Health-related quality of life, work productivity, and health care resource utilization of subjects with irritable bowel syndrome: baseline results from LOGIC (Longitudinal Outcomes Study of Gastrointestinal Symptoms in Canada), a naturalistic study.

BACKGROUND: Abdominal pain/discomfort, bloating, and constipation are gastrointestinal dysmotility and sensory symptoms associated with irritable bowel syndrome (IBS). No studies have followed patients with IBS symptoms for 1 year under conditions of routine clinical practice to assess prospectively the impact of treatments on health outcomes. OBJECTIVE: The objective of this ongoing, naturalistic study is to assess the long-term impact of IBS treatments on quality of life (QOL), work productivity, and resource utilization. This report describes the baseline characteristics and patterns of care of the patients enrolled in this study. METHODS: Patients with physician-diagnosed IBS symptoms were enrolled from 147 physician sites across Canada between May 4, 2004, and March 31, 2005. Clinical data were collected at baseline and at the end of the 12-month follow-up (patients were followed for 1 year between May 4, 2005, and March 31, 2006). Patient-reported outcomes were collected at baseline and at months 1, 2, 6, 9, and 12. Health-related QOL, health status, and work productivity were assessed with the IBS-QOL, a 5-item EuroQol descriptive system, and Work Productivity and Activity Impairment questionnaires, respectively. A resource utilization questionnaire elicited information on physician; visits, treatments, and procedures. Baseline data are reported here. RESULTS: Data were obtained from 1555 patients; 85.1% (1320/1552) were women. Patients had a mean (SD) age of 45.8 (15.0) years and mean (SD) duration of IBS symptoms of 11.4 (11.5) years. Self-reported bowel patterns were predominantly constipation (41.0%, 587/1433) and constipation alternating with diarrhea (39.4%, 564/1433); 60.3% (938/1555) of subjects used > or =3 IBS treatments in the previous 4 weeks. Approximately 50% of all patients reported distress "quite a bit or "extremely" for abdominal pain, gas, bloating, and constipation. The mean overall IBS-QOL score (0-100 scale, with 0 indicating poor QOL) was 66.3; food avoidance (51.8) and health worry (59.3) were the most serious concerns. Patients reported 5.6% work absenteeism, 31.4% presenteeism, and 34.6% overall work productivity loss, equivalent to 13.8 hours lost productivity per 40-hour workweek. CONCLUSIONS: The baseline data from this ongoing, prospective, naturalistic study are consistent with previous findings that suggested significant use of health care resources with concomitant low QOL and decreased work productivity in patients with IBS symptoms.

Validation of electronic data capture of the Irritable Bowel Syndrome--Quality of Life Measure, the Work Productivity and Activity Impairment Questionnaire for Irritable Bowel Syndrome and the EuroQol.

OBJECTIVES: To assess the comparability, reliability, and subject acceptability of electronic data capture (EDC) versions of Irritable Bowel Syndrome-Quality of Life (IBS-QOL), EuroQoL (EQ-5D) and Work Productivity and Activity Impairment (WPAI:IBS) instruments. METHODS: Comparability of EDC and paper questionnaires was evaluated in 72 subjects with IBS who completed a baseline EDC or paper questionnaire, a crossover questionnaire 24 hours later, and a retest of the crossover version at 1 week. The EDC version was presented on a hand-held device. Comparability was assessed using paired t-test statistics, intraclass correlation coefficients (ICC) and tests for internal consistency (Cronbach's alpha). RESULTS: No significant differences were found between scores obtained by paper questionnaire and EDC at the baseline and crossover assessments. ICCs between baseline and crossover assessments ranged from 0.83 to 0.96 for the IBS-QOL scores, 0.82 to 0.96 for the WPAI:IBS scores, and 0.77 to 0.82 for the EQ-5D. Internal consistency was comparable for the two data collection methods for the IBS-QOL overall score (0.96) and subscales and the EQ-5D Index (0.70 vs. 0.74). Retest statistics (ICC) were generally comparable between the EDC and paper versions for all scores. Ease of use was comparable for the two modes of administration, but more patients preferred EDC (47.2%) than the paper questionnaire (23.6%). CONCLUSIONS: EDC versions of the IBS-QOL, EQ-5D, and WPAI:IBS are comparable to paper questionnaires in internal consistency and test-retest reliability, and have greater patient acceptability.

Economic considerations in the prescribing of third-generation antidepressants.

A comprehensive, multinational literature search was conducted of all articles published from 1993 to 2003 regarding the cost effectiveness of antidepressant drugs, with special emphasis on comparing third-generation antidepressants (TGAs) with tricyclic antidepressants (TCAs) and selective serotonin reuptake inhibitors (SSRIs). Information from the collected articles was entered into a database and then analysed to assess the different approaches to cost effectiveness comparisons for the various classes of antidepressants. Factors examined included direct and indirect costs, treatment endpoints, healthcare cost burden and productivity gains for patients successfully treated for depression. Most model-based studies published between 1993 and 2003 supported the cost effectiveness of TGAs compared with TCAs or SSRIs. While the purchase price of TGAs may be greater, cost savings in terms of direct and indirect costs were realised because of the reduced adverse effects of TGAs and subsequent improved patient compliance. Studies based on patient level cost data, however, were less conclusive about the economic benefits of TGAs compared with SSRIs or TCAs. While it may be premature to conclude that TGAs have a significant net economic benefit compared with other antidepressant classes, prescribers and payers may find it helpful when choosing antidepressants for depressed patients to consider that the higher drug prices for TGAs may be offset by savings, in terms of their greater compliance and resultant therapeutic success rates compared with TCAs or SSRIs. Additional research is needed to clarify how cost effectiveness is assessed in different patient populations, such as geriatric patients--who commonly have more co-morbidities and higher total healthcare costs than other patient populations.

Work-related outcomes after a myocardial infarction.

STUDY OBJECTIVE: To evaluate work-related outcomes of patients at 7 months after a myocardial infarction and to identify patient, disease, and intervention characteristics associated with these outcomes. DESIGN: Cross-sectional survey analysis. SETTING: Large Midwestern academic health system. PATIENTS: Eighty-nine patients with the discharge diagnosis of acute myocardial infarction during a 1-year index period. INTERVENTION: Work performance questionnaire administered by telephone, and medical record review. MEASUREMENTS AND MAIN RESULTS: Seven months after discharge, 232 patients were interviewed by telephone to determine work status before and after myocardial infarction, work-related outcomes (absenteeism and perceived work performance, assessed by the Work Performance Scale [WPS] of the Functional Status Questionnaire), and health-related quality of life. Univariate analyses were used to determine the association between individual characteristics and work-related outcomes. Of the 89 patients who had worked before the index myocardial infarction, 21 (23.6%) did not return to work. Variables associated with the outcome of not returning to work were past myocardial infarction (before the index myocardial infarction), coronary artery bypass graft surgery, heart failure, positive stress test, and low score on the Physical Component Summary (PCS-12) scale of the Short Form-12. Patients who did not return to work also tended to have more comorbidities and take more prescribed drugs than those who returned to work. Median WPS scores were higher for patients who had higher ejection fractions at discharge, had not experienced a myocardial infarction before the index event, underwent a percutaneous revascularization intervention at the time of hospitalization, and had not recently been absent from work. Workers reporting absences had lower PCS-12 scores than their counterparts or reported a rehospitalization before the survey. CONCLUSION: Preexisting cardiac disease and poorer physical functioning were consistently related to worse work-related outcomes. This small study demonstrates the need for a larger, broader study that includes health beliefs, treatment, and other job and patient factors that may influence work-related outcomes.

An economic analysis of the Atorvastatin Comparative Cholesterol Efficacy and Safety Study (ACCESS).

INTRODUCTION: The objective of the Atorvastatin Comparative Cholesterol Efficacy and Safety Study (ACCESS) was to compare the efficacy and safety of the five 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors in a randomised, controlled, yet large-scale study. ACCESS also produced data that permitted comparative analysis of the cost to achieve National Cholesterol Education Panel (NCEP) II low density lipoprotein-cholesterol (LDL-C) targets. STUDY DESIGN: A 54-week, multicentre, open-label, randomised, parallel-arm, active-control study in men and women with or without documented coronary heart disease or peripheral vascular disease. Data included medication use, clinic visits, adverse events, LDL-C and other laboratory measures. Analyses of resource use and cost are reported from a third-party payer perspective. METHODS: Patients were randomly assigned to receive one of the following treatments: atorvastatin (10-80 mg/day); fluvastatin (20-40 mg/day, or 40 mg twice daily); lovastatin (20-40 mg/day, or 40 mg twice daily); pravastatin (10-40 mg/day); or simvastatin (10-40 mg/day). Patients were started at the lowest available dose and titrated to higher doses at 6-week intervals until they achieved the NCEP II LDL-C target or reached the highest available dose of medication. PATIENTS: A total of 153 centres enrolled 3887 patients: atorvastatin (n = 1944); fluvastatin (n = 493); lovastatin (n = 494); pravastatin (n = 478); and simvastatin (n = 478). Inclusion criteria included LDL-C >or= 30 mg/dL higher than NCEP II LDL-C target (stratified by risk factors), fasting triglyceride values < 400 mg/dL, and a confirmed negative serum pregnancy test. Known hypersensitivity to statins, use of prohibited medications, uncontrolled diabetes, acute liver disease and age > 80 years or < 18 years were among the exclusion criteria. RESULTS: Mean total treatment costs to reach LDL-C targets for patients receiving atorvastatin (US dollars 683.37 in 2001) were significantly less than mean total treatment costs for patients receiving fluvastatin (difference = US dollars 211.35, p < 0.01), lovastatin (US dollars 607.96, p < 0.01), pravastatin (US dollars 424.60, p < 0.01) and simvastatin (US dollars 95.74, p < 0.01). Results were robust to sensitivity analyses using alternative definitions of the patient population (randomised, intent-to-treat, completers) and cost measures (50th percentile charges, 95th percentile charges, Medicare prices). CONCLUSIONS: Compared with the other statins studied, atorvastatin was associated with the lowest resource use and costs when used to treat patients to their NCEP II LDL-C targets. Atorvastatin was also associated with the highest percentage of patients achieving their desired clinical outcomes. Therefore, in cost-effectiveness terms, it dominated the four other statins.

Health-related quality of life in patients 7 months after a myocardial infarction: factors affecting the Short Form-12.

We assessed patients' health-related quality of life after myocardial infarction and identified related variables. Clinical data were obtained retrospectively from medical records of consecutive patients admitted to a Midwestern university-affiliated medical center with diagnosis of myocardial infarction from July 1999-July 2000. Telephone interviews 7 months after discharge were made to administer the Short Form-12 (SF-12) and obtain patient, disease, drug, and intervention data. Complete information was obtained from 200 patients (mean age 63.4 +/- 13.1 yrs, 68% men). The mean Physical Component Summary (PCS)-12 score was 40.6 +/- 12.0, and the mean Mental Component Summary (MCS)-12 score was 52.1 +/- 10.0. Based on univariate analyses, low PCS-12 scores were associated with women; non-Q-wave infarctions; greater number of illnesses; history of myocardial infarction, chronic heart failure (CHF), transient ischemic attack (TIA), renal disease, peripheral vascular disease, or percutaneous coronary intervention (PCI); rehospitalization during the interim period; and unscheduled PCI since index myocardial infarction. Low MCS-12 scores were associated with age below 65 years, low overall self-reported drug therapy compliance, low self-reported compliance with angiotensin-converting enzyme inhibitor and lipid-lowering therapy, no history of coronary artery bypass graft, and no stress test since index myocardial infarction. A multivariate regression model for PCS-12 kept the following variables: greater number of illnesses, history of CHF or TIA, and rehospitalization since index myocardial infarction. The MCS-12 model contained age below 65 years, low overall compliance, and low compliance with lipid-lowering therapy. Further work is necessary to determine noncardiovascular predictors of quality of life and whether interventions for these patients will result in improved quality of life.

Trimethoprim-sulfamethoxazole activity and pharmacodynamics against glycopeptide-intermediate Staphylococcus aureus.

STUDY OBJECTIVE: To determine the activity of trimethoprim-sulfamethoxazole (TMP-SMX) against glycopeptide-intermediate Staphylococcus aureus (GISA). DESIGN: In vitro study. SETTING: University laboratory. MEASUREMENTS AND MAIN RESULTS: Minimum inhibitory concentrations (MICs) of TMP-SMX were determined for three GISA strains. Time-kill assays were conducted at 1 x MIC and at simulated peak serum concentrations (Cmax). Two dosing regimens of TMP-SMX were investigated: TMP-SMX 8 mg (TMP)/kg/day and TMP-SMX 15 mg/kg/day, each divided into two doses/day Both dosages were studied against each strain in a two-compartment in vitro model to determine concentration-related activity. All isolates were susceptible to TMP-SMX. In time-kill studies at 1 x MIC, TMP-SMX was bacteriostatic against all isolates and bactericidal against two of three strains at simulated Cmax. The 15 mg/kg/day (divided-dose) regimen provided the best overall reduction in colony-forming units/ml. CONCLUSION: All GISA strains were susceptible to TMP-SMX. In addition, it appears that TMP-SMX may have concentration-dependent antibacterial activity against these organisms. As an option in the management of GISA infection, TMP-SMX merits further study.