Pneumococcal Conjugate Vaccine Safety in Elderly Adults.

BACKGROUND: The 13-valent pneumococcal conjugate vaccine (PCV13) and the 23-valent pneumococcal polysaccharide vaccine (PPSV23) were both recommended to adults aged ≥65 years. The study examines adults ≥65 years for risk of adverse events (AEs) requiring medical attention following vaccination with PCV13 as compared with vaccination with PPSV23, a long-standing vaccine with a satisfactory safety profile. METHODS: The cohort study included 6 Vaccine Safety Datalink sites. The exposed person-time included follow-up time of the first PCV13 received by subjects age ≥65 years from January 1 to August 15, 2015. The comparator person-time included follow-up time after the first PPSV23 received by subjects of the same age during Janaury 1 to August 15 of each year of 2011-2015. The prespecified AEs included cardiovascular events, Bell's palsy, Guillain-Barré syndrome, syncope, erythema multiforme, thrombocytopenia, cellulitis and infection, allergic reaction, and anaphylaxis. Inverse probability of treatment weighting-adjusted Poisson regression models was used to estimate the relative risk (RR) of each AE. RESULTS: A total of 313 136 doses of PCV13 and 232 591 doses of PPSV23 were included. The adjusted RRs comparing the incidence of AEs following PCV13 vs PPSV23 were all <1, except for anaphylaxis, which was insignificant with an RR of 1.32 (95% confidence interval, 0.30-5.79). Only 1 patient who received PCV13 and 4 other vaccines concomitantly was confirmed by medical chart review as having experienced anaphylaxis after vaccination. CONCLUSIONS: These data do not support an increased rate of adverse events following PCV13 administration in elders compared with PPSV23 and should provide reassurance regarding continued use of PCV13.

Use of Phosphorus Binders among Non-Dialysis Chronic Kidney Disease Patients and Mortality Outcomes.

BACKGROUND: Whether the benefits of phosphorus binders extend to those without end stage renal disease is uncertain. Among a large diverse non-dialysis chronic kidney disease (CKD) population with hyperphosphatemia, we sought to evaluate phosphorus binder use and compare mortality risk between patients prescribed and not prescribed binders. METHODS: A retrospective cohort study within an integrated health system (January 1, 1998 - December 31, 2012) among CKD patients (age ≥18) was performed. Non-dialysis CKD patients with 2 separate estimated glomerular filtrate rate (eGFR) <30 mL/min/1.73 m2 and serum phosphorus ≥5.0 mg/dL within 180 days of eGFR were included. Multivariable cox proportional hazards and inverse probability of treatment-weighted models were used to estimate mortality hazard ratios (HRs) for patients who received phosphorus binders compared to no binders. RESULTS: Among 10,165 study patients, 2,733 subjects (27%) received phosphorus binders. Compared to the no-phosphorus-binder group, the binder group had mortality HRs (95% CI) of 0.86 (0.79-0.94) and 0.86 (0.80-0.93) using traditional multivariable and inverse probability of treatment-weighted models respectively. Sensitivity analyses removing patients who were prescribed binders >180 days after index date revealed no difference in mortality between those with binders and with no binders. CONCLUSION: Our findings from a real-world clinical environment revealed that 27% of hyperphosphatemic non-dialysis CKD patients were prescribed binders. They also had lower risk of mortality compared to those not prescribed phosphorus binders. However, the lower mortality risk was not observed when we accounted for immortal time bias. Whether phosphorus binder use in CKD improves survival remains to be determined.

Characteristics of resistant hypertension in a large, ethnically diverse hypertension population of an integrated health system.

OBJECTIVE: To evaluate the prevalence of and characterize resistant hypertension in a large representative population with successful hypertension management and reliable health information. PATIENT AND METHODS: We performed a cross-sectional study using clinical encounter, laboratory, and administrative information from the Kaiser Permanente Southern California health system between January 1, 2006, and December 31, 2007. From individuals older than 17 years with hypertension, resistant hypertension was identified and prevalence was determined. Multivariable logistic regression was used to calculate odds ratios (ORs), with adjustments for demographic characteristics, clinical variables, and medication use. RESULTS: Of 470,386 hypertensive individuals, 60,327 (12.8%) were identified as having resistant disease, representing 15.3% of those taking medications. Overall, 37,061 patients (7.9%) had uncontrolled hypertension while taking 3 or more medicines. The ORs (95% CIs) for resistant hypertension were greater for black race (1.68 [1.62-1.75]), older age (1.11 [1.10-1.11] for every 5-year increase), male sex (1.06 [1.03-1.10]), and obesity (1.46 [1.42-1.51]). Medication adherence rates were higher in those with resistant hypertension (93% vs 89.8%; P<.001). Chronic kidney disease (OR, 1.84; 95% CI, 1.78-1.90), diabetes mellitus (OR, 1.58; 95% CI, 1.53-1.63), and cardiovascular disease (OR, 1.34; 95% CI, 1.30-1.39) were also associated with higher risk of resistant hypertension. CONCLUSION: In a more standardized hypertension treatment environment, we observed a rate of resistant hypertension comparable with that of previous studies using more fragmented data sources. Past observations have been limited due to nonrepresentative populations, reliability of the data, heterogeneity of the treatment environments, and less than ideal control rates. This cohort, which was established using an electronic medical record-based approach, has the potential to provide a better understanding of resistant hypertension and outcomes.

Phosphorus and risk of renal failure in subjects with normal renal function.

PURPOSE: Whether higher serum phosphorus levels increase risk for kidney disease onset and progression to end-stage renal disease in those with normal renal function is largely unknown. We sought to determine whether higher serum phosphorus levels increase risk for end-stage renal disease within a large ethnically diverse population with normal kidney function. METHODS: A retrospective longitudinal cohort study was performed in the period January 1, 1998 through December 31, 2008 of adults within a vertically integrated health plan (3.4 million members). The primary objective was to determine risk of incident end-stage renal disease. Baseline and time-averaged phosphorus were used for Cox regressions analyses to calculate hazard ratios (HR) adjusting for age, sex, race, pre-existing hypertension, and diabetes. RESULTS: A total of 94,989 subjects were identified in the 11-year observation period. Mean age of the cohort was 50 years, with 61% female, 38% white, 14% black, and 25% Hispanic. Population-based phosphorus quartile ranges were 1.9-3.0 mg/dL, 3.1-3.4 mg/dL, 3.5-3.8 mg/dL, and 3.9-5.7 mg/dL. End-stage renal disease occurred in 130 (0.1%) subjects. Every 0.5-mg/dL phosphorus increase demonstrated an adjusted HR of 1.40 (95% confidence interval [CI], 1.06-1.84) and HR for mortality of 1.09 (95% CI, 1.06-1.13). Adjusted HRs were 0.64 (95% CI, 0.37-1.11), 0.83 (95% CI, 0.50-1.39), and 1.48 (95% CI, 0.96-2.28) in the 2nd, 3rd, and 4th quartile, respectively, compared with the first phosphorus quartile. Time-averaged serum phosphorus demonstrated a similar relationship across quartiles and as a continuous variable. CONCLUSION: In our large, ethnically diverse cohort of non kidney disease subjects, higher serum phosphorus levels were associated with greater risk for end-stage renal disease and mortality.

Positive relationship of sleep apnea to hyperaldosteronism in an ethnically diverse population.

OBJECTIVE: Approximately, 50-60% of patients with sleep apnea have hypertension. To explore a mechanism of this relationship, we compared its prevalence in a hypertensive population with and without hyperaldosteronism. METHODS: Using the Kaiser Permanente Southern California database, hypertensive individuals who had plasma aldosterone and plasma renin activity measured between 1 January 2006 and 31 December 2007 were evaluated. Hyperaldosteronism was defined as an aldosterone : renin ratio more than 30 and plasma aldosterone more than 20 ng/dl or an aldosterone : renin ratio more than 50 (ng/dl : ng/ml per h). Hypertension was identified by International Classification of Disease, Ninth Revision (ICD-9) coding and sleep apnea was defined by ICD-9 coding or procedural coding for dispensation of positive airway devices. RESULTS: Of 3428 hypertensive patients, 575 (17%) had hyperaldosteronism. Sleep apnea was present in 18% (105) with hyperaldosteronism vs. 9% (251) without hyperaldosteronism (P < 0.001). Odds ratio for sleep apnea in patients with hyperaldosteronism was 1.8 (95% confidence interval 1.3-2.6) after controlling for other sleep apnea risk factors. No ethnic group was at greater risk for sleep apnea. CONCLUSION: The prevalence of sleep apnea in a diverse hypertensive population is increased in patients with hyperaldosteronism, even when controlling for other sleep apnea risk factors.

25-hydroxyvitamin D levels and hypertension rates.

Vitamin D deficiency has been linked to cardiovascular disease and risk factors including hypertension. The authors sought to determine prevalence rates of hypertension in adults tested for 25-hydroxyvitamin D categorized by their levels and evaluate odds ratios for hypertension at lower 25-hydroxyvitamin D levels compared with optimal levels. A cross-sectional study was conducted January 1, 2004, through December 31, 2006, of patients aged 18 years and older within a large ethnically diverse population. Diagnosis of hypertension was determined by International Statistical Classification of Diseases and Related Health Problems codes. Patients were categorized into quartiles according to 25-hydroxyvitamin D levels: ideal (≥40 ng/mL), adequate (30-39 ng/mL), deficient (15-29 ng/mL), and severely deficient (<15 ng/mL). Prevalence rates of hypertension and odds ratios were calculated for each 25-hydroxyvitamin D quartile, adjusting for age, sex, race, and renal insufficiency. A total of 2722 individuals met the inclusion criteria for the study. The overall prevalence of hypertension in the study population was 24%. Hypertension rates were 52%, 41%, 27%, and 20% in 25-hydroxyvitamin D quartiles <15 ng/mL, 15 to 29 ng/mL, 30 to 39 ng/mL, and ≥40 ng/mL, respectively (P<.001). Odds ratios (95% confidence intervals) for hypertension adjusting for age, sex, race, and renal insufficiency were 2.7 (1.4-5.2), 2.0 (1.5-2.6), and 1.3 (1.2-1.6) for 25-hydroxyvitamin D levels <15 ng/mL, 15 to 29 ng/mL, and 30 to 39 ng/mL, respectively, compared with the ≥40 ng/mL group. This study demonstrates increased rates of hypertension in individuals who tested for lower levels of 25-hydroxyvitamin D starting at levels <40 ng/mL. This retrospective analysis raises the question of whether supplementing to optimal vitamin D levels can prevent or improve hypertension.

Vitamin D deficiency and anemia: a cross-sectional study.

Vitamin D has been suggested to have an effect on erythropoiesis. We sought to evaluate the prevalence of anemia in a population of individuals with vitamin D deficiency compared with those with normal levels in a population of a large integrated healthplan. A cross-sectional analysis in the period 1 January 2004 through 31 December 2006 of subjects with documented concurrent levels of 25-hydroxyvitamin D and hemoglobin were evaluated. Vitamin D deficiency was defined as <30 ng/mL and anemia was defined as a hemoglobin <11 g/dL. A total of 554 subjects were included in the analysis. Anemia was present in 49% of 25-hydroxyvitamin D-deficient subjects compared with 36% with normal 25-hydroxyvitamin D levels (p < 0.01). Odds ratio for anemia in subjects with 25-hydroxyvitamin D deficiency using logistic regressions and controlling for age, gender, and chronic kidney disease was 1.9 (95% CI 1.3-2.7). 25-hydroxyvitamin D-deficient subjects had a lower mean Hb (11.0 vs. 11.7; p = 0.12 ) and a higher prevalence of erythrocyte stimulating agent use (47% vs. 24%; p < 0.05). This study demonstrates an association of vitamin D deficiency and a greater risk of anemia, lower mean hemoglobin, and higher usage of erythrocyte-stimulating agents. Future randomized studies are warranted to examine whether vitamin D directly affects erythropoiesis.

Incidence of end-stage renal disease and death among insured African Americans with chronic kidney disease.

African Americans have the highest incidence of end-stage renal disease (ESRD) in the United States. To understand the basis of this disparity, we examined data from a prepaid, integrated health system for this retrospective cohort study of members who had one or more serum creatinine tests performed over a 9-year period. The cohort included 182,959 adults (8% black) with stage 3 or 4 chronic kidney disease based on their estimated glomerular filtration rate (eGFR). Competing-risk methods were used to determine the incidence of ESRD and death prior to ESRD. At all follow-up times and from any entry eGFR, the cumulative incidence of ESRD was significantly greater in blacks. The age and gender-adjusted hazard ratios for ESRD and death prior to ESRD in blacks compared to non-blacks were 1.83 and 1.15, respectively. Increased survival free of ESRD was found in blacks 70 years and older with eGFR stage 4. The hazard ratio for the combined outcomes of ESRD or death was 1.31 in blacks as compared to non-blacks. Despite equivalent health insurance benefits, blacks with chronic kidney disease were at increased risk for ESRD and death prior to ESRD. Compared to non-blacks, blacks with chronic kidney disease were twice as likely to enter into ESRD as to die prior to ESRD.

Who is at risk for developing chronic anal fistula or recurrent anal sepsis after initial perianal abscess?

PURPOSE: This study was designed to determine factors that contribute to chronic anal fistula or recurrent sepsis after initial perianal abscess. METHODS: A retrospective cohort study was conducted in patients with a first-time perianal abscess who were treated at Kaiser Permanente Los Angeles between 1995 and 2007. Univariate and multivariable analyses were performed with the Cox proportional hazards model to determine predictors of risk for recurrent disease. RESULTS: One hundred and forty-eight patients met inclusion criteria (105 men, 43 women; mean age, 43.6 years). During a mean follow-up of 38 months, the cumulative incidence of chronic anal fistula or recurrent sepsis was 36.5 percent. Univariate and multivariable analyses showed more than two-fold increased risk of recurrence in patients <40 years vs. those >/=40 years (P < 0.01), and univariate analysis showed nondiabetics were 2.69 times as likely to experience recurrence as diabetics (P = 0.04). No significant differences in risk of recurrence were noted for men vs. women (HR = 0.78; P = 0.39), nonsmokers vs. smokers (HR = 1.17; P = 0.58); perioperative antibiotics vs. no antibiotics (HR = 1.51; P = 0.19); or HIV-positive vs. HIV- negative status (HR = 0.72; P = 0.44). CONCLUSIONS: Age younger than 40 years significantly increased risk of chronic anal fistula or recurrent anal sepsis after a first-time episode of perianal abscess. Patients with diabetes may have a decreased risk compared with nondiabetic patients. Gender, smoking history, perioperative antibiotic treatment, and HIV status were not risk factors for chronic anal fistula or recurrent anal sepsis.

Sleep apnea in early and advanced chronic kidney disease: Kaiser Permanente Southern California cohort.

BACKGROUND: Sleep apnea (SA) has been reported to be highly prevalent in the dialysis population. The reported rates of SA in dialysis are severalfold greater than the 2 to 4% estimated in the general population. This study sought to determine whether an association exists between SA and early stages of chronic kidney disease (CKD) where SA may represent an important comorbidity and potential risk factor in kidney disease. METHODS: Cross-sectional study of adults from an integrated health plan with documented serum creatinine levels in the period January 1, 2002, through December 31, 2004. SA diagnosis determined by International Classification of Diseases, ninth revision, coding for SA and Current Procedural Terminology coding for positive airway pressure devices. Kidney function was determined by the estimated glomerular filtration rate (eGFR). Logistic was regression used to estimate the relative risk for SA. RESULTS: The overall prevalence of SA was 2.5% in the study population that included subjects with normal renal function and those with CKD. The odds ratios (ORs) for SA by eGFRs of 75 to 89, 60 to 74, 45 to 59, 30 to 44, and 15 to 29 mL/min per 1.73 m(2), respectively, compared to normal kidney function, after adjustment for age, sex, and number of visits, were as follows: 1.22 (95% confidence interval [CI], 1.18 to 1.25); 1.32 (95% CI, 1.27 to 1.37); 1.42 (95% CI, 1.35 to 1.50); 1.37 (95% CI, 1.25 to 1.50); and 1.32 (95% CI, 1.13 to 1.55). The increased ORs for eGFRs > 45 mL/min per 1.73 m(2) were sustained even after controlling for diabetes, heart failure, and hypertension. CONCLUSION: This study demonstrated an increased risk of SA in patients with early CKD. Further evidence of a causal relationship should be sought in the hope that the detection and management of SA may improve the course of CKD.

Trends and correlates of HIV testing during pregnancy in racially/ethnically diverse insured population, 1997-2006.

OBJECTIVES: To describe the trends in human immunodeficiency virus (HIV) testing during pregnancy from 1997 through 2006, and the demographic, clinical, and health system correlates of being tested in a diverse insured population. METHODS: Health plan members who had one or more births at > or = 20 weeks gestation from January 1, 1997 through December 31, 2006 in Kaiser Permanente Southern California hospitals were included in this retrospective analysis. Data were obtained from the infants' birth certificate, and administrative and laboratory databases. Multiple log binomial regression analyses were used to generate adjusted prevalence ratios (PR) and 95% confidence interval (CI) for each characteristic. RESULTS: Of the 240,575 women with 302,246 pregnancies, the proportion tested for HIV during pregnancy increased from 77.6% in 1997 to 91.0% in 2006 (P (trend) < 0.0001). Compared with Hispanic women, of which 90% were tested, non-Hispanic white women were least likely to be tested (81.7%: PR: 0.965; 95% CI: 0.957-0.973). Demographic characteristics negatively associated with HIV testing were maternal age >/=30, having more than a high school education, and residing in census blocks with the highest income tertile. Additionally, women were less likely to be tested after their first birth, if enrolling in prenatal care in the third trimester, or if they had a gap in insurance during their pregnancy. Of the 53,566 women with two sequential pregnancies, 78.5% were tested during both pregnancies. CONCLUSION: In an insured racially/ethnically patient population, the testing rate exceeded 90% in 2006. Achieving and sustaining these high testing levels has public health implications.

Comparison of outcomes of peritoneal dialysis catheters placed by the fluoroscopically guided percutaneous method versus directly visualized surgical method.

PURPOSE: To compare complications in catheters placed by the fluoroscopically guided percutaneous method versus directly visualized surgery. MATERIALS AND METHODS: A retrospective cohort analysis was performed. Mechanical complication rate data, including catheter leakage, malfunction, malposition, and bleeding, were compared between the two groups over a 1-year follow-up period. Additionally, exit site infection rates, tunnel infection rates, and peritonitis episodes were evaluated based on the incidence within 30 days of insertion and 30 days to 1 year after insertion. RESULTS: A total of 101 patients were analyzed (52 in the fluoroscopic guidance group, 49 in the direct visualization group). Prevalence of diabetes was similar: 56% in the directly visualized surgery group and 47% in the fluoroscopically guided treatment group (P = .37). Although the difference was not significant, complication rates tended to be higher in the directly visualized surgery group compared with the percutaneous placement group. These included catheter leakage (13% vs 4%; P = .093), malfunction (11% vs 9%; P = .73), malposition (13% vs 6%; P = .20), and bleeding (8% vs 2%; P = .21). There were no differences in early and late exit site infections and tunnel infections. Late peritonitis rates were lower in the percutaneous placement group (20%) than in the direct visualization group (42%) (P = .018). Diabetic patients had approximately six times greater risk of catheter malfunction than nondiabetic patients regardless of method of catheter insertion. CONCLUSIONS: Placement of peritoneal dialysis catheters percutaneously with fluoroscopic guidance is as safe as placement with direct visualization techniques.

Long-term outcomes by clopidogrel duration and stent type in a diabetic population with de novo coronary artery lesions.

OBJECTIVES: The purpose of this study was to determine whether long-term clinical outcomes differed between bare-metal stents (BMS) and drug-eluting stents (DES) by duration of clopidogrel use among diabetic patients. BACKGROUND: There is concern that DES are associated with late adverse events such as death and myocardial infarction (MI) secondary to stent thrombosis. However, data on outcomes in diabetic patients remain limited. METHODS: We identified 749 patients with diabetes mellitus who underwent stent implantation with either BMS (n = 251) or DES (n = 498) from October 2002 to December 2004. We performed survival analysis on the full cohort and on those event-free from death, MI, or repeat revascularization at 6 months (n = 671). RESULTS: By clopidogrel duration, the event rate for death or MI was 3.2% in the >9-month group, 9.4% in the 6- to 9-month group, and 16.5% in the <6-month group, p < 0.001. For death alone, the event rate was 0.5% in the >9-month group, 4.3% in the 6- to 9-month group, and 10.0% in the <6-month group, p < 0.001. When taking BMS clopidogrel non-users as a referent in the multivariate analysis, the hazard ratio (95% confidence interval [CI]) for death and nonfatal MI for DES clopidogrel users, DES clopidogrel nonusers, and BMS clopidogrel users were: HR 0.22 (95% CI 0.08 to 0.62, p = 0.005), HR 0.39 (95% CI 0.13 to 1.13, p = 0.08), and HR 0.25 (95% CI 0.08 to 0.81, p = 0.02), respectively. CONCLUSIONS: Longer duration of clopidogrel use was associated with a lower incidence of death or MI in both the BMS and DES groups. Among clopidogrel nonusers, the incidence of death/MI or death did not differ by stent type.

Complications following bilateral prophylactic mastectomy.

BACKGROUND: Bilateral prophylactic mastectomy significantly decreases breast cancer risk, but complications of the procedure have only been described in single-site studies. We describe the frequency and type of complications in women who underwent bilateral prophylactic mastectomy in a multisite community-based cohort. METHODS: Women aged 18-80 years undergoing bilateral prophylactic mastectomy without a personal history of breast cancer at one of six health plans were eligible. We identified women from automated data sources, then reviewed hospital data, ambulatory notes, and other chart elements to confirm eligibility and obtain all charted information about complications and surgeries performed after prophylactic mastectomy, including reconstructive procedures. Reconstructions were characterized by type (implant vs. tissue graft). Complications were noted for a 1-year period after any surgical procedure. RESULTS: We identified 269 women with prophylactic mastectomy who were followed for a mean of 7.4 years. Their mean age was 44.9 years. Nearly 80% undertook reconstruction, most with prosthetic implants. One or more complications occurred in 64%. The most common complications were pain (35% of women), infection (17%), and seroma (17%). Women with no reconstruction had fewer complications (mean of .93) than women who had implant (2.0) or tissue graft (2.4) reconstruction procedures (differences from no reconstruction: 1.07 [95% confidence interval = 0.36 to 1.77] and 1.50 [95% confidence interval = 0.44 to 2.56] respectively). Delay of reconstruction after mastectomy was associated with a borderline-significant higher risk of complications (80.6%) compared to simultaneous reconstruction (64.0%, P = .055). CONCLUSION: We found that almost two-thirds of women undergoing bilateral prophylactic mastectomy had at least one complication following surgery. Further work should be done to minimize and to understand the effect of complications of bilateral prophylactic mastectomy.

Race and ethnicity: comparing medical records to self-reports.

Understanding and eliminating health disparities requires accurate data on race/ethnicity. To assess the quality of race/ethnicity data, we compared medical record classifications to self-report of a study of prophylactic mastectomy. A total of 788 women had race/ethnicity from both sources; 69.9% were 55 years of age or older, 38.3% were at least college graduates, and 67.8% were married or living with someone. There were 817 race/thnicity classifications for the 788 women, of which 758 (92.3%) were identical in the medical record and self-report. Sensitivity and positive predictive value were high (86.7%-97.2%) for whites, Asians, and blacks and moderate (64.0% and 68.1%) for Latinas. However, only one of 18 Native Americans was correctly identified in her medical record. Our results indicate that even if the overall accuracy of medical record classifications for race/ethnicity is high, such a finding may obscure substantial inaccuracies in the recording for racial/ethnic minorities, especially Latinas and Native Americans.