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Background-Investigators of clinical trials in which the list of outcomes include patient-reported outcomes (PROs) -usually labeled quality of life (QoL) -have a large number of instruments from which to choose. The extent and manner in which PRO instruments are used in clinical trials can be assessed using data from clinical trial registries. Most medical journals now require a clinical trial be registered before its results are considered for publication. This requirement is intended to discourage publication bias, such as the reporting of tests of hypotheses different from those stipulated at the start of the trial and selective reporting of partial results.Purpose-To assess the usage of PRO instruments in registered trials by various trial characteristics and to determine if the instruments are adequately identified in the registry.Methods-A local copy of the ClinicalTrials.gov database was made in September 2007. The outcomes of all interventional trials registered since September 2004 were assessed for usage of a PRO instrument. Odds ratios of PRO usage were estimated by a logistic regression model.Results-Of 17,704 interventional trials, 2,481 (14.0%) used at least one PRO instrument. However, less than half of those trials (41.0%) identified the instrument to be used. PRO usage is positively associated with phase (III), randomization type (randomized), intervention type (behavior) and sponsorship type (university/research organization).Conclusions-PRO instruments are used in a significant percentage but minority of clinical trials. Trial registries should require that all PRO instruments be identified, including the concepts or outcomes they are intended to measure.

Purpose Distance to provider might be an important barrier to timely diagnosis and treatment for cancer patients who qualify for Medicaid coverage. Whether driving time or driving distance is a better indicator of travel burden is also of interest. Methods Driving distances and times from patient residence to primary care provider were calculated for 3,917 breast, colorectal (CRC) and lung cancer Medicaid patients in Washington State from 1997 to 2003 using MapQuest.com. We fitted regression models of stage at diagnosis and time-to-treatment (number of days between diagnosis and surgery) to test the hypothesis that travel burden is associated with timely diagnosis and treatment of cancer. Findings Later stage at diagnosis for breast cancer Medicaid patients is associated with travel burden (OR = 1.488 per 100 driving miles, P = .037 and OR = 1.270 per driving hour, P = .016). Time-to-treatment after diagnosis of CRC is also associated with travel burden (14.57 days per 100 driving miles, P = .002 and 5.86 days per driving hour, P = .018). Conclusions Although travel burden is associated with timely diagnosis and treatment for some types of cancer, we did not find evidence that driving time was, in general, better at predicting timeliness of cancer diagnosis and treatment than driving distance. More intensive efforts at early detection of breast cancer and early treatment of CRC for Medicaid patients who live in remote areas may be needed.

Objective. Members of the International Committee of Medical Journal Editors require, as a condition of consideration for publication, that all clinical trials be registered in a public trials registry. We evaluated the proportion of registered trials that are published in the peer-reviewed literature.Methods. After downloading the contents of the National Institutes of Health's ClinicalTrials.gov registry, we used key words to identify trials in oncology. We then evaluated the proportion of trials that had been published in journals listed in PubMed.gov. Among trials with published results, we determined the proportion that reported positive versus negative results.