Resource use, costs, and utility estimates for patients with cystic fibrosis with mild impairment in lung function: analysis of data collected alongside a 48-week multicenter clinical trial.

OBJECTIVES: Transport of ions to generate epithelial rehydration (TIGER)-1 was a randomized trial conducted to evaluate the safety and efficacy of denufosol versus placebo in patients with cystic fibrosis with mild impairment in lung function. The trial met its primary end point at 24 weeks, but a subsequent trial did not show a sustained effect of denufosol at 48 weeks. By using the 48-week data, we characterized resource use, direct medical costs, indirect costs, and utility estimates. METHODS: Data on medications, outpatient and emergency visits, hospital admissions, tests, procedures, and home nursing were captured on study case report forms. Sources for unit costs included the Medicare Physician Fee Schedule, the Nationwide Inpatient Sample, and the Red Book. Health utilities were derived from the Health Utilities Index Mark 2/3. We used multivariable regression to evaluate the impact of baseline covariates on costs. RESULTS: Characteristics of the 352 participants at enrollment included mean age of 14.6 years, history of Pseudomonas aeruginosa colonization in 45.2%, use of dornase alfa in 77.0%, and long-term use of inhaled antibiotics in 37.2%. Over 48 weeks, 22.4% of participants were hospitalized and, on average, participants missed 7.4 days of school or work. Mean total costs (excluding denufosol) were $39,673 (SD $26,842), of which 85% were attributable to medications. Female sex and P. aeruginosa colonization were independently associated with higher costs. CONCLUSIONS: Prospective economic data collection alongside a clinical trial allows for robust estimates of cost of illness. The mean annual cost of care for patients with cystic fibrosis with mild impairment in lung function exceeds $43,000 and is driven by medication costs.

Variation in the type and frequency of postoperative invasive Staphylococcus aureus infections according to type of surgical procedure.

OBJECTIVE: To determine the epidemiological characteristics of postoperative invasive Staphylococcus aureus infection following 4 types of major surgical procedures.design. Retrospective cohort study. SETTING: Eleven hospitals (9 community hospitals and 2 tertiary care hospitals) in North Carolina and Virginia. PATIENTS: Adults undergoing orthopedic, neurosurgical, cardiothoracic, and plastic surgical procedures. METHODS: We used previously validated, prospectively collected surgical surveillance data for surgical site infection and microbiological data for bloodstream infection. The study period was 2003 through 2006. We defined invasive S. aureus infection as either nonsuperficial incisional surgical site infection or bloodstream infection. Nonparametric bootstrapping was used to generate 95% confidence intervals (CIs). P values were generated using the Pearson chi2 test, Student t test, or Wilcoxon rank-sum test, as appropriate. RESULTS: In total, 81,267 patients underwent 96,455 procedures during the study period. The overall incidence of invasive S. aureus infection was 0.47 infections per 100 procedures (95% CI, 0.43-0.52); 227 (51%) of 446 infections were due to methicillin-resistant S.aureus. Invasive S. aureus infection was more common after cardiothoracic procedures (incidence, 0.79 infections per 100 procedures [95%CI, 0.62-0.97]) than after orthopedic procedures (0.37 infections per 100 procedures [95% CI, 0.32-0.42]), neurosurgical procedures (0.62 infections per 100 procedures [95% CI, 0.53-0.72]), or plastic surgical procedures (0.32 infections per 100 procedures [95% CI, 0.17-0.47]) (P < .001). Similarly, S. aureus bloodstream infection was most common after cardiothoracic procedures (incidence, 0.57 infections per 100 procedures [95% CI, 0.43-0.72]; P < .001, compared with other procedure types), comprising almost three-quarters of the invasive S. aureus infections after these procedures. The highest rate of surgical site infection was observed after neurosurgical procedures (incidence, 0.50 infections per 100 procedures [95% CI, 0.42-0.59]; P < .001, compared with other procedure types), comprising 80% of invasive S.aureus infections after these procedures. CONCLUSION: The frequency and type of postoperative invasive S. aureus infection varied significantly across procedure types. The highest risk procedures, such as cardiothoracic procedures, should be targeted for ongoing preventative interventions.

Views of potential research participants on financial conflicts of interest: barriers and opportunities for effective disclosure.

BACKGROUND: There is little guidance regarding how to disclose researchers' financial interests to potential research participants. OBJECTIVE: To determine what potential research participants want to know about financial interests, their capacity to understand disclosed information and its implications, and the reactions of potential research participants to a proposed disclosure statement. DESIGN AND PARTICIPANTS: Sixteen focus groups in 3 cities, including 6 groups of healthy adults, 6 groups of adults with mild chronic illness, 1 group of parents of healthy children, 1 group of parents of children with leukemia or brain tumor, 1 group of adults with heart failure, and 1 group of adults with cancer. APPROACH: Focus group discussions covered a range of topics including financial relationships in clinical research, whether people should be told about them, and how they should be told. Audio-recordings of focus groups were transcribed, verified, and coded for analysis. RESULTS: Participants wanted to know about financial interests, whether or not those interests would affect their participation. However, they varied in their desire and ability to understand the nature and implications of financial interests. Whether disclosure was deemed important depended upon the risk of the research. Trust in clinicians was also related to views regarding disclosure. If given the opportunity to ask questions during the consent process, some participants would not have known what to ask; however, after the focus group sessions, participants could identify information they would want to know. CONCLUSIONS: Financial interests are important to potential research participants, but obstacles to effective disclosure exist.

Staphylococcus aureus bacteremia in patients with prosthetic devices: costs and outcomes.

PURPOSE: Although Staphylococcus aureus is a leading cause of nosocomial infection, little is known about the impact of S. aureus bacteremia on patients with prosthetic devices. This investigation sought to define the clinical outcome, health care resource use, and infection-associated costs of S. aureus bacteremia in patients with prostheses. SUBJECTS AND METHODS: All hospitalized patients with a prosthetic device and S. aureus bacteremia during the 96-month study period were identified prospectively. Clinical data were collected at the time of hospitalization. Data regarding infection-related resource utilization and infection-related costs within 12 weeks of the initial bacteremia were also recorded. RESULTS: 298 patients with > or =1 prosthesis and S. aureus bacteremia were identified (cardiovascular device--122 patients, orthopedic device--73 patients, long-term catheter--71 patients, and other devices-32 patients). Overall, 58% of patients underwent surgery as a consequence of the infection. Infection-related complications occurred in 41% and the overall 12-week mortality was 27%. The mean infection-related cost was 67439 dollars for patients with hospital-acquired S. aureus bacteremia and 37868 dollars for community-acquired S. aureus bacteremia (cost difference 29571 dollars; 95% confidence interval, 14370 dollars-49826 dollars). Rates of device infection, complications, 12-week mortality, and mean cost varied by prosthesis type. CONCLUSION: S. aureus bacteremia in patients with prosthetic devices is associated with frequent complications, substantial cost, and significant health care resource utilization.

Treatment patterns and costs associated with sessile colorectal polyps.

OBJECTIVES: Because of the paucity of existing literature on treatment and costs associated with sessile lesions, the objectives of this study were to perform a retrospective analysis on patients with sessile polyps to identify patient and polyp characteristics, to determine treatment patterns, and to estimate the cost of treating these patients. METHODS: We conducted a retrospective, observational cohort study of 280 patients who presented to a large teaching hospital between 1997 and 2000 with at least one sessile or broad-based pedunculated colorectal polyp of any size or histology, not including adenocarcinoma greater than stage T1. RESULTS: Mean polyp size was 1.3 cm, and two thirds of polyps were removed in a single procedure. The number of repeat procedures increased with polyp size (Kendall T-b = 0.47; 95% CI = 0.39-0.55). Patients with polyps > or = 2 cm were 5.88 times more likely than patients with smaller polyps to undergo a surgical procedure. Surgical procedures required 88.01 min longer than nonsurgical procedures (95% CI = 74.43-102.42). Mean total cost of treatment was $2,038 (range $153 to $14,838). Open resection ($6,165) was the most costly surgical procedure, and piecemeal polypectomy ($892) was the most costly nonsurgical therapeutic procedure. CONCLUSIONS: One third of polyps required more than one procedure. Surgical procedures accounted for the majority of resource use in this sample. Finally, patients with polyps > or = 2 cm incurred almost half the total costs while accounting for only 22% of the sample. The greatest economic gains could be made by improving efficiency of polyp removal for these patients.