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ABSTRACT: BACKGROUND:Data from racially and ethnically diverse US boys are needed to determine ages of onset of secondary sexual characteristics and examine secular trends. Current international studies suggest earlier puberty in boys than previous studies, following recent trend in girls.METHODS:Two hundred and twelve practitioners collected Tanner stage and testicular volume data on 4131 boys seen for well-child care in 144 pediatric offices across the United States. Data were analyzed for prevalence and mean ages of onset of sexual maturity markers.RESULTS:Mean ages for onset of Tanner 2 genital development for non-Hispanic white, African American, and Hispanic boys were 10.14, 9.14, and 10.04 years and for stage 2 pubic hair, 11.47, 10.25, and 11.43 years respectively. Mean years for achieving testicular volumes of ≥3 mL were 9.95 for white, 9.71 for African American, and 9.63 for Hispanic boys; and for ≥4 mL were 11.46, 11.75, and 11.29 respectively. African American boys showed earlier (P < .0001) mean ages for stage 2 to 4 genital development and stage 2 to 4 pubic hair than white and Hispanic boys. No statistical differences were observed between white and Hispanic boys.CONCLUSIONS:Observed mean ages of beginning genital and pubic hair growth and early testicular volumes were 6 months to 2 years earlier than in past studies, depending on the characteristic and race/ethnicity. The causes and public health implications of this apparent shift in US boys to a lower age of onset for the development of secondary sexual characteristics in US boys needs further exploration.
PEDIATRICS 10/2012; · 4.47 Impact Factor
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ABSTRACT: The recently renewed Best Pharmaceuticals for Children and Pediatric Research Equity Acts (BPCA/PREA) have continued industry incentives and opportunities for pediatric drug trials (PDTs). However, there is no current assessment of the capacity to perform PDTs.
The aim of this study was to deepen understanding of the capacity for US PDTs by assessing PDT infrastructure, present barriers to PDTs, and potential approaches and solutions to identified issues.
Pediatric clinical research experts participated in semi-structured interviews on current US pediatric research capacity (February-July 2007). An initial informant list was developed using purposive sampling, and supplemented and refined to generate a group of respondents to explore emerging themes. Each phone interview included a physician researcher and two health researchers who took notes and recorded the calls. Health researchers produced detailed summaries, which were verified by the physician researcher and informants. We then undertook qualitative analysis of the summaries, employing multiple coding, with the two health researchers and the physician researcher independently coding each summary for themes and subthemes. Coding variations were resolved by physician researcher/health researcher discussion and consensus achieved on themes and subthemes.
The 33 informants' primary or secondary roles included academia (n = 21), federal official (5), industry medical officer (8), pediatric research network leader (10), pediatric specialist leader (8), pediatric clinical pharmacologist (5), and practitioner/research site director (9). While most experts noted an increase in PDTs since the initial passage of BPCA/PREA, a dominant theme of insufficient US PDT capacity emerged. Subthemes included (i) lack of systems for finding, incentivizing, and/or maintaining trial sites; (ii) complexity/demands of conducting PDTs in clinical settings; (iii) inadequate numbers of qualified pediatric pharmacologists and clinician investigators trained in FDA Good Clinical Practice; and (iv) poor PDT protocol design resulting in operational and enrollment difficulties in the pediatric population. Suggested potential solutions for insufficient PDT capacity included (i) consensus-building among stakeholders to create PDT systems; (ii) initiatives to train more pediatric pharmacologists and educate clinicians in Good Clinical Practice; (iii) advocacy for PDT protocols designed by individuals sensitive to pediatric issues; and (iv) physician and public education on the importance of PDTs. Conclusions: Insufficient US PDT capacity may hinder the development of new drugs for children and limit studies on the safety and efficacy of drugs presently used to treat pediatric conditions. Further public policy initiatives may be needed to achieve the full promise of BPCA/PREA.
Paediatric Drugs 04/2011; 13(2):119-24. · 1.79 Impact Factor
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Emalee G Flaherty,
Robert D Sege,
John Griffith,
Lori Lyn Price,
Richard Wasserman, Eric Slora,
Niramol Dhepyasuwan,
Donna Harris,
David Norton,
Mary Lu Angelilli,
Dianna Abney,
Helen J Binns
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ABSTRACT: The goals were to determine how frequently primary care clinicians reported suspected physical child abuse, the levels of suspicion associated with reporting, and what factors influenced reporting to child protective services.
In this prospective observational study, 434 clinicians collected data on 15003 child injury visits, including information about the injury, child, family, likelihood that the injury was caused by child abuse (5-point scale), and whether the injury was reported to child protective services. Data on 327 clinicians indicating some suspicion of child abuse for 1683 injuries were analyzed.
Clinicians reported 95 (6%) of the 1683 patients to child protective services. Clinicians did not report 27% of injuries considered likely or very likely caused by child abuse and 76% of injuries considered possibly caused by child abuse. Reporting rates were increased if the clinician perceived the injury to be inconsistent with the history and if the patient was referred to the clinician for suspected child abuse. Patients who had an injury that was not a laceration, who had >1 family risk factor, who had a serious injury, who had a child risk factor other than an inconsistent injury, who were black, or who were unfamiliar to the clinician were more likely to be reported. Clinicians who had not reported all suspicious injuries during their career or who had lost families as patients because of previous reports were more likely to report suspicious injuries.
Clinicians had some degree of suspicion that approximately 10% of the injuries they evaluated were caused by child abuse. Clinicians did not report all suspicious injuries to child protective services, even if the level of suspicion was high (likely or very likely caused by child abuse). Child, family, and injury characteristics and clinician previous experiences influenced decisions to report.
PEDIATRICS 09/2008; 122(3):611-9. · 4.47 Impact Factor
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ABSTRACT: Primary care clinicians participating in the Child Abuse Reporting Experience Study did not report all suspected physical child abuse to child protective services. This evaluation of study data seeks (1) to identify factors clinicians weighed when deciding whether to report injuries they suspected might have been caused by child abuse; (2) to describe clinicians' management strategies for children with injuries from suspected child abuse that were not reported; and (3) to describe how clinicians explained not reporting high-suspicion injuries.
From the 434 pediatric primary care clinicians who participated in the Child Abuse Reporting Experience Study and who indicated they had provided care for a child with an injury they perceived as suspicious, a subsample of 75 of 81 clinicians completed a telephone interview. Interviewees included 36 clinicians who suspected child abuse but did not report the injury to child protective services (12 with high suspicion and 24 with some suspicion) and 39 who reported the suspicious injury. Interviews were analyzed for major themes and subthemes, including decision-making regarding reporting of suspected physical child abuse to child protective services and alternative management strategies.
Four major themes emerged regarding the clinicians' reporting decisions, that is, familiarity with the family, reference to elements of the case history, use of available resources, and perception of expected outcomes of reporting to child protective services. When they did not report, clinicians planned alternative management strategies, including active or informal case follow-up management. When interviewed, some clinicians modified their original opinion that an injury was likely or very likely caused by abuse, to explain why they did not report to child protective services.
Decisions about reporting to child protective services are guided by injury circumstances and history, knowledge of and experiences with the family, consultation with others, and previous experiences with child protective services.
PEDIATRICS 09/2008; 122(2):259-66. · 4.47 Impact Factor
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ABSTRACT: 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.
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.
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.
This randomized, controlled trial demonstrated decreased media exposure and increased safe firearm storage as a result of a brief office-based violence-prevention approach.
PEDIATRICS 08/2008; 122(1):e15-25. · 4.47 Impact Factor
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ABSTRACT: 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.
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.
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.
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).
Southern medical journal 07/2008; 101(7):693-8. · 0.92 Impact Factor
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ABSTRACT: Postpartum discharge of mothers and infants who are not medically or psychosocially ready may place the family at risk. Most studies of postpartum length of stay, however, do not reflect the necessary complexity of decision-making. With this study we aimed to characterize decision-making on the day of postpartum discharge from the perspective of multiple key informants and identify correlates of maternal and newborn unreadiness for discharge.
This was a prospective observational cohort study of healthy term infants with mothers, pediatric providers, and obstetricians as key informants to assess the decision-making process regarding mother-infant dyad unreadiness for discharge. A mother-infant dyad was defined as unready for postpartum hospital discharge if > or = 1 of 3 informants perceived that either the mother or infant should stay longer at time of nursery discharge. Data were collected through self-administered questionnaires on the day of discharge.
Of 4300 mother-infant dyads, unreadiness was identified in 17% as determined by the mother (11%), pediatrician (5%), obstetrician (1%), and > or = 2 informants (< 1%). Significant correlates of unreadiness were as follows: black non-Hispanic maternal race/ethnicity, maternal history of chronic disease, primigravid status, inadequate prenatal care as determined by the Kotelchuck Adequacy of Prenatal Care Utilization Index, delivering during nonroutine hours, in-hospital neonatal problems, receiving a limited number of in-hospital classes, and intent to breastfeed.
Mothers, pediatricians, and obstetricians must make decisions about postpartum discharge jointly, because perceptions of unreadiness often differ. Sensitivity toward specific maternal vulnerabilities and an emphasis on perinatal education to insure individualized discharge plans may increase readiness and determine optimal timing for discharge and follow-up care.
PEDIATRICS 09/2007; 120(2):e391-400. · 4.47 Impact Factor
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Current problems in pediatric and adolescent health care 05/2003; 33(4):115-23.
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ABSTRACT: To describe what pediatric primary care providers involved in the Pediatric Research in Office Settings (PROS) research network think are important yet inadequately addressed questions in pediatric primary care research.
A total of 1785 pediatric primary care providers in the PROS network were asked what they thought were important yet inadequately addressed areas of primary care research. We used a single, open-ended question in a mail survey. Written answers to this question were analyzed by qualitative methods to determine the main themes of interest to pediatric primary care providers.
Overall survey response rate was 48.7%; the open-ended question yielded 1109 individual answers. Six lines of inquiry were identified as being important to these providers: (1) effective counseling techniques to use in anticipatory guidance; (2) strategies to prevent and treat obesity; (3) the effectiveness of well-child care; (4) ongoing management of patients with attention-deficit/hyperactivity disorder; (5) the role of the primary care provider in caring for children with mental health needs; and (6) optimal organization of office practices.
The translation of research into practice may be improved by a better understanding of the needs and interests of those who see pediatric patients in the primary care setting.
Ambulatory Pediatrics 6(6):352-5. · 1.60 Impact Factor
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ABSTRACT: This study examined the validity of primary health care providers' (PHCPs) assessment of suspicion that an injury was caused by child abuse and their decision to report suspected child abuse to child protective services (CPS).
By using a subsample of injuries drawn from the 15,003 childhood injuries evaluated in the Child Abuse Recognition and Evaluation Study, PHCPs completed telephone interviews concerning a stratified sample (no suspicion of abuse; suspicious but not reported; and suspicious of abuse and reported) of 111 injury visits. Two techniques were used to validate the PHCPs' initial decision: expert review and provider retrospective self-assessment. Five child abuse experts reviewed clinical vignettes created by using data prospectively collected by PHCPs about the patient encounter. The PHCPs' opinions 6 weeks and 6 months after the injury-related visits were elicited and analyzed.
PHCPs and experts agreed about the suspicion of abuse in 81% of the cases of physical injury. PHCPs did not report 21% of injuries that experts would have reported. Compared with expert reviewers, PHCPs had a 68% sensitivity and 96% specificity in reporting child abuse. A PHCP's decision to report suspected child abuse to CPS did not reduce the frequency of primary care follow-up in the 6 months after the index visit. PCHPs received information from their state CPS in 70% of the reported cases.
Child abuse experts and PHCPs are in general agreement concerning the assessment of suspected child physical abuse, although experts would have reported suspected abuse to CPS more frequently than the PHCPs. Future training should focus on clear guidance for better recognition of injuries that are suspicious for child abuse and state laws that mandate reporting.
Academic pediatrics 11(6):460-6.