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Impact of specialization of primary nephrologist on the care of pediatric hemodialysis patients.

BACKGROUND: Children with end-stage renal disease (ESRD) receiving hemodialysis may have their care overseen primarily by a pediatric nephrologist or internal medicine (IM) nephrologist. METHODS: To examine specific clinical outcomes by nephrologist specialization, a cross-sectional analysis of demographic and clinical data collected in the 2002 ESRD Clinical Performance Measures Project was performed. RESULTS: Of 653 pediatric patients meeting inclusion criteria, 27% were cared for by IM nephrologists, and 73%, by pediatric nephrologists. Pediatric nephrologists were significantly more likely than IM nephrologists to care for patients who were younger and of Hispanic ethnicity. Patients of pediatric compared with IM nephrologists also were more likely to have a congenital cause of ESRD, smaller body mass index, and longer time on dialysis therapy. No significant differences in achieving a mean Kt/V of 1.2 or greater or mean hemoglobin level of 11 g/dL or greater (> or =110 g/L) according to nephrologist specialization were observed. After adjustment for patient clinical characteristics, no significant difference in use of arteriovenous fistulae was observed. Patients cared for by pediatric nephrologists were less likely to achieve a mean serum albumin level of 4.0/3.7 g/dL (40/37 g/L; bromcresol green laboratory method/bromcresol purple laboratory method; adjusted odds ratio, 0.60; 95% confidence interval, 0.42 to 0.86). Patients cared for by pediatric nephrologists had significantly greater serum calcium levels, lower serum phosphate levels, and lower intact parathyroid hormone levels. CONCLUSION: Using adult-focused clinical care targets, care provided by pediatric and IM nephrologists to pediatric patients receiving hemodialysis in the United States is similar. However, differences exist, and the significance of these differences requires further study.

Adolescent↗

Training and delivery of pediatric surgery services in Asia.

PURPOSE: The purpose of this report is to obtain an overview of pediatric surgery training in Asia and to have a glimpse of its delivery. METHODS: A questionnaire survey was conducted, and the returns from 41 (67%) pediatric surgeons from 14 (88%) Asian countries were reviewed. RESULTS: The number of pediatric surgeons per million population is lowest in Indonesia (0.1) and highest in Japan (25). Two cities in China have 100 or more pediatric surgeons. The number of staff surgeons per center ranges from 1 to 36. Centers with 5 or fewer neonatal surgical operations per staff surgeon per year are located in Cambodia, China, and Japan, and centers with more than 40 neonatal surgical operations per staff surgeon per year are found in India, South Korea, Myanmar, and Thailand. There are centers in which more than 400 postneonatal pediatric surgical operations are performed per staff surgeon each year in Cambodia, India, Indonesia, South Korea, and Myanmar. After general surgery training, pediatric surgery training commonly lasts 2 to 3 years (71%). The shortest training period is 1 year in a center in 1 country to 5 or more years in a few countries. At the end of the training, a variety of exit examinations or assessments (clinicals, orals, written) are conducted in most countries. CONCLUSIONS: Pediatric surgery training programs in Asia are diverse. Clinical cases per trainee surgeon vary greatly. Although some countries have an adequate number of pediatric surgeons to deliver a high quality service, others are severely short staffed, and have huge caseloads, delivering pediatric surgical services under extremely difficult conditions. Governments subsidize the cost of surgical care in most countries (93%): self-payment is common (86%) and insurance is least practiced (64%).

Asia↗

Critical pediatric equipment availability in Canadian hospital emergency departments.

STUDY OBJECTIVE: Of all child visits to emergency departments, 1% to 5% involve critically ill children who require cardiopulmonary resuscitation. Numerous versions of pediatric equipment lists for EDs have been published. Despite these efforts, many EDs remain unprepared for pediatric emergencies. The objectives of this study were to assess the availability of pediatric resuscitation equipment items in Canadian hospital EDs and to identify risk factors for the unavailability of these items. METHODS: Using the updated database of the Canadian Association of Emergency Physicians (CAEP), a questionnaire survey was sent to 737 Canadian hospital EDs with a maximum of 3 mailings to nonresponders. On-site visits to a selected subset of hospital EDs were completed to validate the results obtained by the mailed questionnaire. RESULTS: The response rate was 88.3% (650/737). Results showed the following overall equipment unavailability: intraosseous needle, 15.9%; pediatric drug dose guidelines, 6.6%; infant blood pressure cuff, 14.8%; pediatric defibrillator paddles, 10.5%; infant warming device, 59.4%; infant bag-valve-mask device, 3.5%; infant laryngoscope blade, 3.5%; 3-mm endotracheal tube, 2.5%; and pediatric pulse oximeter, 18.0%. Low percentage of pediatric visits, lack of an on-call pediatrician for the ED, and lack of a pediatric advanced life support-trained physician on staff were independently associated with equipment unavailability. CONCLUSION: This study demonstrated that essential pediatric resuscitation equipment is unavailable in a disturbingly high number of EDs across Canada and has identified several determinants of this unavailability.

Canada↗

Improving women's health during internatal periods: developing an evidenced-based approach to addressing maternal depression in pediatric settings.

The internatal period, the time between births of successive children, has become a focal point for risk assessment and health promotion in women's healthcare. This period represents a time when women are at high risk for a depressive disorder. The pediatric venue offers a unique opportunity for the identification and management of depression in the internatal period, as mothers who do not attend their own medical appointments are likely to accompany their child to pediatric visits. This paper discusses the role pediatric providers can undertake to improve women's health in the internatal period through the detection and management of maternal depression at well-child visits. Successful models of the management of depression in other primary care settings are explored for their potential for implementation in the pediatric venue. A specific model developed and implemented as part of a 3-year project is presented to highlight the feasibility of an evidenced-based approach to the management of maternal depression in the pediatric setting. We present evidence demonstrating that pediatric providers can successfully identify postpartum women with depression, monitor symptoms and treatment adherence, and communicate results to a woman's healthcare provider. Yet more investigation is needed to create preventive interventions for maternal depression that integrate evidenced-based practice standards for the treatment of depression in primary care venues into pediatric settings. Future programs and policies targeting maternal depression in the pediatric environment should address patient mental health literacy and stigma, the training and education of pediatric providers, and issues of privacy and reimbursement.

Adult↗

Multi-institutional survey of graduates of pediatric anesthesia fellowship: assessment of training and current professional activities.

UNLABELLED: We surveyed all the graduates of four fellowship programs in pediatric anesthesia between 1985 and 1993 to assess their current professional activities, their evaluation of fellowship training, and their opinions on future directions of such training. One-hundred ninety-one (62%) of the graduates responded. Nearly all of the respondents had sought fellowship training for pediatric anesthesia and thought that the training was worthwhile. At the time of the survey, 40% worked in a children's hospital, 72% had university or affiliate positions, and 54% had a practice that was > 50% pediatric. Those with > or = 12 mo fellowship and/or board certification in pediatrics were the most likely to have a pediatric-dedicated practice. Seventy percent of the respondents thought that fellowship training should be for 12 mo, and the proportion of respondents who recommended inclusion of training in pain management and clinical research was greater than the number who had actually received such training. Fifty-eight percent of respondents supported restriction of fellowship positions in the future, but 83% did not support a mandatory 2-yr fellowship with research training. We conclude that fellowships in pediatric anesthesia seem to be successful in providing training that is not only satisfying to the trainees, but that is also followed by active involvement in the care of children and in the training of residents and fellows in anesthesia. Additional information should be gathered to assess the impact of this training on pediatric care, to formulate a standardized curriculum, and to justify support for such training in the future. IMPLICATIONS: We surveyed graduates of four fellowship programs in pediatric anesthesia (1985-1993) to assess current professional activities, fellowship training, and future directions of such training. Fellowships in pediatric anesthesia seem to provide training that is satisfying to trainees and that is followed by active involvement in the care of children.

Anesthesiology↗

Reduction of morbidity in interhospital transport by specialized pediatric staff.

OBJECTIVE: We prospectively compared the occurrence of morbidity during high-risk interhospital transport in two types of transport systems: specialized tertiary center-based vs. nonspecialized, referring hospital-based. DESIGN: Concurrent, prospective comparison of morbidity at two pediatric centers that use different types of transport team. SETTING: Two tertiary care pediatric intensive care units (ICU). The specialized team consisted of a pediatric resident, pediatric intensive care nurse, and a pediatric respiratory therapist. Comparison was made with referring institution transports by nonspecialized personnel to a second center. The two centers were similar in size and patient mix, with referral areas of similar population and rural/urban ratio. PATIENTS: One hundred forty-one patients transported to two tertiary pediatric ICUs. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Two types of events were assessed: vital signs and other observable clinical events were described as "physiologic deteriorations." Events such as loss of intravenous access, endotracheal tube mishaps, and exhaustion of oxygen supply were described as "intensive care-related adverse events." Pretransport severity of illness and therapy were described by Pediatric Risk of Mortality (PRISM) and Therapeutic Intervention Scoring System (TISS) scores. Only high-risk patients with PRISM scores of > or = 10 were analyzed. Intensive care-related adverse events occurred in one (2%) of 49 transports by the specialized team and 18 (20%) of 92 transports by nonspecialized personnel. The difference is statistically significant (p < .05). Physiologic deterioration was similar in the two groups occurring in five (11%) of 47 specialized team transports and 11 (12%) of 92 transports by the nonspecialized team. CONCLUSION: We conclude that specialized pediatric teams can reduce transport morbidity. This is the first published study to compare two models of pediatric transport using identical definitions of severity and morbidity.

Age Distribution↗

Variation in therapy and outcome for pediatric head trauma patients.

OBJECTIVE: This study was undertaken to examine variation in therapies and outcome for pediatric head trauma patients by patient characteristics and by pediatric intensive care unit. Specifically, the study was designed to examine severity of illness on admission to the pediatric intensive care unit, the therapies used during the pediatric intensive care unit stay, and patient outcomes. DATA SOURCES AND SETTING: Consecutive admissions from three pediatric intensive care units were recorded prospectively (n = 5,749). For this study, all patients with an admitting diagnosis of head trauma were included (n = 477). Data collection occurred during an 18-month period beginning in June 1996. All of the pediatric intensive care units were located in children's hospitals, had residency and fellowship training programs, and were headed by a pediatric intensivist. METHODS: Admission severity was measured as the worst recorded physiological derangement during the period 1 yr old (16.1% vs. 6.1%; p = .002). Comparisons by insurance status indicated that observed mortality rates were highest for self-paying patients. However, patient characteristics were not associated with use of therapies or standardized mortality rates after adjustment for patient severity. There was significant variation in the use of paralytic agents, seizure medications, induced hypothermia, and intracranial pressure monitoring on admission across the three pediatric intensive care units. In multivariate models, only the use of seizure medications was associated significantly with reduced mortality risk (odds ratio = 0.17; 95% confidence interval = 0.04-0.70; p = .014). CONCLUSIONS: Therapies and outcomes vary across pediatric intensive care units that care for children with head injuries. Increased use of seizure medications may be warranted based on data from this observational study. Large randomized controlled trials of seizure prophylaxis in children with head injury have not been conducted and are needed to confirm the findings presented here.

Child, Preschool↗

Confidence in performance of pediatric emergency medicine procedures by community emergency practitioners.

OBJECTIVE: To survey a cohort of physicians who work in general community emergency departments (ED) in order to assess their comfort levels in performing urgent and emergent medical procedures on children. METHODS: One hundred seventeen emergency physicians were surveyed at 23 institutions within the referral base of Hasbro Children's Hospital, a tertiary care pediatric ED. Physicians rated their comfort levels (4-point scale: 1 = comfortable, 2 = moderately comfortable, 3 = uncomfortable but would perform in an emergency, 4 = uncomfortable and would never perform) for all procedures in which the American Academy of Pediatrics recommends competence for pediatric emergency physicians. RESULTS: Sixty (51%) physicians completed the survey. Residency training included internal medicine, family practice, surgery, general practice, pediatrics, and emergency medicine, while only 32 (53%) were Board certified in emergency medicine. All respondents treated pediatric patients. Over 25% were uncomfortable (level 3 or 4) with performing certain potentially life-saving pediatric procedures. These included cardioversion, defibrillation, external pacing, nasal intubation, needle cricothyrotomy, rapid sequence intubation, laryngoscopy, tracheostomy replacement, chest tube placement, vascular cutdowns, emergency childbirth, pericardiocentesis, intraosseous line placement, infant subdural and ventriculoperitoneal (V-P) shunt taps, and upper airway foreign body removal. Over 25% of respondents were also uncomfortable with non-life-saving procedures such as temperomandibular joint (TMJ) reductions, tooth reinsertions, rape evaluations, suprapubic taps, tympanocentesis, retrograde urethrograms, thoracentesis, paraphimosis reduction, ear foreign body removal, and pain management. CONCLUSION: While emergency physicians within the catchment area of a tertiary care children's hospital feel comfortable with most pediatric procedures, they express a significant degree of discomfort with many potentially life-saving skills. Because of the infrequent need for many of these interventions in children, the high levels of discomfort are not surprising. These procedures may most comfortably be performed at pediatric centers but can be accomplished well at all EDs if personnel are adequately trained. A strong working relationship with pediatric emergency centers and an enhanced teaching of these procedures may increase comfort levels with these potentially life-saving measures.

Attitude of Health Personnel↗

The need for pediatric-specific triage criteria: results from the Florida Trauma Triage Study.

OBJECTIVE: The objective of the Florida Trauma Triage Study was to assess the performance of state-adopted field triage criteria. The study addressed three specific age groups: pediatric (age < 15 years), adult (age 15-54 years), and geriatric (age 55+ years). Since 1990, Florida has used a uniform set of eight triage criteria, known as the trauma scorecard, for triaging adult trauma patients to state-approved trauma centers. However, only five of the criteria are recommended for use with pediatric patients. This article presents the findings regarding the performance of the scorecard when applied to a pediatric population. DESIGN: We used state trauma registry data linked to state hospital discharge data in a retrospective analysis of trauma patients transported by prehospital providers to any acute care hospital within nine selected Florida counties between July 1, 1991, and December 31, 1991. We used cross-table and logistic regression analysis to determine the ability of triage criteria to correctly identify patients who were retrospectively defined as major trauma. We applied the field criteria to physiologic and anatomy/mechanism of injury data contained in the trauma registry to "score" the patient as major or minor trauma. To make our retrospective determination of major or minor trauma we used the protocols developed by an expert medical panel as described by E. J. MacKenzie et al. (1990). MAIN OUTCOME MEASURES: We calculated sensitivity, specificity, and the corresponding over- and undertriage rates by comparing patient classifications (major or minor trauma) produced by the triage criteria and the retrospective algorithm. We used logistic regression to identify which triage criteria were statistically significant in predicting major trauma. RESULTS: Pediatric cases accounted for 9.2% of the total study population, 6.0% of all hospitalized cases, and 6.8% of all trauma deaths. Of the 1505 pediatric cases available for analysis, the triage criteria classified 269 cases as expected major trauma and 1236 cases as expected minor trauma. The retrospective algorithm classified 78 cases as expected major trauma and 1427 cases as expected minor trauma. The resulting specificity is 84.8% (15.2% overtriage), and the sensitivity is 66.7% (33.3% undertriage). Logistic regression indicated that, of the eight state-adopted field triage criteria, only the Glasgow coma score, ejection from vehicle, and penetrating injuries have a statistically significant impact on predicting major trauma in pediatric patients. CONCLUSIONS: Although the state-adopted trauma scorecard, applied to a pediatric population, produced acceptable overtriage, it did not produce acceptable undertriage. However, our undertriage rate is comparable to the results of other published studies on pediatric trauma. As a result of the Florida Trauma Triage Study, a new pediatric triage instrument was developed. It is currently being field-tested.

Adolescent↗

Rapid sequence intubation for pediatric emergency airway management.

OBJECTIVES: To characterize current practice with respect to pediatric emergency airway management using a multicenter data set. METHODS: A multicenter collaboration was undertaken to gather data prospectively regarding emergency intubation. Analysis of data on adult emergency department (ED) intubations clearly demonstrated that rapid sequence intubation (RSI) was the method used most often. We then conducted an observational study of the prospectively collected database of pediatric ED intubations (EDIs) using the National Emergency Airway Registry Phase One data, gathered in 11 participating EDs over a 16-month time period. A data form completed at the time of EDI enabled analysis of patients' ages, weights, and indications for EDI; personnel; methods employed to facilitate EDI; success rates; and adverse events. Data forms were analyzed regarding the methods of intubation employed, and frequencies, success rates, and adverse event rates among various intubation modalities were compared. RESULTS: Of 1288 EDIs, there were 156 documented pediatric patients. Initial intubation attempts were all oral, including rapid sequence intubation in 81%, without medications (NOM) in 13%, and sedation without neuromuscular blockade (SED) in 6%. Older children and trauma patients were more likely to be intubated with RSI compared to younger children and patients presenting with medical illnesses. Intubation using RSI was more successful on the first attempt (78%) compared with either NOM (47%, < 0.01) or SED (44%, < 0.05), though this finding is likely explainable by the age differences among groups. Intubation was successfully performed by the initial intubator in 85% of RSI, 75% of NOM, and 89% of SED attempts ( = NS for both comparisons vs RSI). Overall, successful intubation occurred in 99% of RSI and 97% of non-RSI intubation attempts ( = NS). Only one of 156 patients required surgical airway management. True complications occurred in 1%, 5%, and 0% of RSI, NOM, and SED attempts, respectively ( = NS for both comparisons vs RSI). The majority of initial intubation attempts were by emergency medicine residents (59%), pediatric emergency medicine fellows (17%), and pediatrics residents (10%). These groups were 77%, 77%, and 50% successful, respectively, on the first laryngoscopy attempt, and 89%, 89%, and 69% successful overall. CONCLUSIONS: A large, prospective, multicenter observational study of pediatric EDIs was conducted at university-affiliated EDs. RSI is the method of choice for the majority of pediatric emergency intubations; it is associated with a high success rate and a low rate of serious adverse events. Pediatric intubation as practiced in academic EDs, with most initial attempts by emergency and pediatrics residents and fellows under attending physician supervision, is safe and highly successful.

Adolescent↗

Variation in the management of pediatric splenic injuries in the United States.

BACKGROUND: This study examines the existence and sources of variation in the management of pediatric splenic injuries among hospitals in the United States and the factors associated with splenectomy. METHODS: Information on children 15 years of age and younger with a splenic injury diagnosis code was extracted from the Kids' Inpatient Database 2000, a pediatric inpatient database of 2,784 hospitals in 27 states covering 72% of the nation's population for the year 2000. Patient variables included age, sex, race, injury diagnoses, grade of splenic injury, splenic procedure code, and calculated Injury Severity Score. Hospital variables included pediatric status (free-standing, unit and adult), teaching status, annual pediatric splenic trauma volume, and national region. A multivariate logistic regression model was used to predict the factors associated with splenectomy based upon patient and hospital characteristics. RESULTS: In all, 2,191 children with splenic injuries were identified; 253 (12%) underwent splenectomy. The crude rate of splenectomy varied significantly among pediatric hospital types: 3% (11/339) at freestanding children's hospitals, 9% (45/525) at unit hospitals and 15% (197/1327) at adult hospitals (p < 0.001). Risk of splenectomy increased with the grade of splenic injury, patient age, and the presence of multiple injuries. Teaching hospitals and hospitals with higher patient volume were associated with lower risk for splenectomy. There was no relationship between splenectomy and gender, race, or national region. Despite adjustment for the above noted hospital and patient-specific variables, children treated at an adult hospital had 2.8 times the odds, and those treated at a unit pediatric hospital 2.6 times the odds, of undergoing splenectomy as those cared for at a free-standing pediatric hospital (p = 0.003 and 0.013, respectively). CONCLUSION: Nationally, children cared for at freestanding pediatric hospitals have a significantly lower risk of splenectomy than children treated at either adult hospitals or pediatric hospitals within an adult hospital. This may have implications for education, trauma triage and the establishment of practice guidelines.

Adolescent↗

[Pediatric environmental health specialty units in Europe: from theory to practice].

BACKGROUND: The World Health Organization encourages the development of strategies to identify, increase awareness and solve problems of Pediatric Environmental Health (PEH) in units and centers of excellence. Pediatricians are in an excellent position to identify children at environmental risk, advise parents about the best way to reduce or prevent these risks, and recommend changes in health policies to politicians. OBJECTIVE: To inform pediatricians about the underlying principles and activities of pediatric environmental health specialty units (PEHSU) in Spain and Europe. To analyze up-to-date knowledge and the steps required for the development of PEH in Spain and Europe. MATERIAL AND METHODS: Review of the strategies, initiatives and examples of useful practices for national and international organizations involved in the development and implementation of PEH. Report of activities of PEHSUs. RESULTS: In Spain and Europe pediatricians do not receive training in PEH. PEHSUs are centers specialized in the diagnosis, treatment, and prevention of environmentally-related diseases. These centers are composed of multidisciplinary teams of health and other professionals, coordinated by pediatricians specialized in PEH, that have the study of environment-related pediatric problems as a common denominator. The activity of these units emphasizes teaching, research, scientific activity, the development of environmental history in pediatrics, diagnosis and treatment of the "pediatric environmental wound", assessment of risks in pediatrics, and specialization in the critical review of the literature on PEH to train pediatricians to be experts in environmental health. The activities and fields of PEHSU can be summarized as: medical care, training, research, and community health (school health). CONCLUSIONS: PEH should be considered by Ministries of Health and Pediatrics Associations as an important emergent area for current and future generations of pediatricians. Thus, it is necessary: a) to develop an integral plan for pediatric training in PEH; b) to actively seek funding and support to increase the presence of PEHSUs in Europe, and c) to create expert committees in PEH in National Associations of Pediatrics in Europe.

Community Health Services↗

Influence of the clinical rotation on intern attitudes toward pediatrics.

Knowledge of graduate student's impressions and attitudes toward pediatrics is important for planning strategies to stimulate their interest in pursuing a career in pediatrics. The clinical pediatric experience may influence many of their misconceptions and apprehension. This study was designed to examine this hypothesis. Rotating interns who were starting pediatric rotations between January 8, 1998 and January 4, 2001 were included prospectively. A structured 2-part, 28-item questionnaire examining their impressions and attitudes toward pediatrics was completed on the first week and at the end of the 8-week rotation. One hundred eighty-eight interns (53.5% males) aged 23 to 30 years (mean 24.8, SD 1.3) were included. One hundred two pre- and 86 post-rotation questionnaires were completed. Selecting pediatrics as the first future career choice did not change significantly at the end of the rotation, from 19.5% to 26% post-rotation. Females were 3.4 times more likely to select pediatrics (95% CI 1.6-7.8, p = 0.001). Several impressions about the specialty were significantly changed at the end of the rotation including worry about inflicting pain (28% vs 12%, p = 0.01), concerns about difficulties in the examination and cooperation of children (22% vs 8%, p = 0.01), and difficulties with intravenous access (43% vs 17%, p = 0.0003). Most interns (76%) felt that their pediatric rotation was better than anticipated. To conclude, although the rotation experience did not increase the likelihood of selecting pediatrics as the first future career choice, many impressions and concerns were positively influenced. The majority reported a better than anticipated experience.

Adult↗

The paradox of the nested pediatric emergency department.

OBJECTIVES: Nested pediatric emergency departments (nPEDs) are defined as dedicated treatment areas operating during peak pediatric hours within general emergency departments (EDs). This study examined three staffing models for nPEDs and their impact on pediatric encounters. METHODS: Three models were applied to children younger than 37 months presenting to the ED of an urban community hospital over one year. In the nPED, physicians cared only for nPED patients. In the restricted (rPED) model, physicians cared only for pediatric patients presenting outside nPED hours. In the total ED (tED) model, physicians treated all pediatric patients regardless of time. Full-time equivalent pediatric encounters, potential neonatal lumbar punctures, and illness severity were determined for all models. Statistical analysis was performed by analysis of variance and chi-square test. RESULTS: For the 3,389 eligible ED visits, the number of annual patient encounters per full-time equivalent was 1,236 for the nPED, 805 for the tED, and 336 for the rPED (p < 0.001). Physicians practicing only in the nPED treated 3.7 times the number of children younger than 37 months than did physicians in the rPED model and 1.5 times the number than did physicians in the tED model. Spending 10% of total practice hours in the nPED would increase pediatric encounters 26% for rPED physicians, while practicing 25% of time in the nPED would increase pediatric encounters 67% and equate to 45% of nPED encounters. An nPED physician could expect to perform 17 neonatal lumbar punctures, compared with ten for a tED physician and four for an rPED physician (p < 0.001). There was no significant difference in severity of illness for the three models. CONCLUSIONS: Physicians practicing in facilities that include an nPED must dedicate some portion of their practice to the nPED to maintain equivalent pediatric encounters.

Emergency Service, Hospital↗

Regulatory approvals of pediatric oncology drugs: previous experience and new initiatives.

PURPOSE: To review the Food and Drug Administration (FDA) experience with approvals of new drugs for pediatric oncology and to discuss new regulatory initiatives directed at pediatric oncology. METHODS: A retrospective review of FDA archival documents and the published literature. RESULTS: More than 100 drugs have been approved by the Division of Oncology Drug Products of the FDA for the treatment of malignancies. Only 15 have pediatric use information in their labeling, which is less than 50% of the drugs commonly used in the treatment of pediatric malignancies. In the past 20 years, there have been six submissions to the FDA for pediatric oncology indications. To illustrate principles of the approval process, each submission is discussed. CONCLUSION: Potential reasons for a lack of New Drug Application submissions for pediatric oncology include the small pediatric oncology market compared with the adult oncology market and perceived barriers to performing studies in children. Reasons for failure to approve pediatric indications include small numbers of patients, lack of appropriate controls, and failure to demonstrate patient benefit. Approval criteria include the use of controlled trials, prospective data collection, and disease-appropriate end points. Regulatory initiatives to promote pediatric therapeutic development and product labeling are discussed.

Antineoplastic Agents↗

Role of pediatric and internist rheumatologists in treating children with rheumatic diseases.

OBJECTIVE: To quantify and describe the role of internist and pediatric rheumatologists in the care of children with rheumatic diseases and identify factors associated with internist rheumatologists' willingness to treat children. METHODS: We surveyed physician members of the American College of Rheumatology who currently practice in California (n = 589). Bivariate and logit analyses were used to examine the effects of training, provider, practice, and distance to the nearest pediatric rheumatologist on the likelihood that an internist rheumatologist treated children. RESULTS: Our effective response rate was 51%. More than one third of internist rheumatologists who practice in California reported treating pediatric patients. On average, internist rheumatologists who treated children saw 3.1 patients younger than 18 years weekly; half of these patients were 16 and 17 years of age. In logistic regression analysis, internist rheumatologists who treat pediatric patients were significantly more likely to practice in a multispecialty clinic (adjusted odds ratio: 3.5; 95% confidence interval: 1.9-9.7) and to live >50 miles from a pediatric rheumatologists (adjusted odds ratio: 6.8; 95% confidence interval: 2.1-22.7). In aggregate, we estimate that pediatric rheumatologists and internist rheumatologists provide care to 550 and 419 patients younger than 18 years per week, respectively. CONCLUSIONS: A substantial number of California internist rheumatologists are involved in the care of children, especially adolescents. The heavy involvement of internist rheumatologists in the care of children suggests that additional pediatric rheumatologists may be needed in select areas. Our findings have important implications for the size and distribution of the pediatric rheumatology workforce, the content of fellowship training for internist rheumatologists, and future studies of the relative quality of pediatric rheumatology care offered by internist rheumatologists. Furthermore, the role of internist subspecialists in caring for children with other chronic illness should be assessed.

Adolescent↗

Prevalence and correlates of successful transfer from pediatric to adult health care among a cohort of young adults with complex congenital heart defects.

OBJECTIVES: More than 85% of children born today with chronic medical conditions will live to adulthood, and many should transfer from pediatric to adult health care. The numbers of adults with congenital heart defects (CHDs) are increasing rapidly. Current guidelines recommend that just over half of adult CHD patients should be seen every 12 to 24 months by a cardiologist with specific CHD expertise at a regional CHD center, because they are at risk for serious complications (eg, reoperation and/or arrhythmias) and premature mortality. The present study aimed to determine the percent of young adults with CHDs who successfully transferred from pediatric to adult care and examine correlates of successful transfer. DESIGN: Cross-sectional study with prevalence data from an entire cohort. SETTING AND PATIENTS: All patients (n = 360) aged 19 to 21 years with complex CHDs who, according to current practice guidelines, should be seen annually at a specialized adult CHD center were identified from the database of the cardiology program at the Hospital for Sick Children in Toronto, Canada, a pediatric tertiary care center. Of these patients, 234 completed measures about health beliefs, health behaviors, and medical care since age 18 years. MAIN OUTCOME MEASURE: All 15 specialized adult CHD centers in Canada formed the Canadian Adult Congenital Heart (CACH) Network. Attendance for at least 1 follow-up appointment at a CACH center before the age of 22 years was ascertained for all eligible patients. Attendance at a CACH center provides a clear criterion for successful transfer. RESULTS: In the total cohort, 47% (95% confidence interval [CI]: 42-52) had transferred successfully to adult care. There was no difference in rates of successful transfer between patients consenting to complete questionnaires (48%) and those who declined (47%). More than one quarter (27%) of the patients reported having had no cardiac appointments since 18 years. In multivariate analyses of the entire cohort, successful transfer was significantly associated with more pediatric cardiovascular surgeries (odds ratio [OR]: 2.47; 95% CI: 1.40-4.37), older age at last visit to the Hospital for Sick Children (OR: 1.29; 95% CI: 1.10-1.51), and documented recommendations in the medical chart for follow-up at a CACH center. In multivariate analyses of the patients completing questionnaires, successful transfer was significantly related to documented recommendations and patient beliefs that adult CHD care should be at a CACH center (OR: 3.64; 95% CI: 1.34-9.90). Comorbid conditions (OR: 3.13; 95% CI: 1.13-8.67), not using substances (eg, binge drinking; OR: 0.18; 95% CI: 0.07-0.50), using dental antibiotic prophylaxis (OR: 4.23; 95% CI: 1.48-12.06), and attending cardiac appointments without parents or siblings (OR: 6.59; 95% CI: 1.61-27.00) also correlated with successful transfer. CONCLUSIONS: This is the first study to document the percent of young adults with a chronic illness who successfully transfer to adult care in a timely manner. Patients were from an entire birth cohort from the largest pediatric cardiac center in Canada, and outcome data were obtained on all eligible patients. Similar data should be obtained for other chronic illnesses. There is need for considerable improvement in the numbers of young adults with CHDs who successfully transfer to adult care. At-risk adolescents with CHDs should begin the transition process before their teens, should be educated in the importance of antibiotic prophylaxis, should be contacted if a follow-up appointment is missed, and should be directed to a specific CHD cardiologist or program, with the planned timing being stated explicitly. Adult care needs to be discussed in the pediatric setting, and patients must acquire appropriate beliefs about adult care well before transfer. Developmentally appropriate, staged discussions involving the patient, with and without parents, throughout adolescence may help patients acquire these beliefs and an understanding of the need for ongoing care. Improved continuity of pediatric care and provision of clear details for adult follow-up might be sufficient to cause substantive improvements in successful transfer. An understanding of why patients drop out of pediatric care may be needed to improve the continuity of care throughout adolescence. Almost one quarter of the patients believed adult care should be somewhere other than at a CACH center despite opposite recommendations. For these patients, a single discussion of adult care during the final pediatric visit may be too little, too late. In addition to earlier discussions, multiple mechanisms such as referral letters and transition clinics are needed. Similarly, patients engaging in multiple risky or poor health behaviors such as substance use may need more intensive programs to make substantial changes in these behaviors, which hopefully would lead to successful transfer. Overall, these data support the view that transition to adult care (a planned process of discussing and preparing for transfer to an adult health center) is important and should begin well before patients are transferred. The future health of adults with chronic conditions may depend on our ability to make these changes.

Adolescent↗

The changing composition of the pediatric medical subspecialty workforce.

OBJECTIVES: To characterize the composition of the pediatric subspecialty workforce in terms of the distribution of women and international medical graduates (IMGs) across pediatric medical subspecialties and to determine whether the proportions of board-certified pediatric subspecialists who are women or IMGs differ between graduation cohorts. STUDY DESIGN: We used board certification data from the American Board of Pediatrics. Within each pediatric subspecialty, we classified physicians into 2 groups, ie, recent graduates, defined as those who completed medical school after January 1, 1987, and nonrecent graduates, who completed medical school before that date. We calculated the percentage of female physicians for each subspecialty and computed 95% confidence intervals around those estimates to identify male-dominated subspecialties. Using Pearson chi2 tests, we compared the percentages of women between the 2 graduation cohorts for each subspecialty. Similar calculations were performed for the percentage of IMGs in each subspecialty. Sensitivity analyses were performed with data from the 2002 American Medical Association Physician Masterfile. RESULTS: For 9 of 16 pediatric medical subspecialties studied, the percentages of board-certified women were significantly greater in the recent cohort than in the nonrecent cohort. Subspecialties that remain predominantly male in the recent graduation cohort include cardiology, critical care medicine, gastroenterology, pulmonology, and sports medicine. In contrast, the percentages of board-certified IMGs were significantly lower for 6 of the 16 specialties studied; endocrinology and gastroenterology remain relatively reliant on IMGs. CONCLUSIONS: For the majority of pediatric medical subspecialties, concerns that the predominance of women in pediatric training may negatively affect the supply of subspecialists are likely unfounded; however, a small number of procedure-based specialties, as well as sports medicine, continue to rely disproportionately on men. There do not seem to be consistent differences in the role of IMGs across the pediatric medical subspecialties between recent and nonrecent graduates, which may reflect differing tendencies to become certified.

Certification↗