An informed approach to the development of primary care pediatric firearm safety messages.

BACKGROUND: Firearm ownership is prevalent in the US and many children spend time in areas where firearms are not stored safely. The AAP recommends firearm safety counseling at pediatric well-visits. METHODS: We developed and tested six contextual messages to promote safe firearm storage based on: absence of harm, collective appeal to understanding child behavior, pediatrician's authority, evidence-based, fear appeal, and general safety considerations. One hundred four parents who keep firearms at home were recruited from Amazon Mechanical Turk Prime and viewed video messages and reported behavioral intentions and emotional reactions following each message. RESULTS: All six contextual messages were perceived as important and believable and increased parents' intentions to follow safety advice provided, but also elicited negative emotions. The authority message elicited more negative emotions and resulted in lower intentions to follow safe storage advice. CONCLUSIONS: Including firearm messages with other child safety advice merits further evaluation. Authority messages should be avoided.

The Third Rail of Pediatric Communication: Discussing Firearm Risk and Safety in Well-Child Exams.

This research endeavors to understand how pediatricians and parents discuss - or do not discuss - firearm risks for children during well-child visits. Through individual semi-structured interviews with 16 pediatric providers and 20 parents, the research explores discursive barriers to open conversation, perspectives on anticipatory guidance, and new ideas for culturally competent messaging. The research focuses particularly on how parents' and providers' perspectives on firearm risk communication are tied to cultural norms and expectations. One salient theme that emerged is that the American Academy of Pediatrics recommendation that pediatricians ask parents about ownership status is deemed undesirable by pediatricians and parents because of the delicate intercultural setting. Born out of pediatric and parent experiences, and mindful of culturally salient barriers, this study offers alternative strategies for discussing firearm risk in well-child exams.

Barriers and facilitators to HPV vaccination in primary care practices: a mixed methods study using the Consolidated Framework for Implementation Research.

BACKGROUND: In the United States, the effective, safe huma papilloma virus (HPV) vaccine is underused and opportunities to prevent cancer continue to be missed. National guidelines recommend completing the 2-3 dose HPV vaccine series by age 13, well before exposure to the sexually transmitted virus. Accurate characterization of the facilitators and barriers to full implementation of HPV vaccine recommendations in the primary care setting could inform effective implementation strategies. METHODS: We used the Consolidated Framework for Implementation Research (CFIR) to systematically investigate and characterize factors that influence HPV vaccine use in 10 primary care practices (16 providers) using a concurrent mixed methods design. The CFIR was used to guide collection and analysis of qualitative data collected through in-person semi-structured interviews with the primary care providers. We analyzed HPV vaccine use with data abstracted from medical charts. Constructs that most strongly influenced vaccine use were identified by integrating the qualitative and quantitative data. RESULTS: Of the 72 CFIR constructs assessed, seven strongly distinguished and seven weakly distinguished between providers with higher versus lower HPV vaccine coverage. The majority of strongly distinguishing constructs were facilitators and were related to characteristics of the providers (knowledge and beliefs; self-efficacy; readiness for change), their perception of the intervention (relative advantage of vaccinating younger vs. older adolescents), and their process to deliver the vaccine (executing). Additional weakly distinguishing constructs that were facilitators were from outer setting (peer pressure; financial incentives), inner setting (networks and communications and readiness for implementation) and process (planning; engaging, and reflecting and evaluating). Two strongly distinguishing constructs were barriers to use, one from the intervention (adaptability of the age of initiation) and the other from outer setting (patient needs and resources). CONCLUSIONS: Using CFIR to systematically examine the use of this vaccine in independent primary care practices enabled us to identify facilitators and barriers at the provider, interpersonal and practice level that need to be addressed in future efforts to increase vaccine use in such settings. Our findings suggest that implementation strategies that target the provider and help them to address multi-level barriers to HPV vaccine use merit further investigation.

Characteristics of youth agreeing to electronic sexually transmitted infection risk assessment in the emergency department.

OBJECTIVES: Adolescents and young adults are at high risk for sexually transmitted infections (STIs). We previously reported an increase in STI testing of adolescents in our ED by obtaining a sexual history using an Audio-enhanced Computer-Assisted Self-Interview (ACASI). We now examine associations among demographics, sexual behaviour, chief complaint and willingness to be tested. METHODS: This was a prospective study conducted in a paediatric ED between April and December 2011. After triage, eligible patients between 15 and 21 years presenting with non-life-threatening conditions were asked to participate in the study. Consenting participants used an ACASI to provide their demographic data and answer questions about their sexual history and willingness to be tested. Our primary outcome was the association of demographics, chief complaint and ACASI recommendation with the participant's willingness to be tested. RESULTS: We approached 1337 patients, of whom 800 (59%) enrolled and completed the ACASI. Eleven who did not answer questions related to their sexual history were excluded from analysis. Of 789 participants, 461 (58.4%) were female and median age was 16.9 years (IQR 16.0-17.8); 509 (64.5%) endorsed a history of anal, oral and/or vaginal intercourse. Disclosing a sexual history and willingness to be tested did not differ significantly by gender. 131 (16.6%) had a chief complaint potentially referable to an STI; among the 658 participants with non-STI-related complaints, 412 (62.6%) were sexually active, many of whom disclosed risky behaviours, including multiple partners (46.4%) and inconsistent condom use (43.7%). The ACASI identified 419 patients as needing immediate STI testing; the majority (81%) did not have a chief complaint potentially related to STIs. 697 (88.3%) participants were willing to receive STI testing. Most (94.6%) of the patients with STI-related complaints were willing to be tested, and 92.1% of patients with a recommendation for immediate testing by the ACASI indicated a willingness to be tested. CONCLUSIONS: Adolescents were willing to disclose sexual activity via electronic questionnaires and were willing to receive STI testing, even when their chief complaint was not STI related. The ACASI facilitated identification of adolescent ED patients needing STI testing regardless of chief complaint.

What Are Parents Willing to Discuss with Their Pediatrician About Firearm Safety? A Parental Survey.

OBJECTIVE: To determine if parents are receptive to discussing firearm safety with their pediatrician. STUDY DESIGN: Parents completed a self-administered paper survey during a pediatric office visit. Responses of those who confirmed and denied household firearms were compared using Fisher exact test. RESULTS: Between March 23 and May 21, 2015, 1246 of 1363 eligible parents (91.4%) completed the survey (22.6% African American, 79.5% at least some college education); 36% of respondents reported household firearms (owners). An additional 14.3% reported that their child was often in homes that contained firearms. Of the 447 owners, 25.1% reported ≥1 firearm was stored loaded, and 17.9% carried a firearm when leaving the house. Seventy-five percent of parents thought the pediatrician should advise about safe storage of firearms (owners 71.1%, others 77.5%), 16.9% disagreed (owners 21.9%, others 13.4%), and 8.2% were uncertain. Sixty-six percent thought pediatricians should ask about the presence of household firearms (owners 58.4%, others 70.9%), 23.2% disagreed (owners 31.5%, others 17.8%), and 10.5% were uncertain. Differences in parental opinions between owners and other parents were statistically significant. Twenty-two percent of owners would ignore advice to not have household firearms for safety reasons, and 13.9% would be offended by such advice. Only 12.8% of all parents reported a discussion about firearms with the pediatrician. CONCLUSIONS: Avoiding direct questioning about firearm ownership and extending the discussion about why and how to ensure safe storage of firearms to all parents may be an effective strategy to decrease firearm-related injuries and fatalities in children.

A cluster-randomized trial shows telephone peer coaching for parents reduces children's asthma morbidity.

BACKGROUND: Childhood asthma morbidity remains significant, especially in low-income children. Most often, asthma management is provided by the child's primary care provider. OBJECTIVE: We sought to evaluate whether enhancing primary care management for persistent asthma with telephone-based peer coaching for parents reduced asthma impairment and risk in children 3 to 12 years old. METHODS: Over 12 months, peer trainers provided parents with asthma management training by telephone (median, 18 calls) and encouraged physician partnership. The intervention was evaluated in a cluster-randomized trial of 11 intervention and 11 usual care pediatric practices (462 and 486 families, respectively). Patient outcomes were assessed by means of telephone interviews at 12 and 24 months conducted by observers blinded to intervention assignment and compared by using mixed-effects models, controlling for baseline values and clustering within practices. In a planned subgroup analysis we examined the heterogeneity of the intervention effect by insurance type (Medicaid vs other). RESULTS: After 12 months, intervention participation resulted in 20.9 (95% CI, 9.1-32.7) more symptom-free days per child than in the control group, and there was no difference in emergency department (ED) visits. After 24 months, ED visits were reduced (difference in mean visits/child, -0.28; 95% CI, -0.5 to -0.02), indicating a delayed intervention effect. In the Medicaid subgroup, after 12 months, intervention participation resulted in 42% fewer ED visits (difference in mean visits/child, -0.50; 95% CI, -0.81 to -0.18) and 62% fewer hospitalizations (difference in mean hospitalizations/child, -0.16; 95% CI, -0.30 to -0.014). Reductions in health care use endured through 24 months. CONCLUSIONS: This pragmatic telephone-based peer-training intervention reduced asthma impairment. Asthma risk was reduced in children with Medicaid insurance.

HIV and Sexually Transmitted Infection Testing Among High-Risk Youths: Supporting Positive Opportunities With Teens (SPOT) Youth Center.

OBJECTIVES: We investigated the development of and service utilization at Supporting Positive Opportunities with Teens (SPOT)-a community-based health and social service facility in St. Louis, Missouri, for youths that focuses on increasing HIV and sexually transmitted infection (STI) testing. METHODS: We identified the US-based, co-located youth health and social service models that guided the establishment of the SPOT. We analyzed the first 5 years (2008-2013) of service delivery and utilization data. RESULTS: During the study period, the SPOT provided services for 8233 youths in 37,480 visits. The 5 most utilized services included HIV and STI screening, food, transportation, contraception, and case management. A total of 9812 gonorrhea and chlamydia screenings revealed 1379 (14.1%) cases of chlamydia and 437 (4.5%) cases of gonorrhea, and 5703 HIV tests revealed 59 HIV infections (1.0%); 93.0% of patients found to have an STI were treated within a 5-day window. CONCLUSIONS: Co-locating health and social services in informal community settings attracts high-risk youths to utilize services and can prove instrumental in reducing STI burden in this population.

Computerized self-interviews improve Chlamydia and gonorrhea testing among youth in the emergency department.

STUDY OBJECTIVE: National guidelines recommend annual Chlamydia trachomatis and Neisseria gonorrhoeae screening for sexually active youth at risk for infection. These infections have serious sequelae in women if untreated, and methods to improve testing are needed. We hypothesize that an electronic method of identifying at-risk youth will significantly increase testing for these sexually transmitted infections during emergency department (ED) visits. METHODS: We developed an audio-enhanced computer-assisted self-interview (ACASI) to obtain sexual histories from ED patients and an embedded decision tree to create a sexually transmitted infection testing recommendation. ED health care providers were prompted by the electronic medical record to review the participant answers and testing recommendations, and to offer testing to at-risk youth. Patients aged 15 to 21 years and visiting the St. Louis Children's Hospital ED, regardless of complaint, were eligible for participation. RESULTS: Sexually transmitted infection testing among all 15- to 21-year-old ED patients increased from 9.3% in the 3 months before the ACASI to 17.8% during the 8-month period the ACASI was available and diminished to 12.4% in the 3 months after ACASI withdrawal (P<.001). During the ACASI period, we approached 51.4% of eligible patients and enrolled 59.8% (800/1,337) of those approached. Among ACASI participants, 52.4% (419/800) received a recommendation to receive sexually transmitted infection testing. Of these patients, 52.7% (221/419) received testing in the ED and 18.1% (40/221) of those tested had positive results for chlamydia or gonorrhea, 55% of whom (22/40) had chief complaints unrelated to sexually transmitted infections. Most participants (89%) rated the ACASI easy to use. CONCLUSION: Sexually transmitted infection testing in the ED significantly increased during ACASI use and diminished after withdrawal. The ACASI was well accepted by youth and holds promise for enhancing sexually transmitted infection testing in the ED.

Primary care visits for asthma monitoring over time and association with acute asthma visits for urban Medicaid-insured children.

OBJECTIVES: To examine the association between numbers of primary care provider (PCP) visits for asthma monitoring (AM) over time and acute asthma visits in the emergency department (ED) and at the PCP for Medicaid-insured children. METHODS: We prospectively enrolled 2-10 years old children during ED asthma visits. We audited hospital and PCP records for each subject for three consecutive years. We excluded subjects also receiving care from asthma subspecialists. PCP AM visits were those with documentation that suggested discussion of asthma management but no acute asthma symptoms or findings. PCP "Acute Asthma" visits were those with documentation of acute asthma symptoms or findings, regardless of treatment. ED asthma visits were those with documented asthma treatment. Generalized liner models were used to analyze the association between numbers of AM visits and acute asthma visits to the ED and PCP. RESULTS: One hundred three subjects were analyzed. Over the 3 years, the mean number of AM visits/child was 2.5 ± 2.3 (standard deviation), range 0-10. Only 50% of subjects had at least 1 PCP visit with an asthma controller medication documented. The mean number of ED asthma visits/child was 3.2 ± 2.8; range 1-18. The mean number of PCP Acute Asthma visits/child was 0.7 ± 1.6; range 0-11. Increasing AM visits was associated with more ED visits (estimate 0.088; 95% CI 0.001, 0.174), and more PCP Acute Asthma visits (estimate 0.297; 95% CI 0.166, 0.429). Increasing PCP visits for any diagnosis was not associated with ED visits (estimate 0.021; 95% CI -0.018, 0.06). CONCLUSIONS: Asthma monitoring visits and documented controller medication for these urban Medicaid-insured children occurred infrequently over 3 years, and having more asthma monitoring visits was not associated with fewer ED or PCP acute asthma visits.

Use of factor analysis models to evaluate measurement invariance property of the Asthma Control Questionnaire (ACQ).

PURPOSES: To demonstrate the assessment of measurement invariance property in a health status instrument and to increase the awareness of its importance, we evaluate the measurement invariance of the Asthma Control Questionnaire (ACQ) across age and gender subgroups. METHODS: Data are obtained from children 7-12 years of age at entry into a randomized trial, which evaluates the effect of a telephone coaching program on improving asthma outcome. Multi-group confirmatory factor analysis is used to assess the comparability of factor loadings and intercepts across age and gender subgroups. Since age is a continuous variable, two different categorizations (7-10 vs 11-12 and 7-9 vs 10-12) are analyzed. RESULTS: The factor loadings and intercepts of all six items in ACQ are comparable across gender subgroups. Although the factor loadings are comparable across age 7-10 and 11-12 subgroups, one intercept is statistically but not practically different. For age 7-9 versus 10-12 subgroup comparison, the factor loadings are not comparable. CONCLUSION: In children, the ACQ can be used to compare asthma control construct between boys and girls and between age 7-10 and 11-12 subgroups. Measurement invariance is an important property that should be examined when the latent construct(s) are compared across different subgroups.

Pediatric providers' attitudes toward retail clinics.

OBJECTIVE: To describe pediatric primary care providers' attitudes toward retail clinics and their experiences of retail clinics use by their patients. STUDY DESIGN: A 51-item, self-administered survey from 4 pediatric practice-based research networks from the midwestern US, which gauged providers' attitudes toward and perceptions of their patients' interactions with retail clinics, and changes to office practice to better compete. RESULTS: A total of 226 providers participated (50% response). Providers believed that retail clinics were a business threat (80%) and disrupted continuity of chronic disease management (54%). Few (20%) agreed that retail clinics provided care within recommended clinical guidelines. Most (91%) reported that they provided additional care after a retail clinic visit (median 1-2 times per week), and 37% felt this resulted from suboptimal care at retail clinics "most or all of the time." Few (15%) reported being notified by the retail clinic within 24 hours of a patient visit. Those reporting prompt communication were less likely to report suboptimal retail clinic care (OR 0.20, 95% CI 0.10-0.42) or disruption in continuity of care (OR 0.32, 95% CI 0.15-0.71). Thirty-six percent reported changes to office practice to compete with retail clinics (most commonly adjusting or extending office hours), and change was more likely if retail clinics were perceived as a threat (OR 3.70, 95% CI 1.56-8.76); 30% planned to make changes in the near future. CONCLUSIONS: Based on the perceived business threat, pediatric providers are making changes to their practice to compete with retail clinics. Improved communication between the clinic and providers may improve collaboration.

A telephone coaching intervention to improve asthma self-management behaviors.

Long recognizing that asthma, one of the most common chronic childhood diseases, is difficult to manage, the National Asthma Education Prevention Program developed clinical practice guidelines to assist health care providers, particularly those in the primary care setting. Yet, maintenance asthma care still fails to meet national standards. Therefore, in an attempt to improve and support asthma self-management behaviors for parents of children 5 to 12 years of age with persistent asthma, a novel nurse telephone coaching intervention was tested in a randomized, controlled trial. A detailed description of the intervention is provided along with parent satisfaction results, an overview of the training used to prepare the nurses, and a discussion of the challenges experienced and lessons learned.

Provider and Practice Factors Associated With On-Time HPV Vaccination in Primary Care.

BACKGROUND: In 2018, only one third of girls and boys completed the 2-dose series of the human papillomavirus vaccine by their 13th birthday, the target for on-time vaccination. The study objective was to identify key patient, provider and practice-level factors associated with on-time vaccination in the primary care setting. METHODS: We examined data from 20 primary care pediatric practices (89 providers) in St. Louis including: the percentage of eligible patients with on-time vaccination assessed from medical records; providers' knowledge, attitudes and behaviors regarding on-time vaccination assessed with a survey; and practice-level strategies used to optimize vaccine delivery assessed with a 19-item vaccine delivery system score (VDSS). Factors that increased on-time vaccination were identified using logistic regression, controlling for clustering within providers. RESULTS: Completion of on-time vaccination occurred in 1347/3125 (43.10%) of patients (95% confidence interval [CI], 41.36%-44.86%) and varied among practices (7.39%-64.24%) and among providers (2.63%-82.50%). Independent predictors for higher completion of on-time vaccination included more frequent use by providers of the announcement style for vaccine recommendation (odds ratio [OR] 1.18, 95% CI, 1.04, 1.35), higher provider self-efficacy to deliver the vaccine according to guideline recommendations if parents were hesitant (OR 1.21, 95% CI, 1.05, 1.40), and higher VDSS (OR 1.20, 95% CI, 1.10, 1.31). CONCLUSIONS: Provider and practice-level factors were identified that may represent modifiable targets for improvement in on-time vaccine uptake. Future research is needed to test interventions built on these findings.

Household versus individual approaches to eradication of community-associated Staphylococcus aureus in children: a randomized trial.

BACKGROUND: Community-associated Staphylococcus aureus infections often affect multiple members of a household. We compared 2 approaches to S. aureus eradication: decolonizing the entire household versus decolonizing the index case alone. METHODS: An open-label, randomized trial enrolled 183 pediatric patients (cases) with community-onset S. aureus skin abscesses and colonization of anterior nares, axillae, or inguinal folds from 2008 to 2009 at primary and tertiary centers. Participants were randomized to decolonization of the case alone (index group) or of all household members (household group). The 5-day regimen included hygiene education, twice-daily intranasal mupirocin, and daily chlorhexidine body washes. Colonization of cases and subsequent skin and soft tissue infection (SSTI) in cases and household contacts were ascertained at 1, 3, 6, and 12 months. RESULTS: Among 147 cases with 1-month colonization data, modified intention-to-treat analysis revealed S. aureus eradication in 50% of cases in the index group and 51% in the household group (P = 1.00). Among 126 cases completing 12-month follow-up, S. aureus was eradicated from 54% of the index group versus 66% of the household group (P = .28). Over 12 months, recurrent SSTI was reported in 72% of cases in the index group and 52% in the household group (P = .02). SSTI incidence in household contacts was significantly lower in the household versus index group during the first 6 months; this trend continued at 12 months. CONCLUSIONS: Household decolonization was not more effective than individual decolonization in eradicating community-associated S. aureus carriage from cases. However, household decolonization reduced the incidence of subsequent SSTI in cases and their household contacts. CLINICAL TRIALS REGISTRATION: NCT00731783.

Clinical outcomes after withdrawal of anti-tumor necrosis factor α therapy in patients with juvenile idiopathic arthritis: a twelve-year experience.

OBJECTIVE: To estimate the length of time to disease flare and the likelihood of achieving clinical remission after discontinuation of treatment with tumor necrosis factor α (TNFα) blockers in patients with juvenile idiopathic arthritis (JIA). METHODS: We conducted a retrospective chart review in a cohort of patients with JIA treated with TNFα inhibitors between January 1, 1998 and November 1, 2009. Demographic information, laboratory data, and medication exposure were extracted using a standardized tool. Outcomes of interest were based on preliminary criteria for remission in JIA. RESULTS: One hundred seventy-one patients with 255 discrete episodes of anti-TNFα treatment were reviewed. The median duration of patient observation was 59.7 months (range 5.8-211.2 months). Among patients in whom disease was inactive after discontinuation of anti-TNFα therapy, 50% had persistently inactive disease at 6 months, and 33% had clinical remission at 12 months. The median duration of anti-TNFα therapy after inactive disease was obtained was 6.1 months (range 0-67.9 months). No significant association was observed between the time to disease flare after cessation of treatment with TNFα antagonists and the length of time from the diagnosis of JIA to the initiation of anti-TNFα therapy, the duration of therapy following the onset of inactive disease, or the total duration of treatment with TNFα antagonists prior to discontinuation. The category of JIA, sex, and age at diagnosis were not associated with the risk of relapse. CONCLUSION: One-third of patients with JIA can successfully undergo withdrawal of treatment with TNFα antagonists and be spared the cost and potential morbidity of treatment for at least 12 months. Further studies are needed to identify factors to accurately identify these patients.

Partner randomized controlled trial: study protocol and coaching intervention.

BACKGROUND: Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. METHODS AND DESIGN: This paper describes the protocol for a randomized controlled trial (RCT) to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1) effective use of controller medications, 2) effective use of rescue medications and 3) monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1) the child's asthma control score, 2) the parent's quality of life score, and 3) the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications, having maintenance care visits at least twice a year, and an asthma action plan. Cost-effectiveness of the intervention was also measured. DISCUSSION: Twenty-two practices (66 physicians) were randomized (11 per treatment group), and 950 families with a child 3-12 years old with persistent asthma were enrolled. A description of the coaching intervention is presented.

Clinical and laboratory factors associated with negative oral food challenges.

Children with food-specific IgE (FSIgE) ≤2 kUa/L to milk, egg, or peanut (or ≤5kUa/L to peanut without history of previous reaction) are appropriate candidates for oral food challenge (OFC) to investigate resolution of food allergy, because these FSIgE cutoffs are associated with ∼50% likelihood of negative OFC. This study was designed to identify characteristics of children undergoing OFC, based on these FSIgE levels, who are most likely to show negative OFC. We collected demographics, severity of previous reaction, history of atopic diseases, total IgE and FSIgE values, and skin tests results on children who underwent OFCs to milk, egg, or peanut, based on the recommended FSIgE cutoffs. We identified independent factors associated with negative OFCs. Four hundred forty-four OFCs met our inclusion criteria. The proportions of negative OFCs performed based on FSIgE cutoffs alone were 58, 42, and 63% to milk, egg, and peanuts, respectively. Regression models identified independent factors associated with negative OFCs: lower FSIgE levels (all three foods), higher total IgE (milk), consumption of baked egg products (egg), and non-Caucasian race (eggs and peanuts). Combinations of these factors identified subgroups of children with proportions of negative OFCs of 83, 75, and 75% for milk, eggs, and peanuts, respectively. Combinations of clinical and laboratory elements, together with FSIgE values, might identify more children who are likely to have negative OFCs compared with current recommendations using FSIgE values alone. Once validated in a different population, these factors might be used for selection of patients who are most likely to show negative OFCs.

Amoxicillin for acute rhinosinusitis: a randomized controlled trial.

CONTEXT: Evidence to support antibiotic treatment for acute rhinosinusitis is limited, yet antibiotics are commonly used. OBJECTIVE: To determine the incremental effect of amoxicillin treatment over symptomatic treatments for adults with clinically diagnosed acute rhinosinusitis. DESIGN, SETTING, AND PARTICIPANTS: A randomized, placebo-controlled trial of adults with uncomplicated, acute rhinosinusitis were recruited from 10 community practices in Missouri between November 1, 2006, and May 1, 2009. INTERVENTIONS: Ten-day course of either amoxicillin (1500 mg/d) or placebo administered in 3 doses per day. All patients received a 5- to 7-day supply of symptomatic treatments for pain, fever, cough, and nasal congestion to use as needed. MAIN OUTCOME MEASURES: The primary outcome was improvement in disease-specific quality of life after 3 to 4 days of treatment assessed with the Sinonasal Outcome Test-16 (minimally important difference of 0.5 units on a 0-3 scale). Secondary outcomes included the patient's retrospective assessment of change in sinus symptoms and functional status, recurrence or relapse, and satisfaction with and adverse effects of treatment. Outcomes were assessed by telephone interview at days 3, 7, 10, and 28. RESULTS: A total of 166 adults (36% male; 78% with white race) were randomized to amoxicillin (n = 85) or placebo (n = 81); 92% concurrently used 1 or more symptomatic treatments (94% for amoxicillin group vs 90% for control group; P = .34). The mean change in Sinonasal Outcome Test-16 scores was not significantly different between groups on day 3 (decrease of 0.59 in the amoxicillin group and 0.54 in the control group; mean difference between groups of 0.03 [95% CI, -0.12 to 0.19]) and on day 10 (mean difference between groups of 0.01 [95% CI, -0.13 to 0.15]), but differed at day 7 favoring amoxicillin (mean difference between groups of 0.19 [95% CI, 0.024 to 0.35]). There was no statistically significant difference in reported symptom improvement at day 3 (37% for amoxicillin group vs 34% for control group; P = .67) or at day 10 (78% vs 80%, respectively; P = .71), whereas at day 7 more participants treated with amoxicillin reported symptom improvement (74% vs 56%, respectively; P = .02). No between-group differences were found for any other secondary outcomes. No serious adverse events occurred. CONCLUSION: Among patients with acute rhinosinusitis, a 10-day course of amoxicillin compared with placebo did not reduce symptoms at day 3 of treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00377403.

Chatbot-Delivered Cognitive Behavioral Therapy in Adolescents With Depression and Anxiety During the COVID-19 Pandemic: Feasibility and Acceptability Study.

BACKGROUND: Symptoms of depression and anxiety, suicidal ideation, and self-harm have escalated among adolescents to crisis levels during the COVID-19 pandemic. As a result, primary care providers (PCPs) are often called on to provide first-line care for these youth. Digital health interventions can extend mental health specialty care, but few are evidence based. We evaluated the feasibility of delivering an evidence-based mobile health (mHealth) app with an embedded conversational agent to deliver cognitive behavioral therapy (CBT) to symptomatic adolescents presenting in primary care settings during the pandemic. OBJECTIVE: In this 12-week pilot study, we evaluated the feasibility of delivering the app-based intervention to adolescents aged 13 to 17 years with moderate depressive symptoms who were treated in a practice-based research network (PBRN) of academically affiliated primary care clinics. We also obtained preliminary estimates of app acceptability, effectiveness, and usability. METHODS: This small, pilot randomized controlled trial (RCT) evaluated depressive symptom severity in adolescents randomized to the app or to a wait list control condition. The primary end point was depression severity at 4-weeks, measured by the 9-item Patient Health Questionnaire (PHQ-9). Data on acceptability, feasibility, and usability were collected from adolescents and their parent or legal guardian. Qualitative interviews were conducted with 13 PCPs from 11 PBRN clinics to identify facilitators and barriers to incorporating mental health apps in treatment planning for adolescents with depression and anxiety. RESULTS: The pilot randomized 18 participants to the app (n=10, 56%) or to a wait list control condition (n=8, 44%); 17 participants were included in the analysis, and 1 became ineligible upon chart review due to lack of eligibility based on documented diagnosis. The overall sample was predominantly female (15/17, 88%), White (15/17, 88%), and privately insured (15/17, 88%). Mean PHQ-9 scores at 4 weeks decreased by 3.3 points in the active treatment group (representing a shift in mean depression score from moderate to mild symptom severity categories) and 2 points in the wait list control group (no shift in symptom severity category). Teen- and parent-reported usability, feasibility, and acceptability of the app was high. PCPs reported preference for introducing mHealth interventions like the one in this study early in the course of care for individuals presenting with mild or moderate symptoms. CONCLUSIONS: In this small study, we demonstrated the feasibility, acceptability, usability, and safety of using a CBT-based chatbot for adolescents presenting with moderate depressive symptoms in a network of PBRN-based primary care clinics. This pilot study could not establish effectiveness, but our results suggest that further study in a larger pediatric population is warranted. Future study inclusive of rural, socioeconomically disadvantaged, and underrepresented communities is needed to establish generalizability of effectiveness and identify implementation-related adaptations needed to promote broader uptake in pediatric primary care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04603053; https://clinicaltrials.gov/ct2/show/NCT04603053.