William C. Grant

Trends in health care resource use for hepatitis C virus infection in the United States

Chronic hepatitis C virus (HCV) infection affects approximately 3 million people in the United States and places tremendous demands on the health care system. As many observers have predicted, the disease burden continues to grow as the infected population ages. In this study, we analyzed inpatient data from the Healthcare Cost and Utilization Project, outpatient data from the National Ambulatory Medical Care Survey, and drug data from the Verispan Source Prescription Audit. We examined recent growth in the use of health care resources among HCV patients by age group and found average annual increases of 25% to 30% for hospitalizations, charges, hospital days, and physician visits. Corresponding time‐trend coefficients were positive (P < .001). From 1994 to 2001, the HCV burden increased among patients aged 40 to 60 years, reflecting the natural history of disease progression. In sensitivity analysis, HCV outcome growth rates remained significant, unless more than 3 out of 4 cases were initially underreported. Also, patients co‐infected with HIV and HCV in 2001 constituted 7.5 times as many hospitalizations and incurred 2.9 times the charges in 1994, relative to all HIV hospitalizations and charges. Our findings highlight the urgency concerning HCV outcomes. In conclusion, as patients continue to age and disease burden progresses, suboptimal decisions regarding HCV treatments will bring increasing opportunity costs for the health care system and society. (HEPATOLOGY 2005;42:1406–1413.)

Sensitivity designs for preventing bias replication in randomized clinical trials

It is common, after a trial is completed, to employ sensitivity analyses to test the extent to which the results depend on various assumptions or conventions. There is a comparable benefit to employing sensitivity designs when planning a trial, so that features that cannot be varied at the analysis stage can instead be varied (e.g., across centres of a multi-centre trial) during the design stage. Design features amenable to such variation include: (1) the specific randomization methods, (2) the duration of follow-up and (3) the use or non-use of a surrogate endpoint as a replacement for a clinical endpoint. Generally, all centres in a given trial, and all trials in a given program, will employ identical protocols. This means that all will be vulnerable to the same types of biases, meaning that a single bias can by itself render all results unreliable. But by varying the randomization techniques, duration and primary endpoint, one can vary also the biases to which the site-specific results are vulnerable. This means that, if a significant result is found, then one can state that either the treatment worked or there were numerous biases (not just one) at play. This of course makes the attribution of the results to the treatments much more plausible and makes the findings much more robust to violations of assumptions.

Resource Use and Costs of Treatment With Anticoagulation and Antiplatelet Agents: Results of the WATCH Trial Economic Evaluation

BACKGROUND The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial revealed no significant differences among 1587 symptomatic heart failure patients randomized to warfarin, clopidogrel, or aspirin in time to all-cause death, nonfatal myocardial infarction, or nonfatal stroke. We compared within-trial medical resource use and costs between treatments. METHODS AND RESULTS We assigned country-specific costs to medical resources incurred during follow-up. Annualized rates of hospitalizations, inpatient and outpatient procedures, and emergency department visits did not differ significantly between groups. Annualized total costs averaged

Run-Reversal Equilibrium for Clinical Trial Randomization.

5901 (95% confidence interval [CI],

A Model of Patient Choice with Mid-Therapy Information

4776-

The burden of hepatitis C virus infection in children: estimated direct medical costs over a 10-year period.

7520) for the aspirin group,

Minimizing selection bias in randomized trials: A Nash equilibrium approach to optimal randomization

5646 (95% CI,

Unequal allocation and allocation concealment

4903-

Games superheroes play: Teaching game theory with comic book favorites

6584) for the clopidogrel group, and

Review of Randomization Methods in Clinical Trials

5830 (95% CI,