Effect of Drug Disposal Bag Provision on Proper Disposal of Unused Opioids by Families of Pediatric Surgical Patients: A Randomized Clinical Trial.

IMPORTANCE: Although opioids are an important component of pain management for children recovering from surgery, postoperative opioid prescribing has contributed to the current opioid crisis in the United States because these medications are often prescribed in excess and are rarely properly disposed. One potential strategy to combat opioid misuse is to remove excess postoperative opioids from circulation by providing patients with drug disposal products that enable safe disposal of opioids in the home garbage. OBJECTIVE: To determine whether the provision of a drug disposal bag increases proper opioid disposal among the families of pediatric patients undergoing ambulatory surgery. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial enrolled 202 parents or guardians of children 1 to 17 years of age who underwent otolaryngologic or urologic surgery at the outpatient surgery centers of a tertiary children's hospital in Columbus, Ohio, from June to December 2018 and who received an opioid prescription prior to discharge. INTERVENTIONS: Families randomized to intervention were provided a drug disposal bag containing activated charcoal and instructions for use plus standard postoperative discharge instructions on opioid use, storage, and disposal. Families in standard care arm received standard postoperative discharge instructions only. All participants completed a baseline survey and a follow-up survey 2 to 4 weeks postoperatively. MAIN OUTCOMES AND MEASURES: Primary outcome was proper opioid disposal, defined as disposal using a drug disposal bag or a disposal method recommended by the US Food and Drug Administration. RESULTS: Of 202 parents or guardians enrolled, 181 completed follow-up (92 in intervention arm and 89 in standard care arm). Most patients in both groups were white (75 [73.5%] vs 79 [80.6%]) and male (63 [61.2%] vs 54 [54.6%]), and the median (interquartile range) age was 6 (5-9) years in the intervention arm and 7 (6-10) years in the standard care arm. For intention-to-treat analyses, 92 families receiving a disposal bag and 89 families not receiving a disposal bag were included. Among them, 66 families (71.7%) randomized to receive a disposal bag reported properly disposing of their child's opioids, whereas 50 parents (56.2%) who did not receive a disposal bag reported proper opioid disposal (difference in proportions, 15.5%; 95% CI, 1.7%-29.3%; P = .03). Among only those families who filled an opioid prescription and had leftover opioids after resolution of their child's pain, 66 of 77 parents or guardians (85.7%) who had received a disposal bag and 50 of 77 parents or guardians (64.9%) who had received standard care reported properly disposing of their child's opioids (difference in proportions, 20.8%; 95% CI, 7.6%-34.0%). CONCLUSIONS AND RELEVANCE: Results of this study indicated that providing drug disposal bags to families of children receiving postoperative opioids increased the likelihood of excess opioid disposal. Greater availability of disposal products may complement ongoing prescribing reduction efforts aimed at decreasing opioid misuse. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03575377.

Effects of a Patient Activation Tool on Decision Making Between Surgery and Nonoperative Management for Pediatric Appendicitis: A Randomized Clinical Trial.

Importance: Strategies to activate and engage patients and caregivers in shared decision making in the acute care setting may result in improved outcomes. Objective: To determine whether a patient activation tool (PAT) can improve decision-making and patient-centered outcomes among pediatric patients and their caregivers who choose between surgery and nonoperative management for their child's appendicitis. Design, Setting, and Participants: This single-blind, randomized clinical trial collected data from a single tertiary children's hospital from March 1, 2014, through April 30, 2016, with 1-year follow-up completed on May 1, 2017. Two hundred of 236 eligible children and adolescents aged 7 to 17 years with uncomplicated appendicitis enrolled with their caregivers. After receiving the randomized clinical intervention, caregivers chose surgery or nonoperative management. Data were analyzed from March 1, 2014, through May 1, 2017. Interventions: Randomization to a scripted standardized surgical consultation that emphasized patient choice or a scripted standardized surgical consultation plus the PAT (a tablet-based tool that presents each treatment, encourages participation in medical decision making, and aims at alleviating decisional uncertainty). Main Outcomes and Measures: Decisional self-efficacy immediately after treatment decision, health care satisfaction at discharge, and disability days for the child at 1-year follow-up. Results: Among 200 participants (median age, 12 years [interquartile range (IQR), 9-15 years]; 120 [60.0%] male), 98 were randomized to the PAT and 102 to the standardized consultation groups. The percentages choosing nonoperative management were similar (standardized consultation group, 42 of 102 [41.2%]; PAT group, 31 of 98 [31.6%]; P = .19). Immediate decisional self-efficacy was similar in the standardized consultation and PAT groups (median score, 100 [IQR, 97.7-100] vs 100 [IQR, 95.5-100]; P = .03), which was not significant at the planned significance level of P = .02. Total scores on health care satisfaction at discharge were similar (median, 99 [IQR, 94.7-100] vs 98 [IQR, 91.7-100]; P = .27). Disability days at 1-year follow-up were also similar (median, 6 [IQR, 2-11] vs 5 [IQR, 2-15]; P = .67). No difference in the failure rate of nonoperative management at 1 year (13 of 38 [34.2%] vs 11 of 30 [36.7%]; P > .99) or in the rate of complicated appendicitis 30 days after discharge (7 of 68 [10.3%] vs 9 of 71 [12.7%]; P = .79) occurred. Conclusions and Relevance: In this study, a technology-based PAT did not improve measures of decision making for pediatric patients and caregivers needing to make an urgent treatment decision between surgery and nonoperative management for appendicitis. However, the overall high scores in both groups suggest that pediatric patients and caregivers can process information in the acute care setting and effectively participate in an informed shared decision-making process around the need for surgery. Trial Registration: ClinicalTrials.gov identifier: NCT02110485.

Development of a Patient-reported Experience and Outcome Measures in Pediatric Patients Undergoing Bowel Management for Constipation and Fecal Incontinence.

AIMS AND OBJECTIVES: The aim of this review is develop a reliable and valid questionnaire that assesses patient-reported experience measures (PREMs) and patient-reported outcome measures (PROMs) of caregivers, families, and patients with severe constipation and fecal incontinence who failed conservative treatments and require a formal bowel management program (BMP). METHODS: A 5-step iterative process was utilized to ensure the reliability and validity of the final instrument. Parents or guardians of patients undergoing our week-long BMP were first asked 20 open-ended questions aimed at understanding the challenges in managing their child's condition. Responses were transformed into an initial 41-item survey constituted of 2 constructs relating to PREMs (24 items) and PROMs (17 items). Survey items were then administered to 359 parents and guardians undergoing BMP. Cognitive interviews were performed with 20 families to assess face validity and to further refine the survey. Instrument readability and reliability was assessed by Flesch-Kincaid and Crohnbach α analyses. Items that weakly correlated were deleted to yield a final instrument that was both valid and reliable. RESULTS: A 33-statement survey was developed that encompasses important physical and emotional health concerns, quality of life, treatment success, financial considerations, schooling, parental employment, and social concerns. The final instrument, the Patient-Reported Experience and Outcome Measure in a Bowel Management Program (PREOM-BMP), is divided into 2 separate constructs that assess important patient-reported experience (22 items) and outcome (11 items) measures. Reliability analyses on the final instrument yielded a Crohnbach α of 0.925. CONCLUSIONS: The PREOM-BMP offers physicians and nursing professionals a brief and valid tool to measure the impact of a bowel management program on both the child and the family unit.

Health care quality measures for children and adolescents in Foster Care: feasibility testing in electronic records.

BACKGROUND: Preventive quality measures for the foster care population are largely untested. The objective of the study is to identify healthcare quality measures for young children and adolescents in foster care and to test whether the data required to calculate these measures can be feasibly extracted and interpreted within an electronic health records or within the Statewide Automated Child Welfare Information System. METHODS: The AAP Recommendations for Preventive Pediatric Health Care served as the guideline for determining quality measures. Quality measures related to well child visits, developmental screenings, immunizations, trauma-related care, BMI measurements, sexually transmitted infections and depression were defined. Retrospective chart reviews were performed on a cohort of children in foster care from a single large pediatric institution and related county. Data available in the Ohio Statewide Automated Child Welfare Information System was compared to the same population studied in the electronic health record review. Quality measures were calculated as observed (received) to expected (recommended) ratios (O/E ratios) to describe the actual quantity of recommended health care that was received by individual children. RESULTS: Electronic health records and the Statewide Automated Child Welfare Information System data frequently lacked important information on foster care youth essential for calculating the measures. Although electronic health records were rich in encounter specific clinical data, they often lacked custodial information such as the dates of entry into and exit from foster care. In contrast, Statewide Automated Child Welfare Information System included robust data on custodial arrangements, but lacked detailed medical information. Despite these limitations, several quality measures were devised that attempted to accommodate these limitations. CONCLUSIONS: In this feasibility testing, neither the electronic health records at a single institution nor the county level Statewide Automated Child Welfare Information System was able to independently serve as a reliable source of data for health care quality measures for foster care youth. However, the ability to leverage both sources by matching them at an individual level may provide the complement of data necessary to assess the quality of healthcare.

High failure rate of nonoperative management of acute appendicitis with an appendicolith in children.

BACKGROUND: The purpose of this study was to investigate the feasibility of nonoperative management of acute appendicitis in children with an appendicolith identified on preoperative imaging. STUDY DESIGN: We performed a prospective nonrandomized trial of nonoperative management of uncomplicated acute appendicitis with an appendicolith in children aged 7 to 17years. The primary outcome was the failure rate of nonoperative management, defined as having undergone an appendectomy. Early termination was set to occur if the lower limit of the 95% confidence interval of the failure rate was greater than 20% at 30days or 30% at 1year. RESULTS: Recruitment for this study was halted after enrollment of 14 patients (N=5 nonoperative; N=9 surgery). The failure rate of nonoperative management was 60% (3/5) at a median follow-up of 4.7months (IQR 1.0-7.6) with a 95% CI of 23%-88%. None of the three patients that failed nonoperative management had complicated appendicitis at the time of appendectomy, while six out of nine patients who chose surgery had complicated appendicitis (0/3 vs. 6/9, p=0.18). The trial was stopped for concerns over patient safety. CONCLUSIONS: Nonoperative management of acute appendicitis with an appendicolith in children resulted in an unacceptably high failure rate.

Does delay in appendectomy affect surgical site infection in children with appendicitis?

PURPOSE: The purpose of this study was to investigate the association between time from diagnosis to operation and surgical site infection (SSI) in children undergoing appendectomy. METHODS: Pediatric patients undergoing appendectomy in 2010-2012 were included. We collected data on patient demographics; length of symptoms; times of presentation, admission and surgery; antibiotic administration; operative findings; and occurrence of SSI. RESULTS: 1388 patients were analyzed. SSI occurred in 5.1% of all patients, 1.4% of simple appendicitis (SA) patients, and 12.4% of complex appendicitis (CA) patients. SSI did not increase significantly as the length of time between ED triage and operation increased (all patients, p=0.51; SA patients, p=0.91; CA patients, p=0.44) or with increased time from admission to operation (all patients, p=0.997; SA patients, p=0.69; CA patients, p=0.96). However, greater length of symptoms was associated with an increased risk of SSI (p<0.05 for all, SA and CA patients). In univariable analysis, obesity, and increased admission WBC count were each associated with significantly increased SSI. In multivariable analysis, only CA was a significant risk factor for SSI (p<0.0001). CONCLUSION: We found no significant increase in the risk of SSI related to delay in appendectomy. A future multi-institutional study is planned to confirm these results.

Using computer-extracted data from electronic health records to measure the quality of adolescent well-care.

OBJECTIVE: To determine whether quality measures based on computer-extracted EHR data can reproduce findings based on data manually extracted by reviewers. DATA SOURCES: We studied 12 measures of care indicated for adolescent well-care visits for 597 patients in three pediatric health systems. STUDY DESIGN: Observational study. DATA COLLECTION/EXTRACTION METHODS: Manual reviewers collected quality data from the EHR. Site personnel programmed their EHR systems to extract the same data from structured fields in the EHR according to national health IT standards. PRINCIPAL FINDINGS: Overall performance measured via computer-extracted data was 21.9 percent, compared with 53.2 percent for manual data. Agreement measures were high for immunizations. Otherwise, agreement between computer extraction and manual review was modest (Kappa = 0.36) because computer-extracted data frequently missed care events (sensitivity = 39.5 percent). Measure validity varied by health care domain and setting. A limitation of our findings is that we studied only three domains and three sites. CONCLUSIONS: The accuracy of computer-extracted EHR quality reporting depends on the use of structured data fields, with the highest agreement found for measures and in the setting that had the greatest concentration of structured fields. We need to improve documentation of care, data extraction, and adaptation of EHR systems to practice workflow.

Associations between maternal and infant morbidities and sRAGE within the first week of life in extremely preterm infants.

BACKGROUND: Soluble RAGE (sRAGE) has been associated with multiple inflammatory responses including maternal chorioamnionitis and preeclampsia. Analysis of umbilical cord blood levels have also indicated that sRAGE levels in the infant are affected by maternal inflammation. S100b is a ligand for RAGE and increases in circulating S100b levels are associated with poor neurological outcome in preterm infants. The objective of this study was to determine whether sRAGE or s100b levels in plasma samples from extremely preterm infants at the end of the first week of life were correlated with infant morbidities and whether sRAGE and s100b levels at this time point were still associated with maternal inflammation. METHODS: Plasma samples were collected from 130 preterm infants (≤28 weeks) at days of life 5, 6, or 7. sRAGE and s100b levels were measured by ELISA and data were analyzed by Pearson's correlation or Generalized Estimating Equations. RESULTS: sRAGE was negatively correlated with development of sepsis (p=0.024), the FiO2 requirement of the infant at the time of sampling (p=0.030), as well as maternal preeclampsia (p=0.046), and positively correlated with maternal chorioamnionitis (p=0.006). s100b levels were positively associated with maternal chorioamnionitis (p=0.039). No correlations were observed with other infant morbidities. CONCLUSION: These data indicate that sRAGE could potentially be a biomarker of early severe inflammatory responses in the preterm infant. However, more studies are needed to confirm the present findings.

Plasma lipid metabolites are associated with gestational age but not bronchopulmonary dysplasia.

AIM: To test the hypothesis that plasma lipid metabolite levels in premature infants are associated with the development of bronchopulmonary dysplasia (BPD). The studies also tested a secondary hypothesis that plasma lipid metabolite levels were correlated with gestational age. METHODS: Infants born <32 weeks' gestation were enrolled during the first 72 h of life. Plasma samples were obtained and lipid levels were measured by LC-MS/MS. Clinical data were collected to determine infant outcomes and BPD diagnosis. RESULTS: Following adjustment for confounders, lipid levels were not associated with BPD; however, levels of specific lipid metabolites were correlated with gestational age. CONCLUSION: Immature lipid metabolism pathways in premature infants may contribute to the pathogenesis of BPD and other diseases.