Mortality following development of breast cancer while using oestrogen or oestrogen plus progestin: a computer record-linkage study.

The literature on the relationship between breast cancer mortality and postmenopausal oestrogen and combined oestrogen/progestin therapy is seemingly contradictory. This study explored survival after exposure to oestrogen or oestrogen plus progestin at or in the year prior to breast cancer diagnosis. Information on patients first diagnosed with invasive breast cancer between 1993 and 1998 was linked with outpatient pharmacy data from 1992 to 2000. Patients were classified according to use of oestrogen alone or oestrogen plus progestin at or in the year prior to diagnosis. Compared to nonusers, and adjusting for age at diagnosis, race/ethnicity, tumour size and grade, oestrogen receptor status, surgery status, and chemotherapy and hormone therapy for breast cancer treatment, oestrogen plus progestin users had lower all-cause mortality (stage I hazard ratio (HR) = 0.69, 95% confidence interval (CI)= 0.48-0.99; stage II HR = 0.53, 95% CI = 0.39-0.72) and breast cancer mortality (stage I HR = 0.52, 95% CI = 0.26-1.04; stage II HR = 0.69, 95% CI = 0.48-0.98). Oestrogen users experienced little or no survival benefit for all-cause mortality (stage I HR = 1.04, 95% CI = 0.77-1.42; stage II HR = 0.86, 95% CI = 0.65-1.14) or breast cancer mortality (stage I HR = 1.23, 95% CI 0.72-2.10; stage II HR = 1.01, 95% CI 0.72-1.41). Our findings suggest, relative to nonusers, a lower risk of death from all causes and from breast cancer in patients who were diagnosed with breast cancer while exposed to oestrogen plus progestin, but not in patients exposed to oestrogen only.

Approaches to heterogeneity in meta-analysis.

This paper reviews publications from January 1999 to March 2001 on reproductive health topics that were self-identified as meta-analysis or were indexed as meta-analysis in MEDLINE. It sought to assess whether tests of statistical heterogeneity were done, whether the results were reported, and how a finding of significance for a test of statistical heterogeneity was handled and the results interpreted. The review identified some concerns. Tests of statistical heterogeneity were not done universally even though virtually all writers on the topic emphasize their importance. Even when done, results of these tests were not universally reported. Although the consensus appears to be that heterogeneity tests are conservative for meta-analysis of studies and a probability value of 0.10 is preferred, many meta-analyses used the conventional value of 0.05 without providing a reason. The rationale for the choice of a random or fixed effects model was not generally evident. The review also provided some positive models and some recommendations for assessing, reporting and exploring heterogeneity are made considering these models and the published recommendations of experts.

Rehospitalisation for neonatal jaundice: risk factors and outcomes.

This case-control study sought to determine whether rehospitalisation for jaundice in newborns is associated with the length of hospital stay after birth and to identify risk factors for and outcomes of rehospitalisation for jaundice. It was carried out among women who delivered a normal, term infant vaginally at any of 10 medical centres from 1992 to 1994. Cases were infants rehospitalised with jaundice within 14 days of birth. Controls were randomly selected from normal, term infants delivered vaginally but not rehospitalised within 90 days of birth. Maternal medical records for pregnancy, labour and delivery care, records for all the birth hospitalisations, and rehospitalisations for the cases were abstracted. The length of birth hospitalisation did not differ between case and control infants, whether length was measured as a categorical variable or as a continuous measure (median = 22.8 h for cases and 23.3 h for controls, P = 0.931). Rehospitalisation for jaundice was associated with race/ethnicity, primiparity, preterm birth, breast feeding and suspicion of jaundice during the birth hospitalisation. None of the rehospitalised infants died, were diagnosed with kernicterus or required resuscitation. Attention to risks associated with jaundice rehospitalisation might reduce this undesirable, but not commonly severe, outcome.

Emergency contraception: knowledge and attitudes of health care providers in a health maintenance organization.

One hundred sixty-four health care providers in a health maintenance organization were surveyed in 1996 regarding their knowledge of, attitudes toward, and perception of barriers regarding emergency contraceptive pills (ECPs), as well as their ECP prescribing practices. Providers reported primarily positive attitudes regarding ECPs. Only 42% reported having ever prescribed ECPs; those who had prescribed had more positive attitudes about ECPs. Knowledge of ECP provision was incomplete, with 40% believing treatment had to be initiated in 48 hours or less. Barriers identified by providers included lack of a dedicated product, lack of awareness of ECPs among providers, and liability issues.

Salt and blood pressure. Conventional wisdom reconsidered.

The salt hypothesis is that higher levels of salt in the diet lead to higher levels of blood pressure, increasing the risk of cardiovascular disease. Intersalt, a cross-sectional study of salt levels and blood pressures in 52 populations, is often cited to support the salt hypothesis, but the data are somewhat contradictory. Four of the populations (Kenya, Papua, and 2 Indian tribes in Brazil) do have low levels of salt and blood pressure. Across the other 48 populations, however, blood pressures go down as salt levels go up, contradicting the hypothesis. Experimental evidence suggests that the effect of a large reduction in salt intake on blood pressure is modest, and health consequences remain to be determined. Funding agencies and medical journals have taken a stronger position favoring the salt hypothesis than is warranted, raising questions about the interaction between the policy process and science.

Changes in providers' views and practices about emergency contraception with education.

OBJECTIVE: To assess changes in the prescribing practices, knowledge, attitudes, and perceptions of health care providers after an educational program about emergency contraception. METHODS: Health care providers completed self-administered questionnaires before and 1 year after full implementation of the project. The 102 providers who completed both questionnaires were physicians (64%) and mid-level professionals from 13 San Diego County Kaiser Permanente medical offices working in departments such as obstetrics and gynecology, primary care, and emergency medicine. RESULTS: The frequency of prescription for emergency contraceptive pills increased significantly from baseline to follow-up. There was an increase of almost 20% in the percentage who prescribed emergency contraception at least once a year. Knowledge also improved significantly, and perceptions of barriers to prescribing emergency contraceptive pills within the health maintenance organization decreased significantly. In contrast, attitudes about emergency contraception showed little change. CONCLUSION: This study suggests that providers who participate in in-service training and other aspects of a demonstration project show changes in perceptions, knowledge, and behavior. However, findings also suggest that significant gaps remain in knowledge about medications, side effects, and mode of action. It is likely that many providers in other health care settings also need additional information and training concerning protocols of emergency contraception provision and its modes of action and effects.

Randomized trial of fructosamine home monitoring in patients with diabetes.

CONTEXT: Recognition of the importance of glycemic control in type 2 diabetes has generated interest in developing ways to improve such control. Levels of fructosamine, 1-amino-1-deoxyfructose, are highly correlated with those of hemoglobin A1c (HbA1c) and can be monitored in the home. DESIGN: Randomized trial. PARTICIPANTS: 140 adult patients with HbA1c values of 8% or greater were recruited to the trial through referral from physicians and a direct mailing to potentially eligible persons. INTERVENTION: Weekly home fructosamine monitoring in addition to daily glucose monitoring. Control patients monitored daily glucose only. Both groups of patients were contacted regularly by telephone and were given the same instructions on diet and exercise. OUTCOME: Measures of glycemic control 3 and 6 months after randomization. RESULTS: No significant difference was found between the two groups in the mean absolute decrease of HbA1c levels at 3 months (0.5% in the fructosamine group vs. 0.8% in the control group; P > 0.2), and the difference favored the control group at 6 months (0.7% fructosamine vs. 1.2% control; P = 0.04). Both groups had a statistically significant improvement in glycemic control. CONCLUSIONS: The addition of home fructosamine monitoring to routine glucose monitoring did not improve glycemic control.

Split sample analysis of serum folate levels after 18 days in frozen storage.

Reliable measurement of folate is becoming increasingly important as links between dietary folate intake, the use of vitamins containing folic acid, and health outcomes such as birth defects and cardiovascular disease are identified. This study was undertaken to formally assess whether the quantity of folate in serum declines after the serum is frozen and stored. Blood samples from 83 pregnant women were tested for serum folate shortly after collection and again after 18 days of storage at -20 degrees C. A shift from higher to lower serum folate categories was observed after 18 days of storage. For the first test, 40.9 % of the samples were > or = 20 microg/L compared with 19.3 % of the test results on second test. For the 75 samples in the quantifiable range (< 40 microg/L), a mean decrease of 5.0 microg/L (+/- 0.5) of serum folate was observed (p < 0.0001). When compared to serum samples stored in a non frost-free freezer at -20 degrees C or -70 degrees C, serum stored in a frost-free freezer at -20 degrees C for even a short period of time may be relatively unstable and sensitive to minor temperature fluctuations associated with the freeze-thaw cycles.

Hormone replacement therapy and the risk of myocardial infarction in women with coronary risk factors.

To assess the risk of myocardial infarction in users of post-menopausal hormone replacement therapy who are at high risk of coronary disease because of hypertension, diabetes mellitus, or smoking, we used data from a previously published case-control study of women 45-74 years. After adjustment for age, ethnicity, and education, the odds ratio for myocardial infarction in current users of hormone replacement therapy was 0.9 (95% confidence interval (CI) = 0.5-1.6) in women with no major coronary risk factors, 0.8 (95% CI = 0.5-1.8) in women with one risk factor, and 1.1 (95% CI = 0.5-2.2) in women with two risk factors.

The influence of intrapartum antibiotics on the clinical spectrum of early-onset group B streptococcal infection in term infants.

OBJECTIVE: The use of intrapartum antibiotics to prevent early-onset group B streptococcal (EOGBS) infection has left pediatricians in a quandary about the appropriate evaluation and treatment of infants at risk for this infection. The aim of this study was to determine whether intrapartum antibiotic prophylaxis changed the constellation and timing of onset of clinical signs of group B streptococcal (GBS) infection in term infants. METHODOLOGY: We conducted a retrospective chart review of infants who had EOGBS infection and were born in Southern California Kaiser Permanente Hospitals from 1988 through 1996. Objective criteria were used to ascertain maternal risk of infection, intrapartum antibiotic prophylaxis, and onset of clinical signs of infection. RESULTS: Three hundred nineteen infants with EOGBS sepsis, bacteremia, or clinically suspected infection were identified from a population of 277 912 live births. Of the 172 term infants with culture-positive infection who had clinical signs of infection, 95% exhibited them in the first 24 hours of life. All of the infants exposed to intrapartum antibiotics became ill within the first 24 hours of life. CONCLUSIONS: Exposure to antibiotics during labor did not change the clinical spectrum of disease or the onset of clinical signs of infection within 24 hours of birth for term infants with EOGBS infection. A 48-hour stay is not required to monitor asymptomatic term infants exposed to intrapartum antibiotics for onset of GBS infection.

Evaluation of the effect of performance monitoring and feedback on care process, utilization, and outcome.

OBJECTIVE: We evaluated a program of performance measurement and monitoring by assessing care process, utilization of services, and outcomes. RESEARCH DESIGN AND METHODS: Information on 63,264 diabetic individuals who were continuously enrolled as members of Kaiser Permanente Southern California from 1 January 1994 to 31 December 1997 was used to evaluate the program. Time trends in testing for glycemic test and control and screening for dyslipidemia, use of lipid-lowering drugs, and microalbuminuria were evaluated as measures of care process. Time trends in hospitalization, outpatient appointments, prescriptions, and laboratory tests were evaluated as measures of utilization. Outcomes were hospitalization for myocardial infarction, ischemic stroke, and lower-limb amputation. RESULTS: Between 1994 and 1997, improvements were evident in the process measures. The mean number of hospitalizations and the mean and median number of outpatients visits did not change. The mean number of laboratory tests increased from 13.2 in 1994 to 23.6 in 1997. The mean number of prescriptions for any medication increased from 19.7 to 24.3. Hospitalization rates for myocardial infarction did not change, but rates increased for ischemic stroke and lower-limb amputation. CONCLUSIONS: Our findings suggest that measurement and monitoring of clinical performance can bring about modest improvements in measures of the processes of care in the absence of financial incentives, centrally driven interventions, and specialty care for all patients. In our setting, process improvements were associated with higher utilization of laboratory services and more prescriptions without an immediate return in terms of lower hospital utilization.

Steroid hormone contraception and bone mineral density: a cross-sectional study in an international population. The WHO Study of Hormonal Contraception and Bone Health.

OBJECTIVE: To evaluate relationships between bone mineral density and use of steroid hormonal contraceptives. METHODS: This was a multicenter cross-sectional study in seven centers in three regions of the developing world from April 1994 to June 1997. Women 30-34 years old attending family planning clinics, with at least 24 months of lifetime use of combined oral contraceptives (OC), depot-medroxyprogesterone acetate (DMPA), or levonorgestrel implants, or no or only short-term (less than 6 months) use of steroid hormonal contraceptives, had bone mineral density (BMD) measured at the distal radius and the midshaft of the ulna using single-photon x-ray absorptiometry. RESULTS: In the study, 2474 women were examined. For OC use, adjusted mean BMD was significantly higher in short-term, current users compared with women who never used hormonal contraceptives. For DMPA and levonorgestrel implants, adjusted mean BMD was statistically significantly lower in short-term current users compared with those who never used hormonal contraceptives. For all three hormonal methods, there were no significant differences in BMD between past users of hormonal contraceptives and never users, even among those who had used the methods for 4 or more years. The magnitude of changes in BMD was small and less than one standard deviation (SD) from the mean of those who never used steroid contraceptives. CONCLUSION: This study suggests that hormonal contraceptive use by young adult women is associated with small changes in BMD that occur early after initiation of use and are reversible.

Evaluation of a breast cancer patient information and support program.

CONTEXT: Women with newly diagnosed breast cancer seek answers to many questions about their disease, treatment options, and prognosis. Failure to meet these needs may cause dissatisfaction with the care process. OBJECTIVE: To evaluate the impact of a support and information program for women with newly diagnosed breast cancer. INTERVENTION: A support and information program that featured a program coordinator, information resources, and mentoring from a breast cancer survivor. DESIGN AND OUTCOME MEASURES: Women in whom breast cancer was diagnosed at program sites (n = 111) and a random sample of women whose breast cancer was diagnosed at nonprogram sites (n = 277) were surveyed by mail to ascertain their level of satisfaction with various aspects of their medical care. The response rates were 74% and 81%, respectively. RESULTS: 75% of women at program sites used the information resources, and 60% requested a patient mentor. Demographic characteristics and satisfaction with non-breast cancer care were almost identical among program and non-program site respondents. For overall breast cancer care, 71% of program site respondents but only 56% of non-program site respondents were very satisfied. More than half of program site respondents rated presurgery care, provision of information, and support received as excellent, versus about 40% of non-program site respondents. Program site respondents were consistently more likely to rate the amount of reassurance and support provided by physicians and nurses as excellent and were less likely to want a second opinion (35% vs. 51%). CONCLUSIONS: The support and information program appears to have had a positive impact on satisfaction with breast cancer care.

Trends in serum folate after food fortification.

From 1994 to 1998, median serum folate values in clinical specimens increased from 12.6 to 18.7 microg/L. The percentage of low values decreased. Food fortification with folic acid is a likely explanation.

Research interests of physicians in two practice-based primary care research networks.

Regional practice-based network research has grown significantly in the past 15 years. Previous studies have reported on characteristics of physicians who participate in network research, but little is known about the specific a priori research interests of practicing physicians. Knowledge of such interests could be useful in planning network research studies. We conducted a mail survey to assess the research interests of primary care physicians in two contiguous research networks at the University of California at San Francisco (UCSF) and at Stanford University. Among 120 respondents from the UCSF Collaborative Research Network and 85 from the Stanford Ambulatory Research Network, the most common topics of interest were disease prevention, communication and compliance, and managed care. Among specific conditions, heart disease, hypertension, and respiratory infection were of interest to the majority of respondents. Topics not of interest to network members were obstetrics, diagnostic procedures, alcoholism, drug abuse, tuberculosis, male genito-urinary problems, occupational hazards, domestic violence, and AIDS and HIV. Identification of network physician research interests can help focus research and recruitment efforts on topics of interest and provide estimates of participation levels for planning studies and preparing funding applications for research networks.

Critical care transport: outcome evaluation after interfacility transfer and hospitalization.

STUDY OBJECTIVE: To test the hypothesis that interfacility transfer is not associated with increased mortality, duration of stay, or readmission within 7 days. METHODS: We matched 3,298 patients who were hospitalized for chest pain or related complaints in Kaiser Permanente medical centers after transfer from the emergency department of a nonplan hospital (transported patients) with 3,298 patients of the same gender and age (+/-5 years) and with the same principal diagnosis who were hospitalized within 6 months without transfer in the same Kaiser Permanente medical center (directly admitted patients). Patients were compared in terms of outcome measures: in-hospital deaths, continued care in another facility, readmission within 7 days, in-patient length of stay (LOS), and LOS in special care units. RESULTS: The adjusted odds ratios for in-hospital mortality and readmission within 7 days were 1.0 (95% confidence interval,.8 to 1.4) and.9 (95% confidence interval,.7 to 1.2), respectively. The adjusted mean difference in LOS was -.1 days (95% confidence interval, -.2 to.1). Transported and directly admitted cardiac patients were also compared for all examined outcome measures at each of 10 medical centers. At a few medical centers, we observed significant difference in LOS, special care LOS, and continued care in another facility. However, all these differences were small, and most were probably random errors. CONCLUSION: Conservative patient selection criteria, pretransfer stabilization, and the use of appropriate equipment and medical personnel have resulted in the interfacility transfer program's achieving its goal of transferring high-risk patients without adverse impact on clinical outcomes or resource use.

Satisfaction with pregnancy and newborn care: development and results of a survey in a health maintenance organization.

OBJECTIVE: To measure patient satisfaction with pregnancy and newborn care. STUDY DESIGN: To develop our survey, we reviewed domains of care that had been identified by national groups working to develop measures of satisfaction with care. Within these domains of care, items pertinent to pregnancy and newborn care were written, reviewed, and pilot tested in focus groups of women who had recently delivered a baby. A 24-item survey instrument was the result of this process. PATIENTS AND METHODS: We sent our survey to 2337 female members of the Southern California Kaiser Permanente Medical Care Program approximately 8 weeks after they had delivered a baby. The demographic and clinical characteristics of the respondents were compared with those of the nonrespondents. RESULTS: A total of 1017 women (44%) completed and returned the survey. Eighty-eight percent of the women who responded were very or somewhat satisfied with the care they received during their pregnancy and the newborn period. Women who responded differed from those who did not respond on infant birthweight, maternal age and education, and other variables. The results of our survey were forwarded to local quality managers and physicians. CONCLUSION: Satisfaction with care is an important measure of quality of care. Many changes in the delivery system were made in response to the information provided by survey respondents, including offering alternative appointment times and scheduling postpartum appointments before hospital discharge. Our survey instrument, which assesses satisfaction with pregnancy and newborn care, might be useful for other health maintenance organizations for identifying areas where improvement in care is needed.

Emergency contraception: preliminary report of a demonstration and evaluation project.

Kaiser Permanente Southern California and the Pacific Institute for Women's Health began a demonstration and evaluation project on emergency contraceptive pills (ECPs) in the summer of 1996 with the goal of evaluating the feasibility and acceptability of ECPs in a large health maintenance organization and developing institutional templates, provider training and patient education materials that could be used to replicate the project. The ECP program had six components: repackaging of oral contraceptives in an ECP "kit," development of provider education materials, development of patient education materials, in-service training, making ECPs kits available in convenient locations, and development of materials to support replication of the project inside and outside Kaiser Permanente. Although data are still being analyzed, preliminary results are promising. The success of the project within this relatively conservative, but well-established medical care organization provides a model for others. The development of a standard set of educational materials and approaches to implementation should facilitate dispensing ECPs in other settings.