Clinician Prompts for Human Papillomavirus Vaccination: A Cluster Randomized Trial.

OBJECTIVE: We assessed the impact of an online intervention using clinician prompts for human papillomavirus (HPV) vaccination with a cluster randomized controlled trial. METHODS: The randomized trial occurred July 2021-January 2022 in 48 primary care pediatric practices (24 intervention, 24 control) across the US. We trained clinicians via two online learning modules, plus weekly ''quick tips'' delivered via text or email. The training taught practices to implement a staff prompt to the clinician (e.g., printed reminders placed on the keyboard) plus electronic health record (EHR) prompts (if not already done) at well and acute/chronic visits for initial and subsequent HPV vaccination. We assessed missed opportunities for HPV vaccination using logistic regression models accounting for clustering by practice on an intent to treat basis. Surveys assessed facilitators and barriers to using prompts. RESULTS: During the 6-month intervention, missed opportunities for HPV vaccination increased (worsened) in both intervention and control groups. However, at well child care visits, missed opportunities for the initial HPV vaccine increased by 4.5 (95% CI: -9.0%, -0.1%) percentage points less in intervention versus control practices. Change in missed opportunities for subsequent doses at well child care and non-well child care visits did not differ between trial groups. An end-of trial survey found understaffing as a common challenge. CONCLUSIONS: Clinician prompts reduced missed opportunities for HPV vaccination at well child care visits. Understaffing related to the COVID-19 pandemic may have led to worsening missed opportunities for both groups and likely impeded practices in fully implementing changes.

Examination of Text Message Plans and Baseline Usage of Families Enrolled in a Text Message Influenza Vaccine Reminder Trial: Survey Study.

BACKGROUND: Mobile health (mHealth) is quickly expanding as a method of health promotion, but some interventions may not be familiar or comfortable for potential users. SMS text messaging has been investigated as a low-cost, accessible way to provide vaccine reminders. Most (97%) US adults own a cellphone and of those adults most use SMS text messaging. However, understanding patterns of SMS text message plan type and use in diverse primary care populations needs more investigation. OBJECTIVE: We sought to use a survey to examine baseline SMS text messaging and data plan patterns among families willing to accept SMS text message vaccine reminders. METHODS: As part of a National Institutes of Health (NIH)-funded national study (Flu2Text) conducted during the 2017-2018 and 2018-2019 influenza seasons, families of children needing a second seasonal influenza vaccine dose were recruited in pediatric primary care offices at the time of their first dose. Practices were from the American Academy of Pediatrics' (AAP) Pediatric Research in Office Settings (PROS) research network, the Children's Hospital of Philadelphia, and Columbia University. A survey was administered via telephone (Season 1) or electronically (Season 2) at enrollment. Standardized (adjusted) proportions for SMS text message plan type and texting frequency were calculated using logistic regression that was adjusted for child and caregiver demographics. RESULTS: Responses were collected from 1439 participants (69% of enrolled). The mean caregiver age was 32 (SD 6) years, and most children (n=1355, 94.2%) were aged 6-23 months. Most (n=1357, 94.3%) families were English-speaking. Most (n=1331, 92.8%) but not all participants had an unlimited SMS text messaging plan and sent or received texts at least once daily (n=1313, 91.5%). SMS text messaging plan type and use at baseline was uniform across most but not all subgroups. However, there were some differences in the study population's SMS text messaging plan type and usage. Caregivers who wanted Spanish SMS text messages were less likely than those who chose English to have an unlimited SMS text messaging plan (n=61, 86.7% vs n=1270, 94%; risk difference -7.2%, 95% CI -27.1 to -1.8). There were no significant differences in having an unlimited plan associated with child's race, ethnicity, age, health status, insurance type, or caregiver education level. SMS text messaging use at baseline was not uniform across all subgroups. Nearly three-quarters (n=1030, 71.9%) of participants had received some form of SMS text message from their doctor's office; most common were appointment reminders (n=1014, 98.4%), prescription (n=300, 29.1%), and laboratory notifications (n=117, 11.4%). Even the majority (n=64, 61.5%) of those who did not have unlimited plans and who texted less than daily (n=72, 59%) reported receipt of these SMS text messages. CONCLUSIONS: In this study, most participants had access to unlimited SMS text messaging plans and texted at least once daily. However, infrequent texting and lack of access to an unlimited SMS text messaging plan did not preclude enrolling to receive SMS text message reminders in pediatric primary care settings.

Missed Opportunities for Adolescent Immunizations at Well-Care Visits During the COVID-19 Pandemic.

PURPOSE: The Coronavirus Disease 2019 pandemic disrupted healthcare, but the impact on vaccination missed opportunities (MOs, vaccine-eligible visits without vaccination) is unknown. We evaluated pandemic-related trends in MOs at adolescent well-care visits for three vaccines: human papillomavirus; quadrivalent meningococcal conjugate; and tetanus, diphtheria, and acellular pertussis (Tdap). METHODS: We analyzed electronic health record data from 24 pediatric primary care practices in 13 states from 1/1/2018 to 12/31/2021. Segmented logistic regression estimated risk differences for MOs during the pandemic relative to prepandemic trends. RESULTS: Among 106,605 well-care visits, we observed decreases in MOs prepandemic followed by an increase in MOs during the pandemic for all three vaccines. Relative to prepandemic, MOs increased for human papillomavirus (+15.9%, 95% confidence interval [CI]: 11.7%, 20.1%), meningococcal conjugate (+9.4%, 95% CI: 5.2%, 13.7%), and tetanus, diphtheria, and acellular pertussis (Tdap) (+ 8.2%, 95% CI: 4.3%, 12.1%). DISCUSSION: Increases in vaccine MOs during the pandemic equaled or exceeded pre-pandemic decreases. Reducing MOs in adolescent well-care could raise vaccine coverage.

Performance Feedback for Human Papillomavirus Vaccination: A Randomized Trial From the American Academy of Pediatrics Pediatric Research in Office Settings Research Network.

OBJECTIVE: To test the hypothesis that a feedback-based intervention would reduce human papillomavirus (HPV) vaccine missed opportunities. METHODS: In a longitudinal cluster randomized controlled trial of 48 pediatric primary care practices, we allocated half the practices to receive a sequential, multicomponent intervention phased over consecutive periods. In a prior trial (period 1), communication skills training reduced missed opportunities for the initial HPV vaccine dose at well visits but not at acute/chronic visits. The current trial (period 2) evaluated the added value of performance feedback to clinicians after communication training. Performance feedback consisted of an introductory training module, weekly electronic "Quick Tips," and 3 individualized performance feedback reports to clinicians. We fit logistic regression models for the primary outcome of HPV vaccination missed opportunities using generalized estimating equations with independence working correlation, accounting for clustering at the practice level. RESULTS: Performance feedback resulted in a 3.4 (95% confidence interval [CI]: -6.8, 0.0) percentage point greater reduction in missed HPV vaccine opportunities for the intervention versus control group during acute/chronic visits for subsequent HPV vaccinations (dose 2 or 3). However, during well visits for HPV vaccination dose #1, intervention practices increased missed opportunities (worsened) by 4.2 (95% CI: 1.0, 7.4) percentage points more than control practices, reducing the prior period 1 improvements and blunting the overall effect of performance feedback. We did not observe differences for the other visit/dose categories. CONCLUSIONS: Performance feedback improved HPV vaccination for one subset of visits (acute/chronic, subsequent HPV vaccinations due), but not for well visits.

Pediatric Practices' Perceptions of Text Message Communication with Families: An American Academy of Pediatrics (AAP), Pediatric Research in Office Settings (PROS) Study.

Background: Text messages can be an effective and low-cost mechanism for patient reminders; however, they are yet to be consistently integrated into pediatric primary care. Objective: The aim of this study was to explore pediatric primary care clinician and staff perceptions of pediatric office text message communication with families. Methods: As part of the National Institutes of Health-funded Flu2Text randomized controlled trial of second-dose influenza vaccine text message reminders, we conducted 7 focus groups and 4 individual interviews in July-August 2019 with primary care pediatric clinicians and staff (n = 39). Overall, 10 Pediatric Research in Office Settings (PROS) pediatric practices in 10 states were selected using stratified sampling. Semi-structured discussion guides included perspectives on possible uses, perceived usefulness, and ease of use of text messages; practices' current text messaging infrastructure; and perceived barriers/facilitators to future use of texting. Two investigators independently coded and analyzed transcripts based on the technology acceptance model using NVIVO 12 Plus (intercoder reliability, K = 0.86). Results: Overall, participants were supportive of text reminders for the second-dose influenza vaccine, other vaccines, and appointments and perceived texting as a preferred method of communication for caregivers. Health information privacy and patient confidentiality were the main concerns cited. Only respondents from practices with no internal appointment text message reminder system prior to the study expressed concerns about technology implementation logistics, time, and cost. Conclusion: Text message reminders, for various uses, appear to be well accepted among a group of geographically widespread pediatric practices after participation in a trial of influenza vaccine text message reminders. Privacy, confidentiality, and resource barriers need to be addressed to facilitate successful implementation.

Effect of Sitagliptin on Islet Function in Pancreatic Insufficient Cystic Fibrosis With Abnormal Glucose Tolerance.

PURPOSE: Impaired incretin secretion may contribute to the defective insulin secretion and abnormal glucose tolerance (AGT) that associate with worse clinical outcomes in pancreatic insufficient cystic fibrosis (PI-CF). The study objective was to test the hypothesis that dipeptidyl peptidase-4 (DPP-4) inhibitor-induced increases in intact incretin hormone [glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)] concentrations augment insulin secretion and glucagon suppression and lower postprandial glycemia in PI-CF with AGT. METHODS: 26 adults from Children's Hospital of Philadelphia and University of Pennsylvania CF Center with PI-CF and AGT [defined by oral glucose tolerance test glucose (mg/dL): early glucose intolerance (1-h ≥ 155 and 2-h < 140), impaired glucose tolerance (2-h ≥ 140 and < 200 mg/dL), or diabetes (2-h ≥ 200)] were randomized to a 6-month double-blind trial of DPP-4 inhibitor sitagliptin 100 mg daily or matched placebo; 24 completed the trial (n = 12 sitagliptin; n = 12 placebo). Main outcome measures were mixed-meal tolerance test (MMTT) responses for intact GLP-1 and GIP, insulin secretory rates (ISRs), glucagon suppression, and glycemia and glucose-potentiated arginine (GPA) test-derived measures of ß- and α-cell function. RESULTS: Following 6-months of sitagliptin vs placebo, MMTT intact GLP-1 and GIP responses increased (P < 0.001), ISR dynamics improved (P < 0.05), and glucagon suppression was modestly enhanced (P < 0.05) while GPA test responses for glucagon were lower. No improvements in glucose tolerance or ß-cell sensitivity to glucose, including for second-phase insulin response, were found. CONCLUSIONS: In glucose intolerant PI-CF, sitagliptin intervention augmented meal-related incretin responses with improved early insulin secretion and glucagon suppression without affecting postprandial glycemia.

Effect of Training Pediatric Clinicians in Human Papillomavirus Communication Strategies on Human Papillomavirus Vaccination Rates: A Cluster Randomized Clinical Trial.

Importance: Missed opportunities for human papillomavirus (HPV) vaccination during pediatric health care visits are common. Objectives: To evaluate the effect of online communication training for clinicians on missed opportunities for HPV vaccination rates overall and at well-child care (WCC) visits and visits for acute or chronic illness (hereafter referred to as acute or chronic visits) and on adolescent HPV vaccination rates. Design, Setting, and Participants: From December 26, 2018, to July 30, 2019, a longitudinal cluster randomized clinical trial allocated practices to communication training vs standard of care in staggered 6-month periods. A total of 48 primary care pediatric practices in 19 states were recruited from the American Academy of Pediatrics Pediatric Research in Office Settings network. Participants were clinicians in intervention practices. Outcomes were evaluated for all 11- to 17-year-old adolescents attending 24 intervention practices (188 clinicians) and 24 control practices (177 clinicians). Analyses were as randomized and performed on an intent-to-treat basis, accounting for clustering by practice. Interventions: Three sequential online educational modules were developed to help participating clinicians communicate with parents about the HPV vaccine. Weekly text messages were sent to participating clinicians to reinforce learning. Statisticians were blinded to group assignment. Main Outcomes and Measures: Main outcomes were missed opportunities for HPV vaccination overall and for HPV vaccine initiation and subsequent doses at WCC and acute or chronic visits (visit-level outcome). Secondary outcomes were HPV vaccination rates (person-level outcome). Outcomes were compared during the intervention vs baseline. Results: Altogether, 122 of 188 clinicians in intervention practices participated; of these, 120, 119, and 116 clinicians completed training modules 1, 2, and 3, respectively. During the intervention period, 29 206 adolescents (14 664 girls [50.2%]; mean [SD] age, 14.2 [2.0] years) made 15 888 WCC and 28 123 acute or chronic visits to intervention practices; 33 914 adolescents (17 069 girls [50.3%]; mean [SD] age, 14.2 [2.0] years) made 17 910 WCC and 35 281 acute or chronic visits to control practices. Intervention practices reduced missed opportunities overall by 2.4 percentage points (-2.4%; 95% CI, -3.5% to -1.2%) more than controls. Intervention practices reduced missed opportunities for vaccine initiation during WCC visits by 6.8 percentage points (-6.8%; 95% CI, -9.7% to -3.9%) more than controls. The intervention had no effect on missed opportunities for subsequent doses of the HPV vaccine or at acute or chronic visits. Adolescents in intervention practices had a 3.4-percentage point (95% CI, 0.6%-6.2%) greater improvement in HPV vaccine initiation compared with adolescents in control practices. Conclusions and Relevance: This scalable, online communication training increased HPV vaccination, particularly HPV vaccine initiation at WCC visits. Results support dissemination of this intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT03599557.

Missed opportunities for human papillomavirus vaccination at office visits during which influenza vaccine was administered: An AAP pediatric research in office settings (PROS) national primary care research network study.

INTRODUCTION: Little is known about missed opportunities (MOs) for HPV vaccination during primary care visits at which influenza vaccination is delivered. METHODS: We extracted electronic health records for HPV vaccine-eligible 11-to-17-year-olds. We assessed the proportion of visits during which an influenza vaccine was given and an HPV vaccine was due, but not given (i.e., MOs). RESULTS: Of 56,135 eligible visits, 57.5% represented MOs for HPV vaccination. MOs were more common at visits where an initial versus subsequent HPV vaccine dose was due (68.6% vs. 31.3%) and for acute/chronic and nurse-only visits compared to preventive visits (74.0% and 80.2% vs. 36.7%). In a multivariable model, MOs were more likely for the initial HPV dose and for non-preventive visits, but did not vary by patient sex/age. CONCLUSIONS: HPV vaccine MOs were common during visits where influenza vaccine was administered. Increasing simultaneous administration of HPV and influenza vaccines could increase HPV vaccine coverage.

Sustained Inflation vs Standard Resuscitation for Preterm Infants: A Systematic Review and Meta-analysis.

Importance: Most preterm infants require respiratory support to establish lung aeration after birth. Intermittent positive pressure ventilation and continuous positive airway pressure are standard therapies. An initial sustained inflation (inflation time >5 seconds) is a widely practiced alternative strategy. Objective: To conduct a systematic review and meta-analysis of sustained inflation vs intermittent positive pressure ventilation and continuous positive airway pressure for the prevention of hospital mortality and morbidity for preterm infants. Data Sources: MEDLINE (through PubMed), Embase, the Cumulative Index of Nursing and Allied Health Literature, and the Cochrane Central Register of Controlled Trials were searched through June 24, 2019. Study Selection: Randomized clinical trials of preterm infants born at less than 37 weeks' gestation that compared sustained inflation (inflation time >5 seconds) vs standard resuscitation with either intermittent positive pressure ventilation or continuous positive airway pressure were included. Studies including other cointerventions were excluded. Data Extraction and Synthesis: Two reviewers assessed the risk of bias of included studies. Meta-analysis of pooled outcome data used a fixed-effects model specific to rarer events. Subgroups were based on gestational age and study design (rescue vs prophylactic sustained inflation). Main Outcomes and Measures: Death before hospital discharge. Results: Nine studies recruiting 1406 infants met inclusion criteria. Death before hospital discharge occurred in 85 of 736 infants (11.5%) treated with sustained inflation and 62 of 670 infants (9.3%) who received standard therapy for a risk difference of 3.6% (95% CI, -0.7% to 7.9%). Although analysis of the primary outcome identified important heterogeneity based on gestational age subgroups, the 95% CI for the risk difference included 0 for each individual gestational age subgroup. There was no difference in the primary outcome between subgroups based on study design. Sustained inflation was associated with increased risk of death in the first 2 days after birth (risk difference, 3.1%; 95% CI, 0.9%-5.3%). No differences in the risk of other secondary outcomes were identified. The quality-of-evidence assessment was low owing to risk of bias and imprecision. Conclusions and Relevance: There was no difference in the risk of the primary outcome of death before hospital discharge, and there was no evidence of efficacy for sustained inflation to prevent secondary outcomes. These findings do not support the routine use of sustained inflation for preterm infants after birth.

Vaccine hesitancy and influenza beliefs among parents of children requiring a second dose of influenza vaccine in a season: An American Academy of Pediatrics (AAP) Pediatric Research in Office Settings (PROS) study.

To receive adequate protection against influenza, some children 6 months through 8 y old need two doses of influenza vaccine in a given season. Currently, only half of those receiving the first dose receive a second. Our objective was to assess vaccine hesitancy and influenza disease and vaccine knowledge, attitudes, and beliefs among caregivers of children who received the first of their two needed doses. As part of a national-randomized control trial of second dose text-message influenza vaccine reminders (2017-2018 season), a telephone survey collected caregiver and index child demographic information. Each child had received the first of two needed influenza vaccine doses. Caregivers completed a measure of general vaccine hesitancy - the five-question Parent Attitudes About Childhood Vaccines Survey Tool (PACV-5) - and questions about influenza infection and vaccine. We assessed associations between participant demographic characteristics, vaccine hesitancy, and influenza beliefs and calculated the standardized proportion of caregivers endorsing each outcome using logistic regression. Analyses included responses from 256 participants from 36 primary care practices in 24 states. Some caregivers (11.7%) reported moderate/high vaccine hesitancy and many had misperceptions about influenza disease and vaccine. In multivariable models, no single variable was consistently associated with inaccurate knowledge, attitudes, and beliefs. These results demonstrate that caregivers whose children received the first dose of influenza vaccine may still be vaccine hesitant and have inaccurate influenza beliefs. Pediatricians should consider broadly addressing inaccurate beliefs and promoting vaccination even after caregivers agree to the first dose.

Randomized Controlled Trial of Imagery Rehearsal for Posttraumatic Nightmares in Combat Veterans.

STUDY OBJECTIVES: To examine the efficacy of imagery rehearsal (IR) combined with cognitive behavioral therapy for insomnia (CBT-I) compared to CBT-I alone for treating recurrent nightmares in military veterans with posttraumatic stress disorder (PTSD). METHODS: In this randomized controlled study, 108 male and female United States veterans of the Iraq and Afghanistan conflicts with current, severe PTSD and recurrent, deployment-related nightmares were randomized to six sessions of IR + CBT-I (n = 55) or CBT-I (n = 53). Primary outcomes were measured with the Nightmare Frequency Questionnaire (NFQ) and Nightmare Distress Questionnaire (NDQ). RESULTS: Improvement with treatment was significant (29% with reduction in nightmare frequency and 22% with remission). Overall, IR + CBT-I was not superior to CBT-I (NFQ: -0.12; 95% confidence interval = -0.87 to 0.63; likelihood ratio chi square = 4.7(3), P = .2); NDQ: 1.5, 95% confidence interval = -1.4 to 4.4; likelihood ratio chi square = 7.3, P = .06). CONCLUSIONS: Combining IR with CBT-I conferred no advantage overall. Further research is essential to examine the possibly greater benefit of adding IR to CBT-I for some subgroups of veterans with PTSD. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Cognitive Behavioral Therapy (CBT) for Nightmares in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans; Identifier: NCT00691626; URL: https://clinicaltrials.gov/ct2/show/NCT00691626.

Effect of Sustained Inflations vs Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death Among Extremely Preterm Infants: The SAIL Randomized Clinical Trial.

Importance: Preterm infants must establish regular respirations at delivery. Sustained inflations may establish lung volume faster than short inflations. Objective: To determine whether a ventilation strategy including sustained inflations, compared with standard intermittent positive pressure ventilation, reduces bronchopulmonary dysplasia (BPD) or death at 36 weeks' postmenstrual age without harm in extremely preterm infants. Design, Setting, and Participants: Unmasked, randomized clinical trial (August 2014 to September 2017, with follow-up to February 15, 2018) conducted in 18 neonatal intensive care units in 9 countries. Preterm infants 23 to 26 weeks' gestational age requiring resuscitation with inadequate respiratory effort or bradycardia were enrolled. Planned enrollment was 600 infants. The trial was stopped after enrolling 426 infants, following a prespecified review of adverse outcomes. Interventions: The experimental intervention was up to 2 sustained inflations at maximal peak pressure of 25 cm H2O for 15 seconds using a T-piece and mask (n = 215); standard resuscitation was intermittent positive pressure ventilation (n = 211). Main Outcome and Measures: The primary outcome was the rate of BPD or death at 36 weeks' postmenstrual age. There were 27 prespecified secondary efficacy outcomes and 7 safety outcomes, including death at less than 48 hours. Results: Among 460 infants randomized (mean [SD] gestational age, 25.30 [0.97] weeks; 50.2% female), 426 infants (92.6%) completed the trial. In the sustained inflation group, 137 infants (63.7%) died or survived with BPD vs 125 infants (59.2%) in the standard resuscitation group (adjusted risk difference [aRD], 4.7% [95% CI, -3.8% to 13.1%]; P = .29). Death at less than 48 hours of age occurred in 16 infants (7.4%) in the sustained inflation group vs 3 infants (1.4%) in the standard resuscitation group (aRD, 5.6% [95% CI, 2.1% to 9.1%]; P = .002). Blinded adjudication detected an imbalance of rates of early death possibly attributable to resuscitation (sustained inflation: 11/16; standard resuscitation: 1/3). Of 27 secondary efficacy outcomes assessed by 36 weeks' postmenstrual age, 26 showed no significant difference between groups. Conclusions and Relevance: Among extremely preterm infants requiring resuscitation at birth, a ventilation strategy involving 2 sustained inflations, compared with standard intermittent positive pressure ventilation, did not reduce the risk of BPD or death at 36 weeks' postmenstrual age. These findings do not support the use of ventilation with sustained inflations among extremely preterm infants, although early termination of the trial limits definitive conclusions. Trial Registration: clinicaltrials.gov Identifier: NCT02139800.

Use and Utility of Skeletal Surveys to Evaluate for Occult Fractures in Young Injured Children.

OBJECTIVE: To describe the percentage and characteristics of children aged <24 months with non-motor vehicle crash (MVC)-related injuries who undergo a skeletal survey and have occult fractures. METHODS: We performed a retrospective chart review of a stratified, systematic random sample of 1769 children aged<24 months with non-MVC-related bruises, burns, fractures, abdominal injuries, and head injuries at 4 children's hospitals between 2008 and 2012. Sampling weights were assigned to each child to allow for representative hospital-level population estimates. Logistic regression models were used to test for associations between patient characteristics with outcomes of skeletal survey completion and occult fracture identification. RESULTS: Skeletal surveys were performed in 46.3% of children aged 0 to 5 months, in 21.1% of those aged 6 to 11 months, in 8.0% of those aged 12 to 17 months, and in 6.2% of those aged 18 to 24 months. Skeletal surveys were performed most frequently in children with traumatic brain injuries (64.7%) and rib fractures (100%) and least frequently in those with burns (2.1%) and minor head injuries (4.4%). In adjusted analyses, older age, private insurance, and reported history of accidental trauma were associated with decreased skeletal survey use (P ≤ .001 for all). The prevalence of occult fractures on skeletal surveys ranged from 24.6% in children aged 0 to 5months to 3.6% in those aged 18 to 24 months, and varied within age categories based on the presenting injury (P < .001). CONCLUSIONS: The high rate of occult fractures in infants aged 0 to 5 months underscores the importance of increasing the use of skeletal surveys in this population. Further research is needed to identify the injury characteristics of older infants and toddlers most at risk for occult fractures.

Incidence of Healthcare-Associated Influenza-Like Illness After a Primary Care Encounter Among Young Children.

BACKGROUND: Despite potential respiratory virus transmission in pediatric clinics, little is known about the risk of healthcare-associated viral infections attributable to outpatient encounters. We evaluated whether exposure to a pediatric clinic visit was associated with subsequent influenza-like illness (ILI). METHODS: Using electronic health record data, we conducted a retrospective cohort study of all children aged <6 years who presented to a provider in a 29-clinic pediatric primary care network for a non-ILI-related encounter over 2 respiratory virus seasons (September 1, 2012, to April 30, 2014). We defined a risk period for potential healthcare-associated (HA) ILI of 1 to 8 days after a non-ILI clinic visit and identified all cases of ILI to compare the incidences of ILI visits 1 to 8 days after a non-ILI encounter and those of visits >8 days after a non-ILI encounter. RESULTS: Among 149987 children <6 years of age (mean age, 2.5 years) with ≥1 non-ILI visit during the study period, 531928 total encounters and 13951 (2.9%) ILI encounters were identified; 1941 (13.9%) occurred within the HA-ILI risk window. The incidence rate ratios (IRRs) for ILI 1 to 8 days after compared with ILI >8 days after a non-ILI visit during season 1 were 1.36 (95% confidence interval, 1.22-1.52) among children ≥2 years of age and 1.01 (95% confidence interval, 0.93-1.09) among children <2 years of age. Estimates remained consistent during season 2 and with a risk window of 3, 4, or 9 days. CONCLUSIONS: Pediatric clinic visits during a respiratory virus season were significantly associated with an increased incidence of subsequent ILI among children aged 2 to 6 years but not among those aged <2 years. These findings support the hypothesis that respiratory virus transmission in a pediatric clinic can result in HA ILI in young children.

Electronic health record (EHR) based postmarketing surveillance of adverse events associated with pediatric off-label medication use: A case study of short-acting beta-2 agonists and arrhythmias.

PURPOSE: Use electronic health record (EHR) data to (1) estimate the risk of arrhythmia associated with inhaled short-acting beta-2 agonists (SABA) in pediatric patients and (2) determine whether risk varied by on-label versus off-label prescribing. METHODS: Retrospective cohort study of 335 041 children ≤18 years using EHR primary care data from 2 pediatric health systems (2011-2013). A series of monthly pseudotrials were created, using propensity score methodology to balance baseline characteristics between SABA-exposed (identified by prescription) and SABA-unexposed children. Association between SABA and subsequent arrhythmia for each health system was estimated through pooled logistic regression with separate estimates for children initiating under and over 4 years old (off-label and on-label, respectively). RESULTS: Eleven percent of the cohort received a SABA prescription, 57% occurred under the age of 4 years (off-label). During the follow-up period, there were 283 first arrhythmia events, most commonly atrial tachyarrhythmias and premature ventricular/atrial contractions. In 1 health system, adjusted risk for arrhythmia was increased among exposed children (OR 1.89, 95% CI 1.31-2.73) without evidence of interaction between label status and risk. The absolute adjusted rate difference was 3.6/10 000 person-years of SABA exposure. The association between SABA exposure and arrhythmias was less strong in the second system (OR 1.26, 95% CI 0.30-5.33). CONCLUSION: Using EHR data, we could estimate the risk of a rare event associated with medication use and determine difference in risk related to on-label versus off-label status. These findings support the value of EHR-based data for postmarketing drug studies in the pediatric population.

A Toddler Parenting Intervention in Primary Care for Caregivers With Depression Symptoms.

Caregiver depression impacts parenting behaviors and has deleterious effects on child behavior. Evidence-based interventions to address parenting have not been adapted for use with depressed caregivers in pediatric primary care settings. Our study examined the feasibility and explored outcomes of an evidence-based parenting program implemented in primary care and adapted for caregivers with depressive symptoms caring for toddlers. We conducted a randomized controlled trial with a wait-list control. Participants were caregivers who screened positive for depressive symptoms in pediatric settings with a toddler. Our study was implemented from July 2011 to June 2012. We adapted the Incredible Years Parents, Babies and Toddlers program with the addition of depression psychoeducation (12 weekly sessions), and assessed caregivers at baseline and immediately post-intervention. We assessed participation rates, depressive symptoms, parenting discipline practices, social support, and parenting stress. Our results revealed that 32 caregivers participating in the intervention group had significantly greater improvement in self-reported parenting discipline practices compared to the 29 wait-list control group caregivers. We found no differences between groups in depressive symptoms, social support, or parenting stress. Our study demonstrated that the average attendance was poor (mean attendance = 3.7 sessions). We adapted an evidence-based parenting intervention for caregivers with depressive symptoms and toddlers in primary care; however, participation was challenging. Alternative intervention strategies are needed to reach and retain low-income caregivers with depression symptoms as they face multiple barriers to participation in groups within center-based services. Trial Registration Clinical Trials.gov identifier NCT01464619.

Intravenous Versus Oral Antibiotics for the Prevention of Treatment Failure in Children With Complicated Appendicitis: Has the Abandonment of Peripherally Inserted Catheters Been Justified?

OBJECTIVE: To compare treatment failure leading to hospital readmission in children with complicated appendicitis who received oral versus intravenous antibiotics after discharge. BACKGROUND: Antibiotics are often employed after discharge to prevent treatment failure in children with complicated appendicitis, although existing studies comparing intravenous and oral antibiotics for this purpose are limited. METHODS: We identified all patients aged 3 to 18 years undergoing appendectomy for complicated appendicitis, who received postdischarge antibiotics at 35 childrens hospitals from 2009 to 2012. Discharge codes were used to identify study subjects from the Pediatric Health Information System database, and chart review confirmed eligibility, treatment assignment, and outcomes. Exposure status was based on outpatient antibiotic therapy, and analysis used optimal and full matching methods to adjust for demographic and clinical characteristics. Treatment failure (defined as an organ-space infection) requiring inpatient readmission was the primary outcome. Secondary outcomes included revisits from any cause to either the inpatient or emergency department setting. RESULTS: In all, 4579 patients were included (median: 99/hospital), and utilization of intravenous antibiotics after discharge ranged from 0% to 91.7% across hospitals. In the matched analysis, the rate of treatment failure was significantly higher for the intravenous group than the oral group [odds ratio (OR) 1.74, 95% confidence interval (CI) 1.05-2.88; risk difference: 4.0%, 95% CI 0.4-7.6%], as was the rate of all-cause revisits (OR 2.11, 95% CI 1.44-3.11; risk difference: 9.4%, 95% CI 4.7-14.2%). The rate of peripherally inserted central catheter line complications was 3.2% in the intravenous group, and drug reactions were rare in both groups (intravenous: 0.7%, oral: 0.5%). CONCLUSIONS: Compared with oral antibiotics, use of intravenous antibiotics after discharge in children with complicated appendicitis was associated with higher rates of both treatment failure and all-cause hospital revisits.

Intravenous Versus Oral Antibiotics for Postdischarge Treatment of Complicated Pneumonia.

BACKGROUND AND OBJECTIVES: Postdischarge treatment of complicated pneumonia includes antibiotics administered intravenously via a peripherally inserted central venous catheter (PICC) or orally. Antibiotics administered via PICC, although effective, may result in serious complications. We compared the effectiveness and treatment-related complications of postdischarge antibiotics delivered by these 2 routes. METHODS: This multicenter retrospective cohort study included children ≥2 months and <18 years discharged with complicated pneumonia between 2009 and 2012. The main exposure was the route of postdischarge antibiotic administration, classified as PICC or oral. The primary outcome was treatment failure. Secondary outcomes included PICC complications, adverse drug reactions, other related revisits, and a composite of all 4 outcomes, termed "all related revisits." RESULTS: Among 2123 children, 281 (13.2%) received antibiotics via PICC. Treatment failure rates were 3.2% among PICC and 2.6% among oral antibiotic recipients and were not significantly different between the groups in across-hospital-matched analysis (matched odds ratio [OR], 1.26; 95% confidence interval [CI], 0.54 to 2.94). PICC complications occurred in 7.1%. Adverse drug reactions occurred in 0.6% of children; PICC antibiotic recipients had greater odds of adverse drug reaction in across hospital matched analysis (matched OR, 19.1; 95% CI, 4.2 to 87.3). The high rate of PICC complications and differences in adverse drug reactions contributed to higher odds of the composite outcome of all related revisits among PICC antibiotic recipients (matched OR, 4.71; 95% CI, 2.97 to 7.46). CONCLUSIONS: Treatment failure rates between PICC and oral antibiotics did not differ. Children with complicated pneumonia should preferentially receive oral antibiotics at discharge when effective oral options are available.