Contribution of Food Groups to Energy and Nutrient Intakes in Five Developed Countries.

Economic growth in developing countries and globalization of the food sector is leading to increasingly similar food consumption patterns worldwide. The aim of this study was to describe similarities and differences in the contributions of main food groups to energy and nutrient intakes in five developed countries across three continents. We obtained summary reports of national food consumption survey data from Australia, France, Denmark, the Netherlands, and the United States. Survey years spanned 2003-2012; sample size ranged from 1444 to 17,386. To mitigate heterogeneity of food groups across countries, we recategorized each survey's reported food groups and subgroups into eight main food groups and, for three countries, a ninth "mixed dishes" group. We determined the percent contribution of each food group to mean daily intakes of energy, saturated fat, sodium, fiber, and ten vitamins and minerals that are commonly under-consumed. Differences in findings from surveys utilizing a foods-as-consumed versus a disaggregated or ingredients approach to food group composition and contributions from the milk and milk products group, a source of several under-consumed nutrients, were explored. Patterns of food group contributions to energy and nutrient intakes were generally similar across countries. Some differences were attributable to the analytical approach used by the surveys. For the meat/protein, milk and milk products, vegetables, and fruit groups, percent contributions to key nutrient intakes exceeded percent contributions to energy intake. The mixed dishes group provided 10%-20% of total daily energy and a similar 10%-25% of the daily intake of several nutrients. This descriptive study contributes to an understanding of food group consumption patterns in developed countries.

Can outpatient pharmacy data identify persons with undiagnosed COPD?

OBJECTIVE: To develop and validate a method for identifying persons with undiagnosed chronic obstructive pulmonary disease (COPD) using outpatient pharmacy data. STUDY DESIGN: Case-control analysis of managed care administrative data with clinical validation by spirometry and standardized questionnaires. METHODS: Patients with a new diagnosis of COPD were matched to 3 control subjects by age and sex. Outpatient pharmacy utilization for the 2 years prior to the initial diagnosis was captured. Drugs associated with an eventual diagnosis of COPD were identified using conditional logistic regression, and then entered into a predictive algorithm using discriminant function analysis. The algorithm was tested in a second population from the same health plan and externally validated using 2 large multicenter databases. This system was clinically validated by testing 100 individuals identified by the algorithm with spirometry plus health status and respiratory symptoms questionnaires. RESULTS: COPD patients used significantly more antibiotics, cardiac medications, and respiratory drugs than their matched controls. The final algorithm identified COPD patients with a sensitivity of 60% and specificity of 70%, without the benefit of knowing any patient's smoking history. Of the first 100 persons identified by the algorithm as being at risk and recruited for testing, 25 were proven to have previously undiagnosed COPD. CONCLUSIONS: Pharmacy utilization increases in the years prior to initial COPD diagnosis. Algorithms based on pharmacy utilization can efficiently identify persons at risk for undiagnosed COPD.

The role of fluticasone propionate/salmeterol combination therapy in preventing exacerbations of COPD.

Exacerbations contribute significantly to the morbidity of COPD, leading to an accelerated decline in lung function, reduced functional status, reduced health status and quality of life, poorer prognosis and increased mortality. Prevention of exacerbations is thus an important goal of COPD management. In patients with COPD, treatment with a combination of the inhaled corticosteroid fluticasone propionate (250 microg) and the long-acting beta(2)-agonist salmeterol (50 microg) in a single inhaler (250/50 microg) is an effective therapy option that has been shown to reduce the frequency of exacerbations, to improve lung function, dyspnea and health status, and to be relatively cost-effective as a COPD maintenance therapy. Importantly, results of various studies suggest that fluticasone propionate and salmeterol have synergistic effects when administered together that improve their efficacy in controlling symptoms and reducing exacerbations. The present non-systematic review summarizes the role of fluticasone propionate/salmeterol combination therapy in the prevention of exacerbations of COPD and its related effects on lung function, survival, health status, and healthcare costs.

The role of combination inhaled corticosteroid/long-acting beta-agonist therapy in COPD management.

Chronic obstructive pulmonary disease (COPD) is now the fourth leading cause of death, affects an estimated 24 million Americans, and accounts for over ten million physician and emergency department (ED) visits and hospitalisations each year. The diagnosis and management of COPD falls largely to primary care practitioners. Previously, COPD management options were limited, but newer treatments have been shown to slow lung deterioration, reduce symptoms and preserve quality of life. Combination therapy with an inhaled corticosteroid and a long-acting beta2-agonist (ICS/LABA) is an effective therapy for COPD that, compared to other therapies, has been shown to reduce exacerbations, hospitalisations, ED visits and health care costs. This review focuses on the role of combination ICS/LABA therapy in managing COPD, including indications, potential benefits and considerations that affect therapy decisions.

An algorithm for the identification of undiagnosed COPD cases using administrative claims data.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a major cause of death in the United States, but most persons who have airflow obstruction have never been diagnosed with lung disease. This undiagnosed COPD negatively affects health status, and COPD patients may have increased health care utilization several years before the initial diagnosis of COPD is made. OBJECTIVE: To investigate whether utilization patterns derived from analysis of administrative claims data using a discriminant function algorithm could be used to identify undiagnosed COPD patients. METHODS: Each patient who had a new diagnosis of COPD during the study period (N = 2,129) was matched to as many as 3 control subjects by age and gender. Controls were assigned an index date that was identical to that of the corresponding case, and then all health care utilization for cases and controls for the 24 months prior to the initial COPD diagnosis was compared using logistic regression models. Factors that were significantly associated with COPD were then entered into a discriminant function algorithm. This algorithm was then validated using a separate patient population. RESULTS: In the main model, 19 utilization characteristics were significantly associated with preclinical COPD, although most of the power of the discriminant function algorithm was concentrated in a few of these factors. The main model was able to identify COPD patients in the validation population of adult subjects aged 40 years and older (N = 41,428), with a sensitivity of 60.5% and specificity of 82.1%, even without having information on the history of tobacco use for the majority of the group. Models developed and tested on only 12 months of utilization data performed similarly. CONCLUSION: Discriminant function algorithms based on health care utilization data can be developed that have sufficient positive predictive value to be used as screening tools to identify individuals at risk for having undiagnosed COPD.

Survival of COPD patients using inhaled corticosteroids and long-acting beta agonists.

We conducted a historical cohort study to examine the relationship between survival and use of inhaled corticosteroids (ICS) and/or long-acting beta agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD). All COPD patients aged 40 years who were enrolled in one of two regional managed care organizations during 1995-2000, and who had 90 days use of an ICS and/or LABA (N=1288) or of a short-acting bronchodilator (N=397), were identified. Of patients treated with ICS and/or LABA, 14.4% died during the follow-up period, as compared to 28.2% of comparison patients (P<0.01). In a Cox proportional hazards model that controlled for age, sex, comorbidities, COPD severity, and asthma status, a reduced risk of death was found for ICS treatment (HR 0.59 [95% CI 0.46-0.78]), LABA (HR 0.55 [0.34-0.89]), and ICS plus LABA treatment (HR 0.34 [0.21-0.56]). A second model that excluded any patient who also had an ICD-9 code for asthma (N=840) still found improved survival among those using the combination of ICS plus LABA (HR 0.35 [CI 0.17-0.71]). Additional analyses that varied the exposure criteria also found a consistent treatment benefit. Inclusion of ICS or bronchodilator treatment during the follow-up period as a time-dependent function appears to negate the survival benefit; however, the underlying assumptions for valid time-dependent modeling are clearly violated in this situation. In conclusion, we found that COPD patients who used ICS alone or in combination with LABA had substantially improved survival even after adjustment for asthma and other confounding factors.

Economic evaluation of treating chronic obstructive pulmonary disease with inhaled corticosteroids and long-acting beta2-agonists in a health maintenance organization.

OBJECTIVES: In light of recent results from observational studies showing prolonged survival in subjects taking long-acting beta2-agonists (LABA) and/or inhaled corticosteroids (ICS) for chronic obstructive pulmonary disease (COPD), we investigated their cost-effectiveness (CE). METHODS: Costs and survival data were collected for a sample of members enrolled in a large Health Maintenance Organization in the United States. An observational study design was used to evaluate cumulative costs and health benefits of LABA, ICS, ICS+LABA, or comparison drugs. Survival was estimated using a parametric regression model. Costs were adjusted for censoring and prognostic factors. CE was evaluated over a time horizon of 36 months and the remaining lifetime of subjects. RESULTS: Over 36 months, life expectancy and costs were: 2.4 years (95% confidence interval (CI): 2.3; 2.5) and $28,030 (CI: $23,400; $33,570) for not receiving ICS or LABA; 2.6 years (CI: 2.6; 2.7) and $35,170 (CI: $29,970; $40,620) for ICS alone; 2.6 years (CI: 2.5; 2.7) and $27,380 (CI: $21,780; $32,510) for LABA alone; and, 2.7 years (CI: 2.6; 2.8) and $33,780 (CI: $28,700; $39,440) for subjects treated with ICS+LABA. The lifetime analysis showed similar trends. CONCLUSIONS: There is an acute need to find effective, life-extending treatments for persons with COPD. ICS, LABA or their combination represent promising treatment options and are currently being tested in randomized trials. If the impact on survival seen in these trials compares to that seen in observational studies, LABA and the combination treatment are likely to be cost-effective in the United States.

Predicting the costs of managing patients with chronic obstructive pulmonary disease.

The economic consequences of chronic obstructive pulmonary disease (COPD) are considerable, although the factors that best predict costs are largely unknown. This study used a population-based cohort to identify the clinical factors during an index year that were most predictive of increased direct medical costs in the subsequent year, and to develop a predictive model that described the cost variations in COPD. The medical records of 2116 patients enrolled in one regional health system who had COPD and health-care resource utilisation data for 1998 and 1999, were abstracted for information about symptoms, smoking history, chronic illnesses, and pulmonary function data. All inpatient, outpatient and pharmacy utilisation data for each subject for 1999 were extracted from the database. Total costs for each individual were transformed to a log scale. Potential causes of cost variability (predictor variables) were defined and classified into sets (or domains). Multiple linear regression models were fitted for each domain. The study demonstrated that severity of airflow obstruction, as assessed by FEV(1)% predicted, is a significant but weak predictor of future health-care resource utilisation-prior hospitalisation and home oxygen use, the presence of comorbid conditions and symptoms of dyspnoea are better predictors of costs. Those interested in the economic benefits of new COPD treatments and disease management programs need to carefully account for these factors.

Laboratory safety monitoring of chronic medications in ambulatory care settings.

OBJECTIVE: To evaluate laboratory safety monitoring in patients taking selected chronic prescription drugs. DESIGN: Retrospective study using 1999-2001 claims data to calculate rates of missed laboratory tests (potential laboratory monitoring errors). Eleven drugs/drug groups and 64 laboratory tests were evaluated. SETTING: Two staff/network model health maintenance organizations. PATIENTS: Continuously enrolled health plan members age> or =19 years taking > or =1 chronic medications. MEASUREMENTS AND MAIN RESULTS: Among patients taking chronic medications (N=29,823 in 1999, N=32,423 in 2000, and N=36,811 in 2001), 47.1% in 1999, 45.0% in 2000, and 44.0% in 2001 did not receive > or =1 test recommended for safety monitoring. Taking into account that patients were sometimes missing more than 1 test for a given drug and that patients were frequently taking multiple drugs, the rate of all potential laboratory monitoring errors was 849/1,000 patients/year in 1999, 810/1,000 patients/year in 2000, and 797/1,000 patients/year in 2001. Rates of potential laboratory monitoring errors varied considerably across individual drugs and laboratory tests. CONCLUSIONS: Lapses in laboratory monitoring of patients taking selected chronic medications were common. Further research is needed to determine whether, and to what extent, this failure to monitor patients is associated with adverse clinical outcomes.

Quality of anticoagulation control and costs of monitoring warfarin therapy among patients with atrial fibrillation in clinic settings: a multi-site managed-care study.

BACKGROUND: Warfarin is recommended for prevention of stroke in patients with atrial fibrillation who are at moderate or high risk, but requires intensive management to achieve safe and optimal anticoagulation control. Anticoagulation clinics are often used to administer warfarin therapy more effectively. OBJECTIVE: To collect data from multiple sites and assess the quality and costs associated with anticoagulation clinic services. METHODS: A random sample of 600 adults with chronic nonvalvular atrial fibrillation (CNVAF) receiving warfarin was selected from anticoagulation clinics affiliated with 3 health plans. Patients were identified between 1996 and 1998 and followed for up to one year. We assessed the proportion of time that international normalized ratio (INR) values were within the recommended range (2.0-3.0) and the costs of anticoagulation clinic care. RESULTS: Patients had an average of 18 clinic contacts over a mean duration of follow-up of 10.5 months. On average, patients were within the recommended INR range 62% of this time, with 25% of days below range and 13% above range. The mean per-patient cost of warfarin monitoring over the follow-up period averaged $261 at site A, $305 at site B, and $205 at site C (in 2003 US$). Mean costs for patients treated for one full year were $288, $339, and $216, respectively. CONCLUSIONS: In 3 geographically diverse health plans, anticoagulation clinics provided a generally higher quality of control than previously reported in other observational studies. This study highlights the costs of obtaining this level of control.

Measuring patient safety in ambulatory care: potential for identifying medical group drug-drug interaction rates using claims data.

OBJECTIVE: To evaluate the feasibility of using health-plan administrative data to measure potential drug-drug interaction (DDI) rates in the ambulatory setting at the medical-group level and to assess the potential use of DDI rates in performance measurement, quality improvement, and research in patient safety. STUDY DESIGN: We combined administrative and pharmacy claims data from 2 large health plans to calculate the rates at which member users of selected chronic medications were potentially exposed to a second drug known to pose a risk of harmful interactions. METHODS: We divided 44 medication combinations with risk of adverse interactions into those with DDIs of moderate/severe clinical significance and those with DDIs of mild significance. We then calculated yearly rates of potential DDIs in continuously enrolled members aged 19 and older from 1998 through 2001. Rates were calculated for all members, overall base-medication users, and, individual medical groups responsible for their care. RESULTS: The analytic data set included 756 047 patient-years of data and 110 to 123 medical groups per year. During the 4-year interval, one or more unique potential DDIs occurred in 6.2% to 6.7% of base-drug users and 2.0% to 2.3% of all adult health-plan members per year. Medical-group mean user rates were slightly lower (5.33%-5.81%), with wide variance (SD = 2.6%-3.1%) and high stability over time. CONCLUSION: Potential DDI rates calculated from health-plan data have promise for measurement in patient medication safety. This readily available and inexpensive evaluation tool has potential for monitoring, improvement, and research purposes if further studies validate their relationship to actual adverse events.

Costs and clinical outcomes associated with low-molecular-weight heparin vs unfractionated heparin for perioperative bridging in patients receiving long-term oral anticoagulant therapy.

STUDY OBJECTIVES: There have been no health-care cost evaluations comparing the use of low-molecular-weight heparin (LMWH) to unfractionated heparin (UH) as "bridge therapy" in the perioperative period in patients receiving long-term oral anticoagulant (OAC) therapy who need interruption of therapy to undergo an elective surgical procedure. We performed a retrospective analysis of the medical and administrative records of health plan members in a managed care organization who underwent bridge therapy perioperatively with either i.v. UH, administered in a hospital setting, or LMWH, administered primarily in the outpatient setting using disease management guidelines. DESIGN: A retrospective analysis of medical and administrative records of treated health plan members meeting inclusion/exclusion criteria during the two study periods (ie, from 1994 to 1996 and from 1998 to 2000). SETTING: Staff-model health maintenance organization serving New Mexico. PATIENTS: The UH group included persons receiving long-term warfarin therapy from 1994 to 1996 (26 patients), and the LMWH group included persons receiving long-term warfarin therapy from 1998 to 2000 (40 patients) with perioperative use of heparin (either UH or LMWH) as bridge therapy for an elective surgical procedure. INTERVENTIONS: Costs were calculated for the period from 10 days before the procedure through 30 days after the procedure. The rates of adverse events (ie, valvular or mural thrombus, intracranial event, transient ischemic attack, peripheral arterial event, venous thromboembolic event, major and minor bleeding, thrombocytopenia, and death) occurring 1 to 30 days postprocedure were determined. MEASUREMENTS AND RESULTS: The groups were similar in age, sex, Charlson score, indication for long-term warfarin therapy (ie, arterial/cardiac vs venous), mean international normalized ratio prior to procedure, procedure duration, use of intraprocedural anticoagulant agents or thrombolytic agents, and use of general anesthesia during the procedure (all p > 0.05). A total of 34.6% of UH patients and 40.0% of LMWH patients experienced one or more clinical adverse events within 30 days of the postoperative period, a difference that was not statistically significant (p = 0.67). The mean total health-care costs were 31,625 dollars in the UH group and 18,511 dollars in the LMWH group (p < 0.01). The mean inpatient costs were 28,515 dollars in the UH group and 14,330 dollars in the LMWH group (p < 0.01). Outpatient surgery costs (1,159 dollars vs 53 dollars, respectively; p = 0.01) and pharmacy costs (639 dollars vs 133 dollars, respectively; p < 0.01) were higher in the LMWH group. CONCLUSIONS: The mean total health-care costs in the perioperative period were significantly lower (by 13,114 dollars) in patients receiving long-term OAC therapy using LMWH compared to those receiving it using UH for an elective surgical procedure. The cost savings associated with LMWH use were accomplished through the avoidance or minimization of inpatient stays and no increase in the overall rate of clinical adverse events in the postoperative period.

A cohort study of the incidence of serious acute liver injury in diabetic patients treated with hypoglycemic agents.

BACKGROUND: The incidence of acute liver failure or serious liver injury in diabetic patients is needed to evaluate the safety of hypoglycemic drug therapy. METHODS: We conducted a retrospective cohort study of 5 health maintenance organizations. Study patients were 171,264 health plan members 19 years or older when they received oral hypoglycemic drugs or insulin between April 1, 1997, and June 30, 1999. We searched for hospital discharge diagnoses and procedures potentially indicative of acute liver injury and reviewed the full-text medical records. Acute liver failure was defined as acute liver disease and (1) hepatic encephalopathy, (2) prothrombin time prolongation greater than 3 seconds or international normalized ratio greater than 1.5, and (3) a total bilirubin level greater than 3.0 mg/dL (>51 micro mol/L). Acute liver injury was diagnosed in individuals who did not meet 1 or more of the criteria for acute liver failure but had alanine transaminase or aspartate transaminase levels greater than 500 U/L. RESULTS: We identified 35 cases of acute liver failure or injury not clearly attributable to a known cause other than use of hypoglycemic agents. The age- and sex-standardized incidence per 1000 person-years was 0.15 for insulin users, 0.08 for sulfonylurea users, 0.12 for metformin users, and 0.10 for troglitazone users. The incidence was higher (on the order of 0.3 per 1000) during the first 6 months of exposure to all hypoglycemic agents. CONCLUSIONS: Acute liver failure or injury not clearly attributable to other known causes occurred on the order of 1 per 10,000 person-years among diabetic patients treated with oral hypoglycemic drugs or insulin.

Management of acute proximal deep vein thrombosis: pharmacoeconomic evaluation of outpatient treatment with enoxaparin vs inpatient treatment with unfractionated heparin.

OBJECTIVES: A landmark Canadian randomized controlled clinical trial compared treatment of acute proximal vein thrombosis via low-molecular-weight heparin (LMWH) [enoxaparin] administered primarily at home with IV unfractionated heparin (UH) in the hospital. Results demonstrated equivalent safety and efficacy for home care with enoxaparin with a reduction in cost. Our objective was to validate these findings in the routine practice setting of a US health maintenance organization. DESIGN: Retrospective analysis of medical and administrative records of health-plan members meeting inclusion-exclusion criteria of the Canadian trial during the period from 1995 to 1998. SETTING: Staff-model health maintenance organization serving New Mexico. PATIENTS: Persons presenting as outpatients from 1995 to 1996 or from 1997 to 1998 with acute, proximal deep vein thrombosis (DVT) diagnosed by duplex ultrasonography. INTERVENTIONS: Initial anticoagulant therapy of IV UH administered in the hospital (from 1995 to 1996 group, n = 64) or subcutaneous LMWH (enoxaparin) administered primarily at home (from 1997 to 1998 group, n = 65), followed by warfarin therapy. RESULTS: No statistically significant differences were observed in the number of recurrent venous thromboembolic events (p = 0.36) or bleeding events (p = 1.0). Mean +/- SD cost per patient was 9,347 dollars +/- 8,469 in the enoxaparin group compared with 11,930 dollars +/- 10,892 in the UH group, a difference of - 2,583 dollars (95% bootstrap-adjusted asymmetrical confidence interval, - 6,147 dollars, + 650 dollars). CONCLUSIONS: Retrospective replication of the Canadian study in a US routine (managed) care setting found similar clinical and economic outcomes. Treatment of acute proximal DVT with enoxaparin in a primarily outpatient setting can be accomplished safely and yields savings through avoidance or minimization of inpatient stays.