Benjamin Gutierrez

Quality of care for patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease.

Context Evidence-based guidelines for the care of patients with chronic obstructive pulmonary disease (COPD) recommend explicit criteria for appropriate management of the disease. These guidelines identify tests and treatments of uncertain benefit as well as those that are potentially harmful. The degree of adherence to these guidelines is unknown. Contribution By surveying 360 hospitals, these investigators found that use of ideal care varied from 10% at some hospitals to greater than 60% at others. Cautions Administrative data were used instead of medical chart review to determine adherence to guidelines. Implications Despite well-accepted criteria for care of acute exacerbations of COPD, guideline adherence remains poor. The Editors Chronic obstructive pulmonary disease (COPD) affects approximately 16 million adults, accounts for more than

Cost-effectiveness of aripiprazole once-monthly compared with paliperidone palmitate once-monthly injectable for the treatment of schizophrenia in the United States.

18 billion in annual health care costs, and is the fourth leading cause of death in the United States (1, 2). In 2002, approximately 620000 persons were hospitalized for acute exacerbation of COPD, making this 1 of the 10 leading causes of hospitalization among U.S. adults (3). In 1987, the American Thoracic Society became the first organization to produce clinical practice guidelines for the management of COPD (4). The number of standards has grown steadily since then, and various national and international organizations now produce guidelines (5-11). The American College of Physicians and the American College of Chest Physicians have coproduced evidence-based guidelines recommending that patients with acute exacerbations of COPD undergo a diagnostic evaluation that includes chest radiography and arterial blood gas analysis, followed by treatment with supplemental oxygen; anticholinergic bronchodilators; short-acting 2-agonists; systemic corticosteroids; antibiotics; and, in some circumstances, noninvasive positive-pressure ventilation. These guidelines identify spirometry, mucolytic agents, sputum examinations, methylxanthine bronchodilators, and chest physiotherapy to be of uncertain or no benefit, with the latter 2 treatments being potentially harmful (5). While the attention of policymakers, regulatory agencies, and the federal government has focused on measuring and improving quality of care for patients with pneumonia (12-17), remarkably little is known about the management of patients with acute exacerbations of COPD. General information about the quality of care for patients with COPD is lacking, and it is unknown whether regional differences in treatment exist or whether there is a positive relationship between hospital volume and quality of care for patients with COPD (such relationships are well documented for some surgical procedures and medical conditions [18]). Similarly, it is unclear whether disparities that have been observed between sexes and among ethnic groups across a wide variety of conditions and treatment settings are found in the management of patients with acute exacerbations of COPD (19). Consequently, we evaluated the quality of care provided to patients hospitalized for acute exacerbations of COPD by measuring adherence to current guideline recommendations and examining the impact of hospital and patient characteristics on composite measures of performance. Methods Setting and Participants We conducted a retrospective cohort study using data from 360 hospitals that participate in Perspective (Premier Inc., Charlotte, North Carolina), a database developed for measuring quality and health care utilization. Participating hospitals represent all regions of the United States, are predominantly small to medium-sized nonteaching facilities, and serve mostly urban patient populations. In addition to the information available in the standard hospital discharge file, Perspective contains a date-stamped log of all billed items (including medications and laboratory, diagnostic, and therapeutic services) at the individual patient level. Patients were included in our analysis if they were 40 years of age and older, had a principal diagnosis of COPD or a principal diagnosis of respiratory failure paired with a secondary diagnosis of COPD, and were discharged between 1 January 2001 and 31 December 2001. International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes were used to assess diagnostic information. Patients were excluded if they had a secondary diagnosis of pneumonia. The All Patient RefinedDiagnosis-Related Group classification system, version 15.0 (3M Corp., Minneapolis, Minnesota), was used to exclude patients if they were assigned to a diagnosis-related group other than COPD or one consistent with a hospitalization for COPD, such as respiratory failure. The institutional review board at Baystate Medical Center approved the study, and the need for written informed consent was waived. Data Elements In addition to age, sex, and ethnicity, we recorded the presence of congestive heart failure, valvular heart disease, pulmonary circulation disorders, peripheral vascular disorders, hypertension, paralysis and other neurologic disorders, diabetes, hypothyroidism, renal failure, liver disease, chronic peptic ulcer disease, HIV and AIDS, lymphoma, metastatic cancer, solid tumor without metastasis, rheumatoid arthritis and collagen vascular diseases, coagulation deficiency, obesity, weight loss, fluid and electrolyte disorders, blood loss anemia, deficiency anemias, alcohol abuse, drug abuse, psychoses, and depression. On the basis of work by Elixhauser and colleagues (20), we assessed comorbid conditions using Healthcare Cost and Utilization Project Comorbidity Software, version 3.1 (Agency for Healthcare Research and Quality, Rockville, Maryland). We obtained data regarding in-hospital mortality; length of stay; and disease-specific, pulmonary-specific, and overall readmission rates at 14 and 30 days from the Perspective discharge file. In addition to information related to the admission, we noted each hospitals bed size, annual number of admissions for acute exacerbations of COPD, teaching status, geographic region, and whether the institution served an urban or rural population. Adherence to Guideline Recommendations Using guidelines produced collaboratively by the American College of Physicians and the American College of Chest Physicians (5), we developed a set of performance measures that could be used to evaluate quality of care. On the basis of recommendations contained in these guidelines, we categorized the following diagnostic evaluations and treatments as beneficial: chest radiography, arterial blood gas analysis, supplemental oxygen, inhaled anticholinergic bronchodilators, inhaled short-acting 2-agonists, systemic corticosteroids, antibiotics, and noninvasive positive-pressure ventilation. Antibiotic regimens were classified as providing broad- or narrow-spectrum coverage. Narrow-spectrum coverage was defined as treatment with first-generation penicillins, first-generation cephalosporins, macrolides, tetracyclines, sulfonamides, vancomycin, or clindamycin. Broad-spectrum coverage was defined as treatment with second- or later-generation cephalosporins, antistaphylococcal penicillins, aminopenicillins, antipseudomonal penicillins, fluoroquinolones, carbapenems, monobactams, aminoglycosides, aztreonam, or combination therapy that included 2 or more narrow-spectrum agents. In addition, we categorized the following management strategies as having uncertain or no benefit and possibly causing harm: sputum examinations, acute spirometry, mucolytic agents, chest physiotherapy, and methylxanthine bronchodilators. Acute spirometry was defined as spirometry performed before the day of discharge. Adherence to these measures was assessed by using a combination of pharmacy billing data and records of other diagnostic and therapeutic services rendered during the hospitalization. Statistical Analysis Summary statistics at both the patient and the hospital level were constructed by using frequencies and proportions for categorical data and by using means, standard deviations, medians, and interquartile ranges for continuous variables. By applying the Institute for Healthcare Improvements (21) concept of the bundle, a collection of processes needed to effectively care for patients with a particular condition, we classified patients as receiving recommended care if they received all of the following diagnostic tests and treatments: chest radiography, supplemental oxygen, bronchodilator therapy, systemic corticosteroid therapy, and antibiotic treatment. The authors of the American College of Physicians and American College of Chest Physicians guideline viewed arterial blood gas analysis as helpful; however, given insufficient evidence demonstrating a benefit, the guideline stopped short of giving this test a full recommendation. Consequently, arterial blood gas analysis was not included in the recommended care bundle. Patients were identified as receiving nonrecommended care if they received any of the following: sputum examination, acute spirometry, therapy with methylxanthine bronchodilator or mucolytic agents, or chest physiotherapy. Patients were considered to have received ideal care if they received all 5 recommended care elements and none of the nonrecommended ones. We examined the association of patient age (differentiating patients who were 40 to 64 years of age, 65 to 74 years of age, and 75 years of age), sex, and ethnicity with the provision of recommended and ideal care by using chi-square statistics. The MantelHaenszel chi-square test was used to adjust for hospital, and hospital-adjusted relative risks for receiving recommended and ideal care were computed. In addition, KruskalWallis analysis of variance was used to determine if hospital region, teaching status, and the annual number of patients admitted with COPD were associated with hospital rates of delivery of recommended and ideal care. All analyses wer

Adherence to risk evaluation and mitigation strategies (REMS) requirements for monthly testing of liver function.

Abstract Objective: To develop a decision-analytic model to estimate the cost-effectiveness of initiating maintenance treatment with aripiprazole once-monthly (AOM) vs paliperidone long-acting injectable (PLAI) once-monthly among patients with schizophrenia in the US. Methods: A decision-analytic model was developed to evaluate a hypothetical cohort of patients initiating maintenance treatment with AOM or PLAI. Rates of relapse, adverse events (AEs), and direct medical costs were estimated for 1 year. Patients either remained on initial treatment or discontinued treatment due to lack of efficacy, AEs, or other reasons, including non-adherence. Data from placebo-controlled pivotal trials and product prescribing information (PI) were used to estimate treatment efficacy and AEs. Analyses were performed assuming dosing of clinical trials, real-world practice, PIs, and highest therapeutic dose available, because of variation in practice settings. The main outcome of interest was incremental cost per schizophrenia hospitalization averted with AOM vs PLAI. Results: Based on placebo-controlled pivotal trials’ dosing, AOM improved clinical outcomes by reducing schizophrenia relapses vs PLAI (0.181 vs 0.277 per person per year [pppy]) at an additional cost of US

Progression of autosomal dominant kidney disease: measurement of the stage transitions of chronic kidney disease

1276 pppy, resulting in an incremental cost-effectiveness ratio (ICER) of US

Reduction in inpatient resource utilization and costs associated with long-acting injectable antipsychotics across different age groups of Medicaid-insured schizophrenia patients.

13,280/relapse averted. When PI dosing was assumed, this ICER increased to US

Inpatient resource use and costs associated with switching from oral antipsychotics to aripiprazole once-monthly for the treatment of schizophrenia

19,968/relapse averted. When real-world dosing and highest available dosing were assumed, AOM was associated with fewer relapses and lower overall treatment costs vs PLAI. Conclusions: AOM consistently provided favorable clinical benefits. Under various dosing scenarios, AOM results indicated fewer relapses at lower overall costs or a reasonable cost-effectiveness threshold (i.e., less than the cost of a hospitalization relapse) vs PLAI. Given the heterogeneous nature of schizophrenia and variability in treatment response, health plans may consider open access for treatments like AOM. Since model inputs were based on data from separate placebo-controlled trials, generalization of results to the real-world setting is limited.

Perioperative beta-blocker therapy and mortality after major noncardiac surgery

Background: Risk evaluation and mitigation strategies (REMS), as mandated by the US Food and Drug Administration (FDA) for medications with the potential for harm, are increasingly incorporating rigid protocols for patient evaluation, but little is known about compliance with these programs. Despite the inherent limitations, data on administrative claims may provide an opportunity to investigate adherence to these programs. Methods: We assessed adherence to liver function test (LFT) requirements included in the REMS program for bosentan through use of administrative claims. Patients observed in the Optum Research Database who were initiators of bosentan from November 20, 2001 to March 31, 2013 were included. Adherence to LFTs was calculated using pharmacy claims for bosentan dispensation and medical claims for laboratory services, and was assessed at the time of drug initiation and within specified time intervals throughout follow-up. Results: Of 742 patients, 523 (70.5%) had ≥1 qualifying LFT. Among patients with ≥12 dispensations, claims for LFTs at individual dispensations were 53.2–64.0%. Median proportion of dispensations with ≥1 LFT was 0.8 among patients with ≥6 (interquartile range, 0.7–1.0) or ≥12 (0.7–0.9) dispensations. Adherence was 90–100% for 33.3% of all initiators, whereas 29.3% of initiators were non-adherent (defined as <50% of on-therapy LFTs). Conclusions: Analyses of administrative claims suggest that the REMS program for bosentan may not have adequately guaranteed adherence to the program’s monthly monitoring of LFTs. Such investigations of existing REMS programs may provide insight on how to accomplish more successful evaluation of REMS.

Perioperative beta-blocker therapy and mortality after major noncardiac surgery.

Background: Autosomal dominant polycystic kidney disease (ADPKD) is a progressive genetic disorder characterized by the development of numerous kidney cysts that result in kidney failure. Little is known regarding the key patient characteristics and utilization of healthcare resources for ADPKD patients along the continuum of disease progression. This observational study was designed to describe the characteristics of ADPKD patients and compare them with those of patients with other chronic kidney diseases. Methods: This retrospective cohort study involved patients with a claim for ADPKD or PKD unspecified from 1/1/2000–2/28/2013 and ≥6 months of previous continuous enrollment (baseline) within a large database of administrative claims in the USA. A random sample of chronic kidney disease (CKD) patients served as comparators. For a subset of ADPKD patients who had only a diagnosis code of unspecified PKD, abstraction of medical records was undertaken to estimate the proportion of patients who had medical chart-confirmed ADPKD. In patients with linked electronic laboratory data, the estimated glomerular filtration rate was calculated via serum creatinine values to determine CKD stage at baseline and during follow-up. Proportions of patients transitioning to another stage and the mean age at transition were calculated. Results: ADPKD patients were, in general, younger and had fewer physician visits, but had more specific comorbidities at observation start compared with CKD patients. ADPKD patients had a longer time in the milder stages and longer duration before recorded transition to a more severe stage compared with CKD patients. Patients with ADPKD at risk of rapid progression had a shorter time-to-end-stage renal disease than patients with CKD and ADPKD patients not at risk, but stage duration was similar between ADPKD patients at risk and those not at risk. Conclusions: These results suggest that distribution of patients by age at transition to next stage may be useful for identification of ADPKD patients at risk of rapid progression. The results also suggest that medical claims with diagnosis codes for “unspecified PKD”, in absence of a diagnosis code for autosomal recessive polycystic kidney disease, may be a good proxy for ADPKD.

Lipid-Lowering Therapy and In-Hospital Mortality Following Major Noncardiac Surgery

Objective: Evaluate utilization of inpatient healthcare resources and associated costs after 12 months of treatment using long-acting injectable (LAI) antipsychotic medications among a large sample of Medicaid-insured patients categorized by different age groups. Method: Adult patients with schizophrenia were identified from the Thomson Reuters MarketScan Research database (1/1/2006–12/31/2010) before initiation of treatment using LAI antipsychotic agents. Utilization of inpatient healthcare resources and associated direct medical costs were compared for 12-month baseline and 12-month follow-up periods. Results: Among 3,094 Medicaid-insured patients with schizophrenia initiating treatment with LAIs, the mean number of all-cause hospitalizations and hospitalization days were reduced by 24% and 31% (p<0.0001) compared with baseline, respectively, with similar significant reductions among all age groups (18–30, 31–40, 41–50, and 51–60 years). During 12-month follow-up with LAIs, mean reductions in all-cause costs were

Economic Burden in Direct Costs of Concomitant Chronic Obstructive Pulmonary Disease and Asthma in a Medicare Advantage Population

4,369 (18–30 years, p<0.0001),