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Biomedical subjects

P H Shiono

Publications and source records attributed to P H Shiono.

At least 19 recordsLinked to original sources

Real time patient safety audits: improving safety every day.

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.

Delphi Technique↗

Father's effect on infant birth weight.

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.

Adult↗

Clinical practice guidelines in pediatric and newborn medicine: implications for their use in practice.

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.

Health Services↗

Hospital and patient characteristics associated with variation in 28-day mortality rates for very low birth weight infants. Vermont Oxford Network.

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.

Health Care Surveys↗

Ethnic differences in birthweight: the role of lifestyle and other factors.

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.

Black or African American↗

The impact of cocaine and marijuana use on low birth weight and preterm birth: a multicenter study.

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.

Abruptio Placentae↗

The direct cost of low birth weight.

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.

Adolescent↗

Epidemiology of divorce.

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.

Child↗

The risk of childhood cancer after neonatal exposure to vitamin K.

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.

Case-Control Studies↗

A review of risk scoring for preterm birth.

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)

Discriminant Analysis↗

The effect of two mailing strategies on the response to a survey of physicians.

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.

Confidence Intervals↗

Spontaneous and induced abortion among resident physicians.

Female resident physicians are believed to be at an increased risk for a variety of third-trimester pregnancy complications. However, early pregnancy complications have been less well studied. This report compares spontaneous and induced abortions in a nationally representative sample of 5096 female medical school graduates (who experienced 1284 pregnancies) and of the sexual partners of 5000 of their male classmates (who experienced 1481 pregnancies). The response to the survey was 86.1%. The life-table probability of spontaneous abortion was 14.8% for female residents compared with 12.6% for the sexual partners of male residents. However, female residents were more likely than the male residents' sexual partners to terminate a pregnancy voluntarily (8.2% vs 2.7%). The increased risk of voluntary termination persisted when only married women were studied (3.6% vs 1.4%). However, female residents' pregnancies were at approximately half the risk of voluntary termination compared with pregnancies among the general US population of women aged 25 to 34 years. These results provide reassurance to those residents who would like to become pregnant but are concerned about the possible effect of their occupation on the course of the pregnancy.

Abortion, Induced↗

Anemia and spontaneous preterm birth.

The association between anemia during pregnancy and spontaneous preterm birth was studied with a two-stage case-control design in a large, multiethnic cohort. Results of all hematologic measurements were abstracted from the prenatal and delivery records of 1706 of the 26,901 women in the cohort. Among women delivered of infants at term, mean hematocrit value was low during the early phase of the second trimester, stable until near term, then reached a maximum at 40 weeks' gestation. The mean hematocrit value of black women was consistently lower than that of Asian, Mexican, and white women. Anemia (hematocrit value less than the tenth percentile for ethnic group and duration of pregnancy) at any time during the second trimester was positively associated with subsequent spontaneous preterm birth (odds ratio, 1.9; 95% confidence interval, 1.3 to 2.8). Compared with white women, the odds ratios for preterm birth were 2.0 (95% confidence interval, 1.6 to 2.4) for black, 1.2 (95% confidence interval, 0.9 to 1.6) for Asian, and 1.2 (95% confidence interval, 1.0 to 1.5) for Mexican women. Adjustment for second-trimester anemia had minimal influence on the odds ratios. We conclude that anemia during the second trimester was associated with preterm birth. However, it does not account for the large ethnic differences in preterm birth.

Anemia↗

Early formula supplementation of breast-feeding.

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.

Adult↗

Outcomes of pregnancy in a national sample of resident physicians.

BACKGROUND: Physically demanding, highly stressful work during pregnancy has been reported to cause a variety of adverse outcomes. It has been difficult, however, to separate the effects of work from those of socioeconomic status. METHODS: By means of a national questionnaire-based survey, we studied the outcomes of pregnancy during residency for 4412 women who graduated from medical school in 1985 and for the wives of 4236 of their male classmates, who served as controls. RESULTS: The rate of response to our survey was 87 percent (4412 of 5079) for the women residents and 85 percent (4236 of 4968) for the wives of the male residents. There were no significant differences in the proportion of pregnancies ending in miscarriage (13.8 percent for residents vs. 11.8 percent for their classmates' wives, P = 0.12), ectopic gestations (0.5 percent vs. 0.8 percent, P = 0.69), and stillbirths (0.2 percent vs. 0.5 percent, P = 0.20). There were 989 women residents and 1238 residents' wives whose first pregnancy during residency resulted in the live birth of a singleton infant. Although during each trimester the women residents worked many more hours than the wives of the male residents, the frequency of preterm births (less than 37 weeks' gestation) was similar: 6.5 percent for residents and 6.0 percent for residents' wives (odds ratio = 1.1; 95 percent confidence interval, 0.7 to 1.5). Infants who were small for gestational age (with birth weights less than the 10th percentile for gestational age) were born to 5.3 percent of the residents and 5.8 percent of the residents' wives (odds ratio = 0.9; 95 percent confidence interval, 0.6 to 1.3). Adjustment for factors that differed between the women residents and the wives of male residents resulted in odds ratios of 1.2 (95 percent confidence interval, 0.8 to 1.7) for preterm delivery and 0.9 (95 percent confidence interval, 0.6 to 1.3) for the delivery of an infant who was small for gestational age. However, the women residents more frequently reported having had preterm labor (11 percent vs. 6 percent), but not preterm delivery (6.5 percent vs. 6.0 percent); preeclampsia was also more common among the women residents (8.8 percent vs. 3.5 percent). CONCLUSIONS: These results suggest that working long hours in a stressful occupation has little effect on the outcome of pregnancy in an otherwise healthy population of high socioeconomic status.

Abortion, Spontaneous↗