Association of Severe Acute Respiratory Syndrome Coronavirus 2 Infection With Early Breastfeeding.

OBJECTIVE: The association of maternal severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) status before delivery with breastfeeding is unknown. This study compares breastfeeding initiation, exclusivity, and duration between SARS-CoV-2-positive (+) and SARS-CoV-2-negative (-) mothers during the first 2 months of their newborns' lives. METHODS: A single center, retrospective cohort study of pediatric contacts during the first 2 months in a diverse mother-infant population (n = 285) compared breastfeeding outcomes by maternal SARS-CoV-2 status during a pandemic surge. Infants of SARS-CoV-2 positive mothers were also tested before discharge. Comparison of maternal demographics (age, race, ethnicity), maternal/infant characteristics (parity, insurance, delivery mode, infant sex, hospital length of stay), and pediatric contacts by maternal SARS-CoV-2 status included Fisher's exact and Wilcoxon tests and Poisson regression for count outcomes. Logistic regression compared breastfeeding outcomes between the 2 groups, adjusting for potential confounders and effect modifiers. RESULTS: Maternal demographics and maternal/infant characteristics were similar. While 19% of mothers tested positive for SARS-CoV-2 (n = 54), their infants were all negative. SARS-CoV-2 positive mothers had fewer in-person, but more virtual pediatric contacts. After controlling for the above variables, SARS-CoV-2 positive mothers had lower odds of breastfeeding initiation within 1 to 7 days of life (78% vs 88%; adjusted odds ratio [aOR] = 0.40, 95% confidence interval [CI]: 0.17, 0.96) and of any breastfeeding during month 2 (54% vs 76%; aOR = 0.37, 95% CI: 0.16, 0.86) compared with SARS-CoV-2 negative mothers. CONCLUSIONS: Maternal SARS-CoV-2 positivity at delivery was independently associated with less initiation and shorter duration of any breastfeeding during month 2. SARS-CoV-2 positive women would likely benefit from additional breastfeeding support during pandemic surges.

Pediatric clinical research networks: current status, common challenges, and potential solutions.

OBJECTIVES: The goals were (1) to describe and to characterize pediatric clinical research networks (PCRNs) in the United States and Canada, (2) to identify PCRN strengths and weaknesses, (3) to evaluate the potential for collaboration among PCRNs, and (4) to assess untapped potential interest in PCRN participation. METHODS: Data collection included (1) initial identification of PCRNs through an Internet search and word of mouth, (2) follow-up surveys of PCRN leaders, (3) telephone interviews with 21 PCRN leaders, and (4) a survey of 43 American Academy of Pediatrics specialty leaders regarding untapped interest in network research. RESULTS: Seventy exclusively pediatric networks were identified. Of those, specialty care networks constituted the largest proportion (50%), followed by primary care (28.6%) and disease-specific (21.4%) networks. A network profile survey (response rate: 74.3%) revealed that ∼90% held infrastructure funding. Nearly 75% of respondents viewed cross-network collaborations positively. In-depth telephone interviews corroborated the survey data, with cross-network collaboration mentioned consistently as a theme. American Academy of Pediatrics specialty leaders indicated that up to 30% of current nonparticipants might be interested in research involvement. CONCLUSIONS: Pediatric networks exist across the care continuum. Significant numbers of uninvolved practitioners may be interested in joining PCRNs. A strong majority of network leaders cited potential benefits from network collaboration.

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.

Assessing inter-rater reliability (IRR) of Tanner staging and orchidometer use with boys: a study from PROS.

BACKGROUND: Few studies have systematically assessed the reliability of pubertal markers; most are flawed by limited numbers of markers and ages studied. AIM: To conduct a comprehensive examination of inter-rater reliability in the assessment of boys' sexual maturity. SUBJECTS: Eight pairs of practitioners independently rated 79 consecutive boys aged 8-14 years. METHODS: Two raters in each of eight practices independently rated boys aged 8-14 years, presenting for physical examinations, on key pubertal markers: pubic hair and genitalia (both on 5-point Tanner scales), testicular size (via palpation and comparison with a four-bead Prader orchidometer), and axillary hair (via a three-point scale). RESULTS: Intraclass correlations assessing degree of inter-rater reliability for pubertal markers ranged from 0.61 to 0.94 (all significant at p < 0.001). Rater Kappas for signs of pubertal initiation ranged from 0.49 to 0.79. CONCLUSIONS: Practitioners are able to reliably stage key markers of male puberty and identify signs of pubertal initiation.

Patient visits to a midwestern primary care practice-based research network: a comparison to two national primary care data sets.

BACKGROUND: Regional primary care practice-based research networks (PBRNs) have made important contributions to the primary care literature, but have not been well-described. This study compares pediatric patient characteristics within a new regional PBRN to pediatric patient characteristics from two previously published national data sets. METHODS: Descriptive patient data were collected by 25 Southwestern Ohio Ambulatory Research Network (SOAR-Net) clinicians between July 2003 and June 2004. These data were compared to pediatric patient characteristics from 57 Pediatric Research in Office Setting clinicians and 33 primary care pediatric clinicians who participated in the National Ambulatory Medical Care Survey. RESULTS: SOAR-Net patients were almost twice as likely to use Medicaid (41.9% vs 22.0%/22.4%, p = 0.0001). SOAR-Net patients also were more likely to be African-American (23.7% vs 7.5%/17.6%, p = 0.002). About one third of patients in each sample were seen for a well visit. CONCLUSION: Regional networks with unique characteristics, such as a large number of Medicaid patients and/or many underserved minority patients have the potential to make significant contributions to primary care research by focusing on problems experienced within those segments of a population (e.g., indigent children and their families).

Improving pediatric practice immunization rates through distance-based quality improvement: a feasibility trial from PROS.

The feasibility and effectiveness of a distance-based quality improvement model were examined in a cohort of Pediatric Research in Office Settings (PROS) practices, with the goal of improving immunization rates and practitioner behaviors and attitudes. Of an initially assessed 82 practices, 29 with baseline rates of < or =88% for children 8 to 15 months of age were randomized into year-long paper-based education or distance-based quality improvement intervention groups. Outcomes were utility/helpfulness of quality improvement modalities, immunization rate change, and behavior/attitude change. Quality improvement participants attended approximately 75% of monthly conference calls but used the quality improvement Listserv and Web site infrequently (mean 1.09 and 0.92 uses, respectively). Helpfulness ratings of quality improvement modalities mirrored usage. Analyses revealed a 4.9% increase in quality improvement group immunization rates (P = .061), a 0.8% education group increase (P = .752), and a 4.1% difference between groups (P = .261). More quality improvement practices adopted systems identifying children behind in immunizations. A distance-based quality improvement model is feasible and may improve immunization rates.

Office-based motivational interviewing to prevent childhood obesity: a feasibility study.

OBJECTIVE: To determine whether pediatricians and dietitians can implement an office-based obesity prevention program using motivational interviewing as the primary intervention. DESIGN: Nonrandomized clinical trial. Fifteen pediatricians belonging to Pediatric Research in Office Settings, a national practice-based research network, and 5 registered dietitians were assigned to 1 of 3 groups: (1) control; (2) minimal intervention (pediatrician only); or (3) intensive intervention (pediatrician and registered dietitian). SETTING: Primary care pediatric offices. PARTICIPANTS: Ninety-one children presenting for well-child care visits met eligibility criteria of being aged 3 to 7 years and having a body mass index (calculated as the weight in kilograms divided by the height in meters squared) at the 85th percentile or greater but lower than the 95th percentile for the age or having a normal weight and a parent with a body mass index of 30 or greater. INTERVENTIONS: Pediatricians and registered dietitians in the intervention groups received motivational interviewing training. Parents of children in the minimal intervention group received 1 motivational interviewing session from the physician, and parents of children in the intensive intervention group received 2 motivational interviewing sessions each from the pediatrician and the registered dietitian. MAIN OUTCOME MEASURE: Change in the body mass index-for-age percentile. RESULTS: At 6 months' follow-up, there was a decrease of 0.6, 1.9, and 2.6 body mass index percentiles in the control, minimal, and intensive groups, respectively. The differences in body mass index percentile change between the 3 groups were nonsignificant (P=.85). The patient dropout rates were 2 (10%), 13 (32%), and 15 (50%) for the control, minimal, and intensive groups, respectively. Fifteen (94%) of the parents reported that the intervention helped them think about changing their family's eating habits. CONCLUSIONS: Motivational interviewing by pediatricians and dietitians is a promising office-based strategy for preventing childhood obesity. However, additional studies are needed to demonstrate the efficacy of this intervention in practice settings.

Patient visits to a national practice-based research network: comparing pediatric research in office settings with the National Ambulatory Medical Care Survey.

OBJECTIVE: Our objective with this study was to assess the extent to which patients who are seen by practitioners in Pediatric Research in Office Settings, a national primary care practice-based research network, are representative of those who are seen in ambulatory office-based pediatric primary care in the United States. METHODS: Pediatric Research in Office Settings patient data were collected from the offices of 57 randomly selected network practitioners as part of an Agency for Healthcare Research and Quality-funded effort to describe primary care visits and replicate the National Ambulatory Medical Care Survey in primary care practice-based research networks. These data were from 1706 randomly selected pediatric patient visits that occurred between March and June 2002. National comparison data were 948 randomly selected pediatric patient visits that occurred between March and June 2000 in the offices of the 33 primary care pediatric practitioners who had participated in the National Ambulatory Medical Care Survey. The groups were compared on patient demographics (age, gender, race, ethnicity, and socioeconomic status, as represented by Medicaid status), visit characteristics (percentages of patients referred, practitioner designation of visit as acute versus nonacute, and continuity of care), the top patient/parent-articulated reasons for visit, and the top practitioner diagnoses. RESULTS: Comparisons revealed substantial similarities between Pediatric Research in Office Settings and national data, including gender, ethnicity, socioeconomic status, and visit characteristics. Differences were noted for age and race, with Pediatric Research in Office Settings children approximately 1 year older and comprising a significantly lower proportion of black patients than their National Ambulatory Medical Care Survey counterparts. Although the top 6 reasons that were articulated by parents for outpatient visits in the 2 groups were remarkably similar in rank order and proportions, there were overall differences, mostly attributable to a larger number of the "other" category in the Pediatric Research in Office Settings cases. There were no significant differences among the top 5 practitioner visit diagnoses between the Pediatric Research in Office Settings and National Ambulatory Medical Care Survey data. CONCLUSIONS: The Pediatric Research in Office Settings patient population is reasonably representative of patients who are seen in US ambulatory office-based pediatric primary care practices; therefore, the Pediatric Research in Office Settings is an appropriate laboratory for studies of care in such settings.

Postpartum discharge: do varying perceptions of readiness impact health outcomes?

OBJECTIVE: To assess maternal and pediatrician perceptions of mother-infant readiness for postpartum discharge and the impact of this decision making during the neonatal period. METHODOLOGY: We performed a prospective cohort study of mothers and healthy term infants during the first month of life. On nursery discharge and 1 month later, mothers and practitioners completed self-administered questionnaires assessing the discharge decision, maternal confidence in newborn care, and the adequacy of the length of obstetric care. We used Fisher exact tests, Wilcoxon tests, and exact logistic regression for analysis. RESULTS: Twenty percent of 55 mother-infant pairs were classified as unready at postpartum discharge. Maternal education less than high school was a significant predictor for lack of readiness (P =.01). During the month after discharge, unready mothers identified themselves as being less happy, made twice as many phone calls on behalf of their infants, and more often placed their infants in the prone sleeping position (P <.01 for each) when compared with ready mothers. The latter 2 variables remained significant in multivariate analyses. The percent agreement between mothers and practitioners about readiness was 92% on discharge but 59% (kappa = 0.09; P =.34) 1 month later. CONCLUSIONS: Maternal and pediatric perceptions of readiness for postpartum discharge of mothers and infants show substantial variation on the day of discharge and over time.