Overcoming challenges in the changing environment of practice-based research.

PURPOSE: Conducting studies in national practice-based research networks presents logistic and methodologic challenges. Pediatric Research in Office Settings (PROS) has learned valuable lessons in implementing new strategies and adapting to challenges. We describe practical challenges and results of novel applied strategies in implementing and testing the Clinical Effort Against Secondhand Smoke Exposure (CEASE) intervention as part of a national-level cluster-randomized controlled trial. METHODS: In the trial, 20 PROS practices were randomized to either a CEASE intervention arm or a control arm. Parents of children seen in the office who indicated smoking in the past 7 days were asked to complete a postvisit enrollment interview and telephone interviews 3 and 12 months later. Identified challenges included (1) recruiting 20 practices serving a high percentage of parent smokers; (2) screening all parents bringing children for visits and enrolling eligible parents who smoked; and (3) achieving an acceptable 12-month telephone response rate. RESULTS: A total of 47 interested practices completed the Practice Population Survey, of which 20 practices in 16 states completed parent enrollment. Thirty-two research assistants screened 18,607 parents and enrolled 1,980 of them. The initial telephone interview response rate was 56% at 12 months, with incorrect and disconnected numbers accounting for nearly 60% of nonresponses. The response rate rose to 67% after practices supplied 532 new contact numbers and 754 text messages were sent, with 389 parents completing interviews. CONCLUSION: The strategies we used to overcome methodologic barriers in conducting a national intervention trial allowed data collection to be completed in the office setting and increased the telephone interview response rate.

Unreadiness for postpartum discharge following healthy term pregnancy: impact on health care use and outcomes.

OBJECTIVE: To document the association between a lack of readiness, termed "unreadiness," for postpartum discharge and the health of mothers and their term newborns. METHODS: Prospective observational cohort study of 4300 mother-infant dyads in a national, pediatric, practice-based research network. The association between unreadiness for discharge and health care use, health-related behaviors, and health outcomes was analyzed by the use of bivariate, multivariate linear, and logistic models. RESULTS: Sixteen percent of mother-infant dyads were unready for discharge. Unreadiness was significantly associated with maternal and infant health care use and health outcomes but not independently associated with health-related behaviors. In multivariable analyses, after we controlled for important covariates and confounders, unready dyads had more calls to health care providers than ready dyads (13.3% increase for mothers, P = .01; 18.7% increase for infants, P < .01) during the first 2 weeks after discharge. In this same time frame, unready dyads also had more symptom days (8.5% increase for mothers, P < .01; 8.7% increase for infants, P < .01). Unready mothers had lower mean physical (5.0% decrease, P < .01) and mental (4.4% decrease, P < .01) health status scores at 4 weeks after discharge. CONCLUSIONS: Unreadiness at postpartum discharge was associated with increased health care use and poorer health outcomes in the first 2 to 4 weeks after discharge. Discharge plans should be individualized and jointly tailored to a family's needs rather than to a set timescale.

Effects of local institutional review board review on participation in national practice-based research network studies.

OBJECTIVE: To describe the process and outcomes of local institutional review board (IRB) review for 2 Pediatric Research in Office Settings (PROS) studies. DESIGN: Pediatric Research in Office Settings conducted 2 national studies concerning sensitive topics: (1) Child Abuse Recognition Experience Study (CARES), an observational study of physician decision making, and (2) Safety Check, a violence prevention intervention trial. Institutional review board approval was secured by investigators' sites, the American Academy of Pediatrics, and practices with local IRBs. Practices were queried about IRB rules at PROS enrollment and study recruitment. SETTING: Pediatric Research in Office Settings practices in 29 states. PARTICIPANTS: Eighty-eight PROS practices (75 IRBs). Main Exposure Local IRB presence. MAIN OUTCOME MEASURES: Local IRB presence, level of PROS assistance, IRB process, study participation, data collection completion, and minority enrollment. RESULTS: Practices requiring additional local IRB approval agreed to participate less than those that did not (CARES: 33% vs 52%; Safety Check: 41% vs 56%). Of the 88 practices requiring local IRB approval, 55 received approval, with nearly 50% needing active PROS help, many requiring consent changes (eg, contact name additions, local IRB approval stamps), and 87% beginning data collection. Median days to obtain approval were 81 (CARES) and 109 (Safety Check). Practices requiring local IRB approval were less likely to complete data collection but more likely to enroll minority patients. CONCLUSIONS: Local IRB review was associated with lower participation rates, substantial effort navigating the process (with approval universally granted without substantive changes), and data collection delays. When considering future reforms, the national human subject protections system should consider the potential redundancy and effect on generalizability, particularly regarding enrollment of poor urban children, related to local IRB review.

Office-based treatment and outcomes for febrile infants with clinically diagnosed bronchiolitis.

OBJECTIVES: The goals were to describe the (1) frequency of sepsis evaluation and empiric antibiotic treatment, (2) clinical predictors of management, and (3) serious bacterial illness frequency for febrile infants with clinically diagnosed bronchiolitis seen in office settings. METHODS: The Pediatric Research in Office Settings network conducted a prospective cohort study of 3066 febrile infants (<3 months of age with temperatures >or=38 degrees C) in 219 practices in 44 states. We compared the frequency of sepsis evaluation, parenteral antibiotic treatment, and serious bacterial illness in infants with and without clinically diagnosed bronchiolitis. We identified predictors of sepsis evaluation and parenteral antibiotic treatment in infants with bronchiolitis by using logistic regression models. RESULTS: Practitioners were less likely to perform a complete sepsis evaluation, urine testing, and cerebrospinal fluid culture and to administer parenteral antibiotic treatment for infants with bronchiolitis, compared with those without bronchiolitis. Significant predictors of sepsis evaluation in infants with bronchiolitis included younger age, higher maximal temperature, and respiratory syncytial virus testing. Predictors of parenteral antibiotic use included initial ill appearance, age of <30 days, higher maximal temperature, and general signs of infant distress. Among infants with bronchiolitis (N = 218), none had serious bacterial illness and those with respiratory distress signs were less likely to receive parenteral antibiotic treatment. Diagnoses among 2848 febrile infants without bronchiolitis included bacterial meningitis (n = 14), bacteremia (n = 49), and urinary tract infection (n = 167). CONCLUSIONS: In office settings, serious bacterial illness in young febrile infants with clinically diagnosed bronchiolitis is uncommon. Limited testing for bacterial infections seems to be an appropriate management strategy.

Is office-based counseling about media use, timeouts, and firearm storage effective? Results from a cluster-randomized, controlled trial.

OBJECTIVE: The objective of this study was to determine whether patients' families' violence-prevention behaviors would be affected by their primary care practitioner's use of a violence-prevention clinical intervention during the routine well-child examination. METHODS: In this cluster-randomized, controlled trial (2002-2006), 137 Pediatric Research in Office Settings practices were randomly assigned and initiated patient recruitment for either an office-based violence-prevention intervention or a control group (educational handout on literacy promotion provided). Primary caregivers of children who were aged 2 to 11 years and presented for a well-child visit were surveyed at baseline and 1 and 6 months. Practitioners were trained to (1) review a parent previsit summary regarding patient-family behavior and parental concern about media use, discipline strategies, and children's exposure to firearms, (2) counsel using brief principles of motivational interviewing, (3) identify and provide local agency resources for anger and behavior management when indicated, and (4) instruct patient-families on use of tangible tools (minute timers to monitor media time/timeouts and firearm cable locks to store firearms more safely where children live or play). Main outcomes were change over time in self-reported media use <120 minutes per day, use of timeouts, and use of firearm cable locks. RESULTS: Generalized estimating equation analysis revealed a significant effect at 6 months for decreased media use and safer firearm storage. The intervention group compared with the control group showed an increase in limiting media use to <120 minutes per day. There was no significant effect for timeout use. There was a substantial increase in storing firearms with cable locks for the intervention group versus a decrease for the control group. CONCLUSIONS: This randomized, controlled trial demonstrated decreased media exposure and increased safe firearm storage as a result of a brief office-based violence-prevention approach.

Practice-based research network solutions to methodological challenges encountered in a national, prospective cohort study of mothers and newborns.

The emergence of practice-based research networks (PBRN) has facilitated the execution of multifaceted community-based studies. As study complexity increases, so does the number of methodological barriers encountered. This paper's goal was to delineate methodological barriers and to evaluate the effectiveness of selected strategies and approaches developed and implemented in allowing a prospective, national PBRN cohort study to succeed in enrolling geographically dispersed mother/healthy term infant dyads (n = 4300) on the day of post-partum discharge. Specific methodological barriers included: (1) obtaining multiple Institutional Review Board (IRB) approvals; (2) gathering longitudinal data from multiple individuals; (3) soliciting multiple perspectives on discharge decision making; and (4) bolstering minority enrolment. The most effective strategies and approaches we employed to address these methodological challenges were: (1) preparing and distributing the 'IRB Packet'; (2) recruiting multiple practices covered by the same IRB; and (3) obtaining supplemental funding for increasing minority enrolment. We expect that other PBRN investigators can benefit from our experience and solutions in the successful conduct of this multifaceted community-based study.

Impact of pediatricians' perceived self-efficacy and confidence on violence prevention counseling: a national study.

OBJECTIVE: To measure impact of pediatricians' perceived self-efficacy and confidence on current practices and attitudes regarding four violence prevention (VP) topics (gun storage, gun removal, limiting exposure to media violence, discipline techniques) during health supervision for children ages 2-11. METHODS: Random sample survey of American Academy of Pediatrics Fellows (n = 486; 53% response rate) providing health supervision for children ages 2-11. Participants surveyed about VP issues regarding: (1) current counseling practices for 2-5 and 6-11 year olds; (2) amount of time spent addressing; (3) confidence in addressing; and (4) perceived self-efficacy at changing patients' behaviors. Multivariate analyses explored relationships between pediatricians' perceived self-efficacy and confidence versus VP counseling frequency. RESULTS: VP topics were not routinely discussed during health supervision. Most pediatricians (64%) reported spending too little time addressing these topics. Although most pediatricians felt confident discussing and effective at changing behaviors regarding limiting exposure to media violence (89% vs. 50%) and discipline techniques (91% vs. 76%), they were less so for safe gun storage (54% vs. 35%) and gun removal (51% vs. 17%). Perceived self-efficacy was the mediating factor on self-reported VP counseling frequencies for all topics. CONCLUSIONS: Pediatricians reported spending insufficient time on VP counseling. Confidence and perceived self-efficacy levels varied by VP topic, but for all topics pediatricians felt more confident discussing than effective at changing behaviors. Since pediatricians' self-efficacy was related to counseling practices, boosting self-efficacy could ultimately improve counseling frequencies. Further research is needed to identify methods to build providers' perceived self-efficacy regarding these VP areas.

Does clinical presentation explain practice variability in the treatment of febrile infants?

BACKGROUND: Previous studies documented considerable variability in the treatment of febrile infants, despite the existence of practice guidelines for this condition. None of those studies documented the extent to which this variability is accounted for by differences in clinical severity. OBJECTIVE: To quantify the individual effects of the patient's clinical presentation, demographic, provider, and practice characteristics, and regional variables on practice variability in the evaluation and treatment of febrile infants. METHODS: With data collected through the Pediatric Research in Office Settings network, we analyzed data on the treatment of 2712 febrile infants examined by 484 pediatricians located in 194 practices. We analyzed hospitalization, lumbar puncture, urinalysis and/or urine culture, blood work, and initial antibiotic administration. We obtained a summary score for evaluation and treatment intensity (ranging from no tests or treatments to comprehensive testing, hospitalization, and antibiotic therapy) by performing principal-components analysis with these 5 variables. This summary score was regressed with respect to patients' clinical presentation, demographic and practice/practitioner features, and geographic region. Provider fixed effects were also included in the model. RESULTS: Although the overall model explained 46.5% of the variance, the clinical characteristics of the patient alone explained 29.7% of the overall variance. Practice site fixed effects explained nearly 15% of the overall variance. Provider and practitioner characteristics and geographic region had minimal explanatory power. CONCLUSIONS: Our results show that measures of the patient's clinical presentation account for nearly one third of the variability that our model explains. This suggests that differences in clinical presentation and severity of illness underlie much of the observed practice variability among pediatricians evaluating and treating febrile infants. These findings demonstrate that the management of this common and potentially serious condition depends more on the clinical presentation of the patient than on the characteristics of the provider/practice and the residential region.

Choice of urine collection methods for the diagnosis of urinary tract infection in young, febrile infants.

BACKGROUND: The optimal method of urine collection in febrile infants is debatable; catheterization, considered more accurate, is technically difficult and invasive. OBJECTIVES: To determine predictors of urethral catheterization in febrile infants and to compare bag and catheterized urine test performance characteristics. DESIGN: Prospective analysis of infants enrolled in the Pediatric Research in Office Settings' Febrile Infant Study. SETTING: A total of 219 practices from within the Pediatric Research in Office Settings' network, including 44 states, the District of Columbia, and Puerto Rico. PATIENTS: A total of 3066 infants aged 0 to 3 months with temperatures of 38 degrees C or higher. MAIN OUTCOME MEASURES: We calculated adjusted odds ratios for predictors of catheterization. Diagnostic test characteristics were compared between bag and catheterization. Urinary tract infection was defined as pure growth of 100 000 CFU/mL or more (bag) and 20 000 CFU/mL or more (catheterization). RESULTS: Seventy percent of urine samples were obtained by catheterization. Predictors of catheterization included female sex, practitioner older than 40 years, Medicaid, Hispanic ethnicity, nighttime evaluation, and severe dehydration. For leukocyte esterase levels, bag specimens demonstrated no difference in sensitivity but somewhat lower specificity (84% [bag] vs 94% [catheterization], P<.001) and a lower area under the receiver operating characteristic curve for white blood cells (0.71 [bag] vs 0.86 [catheterization], P = .01). Infection rates were similar in bag and catheterized specimens (8.5% vs 10.8%). Ambiguous cultures were more common in bag specimens (7.4% vs 2.7%, P<.001), but 21 catheterized specimens are needed to avoid each ambiguous bag result. CONCLUSIONS: Most practitioners obtain urine from febrile infants via catheterization, but choice of method is not related to the risk of urinary tract infection. Although both urine cultures and urinalyses are more accurate in catheterized specimens, the magnitude of difference is small but should be factored into clinical decision making.

Management and outcomes of care of fever in early infancy.

CONTEXT: Fever in infants challenges clinicians in distinguishing between serious conditions, such as bacteremia or bacterial meningitis, and minor illnesses. To date, the practice patterns of office-based pediatricians in treating febrile infants and the clinical outcomes resulting from their care have not been systematically studied. OBJECTIVES: To characterize the management and clinical outcomes of fever in infants, develop a clinical prediction model for the identification of bacteremia/bacterial meningitis, and compare the accuracy of various strategies. DESIGN: Prospective cohort study. SETTING: Offices of 573 practitioners from the Pediatric Research in Office Settings (PROS) network of the American Academy of Pediatrics in 44 states, the District of Columbia, and Puerto Rico. PATIENTS: Consecutive sample of 3066 infants aged 3 months or younger with temperatures of at least 38 degrees C seen by PROS practitioners from February 28, 1995, through April 25, 1998. MAIN OUTCOME MEASURES: Management strategies, illness frequency, and rates and accuracy of treating bacteremia/bacterial meningitis. RESULTS: The PROS clinicians hospitalized 36% of the infants, performed laboratory testing in 75%, and initially treated 57% with antibiotics. The majority (64%) were treated exclusively outside of the hospital. Bacteremia was detected in 1.8% of infants (2.4% of those tested) and bacterial meningitis in 0.5%. Well-appearing infants aged 25 days or older with fever of less than 38.6 degrees C had a rate of 0.4% for bacteremia/bacterial meningitis. Frequency of other illnesses included urinary tract infection, 5.4%; otitis media, 12.2%; upper respiratory tract infection, 25.6%; bronchiolitis, 7.8%; and gastroenteritis, 7.2%. Practitioners followed current guidelines in 42% of episodes. However, in the initial visit, they treated 61 of the 63 cases of bacteremia/bacterial meningitis with antibiotics. Neither current guidelines nor the model developed in this study performed with greater accuracy than observed practitioner management. CONCLUSIONS: Pediatric clinicians in the United States use individualized clinical judgment in treating febrile infants. In this study, relying on current clinical guidelines would not have improved care but would have resulted in more hospitalizations and laboratory testing.

Urine testing and urinary tract infections in febrile infants seen in office settings: the Pediatric Research in Office Settings' Febrile Infant Study.

OBJECTIVE: To determine the predictors and results of urine testing of young febrile infants seen in office settings. DESIGN: Prospective cohort study. SETTING: Offices of 573 pediatric practitioners from 219 practices in the American Academy of Pediatrics Pediatric Research in Office Settings' research network. SUBJECTS: A total of 3066 infants 3 months or younger with temperatures of 38 degrees C or higher were evaluated and treated according to the judgment of their practitioners. MAIN OUTCOME MEASURES: Urine testing results, early and late urinary tract infections (UTIs), and UTIs with bacteremia. RESULTS: Fifty-four percent of the infants initially had urine tested, of whom 10% had a UTI. The height of the fever was associated with urine testing and a UTI among those tested (adjusted odds ratio per degree Celsius, 2.2 for both). Younger age, ill appearance, and lack of a fever source were associated with urine testing but not with a UTI, whereas lack of circumcision (adjusted odds ratio, 11.6), female sex (adjusted odds ratio, 5.4), and longer duration of fever (adjusted odds ratio, 1.8 for fever lasting > or = 24 hours) were not associated with urine testing but were associated with a UTI. Bacteremia accompanied the UTI in 10% of the patients, including 17% of those younger than 1 month. Among 807 infants not initially tested or treated with antibiotics, only 2 had a subsequent documented UTI; both did well. CONCLUSIONS: Practitioners order urine tests selectively, focusing on younger and more ill-appearing infants and on those without an apparent fever source. Such selective urine testing, with close follow-up, was associated with few late UTIs in this large study. Urine testing should focus particularly on uncircumcised boys, girls, the youngest and sickest infants, and those with persistent fever.