An Open-Label, Pragmatic, Randomized Controlled Clinical Trial to Evaluate the Comparative Effectiveness of Daptomycin Versus Vancomycin for the Treatment of Complicated Skin and Skin Structure Infection

Treatment of complicated skin and skin structure infection (cSSSI) places a tremendous burden on the health care system. Understanding relative resource utilization associated with different antimicrobials is important for decision making by patients, health care providers, and payers. Methods: The authors conducted an open-label, pragmatic, randomized (1:1) clinical study (N = 250) to compare the effectiveness of daptomycin with that of vancomycin for treatment of patients hospitalized with cSSSI caused by suspected or documented methicillin-resistant Staphylococcus aureus infection. The primary study end point was infection-related length of stay (IRLOS). Secondary end points included health care resource utilization, cost, clinical response, and patient-reported outcomes. Patient assessments were performed daily until the end of antibiotic therapy or until hospital discharge, and at 14 days and 30 days after discharge. Results: No difference was found for IRLOS, total LOS, and total inpatient cost between cohorts. Hospital LOS contributed 85.9 % to the total hospitalization cost, compared with 6.4 % for drug costs. Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3. In the multivariate analyses, vancomycin was associated with a lower likelihood of day 2 clinical success (odds ratio [OR] = 0.498, 95 % confidence interval [CI], 0.249-0.997; P < 0.05). Conclusion: This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes. The data suggest that physician and patient preference, rather than drug acquisition cost, should be the primary driver of initial antibiotic selection for hospitalized patients with cSSSI.Merck & Co., Inc., Kenilworth, NJ USAKinesiology and Health Educatio

Use of the Stroke Recovery of Activities of Daily Living and Mobility (RAM) Index for prediction of outcome

This study examined the predictive utility of the Stroke Recovery of Activities of Daily Living and Mobility (RAM) Index. The Stroke RAM Index is a prognostic index that establishes the likelihood of a stroke survivor achieving a specific stage of recovery based on a set of clinical characteristics known at rehabilitation admission. The outcome predicted by the Stroke RAM Index is modified functional independence (Mod-FI), which specifies a minimum level of performance of activities of daily living and mobility. Database case records of 991 stroke patients discharged in 1998 were obtained from 8 acute inpatient rehabilitation facilities. The Stroke RAM Index was used to calculate the probability of achieving Mod-FI for each patient. Actual achievement or non-achievement of Mod-FI for each patient at discharge was determined. Logistic regression was performed with Mod-FI as outcome and the Stroke RAM Index variables as the set of predictors. To assess predictive utility, the area under the ROC curve, R2 statistic, and sensitivity and specificity were calculated. The results show that the Stroke RAM Index predicts as well for the 1998 sample as for the original 1990 model-building sample. The area under the ROC curve was .85 for the 1998 dataset and .86 for the 1990 dataset. Values of sensitivity, specificity for a cutpoint of probability .50 were similar to the values obtained for the 1990 dataset. Re-estimation of the model parameters resulted in different parameter estimates for some of the variables, but no improvement in predictive utility over the Stroke RAM Index. The stage of Mod-FI was achieved by 29% of the patients. Of the patients who achieved Mod-FI, 96% were discharged to the community, as opposed to 77% of those who did not achieve it. These findings suggest that the Stroke RAM Index has utility as a prognostic tool for the prediction of a specific level of function (Mod-FI). The use of the Stroke RAM Index for estimation of prognosis for stroke patients would provide a means to make equitable comparisons of outcomes across treatment settings, improve triage into the most appropriate level of care, and to confirm equating of factors in treatment effectiveness studies

A population-based osteoporosis screening program: who does not participate, and what are the consequences?

ObjectivesTo describe differences in osteoporosis risk factors and rates of fracture and antiresorptive therapy use in women who did and did not participate in an osteoporosis screening program.SettingGroup Health Cooperative, a health maintenance organization in western Washington state.ParticipantsA total of 9,268 women (aged 60-80) who were not using any antiresorptive therapy were invited to participate in an osteoporosis screening program. This study compares the 35% who participated with the 65% who did not.DesignThis observational cohort study of women invited to participate in a randomized, controlled trial of an osteoporosis screening program provided all participants with personalized feedback on their risk of osteoporosis. Some participants also received bone density testing. Automated administrative data were used to examine differences between participants and nonparticipants in fracture outcomes and medication initiation before and after invitation.ResultsBaseline fracture rates did not differ between participants and nonparticipants. After age adjustment, nonparticipants had a higher hip fracture rate (14.1 vs 8.3 per 1,000) and a lower rate of initiating any antiresorptive therapy (10.3 vs 17.9 per 100) than participants after an average of 28 to 29 months of follow-up.ConclusionParticipants had reduced hip fracture rates and increased initiation of antiresorptive therapy compared with nonparticipants. It was not possible to determine whether participating in the screening program, unmeasured confounding, or selection bias accounted for differences in hip fracture or therapy initiation rates. These results suggest that women who do not participate in osteoporosis screening should be pursued to identify individuals who could benefit from primary and secondary osteoporosis prevention

Evaluation of three population-based strategies for fracture prevention: results of the osteoporosis population-based risk assessment (OPRA) trial.

BackgroundThe integration of bone density testing into well-designed fracture prevention programs that can be applied in populations has not been studied.ObjectivesWe sought to compare the outcomes of 3 strategies for allocating bone density testing within an HMO-based fracture prevention program.Research designWomen were randomly sampled and allocated to one of 3 groups: (1) a universal group, in which all were offered bone mineral density (BMD) testing (1986 contacted; 415 participated); 2) the SCORE group, in which women scoring &gt; or = 7 on the SCORE questionnaire were invited for BMD testing (1940 contacted; 576 participated); and (3) the Study of Osteoporotic Fracture (SOF)-based group, in which women with &gt; or = 5 hip fracture risk factors were invited for BMD testing (5342 contacted; 2176 participated).SubjectsWomen aged 60-80 not taking hormone therapy or osteoporosis medication were included.MeasuresOutcomes ascertained during 33 months of follow-up in all women contacted included initiation of osteoporosis treatment and hip and total fracture rates. Outcomes evaluated among all participants included changes in fracture risk factors, osteoporosis knowledge, and satisfaction with the program.ResultsOsteoporosis treatment rates did not differ among all women contacted but were slightly higher among trial participants in the universal and SCORE groups (21.1% and 20.2%, respectively; versus 16.7% in the SOF-based group (P value versus universal = 0.04). Among all women contacted, fracture rates were lowest in the universal group (74.11/1000) and differed significantly compared with the SCORE (99.44/1000; P = 0.009) and SOF-based groups (91.77/1000;P = 0.02). Knowledge about osteoporosis risk factors was highest in the universal group and lowest in the SOF-based group (P &lt; 0.01).ConclusionsThe degree to which BMD testing was offered to women in a fracture prevention program significantly affected total fracture rates, change in some fracture risk factors, and knowledge about risk factors

Evaluation of decision rules to identify postmenopausal women for intervention related to osteoporosis.

Decision rules for intervention that utilize screening tools for bone mineral density (BMD) testing and incorporating the BMD findings and other risk factors to identify high-risk women to prevent fracture have not been evaluated. We examine the sensitivity and specificity of decision rules for intervention based on two pre-BMD screening tools: Simple Calculated Osteoporosis Risk Estimation (SCORE) and a Study of Osteoporotic Fractures (SOF)-based tool. Women 60 years of age and older without previous osteoporosis diagnosis were randomly selected from a managed care population and invited to receive a BMD test. Four hundred sixteen women had complete information and were included in the study. Women were classified as high risk requiring intervention using three different criteria: World Health Organization (t-score -2.5 or less), National Osteoporosis Foundation (t-score -2.0 or less, or -1.5 or less with one or more risk factors), and the SOF-based criteria (prior fracture; or age 60-64 with t-score less than -2.5 or age 65 or older with z-score less than -0.43 and five or more risk factors). SCORE identified 82% of the women as appropriate for BMD testing, whereas the SOF-based tool identified 26%. Sensitivity and specificity were 89.8%-96.5% and 23.8%-34.8%, respectively, for the decision rule using SCORE as the screening tool and 30.5%-84.9% and 76.0%-95.8%, respectively, for the decision rule based on SOF screening criteria. SCORE correctly identified more women who were at high risk for intervention, whereas the SOF-based tool correctly identified more women who do not meet intervention criteria. The appropriate selection of a screening tool depends upon the objective for intervention and trade-off between not identifying women for BMD testing who are at high risk and identifying more women for BMD testing who are at low risk

A cross-sectional survey of work and income loss consideration among patients with herpes zoster when completing a quality of life questionnaire

Abstract Background Prior research suggests that many patients do not spontaneously include work/income loss when responding to utility assessments, although this remains unconfirmed in the US due to almost no published US-based studies to date, and has not been previously studied among patients with herpes zoster (HZ). The objective of this study was to examine whether patients with HZ consider work and income loss when completing a quality of life survey. Methods A cross-sectional survey was administered to 2000 US adult commercial health plan enrollees aged 50–64 years with ≥ 1 HZ medical claim during 2014. The survey collected information related to health status (EQ-5D), work productivity, and HZ severity and clinical features. Results Mean respondent age was 58.4 years [standard deviation (SD) 4.1] and 62.0% were female. About 3 in 4 (76.8%) patients (N = 772) were employed either full (69.9%) or part time (6.9%). Less than half (45%) spontaneously considered work/income loss when responding to EQ-5D, and mean EQ-5D scores for patients who considered work/income loss were lower than for patients who did not [0.56 (SD = 0.28) vs. 0.69 (SD = 0.24); p < 0.001]. Overall, 43% of patients reported at least one full day missed (mean = 9 full days) and 29% reported at least one partial day missed (mean = 6 partial days) during the most recent shingles episode. Patients who considered work loss were more likely to have missed full (76.4% vs 26.0%, p < 0.001) or partial (70.9% vs. 35.2%, p < 0.001) days. Patients with absenteeism were more likely to consider work/income loss when completing EQ-5D [odds ratio (OR) = 7.91, 95% confidence interval (CI) 5.01–12.31]. Odds of absenteeism/presenteeism increased significantly with increasing levels of HZ severity, and higher odds were associated with pain located on the face/scalp/neck/eye/ear (OR 1.90, 95% CI 1.06–3.40) and with pain lasting 12+ months (OR = 2.91, 95% CI 1.14–7.42). Conclusions HZ has considerable impact on the work and productivity of adults aged 50–64 years old. However, many patients with HZ do not spontaneously consider work/income loss when completing a standardized quality of life questionnaire. Studies that use health state utilities in HZ based on EQ-5D may not fully reflect the societal costs of work loss