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Objective: In women with diabetes, the changes that accompany menopause may further diminish glycemic control. Little is known about how hormone replacement therapy (HRT) affects glucose metabolism in diabetes. The aim of this study was to examine whether HbA(1c) levels varied by current HRT among women with type 2 diabetes.Research Design and Methods: In a cohort of 15,435 women with type 2 diabetes who were members of a health maintenance organization, HbA(1c) and HRT were assessed by reviewing records in the health plan's computerized laboratory and pharmacy systems. Sociodemographic and clinical information were collected by survey.Results: The mean age was 64.7 years (SD +/- 8.7). The study cohort comprised 55% non-Hispanic whites, 14% non-Hispanic blacks, 12% Hispanics, 11% Asians, 4% "other" ethnic groups, and 4% with missing ethnicity data. Current HRT was observed in 25% of women. HbA(1c) levels were significantly lower in women currently using HRT than in women not using HRT (age-adjusted mean +/- SE: 7.9 +/- 0.03 vs. 8.5 +/- 0.02, respectively, P = 0.0001). No differences in HbA(1c) level were observed between women using unopposed estrogens and women using opposed estrogens. In a Generalized Estimating Equation model, which took into account patient clustering within physician and adjusted for age, ethnicity, education, obesity, hypoglycemic therapy, diabetes duration, self-monitoring of blood glucose, and exercise, HRT remained significantly and independently associated with decreased HbA(1c) levels (P = 0.0001).Conclusions: HRT was independently associated with decreased HbA(1c) level. Clinical trials will be necessary to understand whether HRT may improve glycemic control in women with diabetes. [ABSTRACT FROM AUTHOR]

Objective: Self-monitoring of blood glucose (SMBG) is a cornerstone of diabetes care, but little is known about barriers to this self-care practice.Research Design and Methods: This cross-sectional study examines SMBG practice patterns and barriers in 44,181 adults with pharmacologically treated diabetes from the Kaiser Permanente Northern California Region who responded to a health survey (83% response rate). The primary outcome is self-reported frequency of SMBG.Results: Although most patients reported some level of SMBG monitoring, 60% of those with type 1 diabetes and 67% of those with type 2 diabetes reported practicing SMBG less frequently than recommended by the American Diabetes Association (three to four times daily for type 1 diabetes, and once daily for type 2 diabetes treated pharmacologically). Significant independent predictors of nonadherent practice of SMBG included longer time since diagnosis, less intensive therapy, male sex, age, belonging to an ethnic minority, having a lower education and neighborhood income, difficulty communicating in English, higher out-of-pocket costs for glucometer strips (especially for subjects with lower incomes), smoking, and excessive alcohol consumption.Conclusions: Considerable gaps persist between actual and recommended SMBG practices in this large managed care organization. A somewhat reduced SMBG frequency in subjects with linguistic barriers, some ethnic minorities, and subjects with lower education levels suggests the potential for targeted, culturally sensitive, multilingual health education. The somewhat lower frequency of SMBG among subjects paying higher out-of-pocket expenditures for strips suggests that removal of financial barriers by providing more comprehensive coverage for these costs may enhance adherence to recommendations for SMBG. [ABSTRACT FROM AUTHOR]

OBJECTIVE--To assess excess maternal transmission of type 2 diabetes in a multiethnic cohort. Previous studies have reported higher prevalence of diabetes among mothers of probands with type 2 diabetes than among fathers. This analysis is vulnerable to biases, and this pattern has not been observed in all populations or races. RESEARCH DESIGN AND METHODS--We assessed evidence for excess maternal transmission among 42,533 survey respondents with type 2 diabetes (probands) by calculating the prevalence of diabetes in their siblings and offspring. To assess data quality, we evaluated completeness of family history data provided. Accuracy of family information reported by probands was also evaluated by comparing survey responses in a subsample of 206 probands with family histories modified after further interviews with relatives. RESULTS--Siblings (n = 60,532) of probands with affected mothers had a greater prevalence of diabetes (20%) than those with affected fathers (17%) (P < 0.001 for adjusted odds ratios). Prevalence of diabetes was higher among the offspring (n = 72,087) of female (3.4%) versus male (2.2%) probands (P < 0.001 for adjusted odds ratios). These patterns were evident in all races and both sexes; however, the effect size was clinically insignificant in AfricanAmericans and male offspring. In general, probands provided more complete data about diabetes status for the maternal arm of the pedigree than the paternal arm. Completeness of knowledge was not related to proband sex, but was related to education and race, and inversely to age. Accuracy of proband-reported family history was consistently good (kappa statistics generally >0.70). CONCLUSIONS--Excess maternal transmission was observed in all races and both sexes, although the size of the excess was negligible in African-Americans and male offspring. Potential reporting and censoring biases are discussed. [ABSTRACT FROM AUTHOR]

Background: Limited data have been reported on bariatric surgery within a large, high-volume regional multicenter integrated healthcare delivery system., Objectives: Review clinical characteristics and short- and intermediate-term outcomes and adverse events from a bariatric surgery program within an integrated healthcare delivery system., Setting: Single high-volume, multicenter regional integrated healthcare delivery system., Methods: Adult patients who underwent primary bariatric surgery during 2010-2011 were reviewed. Clinical characteristics, outcomes, and weight loss results were extracted from the electronic medical record., Results: A total of 2399 patients were identified within the study period. The 30-day rates of clinical outcomes for Roux-en-Y gastric bypass (RYGB; n = 1313) and sleeve gastrectomy (SG; n = 1018) were 2.9% for readmission, 3.0% for major complications, .8% for reoperation, and 0% for mortality. One-year and 2-year weight loss results were as follows: percent weight loss (%WL) was 31.4 (±SD 8.5) and 34.2±12.0% for SG and 34.1±9.3 and 39.1±11.9 for RYGB; percent excess weight loss (%EBWL) was 64.2±18.0 and 69.8±23.7 for SG and 68.0±19.3 and 77.8±23.7 for RYGB; percent excess body mass index loss (%EBMIL) was 72.9±21.0 and 77.7±22.4 for SG and 76.6±22.1% and 85.6±21.6 for RYGB. Follow-up for each procedure at 1 year was 76% for SG (n = 778) and 80% for RYGB (n = 1052) and at 2 years was 65% for SG (n = 659) and 67% for RYGB (n = 875)., Conclusions: A large regional high-volume multicenter bariatric program within an integrated healthcare delivery system can produce excellent short-term results with low rates of short- and intermediate-term adverse outcomes., (Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: We tested the effectiveness of offering home fecal immunochemical tests (FITs) during influenza vaccination clinics to increase colorectal cancer screening (CRCS)., Methods: In a clinical trial at Kaiser Permanente Northern California influenza clinics in Redwood City, Richmond, South San Francisco, Union City, and Fresno, we randomly assigned influenza clinic dates to intervention (FIT offered) or control (FIT not offered) and compared subsequent CRCS activity., Results: Clinic staff provided FITs to 53.9% (1805/3351) of intervention patients aged 50 to 75 years. In the intent-to-treat analysis, 26.9% (900/3351) and 11.7% (336/2884) of intervention and control patients completed an FIT, respectively, within 90 days of vaccination (P ≤ .001). The adjusted odds ratio for completing FIT in the intervention versus the control arm was 2.75 (95% confidence interval = 2.40, 3.16). In the per protocol analysis, 35.4% (648/1830) of patients given FIT and 13.3% (588/4405) of patients not given FIT completed FIT within 90 days of vaccination (P ≤ .001)., Conclusions: This intervention may increase CRCS among those not reached by other forms of CRCS outreach. Future research should include the extent to which these programs can be disseminated and implemented nationally.

Breast cancer patients have voiced dissatisfaction regarding their education on breast cancer-related lymphedema risk and risk reduction strategies from their clinicians. Informing patients about lymphedema can contribute to decrease their risk of developing the condition, or among those already affected, prevent it from progressing further. In this cross-sectional study, a lymphedema awareness score was calculated based on responses to a brief telephone interview conducted among 389 women diagnosed with invasive breast cancer at Kaiser Permanente Northern California from 2000 to 2008 and had a previous record of a lymphedema-related diagnosis or procedure in their electronic medical record. During the telephone interview, women self-reported a lymphedema clinical diagnosis, lymphedema symptoms but no lymphedema diagnosis, or neither a diagnosis nor symptoms, and responded to questions on lymphedema education and support services as well as health knowledge. Multivariable logistic regression [odds ratio (OR) and 95 % confidence interval (CI)] was used to determine the associations of selected sociodemographic and clinical factors with the odds of having lymphedema awareness (adequate vs. inadequate). The median (range) of the lymphedema awareness score was 4 (0-7). Compared with patients <50 years of age, patients 70+ years of age at breast cancer diagnosis had lower odds of adequate lymphedema awareness (OR 0.25; 95 % CI 0.07, 0.89), while patients 50-59 and 60-69 years had greater odds of adequate awareness although not statistically significant (OR 2.05; 95 % CI 0.88, 4.78 and OR 1.55; 95 % CI 0.60, 4.02, respectively; p for trend = 0.09). Higher educational level and greater health literacy were suggestive of adequate awareness yet were not significant. These results can help inform educational interventions to strengthen patient knowledge of lymphedema risk and risk reduction practices, particularly in an integrated health care delivery setting. With the growing population of breast cancer survivors, increasing patient awareness and education about lymphedema risk reduction and care after cancer diagnosis is warranted.

Breast cancer survivors have reported dissatisfaction regarding their education on risk of breast cancer-related lymphedema (BCRL) from clinicians. We describe clinician knowledge and treatment referral of patients with BCRL among active oncologists, surgeons, and primary care physicians in the Kaiser Permanente Northern California Medical Care Program. A total of 887 oncologists, surgeons, and primary care clinicians completed a 10-minute web survey from May 2, 2010 to December 31, 2010 on BCRL knowledge, education, and referral patterns. A knowledge score of BCRL was calculated based on clinician responses. Multivariable regression models were used to determine the associations of selected covariates with BCRL knowledge score and clinician referral, respectively. Compared with primary care clinicians, oncologists had the highest mean score followed closely by surgeons (P < 0.0001). In multivariable analyses, being female, an oncologist or surgeon, and recently receiving BCRL materials were each significantly associated with higher BCRL knowledge scores. About 44% of clinicians (n = 381) indicated they had ever made a BCRL referral (100% oncologists, 79% surgeons, and 36% primary care clinicians). Clinicians with a higher knowledge score were more likely to make referrals. In stratified analyses by specialty, the significant associated factors remained for primary care but became non-significant for oncology and surgery. These results can inform educational interventions to strengthen clinician knowledge of the clinical management of BCRL, especially among primary care clinicians. With the growing number of breast cancer survivors, increasing clinician education about BCRL across all specialties is warranted.

Objective: To determine whether offering home fecal immunochemical tests (FITs) to eligible patients during a high volume influenza vaccination clinic could lead to increased colorectal cancer screening (CRCS) rates in a managed care setting., Study Design: Observational study., Methods: During influenza vaccination clinics in 2008, trained staff provided FITs to patients who were eligible for CRCS (FLU-FIT group) (FLU indicates influenza vaccine). Screening outcomes for this cohort of patients were compared with those of a similar group of influenza clinic attendees who were not exposed to the intervention (FLUonly group)., Results: Among eligible participants in the FLU-only group (N = 4653), 13.7% completed FIT within 90 days of their influenza vaccine, and in the FLU-FIT group (N = 2812), 30.3% completed FIT (P <.0001). In the FLU-FIT group, 1447 (51.4%) were provided with a FIT kit, and 653 (45.1%) of these patients completed a FIT kit within 90 days. In multivariate analyses, FLU-FIT group participants were significantly more likely to complete FITs compared with FLU-only group participants (Odds Ratio = 2.76 [95% confidence interval, 2.45-3.11]). Overall, the CRCS rate for the FLU-only group increased from 51.5% to 56.3% (increase of 4.8 percentage points), compared with an increase from 49.2% to 63.2% (increase of 14.0 percentage points) in the FLU-FIT group (P lt;.0001 for change difference)., Conclusions: The FLU-FIT Program is feasible to implement in a high volume influenza vaccination clinic conducted in a managed care setting and increases colorectal cancer screening activity among eligible influenza vaccination recipients who are reached with the intervention.

Background: Although chronic obstructive pulmonary disease (COPD) is a common cause of death and disability, little is known about the effects of socioeconomic status (SES) and race-ethnicity on health outcomes., Methods: The aim of this study is to determine the independent impacts of SES and race-ethnicity on COPD severity status, functional limitations and acute exacerbations of COPD among patients with access to healthcare. Data were used from the Function, Living, Outcomes and Work cohort study of 1202 Kaiser Permanente Northern California Medical Care Plan members with COPD., Results: Lower educational attainment and household income were consistently related to greater disease severity, poorer lung function and greater physical functional limitations in cross-sectional analysis. Black race was associated with greater COPD severity, but these differences were no longer apparent after controlling for SES variables and other covariates (comorbidities, smoking, body mass index and occupational exposures). Lower education and lower income were independently related to a greater prospective risk of acute COPD exacerbation (HR 1.5; 95% CI 1.01 to 2.1; and HR 2.1; 95% CI 1.4 to 3.4, respectively)., Conclusion: Low SES is a risk factor for a broad array of adverse COPD health outcomes. Clinicians and disease management programs should consider SES as a key patient-level marker of risk for poor outcomes.

Unlabelled: A review was conducted of 23 patients who underwent implantation of mesenchymal stem cell allograft for revision foot or ankle surgery. Composed of viable mesenchymal stem cells derived from cadaveric donor tissue, the graft had osteogenic, osteoinductive, and osteoconductive properties, and was capable of direct new bone formation at the site of implantation. In all of the cases, radiographic new bone formation was observed at the area of implantation and a 91.3% union rate was observed, and no evidence of graft rejection or complications associated with implantation were recorded. Wilcoxon rank sum tests were used to determine whether gender, diabetes, chronic renal insufficiency, neuropathy, number of previous surgeries, and smoking were associated with time to healing. Spearman's rank correlation coefficient was calculated in an effort to identify the influence of continuous numeric variables on the time to bone healing. Based on the outcomes observed in this retrospective study, it appears that mesenchymal stem cell allograft is a beneficial biological adjunct to bone healing, and serves as a suitable bone autograft substitute in revision foot and ankle surgery., Level of Clinical Evidence: 4.

Background: Previous studies have documented sex and racial/ethnic disparities in outcomes after acute myocardial infarction (AMI), but the explanation of these disparities remains limited. In a setting that controls for access to medical care, we evaluated whether sex and racial/ethnic disparities in prognosis after AMI persist after consideration of socioeconomic background, personal medical history, and medical management., Methods: We conducted a prospective cohort study of the members (20,263 men and 10,061 women) of an integrated health care delivery system in northern California who had experienced an AMI between January 1, 1995, and December 31, 2002, and were followed up for a median of 3.5 years (maximum, 8 years). Main outcome measures included AMI recurrence and all-cause mortality., Results: In age-adjusted analyses relative to white men, black men (hazard ratio [HR], 1.44; 95% confidence interval [CI], 1.26-1.65), black women (HR, 1.47; 95% CI, 1.26-1.72), and Asian women (HR, 1.37; 95% CI, 1.13-1.65) were at increased risk of AMI recurrence. However, multivariate adjustment for sociodemographic background, comorbidities, medication use, angiography, and revascularization procedures effectively removed the excess risk of AMI recurrence in these 3 groups. Similarly, the increased age-adjusted risk of all-cause mortality seen in black men (HR, 1.55; 95% CI, 1.37-1.75) and black women (HR, 1.45; 95% CI, 1.27-1.66) was greatly attenuated in black men and reversed in black women after full multivariate adjustment., Conclusion: In a population with equal access to medical care, comprehensive consideration of social, personal, and medical factors could explain sex and racial/ethnic disparities in prognosis after AMI.

Objective: The purpose of this study was to determine whether an unengaged vertex significantly increased the risk of cesarean delivery in nulliparous patients at 41 weeks or greater., Study Design: The medical records from all nulliparous patients greater than 41 weeks' gestation delivered at a single institution were reviewed. Patients undergoing both spontaneous and induced labor were included. Multivariate analyses were used to compare the influence of admission fetal station versus induction of labor on the risk of cesarean delivery., Results: Four hundred forty-eight nulliparous women at greater than 41 weeks' gestation were delivered at our institution during the study period. Sixty-two percent of these patients underwent induction of labor. There was a statistically significant increase in cesarean delivery rate compared with station (6% of patients at -1 station, 20% at -2 station, 43% at -3 station, and 77% at -4 station; P=.001). Compared with patients with an engaged vertex, patients with an unengaged vertex had 12.4 times the risk of cesarean delivery. Most of the cesarean deliveries were performed for failure to progress. On the basis of multivariate analysis, the odds of cesarean delivery were better predicted by fetal station than induction of labor., Conclusion: Nulliparous patients at 41 weeks or greater with an unengaged vertex are 12.4 times more likely to be delivered by cesarean section than a patient with an engaged vertex.

Objective: To assess whether, in children, oral magnesium oxide reduces migrainous headache frequency, severity, and associated features compared to placebo., Background: There is no single, safe, widely well-tolerated, and effective prophylactic treatment for all children and adolescents with frequent migrainous headache., Design: Randomized, double-blind, placebo-controlled, parallel-group trial., Methods: This study was conducted between June 1997 and January 2000 using 7 selected Northern California Kaiser Permanente sites. We recruited children of ages 3 to 17 years who reported a 4-week history of at least weekly, moderate-to-severe headache with a throbbing or pulsatile quality, associated anorexia/nausea, vomiting, photophobia, sonophobia, or relief with sleep, but no fever or evidence of infection. Subjects were randomly assigned to receive either magnesium oxide (9 mg/kg per day by mouth divided 3 times a day with food) (n = 58) or matching placebo (n = 60) for 16 weeks. The number of headache days (days with at least one headache) during each of eight 2-week intervals was chosen to be the primary outcome variable., Results: Of those enrolled, 86 (73%) completed the study (42 received magnesium oxide and 44 placebo); 74 of 192 eligible subjects declined to participate. Baseline information on demographic factors, health status, and headache history was similar comparing the 2 groups. By intention-to-treat analysis, we found a statistically significant decrease over time in headache frequency in the magnesium oxide group (P =.0037) but not in the placebo group (P =.086), although the slopes of these 2 lines were not statistically significantly different from each other (P =.88). The group treated with magnesium oxide had significantly lower headache severity (P =.0029) relative to the placebo group., Conclusions: This study does not unequivocally determine whether oral magnesium oxide is or is not superior to placebo in preventing frequent migrainous headache in children, but treatment with the active agent did lead to a significant reduction in headache days. Larger trials involving this safe, appealing complementary therapy are needed.

Background: Although health-related quality of life (HRQL) has been increasingly used as an outcome in asthma, its utility for identifying patients at risk for adverse asthma outcomes has not been established., Objective: In a prospective cohort study, to evaluate the longitudinal impact of HRQL on future health care utilization and cost among adults with asthma, accounting for known risk factors for utilization., Methods: A stratified random sample of 3,482 adult Northern CA Kaiser Permanente members with asthma was selected using computerized utilization databases and a screening survey item. Subjects completed a mail survey that included measures of generic (SF-12) and asthma-specific HRQL (ITG-Asthma Short Form battery). During the 12 months after survey completion, computerized utilization and cost data were ascertained., Results: Better baseline asthma-specific HRQL was associated with a decreased risk of asthma-related emergency department visit or hospitalization during longitudinal followup (odds ratio per 10-point score increment 0.84; 95% confidence interval [CI] 0.74 to 0.95), controlling for demographic and clinical factors. Better baseline generic physical HRQL was associated with a decreased risk of future all-cause hospitalization (odds ratio 0.68; 95% CI 0.60 to 0.77). More favorable asthma-specific HRQL scores were also related to decreased asthma-related health care costs during the ensuing year (-0.086 log-dollars per 10-point score increment; 95% CI -0.11 to -0.06). Better generic physical HRQL scores were associated with lower total costs (-0.24 log-dollars; 95% CI -0.32 to -0.17)., Conclusions: In a large cohort of adult health maintenance organization members with asthma, asthma-specific HRQL was associated with future asthma-related utilization and cost.

Context: Higher rates of microvascular complications have been reported for minorities. Disparate access to quality health care is a common explanation for ethnic disparities in diabetic complication rates in the US population. Examining an ethnically diverse population with uniform health care coverage may be useful., Objective: To assess ethnic disparities in the incidence of diabetic complications within a nonprofit prepaid health care organization., Design and Setting: Longitudinal observational study conducted January 1, 1995, through December 31, 1998, at Kaiser Permanente Medical Care Program in northern California., Participants: A total of 62 432 diabetic patients, including Asians (12%), blacks (14%), Latinos (10%), and whites (64%)., Main Outcome Measures: Incident myocardial infarction (MI), stroke, congestive heart failure (CHF), and nontraumatic lower extremity amputation (LEA), defined by primary hospitalization discharge diagnosis, procedures, or underlying cause of death; and end-stage renal disease (ESRD), defined as renal insufficiency requiring renal replacement therapy or transplantation for survival or by underlying cause of death., Results: Patterns of ethnic differences were not consistent across complications and frequently persisted despite adjustment for a wide range of demographic, socioeconomic, behavioral, and clinical factors. Adjusted hazard ratios (relative to that of whites) were 0.56, 0.68, and 0.68 for blacks, Asians, and Latinos, respectively (P<.001), for MI; 0.76 and 0.72 for Asians and Latinos, respectively (P<.01), for stroke; 0.70 and 0.61 for Asians and Latinos, respectively (P<.01), for CHF; 0.40 for Asians (P<.001) for LEA; and 2.03, 1.85, and 1.46 for blacks, Asians, and Latinos, respectively (P<.01), for ESRD. There were no statistically significant black-white differences for stroke, CHF, or LEA and no Latino-white differences for LEA., Conclusions: This study confirms previous reports of elevated incidence of ESRD among ethnic minorities, despite uniform medical care coverage, and provides new evidence that rates of other complications are similar or lower relative to those of whites. The persistence of ethnic disparities after adjustment suggests a possible genetic origin, the contribution of unmeasured environmental factors, or a combination of these factors.

Objective: To develop and validate a prediction rule for identifying diabetic patients at high short-term risk of complications using automated data in a large managed care organization., Research Design and Methods: Retrospective cohort analyses were performed in 57,722 diabetic members of Kaiser Permanente, Northern California, aged > or =19 years. Data from 1994 to 1995 were used to model risk for macro- and microvascular complications (n = 3,977), infectious complications (n = 1,580), and metabolic complications (n = 316) during 1996. Candidate predictors (n = 36) included prior inpatient and outpatient diagnoses, laboratory records, pharmacy records, utilization records, and survey data. Using split-sample validation, the risk scores derived from logistic regression models in half of the population were evaluated in the second half. Sensitivity, positive predictive value, and receiver operating characteristics curves were used to compare scores obtained from full models to those derived using simpler approaches., Results: History of prior complications or related outpatient diagnoses were the strongest predictors in each complications set. For patients without previous events, treatment with insulin alone, serum creatinine > or =1.3 mg/dl, use of two or more antihypertensive medications, HbA(1c) >10%, and albuminuria/microalbuminuria were independent predictors of two or all three complications. Several risk scores derived from multivariate models were more efficient than simply targeting patients with elevated HbA(1c) levels for identifying high-risk patients., Conclusions: Simple prediction rules based on automated clinical data are useful in planning care management for populations with diabetes.

Purpose: We sought to evaluate the effectiveness of self-monitoring blood glucose levels to improve glycemic control., Subjects and Methods: A cohort design was used to assess the relation between self-monitoring frequency (1996 average daily glucometer strip utilization) and the first glycosylated hemoglobin (HbA1c) level measured in 1997. The study sample included 24,312 adult patients with diabetes who were members of a large, group model, managed care organization. We estimated the difference between HbA1c levels in patients who self-monitored at frequencies recommended by the American Diabetes Association compared with those who monitored less frequently or not at all. Models were adjusted for age, sex, race, education, occupation, income, duration of diabetes, medication refill adherence, clinic appointment "no show" rate, annual eye exam attendance, use of nonpharmacological (diet and exercise) diabetes therapy, smoking, alcohol consumption, hospitalization and emergency room visits, and the number of daily insulin injections., Results: Self-monitoring among patients with type 1 diabetes (> or = 3 times daily) and pharmacologically treated type 2 diabetes (at least daily) was associated with lower HbA1c levels (1.0 percentage points lower in type 1 diabetes and 0.6 points lower in type 2 diabetes) than was less frequent monitoring (P < 0.0001). Although there are no specific recommendations for patients with nonpharmacologically treated type 2 diabetes, those who practiced self-monitoring (at any frequency) had a 0.4 point lower HbA1c level than those not practicing at all (P < 0.0001)., Conclusion: More frequent self-monitoring of blood glucose levels was associated with clinically and statistically better glycemic control regardless of diabetes type or therapy. These findings support the clinical recommendations suggested by the American Diabetes Association.

Objective: Given the directive of the American Academy of Pediatrics to test children for tuberculosis (TB) only if they are at high risk for the disease, we sought to determine how well a risk assessment questionnaire can predict a positive tuberculin skin test (TST) result among children seen in a medical office setting., Methods: In a prospective observational study, we identified 31 926 children who received well-child care in 18 pediatric offices of the Kaiser Permanente Northern California Region from August 1996 through November 1998 and who were due to receive a routine TST (Mantoux method) as part of universal screening. Parents were asked to complete a questionnaire about risk factors for TB infection that included demographic information. The TST result at 48 to 72 hours was compared with questionnaire responses to identify responses that were most highly associated with a positive TST result at both the 10-mm and 15-mm cutoffs. A concurrent study was conducted to determine whether parents can recognize induration., Results: This population was diverse in age (range: 0-18 years), race/ethnicity (white: 37%; Hispanic: 26.4%; Asian: 15.0%; black: 11.8%; other: 8.4%; not stated by parent: 1.6%), and household annual income (range: $10 524-$175 282). Overall incidence of positive TST results was 1.0% at the 10-mm cutoff and 0.5% at the 15-mm cutoff. Positive predictive value of selected individual risk factors at the 10-mm cutoff were: child born outside the United States, 10.4%; history of receiving bacille Calmette-Guérin vaccine, 5.5%; and child having lived outside the United States, 5.3%. Using multivariate analysis, we selected a subset of risk factors that were independently and significantly associated with a positive TST result >/=10 mm: history of receiving bacille Calmette-Guérin vaccine (odds ratio [OR]: 2.31; 95% confidence interval [CI]: 1.70-3.13); household member with history of positive TST result or TB disease (OR: 1.53; 95% CI: 1.14-2.04); child born outside the United States (OR: 8.63; 95% CI: 6.16-12.09); child having lived outside the United States (OR: 2.06; 95% CI: 1.49-2.85); and race/ethnicity reported by parent as Asian (OR: 2.28; 95% CI: 1.59-3.27) or Hispanic (OR: 1.57; 95% CI: 1.09-2.26). Several factors were not statistically significant predictors of a positive TST result: age, sex, household annual income, household member infected with human immunodeficiency virus or who had stayed in a homeless shelter, and being an adopted or foster child. Overall sensitivity of the 9 main items on the questionnaire was 80.9%; when a subset of 4 of these questions plus the race/ethnicity questions were used, sensitivity of responses was 83.5%. Parents failed to recognize positive TST results at a rate of 9.9% (for the 10-mm cutoff) and 5.9% (at the 15-mm cutoff)., Conclusion: A 5-question risk assessment questionnaire completed by parents can be used to accurately identify risk factors associated with TB infection in children. In our population, some risk factors suggested by the American Academy of Pediatrics could not be validated. Parents cannot be relied on to read TST results accurately. Screening for TB can be enabled by using a standardized, validated questionnaire to identify children who should be given tuberculin skin testing.

Objectives: Previous economic studies of Helicobacter pylori eradication in dyspepsia and peptic ulcer disease have not measured quality of life using utilities (preference probabilities), which are needed to compare the cost-effectiveness of such treatment to other health care interventions. The goals of this study were to measure quality of life in patients with dyspepsia or peptic ulcer and apply these measurements to published models of disease management to determine cost-effectiveness in dollars per quality-adjusted life year (QALY) gained., Methods: Utilities for dyspepsia and peptic ulcer disease were measured in adult patients (n = 73) on chronic acid suppression for peptic ulcer or ulcer-like dyspepsia. Median utility values were applied to the results of published cost-effectiveness analyses and a previously validated dyspepsia model. Cost-utility ratios for early H. pylori eradication in uninvestigated dyspepsia and peptic ulcer disease were then computed., Results: The total disutility, or lost quality of life, for an ulcer was 0.11 QALY, of which 0.09 QALY was attributed to dyspeptic symptoms. After these results were incorporated into published studies, cost-utility ratios for ulcer treatment varied from $3,100 to $12,500 per QALY gained, whereas estimates for uninvestigated dyspepsia management ranged from $26,800 to $59,400 per QALY. Sensitivity analyses indicated a range of $1,300 to $27,300 per QALY for management of duodenal ulcer and $15,000 to $129,700 per QALY for dyspepsia., Conclusions: Strategies that emphasize early H. pylori eradication were cost-effective for patients with peptic ulcer and possibly cost-effective for patients with uninvestigated dyspepsia, relative to other medical interventions. Dyspeptic symptoms cause significant disutility that should be incorporated in future cost-effectiveness analyses of treatment strategies.

The liberal use of ultrasonography has been advocated in patients with first trimester cramping or bleeding to avoid misdiagnosis of ectopic pregnancy in the emergency department (ED). The cost-effectiveness of different approaches to ultrasound availability has not been previously reported. In this study, we investigated measures of quality and cost-effectiveness in detecting ectopic pregnancy in the ED over a 6-year period, divided into three approximately equal epochs with three distinct approaches to ultrasound availability. The study retrospectively identified 120 cases of ectopic pregnancy seen in the ED over 6 years. There was significant improvement in the percentage of patients with ectopic pregnancy who were documented to have absence of intrauterine pregnancy (IUP) at the first visit from 76% during Epoch 1, when there was limited availability of ultrasound through medical imaging (MI Sono), to 88% in Epoch 2, when MI Sono was readily available, to 96% in Epoch 3, when both MI Sono and ultrasound by emergency physicians (ED Sono) were readily available (P = .02). The estimated number of MI Sonos ordered by emergency physicians in patients at risk for ectopic pregnancy increased from 5.2 per ectopic pregnancy in Epoch 1 to 11.8 per ectopic pregnancy in Epoch 2, and declined to 5.5 per ectopic pregnancy in Epoch 3, when 19.9 ED Sonos per ectopic pregnancy were also done. The cost of ED Sono in Epoch 3 was more than offset by savings from avoiding calling in ultrasound technicians after regular medical imaging department hours. The specificity of ED Sono in ruling in an IUP was 100% (95% CI 98.3 to 100%), but analysis of secondary quality indicators reflecting times from first ED visit to treatment in Epoch 3 raised the possibility that an adnexal mass or signs of tubal rupture may have been missed on some ED Sonos. We conclude that increased availability of ultrasonography leads to improved quality in the detection of ectopic pregnancy in the ED, but at the expense of a disproportionate increase in the number of ultrasound studies done per ectopic pregnancy detected. Our study suggests that the most cost-effective strategy is for emergency physicians to screen all patients with first trimester cramping and bleeding with ED Sonos, and to obtain MI Sonos at the time of the initial ED visit in all cases in which the ED Sono is indeterminate or shows no IUP.

Background: The number of shots in the childhood immunization schedule has been increasing and is likely to continue to increase in the coming years. Consideration of the psychologic costs of multiple injections, adverse events and vaccine-preventable disease is therefore growing in importance., Methods: We assessed parent preferences, using both the time tradeoff (i.e. amount of parent time willing to trade) and willingness-to-pay (i.e. dollars willing to pay) metrics, for possible outcomes of vaccination among 206 parents of infants receiving care at Kaiser, Northern California Region. We also explored the relationship between preferences and subject characteristics., Results: In general the amount of time subjects were willing to give up and the quantity of money they were willing to spend to avoid an outcome increased with the severity of the outcome. Preferences for our six main outcomes of interest all differed from one another (P < 0.0001, Tukey's multiple comparisons procedure). Rank correlation coefficients between time tradeoff and willingness-to-pay values for the six main outcomes ranged from 0.42 to 0.52 (all P < 0.004). Subject characteristics, including education, income, race/ethnicity and the child's birth order, did not explain the variation in parent preferences., Conclusions: In general subjects were willing to give up more money or time to avoid less desired outcomes. They were willing to give up only very small amounts of their own life expectancy or money to avoid minor, temporary outcomes (e.g. moderate fussiness, fever and pain) whereas they were willing to forego substantial lengths of their life or amounts of money to avoid a major, permanent outcome (i.e. permanent disability). Nonetheless much variation surfaced in the amount of time (or money) subjects were willing to trade to avoid outcomes. If this variation represents true differences in preferences, guideline developers must consider the role of individual parent preferences in decisions concerning vaccination.

Dyspnea with exertion is nearly always present in patients with pulmonary lymphangioleiomyomatosis, but the mechanisms underlying exercise impairment have not been well defined. Spirometry, lung volumes, lung mechanics, and exercise physiology were performed on a cohort of 16 patients. We determined the relative contribution of airflow limitation, gas exchange abnormalities, and pulmonary vascular abnormalities to the exercise performance achieved. The patients had normal TLC and Vtg, but RV was elevated in 88% of the subjects. A moderate to severe obstructive pattern was present in 69% of the subjects, and the DLCO was reduced, often markedly, in 81% of the subjects. Exercise performance was limited (work load, 68% +/- 6) with abnormalities of ventilatory function and gas exchange present. Strong correlations between overall exercise performance (percent predicted VO2max and maximal work load achieved) and indices of airflow and vascular involvement were present. Poor exercise performance was due primarily to ventilatory limitation. The etiology of this ventilatory limitation appears twofold. First, subjects had a reduced ventilatory ceiling because of airflow limitation. Second, subjects demonstrated an excessive ventilatory response as a result of increased dead-space ventilation thought to be due to disease-associated cystic changes and associated pulmonary vascular dysfunction or destruction.

Pulmonary histiocytosis X (PHX) is a diffuse, smoking-related lung disease characterized pathologically by bronchocentric inflammation, cyst formation, and widespread vascular abnormalities and physiologically by exercise limitation. The major mechanism underlying exercise impairment in this disease has not been previously defined. Spirometry, lung volumes, lung mechanics, and exercise physiology were performed on 23 patients with PHX. Two subgroups were identified on the basis of elastic recoil: 12 subjects had an elevated coefficient of elastic recoil with 11 demonstrating a predominant pattern of restriction, and 10 subjects had normal elastic recoil and relatively normal lung function. Exercise performance was severely limited in both subgroups (workload 53 +/- 3%). Abnormalities of ventilatory function and gas exchange were present but did not appear to be exercise-limiting in the majority of subjects. Indices reflecting pulmonary vascular function (DLCO, baseline VD/VT, exercise VD/VT) were abnormal. Strong correlations between overall exercise performance (% predicted VO2max) and indices of vascular involvement were present: DLCO (r = 0.68, p = 0.0004), baseline VD/VT (-0.65, 0.001), exercise VD/VT (-0.67, 0.0004). Similar correlations were found when exercise performance was measured by maximal workload achieved. We conclude that (1) subjects with PHX present with either normal or predominantly restrictive pulmonary physiology and that (2) exercise impairment is common and appears to reflect pulmonary vascular dysfunction.

Background: Studies in asthma with systemic corticosteroids given at 3:00 PM have shown a superior therapeutic benefit compared with dosing at other time points., Objective: The study was designed to compare beneficial and systemic effects of 800 micrograms of inhaled triamcinolone once daily at 3:00 PM (QD group) versus 200 micrograms conventional four times a day dosing (QID group)., Methods: Efficacy outcome measures included forced expiratory volume in 1 second (FEV1), peak expiratory flow rates, bronchial responsiveness, and use of beta-agonist. Systemic effects were blood eosinophil and cortisol levels, 24-hour urinary cortisol, and evaluation for oral candidiasis and dysphonia., Results: The baseline FEV1 was comparable in the two groups: QD = 67% +/- 2% and QID = 66% +/- 2% of predicted value. After 4 weeks of treatment, FEV1 increased similarly in the QD group to 77% +/- 4% and in the QID group to 74% +/- 4% of predicted value. Likewise, the improvement in morning and evening peak expiratory flow rates was not significantly different between the groups. Both QD and QID groups experienced comparable daily decrements in beta-agonist use. The systemic responses to the two regimens as assessed by eosinophil count, morning serum cortisol, and 24-hour urinary cortisol were also comparable., Conclusions: The single daily administration of inhaled triamcinolone at 3:00 PM has no increased systemic effects and produces similar improvement in efficacy variables. A dosing strategy based on once daily dosing should increase compliance of inhaled steroid use in the clinical setting.

Although studies on pharmacologic interventions for nocturnal asthma are increasing, information about the long-term stability of circadian spirometric changes or bronchial responsiveness is not known. This study was undertaken to evaluate these variables in 10 patients with asthma measured quarterly during a 1-year period. We have found that the overnight decrease in peak expiratory flow rate measurements is stable (mean range, 13.8% to 16.4%) during the year, as are the quarterly 4 PM (1600-hour) and 4 AM (0400-hour) FEV1 values. The 4 PM provocative concentration of methacholine that produced a 20% fall in FEV1 (PC20) (range of geometric mean, 0.213 to 0.359 mg/ml) and the 4 AM PC20 (range, 0.057 to 0.152 mg/ml) for the group were also relatively stable. Individual variation was higher for the PC20 values than for the FEV1. We concluded that during a 1-year period, without acute respiratory events, (1) the overnight decrement in peak expiratory flow rate and the 4 AM and 4 PM FEV1 values were constant and (2) bronchial responsiveness demonstrated some individual variability, but for the group, it remained stable.

We studied the frequency of pectus excavatum or otherwise abnormally narrowed anterior-posterior thoracic dimension and of thoracic scoliosis among consecutive series of 67 patients with pulmonary disease due to Mycobacterium avium complex and 55 patients with pulmonary Mycobacterium tuberculosis. Among those with M. avium, pectus excavatum and abnormal narrowing was present in 27% and scoliosis was seen in 52%; overall, 47 of the 67 (70%) had one or both of these anomalies. By comparison, of those with M. tuberculosis only 5% had pectus excavatum or abnormal narrowing, only 13% had scoliosis; and none had both. The prevalence of pectus excavatum and abnormal narrowing among female M. avium complex patients was significantly greater than among female tuberculosis patients (p = 0.05) or in the general population (p less than 0.001). Among male M. avium complex patients, pectus excavatum and abnormal narrowing was significantly more common than in the general population (p less than 0.001) but not significantly different than among male tuberculosis patients (p = 0.264). For all M. avium complex versus all M. tuberculosis patients the prevalence of pectus excavatum abnormal narrowing was significantly greater (p = 0.013). Scoliosis was significantly more common among all M. avium complex patients than among M. tuberculosis patients or the general population. We believe that these anomalies, which are associated with a variety of heritable connective disorders, are phenotypic markers of patients who are at increased risk for pulmonary disease due to environmental mycobacteria, such as M. avium complex.

Objective: To determine the effect of low-dose methotrexate in asthmatic patients on steroid use, asthma symptom scores, pulmonary function, airway reactivity, blood cellular components, and immunoglobulin E levels., Design: A randomized, double-blind, parallel, placebo-controlled, 13-week clinical trial with follow-up of patients in an open trial of methotrexate at the conclusion of the double-blind study., Setting: An asthma care outpatient clinic., Patients: From February 1988 to March 1990, 19 patients with severe, steroid-dependent asthma were enrolled in the study. Two of these patients were excluded from analysis., Interventions: Patients were administered methotrexate or placebo intramuscularly, to assure complete absorption, once weekly during the 13-week study., Results: Patients on methotrexate and placebo both significantly decreased their steroid dose by 39.6% (95% CI, 25.1% to 54.1%, P = 0.001) and 40.2% (CI, 17.9% to 67.4%, P = 0.003), respectively. Pulmonary function did not differ significantly between the methotrexate and placebo groups. In addition, airway reactivity and symptom scores were unchanged on methotrexate or placebo. No significant toxicities were seen during the course of the 13-week blinded study, but one patient on methotrexate and prednisone in the follow-up period developed Pneumocystis carinii pneumonia and died. Despite continuing methotrexate for up to 1 year, and increasing methotrexate to 30 mg weekly, no significant benefit of methotrexate on asthma control could be shown., Conclusion: Our study does not support the use of methotrexate in the treatment of severe asthma.

The Inventory to Diagnose Depression (IDD) was administered to 177 American Indian adolescents attending a tribally administered boarding school. The psychometric properties in this population were studied and compared to those obtained when the Center for Epidemiologic Studies-Depression Scale (CES-D) was administered to a similar population. Analyses were performed on the scale items individually as well as on the continuous summary score and the dichotomous diagnosis. The internal consistency was very good (0.94 to 0.96). There were relatively few gender effects at the item level and none with respect to the diagnosis. IDD prevalence estimates of depression were much closer to the expected rates suggested by epidemiological studies than those generated by other self-report measures like the CES-D. These findings recommend the IDD for additional investigation in terms of its use with adolescent populations.

The treatment outcomes of 60 chronic mentally ill patients who received services at Community Care, a private-sector residential care program, were analyzed. In addition to psychiatric services, the program offers instruction in living skills and vocational preparation, helps patients find jobs and housing, and operates an outpatient support network. Forty-two percent of the patients discharged during the study period achieved independence or near independence in the program and functioned at that level during a three-year follow-up period. Patients' level of education, degree of participation in the program, levels of residential and vocational achievement at discharge, and discharge status were significantly related to outcome. Patients with good participation in the program who stayed with the outpatient support network at discharge had at least a 95 percent probability of good outcome.

Spectral analysis was used to identify correlated sinusoidal frequency components in left and right side diaphragm electromyographic (EMG) recordings from human subjects during voluntary deep inspirations. In 31 of 33 subjects bilaterally correlated high-frequency oscillations were found in broad or narrow bands in the range of 60-84 and 16-40 Hz. To determine if such oscillations were associated also with bilaterally symmetric, phasic, voluntary activation of nonrespiratory muscles, we obtained EMG signals from left and right masseter muscles during clenching of the jaw; left and right sternomastoid muscles during lifting of the head against gravity; and left and right biceps muscles during lifting of a weighted bar. Weakly correlated frequency components, mainly at frequencies below 60 Hz, were found in the left and right masseter EMGs on at least one trial from 12 of 17 subjects. No bilaterally correlated frequency components were found during phasic contraction of biceps and sternomastoid muscles. Power spectra of biceps EMGs, however, sometimes exhibited peaks indicative of oscillations that were not bilaterally correlated. In nine subjects, correlated frequency components in the 60-84 Hz range were found in intercostal EMGs from the axillary region of the fifth interspace during voluntary deep inspirations but not during postural contractions. We conclude that high-frequency oscillations in the range of 60-84 Hz in diaphragm and intercostal EMGs are associated particularly with respiratory activation of respiratory muscles. These results support the hypothesis that high-frequency oscillations may be a manifestation of control of muscular contraction via a central pattern generator.

Bilaterally synchronized high-frequency oscillations have been found in recordings of human diaphragm and intercostal EMGs during spontaneous breathing (SB). Correlated frequencies (28-52 and/or 68-88 Hz) in the left and right diaphragm EMGs during SB: (1) are at similar values, but not as broad-band, as those found during voluntary breathing maneuvers; (2) often occur at the same values as correlated frequencies found in left and right intercostal EMGs; and (3) fluctuate with time.