A randomized, double-blind, crossover design study of sevelamer hydrochloride and sevelamer carbonate in patients on hemodialysis.

AIMS: Sevelamer carbonate is an anion exchange resin with the same polymeric structure as sevelamer hydrochloride in which carbonate replaces chloride as the anion. The study investigated the effects of sevelamer carbonate and sevelamer hydrochloride on serum phosphorus, lipids and bicarbonate levels in hemodialysis patients. MATERIALS AND METHODS: This was a double-blind, randomized, crossover study. 79 hemodialysis patients were randomly assigned to either sevelamer carbonate or sevelamer hydrochloride for 8 weeks followed by a crossover to the other regimen for an additional 8 weeks of treatment. RESULTS: The mean serum phosphorus was 4.6+/-0.9 and 4.7+/-0.9 mg/dl during sevelamer carbonate and sevelamer hydrochloride treatment, respectively. Sevelamer carbonate and sevelamer hydrochloride were equivalent in controlling serum phosphorus, the geometric least square mean ratio was 0.99 (90% CI, 0.95-1.03). Mean total and LDL cholesterol were 144.0+/-33.9 and 59.5+/-24.9 mg/dl, respectively, during sevelamer carbonate treatment and 139.0+/-33.6 and 56.0+/-23.3 mg/dl, respectively, during sevelamer hydrochloride treatment. Serum bicarbonate levels increased by 1.3+/-4.1 mEq/l during sevelamer carbonate treatment. There were fewer gastrointestinal adverse events with sevelamer carbonate. CONCLUSIONS: Sevelamer carbonate and sevelamer hydrochloride were equivalent in controlling serum phosphorus and serum bicarbonate levels increased with sevelamer carbonate. Lipid profiles for both were well-below the levels suggested by KDOQI. Sevelamer carbonate may have advantages over sevelamer hydrochloride in the treatment of hyperphosphatemia in hemodialysis patients.

The validity of self-reported health-care utilization by AIDS patients.

OBJECTIVES: To examine the validity of self-reported health-care utilization among persons with AIDS. DESIGN: A comparison of survey data with information collected from medical and financial records. METHODS: Personal interviews provided information on utilization within a 4-month period for inpatient admissions (n = 296), ambulatory visits (n = 284), and hours of homecare (n = 106). Risk group, socioeconomic characteristics, disease stage, functional status, memory, and respondent's recall ability were also measured. Reporting error was defined as the difference between self reports and medical/financial records. Variations among subgroups of patients were examined using t tests and multiple regression. To determine whether reporting errors affected analysis of utilization data, we compared coefficients from parallel utilization models using each data source to predict use/non-use and total utilization. RESULTS: Mean overall reporting errors were small and not significantly different from zero. Reporting errors were lowest for hospital admissions and highest for homecare. High utilizers underreported all types of services. The interviewer evaluation of recall was an independent and significant predictor of reporting errors for admissions and ambulatory visits. Reporting errors varied by selected subgroup characteristics, but the direction and significance of the error depended on the type of utilization measured. In the parallel utilization models, few differences appeared between models using self-reports and medical/financial records to identify correlates of use/non-use, but some differences between the models of total utilization were apparent. CONCLUSIONS: Self-reports of utilization by AIDS patients with a recall period of 4 months or less provide, on average, valid data for analytic purposes. However, caution should be applied to reports by high or low users or by respondents judged by interviewers to have major recall problems.

Quality of care for two common illnesses in teaching and nonteaching hospitals.

Teaching hospitals are recognized for treating rare diseases, but their value in caring for common illnesses is less clear. To assess quality of care for congestive heart failure and pneumonia, we reviewed the medical records of Medicare beneficiaries in major teaching, other teaching, and nonteaching hospitals in four states. Overall quality was rated better in major and other teaching hospitals than in nonteaching hospitals by physician reviewers and explicit process criteria, but the results varied for different subsets of explicit measures. Future studies should assess whether outcomes differ between teaching and nonteaching hospitals.

Effects of sevelamer and calcium-based phosphate binders on mortality in hemodialysis patients.

Elevated serum phosphorus and calcium are associated with arterial calcification and mortality in dialysis patients. Unlike calcium-based binders, sevelamer attenuates arterial calcification but it is unknown whether sevelamer affects mortality or morbidity. In a multicenter, randomized, open-label, parallel design trial we compared sevelamer and calcium-based binders on all-cause and cause-specific mortality (cardiovascular, infection, and other) in prevalent hemodialysis patients. A total of 2103 patients were initially randomized to treatment and 1068 patients completed the study. All-cause mortality rates and cause-specific mortality rates were not significantly different. There was a significant age interaction on the treatment effect. Only in patients over 65 years of age was there a significant effect of sevelamer in lowering the mortality rate. There was a suggestion that sevelamer was associated with lower overall, but not cardiovascular-linked, mortality in older patients. We suggest that further research is needed to confirm these findings.

Different psychological status in the two hemispheres of two split-brain patients.

Questions of a psychological nature were presented to two split-brain patients from the California series encouraging each hemisphere to respond simultaneously and independently. The responses of both patients indicated that their hemispheres were responding independently. For the first patient, his right hemisphere appeared to be more disturbed than his left by childhood memories of being bullied. The right hemisphere of the second patient seemed to regard himself more positively, but it also seemed to feel more negative emotions such as loneliness and sadness. We discuss the possible significance of the findings.

Quality of care by race and gender for congestive heart failure and pneumonia.

BACKGROUND: Variations in the rates of major procedures by race and gender are well described, but few studies have assessed the quality of care by race and gender for basic hospital services. OBJECTIVE: To assess quality of care by race and gender. RESEARCH DESIGN: Retrospective review of medical records. SUBJECTS: Stratified random sample of 2,175 Medicare beneficiaries hospitalized for congestive heart failure or pneumonia in Illinois, New York, and Pennsylvania during 1991 and 1992. MEASURES: Explicit process criteria and implicit review by physicians. RESULTS: In adjusted analyses, black patients with congestive heart failure or pneumonia received lower quality of care overall than other patients with these conditions by both explicit process criteria and implicit review (P < 0.05). On explicit measures, overall quality of care did not differ by gender for either condition, but significant differences were noted on explicit subscales. Women received worse cognitive care than men from physicians for both conditions, better cognitive care from nurses for pneumonia, and better therapeutic care for congestive heart failure (P < 0.05). Women received worse quality of care than men by implicit review (P = 0.03) for congestive heart failure but not pneumonia. CONCLUSIONS: Consistent racial differences in quality of care persist in basic hospital services for two common medical conditions. Physicians, nurses, and policy makers should strive to eliminate these differences. Gender differences in quality of care are less pronounced and may vary by condition and type of provider or service.

Hospital readmissions and quality of care.

BACKGROUND: Readmission rates are often proposed as markers for quality of care. However, a consistent link between readmissions and quality has not been established. OBJECTIVE: To test the relation of readmission to quality and the utility of readmissions as hospital quality measures. SUBJECTS: One thousand, seven hundred and fifty-eight Medicare patients hospitalized in four states between 1991 to 1992 with pneumonia or congestive heart failure (CHF). DESIGN: Case control. MEASURES: Related adverse readmissions (RARs), defined as readmissions that indicate potentially sub-optimal care during initial hospitalization, were identified from administrative data using readmission diagnoses and intervening time periods designated by physician panels. We used linear regression to estimate the association between implicit and explicit quality measures and readmission status (RARs, non-RAR readmissions, and nonreadmissions), adjusting for severity. We tested whether RARs were associated with inferior care and performed simulations to determine whether RARs discriminated between hospitals on the basis of quality. RESULTS: Compared with nonreadmitted pneumonia patients, patients with RARs had lower adjusted quality measured both by explicit (0.25 standardized units, P = 0.004) and implicit methods (0.17, P = 0.047). Adjusted differences for CHF patients were 0.17 (P = 0.048) and 0.20 (P = 0.017), respectively. In some analyses, patients with non-RAR readmissions also experienced lower quality. However, rates of inferior quality care did not differ significantly by readmission status, and simulations identified no meaningful relationship between RARs and hospital quality of care. CONCLUSIONS: RARs are statistically associated with lower quality of care. However, neither RARs nor other readmissions appear to be useful tools for identifying patients who experience inferior care or for comparing quality among hospitals.

The influence of health-related quality of life and social characteristics on hospital use by patients with AIDS in the Boston Health Study.

OBJECTIVES: The authors examine whether health-related quality of life (HRQL) and social factors were independent predictors of future hospital use for persons with acquired immunodeficiency syndrome (AIDS). METHODS: A panel of 305 patients with AIDS treated at three provider settings in the Boston, Massachusetts area were enrolled during 1990 and 1991. Data were collected at baseline study enrollment and again 4 months later. Patient interviews, hospital bills, and medical charts were used to measure hospital use (admissions and days during the 4 months after enrollment), sociodemographic characteristics (age, gender, race, education, insurance, homelessness, alcohol use, and AIDS risk factors), disease burden (patient severity and a three-level opportunistic diseases and complications score), HRQL (patient-reported symptoms, activities of daily living, neuropsychological status, and global health assessment), system of care, and use of prophylactic drugs. Logistic regression was used to estimate the odds of admission. Total days of hospital care by patients with at least one admission were analyzed using multiple linear regression. Clinical models of hospital use were developed first from the variables measuring disease burden and system of care. Models estimating the associations between hospital use and all other predictor variables measured at baseline then were estimated using stepwise techniques, controlling for variables in the core model. RESULTS: Patients were more likely than their reference groups to be hospitalized if they had serious opportunistic diseases (adjusted odds ratio [OR] = 2.7), had poorer neuropsychological status (OR = 1.9), were non-white (OR = 2.0), or were homeless (OR = 3.3) (all P < or = 0.05). Activities of daily living were associated moderately (OR = 1.3; P = 0.07). Only system of care and neuropsychological status predicted total hospital days. CONCLUSIONS: The results indicate that future hospital use by persons with AIDS may be influenced by social and other health-related factors in addition to the more clinically related characteristics that are recorded in a medical chart. It therefore may be appropriate to assess these factors when considering options for intervention or when comparing patterns of use among patient groups or settings.

Reproducibility and validity of a self-administered physical activity questionnaire for male health professionals.

We assessed the reproducibility and validity of a self-administered physical activity questionnaire used in a prospective study of 51,529 men. The questionnaire was administered by mail twice to 238 participants 2 years apart. During this interval, the participants completed a past-week recall and a 1-week activity diary at four times corresponding to different seasons throughout a year. Also, a step test was taken by a subset of the study participants. The intraclass correlation coefficients used to measure reproducibility were 0.39 for inactivity, 0.42 for nonvigorous activity, and 0.52 for vigorous activity. The correlations between diary-based and questionnaire-based activity scores, adjusted for variation in the diary measurements, were 0.41 for inactivity, 0.28 for nonvigorous activity, and 0.58 for vigorous activity. The distribution of activity scores was similar between the questionnaires and the average of past-week recalls, indicating the participants' ability to incorporate seasonal variation into their recall on a questionnaire. The correlation between vigorous activity and resting pulse was -0.45, whereas, for the pulse rate after stepping, the correlation was -0.41. These data indicate that this physical activity questionnaire is reproducible and provides a useful measure of average weekly activity, particularly vigorous activity, over a 1-year period.

Treatment of rheumatoid arthritis with oral type II collagen. Results of a multicenter, double-blind, placebo-controlled trial.

OBJECTIVE: Oral administration of cartilage-derived type II collagen (CII) has been shown to ameliorate arthritis in animal models of joint inflammation, and preliminary studies have suggested that this novel therapy is clinically beneficial and safe in patients with rheumatoid arthritis (RA). The present study was undertaken to test the safety and efficacy of 4 different dosages of orally administered CII in patients with RA. METHODS: Two hundred seventy-four patients with active RA were enrolled at 6 different sites and randomized to receive placebo or 1 of 4 dosages (20, 100, 500, or 2,500 microg/day) of oral CII for 24 weeks. Efficacy parameters were assessed monthly. Cumulative response rates (percentage of patients meeting the criteria for response at any time during the study) were analyzed utilizing 3 sets of composite criteria: the Paulus criteria, the American College of Rheumatology criteria for improvement in RA, and a requirement for > or = 30% reduction in both swollen and tender joint counts. RESULTS: Eighty-three percent of patients completed 24 weeks of treatment. Numeric trends in favor of the 20 microg/day treatment group were seen with all 3 cumulative composite measures. However, a statistically significant increase (P = 0.035) in response rate for the 20 microg/day group versus placebo was detected using only the Paulus criteria. The presence of serum antibodies to CII at baseline was significantly associated with an increased likelihood of responding to treatment. No treatment-related adverse events were detected. The efficacy seen with the lowest dosage is consistent with the findings of animal studies and with known mechanisms of oral tolerance in which lower doses of orally administered autoantigens preferentially induce disease-suppressing regulatory cells. CONCLUSION: Positive effects were observed with CII at the lowest dosage tested, and the presence of serum antibodies to CII at baseline may predict response to therapy. No side effects were associated with this novel therapeutic agent. Further controlled studies are required to assess the efficacy of this treatment approach.