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OBJECTIVE: The purpose of this study was to examine teratogenic risk of antiretroviral (ARV) drugs. STUDY DESIGN: The Antiretroviral Pregnancy Registry (APR) monitors prenatal exposures to ARV drugs and pregnancy outcome through a prospective exposure-registration cohort. Statistical inference uses exact methods for binomial proportions. RESULTS: Through July 2003, APR has monitored 3583 live births exposed to ARV. Among 1391 first trimester exposures, there were 38 birth defects, prevalence of 2.7% (95% CI 1.9-3.7), not significantly higher than the CDC's population surveillance rate, 3.1 per 100 live births (95% CI 3.1-3.2). For lamivudine, nelfinavir, nevirapine, stavudine, and zidovudine, sufficient numbers of live births (>200) following first-trimester exposures have been monitored to allow detection of a 2-fold increase in risk of birth defects overall; no increases have been detected. CONCLUSION: APR data demonstrate no increase in prevalence of birth defects overall or among women exposed to lamivudine, nelfinavir, nevirapine, stavudine, and zidovudine. [ABSTRACT FROM AUTHOR]

Objective: To evaluate a prenatal education and support program for adolescents. Methods: Quasi-experimental, comparison group design in which historical controls (n=191), geographically close controls (n=312), and resource-similar controls (n=227) were compared with program participants (n=184). Results: Program participants were less likely to have inadequate prenatal care utilization than were historical controls (odds ratio=0.39, 95% confidence interval=0.2, 0.7). There were no consistent effects with regard to maternal weight gain. Program participants were significantly less likely to have low-birth-weight births than were historical controls (odds ratio=0.48, 95% confidence interval=0.2, 0.9). Conclusion: Effects of the program might be strengthened by focusing on improving maternal nutrition. [ABSTRACT FROM AUTHOR]

Objectives: The purpose of this study was to determine whether a systematic, multiple assessment protocol could increase reporting of prenatal violence compared with a one-time routine assessment. Method: In 1994, the Maternity Care Coordination (MCC) program in a health department prenatal clinic in North Carolina implemented a concise, systematic assessment protocol on all 384 women who enrolled in the program from April 1994 to April 1995. The protocol assessed for violence at three times during pregnancy using the direct question, 'Have you been hit, slapped, kicked, or hurt during this pregnancy?' To determine the effectiveness of the system, we retrospectively examined the 1991-1993 MCC records (n = 1056) in which the care coordinators routinely screened all clients for violence at their first visit only. Results: Compared with the routine assessment approach, the new systematic assessment protocol increased reporting of prenatal violence at the initial prenatal visit from 6.3% to 10.9% (relative risk = 1.7, 95% confidence interval = 1.2, 2.5), and the multiple assessments increased reporting of prenatal violence to 14.1% (relative risk = 2.2, 95% confidence interval = 1.6, 3.1). Conclusions: Our study suggests that a concise and systematic screening technique using direct questions combined with multiple assessments increased reporting of prenatal violence compared with a single routine assessment. [ABSTRACT FROM AUTHOR]

Background: The Observational Study of the Use and Safety of Xolair (omalizumab) during Pregnancy (EXPECT) pregnancy registry was a prospective observational study established in 2006 to evaluate perinatal outcomes in pregnant women exposed to omalizumab and their infants., Objective: This analysis compares EXPECT outcomes with those from a disease-matched population of pregnant women not treated with omalizumab. Data from a substudy of platelet counts among newborns are also presented., Methods: The EXPECT study enrolled 250 women with asthma exposed to omalizumab during pregnancy. The disease-matched external comparator cohort of women with moderate-to-severe asthma (n = 1153), termed the Quebec External Comparator Cohort (QECC), was created by using data from health care databases in Quebec, Canada. Outcome estimates were age adjusted based on the maternal age distribution of the EXPECT study., Results: Among singleton infants in the EXPECT study, the prevalence of major congenital anomalies was 8.1%, which was similar to the 8.9% seen in the QECC. In the EXPECT study 99.1% of pregnancies resulted in live births, which was similar to 99.3% in the QECC. Premature birth was identified in 15.0% of EXPECT infants and 11.3% in the QECC. Small for gestational age was identified in 9.7% of EXPECT infants and 15.8% in the QECC., Conclusion: There was no evidence of an increased risk of major congenital anomalies among pregnant women exposed to omalizumab compared with a disease-matched unexposed cohort. Given the observational nature of this registry, however, an absence of increased risk with omalizumab cannot be definitively established., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: The Antiretroviral Pregnancy Registry was established in 1989 to collect data on birth defects after pregnancy exposures to antiretroviral therapy. Using Registry data, this study estimates the birth defect risk after pregnancy exposures to lopinavir/ritonavir., Methods: The analysis population includes all prospective lopinavir/ritonavir-exposed pregnancies enrolled in the Registry from September 2000 through July 2007. Birth defect prevalence after pregnancy exposure is compared with rates from a population-based surveillance system, and first-trimester exposures are compared with combined second/third-trimester exposures., Results: Among 955 live births prenatally exposed to lopinavir/ritonavir, 23 cases with birth defects were reported [2.4%, 95% confidence interval (CI) = 1.5 to 3.6). Among 267 live births with first-trimester exposures, 5 had birth defects (1.9%, 95% CI = 0.6 to 4.3). These rates are similar to the population-based comparator rate of 2.67% and the rate in infants with second/third-trimester exposures (2.6%, 95% CI = 1.6 to 4.1). No pattern of birth defects suggestive of a common etiology was seen., Conclusions: The prevalence of birth defects among infants prenatally exposed to lopinavir/ritonavir is not significantly different from internal or external comparison groups. These data provide reassuring information to patients and clinicians about the safety of lopinavir/ritonavir in the treatment of HIV-positive pregnant women.

This paper describes the Antiretroviral Pregnancy Registry's (APR) monitoring and analysis plan. APR is overseen by a committee of experts in obstetrics, pediatrics, teratology, infectious diseases, epidemiology and biostatistics from academia, government and the pharmaceutical industry. APR uses a prospective exposure-registration cohort design. Clinicians voluntarily register pregnant women with prenatal exposures to any antiretroviral therapy and provide fetal/neonatal outcomes. A birth defect is any birth outcome > or = 20 weeks gestation with a structural or chromosomal abnormality as determined by a geneticist. The prevalence is calculated by dividing the number of defects by the total number of live births and is compared to the prevalence in the CDC's population-based surveillance system. Additionally, first trimester exposures, in which organogenesis occurs, are compared with second/third trimester exposures. Statistical inference is based on exact methods for binomial proportions. Overall, a cohort of 200 exposed newborns is required to detect a doubling of risk, with 80% power and a Type I error rate of 5%. APR uses the Rule of Three: immediate review occurs once three specific defects are reported for a specific exposure. The likelihood of finding three specific defects in a cohort of < or = 600 by chance alone is less than 5% for all but the most common defects. To enhance the assurance of prompt, responsible, and appropriate action in the event of a potential signal, APR employs the strategy of 'threshold'. The threshold for action is determined by the extent of certainty about the cases, driven by statistical considerations and tempered by the specifics of the cases., (Copyright 2004 John Wiley & Sons, Ltd.)

Background: The SynCardia CardioWest total artificial heart (CardioWest TAH) is a biventricular, orthotopic, pneumatic, pulsatile blood pump driven by an external console. For each ventricle, the length of the blood-flow path is shorter and the inflow and outflow valves are larger than in any other bridge-to-transplant device, resulting in greater blood flow at smaller pre-load. Such a device should be optimal for bridging transplant candidates who have biventricular failure and for whom all other therapies have failed., Methods: From January 1, 1993, to April 1, 2002, we prospectively studied 62 consecutive CardioWest TAH implant recipients to document safety and efficacy in bridge to transplantation. We used multisystem monitoring and multidrug therapy for anti-coagulation in 58 patients starting September 1, 1994., Results: Before implantation, patients were critically ill with biventricular heart failure. Mortality in this group from the time of implantation until transplantation was 23%. Causes of death during device support included multi-organ failure (6), sepsis (3), and valve entrapment (2). Forty-eight patients underwent transplantation (77%). Forty-two survived to hospital discharge (68% of the total, 88% of those undergoing transplantation). Adverse events included bleeding (20%), device malfunction (5%), fit complications (3%), mediastinal infections (5%), visceral embolus (1.6%), and stroke during support (1.6%). The linearized stroke rate was 0.068 events per patient-year., Conclusions: Sixty-eight percent of critically ill transplant candidates for whom medical therapy failed were bridged to transplantation with the CardioWest TAH and survived long-term. Most deaths that occurred during device support were related to pre-implant problems. Infection and stroke were rare events. Therefore, we recommend the CardioWest TAH as the biventricular bridge-to-transplant device of choice.

African-American (AA) women have a higher mortality from breast cancer than Caucasians (C). This may be attributed to stage of disease at presentation, but specific prognostic factors are not well identified. We sought to identify prognostic factors in our database of early-stage (stage I and II) breast cancer from 1990 to 1999. There were 153 tumors in 150 AA women and 773 tumors in 760 C women. Prognostic factors are listed according to race with relative risk (RR) and 95 per cent confidence intervals. AA women presented significantly more often than C women under the age of 50 years (RR = 1.8) with palpable disease (RR = 1.3), higher-grade tumors (RR = 1.5), more estrogen receptor-negative disease (RR = 1.7), more progesterone receptor-negative disease (RR = 1.4), higher proliferation indices (RR = 1.9), and more lymph node-positive disease (RR = 1.6). Many of these adverse prognostic features persisted in "good" prognostic groups, i.e., those women over the age of 50 years with tumors <20 mm and having node-negative disease. We conclude that prognostic factors are related to race with AA women presenting at an earlier age and more often with palpable disease. More importantly AA women presented significantly more often with higher-grade tumors, hormone receptor-negative tumors, higher proliferation indices, and node-positive disease. These findings may explain a higher breast cancer mortality in AA women.

Background: Recent publications suggest an inverse relationship between mortality rates in the Whipple procedure for periampullary cancer and hospital volume/teaching status., Methods: The Nationwide Inpatient Sample database from 1988 to 1995, containing 24926 patients undergoing pancreatectomy for periampullary cancer, was used., Results: The mean number of procedures per hospital per year was 1.5, and the overall mortality was 14%. The volume of procedures per year increased from the rural to the urban nonteaching hospitals to the urban teaching hospitals (.6, 1.1, and 2.7, respectively), with a steady decrease in mortality among the three hospital types (18%, 15%, and 11%). A multiple logistic regression model with mortality odds ratios (ORs) showed that male sex (OR, 1.3), increasing age (OR, 1.6 to 6.7 in decades from 50 to > or=80 vs. <50 years), emergency admission (OR, 1.5), and hospital volume (less than one vs. one or more cases per year; OR, 1.5) were significantly predictive for increased in-hospital mortality., Conclusions: In-hospital mortality in the low-volume hospital setting is prohibitive, and review of each institution's mortality rates must occur before these procedures are performed in those institutions. In addition, patients over the age of 60 years, male patients, and those with an urgent admission are at a significant risk of in-hospital death, and consideration should be given toward transfer to an experienced institution.

Objective: To determine the severity and consequences of physical violence during pregnancy among participants in a health department prenatal care coordination program., Study Design: The prospective cohort study included all program participants from 1994 to 1996. Care coordinators screened participants for physical violence during pregnancy using a validated, systematic assessment protocol three times during prenatal care. The protocol was linked with prenatal records, delivery records and infant records to document complications and infant outcomes. Multiple logistic regression was used to assess the relationship between severe physical violence during pregnancy and pregnancy outcome while controlling for confounding factors., Results: Among the 550 participants, 13.5% reported violence during pregnancy; it included 6.7% severe violence (hitting, kicking, injury with a weapon and abdominal injury) and 6.7% moderate violence (threats, slapping, shoving and sexual abuse). Severe physical prenatal violence was significantly associated with spontaneous preterm labor, preterm delivery, very preterm delivery, very low birth weight, preterm/low birth weight, mean birth weight, mean newborn hospital charges, five-minute Apgar < 7, neonatal intensive care unit admission, and fetal or neonatal death. Body site injured, timing of violence and number of violent incidents were significant factors associated with violence during pregnancy and preterm delivery., Conclusion: Because severe physical violence during pregnancy was a significant problem in this population, intervention programs are needed to reduce prenatal violence and its consequences.

Purpose: To examine the severity, manifestations, and consequences of prenatal violence among adolescent and adult participants in a county health department prenatal care coordination program., Methods: The prospective cohort study design included all Medicaid-eligible program participants from 1994 to 1996. Care coordinators screened participants for prenatal violence using a validated, systematic violence assessment protocol at three times during pregnancy. This protocol was linked with prenatal care and hospital delivery records to document pregnancy outcomes. The main outcome variables were low birth weight (<2500 g) and preterm delivery (before 37 weeks' gestation)., Results: Among teens, 16.1% reported prenatal violence, including 9.4% who reported severe violence such as hitting, kicking, or stabbing. Among adults, 11.6% reported prenatal violence, including 4.8% who reported severe violence. Teens were more likely than adults to report abdominal trauma (56% vs. 22%) and violence perpetrated by a relative (23% vs. 5%). Teens who reported severe prenatal violence were more likely to report alcohol use. They were significantly more likely to deliver preterm than teens who reported "other" or "no" prenatal violence (odds ratio 3.5, 95% confidence interval 1.1-10.8) when adjusting for race, adequacy of prenatal care, prior preterm delivery, and alcohol use. For adults, the relationship between prenatal violence and preterm delivery was not statistically significant. The relationship between prenatal violence and low birth weight was not significant for either age cohort., Conclusions: Prenatal violence was a significant risk factor for preterm birth in this population, especially among teens.

Large, randomized prospective clinical trials have not addressed the safety of reoperation for recurrent carotid disease. Our purpose was to determine whether outcomes for carotid endarterectomy for recurrent disease were different from those for primary or contralateral carotid endarterectomy. We reviewed all carotid endarterectomies done in our regional medical center hospital from 1979 through 1997. We analyzed 1656 primary procedures, 377 contralateral carotid procedures, and 63 reoperations. Operation for recurrent disease was done in 3 per cent of those having primary operations. Patients in the three groups did not differ significantly with regard to age, race, or sex. Seventy per cent of patients were symptomatic with transient ischemic attacks, amaurosis, and reversible ischemic neurological deficit being most prominent. There were no deaths and three strokes in the reoperation group for a combined stroke and death rate of 4.8 per cent. This was not significantly different from that of 3.2 per cent for the stroke and death rate for the primary group and 3.5 per cent for the contralateral group. Carotid endarterectomy is a safe treatment for recurrent carotid artery disease.

Objective: To determine whether the rates of death and complications of carotid endarterectomy (CE) were different in the octogenarian population than in patients younger than age 80., Summary Background Data: The utility of CE depends on the ability of the surgeon and hospital to attain low rates of death and complications, including all subgroups of the patient population. In the past 30 years, the number of people age 85 and older has increased 274%., Methods: Detailed chart review was carried out on all CE procedures done from 1979 through 1998. Descriptive demographic data, risk factors, surgical details, length of stay, deaths, and complications were recorded., Results: A total of 2,398 CEs were performed in 1,970 patients; 2,180 procedures were performed in 1,783 patients younger than 80, and 218 CEs were performed in 187 patients age 80 and older. Sixty-five percent of the octogenarians and 67% of patients younger than age 80 had neurologic symptoms. Among asymptomatic patients, 89% had stenosis of 75% or more. There were 62 strokes in the 2,180 procedures in the younger group, for a stroke rate of 2.8%, and 7 strokes in the 218 procedures in the older group, for a stroke rate of 3.2%. The death rates were 0.9% for the octogenarians and 1.4% for the younger group., Conclusions: Carotid endarterectomy can be safely performed in a community hospital in patients age 80 and older. Outcomes in octogenarians were not significantly different than those of younger patients and were within the range required for CE to be considered beneficial in the prevention of stroke.

Background: We assessed whether the increase in performance of laparoscopic cholecystectomy has affected patients aged 80 and older and if outcomes of a laparoscopic approach in this population would show improvement over those for open surgery., Methods: We analyzed an 11-state discharge database obtained from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project. Release 1 contains a 20% sample of United States hospitals for the period 1988 to 1992. Diagnosis-related group (DRG) codes 197 and 198 were searched, and demographics, type of surgery, and outcome measures were analyzed., Results: In 5 years, 350,451 patients underwent cholecystectomy with the DRG codes listed. Of those, 18,500 patients were aged 80 to 105. The total number of cholecystectomies increased each year. Performance of laparoscopic cholecystectomy rose rapidly and that of open cholecystectomy decreased. Overall mortality with laparoscopic cholecystectomy was 1.8%, was lower than that of open cholecystectomy, was lower in women, and decreased with time., Conclusions: Patients aged 80 and older have participated in the increased performance of cholecystectomy and the switch to laparoscopic cholecystectomy. This has a low mortality, low length of stay, and higher proportion of patients being discharged to home compared with patients having open cholecystectomy.

Performance of laparoscopic cholecystectomy (LC) is increasing, and patients age 80 and over comprise an increasingly larger proportion of the LC population. This study documents that the increase is accompanied by safe outcome in this patient population. However, the evidence also suggests that cholelithiasis appears to have been a neglected condition in this age group. The prevalence of nonelective procedures, the conversion rate to an open operation, more intraoperative complications, and the percentage having evidence of common bile duct stone passage all support this assertion. With the technology of LC, we are now appropriately addressing the problem with a treatment that allows less surgical trauma to the patient and shorter recovery time. Same-day LC surgery for the octogenarian appears to be very safe and would justify a decision to perform earlier LC in these patients. Surgery done before the appearance of comorbid conditions that increase the surgical and anesthetic risks may result in improved outcomes for the elderly at lower cost. Even when necessary in the already hospitalized patient, LC can be accomplished with morbidity and mortality comparable to those of elective abdominal procedures in younger populations.

Background: For more than 40 years carotid endarterectomy (CE) has been used in the treatment of extracranial carotid disease for the prevention of stroke. Recent prospective clinical trials have confirmed the benefit of CE for both symptomatic and asymptomatic patients. Our purpose was to examine statewide trends in the numbers of CE over a 6-year time period and to evaluate outcomes., Methods: Using data from the North Carolina Medical Database Commission (NCMDC) all CE procedures from 1988 to 1993 were identified. Numbers of CE were compared with the population and hospital admissions. Variables of length of stay, hospital charges, discharge disposition, and occurrence of stroke and death were analyzed., Results: A total of 11,973 CE were performed in 6 years. Compared by admissions, population, and the proportion of elderly, the number of CE increased yearly. The stroke rate was 1.7% and the death rate 1.2% for an overall in-hospital stroke plus mortality rate of only 2.7%., Conclusions: From a diverse group of hospitals and a large number of surgeons and patients, this hospital-based study documents the acceptance and safety of CE in the treatment of extracranial carotid disease.

Purpose: The purpose of this study was to determine whether a systematic assessment protocol could increase reporting of violence among pregnant adolescents compared with a routine prenatal assessment. This study also sought to examine issues related to violence assessment among maternity care coordinators., Methods: The Maternity Care Coordination (MCC) program in a health department prenatal clinic in North Carolina routinely screened all clients for violence at their first visit. This assessment was not standardized. In 1994, the MCC program implemented a systematic violence assessment protocol for all adolescents (n = 117). The protocol assessed violence at three points during pregnancy by asking one direct question: "Have you been hit, slapped, kicked, or hurt during this pregnancy?" To examine the effectiveness of the system, we retrospectively reviewed the 1993 MCC records in which the coordinators routinely screened clients for violence (n = 129). To examine issues related to screening, we conducted in-depth interviews with the maternity care coordinators., Results: The routine pre-intervention assessment indicated that 5.4% of adolescents 12-19 years of age reported prenatal violence. The systematic assessment protocol resulted in a significant increase in reported violence from 5.4% to 16.2% (odds ratio = 2.9, 95% confidence interval = 1.6, 5.6, adjusted for race). Maternity care coordinators identified five factors related to increased reporting using the standardized protocol: (a) written protocol and data collection form; (b) asking direct, specific questions; (c) not labeling the victim; (d) not naming the perpetrator; and (e) conducting multiple assessments., Conclusions: Multiple, direct, systematic assessments throughout prenatal care resulted in increased reporting of prenatal violence among adolescents compared to single, routine, nonstructured assessments.

Objective: Clinical pathways now highlight both observation and operation as acceptable initial therapeutic options for the management of patients with splenic injury. The purpose of this study was to evaluate treatment trends for splenic injury in all North Carolina trauma centers over a 6-year period., Methods: Splenic injuries in adults over a 6-year period (January 1988-December 1993) were identified in the North Carolina Trauma Registry using ICD-9-CM codes. Patients were divided into four groups by method of management: 1) no spleen operation, 2) splenectomy, 3) definitive splenorrhaphy, and 4) splenorrhaphy failure followed by splenectomy. The authors examined age, mechanism of injury, admitting blood pressure, and severity of injury by trauma score and injury severity score., Summary Background Data: Comparisons were made between adult (17-64 years of age) and geriatric (older than 65 years of age) patients and between patients with blunt and penetrating injury. Resource utilization (length of stay, hospital charges) and outcome (mortality) were compared., Results: One thousand two hundred fifty-five patients were identified with splenic injury. Rate of splenic preservation increased over time and was achieved in more than 50% of patients through nonoperative management (40%) and splenorrhaphy (12%). Splenorrhaphy was not used commonly in either blunt or penetrating injury. Overall mortality was 13%. Geriatric patients had a higher mortality and resource utilization regardless of their mechanism of injury or method of management., Conclusions: Nonoperative management represents the prevailing method of splenic preservation in both the adult and geriatric population in North Carolina trauma center hospitals. Satisfactory outcomes and economic advantages accompany nonoperative management in this adult population.

Recognition of the important role of the spleen within the immune system has prompted surgeons to regularly consider splenic preservation. We studied our experience at a Level II trauma center to determine whether this trend is reflected in our management. We reviewed 81 adult blunt trauma patients with splenic injury admitted between January 1988 and December 1993. We examined age, race, and clinical data including mechanism of injury, trauma and injury severity scores, organ injury scale (OIS) grade, admitting blood pressure, operations, length of stay, hospital charges, and outcome. Thirty-nine patients underwent immediate splenectomy. Nonoperative treatment was successful in 31 of 37 patients (83.7%). Mean OIS grade (American Association for the Surgery of Trauma) was significantly different between patients treated nonoperatively (1.6 +/- 0.9) and patients treated with immediate splenectomy (3.9 +/- 1.1), (P = <0.001). American Association for the Surgery of Trauma OIS grade correlated well between CT classification and classification at operation (r = 0.7, P = 0.0001) but did not predict success in nonoperative management. Hemodynamic stability, injury severity, and abdominal CT scan findings determine choice of therapy. Splenorrhaphy is frequently discussed but infrequently performed. Splenectomy remains the most commonly performed operation for splenic injury in adults with blunt splenic trauma. Nonoperative management is the most common method of splenic salvage at the Level II community hospital trauma center.

Background: To assess the use and usefulness of fine-needle aspiration cytologic biopsy (FNAB) of the thyroid in our hospital., Methods: All cytology slides and charts of patients who had FNAB of the thyroid done in our hospital in 1993 were reviewed. Charts of all patients having thyroid surgery in our hospital in 1993 were reviewed to determine the pathological diagnosis and whether FNAB had been performed preoperatively. Finally, we reviewed all consecutive thyroid surgery cases for an 8-year period, and we calculated the yearly percentage of malignancy., Results: Fifty-five FNAB were done in 53 patients. In 21 patients the FNAB gave indication for thyroid surgery, yet surgery was done in only 12 (57.1%). Forty-two patients had surgery for a thyroid nodule, but only 20 patients (47.6%) had a preoperative FNAB. There were 3 malignancies among the 20; 2 were correctly predicted by FNAB. The FNAB was correct in 18 of 20. In all, 378 thyroid operations were done from 1987 to 1994. The yearly proportion of thyroid malignancy ranged from 11% to 29%, but showed no change corresponding with increasing diagnostic sophistication., Conclusions: Fine-needle aspiration cytologic biopsy in the workup of patients with thyroid masses is strikingly underutilized in our institution. While accurate in 90% of cases where used, FNAB appears to play a minor role in the surgeon's decision regarding surgery. As a result of these findings, we developed a grading system for better communication of the FNAB report and a clinical guideline to improve the evaluation of patients with thyroid masses.

Objective: The objective of this study was to determine the trend of breast conservation surgery (BCS) in North Carolina over a 6-year period and to identify patient, hospital, and surgeon factors associated with the use of BCS., Summary Background Data: Despite evidence that BCS is an appropriate method of treatment for early stage breast cancer, surgeons in the United States have been slow to adopt this treatment method., Methods: Cases of primary breast cancer surgery in all 157 hospitals in the state from 1988 to 1993, inclusive (N = 20,760), were obtained from the State Medical Database Commission, Area Resource File, American Hospital Association and State Board of Medical Examiner's Databases. Multiple logistic regression was used to generate odds ratios (ORs) and 95% confidence intervals (CIs) to determine factors associated with BCS., Results: The rate of BCS doubled from 7.3% in 1988 to 14.3% in 1993, with an overall rate of 10.2% (2117/ 20.760). Multiple logistic regression identified the following factors associated with BCS: patient age younger than 50 years of age (OR = 1.7, 95% CI = 1.4, 2.1), patient age 50 to 69 years of age (OR = 1.2, 95% CI = 1.1, 1.4), private insurance (OR = 1.2, 95% CI = 1.0, 1.4), hospital bed size 401+(OR = 2.0, 95% CI = 1.6, 2.5), bed size 101 to 400 (OR = 1.7, 95% CI = 1.3, 2.1), and surgeon graduation from medical school since 1981 (OR = 1.6, 95% CI = 1.2, 2.0)., Conclusions: Rates of BCS in North Carolina are low. Least likely to have BCS were women older than 70 years of age, without private insurance, treated at small hospitals by older surgeons. To increase the use of BCS, widespread education of surgeons, other health care providers, policy makers, and the general public is warranted.

Objective: To evaluate in a controlled, blind fashion, using both subjective and objective criteria, whether MgSO4 is associated with clinically significant changes in fetal heart rate monitoring., Study Design: Fetal heart rate tracings were prospectively collected before and after MgSO4 loading in 50 preterm labor patients. Three obstetricians, blind to treatment status, graded the tracings using both subjective and objective criteria., Results: The baseline fetal heart rate declined slightly after therapy. Subjective, but not objective, evaluation demonstrated a greater likelihood of decreased variability after MgSO4 loading. There was no difference in periodic changes after MgSO4 loading. Multiple regression analysis showed a greater likelihood of decreased variability at earlier gestational ages but no relationship to the serum magnesium level., Conclusion: Magnesium sulfate tocolysis is associated with a subjective decrease in fetal heart rate variability in the preterm fetus.

Background: Clinical studies have shown equivalent survival rates between breast-conserving surgery (BCS) and mastectomy in early breast cancer; however, rates for BCS remain low. The purpose of this study was to determine (a) the prevalence of BCS in a regional medical center, (b) clinicopathologic factors associated with BCS, and (c) patient perceptions of the treatment decision-making process., Methods: We retrospectively reviewed 251 consecutive breast cancer cases during January 1990-December 1991; 77 patients were ineligible for BCS because of unfavorable pathology. We then interviewed 118 of the 160 women available for interview., Results: BCS was performed in 31 of the eligible patients (18%). Multivariate analysis revealed that tumor size < 10 mm (p = 0.03) was the only significant predictive variable for BCS. Patient interviews revealed that 93% said their surgeon was the primary source of information regarding treatment options. Among 69% of the women whose surgeons reportedly recommended a particular option, 89% recommended mastectomy with 93% compliance, and 11% recommended BCS with 89% compliance. The BCS group more often obtained a second opinion (p = 0.04) and 60% said they made the decision themselves compared with only 37% of the mastectomy group (p = 0.05)., Conclusion: Limiting BCS to women whose tumor size is < 10 mm is too restrictive; this excludes a large number of women who are clinically eligible for BCS. The surgical decision-making process for early-stage breast cancer is very much surgeon-driven, with a high degree of patient compliance.

Objective: This study sought to determine if violence against women is accurately documented in the trauma registry, and if poor documentation in the medical record is associated with incorrect coding in the registry., Design: Retrospective cohort study., Materials and Methods: We identified women aged 15 to 49 in the trauma registry of a regional medical center who had unintentional and intentional injuries over three years, and retrospectively reviewed their medical records to verify registry coding., Measurements and Main Results: Of the 41 assault victims in the registry, 32 were verified by the medical record. Of the 87 unintentional injuries, only 28 were verified; 21 were assault victims according to the medical record, and for the remaining 38, the medical record was too vague to determine intentionality. Thus, the sensitivity of the trauma registry in documenting violence against women was only 57%. Injuries correctly coded in the registry had the details well documented in the medical record, whereas injuries incorrectly coded had poor documentation in the medical record., Conclusions: Violence against women often goes undocumented in hospital data systems.

Purpose: To examine factors associated with the number of prenatal care visits during second pregnancy for adolescents having a short interval between pregnancies., Methods: The sample includes all adolescents aged 13 to 17 years whose first pregnancy resulted in a birth at a regional medical center in southeastern North Carolina from January 1983 to December 1989 and who had a repeat pregnancy within 24 months which resulted in a birth. We abstracted data from medical records and birth certificates. We fit a negative binomial regression model to determine the effects of various factors on the number of prenatal care visits during second pregnancy., Results: The number of prenatal care visits during the first pregnancy, poor first birth outcome, interval between first and second pregnancy, and care provided by health department staff during first pregnancy were all positively associated with number of prenatal care visits during second pregnancy when controlling for gestation age of second birth. Other independent variables in the model included maternal age, education, black race, and being unmarried at the time of second birth., Conclusions: Because prenatal care is important for healthy mothers and babies, adolescents should be encouraged to seek prenatal care early in the first pregnancy. This could be an important time to implement interventions aimed at increasing prenatal care utilization in this and subsequent pregnancies.

The administration of oral contrast (OC) is widely recommended for computed tomography (CT) of the abdomen in patients with blunt trauma. The purpose of this study was to determine whether routine abdominal CT scans performed without OC were associated with diagnostic error in patients with blunt trauma. Four hundred ninety-two patients were identified from our Trauma Registry who had CT scans for the evaluation of blunt abdominal trauma between January 1988 and December 1991. Seventy-six percent (372) of the CT scans were interpreted as negative, and 24% (120) were considered positive. OC was used in 8 (1.6%) of 492 patients. Only 1 of 372 patients whose initial non-OC--enhanced scan was negative subsequently required surgery. There were 5 bowel injuries among the 42 patients who underwent an abdominal operation; in none would the use of OC have ensured the preoperative diagnosis. We found that the omission of OC did not represent a disadvantage to patients with blunt trauma undergoing a routine abdominal CT scan. Potential time delays and the hazards associated with the use of OC were minimized.

Objective: The purpose of this paper is to compare the hospital resources used by elderly, adult, and pediatric patients treated in hospitals reporting to the North Carolina Trauma Registry (NCTR)., Design: We analyzed data on all patients entered into the NCTR from 1 January 1988 to 31 December 1990., Setting: The NCTR is a statewide registry of all trauma patients admitted for at least 24 hours or dead on arrival at the eight Level I and II trauma center hospitals in North Carolina., Patients: The total number of patients included in the study was 21,214; elderly adults included those age 65 and older (n = 2808), adults included those 15 to 64 years old (n = 15,776), and pediatric patients included those 0 to 14 years old (n = 2630)., Main Outcome Measures: We examined hospital resources using three measures: overall length of hospital stay in days, intensive care unit (ICU) length of stay in days for those admitted to the ICU, and total hospital charges billed during the hospitalization., Results: Controlling for injury severity, we found that elderly adults had longer mean hospital and ICU lengths of stay and higher mean hospital charges than adults or children. Whereas only 22% of injuries to elderly adults were transportation-related, transportation injuries generated 38% of their hospital charges. Sixty-eight percent of their injuries were caused by falls, generating total hospital charges of $17.6 million, an average of 15 days in hospital stay and 9 days in ICU stay., Conclusion: A 10% reduction in both transportation injuries and falls among the elderly could save $3.5 million in this population over 3 years.

To determine differences in outcome between unilateral and staged bilateral carotid endarterectomies, we reviewed 850 carotid endarterectomies done by 14 surgeons in a community hospital. Results of 528 unilateral procedures were compared with those of 161 bilateral procedures. Data were abstracted from records for an 11-year period. Twelve of the patients in the unilateral group had nonfatal strokes, and 14 died within 30 days of surgery (stroke + death rate, 4.9%). There were no nonfatal strokes among patients in the bilateral group, and nine died (stroke + death rate, 5.6%). Seven of 14 deaths in the unilateral group and six of nine deaths in the bilateral group were due to neurologic events. In the bilateral group, death was associated with postoperative hypertension and a short intersurgical interval. The stroke + death rate was not significantly different between unilateral and bilateral procedures and compared favorably with North American Symptomatic Carotid Endarterectomy Trial guidelines and other published reports. Staged bilateral carotid endarterectomy can be safely performed in a community hospital.

We compared the prevalence of stroke and death in 133 patients aged 75 and older in whom 170 carotid endarterectomies were performed with that in 501 patients less than age 75 in whom 640 carotid endarterectomies were performed. There were three strokes (2%) in patients aged 75 and older and nine strokes (1%) in younger patients (p = 0.7). There were 8 deaths (5%) in patients aged 75 and older and 14 deaths (2%) in younger patients (p = 0.1). After controlling for the possible confounding effects of diabetes, prior stroke, history of angina, prior carotid artery disease, previous vascular surgery, history of myocardial infarction, preoperative hypertension requiring medication, and female gender, a logistic regression model showed that patients aged 75 and older were no more likely to have a stroke or death than patients under age 75. We conclude that age alone is not a contraindication to the safe performance of carotid endarterectomy in the community hospital.

This study evaluates the effectiveness of the North Carolina Prematurity Prevention Program in reducing low-birthweight births among adolescents seeking prenatal care at the New Hanover Memorial Hospital obstetric clinic. Modeled on programs developed by Papiernik and Creasy, the program includes three components: staff education, patient identification, and patient education. Thirteen percent of the clinic population is 13-17 years old. The same prematurity prevention protocol is used for both adults and adolescents. Overall, 12% of the 847 women who delivered prior to the program had a low-birthweight infant. Among the 748 women who delivered during the program, the number of low-birthweight infants declined to 9.5%. For mothers 13-17 years old, 14% of the preprogram group had a low-birthweight infant, as did 14% of those in the program. A logistic regression model, controlling for certain risk factors, suggests that the program was not effective in reducing low-birthweight births among these adolescents (OR = 0.9; 95% CI = 0.2, 1.8).

This study examines family planning attitudes and practices of 681 Nigerian physicians selected from cities in which large university teaching hospitals are located. About half of the physicians were practicing family planning; the method of choice was the IUD. Obstetrician/gynecologists and general practitioners were more likely to provide methods to their patients than were other types of physicians. The physicians were concerned about population growth and favored family planning, yet a substantial minority believed that family planning is foreign to the culture and that it promotes promiscuity. Physicians were reluctant to promote family planning on a wide scale; many disapproved of non-physicians providing oral contraceptives or IUDs.

The purpose of this study was to evaluate and compare the availability of sterilization services at two hospitals in Honduras. Approximately 7,000 women who had given birth at the Hospital Materno Infantil in Tegucigalpa and the Hospital Leonardo Martinez in San Pedro Sula were asked about their desire for sterilization. Of the women who wanted to be sterilized, a considerable percentage had not been sterilized four months after they had given birth--58 percent of those who had delivered at Materno Infantil and 79 percent of those who had delivered at Leonardo Martinez. Twenty-three percent of the women who delivered at Materno Infantil and 4 percent of the women who delivered at Leonardo Martinez were sterilized before they were discharged. The difference may be attributed to the poor quality of the facilities at Leonardo Martinez.

This study presents information on cesarean section rates for the last baby born to 1,746 women in Northeast Brazil between January 1978 and the date of a 1980 household survey. For hospital deliveries, the c-section rate is 19 per cent. Rates were highest in the major urban areas and lowest in rural areas. Within residence categories, the section rate was related directly to education, early prenatal care, and delivery in private hospitals.

Twelve per cent of the 847 women who delivered in one hospital prior to implementation of the North Carolina Prematurity Prevention Program had low-birthweight births compared with 9.5 per cent of the 748 women who delivered during the program. Controlling for known risk factors, both low- and very-low birthweight births among Whites (Odds Ratio 2.0 and 3.7 respectively) and very-low-birthweight births among Blacks (OR 2.9) were reduced.

In 1980, a study to determine interest in and access to sterilization for females was initiated at two Ministry of Health hospitals in Honduras. Results of the baseline study showed that 42 percent of women desiring sterilization from the Tegucigalpa hospital and 21 percent from the San Pedro Sula hospital had had a tubal ligation. A second study was conducted two years later, following up the interested but unsterilized women from the baseline study. Results show that 33 percent of women in the Tegucigalpa group, compared to 15 percent in the San Pedro Sula group, had been sterilized. Part of this difference can be attributed to an increase in sterilization facilities in Tegucigalpa over the two years after the baseline study was conducted. Among the major reasons women gave for not having been sterilized were financial and time constraints. Over the two-year period, the authors estimate that, of women interested in sterilization at delivery, 52 percent in total were sterilized in Tegucigalpa and 29 percent in San Pedro Sula.

From December 1979 to February 1980, data were collected on access to postpartum sterilization for all obstetric patients at a large maternity hospital in Campinas, Brazil. Of the 827 women wanting no additional children and having knowledge of sterilization, 481 (58%) reported that they wanted to be sterilized. Of these women, 226 (47%) were sterilized postpartum. One year following their deliveries, follow-up forms were administered to the women desiring sterilization, but who had not been sterilized postpartum, to determine if they had been sterilized over the course of the year. Only 13% of the women had been sterilized, but almost 75% of the women not sterilized said they were still interested in getting sterilized. Of the women interviewed, 18% either had become pregnant again since the initial survey or were currently pregnant.