Impact of the Oncology Care Model on Use of Supportive Care Medications During Cancer Treatment.

PURPOSE: The Oncology Care Model (OCM) is an episode-based alternative payment model for cancer care that seeks to reduce Medicare spending while maintaining care quality. We evaluated the impact of OCM on appropriate use of supportive care medications during cancer treatment. METHODS: We evaluated chemotherapy episodes assigned to OCM (n = 201) and comparison practices (n = 534) using Medicare claims (2013-2019). We assessed denosumab use for beneficiaries with bone metastases from breast, lung, or prostate cancer; prophylactic WBC growth factor use for beneficiaries receiving chemotherapy for breast, lung, or colorectal cancer; and prophylactic use of neurokinin-1 (NK1) antagonists and long-acting serotonin antagonists for beneficiaries receiving chemotherapy for any cancer type. Analyses used a difference-in-difference approach. RESULTS: After its launch in 2016, OCM led to a relative reduction in the use of denosumab for beneficiaries with bone metastases receiving bone-modifying medications (eg, 5.0 percentage point relative reduction in breast cancer episodes [90% CI, -7.1 to -2.8]). There was no OCM impact on use of prophylactic WBC growth factors during chemotherapy with high or low risk for febrile neutropenia. Among beneficiaries receiving chemotherapy with intermediate febrile neutropenia risk, OCM led to a 7.6 percentage point reduction in the use of prophylactic WBC growth factors during breast cancer episodes (90% CI, -12.6 to -2.7); there was no OCM impact in lung or colorectal cancer episodes. Among beneficiaries receiving chemotherapy with high or moderate emetic risk, OCM led to reductions in the prophylactic use of NK1 antagonists and long-acting serotonin antagonists (eg, 6.0 percentage point reduction in the use of NK1 antagonists during high emetic risk chemotherapy [90% CI, -9.0 to -3.1]). CONCLUSION: OCM led to the reduced use of some high-cost supportive care medications, suggesting more value-conscious care.

The Oncology Care Model and Adherence to Oral Cancer Drugs: A Difference-in-Differences Analysis.

BACKGROUND: Adherence to oral cancer drugs is suboptimal. The Oncology Care Model (OCM) offers oncology practices financial incentives to improve the value of cancer care. We assessed the impact of OCM on adherence to oral cancer therapy for chronic myelogenous leukemia (CML), prostate cancer, and breast cancer. METHODS: Using 2014-2019 Medicare data, we studied chemotherapy episodes for Medicare fee-for-service beneficiaries prescribed tyrosine kinase inhibitors (TKIs) for CML, antiandrogens (ie, enzalutamide, abiraterone) for prostate cancer, or hormonal therapies for breast cancer in OCM-participating and propensity-matched comparison practices. We measured adherence as the proportion of days covered and used difference-in-difference (DID) models to detect changes in adherence over time, adjusting for patient, practice, and market-level characteristics. RESULTS: There was no overall impact of OCM on improved adherence to TKIs for CML (DID = -0.3%, 90% confidence interval [CI] = -1.2% to 0.6%), antiandrogens for prostate cancer (DID = 0.4%, 90% CI = -0.3% to 1.2%), or hormonal therapy for breast cancer (DID = 0.0%, 90% CI = -0.2% to 0.2%). Among episodes for Black beneficiaries in OCM practices, for whom adherence was lower than for White beneficiaries at baseline, we observed small improvements in adherence to high cost TKIs (DID = 3.0%, 90% CI = 0.2% to 5.8%) and antiandrogens (DID = 2.2%, 90% CI = 0.2% to 4.3%). CONCLUSIONS: OCM did not impact adherence to oral cancer therapies for Medicare beneficiaries with CML, prostate cancer, or breast cancer overall but modestly improved adherence to high-cost TKIs and antiandrogens for Black beneficiaries, who had somewhat lower adherence than White beneficiaries at baseline. Patient navigation and financial counseling are potential mechanisms for improvement among Black beneficiaries.

Association of Participation in the Oncology Care Model With Medicare Payments, Utilization, Care Delivery, and Quality Outcomes.

IMPORTANCE: In 2016, the US Centers for Medicare & Medicaid Services initiated the Oncology Care Model (OCM), an alternative payment model designed to improve the value of care delivered to Medicare beneficiaries with cancer. OBJECTIVE: To assess the association of the OCM with changes in Medicare spending, utilization, quality, and patient experience during the OCM's first 3 years. DESIGN, SETTING, AND PARTICIPANTS: Exploratory difference-in-differences study comparing care during 6-month chemotherapy episodes in OCM participating practices and propensity-matched comparison practices initiated before (January 2014 through June 2015) and after (July 2016 through December 2018) the start of the OCM. Participants included Medicare fee-for-service beneficiaries with cancer treated at these practices through June 2019. EXPOSURES: OCM participation. MAIN OUTCOMES AND MEASURES: Total episode payments (Medicare spending for Parts A, B, and D, not including monthly payments for enhanced oncology services); utilization and payments for hospitalizations, emergency department (ED) visits, office visits, chemotherapy, supportive care, and imaging; quality (chemotherapy-associated hospitalizations and ED visits, timely chemotherapy, end-of-life care, and survival); and patient experiences. RESULTS: Among Medicare fee-for-service beneficiaries with cancer undergoing chemotherapy, 483 319 beneficiaries (mean age, 73.0 [SD, 8.7] years; 60.1% women; 987 332 episodes) were treated at 201 OCM participating practices, and 557 354 beneficiaries (mean age, 72.9 [SD, 9.0] years; 57.4% women; 1 122 597 episodes) were treated at 534 comparison practices. From the baseline period, total episode payments increased from $28 681 for OCM episodes and $28 421 for comparison episodes to $33 211 for OCM episodes and $33 249 for comparison episodes during the intervention period (difference in differences, -$297; 90% CI, -$504 to -$91), less than the mean $704 Monthly Enhanced Oncology Services payments. Relative decreases in total episode payments were primarily for Part B nonchemotherapy drug payments (difference in differences, -$145; 90% CI, -$218 to -$72), especially supportive care drugs (difference in differences, -$150; 90% CI, -$216 to -$84). The OCM was associated with statistically significant relative reductions in total episode payments among higher-risk episodes (difference in differences, -$503; 90% CI, -$802 to -$204) and statistically significant relative increases in total episode payments among lower-risk episodes (difference in differences, $151; 90% CI, $39-$264). The OCM was not significantly associated with differences in hospitalizations, ED visits, or survival. Of 22 measures of utilization, 10 measures of quality, and 7 measures of care experiences, only 5 were significantly different. CONCLUSIONS AND RELEVANCE: In this exploratory analysis, the OCM was significantly associated with modest payment reductions during 6-month episodes for Medicare beneficiaries receiving chemotherapy for cancer in the first 3 years of the OCM that did not offset the monthly payments for enhanced oncology services. There were no statistically significant differences for most utilization, quality, and patient experience outcomes.

Intensive care units with low versus high volume of myocardial infarction: clinical outcomes, resource utilization, and quality metrics.

BACKGROUND: The volume-outcome relationship associated with intensive care unit (ICU) experience with managing acute myocardial infarction (AMI) remains inadequately understood. METHODS AND RESULTS: Within a multicenter clinical ICU database, we identified patients with a primary ICU admission diagnosis of AMI between 2008 and 2010 to evaluate whether annual AMI volume of an individual ICU is associated with mortality, length-of-stay, or quality indicators. Patients were categorized into those treated in ICUs with low-annual-AMI volume (≤50th percentile, <2 AMI patients/month, n=569 patients) versus high-annual-AMI volume (≥90th percentile, ≥8 AMI patients/month, n=17 553 patients). Poisson regression and generalized estimating equation with negative binomial regression were used to calculate the relative risk (95% CI) for mortality and length-of-stay, respectively, associated with admission to a low-AMI-volume ICU. When compared with high-AMI-volume, patients admitted to low-AMI-volume ICUs had substantially more medical comorbidities, higher in-hospital mortality (11% versus 4%, P<0.001), longer hospitalizations (6.9±7.0 versus 5.0±5.0 days, P<0.001), and fewer evidence-based therapies for AMI (reperfusion therapy, antiplatelets, ß-blockers, and statins). However, after adjustment for baseline patient characteristics, low-AMI-volume ICU was no longer an independent predictor of in-hospital mortality (relative risk 1.17 [0.87 to 1.56]) or hospital length-of-stay (relative risk 1.01 [0.94 to 1.08]). Similar findings were noted in secondary analyses of ICU mortality and ICU length-of-stay. CONCLUSIONS: Admission to an ICU with lower annual AMI volume is associated with higher in-hospital mortality, longer hospitalization, and lower use of evidence-based therapies for AMI. However, the relationship between low-AMI-volume and outcomes is no longer present after accounting for the higher-risk medical comorbidities and clinical characteristics of patients admitted to these ICUs.

Prescription fill patterns in underserved children with asthma receiving subspecialty care.

BACKGROUND: Children with asthma receiving specialty care have been found to have improved asthma outcomes. However, these outcomes can be adversely affected by poor adherence with controller medications. OBJECTIVE: To analyze pharmacy fill patterns as a measure of primary adherence in a group of underserved minority children receiving allergy subspecialty care. METHODS: As part of a larger 18-month nebulizer use study in underserved children (ages 2-8 years) with persistent asthma, 53 children were recruited from an urban allergy practice. Pharmacy records were compared with prescribing records for all asthma medications. RESULTS: Allergist controller prescriptions were written in 30-day quantities with refills and short-acting ß-agonists (SABAs) with no refills. Only 49.1% of inhaled corticosteroid (ICS), 49.5% of combination ICS and long-acting ß-agonist, and 64.5% of leukotriene modifier (LTM) initial and refill prescriptions were ever filled during the 18-month period. A mean of 5.1 refills (range, 0-14) for SABAs were obtained during 18 months, although only 1.28 SABA prescriptions were prescribed by the allergist. Mean times between first asthma prescription and actual filling were 30 days (range, 0-177 days) for ICSs, 26.6 days (range, 0-156 days) for LTMs, and 16.8 days (range, 0-139 days) for SABAs. CONCLUSION: Underserved children with asthma receiving allergy subspecialty care suboptimally filled controller prescriptions, yet filled abundant rescue medications from other prescribers. Limiting albuterol prescriptions to one canister without additional refills may provide an opportunity to monitor fill rates of both rescue and controller medications and provide education to patients about appropriate use of medications to improve adherence.

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.

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.

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.

Effect of urologists and medical oncologists on treatment of elderly men with Stage IV prostate cancer.

OBJECTIVES: To examine, among elderly men with incident advanced prostate cancer (PCa), their treatment, in general, and chemotherapy, in particular, in association with a posturologist medical oncologist/hematologist (PUMOH) visit. The role of specialists in the management of advanced PCa is evolving in response to positive chemotherapy trials of PCa. METHODS: Linked Surveillance, Epidemiology, and End results and Medicare data included patients with Stage IV PCa diagnosed from 1994 to 2002 who had visited a urologist after the diagnosis and received treatment. The visits and treatment were examined, comparing patients with and without PUMOH visits. RESULTS: Most (77%) patients received treatment of their PCa and 85% of treated patients had a subsequent visit with a urologist, of whom 91% saw the urologist first (n = 5435). Of these, 43% saw only the urologist, 41% saw a medical oncologist/hematologist, and 32% saw a radiation oncologist. Of the 5435 patients, 16% received chemotherapy and the adjusted odds of chemotherapy receipt were 7.2 times greater (95% confidence interval 6.0-8.7, P < .001) among those with a PUMOH visit. Compared with non-Hispanic whites, black Americans were less likely (adjusted odds ratio 0.53, P < .001) to receive chemotherapy, although the likelihood of a PUMOH visit was similar (adjusted odds ratio 0.86, P = .14) among the groups. CONCLUSIONS: The results of our study have shown that nearly one quarter of men with Stage IV PCa receive no PCa treatment. Although a PUMOH visit is a significant predictor of chemotherapy receipt, many men with advanced PCa received chemotherapy without a medical oncologist/hematologist visit. Black American and elderly men were less likely to receive chemotherapy for advanced PCa.

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.

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.

Adherence feedback to improve asthma outcomes among inner-city children: a randomized trial.

OBJECTIVE: We evaluated the longitudinal effects of home-based asthma education combined with medication adherence feedback (adherence monitoring with feedback [AMF]) and asthma education alone (asthma basic care [ABC]) on asthma outcomes, relative to a usual-care (UC) control group. METHODS: A total of 250 inner-city children with asthma (mean age: 7 years; 62% male; 98% black) were recruited from a pediatric emergency department (ED). Health-outcome measures included caregiver-frequency of asthma symptoms, ED visits, hospitalizations, and courses of oral corticosteroids at baseline and 6-, 12-, and 18-month assessments. Adherence measures included caregiver-reported adherence to inhaled corticosteroid (ICS) therapy and pharmacy records of ICS refills. Multilevel modeling was used to examine the differential effects of AMF and ABC compared with UC. RESULTS: ED visits decreased more rapidly for the AMF group than for the UC group, but no difference was found between the ABC and UC groups. The AMF intervention led to short-term improvements in ICS adherence during the active-intervention phase relative to UC, but this improvement decreased over time. Asthma symptoms and courses of corticosteroids decreased more rapidly for the ABC group than for the UC group. Hospitalization rates did not differ between either intervention group and the UC group. No differences were found between the ABC and AMF groups on any outcome. CONCLUSIONS: Asthma education led to improved adherence and decreased morbidity compared with UC. Home-based educational interventions may lead to modest short-term improvements in asthma outcomes among inner-city children. Adherence feedback did not improve outcomes over education alone.

The frequency of hyperkalemia and its significance in chronic kidney disease.

BACKGROUND: Hyperkalemia is a potential threat to patient safety in chronic kidney disease (CKD). This study determined the incidence of hyperkalemia in CKD and whether it is associated with excess mortality. METHODS: This retrospective analysis of a national cohort comprised 2 103 422 records from 245 808 veterans with at least 1 hospitalization and at least 1 inpatient or outpatient serum potassium record during the fiscal year 2005. Chronic kidney disease and treatment with angiotensin-converting enzyme inhibitors and/or angiotensin II receptor blockers (blockers of the renin-angiotensin-aldosterone system [RAAS]) were the key predictors of hyperkalemia. Death within 1 day of a hyperkalemic event was the principal outcome. RESULTS: Of the 66 259 hyperkalemic events (3.2% of records), more occurred as inpatient events (n = 34 937 [52.7%]) than as outpatient events (n = 31 322 [47.3%]). The adjusted rate of hyperkalemia was higher in patients with CKD than in those without CKD among individuals treated with RAAS blockers (7.67 vs 2.30 per 100 patient-months; P < .001) and those without RAAS blocker treatment (8.22 vs 1.77 per 100 patient-months; P < .001). The adjusted odds ratio (OR) of death with a moderate (potassium, >or=5.5 and <6.0 mEq/L [to convert to mmol/L, multiply by 1.0]) and severe (potassium, >or=6.0 mEq/L) hyperkalemic event was highest with no CKD (OR, 10.32 and 31.64, respectively) vs stage 3 (OR, 5.35 and 19.52, respectively), stage 4 (OR, 5.73 and 11.56, respectively), or stage 5 (OR, 2.31 and 8.02, respectively) CKD, with all P < .001 vs normokalemia and no CKD. CONCLUSIONS: The risk of hyperkalemia is increased with CKD, and its occurrence increases the odds of mortality within 1 day of the event. These findings underscore the importance of this metabolic disturbance as a threat to patient safety in CKD.

Frequency of hypoglycemia and its significance in chronic kidney disease.

BACKGROUND AND OBJECTIVES: This study set out to determine the incidence of hypoglycemia in patients with chronic kidney disease (CKD), with and without diabetes, and the association of hypoglycemia with mortality. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: This was a retrospective cohort analysis of 243,222 patients who had 2,040,206 glucose measurements and were cared for at the Veterans Health Administration. CKD was defined as an estimated GFR of <60 ml/min per 1.73 m(2). Hypoglycemia was set at <70 mg/dl. Mortality was measured 1 day after glucose measurement. RESULTS: The incidence of hypoglycemia was higher in patients with CKD versus without CKD. Among patients with diabetes, the rate was 10.72 versus 5.33 per 100 patient-months and among patients without diabetes was 3.46 versus 2.23 per 100 patient-months, for CKD versus no CKD, respectively. The odds of 1-d mortality were increased at all levels of hypoglycemia but attenuated in CKD versus no CKD. Adjusted odds ratios for 1-d mortality that were associated with glucose values of <50, 50 to 59, and 60 to 69 mg/dl, respectively, versus glucose of >or=70 mg/dl were 6.09, 4.10, and 1.85 for inpatient records from patients with CKD; 9.95, 3.79, and 2.54 for inpatients records from patients without CKD; 6.84, 3.28, and 3.98 for outpatient records from patients with CKD; and 13.28, 7.36, and 4.34 for outpatient records from patients without CKD. CONCLUSIONS: CKD is a risk for hypoglycemia, with or without diabetes. The excessive mortality associated with hypoglycemia makes this complication a significant threat to patient safety in CKD.

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.

Sensitivity of nursing home cost comparisons to method of dementia diagnosis ascertainment.

This study compared the association of differing methods of dementia ascertainment, derived from multiple sources, with nursing home (NH) estimates of prevalence of dementia, length of stay, and costs an understudied issue. Subjects were 2050 new admissions to 59 Maryland NHs, from 1992 to 1995 followed longitudinally for 2 years. Dementia was ascertained at admission from charts, Medicare claims, and expert panel. Overall 59.5% of the sample had some indicator of dementia. The expert panel found a higher prevalence of dementia (48.0%) than chart review (36.9%) or Medicare claims (38.6%). Dementia cases had lower relative average per patient monthly costs, but longer NH length of stay compared to nondementia cases across all methods. The prevalence of dementia varied widely by method of ascertainment, and there was only moderate agreement across methods. However, lower costs for dementia among NH admissions are a robust finding across these methods.

Seasonal patterns of controller and rescue medication dispensed in underserved children with asthma.

OBJECTIVE: To determine whether temporal trends exist for short-acting beta agonist (SABA), oral corticosteroid (OCS), and anti-inflammatory prescription fills in children with persistent asthma. METHOD: This was a longitudinal analysis of pharmacy record data and health information data obtained by parent report over 12 months for children with persistent asthma 2 to 9 years of age. Eligible children had to report current nebulizer use and one or more emergency department visits or hospitalizations within the past 12 months. RESULTS: Children were primarily African-American (89%), male (64%), received Medicaid health insurance (82%), and were a mean age of 4.5 years (SD 2.1). Few families (11%) reported any problems paying for their child's asthma medications at baseline or at the 12-month follow-up. There was a high degree of association between filling a rescue (SABA or OCS) and controller (leukotriene modifier, inhaled corticosteroid, cromolyn) medication during the same month for all months with Pearson's correlation coefficients ranging from a low of 0.28 for October to a high of 0.53 in September. Short-acting beta agonist fills were significantly more likely to be filled concurrently with inhaled corticosteroid fills. However, significantly fewer prescription fills were obtained in the summer months with an acceleration of medication fills in September through December and an increase in early spring. CONCLUSIONS: There was a summer decline in both inhaled corticosteroid and SABA fills. Timing of asthma monitoring visits to occur before peak prescription fill months, i.e., August and December for an asthma "tune-up," theoretically could improve asthma control. During these primary care visits children could benefit from more intensive monitoring of medication use including monitoring lung function, frequency of prescription refills, and assessment of medication device technique to ensure that an effective dose of medication is adequately delivered to the respiratory tract. Additionally, scheduling non-urgent asthma care visits at pre-peak prescription fill months can take advantage of "step down" during decreased symptom periods and when appropriate restart daily controller medications to "step up" prior to peak asthma periods.

Chronic kidney disease adversely influences patient safety.

Reducing medical errors and improving patient safety have become a national priority. Patients with chronic kidney disease (CKD) may be at higher risk for adverse consequences of medical care, but few studies have evaluated this question. Here, data for patients hospitalized in the Veteran's Health Administration during 2004 to 2005 was analyzed to conduct a cross-sectional study of CKD and adverse safety events. Outcomes included 13 patient safety indicators (PSI) defined by the Agency for Healthcare Research and Quality and six experimental PSI relevant to CKD. The 71,666 (29%) hospitalized veterans with CKD had a higher risk for several PSI, even after case-mix adjustment. Among surgical hospitalizations, CKD was associated with increased risk for hip fracture, physiologic/metabolic derangements, and complications of anesthesia. Among all acute hospitalizations, the PSI with the highest risk in patients with CKD were infection as a result of medical care and death among those in diagnosis-related groups normally associated with low mortality. Furthermore, as preadmission estimated GFR decreased, a significant trend of increasing risk for all PSI was observed (P = 0.001). In conclusion, hospitalized patients with CKD are at increased risk for adverse safety events, measured by established PSI. Further investigation is needed to develop and test interventions to reduce this risk.

Concordance of Medicaid and pharmacy record data in inner-city children with asthma.

BACKGROUND: Management of asthma involves adherence to medication regimens. Assessing adherence is difficult for health care providers and researchers. Self-reported medication use is subjective, so objective methods of data collection for medication use are frequently used in asthma research. The aim of this project is to examine the concordance between asthma medication pharmacy data culled from Medicaid claims data ("Medicaid pharmacy data") and patient pharmacy record data obtained from individual pharmacies ("pharmacy record data"). METHODS: Medicaid pharmacy data and pharmacy record data were obtained from inner-city children enrolled in a prospective study of children with persistent asthma. A subject level comparison of pharmacy records and Medicaid pharmacy data pharmacy records was done to determine concordance between the 2 data collection methods. RESULTS: Of 513 children recruited for inclusion, 221 were consented and randomized. Medicaid claims data were collected on 72.8% (n=161) of the 221 enrolled subjects. Pharmacy record data were available on 96.8% (n=214) of the 221 subjects. Data presented represent the 159 subjects who had both Medicaid claims data and pharmacy records data available throughout the study period. There was complete agreement between Medicaid pharmacy data and pharmacy record for 26% (n=42) of subjects. A total of 1858 asthma medication claims were captured by the Medicaid pharmacy data. Medicaid pharmacy data missed 149 claims that were capture by the pharmacy record data. Medicaid pharmacy data failed to capture a single claim on 4.4% (n=7) of subjects. The pharmacy record data captured a total of 1627 asthma medication claims and missed 371 claims that were captured by the Medicaid pharmacy data. Pharmacy record data failed to capture a single claim in 1.9% (n=3) of subjects. CONCLUSIONS: There was overlap between the pharmacy data captured by the Medicaid pharmacy dataset and pharmacy record dataset, but the overall concordance between the two data collection methods was low. Pharmacy records collected directly from the pharmacy included data on more subjects and pharmacy data culled from Medicaid claims captured more total number of claims. In spite of the differences in the methods used to collect data, pharmacy fill records are a rich source of data with both clinical and research applications. Clinicians and researchers must weigh the benefits and limitations of each method used to collect pharmacy data.

Validation of a method for identifying nursing home admissions using administrative claims.

BACKGROUND: Currently there is no standard algorithm to identify whether a subject is residing in a nursing home from administrative claims. Our objective was to develop and validate an algorithm that identifies nursing home admissions at the resident-month level using the MarketScan Medicare Supplemental and Coordination of Benefit (COB) database. METHODS: The computer algorithms for identifying nursing home admissions were created by using provider type, place of service, and procedure codes from the 2000 - 2002 MarketScan Medicare COB database. After the algorithms were reviewed and refined, they were compared with a detailed claims review by an expert reviewer. A random sample of 150 subjects from the claims was selected and used for the validity analysis of the algorithms. Contingency table analysis, comparison of mean differences, correlations, and t-test analyses were performed. Percentage agreement, sensitivity, specificity, and Kappa statistics were analyzed. RESULTS: The computer algorithm showed strong agreement with the expert review (99.9%) for identification of the first month of nursing home residence, with high sensitivity (96.7%), specificity (100%) and a Kappa statistic of 0.97. Weighted Pearson correlation coefficient between the algorithm and the expert review was 0.97 (p < 0.0001). CONCLUSION: A reliable algorithm indicating evidence of nursing home admission was developed and validated from administrative claims data. Our algorithm can be a useful tool to identify patient transitions from and to nursing homes, as well as to screen and monitor for factors associated with nursing home admission and nursing home discharge.