-1.8}^{+2.1}×10^{-40} cm^{2}. This corresponds to a value that is ∼41% lower than predicted using the MARLEY event generator with a measured Gamow-Teller strength distribution. In addition, the observed visible spectrum from charged-current scattering on ^{127}I has been measured between 10 and 55 MeV, and the exclusive zero-neutron and one-or-more-neutron emission cross sections are measured to be 5.2_{-3.1}^{+3.4}×10^{-40} and 2.2_{-0.5}^{+0.4}×10^{-40} cm^{2}, respectively.

Disparities in Delivery of Ambulatory Surgical Care for Children.

This cross-sectional study characterizes the delivery of ambulatory surgical care for children across freestanding ambulatory surgery centers and hospital-based outpatient centers and tests for differences in patient characteristics and features of procedures being performed.

First Probe of Sub-GeV Dark Matter beyond the Cosmological Expectation with the COHERENT CsI Detector at the SNS.

The COHERENT Collaboration searched for scalar dark matter particles produced at the Spallation Neutron Source with masses between 1 and 220 MeV/c^{2} using a CsI[Na] scintillation detector sensitive to nuclear recoils above 9 keV_{nr}. No evidence for dark matter is found and we thus place limits on allowed parameter space. With this low-threshold detector, we are sensitive to coherent elastic scattering between dark matter and nuclei. The cross section for this process is orders of magnitude higher than for other processes historically used for accelerator-based direct-detection searches so that our small, 14.6 kg detector significantly improves on past constraints. At peak sensitivity, we reject the flux consistent with the cosmologically observed dark-matter concentration for all coupling constants α_{D}<0.64, assuming a scalar dark-matter particle. We also calculate the sensitivity of future COHERENT detectors to dark-matter signals which will ambitiously test multiple dark-matter spin scenarios.

Postoperative Respiratory Complications in SARS-CoV-2 Positive Pediatric Patients Across 20 United States Hospitals: A Cohort Study.

INTRODUCTION: Data examining rates of postoperative complications among SARS-CoV-2 positive children are limited. The purpose of this study was to evaluate the impact of symptomatic and asymptomatic SARS-CoV-2 positive status on postoperative respiratory outcomes for children. METHODS: This retrospective cohort study included SARS-CoV-2 positive pediatric patients across 20 hospitals who underwent general anesthesia from March to October 2020. The primary outcome was frequency of postoperative respiratory complications, including: high-flow nasal cannula/non invasive ventilation, reintubation, pneumonia, Extracorporeal Membrane Oxygenation (ECMO), and 30-day respiratory-related readmissions or emergency department (ED) visits. Univariate analyses were used to evaluate associations between patient and procedure characteristics and stratified analyses by symptoms were performed examining incidence of complications. RESULTS: Of 266 SARS-CoV-2 positive patients, 163 (61.7%) were male, and the median age was 10 years (interquartile range 4-14). The majority of procedures were emergent or urgent (n = 214, 80.5%). The most common procedures were appendectomies (n = 78, 29.3%) and fracture repairs (n = 40,15.0%). 13 patients (4.9%) had preoperative symptoms including cough or dyspnea. 26 patients (9.8%) had postoperative respiratory complications, including 15 requiring high-flow oxygen, 8 with pneumonia, 4 requiring non invasive ventilation, 3 respiratory ED visits, and 2 respiratory readmissions. Respiratory complications were more common among symptomatic patients than asymptomatic patients (30.8% vs. 8.7%, p = 0.01). Higher ASA class and comorbidities were also associated with postoperative respiratory complications. CONCLUSIONS: Postoperative respiratory complications are less common in asymptomatic versus symptomatic SARS-COV-2 positive children. Relaxation of COVID-19-related restrictions for time-sensitive, non urgent procedures in selected asymptomatic patients may be reasonably considered. Additionally, further research is needed to evaluate the costs and benefits of routine testing for asymptomatic patients. LEVEL OF EVIDENCE: Iii, Respiratory complications.

Pediatric Patient and Caregiver Agreement on Perioperative Expectations and Self-Reported Outcomes.

INTRODUCTION: Alignment between pediatric patients and caregiver perspectives on patient-reported outcome (PRO) data is contingent upon context. We aimed to assess agreement between patient and caregiver responses to a series of perioperative domains. METHODS: Agreement between pediatric patients and caregiver responses to preoperative and postoperative surveys about surgery preparedness, perioperative expectations, PRO Measurement Information System (PROMIS) measures for overall health and pain, and reaching milestones gathered as part of an ongoing clinical trial for children undergoing gastrointestinal surgery, was evaluated. Gwet's AC and Spearman's correlation coefficients were calculated, as appropriate, to assess agreement. RESULTS: Of 209 enrolled patients, 65 (31.1%) dyads completed all three surveys and were included. For the domains of education, expectations, and comprehension, patients and caregivers had good agreement with Gwet AC1 with values of 0.80, 0.61, and 0.64, respectively. For milestones, patients and caregivers had very good agreement (Gwet AC1 of 0.95). Milestones measured whether patients achieved certain goals within a prespecified time, including enteral intake (Gwet AC1 0.91 and 0.92 respectively), transition to oral pain medication (Gwet AC1 0.94), ambulation (Gwet AC1 1.00), and return of bowel function (Gwet AC1 0.97). There was moderate to strong agreement between patients and caregivers on PROMIS pain questions (Spearman's correlation: 0.71 preoperatively and 0.51 postoperatively). On PROMIS global health questions, there was strong agreement (0.69 preoperatively and 0.65 postoperatively). CONCLUSIONS: Pediatric patient and caregiver agreement on perioperative survey items ranged from moderate to strong. Caregivers' responses may be acceptable when some patient-level responses are not available.

Measurement of the Coherent Elastic Neutrino-Nucleus Scattering Cross Section on CsI by COHERENT.

We measured the cross section of coherent elastic neutrino-nucleus scattering (CEvNS) using a CsI[Na] scintillating crystal in a high flux of neutrinos produced at the Spallation Neutron Source at Oak Ridge National Laboratory. New data collected before detector decommissioning have more than doubled the dataset since the first observation of CEvNS, achieved with this detector. Systematic uncertainties have also been reduced with an updated quenching model, allowing for improved precision. With these analysis improvements, the COHERENT Collaboration determined the cross section to be (165_{-25}^{+30})×10^{-40} cm^{2}, consistent with the standard model, giving the most precise measurement of CEvNS yet. The timing structure of the neutrino beam has been exploited to compare the CEvNS cross section from scattering of different neutrino flavors. This result places leading constraints on neutrino nonstandard interactions while testing lepton flavor universality and measures the weak mixing angle as sin^{2}θ_{W}=0.220_{-0.026}^{+0.028} at Q^{2}≈(50 MeV)^{2}.

Sex-Based Disparities in Timeliness of Trauma Care and Discharge Disposition.

Importance: Differences in time to diagnostic and therapeutic measures can contribute to disparities in outcomes. However, whether there is an association of timeliness by sex for trauma patients is unknown. Objective: To investigate whether sex-based differences in time to definitive interventions exist for trauma patients in the US and whether these differences are associated with outcomes. Design, Setting, and Participants: This was a retrospective cohort study conducted from July 2020 to July 2021, using the 2013 to 2016 Trauma Quality Improvement Program (TQIP) databases from level I to III trauma centers in the US. Patients 18 years or older with an Injury Severity Score (ISS) greater than 15 and who carried diagnoses of traumatic brain injury, intra-abdominal injury, pelvic fracture, femur fracture, and spinal injury as a result of their trauma were included in the study. Data were analyzed from July 2020 to July 2021. Main Outcomes and Measures: Primary outcomes assessed timeliness to interventions, using Wilcoxon signed rank and χ2 tests. Secondary outcomes included location of discharge after injury, using propensity score-matched generalized estimating equations modeling. Results: Of the 28 332 patients included, 20 002 (70.6%) were male patients (mean [SD] age, 43.3 [18.2] years) and 8330 (29.4%) were female patients (mean [SD] age, 48.5 [21.1] years), with significantly different distributions of ISS scores (ISS score 16-24: male patient, 10 622 [53.1%]; female patient, 4684 [56.2%]; ISS score 41-74: male patient, 2052 [10.3%]; female patient, 852 [10.2%]). Male patients more frequently had abdominal (4257 [21.3%] vs 1268 [15.2%]) and spinal cord (3989 [20.0%] vs 1274 [15.3%]) injuries, whereas female patients experienced greater proportions of femur (3670 [44.0%] vs 8422 [42.1%]) and pelvic (3970 [47.6%] vs 6963 [34.8%]) fractures. Female patients experienced significantly longer emergency department length of stay (median [IQR], 184 [92-314] minutes vs 172 [86-289] minutes; P < .001), longer time in pretriage (median [IQR], 52 [36-80] minutes vs 49 [34-77] minutes; P < .001), and increased likelihood of discharge to nursing or long-term care facilities instead of home after matching by age, ISS, mechanism, and injury type (male patient:female patient, odds ratio, 0.72; 95% CI, 0.67-0.78). Conclusions and Relevance: Results of this cohort study suggest that female trauma patients experienced slightly longer delays in trauma care and had a higher likelihood of discharge to long-term care facilities than their male counterparts.

Surgeon perceptions of volume threshold and essential practices for pediatric thyroidectomy✰.

INTRODUCTION: The topics of sub-specialization and regionalization of care have garnered increased attention among pediatric surgeons. Thyroid surgeries are one such sub-specialty and are commonly concentrated within practices. A national survey was conducted examining current surgeon practices and beliefs surrounding pediatric thyroid surgery. METHODS: Non-resident members of the American Pediatric Surgical Association (APSA) were surveyed in October 2020. Respondents were stratified based on self-reported thyroid surgical experience. Those who performed thyroid surgery were asked about surgical technique and operative practices; those who did not were asked about referral patterns. All respondents were asked about perceptions surrounding the volume-outcome relationship for pediatric thyroid surgery. RESULTS: Among 1015 APSA members, 405 (40%) responded, with 79% (317/400) practicing at academic hospitals, 58% (232/401) practicing in major metropolitan area, and 41% (161/392) with over 10 years of attending pediatric surgery experience. Most respondents (88%, n = 356) agreed that thyroid surgery volume affects outcome, though wide variation was reported in the annual case threshold for "high volume" surgery. Eighty-four respondents (21%) reported performing ≥ 1 pediatric thyroid surgery in the past year. Of these, 82% routinely use recurrent laryngeal nerve monitoring, 32% routinely send hemithyroidectomy patients home the same day, and there was little consensus surrounding postoperative hypocalcemia management. The majority of respondents endorse performing thyroid procedures with a colleague. CONCLUSIONS: Pediatric thyroid surgery appears to be performed by a subset of active pediatric surgeons, most of whom endorse the use of a dual operating team. More evidence is needed to build consensus around additional perioperative practices.

Pilot implementation of opioid stewardship measures using the national surgical quality improvement program-pediatric platform.

INTRODUCTION: Data surrounding optimal pediatric postoperative opioid prescribing are incomplete. The objective of this study was to leverage the American College of Surgeons (ACS) National Surgical Quality Improvement Program-Pediatric (NSQIP-P) and assess feasibility of added data collection surrounding pediatric perioperative pain management practices including opioid prescribing at discharge. METHODS: Nineteen (19) novel data elements were added to NSQIP-P data collection of selected patients, ages 5-18 years, who had undergone surgery at a single, free-standing children's hospital. Metrics around data abstraction and completion of variables were collected. Univariate analyses (using Chi-square or Wilcoxon Rank Sum tests) and multiple logistic regressions were performed to describe predictors of opioid prescribing at discharge and to monitor adherence to Food and Drug Administration (FDA) prescribing recommendations. RESULTS: Median abstraction time of the novel variables decreased from 12 to 5 min per patient over 13 months with 94% variable completion rate. Of 878 patients, 302 (36.4%) were prescribed opioids at discharge. Factors associated with an opioid prescription included older age (p < 0.001), white race (p < 0.05), undergoing an orthopedic surgery (p < 0.001), and receiving a regional block perioperatively (p < 0.001). All opioid prescriptions met FDA guidelines with no patients receiving codeine, and 98% of patients receiving opioid prescriptions < 50 morphine milli-equivalents per day. CONCLUSION: Collecting data on current pain management practices, opioid prescribing, and adherence to safety recommendations is feasible using the NSQIP-P with little added burden. Further expansion of data collection is needed to develop generalizable optimal prescribing practices for post-discharge pain management for children.

Effect of surgeon volume on pediatric thyroid surgery outcomes: A systematic review.

BACKGROUND: Pediatric thyroidectomy has been identified as a surgical procedure that may benefit from concentrating cases to high-volume surgeons. This systematic review aimed to address the definition of "high-volume surgeon" for pediatric thyroidectomy and to examine the relationship between surgeon volume and outcomes. METHODS: PubMed, Embase, Cochrane Library, Scopus, Web of Science, ClinicalTrials.gov, and OpenGrey databases were searched for through February 2020 for studies which reported on pediatric thyroidectomy and specified surgeon volume and surgical outcomes. RESULTS: Ten studies, encompassing 6430 patients, were included in the review. Five single-center retrospective studies reported only on high-volume surgeons, one single center retrospective study reported on only low-volume surgeons, and four national database studies (2 cross sectional, 2 retrospective reviews) reported outcomes for both high-volume and low-volume surgeons. Majority of patients underwent total thyroidectomy (54.9%); common indications for surgery were malignancy (41.7%) and hyperthyroidism/thyroiditis (40.5%). Rates of transient hypocalcemia (11.4% - 74.2%), transient recurrent laryngeal nerve injury (0% - 9.7%), and bleeding (0.5% - 4.3%) varied across studies. Definitions for high-volume pediatric thyroid surgeons ranged from ≥9 annual pediatric thyroid operations to >200 annual thyroid operations (with >30 pediatric cases). Four studies reported significantly better outcomes, including lower post-operative complications and shorter length of hospital stay, for patients treated by high-volume surgeons. CONCLUSIONS: Despite significant variation in caseloads to define volume, pediatric thyroid patients have generally better outcomes when operated on by higher volume surgeons. Concentration thyroidectomy cases to a smaller cohort of surgeons within pediatric practices may confer improved outcomes. LEVEL OF EVIDENCE: Systematic Reviews and Meta-Analyses; Level IV.

Postoperative complications in pediatric patients with cerebral palsy.

BACKGROUND/PURPOSE: To assess surgical outcomes of patients with cerebral palsy (CP) and if they differ from patients without CP. METHODS: The NSQIP-Pediatric database from 2012 to 2019 was used to compare differences in presenting characteristics and outcomes between patients with and without CP. Chi-square tests and multivariable logistic regression analysis were used to determine significance. RESULTS: 119,712 patients, 433 (0.4%) with CP, 119,279 (99.6%) without, were identified. Patients with CP had more postoperative complications (19.4% vs. 6.9%, p < 0.001) with an OR of 3.2, (95%CI 2.5-4.1, p < 0.001) on univariable analysis. They underwent fewer laparoscopic procedures (79.1% vs. 90.8%, p < 0.001), had more readmissions (10.2% vs. 3.8%, p < 0.001), reoperations (5.1% vs. 1.2%, p < 0.001), and longer length of stays (LOS) (median 3 versus 1 day, p < 0.001). On multivariable analysis, having CP did not increase the odds of postoperative morbidity (OR 0.99, 95% CI 0.7-1.3), but higher ASA class, congenital lung malformation, gastrointestinal disease, coagulopathy, preoperative inotropic support, oxygen use, nutritional support, and steroid use significantly increase the odds of morbidity, all of which were more common in patients with CP. CONCLUSION: Patients with CP have more postoperative complications, open procedures, and longer LOS. Patient complexity may account for these differences and risk-directed perioperative planning may improve outcomes. LEVEL OF EVIDENCE: Level IV.

Addressing ethical clinical dilemmas with quality improvement methodology.

Application of Quality Improvement methodology to nuanced clinical scenarios may be useful to ensure consistent delivery of equitable and comprehensive care. The purpose of this article is to inform the pediatric surgical readership of opportunities where quality improvement methodology may aid in navigating ethical nuances of complex surgical care. We present three case scenarios and discuss how quality improvement methodology could be utilized to address issues of provider autonomy, patient autonomy, and justice.

Implementing PDSA Methodology for Pediatric Appendicitis Increases Care Value for a Tertiary Children's Hospital.

INTRODUCTION: We used the plan-do-study-act (PDSA) framework to develop and implement an evidence-based clinical practice guideline (CPG) within an urban, tertiary children's referral center. METHODS: We developed an evidence-based CPG for appendicitis using iterative PDSA cycles. Similar CPGs from other centers were reviewed and modified for local implementation. Adjuncts included guideline-specific order sets and operative notes in the electronic medical record system. Outcomes included length of stay (LOS), 30-day readmissions, hospital costs, and patient and family experience (PFE) scores. Our team tracked outcome, process, and balancing measures using Statistical Process Charts. Outcome measures were compared over 2 fiscal quarters preimplementation and 3 fiscal quarters postimplementation, using interrupted time series, student t test, and chi-square tests when appropriate. RESULTS: LOS for simple (uncomplicated) appendicitis decreased to 0.87 days (interquartile range [IQR] 0.87-0.94 days) from 1.1 days (IQR 0.97-1.42 days). LOS for complicated appendicitis decreased to 4.96 days (IQR 4.95-6.15) from 5.58 days (IQR 5.16-6.09). This reduction equated to an average cost-savings of $1,122/patient. Thirty-day readmission rates have remained unchanged. PFE scores increased across all categories and have remained higher than national benchmarks. CONCLUSION: Development and Implementation of a CPG for pediatric appendicitis using the PDSA framework adds value to care provided within a large tertiary center.

Trends and Variation in the Use of Observation Stays at Children's Hospitals.

BACKGROUND: Observation status could improve efficiency of healthcare resource use but also might shift financial burdens to patients and hospitals. Although the use of observation stays has increased for adult patient populations, the trends are unknown among hospitalized children. OBJECTIVE: The goal of this study was to describe recent trends in observation stays for pediatric populations at children's hospitals. DESIGN, SETTING, AND PARTICIPANTS: Both observation and inpatient stays for all conditions were retrospectively studied using the Pediatric Health Information System database (2010 to 2019). EXPOSURE, MAIN OUTCOMES, AND MEASURES: Patient type was classified as inpatient or observation status. Main outcomes included annual percentage of observation stays, annual percentage of observation stays having prolonged length of stay (>2 days), and growth rates of observation stays for the 20 most common conditions. Risk adjusted hospital-level use of observation stays was estimated using generalized linear mixed-effects models. RESULTS: The percentage of observation stays increased from 23.6% in 2010 to 34.3% in 2019 (P < .001), and the percentage of observation stays with prolonged length of stay rose from 1.1% to 4.6% (P < .001). Observation status was expanded among a diverse group of clinical conditions; diabetes mellitus and surgical procedures showed the highest growth rates. Adjusted hospital-level use ranged from 0% to 67% in 2019, indicating considerable variation among hospitals. CONCLUSION: Based on the increase in observation stays, future studies should explore the appropriateness of observation care related to efficient use of healthcare resources and financial implications for hospitals and patients.

ICD-10 Transition Influences Trends in Perforated Appendix Admission Rate.

BACKGROUND: This study sought to evaluate the influence of International Classification of Diseases, Tenth Revision (ICD-10) transition on Perforated Appendix Admission Rate (PAAR), which is a commonly used indicator representing access to care developed by Agency for Healthcare Research and Quality (AHRQ). MATERIALS AND METHODS: In this interrupted time series study of Pediatric Health Information System database from 2013 to 2018, we employed three study phases (pre-implementation, washout, and initial implementation) to evaluate the influence of ICD-10 transition on trends in PAAR. ICD-10 diagnosis codes suggested by AHRQ's specifications were used to identify perforated and simple appendicitis, and PAAR was estimated accordingly. Generalized linear mixed models were used to examine the association of ICD-10 initial implementation and being documented as perforated appendicitis on encounter level. RESULTS: We identified a total of 94,810 encounters diagnosed with appendicitis, and almost all patients' characteristics were similar over the three study phases, except for PAAR. The pre-implementation PAAR in October 2013 was 33.1%, and the immediate influence of ICD-10 transition on PAAR was 3.2% (P = 0.002), with a 0.38% per quarter increase over time (P = 0.02). After adjusting for age, gender, race/ethnicity, payer, and year, the likelihood of being documented as having perforated appendicitis in 2016 was 1.5 times higher than the estimated likelihood before the implementation (adjusted Odds Ratio: 1.51; 95% Confidence Interval: 1.40-1.63; P < 0.001). CONCLUSIONS: The 2015-2018 ICD-10 transition may be erroneously associated with an increasing trend of PAAR. Care should be taken when interpreting the metric during this period.

National Trends and Disparities in the Diffusion of Laparoscopic Surgery for Children in the United States.

Background: Laparoscopic surgery has become the standard of care for many surgical treatments. The diffusion of laparoscopy has been investigated for adult patient populations but is still unknown for pediatric populations. This study sought to describe national trends in diffusion of laparoscopic surgery for common pediatric conditions and identify disparities in use of laparoscopic surgery. Study Design: A retrospective analysis of serial cross-sectional data was performed using the Healthcare Cost and Utilization Project's Kids' Inpatient Database from 1997 to 2016. Pediatric patients (ages ≤18) undergoing appendectomy, cholecystectomy, fundoplication, or inguinal hernia repair were identified. The diffusion of laparoscopy for each procedure was measured using the proportion of laparoscopic surgeries over years. Results: National trends demonstrate increases in the use of laparoscopy for children over the past two decades from 13.4% to 88.7% for appendectomy, from 82.6% to 94.9% for cholecystectomy, from 7.4% to 77.4% for fundoplication, and from 1.5% to 23.5% for repair of inguinal hernia (P < .001). Disparities in diffusion of laparoscopy were found from various pediatric populations, and the disparities varied by specific procedures and years. In particular, the proportion of laparoscopic appendectomy in 1997 was 11.3% at urban teaching hospitals and was 13.9% at rural hospitals (P = .01), while the proportions in 2016 increased to 90.8% at urban teaching hospitals versus 71.3% at rural hospitals (P < .001). Conclusions: Laparoscopy has become the standard surgical care for common pediatric surgical conditions. Widening disparities in use of laparoscopic surgery for pediatric populations appear between urban teaching hospitals and rural hospitals.

A Retrospective Cohort Study of Optimal Contrast for Successful Intussusception Reduction: Institutional Practices Matter.

BACKGROUND: The first-line treatment for intussusception is radiologic reduction with either air-contrast enema (AE) or liquid-contrast enema (LE). The purpose of this study was to explore relationships between self-reported institutional AE or LE intussusception reduction preferences and rates of operative intervention and bowel resection. METHODS: Pediatric Health Information System (PHIS) hospitals were contacted to assess institutional enema practices for intussusception. A retrospective study using 2009-2018 PHIS data was conducted for patients aged 0-5 y to evaluate outcomes. Chi-squared tests were used to test for differences in the distribution of surgical patients by hospital management approach. RESULTS: Of the 45 hospitals, 20 (44%) exclusively used AE, 4 (9%) exclusively used LE, and 21 (46%) used a mixed practice. Of 24,688 patients identified from PHIS, 13,231 (54%) were at exclusive AE/LE hospitals and 11,457 (46%) were at mixed practice hospitals. Patients at AE/LE hospitals underwent operative procedures at lower rates than at mixed practice hospitals (14.8% versus 16.5%, P< 0.001) and were more likely to undergo bowel resection (31.1% versus 27.1%, P= 0.02). CONCLUSIONS: Practice variation exists in hospital-level approaches to radiologic reduction of intussusception and mixed practices may impact outcomes.

First Measurement of Coherent Elastic Neutrino-Nucleus Scattering on Argon.

We report the first measurement of coherent elastic neutrino-nucleus scattering (CEvNS) on argon using a liquid argon detector at the Oak Ridge National Laboratory Spallation Neutron Source. Two independent analyses prefer CEvNS over the background-only null hypothesis with greater than 3σ significance. The measured cross section, averaged over the incident neutrino flux, is (2.2±0.7)×10^{-39} cm^{2}-consistent with the standard model prediction. The neutron-number dependence of this result, together with that from our previous measurement on CsI, confirms the existence of the CEvNS process and provides improved constraints on nonstandard neutrino interactions.

Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial.

BACKGROUND: Perioperative enhanced recovery protocols (ERPs) have been found to decrease hospital length of stay, in-hospital costs, and complications among adult surgical populations but evidence for pediatric populations is lacking. The study is designed to evaluate the adoption, effectiveness, and generalizability of a 21-element ERP, adapted for pediatric surgery. METHODS: The multicenter study is a stepped-wedge, cluster-randomized, pragmatic clinical trial that will evaluate the effectiveness of the ENhanced Recovery In CHildren Undergoing Surgery (ENRICH-US) intervention while also assessing site-specific adaptations, implementation fidelity, and sustainability. The target patient population is pediatric patients, between 10 and 18 years old, who undergo elective gastrointestinal surgery. Eighteen (N = 18) participating sites will be randomly assigned to one of three clusters with each cluster, in turn, being randomly assigned to an intervention start period (stepped-wedge). Each cluster will participate in a Learning Collaborative, using the National Implementation Research Network's five Active Implementation Frameworks (AIFs) (competency, organization, and leadership), as drivers of facilitation of rapid-cycle adaptations and implementation. The primary study outcome is hospital length of stay, with implementation metrics being used to evaluate adoption, fidelity, and sustainability. Additional clinical outcomes include opioid use, post-surgical complications, and post-discharge healthcare utilization (clinic/emergency room visits, telephone calls to clinic, and re-hospitalizations), as well as, assess patient- and parent-reported health-related quality of life outcomes. The protocol adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. DISCUSSION: The study provides a unique opportunity to accelerate the adoption of ERPs across 18 US pediatric surgical centers and to evaluate, for the first time, the effect of a pediatric-specific ENRICH-US intervention on clinical and implementation outcomes. The study design and methods can serve as a model for future pediatric surgical quality improvement implementation efforts. TRIAL REGISTRATION: ClinicalTrials.gov NCT04060303 . Registered on 07 August 2019.