Systems changes to prevent severe hyperbilirubinemia and promote breastfeeding: pilot approaches.

Providing safe and effective care requires coordination among the multiple levels of the health care system. These levels comprise the newborn (patient, family and community), nursery or primary care practice (microsystem), hospital or managed care organization (macro-organization) and policy, payment or regulatory issues (environmental context). Contemporary care practices associated with childbirth and early newborn care often reflect disruptions in coordination of these processes and place newborns at risk for poor outcomes. For example, with routine early postpartum discharge, often at less than 48 h after vaginal birth, the peak of serum bilirubin at 3 to 5 days of age typically occurs at home, rather than observed by clinicians in a newborn nursery. In addition, lactation is rarely well established by early discharge and support is often inadequate, increasing the risk of hyperbilirubinemia and discontinuation of breastfeeding. Also, late preterm infants are frequently cared for in the newborn nursery, although they often have difficulty establishing oral feeding and are at substantially higher risk for severe hyperbilirubinemia than infants born at term. Finally, pediatric follow-up is often delayed beyond the first week, after the optimal time for continued assessment of jaundice and lactation. The American Academy of Pediatrics Safe and Healthy Beginnings Initiative, a pilot quality improvement project, will target newborn nurseries, primary care practices and coordination between these sites using a systems-based approach to facilitate implementation of the 2004 guideline for management of hyperbilirubinemia.

Anatomy of a patient safety event: a pediatric patient safety taxonomy.

BACKGROUND: Idiosyncratic terminology and frameworks in the study of patient safety have been tolerated but are increasingly problematic. Agreement on standard language and frameworks is needed for optimal improvement and dissemination of knowledge about patient safety. METHODS: Patient safety events were assessed using critical incident analysis, a method used to classify risks that has been more recently applied to medicine. Clinician interviews and clinician reports to a web based reporting system were used for analysis of hospital based and ambulatory care events, respectively. Events were classified independently by three investigators. RESULTS: A pediatric patient safety taxonomy, relevant to both hospital based and ambulatory pediatric care, was developed from the analysis of 122 hospital based and 144 ambulatory care events. It is composed of four main categories: (1) problem type; (2) domain of medicine; (3) contributing factors in the patient (child-specific), environment (latent conditions) and care providers (human factors); and (4) outcome or result of the event and level of harm. A classification of preventive mechanisms was also developed. Inter-rater reliability of classifications ranged from 72% to 86% for sub-categories of the taxonomy. CONCLUSIONS: This patient safety taxonomy reflects the nature of events that occur in both pediatric hospital based and ambulatory care settings. It is flexible in its construction, permits analysis to begin at any point, and depicts the relationships and interactions of elements of an event.

Improving preventive service delivery through office systems.

OBJECTIVE: Rates of childhood immunizations and other preventive services are lower in many practices than national goals and providers' own estimates. Office systems have been used in adult settings to improve the delivery of preventive care, but their effectiveness in pediatric practices is unknown. This study was designed to determine whether a group of primary care practices in 1 community could implement office-based quality improvement systems that would significantly improve their delivery of childhood preventive services. The study was part of a larger community-wide intervention study reported in a preceding study. METHODS: All the major providers of primary care to children in 1 community were recruited and agreed to participate (N = 8 practices). Project staff worked on-site with improvement teams in each practice to develop tailored systems to assess and improve the delivery of immunizations and screening for anemia, tuberculosis, and lead exposure. Office-based quality improvement systems typically involved some combination of chart prescreening, risk assessment forms, Post-it prompts, flow-sheets, reminder/recall systems, and patient education materials. Office systems also often involved redistributing responsibilities among office staff. RESULTS: All 8 participating practices created improvement teams. Project staff met with the practices 10 to 15 times over 12 months. After the period of office assistance, the overall rates for all preventive services except tuberculosis screening increased by amounts that were both clinically and statistically significant. Absolute percent improvements included: complete immunizations at 12 months, 7%; complete immunizations at 24 months, 12%; anemia screening, 30%; lead screening, 36%. The amount of improvement achieved varied considerably between practices. CONCLUSIONS: Office systems and the principles of quality improvement that underlie them seem to be effective in improving the delivery of childhood preventive services. Important predisposing factors may exist within practices that affect the likelihood that an individual practice will make significant improvements. prevention, immunizations, improvement, office systems, primary care.

Principles of patient safety in pediatrics.

The American Academy of Pediatrics and its members are committed to improving the health care system to provide the best and safest health care for infants, children, adolescents, and young adults. In response to a 1999 Institute of Medicine report on building a safer health system, a set of principles was established to guide the profession in designing a health care system that maximizes quality of care and minimizes medical errors through identification and resolution. This set of principles provides direction on setting up processes to identify and learn from errors, developing performance standards and expectations for safety, and promoting leadership and knowledge.

Institutional policies of U.S. medical schools regarding tenure, promotion, and benefits for part-time faculty.

PURPOSE: To collect data on institutional policies regarding tenure, promotions, and benefits for part-time faculty at U.S. medical schools and determine the extent to which part-time work is a feasible or attractive option for academic physicians. METHOD: In July 1996, the authors sent a 29-item questionnaire regarding tenure, promotions, and benefit policies for part-time faculty to respondents identified by the deans' offices of medical schools in the United States and Puerto Rico. Responses were analyzed using descriptive statistics and chi-square analyses. RESULTS: Respondents from 104 of 126 medical schools (83%) completed the questionnaire; 58 responded that their schools had written policies about tenure, promotion, or benefits for part-time faculty. Tenure. Of the 95 medical schools with tenure systems, 25 allowed part-time faculty to get tenure and 76 allowed for extending the time to tenure. Allowable reasons to slow the tenure clock included medical leave (65), maternity leave (65), paternity leave (54), other leave of absence (59). Only 23 allowed part-time status as a reason to slow the tenure clock. Policies written by the dean's office and from schools in the midwest or west were more favorable to part-time faculty's being allowed to get tenure. Promotions. The majority of respondents reported that it was possible for part-time faculty to serve as clinical assistant, assistant, associate, and full professors. Benefits. The majority of schools offered retirement benefits and health, dental, disability, and life insurance to part-time faculty, although in many cases part-time faculty had to buy additional coverage to match that of full-time faculty. CONCLUSIONS: Most medical schools do not have policies that foster tenure for part-time faculty, although many allow for promotion and offer a variety of benefits to part-time faculty.

PCNA bearing structures are retained in apoptotic phase of childhood ALL cell cycle.

BACKGROUND: Drug resistance to DNA directed therapy may depend on proliferative as well as apoptotic cell fraction. PCNA/Ki67 ratio excess, possibly reflecting DNA excision repair, is of additional interest to drug resistance in MTT testing. The cell cycle phase/antigen expression pattern in childhood acute lymphoblastic leukemia (ALL) is not known. AIMS: To study the relationship between nuclear expression of PCNA, Ki-67 and Frag-EL positivity in childhood ALL. METHODS: 1.3.1. Study Groups. Diagnostic bone marrow trephine biopsies of 32 consecutive unselected cases of childhood ALL were included in the study. 1.3.2. Immunohistochemistry. Commercially available Moab PCNA (PC10, DAKO, USA), Ki-67 (MM1, NovaCastra, UK) were used to label cycling cells in routinely processed 5 microns paraffin sections. 1.3.3. In-Situ Labelling of Apoptotic Cells. The 3'-OH ends of apoptosis specific DNA fragments were labelled in-situ on subsequent 10 microns sections (Frag-EL, CalBiochem, USA). 1.3.4. Quantitation. After blinding and randomisation, 10 systematic random fields of > 20 nuclei and nuclear size bias correction was used to determine positive nuclei fraction. RESULTS: While the sum of apoptotic and proliferative cell fraction (Ki-67 + Frag-EL%) equalled 100% in 5/32 cases, PCNA expression into at least the early phases of apoptosis ([%PCNA-%K-67] > [100-%Frag-EL] was found in 17/32 cases. CONCLUSIONS: PCNA/Ki67 ratio excess may not reflect DNA excision repair activity but rather slow degradation of antigen bearing structures limiting relevance to drug resistance study.

Apoptosis corrected proliferation fraction in childhood ALL is related to karyotype.

BACKGROUND: Tumour doubling time, a parameter in drug sensitivity testing, reflects both cell proliferation and apoptosis. Variable apoptosis fractions may explain the poor correlation of S-fraction and drug response. DNA aneuploidy (reflecting intrinsic DNA instability) may, by increasing apoptosis, affect drug response. AIM: To assess the relationship between apoptosis corrected proliferation fraction and DNA ploidy in childhood acute lymphoblastic leukemia (ALL). METHODS: 1.3.1. Study Groups. Thirty two consecutive, unselected diagnostic cases of childhood ALL were included in the study. 1.3.2. Karyotype. A normal karyotype was found in 15 cases (7M, 8F, age 8 m-12 yrs); high hyperdiploid aneuploidy (DNA index > 1.5) was found in 7 patients (1M, 7F, age 3-12 yrs) whereas complex karyotypic anomalies, but with 2n or near 2n DNA were present in 10 patients (7M, 3F, age 1 y 7 m -16 yrs). 1.3.3. Proliferation Fraction Assessment. Immunocytochemical demonstration of S-phase associated nuclear expression of the Ki-67 antigen (MM1, NovaCastra, UK). 1.3.4. Apoptosis Fraction Assessment. Binding of a horse radish peroxidase labelled DNA probe for the 3'-OH ends of apoptosis derived Klenow fragments (Frag-EL, CalBiochem, USA). 1.3.5. Quantitation. Computer assisted image analysis (Quantimet 570C), of 10 systematically random fields of a minimum of 20 nuclei each. A nuclear size bias correcting counting frame and rule were used to correct for cell proliferation associated nuclear volume increase and for the expected nuclear volume reduction resulting from apoptosis. RESULTS: Corrected for apoptosis, proliferation fraction was highest (mean 57.5%, range 1-100) in poor prognosis, complex karyotype anomalies. Good prognosis, high hyper diploidy showed significantly lower proliferation rates (mean 24.7%, range 12-40) (p < 0.01, t-test). CONCLUSION: Apoptosis corrected cell proliferation rate in childhood ALL is not independent of karyotype abnormality which may partly explain a relation to therapy response and prognosis.

Differential kinetics of drug resistance in human leukaemic cells measured by SCGE/CLSM.

BACKGROUND: New analogues of DNA directed chemotherapy moieties are available for comparative efficacy testing in human neoplastic disease. In addition to MTT testing direct assessment of DNA excision repair activity after direct exposure of marrow cells may provide information on relative DNA effects in vitro. AIMS: To assess the ability of SCGE/high resolution CLSM to detect differences in drug resistance between human neoplastic cell lines in the DNA excision repair response to chemotherapy. METHODS: Eight human leukaemia samples (4 childhood, 4 adult) were exposed to 1 hour of single concentrations of daunorubicin, DaunoXome (courtesy NeXstar Pharmaceuticals Inc, USA), cyclophosphamide and 4-hydroperoxycyclophosphamide (4-HC, courtesy Dr. M. Colvin, Duke University, USA), followed by SCGE/high resolution CLSM with quantitation of total excised DNA. Differences between cases/drug moieties/exposures were analysed. RESULTS: Although generally equal effect dose levels for DaunoXome were lower than for standard daunorubicin, patients/individual neoplastic cells differed considerably in optimal dose levels. Conventional cyclophosphamide in comparison to 4-HC showed inconsistent results indicating considerable differences in the level of drug resistance to the conventional product. CONCLUSIONS: Direct testing for drug resistance patterns in DNA directed drug moieties by SCGE/CLSM reveals individual variability of human malignant cell lines warranting comparison with results of MTT testing and in-vivo patient response.

Demonstration of differences in drug resistance by direct testing of DNA excision repair activity following standard and liposomal daunorubicin exposure in normal paediatric marrow using high resolution CLSM.

BACKGROUND: High resolution Confocal Laser Scanning Microscopy (CLSM) may be applied to testing of drug resistance in vitro in clinical setting. Rapid analysis of DNA damage by precise quantitation of excised DNA in bone marrow samples exposed to potential treatment moieties directly after isolation but the relative sensitivity of the integrated method is as yet untested. AIMS: To test the clinical applicability of SCGE/high resolution CLSM for differences in drug resistance in marrow cells. METHODS: Cells from normal bone marrow samples were exposed for identical periods and at 4 concentrations to either 1 hour of standard Daunorubicin (.5, 1, 1.5, 2 micrograms/ml) or 8 hours DaunoXome (courtesy of NeXstar Inc, USA) (.05, .1, .15, .2 microgram/ml). After 2 and 6 hours recovery, cells were harvested for SCGE, randomization, analysis of tail length, total excised DNA and fragment size distribution using high resolution CLSM. RESULTS: Tail length and fragment size distribution was not, but total excised DNA was significantly increased after 0.1 microgram/ml Liposomal Daunorubicin (DaunoXome) compared to 1.0 microgram/ml Daunorubicin. CONCLUSION: SCGE/high resolution CLSM effectively demonstrated differences in Daunorubicin resistance of human marrow cells to alternative formulations. The method has potential for use in clinical testing of neoplastic cell drug resistance.

High resolution confocal laser scanning microscopy analysis of DNA excision repair capability in small volume marrow samples exposed to DNA directed treatment moieties.

BACKGROUND: Assessment of resistance to drug moieties in tissue culture is complicated by limited sample, clonal selection and alteration of cycling fraction and cycle duration in clonally mixed lesions. DNA damage assessment by single cell gel electrophoresis (SCGE) of excised DNA is limited by non-linear analysis in fluorescent light microscopy. Confocal Laser Scanning Microscopy (CLSM) with high N.A. magnification allows for quantitation of total excised DNA fragment size distribution but is still limited by the large volume required for labour intensive SCGE, precluding multi-exposure clinical testing. AIMS: To optimise sample requirement for SCGE and CLS. METHODS: Standard slide mounted bed gels were punched with multiple coded 6 mm wells and filled with suspensions of cells subjected to drug/concentration variations. After SCGE, 30 microns frozen sections were prepared of each well and mounted in ethidium bromide solution on multi-well hydrophilic slides to allow for short working distance of high resolution CLSM in a Zeiss Axiovert L410 SM. Testing for feasibility, reproducibility and consistency used both cultured standard leukaemic cell lines, normal human control marrow and clinical samples. RESULTS AND CONCLUSION: Multiple well SCGE followed by frozen section, high resolution CLSM allows for rapid analysis of high numbers of multiple drug exposure permutations clinically required.

Internal medicine-pediatrics combined residency graduates: what are they doing now? Results of a survey.

BACKGROUND: While the number of internal medicine-pediatrics (med/peds) residency training programs has increased considerably in the past decade, questions continue to be raised about career paths of the graduates of these programs. It is uncertain whether med/peds graduates follow a generalist career path and whether they continue to practice both specialties. OBJECTIVE: To determine the career outcomes of graduates of med/peds residency programs. DESIGN: A survey questionnaire of graduates of med/peds residency programs. METHODS: The computer databases of the American Board of Pediatrics and the American Board of Internal Medicine were used to identify 1482 individuals who had completed training in combined med/peds residency programs between 1986 and 1995 and who had applied to either board for certification. The survey questionnaire was mailed to all graduates identified. MAIN OUTCOME MEASURES: Time spent in professional activity (patient care, teaching, administration, and research), site of principal clinical activity, ages of the patient population, types of hospital privileges, practice organization, subspecialty activity, night and weekend coverage arrangements, community size of practice, involvement in teaching, and membership in professional organizations. RESULTS: Of the total group of 1482 graduates, 87.3% are certified by the American Board of Internal Medicine, 91.3% by the American Board of Pediatrics, and 81.6% by both boards. The survey was completed by 1005 graduates (67.8%). The principal activity of almost 70% of the graduates was direct patient care. Most graduates cared for patients of all ages. More than half of all respondents noted that their principal clinical site is a community office practice. Eighty-five percent managed patients who require hospitalization. Approximately 50% of respondents had a medical school appointment. CONCLUSIONS: This study, the largest survey to date of med/peds graduates, provides strong evidence that most med/peds graduates are practicing generalists who care for adults and children. In addition, the fact that 80% of graduates achieve dual board certification suggests that these physicians are well qualified to care for the spectrum of health care needs of children and adults. Because the changing US health care system mandates a strong primary care base, these physicians will play a small but important role in providing high-quality generalist care.

Current positions of graduates of internal medicine-pediatrics training programs.

OBJECTIVE: To determine what positions graduates of internal medicine-pediatrics programs currently hold. DESIGN: A survey of the program directors of residencies in internal medicine-pediatrics. PARTICIPANTS: Program directors of the 85 internal medicine-pediatrics training programs listed in the 1993-1994 Graduate Medical Education Directory. MAIN OUTCOME MEASURES: A 1-page survey that described the current positions of trainees graduating between 1987 and 1993. RESULTS: Seventy-four (87%) of the 85 program directors completed the survey. Of the 708 graduates reported on, 68% were practicing as generalists. The generalists of this cohort (n = 480) were primarily in private practice settings (n = 390, 81%) and most were practicing internal medicine-pediatrics (n = 416, 85%). Only 12% of the generalists had chosen to practice either pediatrics or internal medicine. Twenty-one percent of the total graduates had entered subspecialty training. CONCLUSIONS: To our knowledge, the sample of 708 graduates is the largest survey of graduates of internal medicine-pediatrics programs to date and shows that 68% of graduates are practicing in primary care fields. Graduates of internal medicine-pediatrics programs should be considered as an important source of primary care physicians.

Aortic valve grafts in the rat: evidence for rejection.

OBJECTIVE: The histopathologic changes of fresh rat aortic valve allografts over time and the effect of cryopreservation were examined. METHODS: Fifty-six syngeneic and allogeneic rat aortic valves were transplanted, either fresh or after cryopreservation, and then at different time points they were explanted and histologically examined in a blinded fashion. RESULTS: Histopathologic changes in the first week are similar in syngeneic and allogeneic grafts. Fresh syngeneic grafts and leaflets retained normal structure up to 56 days. Allogeneic grafts showed retrovalvular thrombus formation with leaflet ghosts and neointimal proliferation. Cryopreservation did not alter this process. CONCLUSIONS: Cardiac allograft valves in the rat model undergo changes that are characteristic of cell-mediated rejection and lead to valve failure.

Linking clinical and public health approaches to improve access to health care for socially disadvantaged mothers and children. A feasibility study.

OBJECTIVE: To test the feasibility of combining home- and office-based interventions to improve access to health care and health outcomes of Medicaid-eligible mothers and infants. DESIGN: Randomized trial in 2 counties in North Carolina (1 rural, 1 urban). Information on health and developmental outcomes was obtained by face-to-face interviews, medical chart abstractions, hospital medical records, and state data tapes. PARTICIPANTS: Ninety-three Medicaid-eligible first-time pregnant women in their third trimester and their subsequently born infants, who were followed up until they were 6 months old, and 3 pediatric practices and 1 family practice. INTERVENTIONS: Coordinated home visit and office intervention, office intervention, and usual care. Home visits by 3 public health nurses provided parental education and social support and linked families with needed community resources. Women in the office intervention group were encouraged to seek health care for their infants from one of the primary care practices. Participating offices received assistance with Medicaid billing, help developing a system to improve preventive care, and customized patient education materials. RESULTS: Mothers reported that the nurses helped them in areas related to the content of the program. An office system for prevention was developed and implemented in all 4 practices for study patients. Families in the intervention groups were more likely than control families to have had a prenatal visit with a pediatrician (P = .01, chi 2), a primary care office as the regular source of sick care (P = .02, chi 2), and less waiting time (P = .02, Student t test). They were also more likely to recall receiving patient education materials (P = .007, chi 2). CONCLUSIONS: It is feasible to link clinical and public health approaches to improve the quality and effectiveness of care for socially disadvantaged children. Such interventions should be tested in defined populations.

The delivery of immunizations and other preventive services in private practices.

OBJECTIVES: To measure the proportion of children cared for in private practices who are fully immunized and have been screened for anemia, tuberculosis (TB), and lead poisoning by 2 years of age. DESIGN: Cross-sectional chart review. SETTING: Fifteen private pediatric practices in central North Carolina (11 chosen randomly). PATIENTS: One thousand thirty-two randomly selected 2-year-old children. MAIN OUTCOME MEASURES: Proportion of children immunized and screened for anemia, TB and lead poisoning by 24 months of age and immunization and screening rates of the practices. RESULTS: Sixty-one percent of the children were fully immunized at 24 months of age; the rates among practices varied widely (38% to 82%). Sixty-eight percent of the children had been screened for anemia, 57% had been screened for TB, and 3% had been screened for lead poisoning. Physicians overestimated the proportions of fully immunized children in their practices by an average of 10% (range, -3% to 17%). The median number of well child visits by 2 years of age was 5 (range, 0 to 14), and only 19% of the entire sample made 8 or more well child visits, the number recommended by the American Academy of Pediatrics in the first 18 months of life. The numbers of well child and non-well child visits were the strongest predictors of complete immunization. Practice characteristics associated with being fully immunized included the use of preventive services prompting sheets (eg, flow sheets) in the medical records, not seeing the same physician for all well child care, and having nurses review patients' immunization status during their visits to the office. CONCLUSIONS: Underimmunization and inadequate screening are significant problems in private pediatric practices in North Carolina. Physicians are unaware of the rates of underimmunization in their offices.

What mothers say about why poor children fall behind on immunizations. A summary of focus groups in North Carolina.

OBJECTIVES: To develop a more thorough understanding of the factors that impede poor parents' utilization of health care services for their children and to refine interventions to improve immunization rates. METHODS: We conducted focus group sessions with mothers whose children received care at the health departments in five North Carolina counties. Mothers were uninsured or were receiving Medicaid. A total of 50 women participated; group size varied from three to seven mothers. RESULTS: Socially disadvantaged mothers faced barriers at multiple points in the process of obtaining preventive care for their children. Organizational barriers, such as a lack of flexibility in scheduling and long waiting times, were exacerbated by personal barriers, such as a lack of reliable transportation, chaotic home environments, and employment conflicts. Lack of knowledge regarding the timing of childhood immunizations and misperceptions about the safety of immunizations were also important obstacles. Mothers made several suggestions, such as changes in scheduling, greater assistance with transportation, improved waiting facilities, and increased health education. CONCLUSIONS: Our study suggests that even with improved financing of well-child care, many important barriers to adequate immunization will remain. Many of the changes that mothers in our focus groups advocated are not related to insurance coverage and would be simple and inexpensive to implement. To help with these changes, we developed a checklist for use by health departments to determine which organizational barriers exist at their facility and suggest strategies to overcome the problems. Organizational, personal, and attitudinal barriers pose serious problems for socioeconomically disadvantaged families. To improve vaccination rates for children, new personnel and programs are probably less important than careful strategies to maximize existing resources.

The rest of the access-to-care puzzle. Addressing structural and personal barriers to health care for socially disadvantaged children.

A mother brings her 2-year-old child to the office at 4:30 Friday afternoon. The child has been seen only once in the practice for an episode of otitis media. The child missed her follow-up appointment. When the receptionist asks why the child is here, the mother responds that she was able to get a ride today with a neighbor who has an appointment with another physician in the practice. The child is not covered by health insurance. The mother did not bring her immunization record and is not certain what preventive care the child has received in the past.

Medicare reimbursement for preventive care. Changes in performance of services, quality of life, and health care costs.

A randomized, controlled trial was conducted to assess the effects of a financial and office systems intervention to increase preventive care in physicians' offices for patients aged 65 years or older. A total of 1,914 patients from 10 primary-care medical practices in central North Carolina were randomized within practices to an intervention and a usual-care control group. The intervention consisted of full Medicare reimbursement to physicians for preventive care and health promotion packages (thus making these services free for patients), regular prompting of physicians to routinely schedule preventive care visits, a new office system in which nurses carried out many preventive procedures, and a form for charting preventive care. The performance of screening tests dramatically increased in the intervention group relative to control (P < 0.001), but there was evidence of lack of follow-up of abnormal findings by physicians. At the 2-year follow-up, there were minimal differences between intervention and control groups in health-related quality-of-life indicators. Relative to the $294 per patient 3-year cost to Medicare for waivered services, the intervention was reimbursed-cost neutral or slightly cost reducing ($190 over 3 years) for Medicare. It is concluded that adding reimbursement for preventive services to Medicare--even with the office systems changes made in this study--will not by itself lead to effective implementation of preventive services in community medical practices. To enhance patient benefit from preventive services, greater attention needs to be focused on an organized approach to patient follow-up.