A varying patient safety profile between black and nonblack adults with decreased estimated GFR.

BACKGROUND: Chronic kidney disease is a high-risk condition for a variety of adverse safety events, yet little is known about differential rates of safety events across racial groups with decreased kidney function. We sought to examine the incidence of an array of disease-specific adverse safety events in black versus nonblack patients with decreased estimated glomerular filtration rate (eGFR). STUDY DESIGN: Retrospective observational study of a national US Veterans Affairs cohort. SETTINGS & PARTICIPANTS: Veterans with eGFR <60 mL/min/1.73 m(2) and one or more hospitalization during federal fiscal year 2005 (n = 70,154). PREDICTOR: Self-reported race/ethnicity dichotomized as black or nonblack. OUTCOMES: Hospital discharge coding for Agency for Healthcare Research and Quality (AHRQ) patient safety indicators (PSIs), laboratory records for detection of hyperkalemia and hypoglycemia, and pharmacy records to determine dosing of 4 selected medications. MEASUREMENTS: Relationship between race and disease-specific patient safety events. RESULTS: Black veterans were more likely than nonblack veterans to experience one type of safety event (33% vs 32%, respectively) and multiple types of safety events (32% vs 23%, respectively; both P < 0.001). After adjustment, black veterans were 11% and 36% more likely to have at least one episode of hyperkalemia and hypoglycemia, respectively, than nonblack veterans, but were 14% less likely to experience a medication error (all P < 0.001). There was no association between the occurrence of AHRQ PSIs and race after adjustment. LIMITATIONS: Use of administrative data has a risk of imprecision in coding; Veterans Affairs cohort may limit generalizability. CONCLUSIONS: Black veterans with decreased eGFR are more likely to experience a broad array of safety events than nonblacks with decreased eGFR, with a preponderance of metabolic disturbances rather than medication errors or AHRQ PSIs. The differential safety phenotype in blacks versus nonblacks may have implications for preventive strategies to improve patient safety in an integrated health care system.

Influence of creatinine versus glomerular filtration rate on non-steroidal anti-inflammatory drug prescriptions in chronic kidney disease.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors, are generally contraindicated in chronic kidney disease (CKD). This investigation sought to identify the frequency of NSAID/COX-2 prescription and to determine the influence of serum creatinine (Cr) versus estimated glomerular filtration rate (eGFR) on this practice pattern. METHODS: An established Veterans Health Administration CKD safety cohort (n = 70,154) was examined to determine the frequency of NSAID/COX-2 in fiscal year 2005 (FY05) for up to 30 days preceding the index hospitalization and as many as 365 days during that year. Binomial regression was used to determine adjusted prevalence ratios for prescription of NSAID/COX-2 with respect to continuous eGFR measurement and serum Cr categories. CKD was defined as eGFR <60 ml/min/1.73 m(2). RESULTS: 15.4% of the subjects had an NSAID/COX-2 prescription during the observation period. The proportion of these prescribed agents decreased with declining renal function, but remained significant at any stage of CKD given the renal harm related to these medications. At specific GFR estimates, serum Cr remained a significant predictor of NSAID/COX-2 prescription. At GFR set at 42 ml/min/1.73 m(2), the predicted proportion of prescribed NSAID/COX-2 was 0.29 (95% CI 0.24, 0.36), 0.23 (95% CI 0.22, 0.26), 0.20 (95% CI 0.19, 0.22), and 0.12 (95% CI 0.10, 0.14) for Cr strata of ≤1.3, 1.4-1.6, 1.7-2.1, and ≥2.2 mg/dl, respectively (all p < 0.05). CONCLUSION: A significant proportion of individuals with CKD continue to be prescribed NSAID/COX-2 and serum Cr remains an influential guide to NSAID/COX-2 prescription, even in GFR ranges where these agents are ill advised.

Erythropoiesis-stimulating agents increase the risk of acute stroke in patients with chronic kidney disease.

Erythropoiesis-stimulating agents (ESAs) are effective in ameliorating anemia in chronic kidney disease (CKD). A recent trial in diabetic patients with CKD, however, suggested a greater risk of stroke associated with full correction of anemia with ESAs. Using national Veterans Affairs data we performed a case-control study examining the association of incident ESA use with acute stroke in patients with estimated glomerular filtration rate < 60 cm³/min per 1.73 m² and outpatient hemoglobin <12 g/dl. Using diagnosis codes, we identified 2071 acute hospitalized stroke cases and matched them 1:5 with controls without stroke, resulting in 12,426 total patients for analysis. Conditional logistic regression was used to estimate the association of ESA use with stroke, adjusting for potential confounders. After multivariate adjustment, ESA use in 1026 patients was associated with greater odds of stroke (odds ratio 1.30). There was significant interaction between ESA use and cancer, with greater odds of stroke among ESA-treated cancer patients (odds ratio 1.85), but not in ESA-treated patients without cancer (odds ratio 1.07). ESA-treated patients with cancer received a median initial dose 2.5-4 times greater than ESA-treated patients without cancer, but pre-ESA hemoglobin and its rate of change did not differ between these groups. Hence, in a large national sample of anemic patients with CKD, ESA treatment was associated with an increased risk of acute stroke with the greatest effect among patients with cancer.

CKD as an underrecognized threat to patient safety.

Chronic kidney disease (CKD) is common, but underrecognized, in patients in the health care system, where improving patient safety is a high priority. Poor disease recognition and several other features of CKD make it a high-risk condition for adverse safety events. In this review, we discuss the unique attributes of CKD that make it a high-risk condition for patient safety mishaps. We point out that adverse safety events in this disease have the potential to contribute to disease progression; namely, accelerated loss of kidney function and increased incidence of end-stage renal disease. We also propose a framework in which to consider patient safety in CKD, highlighting the need for disease-specific safety indicators that reflect unsafe practices in the treatment of this disease. Finally, we discuss the hypothesis that increased recognition of CKD will reduce disease-specific safety events and in this way decrease the likelihood of adverse outcomes, including an accelerated rate of kidney function loss and increased incidence of end-stage renal disease.

Use of drugs with anticholinergic properties among nursing home residents with dementia: a national analysis of Medicare beneficiaries from 2007 to 2008.

BACKGROUND: Older adults with dementia are vulnerable to the central deteriorating effects of drugs with anticholinergic properties (DAPs). These effects include falls and confusion and may exacerbate dementia-related symptoms. Many individuals with dementia also receive acetylcholinesterase inhibitors (AChEIs), indicated for mild to moderate Alzheimer's disease. AChEIs have opposing effects to DAPs and, consequently, concomitant use of DAPs and AChEIs may further impair cognition among patients with dementia. OBJECTIVES: Our objectives were to (1) evaluate the anticholinergic burden among nursing home (NH) residents with dementia; (2) characterize trends in use of DAPs and concomitant use of DAPs and AChEIs among NH residents with dementia; and (3) identify factors associated with the use of DAPs and concomitant use of DAPs and AChEIs. METHODS: We conducted a retrospective analysis of Medicare data from 2007 to 2008 linked to the Minimum Data Set. RESULTS: During the study period, 53,805 (77%) NH residents with dementia used at least one DAP each month. Sixty-seven percent of residents with dementia used Anticholinergic Cognitive Burden Scale (ACBS) level 1 DAPs, 3% used level 2 DAPs, and 31% used level 3 DAPs. Thirteen percent of NH residents with dementia concomitantly used ACBS levels 2 or 3 DAPs and AChEIs. CONCLUSIONS: This study sheds new light on the prevalence of DAP use and concomitant use of DAPs and AChEIs among NH residents with dementia. Clinicians should consider alternatives with lower anticholinergic effects, particularly in patients already taking DAPs.

Effect of medications on physical function and cognition in nursing home residents with dementia.

OBJECTIVES: To assess the effectiveness of medications used in the management of Alzheimer's disease and related dementias (ADRD) on cognition and activity of daily living (ADL) trajectories and to determine whether sex modifies these effects. DESIGN: Two-year (2007-2008) longitudinal study. SETTING: Medicare enrollment and claims data linked to the Minimum Dataset 2.0. PARTICIPANTS: Older nursing home (NH) residents with newly diagnosed ADRD (n = 18,950). MEASUREMENTS: Exposures included four medication classes: antidementia medications (ADMs), antipsychotics, antidepressants, and mood stabilizers. Outcomes included ADLs and cognition (Cognitive Performance Scale (CPS)). Marginal structural models were employed to account for time-dependent confounding. RESULTS: The mean age was 83.6, and 76% of the sample was female. Baseline use of ADMs was 15%, antidepressants was 40%, antipsychotics was 13%, and mood stabilizers was 3%. Mean baseline ADL and CPS scores were 16.6 and 2.1, respectively. ADM use was not associated with change in ADLs over time but was associated with a slower CPS decline (slope difference: -0.09 points/year, 99% confidence interval (CI) = -0.14 to -0.03). Antidepressant use was associated with slower declines in ADL (slope difference: -0.36 points/year, 99% CI = -0.58 to -0.14) and CPS (slope difference: -0.12 points/year, 99% CI = -0.17 to -0.08). Sex modified the effect of both antipsychotic and mood stabilizer use on ADLs; female users declined most quickly. Antipsychotic use was associated with slower CPS decline (slope difference: -0.11 points/year, 99% CI = -0.17 to -0.06), whereas mood stabilizer use had no effect. CONCLUSION: Despite the observed statistically significantly slower declines in cognition with ADMs, antidepressants, and antipsychotics and the slower ADL decline found with antidepressants, it is unlikely that these benefits are of clinical significance.

Consideration of ICD-9 code-derived disease-specific safety indicators in CKD.

BACKGROUND AND OBJECTIVES: The Agency for Healthcare and Research Quality patient safety indicators track adverse safety events in hospitalized patients but overlook safety incidents specific to CKD. This study considers candidate CKD-pertinent patient safety indicators and compares them with the Agency for Healthcare and Research Quality patient safety indicators. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Using a national Veterans Health Administration database of hospitalized veterans from fiscal year 2005, 247,160 hospitalized veterans with prehospitalization measures of renal function were retrospectively examined for proposed CKD patient safety indicators versus Agency for Healthcare and Research Quality patient safety indicators using International Classification of Diseases, Ninth Revision diagnosis codes. Candidate CKD-pertinent patient safety indicators included in-hospital acute kidney failure; in-hospital congestive heart failure (and related diagnostic codes); electrolyte disturbances; and medication errors, poisoning, and intoxication. Patients with a prehospital estimated GFR<60 ml/min per 1.73 m(2) (CKD group) were compared with a non-CKD group. For CKD patient safety indicators, hospitalizations were excluded if the admitting condition was a potential cause of the secondary condition. Regression methods were used to present adjusted rates in study groups of interest. RESULTS: The CKD patient safety indicators were generally more common than the Agency for Healthcare and Research Quality patient safety indicators in all groups, tended to occur in different patients than those patients who experienced Agency for Healthcare and Research Quality patient safety indicators, and were more common in the CKD group than the non-CKD group, except for hypoglycemia, hypokalemia, and hyponatremia. The adjusted composite CKD patient safety indicators rate (per 1000 patient-hospitalizations) was 398.0 (95% confidence interval, 391.2 to 405.0) for patients in the CKD group and 250.0 (95% confidence interval, 247.4 to 252.7) for patients in the non-CKD group. The prevalence ratio of CKD patient safety indicators to Agency for Healthcare and Research Quality patient safety indicators was 23.4 (95% confidence interval, 21.9 to 25.0). CONCLUSION: The candidate CKD patient safety indicators that occur in hospitalized patients are distinct from the Agency for Healthcare and Research Quality patient safety indicators and tend to be more common in CKD than non-CKD patients. These measures have the potential to serve as sentinel tools for identifying patients with CKD who warrant examination for disease-pertinent safety events.

Pharmacotherapeutic management of dementia across settings of care.

OBJECTIVES: To describe population-based use of cognitive-enhancing and psychopharmacological medications across care settings in Medicare beneficiaries with dementia. DESIGN: One-year (2008) cross-sectional study. SETTING: Medicare administrative claims from a 5% random sample. PARTICIPANTS: Medicare beneficiaries with dementia aged 65 and older with continuous Medicare Parts A, B, and D coverage and alive throughout 2008. To ascertain dementia, one or more medical claims with a dementia International Classification of Diseases, Ninth Revision, Clinical Modification code was required before 2008, and an additional claim was required in 2008 to confirm active disease. MEASUREMENTS: Use of medications commonly prescribed in managing dementia (cognitive enhancers, antidepressants, antipsychotics, and mood stabilizers) was assessed using three measures: annual prevalence of use, consistency of use, and count of psychopharmacological medication classes. Care setting was determined using the number of months of nursing home (NH) residency: no NH (0 months), partial NH (1-11 months), and full NH (12 months). RESULTS: Community-dwellers represented 41.3% of the cohort, whereas 42.4% and 16.3% resided partially and fully in a NH, respectively. Annual prevalence of use was 57.1% for cognitive enhancers, 56.4% for antidepressants, 34.0% for antipsychotics, and 8.8% for mood stabilizers. Cognitive enhancer use was significantly lower in those with any NH stay (partial NH vs no NH, adjusted prevalence ratio (APR) = 0.84, 99% confidence interval (CI) = 0.83-0.86; full NH vs no NH, APR = 0.83, 99% CI = 0.81-0.85). In contrast, those with any NH residence had significantly higher use of all psychopharmacological medication classes than community-dwellers. More than half the cohort had consistent medication regimens during 2008 (64.8%). The number of psychopharmacological medication classes used increased with increasing NH stay duration. CONCLUSION: This population-based study documents significant differences in medication use for managing dementia between care settings and substantial use of psychopharmacological medications in older adults with dementia.

A sustainable strategy to prevent misuse of antibiotics for acute respiratory infections.

BACKGROUNDS: Over 50% of antibiotics prescriptions are for outpatients with acute respiratory infections (ARI). Many of them are not needed and thus contribute both avoidable adverse events and pressures toward the development of bacterial resistance. Could a clinical decision support system (CDSS), interposed at the time of electronic prescription, adjust antibiotics utilization toward consensus treatment guidelines for ARI? METHODS: This is a retrospective comparison of pre- (2002) and post-intervention (2003-2006) periods at two comprehensive health care systems (intervention and control). The intervention was a CDSS that targeted fluoroquinolone and azithromycin; other antibiotics remained unrestricted. 7000 outpatients visits flagged by an ARI case-finding algorithm were reviewed for congruence with the guidelines (antibiotic prescribed-when-warranted or not-prescribed-when-unwarranted). RESULTS: 3831 patients satisfied the case definitions for one or more ARI: pneumonia (537), bronchitis (2931), sinusitis (717) and non-specific ARI (145). All patients with pneumonia received antibiotics. The relative risk (RR) of congruent prescribing was 2.57 (95% CI = (1.865 to 3.540) in favor of the intervention site for the antibiotics targeted by the CDSS; congruence did not change for other antibiotics (adjusted RR = 1.18 (95% CI = (0.691 to 2.011)). The proportion of unwarranted prescriptions of the targeted antibiotics decreased from 22% to 3%, pre vs. post-intervention (p<0.0001). CONCLUSIONS: A CDSS interposed at the time of e-prescription nearly extinguished unwarranted use targeted antibiotics for ARI for four years. This intervention highlights a path toward sustainable antibiotics stewardship for outpatients with ARI.

Adverse safety events in chronic kidney disease: the frequency of "multiple hits".

BACKGROUND AND OBJECTIVES: Chronic kidney disease (CKD) lacks standardized patient safety indicators (PSIs); however, undetected safety events are likely to contribute to adverse outcomes in this disease. This study sought to determine the proportion of CKD patients who experience multiple potentially hazardous events from varied causes and to identify risk factors for the occurrence of "multiple hits." DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A sample of patients with CKD (n = 70,154) in the Veterans Health Administration (VHA) were retrospectively examined for the occurrence of one or more safety events from a set of indicators defined a priori, including Agency for Healthcare Research and Quality (AHRQ) PSIs, hypoglycemia, hyperkalemia, and dosing for selected medications not accounting for CKD. RESULTS: Approximately half of the cohort participants experienced one or two adverse safety events, whereas 7% had three or four (multiple) distinct events. Individuals with three or four of the predesignated safety events were more likely to be diabetic, non-Caucasian, have an estimated GFR (eGFR) < 30 ml/min/1.73 m(2), and be < or =65 yr of age. A "Safety Risk Index" was developed using these characteristics, and those subjects that had all four traits were 25 times as likely to have three or four adverse safety events versus those with none of the characteristics. CONCLUSIONS: Patients with CKD are at a high risk for safety events pertinent to this disease and a substantial number are subject to multiple events from a diverse set of safety indicators, which could have important consequences in disease outcomes.

Timing of erythropoiesis-stimulating agent initiation and adverse outcomes in nondialysis CKD: a propensity-matched observational study.

BACKGROUND AND OBJECTIVES: The severity of anemia at which to initiate erythropoiesis-stimulating agent (ESA) treatment in nondialysis chronic kidney disease (CKD) patients is unclear. Risk of mortality, hospitalizations, and blood transfusion were compared among nondialysis CKD patients with "early" versus "delayed" ESA initiation. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: A retrospective cohort study was conducted on CKD (estimated GFR <60 ml/min/1.73m(2)) outpatients in the national Veterans Administration who were initiated on ESAs. Patients with ESRD, gastrointestinal bleeding, chemotherapy, or hematologic malignancy were excluded. Patients were characterized as having early [hemoglobin (Hb) 10.0 to 11.0 g/dl] or delayed (Hb 8.0 to 9.9 g/dl) ESA initiation. A propensity score comprising demographic, clinical, and laboratory variables was used to select a 1:1 matched cohort. Cox survival and negative binomial regression were used to compare the matched groups for all-cause mortality, hospitalizations, and blood transfusions. RESULTS: Of 1837 patients who met inclusion criteria, 1410 (77%) were successfully matched. The groups did not differ significantly in 31 characteristics reflecting sociodemographics, comorbidity, healthcare utilization, and renal function. There was no significant difference in mortality with early initiation. Those initiated early had a 17% lower risk of initial hospitalization and a 29% lower risk of transfusion compared with delayed initiation patients. Results did not differ between those with and without pre-ESA transfusion or hospitalization. CONCLUSIONS: In nondialysis CKD, ESA initiation at Hb 10.0 to 11.0 g/dl compared with 8.0 to 9.9 g/dl is associated with reduced risk of blood transfusion and initial hospitalization.