Kaiser Hospitals Research Articles

Evaluating Epidemiologic Trends and Variations in NICU Admissions in California, 2008 to 2018.

Previous research suggests increasing numbers of and variation in NICU admissions. We explored whether these trends were reflected in California by examining NICU admissions and birth data in aggregate and among patient and hospital subpopulations more susceptible to variations in care. In this retrospective cohort study, we evaluated NICU utilization between 2008 and 2018 for all live births at hospitals that provide data to the California Perinatal Quality Care Collaborative. We compared hospital- and admission-level data across birth weight (BW), gestational age (GA), and illness acuity categories. Trends were analyzed by using linear regression models. We identified 472 402 inborn NICU admissions and 3 960 441 live births across 144 hospitals. Yearly trends in NICU admissions remained stable among all births and higher acuity births (mean admission rates 11.9% and 4.1%, respectively). However, analysis of the higher acuity births revealed significant increases in NICU admission rates for neonates with higher BW and GA (BW ≥ 2500g: 1.8% in 2008, 2.1% in 2018; GA ≥ 37 weeks: 1.5% in 2010, 1.8% in 2018). Kaiser hospitals had a decreasing trend of NICU admissions compared to non-Kaiser hospitals (Kaiser: 13.9% in 2008, 10.1% in 2018; non-Kaiser: 11.3% in 2008, 12.3% in 2018). Overall NICU admission rates in California were stable from 2008-2018. However, trends similar to national patterns emerged when stratified by infant GA, BW, and illness acuity as well as Kaiser or non-Kaiser hospitals, with increasing admission rates for infants born at higher BW and GA and within non-Kaiser hospitals.

Labor Induction Outcomes with Outpatient Misoprostol for Cervical Ripening among Low-Risk Women.

In 2012, two Kaiser Permanente Northern California (KPNC) hospitals began offering outpatient cervical ripening with oral misoprostol under a study protocol. We evaluated inpatient time from admission to delivery and adverse maternal and neonatal outcomes associated with outpatient use of misoprostol for cervical ripening among low-risk women with term pregnancies. We conducted a retrospective cohort study comparing three groups: women who received misoprostol (1) outpatient, under a study protocol; (2) inpatient, at the study sites; and (3) inpatient, at all KPNC hospitals. Data were obtained from between 2012 and 2017. The primary outcome was time from inpatient admission to delivery. Secondarily, we evaluated maternal and neonatal outcomes, including the duration and maximum rate of oxytocin administered, rate of cesarean delivery, incidence of chorioamnionitis and blood transfusion, Apgar scores, and neonatal intensive care unit admissions. Demographic and clinical characteristics and outcomes of the outpatient group were compared with both inpatient misoprostol groups using the appropriate statistical test. Variables included in the regression analysis were either statistically significant in the bivariate analyses or have been reported in the literature to be potential confounders: maternal age at admission, race/ethnicity, body mass index, cervical dilation at initial misoprostol, and parity. We analyzed data from 10,253 patients: (1) 345 outpatients, under a study protocol; (2) 1,374 inpatients, at the study sites; and (3) 9,908 inpatients, at all the Kaiser hospitals. Women in the outpatient group were more likely to be white than both inpatient groups (63.3 vs. 56.3% at study sites and 47.1% in all hospitals, p = 0.002 and <0.001, respectively); other demographics were clinically comparable. Most women undergoing labor induction were nulliparous; however, a greater proportion in the outpatient group were nulliparous compared with inpatient groups (70.8 vs. 61.8% and 64.3%, p = 0.002 and 0.01). On inpatient admission for delivery, women who received outpatient misoprostol were more likely to have a cervical dilation of ≥3 cm (39.8 vs. 12.5% at study sites and 9.7% at all KPNC hospitals, p < 0.001 for both). The outpatient group had a shorter mean time between admission and delivery (23.6 vs. 29.4 at study sites and 29.8 hours at all KPNC, p < 0.001 for both). The adjusted estimated mean difference between the outpatient and inpatient group at all the Kaiser hospitals in time from admission to delivery was -6.48 hours (p < 0.001), and the adjusted estimated mean difference in cervical dilation on admission was +1.02 cm (p < 0.001). There was no difference in cesarean delivery rates between groups. The rate of chorioamnionitis in the outpatient group was higher compared with inpatients at all hospitals (17.7 vs. 10.6%, p < 0.001), but similar when compared with the inpatients at the study sites (17.7 vs. 15.4%, p = 0.29). Outpatient use of misoprostol for cervical ripening under the study protocol was associated with reduced inpatient time from admission to delivery compared with inpatient misoprostol. Although there was a higher rate of chorioamnionitis among outpatients under the study protocol compared with inpatients at all hospitals, there was no difference when compared with inpatients at the study sites. There was no difference in rates of cesarean delivery or maternal or neonatal complications with outpatient misoprostol. · Outpatient misoprostol patients had 6.46 fewer hours from admission to delivery compared with inpatients at all hospitals.. · There was no difference in the rate of cesareans between the outpatient versus inpatient misoprostol groups.. · Other maternal and neonatal complications were low and comparable among outpatients and inpatients who received misoprostol; this study was not large enough to assess rare safety outcomes..

My Mother's Facelift

My Mother's Facelift

Granville Coggs (1925-2019) - WWII pilot, pioneering radiologist, and inspiration to minorities in medicine.

Role models play an important role in firing the imagination of medical students and residents, and when it comes to attracting and sustaining under-represented minorities in fields such as medicine, the inspiring stories of minority physicians can make an especially important contribution. One such physician was Granville Coggs, an Arkansas native who overcame a stutter, served among the Tuskegee Airmen during World War II, graduated from Harvard Medical School, became the first black physician at Kaiser Hospital, established the San Antonio Breast Evaluation Center, and won gold medals as a senior track star.

How Total Performance Scores of Medicare Value-Based Purchasing Program Hospitals Change Over Time.

The Medicare Value-Based Purchasing (VBP) program established performance-based financial incentives for hospitals. We hypothesized that total performance scores (TPS) would vary by hospital type. Value-Based Purchasing reports were collected from 2015 to 2017 and merged with the Centers for Medicare and Medicaid Services (CMS) Impact File data. A total of 3,005 hospitals were grouped into physician-owned surgical hospitals (POSH), accountable care organizations (ACO), Kaiser, Vizient, and General hospitals. Longitudinal linear mixed-effects models compared temporal differences of TPS and secondary composite outcome, process, patient satisfaction, safety, and cost efficiency measures between hospital types. Total performance scores decreased across all hospital types (p < .001). Physician-owned surgical hospitals had the highest TPS (59.9), followed by Kaiser (49.2), ACO (36.7), General (34.8), and Vizient (30.7) (p < .001). Hospital types differed significantly in size, geography, mean case-mix index, Medicare patient discharges, percent Medicare days to inpatient days, Disproportionate Share Hospital payments, and uncompensated care per claim. Scores improved in 84% of POSH and 14.6% of Kaiser hospitals using score reallocations. In comparison with General hospitals, the TPS was higher for POSH and Kaiser and lower for Vizient in part due to weighting reallocation and individual domain scores. Centers for Medicare and Medicaid Services scoring system changes have not addressed the methodological biases favoring certain hospital types.

Postoperative Physician Phone Calls as a Method to Decrease Urgent Care and Emergency Department Returns After Ambulatory General Surgery.

Unplanned returns after ambulatory surgery pose a burden to patients and health care providers alike. We hypothesized that a postoperative phone call by a physician would decrease avoidable returns to urgent care (UC) or the emergency department (ED) in the week after anorectal (AR), laparoscopic cholecystectomy (LC), inguinal hernia repair (IHR), and umbilical hernia repair (UHR) operations. A retrospective analysis from 1/2011 to 12/2015 across 14 Kaiser hospitals was conducted to determine baseline UC/ED return rates of patients pre-call. Between 10/2017 and 06/2019, physicians placed phone calls to patients within postoperative days (PODs) 1-4. The cohorts were compared using chi-squared analysis with significance determined at P < .05. In total, 276 patients received a call, with the majority placed on PODs 1-3. There were no statistically significant differences in return rates between the pre- and post-call groups. All of the AR, 50.0% of LC, 66.7% of IHR, and 50.0% of UHR patients returned prior to phone call placement. Our data indicate that a physician phone call does not help in decreasing UC/ED returns. However, it is noteworthy that many of the returns occurred pre-call placement. Future directions should be aimed at placing earlier postoperative phone calls.

LAUNCHING STANDARDIZED GERIATRIC SURGERY PROGRAMS: THE ALPHA AND BETA PILOTS

Then Coalition for Quality in Geriatric Surgery has completed both alpha and beta pilots which represent the initial efforts to launch this national quality initiative to improve the care of all older adults undergoing operations. The alpha phase included hospital stakeholders rating the feasibility of implementing standards related to evidence-based high quality surgical care for older adults on the topics of eliciting patient goals, completing a preoperative frailty risk assessment, educating healthcare professional about care specific to older adults, and implementing postoperative age-friendly care models. The beta pilot phase required 9 medical centers nationally (including an academic hospital, an urban medical center, a Kaiser hospital, a VA hospital and a rural hospital) to implement the evidenced based standards for high quality surgical care of older adults. Site verification visits were completed in the Summer 2018 which evaluated the effectiveness of each medical center’s ability to implement each of the standards.

Observations on the Medicare Value-Based Ranking of Hospitals During Fiscal Years 2015 and 2016.

Medicare's Value-Based Purchasing Program (VBPP) compensates hospitals based on value of care provided. VBPP's total performance score (TPS) components data were evaluated by hospital groups: physician-owned surgical hospitals (POSH), Kaiser Hospitals, University HealthSystem Consortium Hospitals, Pioneer Accountable Care Organization Hospitals, US News and World Report Honor Roll Hospitals, and other hospitals. Multilevel random coefficient models estimated mean and significance of TPS differences from fiscal year (FY) 2015 and FY 2016, by hospital type. Overall mean TPS for 2985 hospitals decreased from 41.65 to 40.25. POSH and Kaiser Hospitals had significantly higher TPS in FY 2015 and FY 2016. POSH Patient Experience Domain scores exceeded all other Patient Experience Domain scores. The Efficiency Domain scores of Kaiser greatly exceeded the scores of all groups. Results suggest that POSH and Kaiser Hospitals provide significantly greater value of care with consistency from year to year when compared with other groups studied.

Retail Clinics: Bringing Health Care to the Neighborhood

Wanda Jacob, BSN, RN, started her nursing career straight out of high school, first as a licensed vocational nurse and in 1991 she became an RN. She spent most of her nursing career in maternal child nursing, with a focus on neonatal and pediatric intensive care nursing. She is often asked how she could do work in the neonatal intensive care unit and pediatric intensive care unit, and her answer has always been, “Nursing has a place for all of us, I couldn't do adults, so someone had to take care of the ‘little people.'” Wanda was a Daisy Award recipient for Kaiser Hospital in Los Angeles in 2010. She returned to school and received her BSN, and in 2012, she transitioned into nursing informatics and is currently the Clinical Systems Nurse Project Manager and member of the Clinical Content Team at Kaiser Permanente Health Connect in Pasadena, CA. When she is not working, Wanda loves to travel with her camera. Wanda is an extraordinary person who gave the gift of love and family by raising her 2 nephews. Today, those young men are successful, due to her guidance; one has a BA in Criminal Justice and works as a Probation Officer and the other is now an U.S. Army Reservist. Address correspondence to Wanda Jacob, BSN, RN, 1319 E. 3rd St, Long Beach, CA 90802 ([email protected]). CM Matters welcomes and invites you to submit articles, stories, practice tips, refl ections, and revelations. How has CM changed you and/or how have you affected the lives of others? All inquiries, questions, comments, and manuscripts should be submitted via e-mail to: [email protected] or by mail to Lynn S. Muller, P.O. Box 164, Bergenfi eld, NJ 07621.Do you have an idea for an article but would like to discuss it, provide your contact information in an e-mail and you will be contacted by your preferred method.The author reports no conflicts of interest.

Achieving Kaiser Permanente quality.

The Kaiser Permanente model of integrated health delivery is highly regarded for high-quality and efficient health care. Efforts to reproduce Kaiser's success have mostly failed. One factor that has received little attention and that could explain Kaiser's advantage is its commitment to and investment in nursing as a key component of organizational culture and patient-centered care. The aim of this study was to investigate the role of Kaiser's nursing organization in promoting quality of care. This was a cross-sectional analysis of linked secondary data from multiple sources, including a detailed survey of nurses, for 564 adult, general acute care hospitals from California, Florida, Pennsylvania, and New Jersey in 2006-2007. We used logistic regression models to examine whether patient (mortality and failure-to-rescue) and nurse (burnout, job satisfaction, and intent-to-leave) outcomes in Kaiser hospitals were better than in non-Kaiser hospitals. We then assessed whether differences in nursing explained outcomes differences between Kaiser and other hospitals. Finally, we examined whether Kaiser hospitals compared favorably with hospitals known for having excellent nurse work environments-Magnet hospitals. Patient and nurse outcomes in Kaiser hospitals were significantly better compared with non-Magnet hospitals. Kaiser hospitals had significantly better nurse work environments, staffing levels, and more nurses with bachelor's degrees. Differences in nursing explained a significant proportion of the Kaiser outcomes advantage. Kaiser hospital outcomes were comparable with Magnet hospitals, where better outcomes have been largely explained by differences in nursing. An important element in Kaiser's success is its investment in professional nursing, which may not be evident to systems seeking to achieve Kaiser's advantage. Our results suggest that a possible strategy for achieving outcomes like Kaiser may be for hospitals to consider Magnet designation, a proven and cost-effective strategy to improve process of care through investments in nursing.

High Variation Between Hospitals in Vena Cava Filter Use for Venous Thromboembolism

The extent to which vena cava filter (VCF) use varies between hospitals in the management of acute venous thromboembolism (VTE) is not clear. We conducted a retrospective observational study that compared the frequency of VCF use among California hospitals from January 1, 2006, through December 31, 2010. Using administrative hospital discharge data, we followed explicit criteria to identify nontrauma patients with acute VTE, and determined the frequency of VCF placement in each of the hospitals that admitted more than 55 VTE patients. Multivariable hierarchical regression models to predict VCF use included important clinical and demographic variables as fixed effects and hospital as a random effect. Among the 263 hospitals included, 130 643 acute VTE hospitalizations occurred with the placement of 19 537 VCFs (14.95%). Variation in the percentage of acute VTE hospitalizations that included VCF placement was very high, from 0% to 38.96% (interquartile range, 6.23%-18.14%), with 18.49% of the observed variation due to differences among the hospitals that provided care. Significant clinical predictors of VCF use included acute bleeding at the time of admission (odds ratio, 3.4 [95% CI, 3.2-3.6]), a major operation after admission for VTE (3.4 [3.3-3.5]), presence of metastatic cancer (1.7 [1.6-1.8]), and extreme severity of illness (2.5 [2.3-2.7] vs mild). Insertion of VCFs occurred more frequently than expected in 109 hospitals and less frequently in 59. Hospital characteristics associated with VCF use included a small number of beds (odds ratio, 0.2 [95% CI, 0.2-0.4], <100 vs >400 beds), a rural location (0.4 [0.2-0.5]), and other private vs Kaiser hospitals (1.5 [1.1-2.0]). Use of VCFs varied widely even in geographically proximate areas. The frequency of VCF use in patients with acute VTE varied widely and depended on which hospital provided the care, even after adjusting for clinical and socioeconomic factors. Further research is needed to determine whether this variation is associated with local cultural differences between hospitals or with differences in the availability of interventional radiologists or specialists, or whether it reflects the absence of high-quality evidence that VCFs are effective.

Immunophenotypic, Proteomic and Genomic Characterization of Human Cord Blood (CB) vs Peripheral Blood (PB) CD56+dim NK Cells: A More Pro NK Phenotype in CB

The Umbilical Cord Blood Collection Program (UCBCP), administered by UC Davis Health System, is a new statewide public program designed to capture the genetic diversity of Californians through collection of cord blood units (CBUs) for unrelated transplantation. This program is funded with revenue from California state birth certificate fees. The vision for the implementation of the mission by UCBCP is to expand access to cord blood stem cells by targeting current inventory deficiencies to provide greater probabilities that people of any race or ethnicity will find an appropriately matched CBU in the National Cord Blood Inventory (NCBI). In support of these goals, the UCBCP plans to promote targeted education programs for health professionals and to utilize best practices for cord blood collections. Through this process UCBCP will facilitate the provision of high quality CBUs for transplantation, as well as promote research and development of effective treatments utilizing cord blood stem cells by making the CBUs collected that do not meet the criteria for banking available to researchers. Much progress has been made toward developing a sustainable cord blood collection program for the state over the first year. The UCBCP leadership team has been developed andwe have identified cord blood banks through an RFP bidding process that will be partnered with hospitals in various parts of the state. The UCBCP is in varying stages of contract negotiations with three of the public banks who responded to the RFP. To date negotiations are in place for California collections in Southern California to occur at five Scripps hospitals, funded in part by the UCBCP; and by collections set to begin at 13 Kaiser Hospitals, also with support from the UCBCP. In the Central Valley, a collection site is being developed in Fresno, at the Community Regional Medical Center. In the Bay area the UCBCP is in negotiations with several hospitals, including California Pacific Medical Center and Alta Bates. In the Sacramento area, the UCBCP has commitments from 2 hospitals and are seeking the same from two additional birthing centers. At UCDHS, we have received IRB approval for the program, and have now initiated cord blood collections for purposes of collector training and process validation.

P44 Expression of calcium/calcineurin pathway-regulated transcription factor NFATc1 and chromatin-remodelling genes BRG1 and BRM in invasive breast cancer

Background: NFATc1 is a transcription factor activated by the calcium/calcineurin pathway, which regulates several physiological processes. Evidence has also shown a role for NFAT transcriptions factors in oncogenesis. BRG1 and BRM are chromatinremodelling genes that are also regulated by calcium homoeostasis. Diminished expression of BRG1 is associated with poor prognosis in breast cancer, non-small-cell lung cancer, colorectal cancer, and prostate cancer. To understand the biological relationship between these two pathways, we examined the expression pattern of NFATc1, BRG1, and BRM in invasive breast cancer. Methods: Paraffin blocks of 150 cases of invasive breast cancer were retrieved from Kaiser Permanente Medical Centre database. Monoclonal antibodies against NFATc1, BRG1, and BRM were used, and expression pattern was determined as no expression, weak (1+ staining intensity), moderate (2+), and high expression (3+). Pearson Chi-Squared test was used for statistical analysis. Findings: NFATc1 was expressed in approximately 22% of the 150 cases of invasive breast cancer, whereas BRG1 was expressed in 56.7% and BRM in 52%. Both nuclear and cytoplasmic expression of NFATc1 was detected, with nuclear expression as the predominant feature. BRM1/BRM are predominantly expressed in the nucleus. Most cases expressing NFATc1 showed 2+ moderate intensity expression patterns. Statistical analysis showed that expression of NFATc1 was highly correlated with the expression of both BRG1 and BRM. Interpretation: Our preliminary data shows that NFATc1 is expressed in a subset of BRG1/BRM-positive invasive breast cancers. This correlation of two calcium homoeostasis-regulated pathways provides insight into the oncogenesis of breast cancer. Funding: Kaiser Hospital Foundation Community Benefit Grant. The author declared no conflicts of interest.

Interpreting Complete Blood Counts Soon After Birth in Newborns at Risk for Sepsis

A complete blood count (CBC) with white blood cell differential is commonly ordered to evaluate newborns at risk for sepsis. To quantify how well components of the CBC predict sepsis in the first 72 hours after birth. For this retrospective cross-sectional study we identified 67 623 term and late-preterm (≥ 34 weeks gestation) newborns from 12 northern California Kaiser hospitals and 1 Boston, Massachusetts hospital who had a CBC and blood culture within 1 hour of each other at <72 hours of age. We compared CBC results among newborns whose blood cultures were and were not positive and quantified discrimination by using receiver operating characteristic curves and likelihood ratios. Blood cultures of 245 infants (3.6 of 1000 tested newborns) were positive. Mean white blood cell (WBC) counts and mean absolute neutrophil counts (ANCs) were lower, and mean proportions of immature neutrophils were higher in newborns with infection; platelet counts did not differ. Discrimination improved with age in the first few hours, especially for WBC counts and ANCs (eg, the area under the receiver operating characteristic curve for WBC counts was 0.52 at <1 hour and 0.87 at ≥ 4 hours). Both WBC counts and ANCs were most informative when very low (eg, the likelihood ratio for ANC < 1000 was 115 at ≥ 4 hours). No test was very sensitive; the lowest likelihood ratio (for WBC count ≥ 20 000 at ≥ 4 hours) was 0.16. Optimal interpretation of the CBC requires using interval likelihood ratios for the newborn's age in hours.

Confirmed Cases of Drug Eruptions at the Osaka Kaiser Hospital

Confirmed Cases of Drug Eruptions at the Osaka Kaiser Hospital

Numbers Needed to Treat With Phototherapy According to American Academy of Pediatrics Guidelines

Our aims were to estimate the efficacy of hospital phototherapy for neonatal jaundice and the number needed to treat to prevent one infant from reaching the exchange transfusion level. From a cohort of 281 898 infants weighing > or =2000 g born at > or =35 weeks' gestation at 12 Northern California Kaiser hospitals from 1995 to 2004, we identified 22 547 who had a "qualifying total serum bilirubin level" within 3 mg/dL of the American Academy of Pediatrics 2004 guideline phototherapy threshold. We used multiple logistic regression to estimate the efficacy of hospital phototherapy within 8 hours at preventing the bilirubin level from exceeding the 2004 guideline's exchange transfusion threshold within 48 hours. We combined this efficacy estimate with other predictors of risk to estimate the numbers needed to treat at different values of covariates. Of the 22 547 eligible newborns, 5251 (23%) received hospital phototherapy within 8 hours of their qualifying bilirubin level. Only 354 (1.6%) ever exceeded the guideline exchange transfusion threshold; 187 (0.8%) did so within 48 hours. Among infants who did not have a positive direct antiglobulin test, hospital phototherapy within 8 hours was highly effective (adjusted odds ratio, 0.16; 95% confidence interval, 0.07-0.34). For infants with bilirubin levels 0-0.9 mg/dL above the phototherapy threshold, the estimated number needed to treat at mean values of covariates was 222 (95% CI: 107-502) for boys and 339 (95% CI: 154-729) for girls, ranging from 10 (95% CI: 6-19) for <24-hour-old, 36-week gestation boys to 3,041 (95% CI: 888-11 096) for > or =3-day-old 41-week girls. Hospital phototherapy was less effective for infants direct antiglobulin test-positive infants (adjusted odds ratio 0.55; 95% CI: 0.21-1.45; P = 0.01 for the direct antiglobulin test x phototherapy interaction). While hospital phototherapy is effective, the number needed to treat according to current guidelines varies considerably across different infant subgroups.

Risk Factors for Severe Hyperbilirubinemia among Infants with Borderline Bilirubin Levels: A Nested Case-Control Study

To estimate the effect of phototherapy and other predictors on the risk of total serum bilirubin (TSB) >or= 25 mg/dL in infants with a TSB of 17 to 22.9 mg/dL at age >or= 48 hours. From a cohort of 285295 infants >or= 34 weeks gestation and >or= 2000 g born between 1995 and 2004 in northern California Kaiser hospitals, we identified 17986 with a TSB of 17 to 22.9 mg/dL at age >or= 48 hours. All infants exhibiting a TSB >or= 25 mg/dL were selected as cases for the study. Four randomly selected controls were matched to each case based on the difference between their qualifying TSB and the American Academy of Pediatrics' phototherapy threshold. A total of 62 cases were identified (0.4%). Six of these (10%) received inpatient phototherapy within 8 hours, along with 101 controls (41%) (adjusted odds ratio [AOR] 0.15; 95% confidence interval [CI] 0.06 to 0.40). Cases more often had lower gestational age (AOR 3.24; 95% CI 1.24 to 8.47 for 38 to 39 weeks and AOR = 3.70; 95% CI 0.61 to 22.4 for 34 to 37 weeks compared with >or= 40-week infants), bruising, (AOR 2.52; 95% CI 1.16 to 5.50), exclusive breast-feeding (AOR 2.09; 95% CI 1.05 to 4.03), and TSB increase of >or= 6 mg/dL/day (AOR 2.39; 95% CI 1.18 to 4.85). Phototherapy was 85% effective in preventing TSB >or= 25 mg/dL. The strongest predictors of TSB >or= 25 mg/dL were gestational age, bruising, family history, and rapid rise in TSB.

Sidney Garfield—A Personal Recollection

Sidney Garfield—A Personal Recollection

Gene expression and breast cancer mortality in Northern California Kaiser Permanente Patients: A large population-based case control study

603 Background: The 21 gene Recurrence Score (RS) assay (Oncotype DX) has been validated to quantify the risk of distant recurrence in tamoxifen-treated (tam+) pts with N-, ER+ breast cancer (BC) (Paik et al, NEJM, 2004). The relation between gene expression and BC mortality in a community hospital setting for ER+ tam+ pts, as well as for tam- and ER- pts, was not known. Methods: We conducted a nested case-control study in BC pts diagnosed from 1985–94 at 14 Kaiser hospitals. Eligibility included negative nodes, age < 75 yrs, and no chemotherapy. Cases died of BC prior to 2002. Up to 3 controls were matched to each case on age, race, tam treatment, facility, diagnosis yr, and follow-up time. Using pre-specified methods, archived tumor tissue was analyzed using the RT-PCR 21 gene expression assay and RS algorithm. Pre-specified primary and secondary endpoints were analyzed by conditional logistic regression to estimate the association between gene expression (for RS, proliferation gene group score, and individual genes, including ER and PR) and BC death, while controlling for tumor size, grade, and confounding variables. Results: Among 4964 potentially eligible BC pts, we identified 220 cases and 570 matched controls. Median age was 59 yr (range 28–74); 30.9% were tam+ (mostly after 1988). Median follow-up time was 4.9 yrs for cases (time to death) and 12.9 yrs for controls. RS was significantly associated with BC death in ER+ pts treated with or without tam (p=0.002). Gene expression for ER and PR had different associations–ER expression was associated with mortality in the ER+ tam+ pts (p = 0.003), but not the ER+ tam- pts (p=0.26), and was predictive of tam benefit but not of prognosis. PR was associated with mortality in the ER+ tam- pts (0.004), and was strongly prognostic. Among both ER+ tam- pts and ER- pts, those with high proliferation gene group scores had over 6 times the risk of BC death compared to those with low scores (p=0.001). Conclusion: A large population-based study from 14 Northern California hospitals demonstrates the Recurrence Score is independently associated with breast cancer mortality, and is both prognostic and predictive. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genomic Health Genomic Health Genomic Health

Perinatal stroke in children with motor impairment: a population-based study.

Risk factors for perinatal arterial stroke (PAS) are poorly understood. Most previous studies lack an appropriate control group and include only infants with symptoms in the newborn period. We set out to determine prenatal and perinatal risk factors for PAS. In a population-based, case-control study nested within the cohort of 231 582 singleton infants who were born at >or=36 weeks' gestation in Northern California Kaiser hospitals from 1991 to 1998, we searched electronically for children with motor impairment and reviewed their medical records to identify diagnoses of PAS. Control subjects were randomly selected from the study population. A medical record abstractor reviewed delivery records without knowledge of case status. The prevalence of PAS with motor impairment was 17/100,000 live births. Of 38 cases, 26 (68%) presented after 3 months of age with hemiparesis or seizures. All 12 newborns with acute stroke symptoms had seizures. A delayed presentation was more common in children with moderate to severe motor impairment than among infants with only mild motor abnormalities (24 of 31 vs 2 of 7). Prepartum risk factors significantly associated with PAS in multivariate analysis were preeclampsia (odds ratio [OR]: 3.6; 95% confidence interval [CI]: 1.1-11.4) and intrauterine growth restriction (OR: 5.3; 95% CI: 1.5-18.6). Newborns with PAS were also at higher risk of delivery complications, such as emergency cesarean section (OR: 6.8; 95% CI: 2.7-16.6), 5-minute Apgar <7 (OR: 23.6; 95% CI: 4.1-237), and resuscitation at birth (OR: 4.5; 95% CI: 1.6-12.3). Preeclampsia and intrauterine growth restriction (IUGR) may be independent risk factors for perinatal stroke resulting in motor impairment. Large multicenter studies that include all children with perinatal stroke are needed to determine further the risk factors and outcome of perinatal stroke.