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BACKGROUND: Timely error detection including feedback to clinical staff is a prerequisite for focused improvement in patient safety. Real time auditing, the efficacy of which has been repeatedly demonstrated in industry, has not been used previously to evaluate patient safety. Methods successful at improving quality and safety in industry may provide avenues for improvement in patient safety. OBJECTIVE: Pilot study to determine the feasibility and utility of real time safety auditing during routine clinical work in an intensive care unit (ICU). METHODS: A 36 item patient safety checklist was developed via a modified Delphi technique. The checklist focused on errors associated with delays in care, equipment failure, diagnostic studies, information transfer and non-compliance with hospital policy. Safety audits were performed using the checklist during and after morning work rounds thrice weekly during the 5 week study period from January to March 2003. RESULTS: A total of 338 errors were detected; 27 (75%) of the 36 items on the checklist detected >or=1 error. Diverse error types were found including unlabeled medication at the bedside (n = 31), ID band missing or in an inappropriate location (n = 70), inappropriate pulse oximeter alarm setting (n = 22), and delay in communication/information transfer that led to a delay in appropriate care (n = 4). CONCLUSIONS: Real time safety audits performed during routine work can detect a broad range of errors. Significant safety problems were detected promptly, leading to rapid changes in policy and practice. Staff acceptance was facilitated by fostering a blame free "culture of patient safety" involving clinical personnel in detection of remediable gaps in performance, and limiting the burden of data collection.

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OBJECTIVE: To make measurable improvements in the quality and cost of neonatal intensive care using a multidisciplinary collaborative quality improvement model. DESIGN: Interventional study. Patient demographic and clinical information for infants with birth weight 501 to 1500 g was collected using the Vermont Oxford Network Database for January 1, 1994 to December 31, 1997. SETTING: Ten self-selected neonatal intensive care units (NICUs) received the intervention. They formed 2 subgroups (6 NICUs working on infection, 4 NICUs working on chronic lung disease). Sixty-six other NICUs served as a contemporaneous comparison group. PATIENTS: Infants with birth weight 501 to 1500 g born at or admitted within 28 days of birth between 1994 and 1997 to the 6 study NICUs in the infection group (n = 3063) and the 66 comparison NICUs (n = 21 509); infants with birth weight 501 to 1000 g at the 4 study NICUs in the chronic lung disease group (n = 738). INTERVENTIONS: NICUs formed multidisciplinary teams that worked together under the direction of a trained facilitator over a 3-year period beginning in January 1995. They received instruction in quality improvement, reviewed performance data, identified common improvement goals, and implemented "potentially better practices" developed through analysis of the processes of care, literature review, and site visits. MAIN OUTCOME MEASURES: The rates of infection after the third day of life with coagulase-negative staphylococcal or other bacterial pathogens for infants with birth weight 501 to 1500 g, and the rates of oxygen supplementation or death at 36 weeks' adjusted gestational age for infants with birth weight 501 to 1000 g. RESULTS: Between 1994 and 1996, the rate of infection with coagulase-negative staphylococcus decreased from 22.0% to 16.6% at the 6 project NICUs in the infection group; the rate of supplemental oxygen at 36 weeks' adjusted gestational age decreased from 43.5% to 31.5% at the 4 NICUs in the chronic lung disease group. There was heterogeneity in the effects among the NICUs in both project groups. The changes observed at the project NICUs for these outcomes were significantly larger than those observed at the 66 comparison NICUs over the 4-year period from 1994 to 1997. CONCLUSION: We conclude that multidisciplinary collaborative quality improvement has the potential to improve the outcomes of neonatal intensive care.

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OBJECTIVE: To make measurable improvements in the quality and cost of neonatal intensive care using a multidisciplinary collaborative quality improvement model. DESIGN: Interventional study. Data on treatment costs were collected for infants with birth weight 501 to 1500 g for the period of January 1, 1994 to December 31, 1997. Data on resources expended by hospitals to conduct this project were collected in a survey for the period January 1, 1995 to December 31, 1996. SETTING: Ten self-selected neonatal intensive care units (NICUs) received the intervention. They formed 2 subgroups (6 NICUs working on infection, 4 NICUs working on chronic lung disease). Nine other NICUs served as a contemporaneous comparison group. PATIENTS: Infants with birth weight 501 to 1500 g born at or admitted within 28 days of birth between 1994 and 1997 to the 6 study NICUs in the infection group (N = 2993) and the 9 comparison NICUs (N = 2203); infants with birth weight 501 to 1000 g at the 4 study NICUs in the chronic lung disease group (N = 663) and the 9 comparison NICUs (N = 1007). INTERVENTIONS: NICUs formed multidisciplinary teams which worked together to undertake a collaborative quality improvement effort between January 1995 and December 1996. They received instruction in quality improvement, reviewed performance data, identified common improvement goals, and implemented "potentially better practices" developed through analysis of the processes of care, literature review, and site visits. MAIN OUTCOME MEASURES: Treatment cost per infant is the primary economic outcome measure. In addition, the resources spent by hospitals in undertaking the collaborative quality improvement effort were determined. RESULTS: Between 1994 and 1996, the median treatment cost per infant with birth weight 501 to 1500 g at the 6 project NICUs in the infection group decreased from $57 606 to $46 674 (a statistical decline); at the 4 chronic lung disease hospitals, for infants with birth weights 501 to 1000 g, it decreased from $85 959 to $77 250. Treatment costs at hospitals in the control group rose over the same period. There was heterogeneity in the effects among the NICUs in both project groups. Cost savings were maintained in the year following the intervention. On average, hospitals spent $68 206 in resources to undertake the collaborative quality improvement effort between 1995 and 1996. Two thirds of these costs were incurred in the first year, with the remaining third in the second year. The average savings per hospital in patient care costs for very low birth weight infants in the infection group was $2.3 million in the post-intervention year (1996). There was considerable heterogeneity in the cost savings across hospitals associated with participation in the collaborative quality improvement project. CONCLUSION: Cost savings may be achieved as a result of collaborative quality improvement efforts and when they occur, they appear to be sustainable, at least in the short run. In high-cost patient populations, such as infants with very low birth weights, cost savings can quickly offset institutional expenditures for quality improvement efforts.

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In recent years, states have increasingly turned to managed care arrangements for financing and delivering health services to Medicaid beneficiaries. In 1996, approximately 40% of all Medicaid recipients were enrolled in some form of managed care. The rapid escalation of managed care in this population has been fueled by states' desire to slow the growth of Medicaid expenditures and by the trend toward managed care enrollment in the private health insurance industry. The effect of managed care on cost containment in the Medicaid program may be limited, however, because 85% to 90% of Medicaid managed care enrollees are women of childbearing age and children, who together account for 69% of Medicaid recipients, but only 26% of program costs. Nonetheless, the increase in managed care enrollment in this population may have a profound impact on health service delivery and health outcomes for U.S. children, approximately 20% of whom received health benefits through the Medicaid program in 1995. In the future, the proportion of Medicaid-eligible children enrolled in managed care will likely increase as a result of recent legislation that relaxed the requirement that states seek federal approval prior to mandating managed care enrollment for Medicaid beneficiaries. More states are relying on fully capitated arrangements as the preferred type of managed care for Medicaid recipients, despite the relative lack of experience many of these plans have in serving this low-income population. Moreover, managed care organizations have few incentives to enroll chronically or disabled children with higher-than-average expected costs. Without mechanisms in place that adequately adjust capitated rates to account for these higher-cost enrollees, managed care organizations may lose money, and children with the greatest health care needs may be underserved. As mandatory managed care enrollment for Medicaid recipients increases nationwide, states should carefully monitor changes in program costs and quality as well as implications for the delivery of pediatric health services and health outcomes.

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OBJECTIVE: We sought to determine whether paternal size at birth and during young adulthood influences the birth weight of the offspring. STUDY DESIGN: This historic cohort study followed up girls born in Copenhagen during 1959 to 1961. Their pregnancies in 1974 to 1989 were traced through the Danish Population Register, and the Personal Identification Numbers of the fathers of the children were obtained. Paternal birth weight was obtained from midwifery records and adult stature from military draft records. RESULTS: Compared with fathers who weighed at least 4 kg at birth, fathers who weighed 3 to 3.99 kg at birth had infants who were 109 gm lighter, and fathers who weighed <3 kg had infants who were 176 gm lighter after adjustment for maternal birth weight and adult stature, smoking, and medical and socioeconomic factors. After adjustment, fathers in the lowest quartile of adult body mass index had infants that were 105 gm lighter than those of fathers in the highest quartile. Both paternal birth weight and adult body mass index exhibited significant trends in association with infant birth weight. CONCLUSION: Independently of maternal size, the father's physical stature, particularly his own size at birth, influences the birth weight of his children.

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OBJECTIVES: The purpose of this study was to expand the search for risk factors for low birthweight and to find new explanations for the ethnic-group disparities in birth outcomes. METHODS: The subjects were 1150 pregnant women from six ethnic groups (African American, Chinese, Dominican, Puerto Rican, Mexican, and White) who received prenatal care at clinics in New York and Chicago between December 1987 and December 1989. Two interviews were conducted during the second and third trimesters of pregnancy. RESULTS: The study, after controlling for poverty and other birthweight correlates, showed that living in public housing and believing that chance plays a major role in determining one's health status were negatively associated with birthweight. Having a stable residence was positively related to birthweight. Material hardship, social adversity, perceived racial discrimination, physical abuse, anxiety, and depression were not associated with birthweight. CONCLUSIONS: The negative role of an impoverished living environment and feelings of helplessness, as well as the positive role of having a stable form of social support, suggest new directions for research on the causes of low birthweight and the ethnic disparities in US birth outcomes.

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BACKGROUND: The outcomes for very low birth weight infants vary among neonatal intensive care units (NICUs), but the reasons for this variation are not well understood. We used the database of a large neonatology research network to determine whether either admission characteristics of the infants or specific characteristics of the units such as annual patient volume and the presence of a pediatric residency program could account for observed differences in neonatal mortality rates among units. METHODS: We studied 7672 infants with birth weights from 501 to 1500 g treated during 1991 and 1992 at 62 NICUs participating in the Vermont Oxford Network Database. RESULTS: Overall, 14.7% of the study infants died within 28 days of birth (interquartile range 9.9% to 18.1%). The ratio of the number of observed deaths at an NICU to the number of deaths predicted based on the characteristics of infants treated at the NICU (standardized neonatal mortality ratio, [SNMR]) varied significantly among units (range 0 to 1.69, z = 4.24). There was no association between annual patient volume and either mortality rate (r = .17) or SNMR (r = .22). Observed mortality rates (17% vs 13%) and SNMR (1.04 vs .87) were both higher at the 24 hospitals with pediatric residency training programs than at the 38 hospitals without such programs. Hospitals with residency programs had higher average annual patient volumes (104 vs 66). In an analysis simultaneously adjusting for patient characteristics, volume, and presence of a residency program, neither volume (odds ratio [OR] per 10 additional cases treated 1.01, 95% confidence interval [CI], .98 to 1.04) nor presence of a pediatric residency program (OR 1.18, 95% CI, .94 to 1.47) was significantly associated with neonatal mortality risk. CONCLUSION: There are differences in neonatal mortality rates among NICUs that cannot be explained by differences in the measured admission characteristics of the infants, suggesting that the effectiveness of medical care varies among units. Neither the annual volume of very low birth weight infants treated in a unit nor the presence of a pediatric residency training program was independently associated with neonatal mortality rates for very low birth weight infants.

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Clinical practice guidelines are becoming pervasive in pediatrics and newborn medicine. They have spanned a wide range of primary care practice parameters from treating otitis media with effusion, to performing complex surgery for congenital heart disease, and management of respiratory distress syndrome and coordinating discharge from the neonatal intensive care unit. Administrators believe that using clinical practice parameters reduces health care costs, improves quality of care, and limits malpractice liability. Practice parameters and guidelines have grown in use because powerful interests-third-party payers, insurers, and health maintenance organizations, as well as hospital administrators bent on reducing variable costs of care and contracting for capitated care-champion their development, implementation, and monitoring. Economic credentialing of physicians with excessive variances without risk-adjusting for other than average patients is problematic and remains unchecked partly because of the fundamental characteristics of the evolving health care industry in which costs are more easily measured than quality. For highly autonomus physicians this standardization of medical decision making may represent a difficult transition into corporate practice by realigning traditional values of the doctor-patient relationship. However, because guidelines are almost certainly here to stay, pediatricians and neonatologists need to think critically about how their content and method of implementation, monitoring, and modification may influence medical teaching and decision making in the future. If guidelines are introduced primarily as a cost savings or containment tool that ignores the impact on the quality of care and restricts necessary care for infants and children, especially those with chronic illness or who are developmentally at risk, then neonatologists and pediatricians must be quick and determined to challenge the potentially damaging use of practice parameters or guidelines. Furthermore, there are many medicolegal implications of guideline implementation that may not favor physicians and leave to hospitals, insurers, and ultimately the courts decisions regarding evidence-based practice. In this review article, we pay special attention to the guidelines developed in newborn medicine. We discuss why and how guidelines are developed and critically evaluate the available evidence describing potential benefits and drawbacks of guidelines in general. There are legal implications to the implementation of guidelines, and guidelines may increase provider susceptibility to malpractice allegations. Neonatologists and pediatricians should critically analyze the following questions when guidelines are being developed: Are clinical practice parameters the most effective means to reduce the costs of health care, or improve the quality of health care services while reducing the need for and protecting physicians from malpractice suits? Or do clinical practice guidelines more closely resemble an audit system developed by health care organizations, insurers, and others including government-sponsored health care to appease powerful interests-with limited evidence for promise and perhaps potential negative cost, quality, and malpractice liability implications? In pediatric and newborn medicine there is limited evidence that guidelines have achieved the desired goals and further analysis of their process of care and the costs of implementation is warranted.

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Medical and technological advances in the care of infants with low birth weight (less than 2,500 grams, or 5 pounds, 8 ounces) and very low birth weight (less than 1,500 grams, or 3 pounds, 5 ounces) have substantially increased the survival rate for these infants and have led to concerns about the demands their care places upon their families and society. The dollar cost of the resources used disproportionately to care for low birth weight children is one measure of the burden of low birth weight. Using analyses of national survey data for 1988 for children ages 0 to 15, this article presents estimates of the direct incremental costs of low birth weight--costs of the resources used to care for low birth weight infants above and beyond those used for infants of normal birth weight. In 1988, health care, education, and child care for the 3.5 to 4 million children ages 0 to 15 born low birth weight between $5.5 and $6 billion more than they would have if those children had been born normal birth weight. Low birth weight accounts for 10% of all health care costs for children, and the incremental direct costs of low birth cost weight are of similar magnitude to those of unintentional injuries among children and in 1988 were substantially greater than the direct costs of AIDS among Americans of all ages in that year.

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OBJECTIVE: Our aim was to evaluate prospectively the effects of cocaine and marijuana use on pregnancy outcomes. STUDY DESIGN: A prospective multicenter cohort study was conducted at seven university-based prenatal clinics in the United States from 1984 to 1989. The cohort described herein consisted of a multiethnic population of 7470 pregnant women. Information on the use of drugs was obtained from personal interviews at entry to the study and assays of serum obtained during pregnancy. Pregnancy outcome data (low birth weight [< 2500 gm], preterm birth [< 37 weeks' gestation], and abruptio placentae) were obtained with a standardized study protocol. RESULTS: A total of 2.3% of the women used cocaine and 11.0% used marijuana during pregnancy. Cocaine use was not associated with having a low-birth-weight infant (adjusted odds ratio 0.7, 95% confidence interval 0.4 to 1.3) or a preterm birth (1.3, 0.9 to 2.0). There was no association between short-term exposure to cocaine and preterm delivery (1.1, 0.3 to 4.0). However, cocaine use was strongly associated with abruptio placentae (adjusted odds ratio 4.2, 1.9 to 9.5). Marijuana use was not associated with low birth weight (1.1, 0.9 to 1.5), preterm delivery (1.1, 0.8 to 1.3) or abruptio placentae (1.3, 0.6 to 2.8). By comparison, 35% of the women smoked cigarettes during pregnancy, and cigarette smoking was positively associated with low birth weight (1.5, 1.2 to 1.8). CONCLUSIONS: In this population of women receiving prenatal care, cocaine use was uncommon and was not related to most adverse birth outcomes. Marijuana use was relatively common and was not related to adverse pregnancy outcomes. Tobacco is still the most commonly abused drug during pregnancy, 15% of all cases of low birth weight in this study could have been prevented if women did not smoke cigarettes during pregnancy.

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The living arrangements of American children have been strongly affected by revolutionary social changes in the past 30 years. Large decreases in first-marriage rates and an increase in the likelihood of married couples to divorce have resulted in a wide diversity of living arrangements for children. In spite of increasing divorce rates, in 1990, the vast majority (71%) of the 64 million American children lived in two-parent households, and most (58%) lived with their biological parents. Since the 1970s, however, there has been a large increase in the proportion of children living with single or divorced mothers. Today, 7.3% (4.7 million) of children live with an unmarried parent, 9.1% (5.9 million) live with a divorced parent, and 7.4% (4.8 million) live with a separated or widowed parent. In each year since the 1970s, more than one million children were affected by divorce. The composition of single-parent households has also changed dramatically. The decreasing mortality rates in the past three decades among married individuals have resulted in fewer households headed by widowed parents. However, the decrease in widowed-parent households has been more than replaced by a corresponding increase in households headed by never-married women. Increasing divorce rates have resulted in more children living in stepfamilies and with divorced single mothers. Legal changes in the 1970s have resulted in an increase in the number of children living with divorced fathers. There are large differences in the living arrangements of children by ethnic group. In the past 25 years, there has been an exponential increase in the proportion of African-American children living with never-married mothers. The most common form of living arrangement for African-American children today is one-parent families.

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BACKGROUND: Two recent studies have found that infants who received intramuscular vitamin K were at twice the expected risk for cancer during childhood. Since nearly all newborns in the United States receive this drug, the public health implications of this association, if confirmed, would be substantial. METHODS: We examined the relation between vitamin K and cancer in a nested case-control study that used data from the Collaborative Perinatal Project, a multi-center, prospective study of pregnancy, delivery, and childhood. Among 54,795 children born from 1959 through 1966, 48 cases of cancer were diagnosed after the first day of life and before the eighth birthday. Each case child was matched with five randomly selected controls whose last study visit occurred at or after the age when the case child's cancer was diagnosed. Exposure to vitamin K was determined from study forms and medical records. RESULTS: Vitamin K had been administered to 68 percent of the 44 case children and 71 percent of the 226 controls for whom data were available (matched odds ratio, 0.84; 95 percent confidence interval, 0.41 to 1.71). The odds ratio was 0.47 (95 percent confidence interval, 0.14 to 1.55) for leukemia and 1.08 (95 percent confidence interval, 0.45 to 2.61) for other cancers. Sequential adjustment for potential confounding factors did not change the results substantially. CONCLUSIONS: We found no association between exposure to vitamin K and an increased risk of any childhood cancer or of all childhood cancers combined, although a slightly increased risk could not be ruled out. The benefits of neonatal vitamin K prophylaxis against hemorrhagic disease have been well described. Unless other evidence supporting an association between vitamin K and cancer appears, there is no reason to abandon the routine administration of vitamin K to newborns.

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Risk scoring is a quantitative method used to screen populations to identify persons at increased risk of developing a specific adverse health outcome. Risk scoring for preterm birth has taken the form of a simple additive score with risk factors based on clinical experience to sophisticated multivariable risk models using a large number of factors from several domains. It appears that our attempts at defining an effective risk scoring method for preterm birth have been unsuccessful. The positive predictive values (the percent of women defined as high risk that actually go on to have a preterm birth) have been relatively low (20% to 30%) and vary depending on the population studied. Several difficulties with risk scoring for preterm birth are identified. The biggest limitation of current efforts at screening for preterm birth is our ignorance of the causes of preterm birth. The role of recently defined risk factors, of the potential for synergistic relationship between risk factors, and of physician or hospital factors needs to be evaluated. Epidemiologic evidence is suggestive that preterm birth can be subclassified into preterm labor, preterm rupture of the membranes, and medically induced preterm births; however, substantial problems with misclassification, detection bias, and questionable biologic feasibility argue that these subgroups need to be validated before they can be used with confidence. Careful attention should also be paid to the statistical and methodologic limitations of risk scoring. Unless a single risk factor for a disease outcome has a relative risk over 5 and is very prevalent in the population (more than 25%), most of the disease cases will not have the risk factor. It may be unrealistic, however, to think that a single risk factor will adequately define women at high risk for preterm birth. Therefore in the future, if several lesser risk factors can be identified, multivariate modeling may prove useful in defining a valid high-risk group. In addition, attention should be paid to ensure that the risk factor assessment tools obtain accurate information and are easily reproducible among different health care providers. The reduction of preterm birth in France that occurred over a decade was accompanied by radical social changes in the ways in which the population and government perceived pregnancy and childbirth. In addition to universal access to prenatal care, population-based social changes to liberalize pregnancy leave policies and a commitment to supporting women during pregnancy were the focus of the government's commitment to reducing preterm birth.(ABSTRACT TRUNCATED AT 400 WORDS)

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Factors influencing early formula supplementation in breast-fed neonates were examined among 726 women who were delivered of their first child in one of three metropolitan Washington, DC, hospitals. Thirty-seven percent of breast-fed neonates were given supplementary formula in the hospital. Mothers who gave birth at a university hospital were more likely to breast-feed exclusively (adjusted odds ratio 3.5; 95% confidence limit 2.1 to 5.9), after adjustment for maternal demographics, hospital factors (such as time of first breast-feed, demand feeding, delivery type, and rooming-in), and the maternal breast-feeding commitment. Aside from delivery hospital, a strong predictor of formula use was the time between birth and initiation of the first breast-feed. The longer a mother waited to initiate breast-feeding the more likely she was to use formula; the adjusted odds ratios for women who initiated breast-feeding 2 to 6 hours, 7 to 11 hours, and 12 or more hours postpartum were 1.1, 0.5, and 0.2, respectively. Feeding the baby on demand, having a vaginal delivery, deciding to breast-feed before pregnancy, having a college education, and being married also were moderately, though significantly, predictive of exclusive breast-feeding. The findings suggest that hospital influences can promote formula use and indirectly shorten breast-feeding duration, particularly those hospital practices that delay early initiation of breast-feeding.

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In 1989, the authors tested the effectiveness of two response-enhancing techniques, a postage stamped or franked return envelope and a prenotification letter, in a survey of pregnancy among 10,047 resident physicians in the United States. The techniques were randomly assigned using a factorial design. No significant interactions were observed between the techniques. After two mailings, those who received a stamped return envelope had a response of 71.2%, compared with 68.2% for those who received a franked return envelope (95% confidence interval 1.3-4.9%). Men who received the stamped envelope had a 5.9% greater response than those who received the franked envelope (p less than 0.001), but the type of postage did not influence response among women (p = 0.84); this interaction was statistically significant (p = 0.006). Physicians who received a prenotification letter had a response of 69.0%, compared with 70.5% for those who did not receive the letter (95% confidence interval -3.3 to 0.2%). The authors conclude that seemingly minor changes in survey design could have saved from 12% to 19% of the total cost of the study.

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