The impact of infusion reactions associated with monoclonal antibodies in metastatic colorectal cancer: a European perspective.

BACKGROUND AND OBJECTIVES: Published data on the clinical and economic impact of infusion reactions to monoclonal antibodies are limited. This study investigated oncologists' and oncology nurses' opinions about resource use associated with infusion reactions and the impact on patient management in Europe. METHODS: Eighty oncologists and nurses from Denmark, France, Germany, Greece, Italy, Spain, Sweden and the UK currently treating patients with metastatic colorectal cancer were interviewed by telephone using a 27-item questionnaire developed for this study. RESULTS: The mean estimated number of staff (physicians and nurses) involved in managing an infusion reaction was 1.97 for a grade 1, 2.35 for a grade 2, 3.6 for a grade 3 and 5.3 for a grade 4 reaction. In respondents' experiences, most patients with grade 3 infusion reactions (73.4%) were admitted to hospital for treatment; 82.5% of those with grade 4 infusion reactions were treated in intensive care. The estimated duration of hospital treatment was 13.3 ± 29 h for a grade 3 infusion reaction, increasing to 48.1 ± 43.7 h for a grade 4 infusion reaction. CONCLUSIONS: According to respondents, management of infusion reactions led to substantial resource use, which increased with the severity of the reaction. More severe reactions also led to anxiety in patients and distress to staff.

Healthcare costs in women with metastatic breast cancer receiving chemotherapy as their principal treatment modality.

BACKGROUND: The economic costs of treating patients with metastatic breast cancer have been examined in several studies, but available estimates of economic burden are at least a decade old. In this study, we characterize healthcare utilization and costs in the US among women with metastatic breast cancer receiving chemotherapy as their principal treatment modality. METHODS: Using a large private health insurance claims database (2000-2006), we identified all women initiating chemotherapy for metastatic breast cancer with no evidence of receipt of concomitant or subsequent hormonal therapy, or receipt of trastuzumab at anytime. Healthcare utilization and costs (inpatient, outpatient, medication) were estimated on a cumulative basis from date of chemotherapy initiation ("index date") to date of disenrollment from the health plan or the end of the study period, whichever occurred first. Study measures were cumulated over time using the Kaplan-Meier Sample Average (KMSA) method; 95% CIs were generated using nonparametric bootstrapping. Findings also were examined among the subgroup of patients with uncensored data. RESULTS: The study population consisted of 1444 women; mean (SD) age was 59.1 (12.1) years. Over a mean follow-up of 532 days (range: 3 to 2412), study subjects averaged 1.7 hospital admissions, 10.7 inpatient days, and 83.6 physician office and hospital outpatient visits. Mean (95% CI) cumulative total healthcare costs were $128,556 ($118,409, $137,644) per patient. Outpatient services accounted for 29% of total costs, followed by medication other than chemotherapy (26%), chemotherapy (25%), and inpatient care (20%). CONCLUSIONS: Healthcare costs-especially in the outpatient setting--are substantial among women with metastatic breast cancer for whom treatment options other than chemotherapy are limited.

Healthcare costs in patients with metastatic lung cancer receiving chemotherapy.

BACKGROUND: To characterize healthcare resource utilization and costs in patients with metastatic lung cancer receiving chemotherapy in the US. METHODS: Using data from a large private multi-payer health insurance claims database (2000-2006), we identified all patients beginning chemotherapy for metastatic lung cancer. Healthcare resource use (inpatient, outpatient, medications) and costs were tallied over time from date of therapy initiation ("index date") to date of disenrollment from the health plan (in most instances, presumably due to death) or the end of the study period, whichever occurred first. Healthcare utilization and costs were characterized using Kaplan-Meier sample average methods. RESULTS: The study population consisted of 4068 patients; mean (SD) age was 65 (11) years. Over a median follow-up of 334 days, study subjects averaged 1.5 hospital admissions, 8.9 total inpatient days, and 69 physician office and hospital outpatient visits. Mean (95% CI) cumulative total healthcare costs were $125,849 ($120,228, $131,231). Costs of outpatient medical services and inpatient care constituted 34% and 20% of total healthcare costs, respectively; corresponding estimates for outpatient chemotherapy and other medication were 22% and 24%. CONCLUSION: Our study sheds additional light on the burden of metastatic lung cancer among patients receiving chemotherapy, in terms of total cost thru end of life as well as component costs by setting and type of service, and may be useful in informing medical resource allocation in this patient population.

Deteriorating dietary habits among adults with hypertension: DASH dietary accordance, NHANES 1988-1994 and 1999-2004.

BACKGROUND: Although the DASH (Dietary Approaches to Stop Hypertension trial) diet is among the therapeutic lifestyle changes recommended for individuals with hypertension (HTN), accordance with the DASH diet is not known. METHODS: Using data from the National Health and Nutrition Examination Survey (NHANES) from the 1988-1994 and 1999-2004 periods, DASH accordance among individuals with self-reported HTN was estimated based on 9 nutrient targets (fat, saturated fat, protein, cholesterol, fiber, magnesium, calcium, sodium, and potassium) (score range, 0-9). Using data from 1999-2004, we compared the DASH score among demographic groups in age- and energy-adjusted models and modeled the odds of a DASH-accordant dietary pattern (>or=4.5) using multivariable logistic regression. The DASH score, DASH accordance, and percentage of participants achieving individual targets were compared with estimates from NHANES 1988-1994 data. RESULTS: Based on 4386 participants with known HTN in the recent survey period (1999-2004), the mean (SE) DASH score, after adjustment for age and energy intake, was 2.92 (0.05), with 19.4% (1.2%) classified as DASH accordant. In multivariable logistic regression models, DASH accordance was associated with older age, nonblack ethnicity, higher education, and known diabetes mellitus. Accordance with DASH was 7.3% lower in the recent survey period compared with NHANES 1988-1994 (26.7% [1.1%]) (P < .001), reflecting fewer patients with HTN meeting nutrient targets for total fat, fiber, and magnesium. CONCLUSION: The dietary profile of adults with HTN in the United States has a low accordance with the DASH dietary pattern, and the dietary quality of adults with HTN has deteriorated since the introduction of the DASH diet, suggesting that secular trends have minimized the impact of the DASH message.

Impact of chronic Immune Thrombocytopenic Purpura (ITP) on health-related quality of life: a conceptual model starting with the patient perspective.

BACKGROUND: Immune thrombocytopenic purpura (ITP), a condition characterized by autoimmune-mediated platelet destruction and suboptimal platelet production, is associated with symptoms such as bruising, epistaxis, menorrhagia, mucosal bleeding from the gastrointestinal and urinary tracts and, rarely central nervous system bleeding. The aim of this research is to develop a conceptual model to describe the impact of ITP and its treatment on patients' health-related quality of life (HRQoL). METHODS: A literature search and focus groups with adult ITP patients were conducted to identify areas of HRQoL affected by ITP. Published literature was reviewed to identify key HRQoL issues and existing questionnaires used to assess HRQoL. Focus group transcripts were reviewed, and common themes were extracted by grouping conceptual categories that described the impact on HRQoL. RESULTS: The literature synthesis and themes from the focus group data suggest that decreased platelet counts, disease symptoms, and treatment side effects influence multiple domains of HRQoL for ITP patients. Key areas affected by ITP and its treatments include emotional and functional health, work life, social and leisure activities, and reproductive health. CONCLUSION: ITP affects various areas of HRQoL. This conceptual model will help inform the evaluation of therapeutic strategies for ITP.

Tumor hormone/HER2 receptor status and pharmacologic treatment of metastatic breast cancer in Western Europe.

INTRODUCTION: Tumor hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) expression are important factors influencing treatment response and selection in patients with metastatic breast cancer (mBC). Using the LifeLink Oncology Analyzer Database, we classified mBC patients by combined HR and HER2 status, and evaluated the use of pharmacological treatment modalities both overall and within these subtypes in Western Europe. PATIENTS AND METHODS: The study population included 4670 women with mBC from five Western European countries (France, Germany, Italy, Spain, UK). The most recent treatment administered (use of chemotherapy, endocrine therapy, HER2-targeted therapy, or others) and tumor marker (HR and HER2) status were captured. The results were summarized descriptively by combined tumor receptor status, current therapy type at the time of the survey, and age. RESULTS: Combined tumor receptor status and the most recent treatment for mBC were known for 4070 and 4060 women, respectively. The proportion of patients with each subtype ranged from 12.6-53.5% of the overall population (HR-/HER2+ least common and HR+/HER2- most common). Overall, chemotherapy was the most frequently reported treatment used followed by endocrine therapy and HER2-targeted therapy (59%, 33% and 15% of patients, respectively). Patients aged ≤55 years were more likely to receive chemotherapy and less likely to receive endocrine treatment compared with patients aged >55. Patterns of treatment also differed by combined tumor receptor status and age although chemotherapy was consistently the mainstay of treatment. These results should be reviewed in light of the study limitations, including the cross-sectional nature of data, the heterogeneity of our mBC population (newly metastasized vs. extensively treated), and the variations in receptor status evaluation among participating centers. CONCLUSIONS: Our analysis highlights the heterogeneity of the mBC population in Europe and illustrates that treatment modalities differed by age and by combined HR/HER2 receptor status.

Economic burden of toxicities associated with metastatic colorectal cancer treatment regimens containing monoclonal antibodies.

OBJECTIVES: Little is known about toxicity-related costs of monoclonal antibody treatments in metastatic colorectal cancer. This study aimed to identify toxicities associated with bevacizumab, cetuximab, and panitumumab and estimate the direct costs of these toxicities. METHODS: Grade 3 and 4 toxicities were identified by a comprehensive literature search. Inpatient costs were estimated using ICD-9 codes and 2007 Medicare payments from the Healthcare Cost and Utilization Project database; costs were converted to 2010 dollars. Outpatient costs were estimated by applying 2010 Medicare reimbursement rates to resource use assumptions (based on in-depth clinical interviews). RESULTS: Toxicities associated with bevacizumab included hypertension, arterial thrombosis, hemorrhage, gastrointestinal (GI) perforation, fistula, and wound-healing complications; toxicities associated with cetuximab and panitumumab included skin rash, hypomagnesemia, and infusion reactions. The inpatient cost per event was highest for GI perforation (USD 32,443), followed by fistula (USD 29,062), arterial thrombosis (USD 20,346), and wound-healing complications (USD 13,240), while inpatient costs per event for hypomagnesemia and skin rash were among the lowest. The cost per event of toxicities treated in the outpatient setting included USD 185 for skin rash up to USD 585 for wound-healing complications. LIMITATIONS: Treatment costs of toxicities for the outpatient setting were determined using assumptions validated by clinicians, and unit costs were based on Medicare reimbursement rates, which are often lower than the reimbursement rates for commercial health insurance plans. Toxicities included were only grades 3 and 4 adverse events and might be limited by differences between clinical studies. CONCLUSIONS: Monoclonal antibodies have different toxicity profiles and the costs associated with managing these toxicities vary greatly.

Patterns of treatment with chemotherapy and monoclonal antibodies for metastatic colorectal cancer in Western Europe.

BACKGROUND AND OBJECTIVES: Treatment outcomes improved in metastatic colorectal cancer (mCRC) due to the introduction of new chemotherapies and monoclonal antibodies. This study describes current patterns of pharmacological treatment for mCRC in clinical practice in four European countries. METHODS: This cohort study used physician-survey data from the LifeLink Oncology Analyzer Database for mCRC patients in France, Germany, Italy and Spain. All patients aged ≥21 years at mCRC diagnosis and with data collected during 2009 were included. Treatment patterns were examined descriptively by lines of therapy. RESULTS: The study sample included 2682 mCRC patients. In first-line, more patients received FOLFOX (infusional 5-fluorouracil/leucovorin and oxaliplatin)- than FOLFIRI (infusional 5-fluorouracil/leucovorin and irinotecan)-, containing regimens in Germany (42 vs. 30%) and Spain (25 vs. 16%), while in Italy and France the reverse was true (Italy: 34% FOLFIRI vs.29% FOLFOX; France: 26 vs. 19%). In second-line, FOLFIRI-containing regimens were more commonly used than FOLFOX-containing regimens in Germany (36 vs. 18%), Italy (29 vs. 14%), and Spain (34 vs. 6%), while similar proportions of FOLFOX and FOLFIRI were used in France (18 vs. 15%). As part of first-line treatment, bevacizumab use ranged from 44% of patients in Italy to 30% in Spain, with slightly lower rates in second-line. Cetuximab first-line use ranged from 14% of patients in Spain to 7% in Italy, increasing in second-line to 30% in Spain, 26% in Italy, 20% in Germany, and 17% in France. LIMITATIONS: This analysis focused on description of treatment patterns, however, the actual clinical benefits of these treatment regimens on survival or quality of life were not addressed due to lack of relevant information in the data source. Some country differences in treatment patterns were observed. These differences might be partly explained by differences in local treatment guidelines, physician prescribing behaviours, reimbursement policies, and response to various regimens due to genetic differences. CONCLUSIONS: In clinical practice in four European countries, FOLFOX- and FOLFIRI-based regimens are common standard of care chemotherapies for mCRC (FOLFOX and bevacizumab + FOLFIRI are the most common regimens), and monoclonal antibodies are often combined with these chemotherapies.

Major surgery in patients with metastatic colorectal cancer in Western europe.

PURPOSE: Given the potential interference between treatment for metastatic colorectal cancer (mCRC) and surgical procedures, we sought to determine the prevalence of major surgery following mCRC diagnosis in clinical practice. METHODS: This cohort study used physician-surveyed data from the LifeLink™ Oncology Analyzer database for mCRC patients in five European countries (France, Germany, Italy, Spain, and the United Kingdom [UK]). All patients aged ≥21 years at mCRC diagnosis and with data collected during 2009 were included. Major surgical procedures were examined descriptively by the purpose and location of surgery. RESULTS: The study sample included 3,249 mCRC patients; 515, 862, 656, 649, and 567 were from France, Germany, Italy, Spain, and the UK, respectively. Following mCRC diagnosis, at least one major surgical procedure for any purpose was seen in 30.5% (UK), 35.2% (Germany), 35.6% (Spain), 36.3% (France), and 38.4% (Italy) of patients, with a mean of 1.3 (UK) to 1.6 (France) procedures. The rate of major surgery for curative purposes was the highest in Italy (13.4%), followed by France (12.8%), Spain (10.3%), and Germany (9.2%); the lowest was in the UK (7.2%). Major surgery performed on the primary tumor (12.4-27.1% of patients, depending on the country) and metastasis (6.4-14.6%) made up the majority of all surgical procedures. CONCLUSIONS: Major surgery is highly prevalent following mCRC diagnosis, suggesting an important role in meeting the goals of mCRC treatment. The role of pharmacological treatment options and their potential to interfere with both surgery use and surgical outcomes should be considered when evaluating mCRC treatment strategies.

Comorbid Conditions in Patients With Metastatic Colorectal Cancer.

BACKGROUND: Patients with metastatic colorectal cancer (mCRC) often have other medical conditions that may impact treatment decisions, prognoses and quality of care. We aimed to assess co-existing medical conditions in the mCRC patient population. This retrospective cohort study used linked medical and pharmacy claims data from two US-based Medstat MarketScan claims databases and identified patients with newly diagnosed mCRC between January 2005 and June 2008. METHODS: Patient data were analyzed for comorbid conditions and medication use in the year prior to diagnosis of mCRC. Univariate analyses were conducted to compare the comorbid conditions between patients aged ≥ 65 and < 65 years old. In total, 12 648 patients aged ≥ 18 years were identified. The study was evenly populated by gender and age above and below 65, and most patients had a primary diagnosis of colon cancer (70.1%). RESULTS: The most prevalent comorbidity was cardiovascular disease (CVD) (55.7% of patients) including hypertension (40.8%), cardiac dysrhythmia (14.2%), coronary artery disease (13.5%), congestive heart failure (7.2%) and arterial and venous thromboembolism (6.2% and 4.6%, respectively). Most comorbidities were significantly more prevalent in patients ≥ 65 years of age, particularly with respect to CVD (67.9% versus 42.5%, respectively; P < 0.0001). Additionally, nearly half (49.7%) of the patients received antihypertensive agents and many patients were prescribed more than one class of medications prior to mCRC diagnosis. CONCLUSIONS: Comorbid medical conditions, particularly CVDs, are common in patients with mCRC, which could increase the complexity of patient management. This should be a consideration integral to the selection of the most appropriate treatment for individual patients.

Cost of illness in patients with metastatic colorectal cancer.

OBJECTIVES: To estimate total costs and metastatic colorectal cancer (mCRC)-related costs and assess primary cost drivers of treating newly diagnosed mCRC patients after the introduction of biologic therapies. METHODS: Using a large national claims database, costs of mCRC patients were estimated in 2004-2009 by examining (1) the cost difference between mCRC patient and their matched non-cancer cohorts, and (2) mCRC-related costs. Costs were further assessed by phase of disease (diagnostic, treatment, and death). The survival analysis technique was used to estimate cost of handling variable length of follow-up and data censoring. RESULTS: A total of 6,746 mCRC patients met all eligibility criteria, 6,675 of them were matched to patients without cancer. Among the three phases of disease, the treatment phase was the longest (16.4 months). Compared with matched patients with no cancer, total monthly costs were $14,585 higher for mCRC patients, which was driven by higher inpatient ($7,546) and outpatient ($6,749) care (p < 0.001 for all comparisons). During the study period, cost share of biologics increased from 4.8% among patients diagnosed in 2004 to 9.4% for those diagnosed in 2008. CONCLUSIONS: The costs associated with treating mCRC are substantial. Inpatient and outpatient care remain key cost drivers in the medical management of mCRC. Cost chare of biologics was low, but increased between 2004 and 2009. The study sample only included patients with commercial and Medicare supplemental insurance in the US thus may not be generalizable to patients with other insurance or in other countries. Indirect costs associated with mCRC were not examined.

Characterizing medical care by disease phase in metastatic colorectal cancer.

PURPOSE: To characterize patterns of medical care by disease phase in patients with newly diagnosed metastatic colorectal cancer (mCRC). METHODS: Patients with mCRC newly diagnosed between 2004 and 2008 were selected from a large US national commercially insured claims database and were observed from initial mCRC diagnosis to death, disenrollment, or end of study period (July 31, 2009), whichever occurred first. The observation period was divided into three distinct phases of disease: diagnostic, treatment, and death. Within each phase, patterns of medical care were examined by the mutually exclusive service categories of inpatient, emergency room (ER), outpatient office and facility, outpatient pharmacy, chemotherapy, and biologic therapy, as measured by estimation of aggregate and category costs per patient per month. RESULTS: A total of 6,675 patients with newly diagnosed mCRC were analyzed. Mean age was 64.1 years; 55.5% were males. Mean costs per patient per month for diagnostic, treatment, and death phases were $16,895, $8,891, and $27,554, respectively. Inpatient care was the primary driver of medical care for both the diagnostic (41.7% of costs) and death (71.4% of costs) phases. The largest category of medical care for the treatment phase was outpatient care (45.0% of costs). Chemotherapy and biologic therapy accounted for 15.6% and 17.6% of costs in the treatment phase, respectively. CONCLUSION: Substantial differences in patterns of medical care were found between mCRC disease phases. Inpatient care was the key driver of medical care in the diagnostic and death phases compared with outpatient care in the treatment phase.

Characterizing medical care by disease phase in metastatic colorectal cancer.

OBJECTIVE: To characterize patterns of medical care by disease phase in patients with newly diagnosed metastatic colorectal cancer (mCRC). METHODS: Patients with mCRC newly diagnosed between 2004 and 2008 were selected from a large US national commercially insured claims database and were observed from initial mCRC diagnosis to death, disenrollment, or end of study period (July 31, 2009), whichever occurred first. The observation period was divided into 3 distinct phases of disease: diagnostic, treatment, and death. Within each phase, patterns of medical care were examined by the mutually exclusive service categories of inpatient, emergency department (ED), outpatient office and facility, outpatient pharmacy, chemotherapy, and biologic therapy, as measured by estimation of aggregate and category costs per patient per month. RESULTS: A total of 6675 patients with newly diagnosed mCRC were analyzed. Mean age was 64.1 years; 55.5% were males. Mean costs per patient per month for diagnostic, treatment, and death phases were $16,895, $8891, and $27,554, respectively. Inpatient care was the primary driver of medical care for both the diagnostic (41.7% of costs) and death (71.4% of costs) phases. The largest category of medical care for the treatment phase was outpatient care (45.0% of costs). Chemotherapy and biologic therapy accounted for 15.6% and 17.6% of costs in the treatment phase, respectively. CONCLUSION: Substantial differences in patterns of medical care were found between mCRC disease phases. Inpatient care was the key driver of medical care in the diagnostic and death phases compared with outpatient care in the treatment phase.

Costs of hospital events in patients with metastatic colorectal cancer.

BACKGROUND: In the last decade, the number of new agents, including monoclonal antibodies, being developed to treat metastatic colorectal cancer (mCRC) increased rapidly. While improving outcomes, these new treatments also have distinct and known safety profiles with toxicities that may require hospitalizations. However, patterns and costs of hospitalizations of toxicities of these new 'targeted' drugs are often unknown. OBJECTIVE: This study aimed to estimate the costs of hospital events associated with adverse events specified in the 'Special Warnings and Precautions for Use' section of the European Medicinal Agency Summary of Product Characteristics for bevacizumab, cetuximab, and panitumumab, in patients with mCRC. METHODS: From the PHARMO Record Linkage System (RLS), patients with a primary or secondary hospital discharge code for CRC and distant metastasis between 2000-2008 were selected and defined as patients with mCRC. The first discharge diagnosis defining metastases served as the index date. Patients were followed from index date until end of data collection, death, or end of study period, whichever occurred first. Hospital events during follow-up were identified through primary hospital discharge codes. Main outcomes for each event were length of stay and costs per hospital admission. RESULTS: Among 2964 mCRC patients, 271 hospital events occurred in 210 patients (mean [SD] duration of follow-up: 34 [31] months). The longest mean (SD) length of stay per hospital admission were for stroke (16 [33] days), arterial thromboembolism (ATE) (14 [21] days), wound-healing complications (WHC), acute myocardial infarction (AMI), congestive heart failure (CHF), and neutropenia (all 9 days; SD 5-15). Highest mean (SD) costs per admission were for stroke (€13,500 [€28,800]), ATE (€13,300 [€18,800]), WHC (€10,800 [€20,500]). LIMITATIONS: Although no causal link could be identified between any specific event and any specific treatment, data from this study are valuable for pharmacoeconomic evaluations of newer treatments in mCRC patients. CONCLUSIONS: Inpatient costs for events in mCRC patients are considerable and vary greatly.

Healthcare costs in postmenopausal women with hormone-positive metastatic breast cancer.

OBJECTIVES: This study examines costs for postmenopausal women with hormone receptor positive (HR+) metastatic breast cancer (mBC). METHODS: Data were obtained from the IHCIS National Managed Care Benchmark Database from 1/1/2001 to 6/30/2006. Women aged 55-63 years were selected for the study if they met the inclusion criteria, including diagnoses for breast cancer and metastases, and at least two fills for a hormone medication. Patients were followed from the onset of metastases until the earliest date of disenrollment from the health plan or 6/30/2006. Patient characteristics were examined at time of initial diagnoses of metastases, while costs were examined post-diagnosis of metastases and prior to receipt of chemotherapy (pre-chemotherapy initiation period) and from the date of initial receipt of chemotherapy until end of data collection (post-chemotherapy initiation period). Costs were adjusted to account for censoring of the data. RESULTS: The study population consisted of 1,266 women; mean (SD) age was 59.05 (2.57) years. Pre-chemotherapy initiation, unadjusted inpatient, outpatient, and drug costs were $4,392, $47,731, and $5,511, while these costs were $4,590, $57,820, and $38,936 per year, respectively, post-chemotherapy initiation. After adjusting for censoring of data, total medical costs were estimated to be $55,555 and $70,587 in the first 12 months and 18 months, respectively in the pre-chemotherapy initiation period. Post-chemotherapy initiation period, 12-month and 18-month adjusted total medical costs were estimated to be $87,638 and $130,738. LIMITATIONS: The use of an administrative claims database necessitates a reliance upon diagnostic codes, age restrictions, and medication use, rather than formal assessments to identify patients with post-hormonal women with breast cancer. Furthermore, such populations of insured patients may not be generalizable to the population as a whole. CONCLUSIONS: These findings suggest that healthcare resource use and costs - especially in the outpatient setting - are high among women with HR+ metastatic breast cancer.

Suboptimal nutritional intake for hypertension control in 4 ethnic groups.

BACKGROUND: This study compared intake of specific nutrients based on the Dietary Approaches to Stop Hypertension (DASH) guidelines for hypertension management among multiethnic middle-aged and older adults. METHODS: We conducted quantitative analysis using baseline data of a prospective cohort study of 5972 adults aged 45 to 84 years recruited between July 2000 and August 2002 who participated in the Multi-Ethnic Study of Atherosclerosis (MESA). Diet information was collected using a 120-item food frequency questionnaire. Bivariate and multivariate methods were used to evaluate associations between DASH-accordant intake of each nutrient (fat, saturated fat, cholesterol, protein, fiber, calcium, magnesium, and potassium) with ethnicity and hypertension status. RESULTS: Less than 30% of MESA participants met any DASH nutrient target. DASH accordance was lowest in saturated fat intake and highest in cholesterol intake (5.3% and 29.5% of the participants, respectively). Multivariate analyses showed significant ethnic differences in DASH accordance in all nutrients but saturated fat. Compared with white participants, Chinese American participants had greater DASH accordance in cholesterol (odds ratio [OR], 1.37; 95% confidence interval [CI], 1.13-1.67) and protein intake (2.32; 1.55-3.49) but less in total fat (0.47; 0.30-0.74), magnesium (0.58; 0.51-0.67), and potassium intake (0.40; 0.20-0.81); African Americans and Hispanics had greater DASH accordance in fiber intake (1.36; 1.13-1.62; and 2.23; 1.53-3.23, respectively) but less in calcium intake (0.44; 0.37-0.52; and 0.79; 0.68-0.91, respectively). Diagnosed and uncontrolled hypertension was associated with less DASH accordance in saturated fat (OR, 0.80; 95% CI, 0.70-0.91) and magnesium (0.80; 0.71-0.91). DASH accordance differed significantly with and without inclusion of dietary supplements in the analysis. CONCLUSIONS: There is significant variation in DASH goal attainment among different ethnic groups. Assessments of nutrient intake that exclude dietary supplements may be underestimating DASH accordance.

Evaluating clinically meaningful change on the ITP-PAQ: preliminary estimates of minimal important differences.

OBJECTIVE: Interpretation of data from health-related quality of life (HRQoL) questionnaires can be enhanced with the availability of minimally important difference (MID) estimates. This information will aid clinicians in interpreting HRQoL differences within patients over time and between treatment groups. The Immune Thrombocytopenic Purpura (ITP)-Patient Assessment Questionnaire (PAQ) is the only comprehensive HRQoL questionnaire available for adults with ITP. RESEARCH DESIGN AND METHODS: Forty centers from within the US and Europe enrolled ITP patients into one of two multicenter, randomized, placebo-controlled, double-blind, 6-month, phase III clinical trials of romiplostim. Patients enrolled in these studies self-administered the ITP-PAQ and two items assessing global change (anchors) at baseline and weeks 4, 12, and 24. Using data from the ITP-PAQ and these two anchors, an anchor-based estimate was computed and combined with the standard error of measurement and standard deviation to compute a distribution-based estimate in order to provide an MID range for each of the 11 scales of the ITP-PAQ. RESULTS: A total of 125 patients participated in these clinical trials and provided data for use in these analyses. Combining results from anchor- and distribution-based approaches, MID values were computed for 9 of the 11 scales. MIDs ranged from 8 to 12 points for Symptoms, Bother, Psychological, Overall QOL, Social Activity, Menstrual Symptoms, and Fertility, while the range was 10 to 15 points for the Fatigue and Activity scales of the ITP-PAQ. These estimates, while slightly higher than other published MID estimates, were consistent with moderate effect sizes. CONCLUSIONS: These MID estimates will serve as a useful tool to researchers and clinicians using the ITP-PAQ, providing guidance for interpretation of baseline scores as well as changes in ITP-PAQ scores over time. Additional work should be done to finalize these initial estimates using more appropriate anchors that correlate more highly with the ITP-PAQ scales.

Health care use and costs associated with use of a health club membership benefit in older adults with diabetes.

OBJECTIVE: The purpose of this study was to determine whether elective use of a health plan-sponsored health club membership had an impact on health care use and costs among older adults with diabetes. RESEARCH DESIGN AND METHODS: Administrative claims for 2,031 older adults with diabetes enrolled in a Medicare Advantage plan were obtained for this retrospective cohort study. Participants (n = 618) in the plan-sponsored health club benefit (Silver Sneakers [SS]) and control subjects (n = 1,413) matched on SS enrollment index date were enrolled in the plan for at least 1 year before the index date. Two-year health care use and costs of SS participants and control subjects were estimated in regressions adjusting for baseline differences. RESULTS: SS participants were more likely to be male, had a lower chronic disease burden, used more preventive services, and had a lower prevalence of arthritis (P or=2 SS visits/week in year 1 had lower total costs in year 2 ($2,141 [-$3,877 to -$405], P = 0.02) than participants who made <2 visits/week. CONCLUSIONS: Use of a health club benefit by older adults with diabetes was associated with slower growth in total health care costs over 2 years; greater use of the benefit was actually associated with declines in total costs.

Modifications to the Healthy Eating Index and its ability to predict obesity: the Multi-Ethnic Study of Atherosclerosis.

BACKGROUND: The Healthy Eating Index (HEI) is a measure of diet quality developed based on the Dietary Guidelines for Americans (DGA). OBJECTIVE: The objective was to assess the diet quality of a multi-ethnic population using and comparing the 2 HEIs, the updated HEI (HEI-05) based on the 2005 DGA and the original 1990 HEI (HEI-90), with the objective of predicting obesity outcomes. DESIGN: A longitudinal analysis of survey and clinical data from 6236 middle-aged and elderly white, African American, Hispanic, and Chinese participants of the Multi-Ethnic Study of Atherosclerosis (MESA) was conducted. Baseline diet quality was assessed with the use of HEI-90 and HEI-05. Baseline and 18-mo follow-up body mass index (BMI) and waist circumference (WC) data were predicted by using z score multiple regression models, and categorical obesity status was predicted by using multinomial logistic regression. RESULTS: Overall, the HEI-05 had larger z score beta coefficients than did the HEI-90 (eg, in whites, -0.53 compared with -0.48 in baseline BMI, -0.54 compared with -0.47 in follow-up BMI, -1.67 compared with -1.56 in baseline WC, and -1.57 compared with -1.44 in follow-up WC). Among whites only, both HEIs were significant predictors of BMI and WC (all P < 0.001). The odds of being obese rather than normal weight were inversely related to HEI z scores primarily in whites (P < 0.05). CONCLUSIONS: The changes to the 2005 DGA, as reflected by HEI-05, appear to better predict obesity outcomes in this multi-ethnic population, primarily in whites. Additional research on ethnic-specific DGA adherence and its relation to health outcomes is needed.