The use of patient-reported outcomes instruments in registered clinical trials: evidence from ClinicalTrials.gov.

Publication Type:

Journal Article

Source:

Contemporary clinical trials, Volume 30, Issue 4, p.289-92 (2009)

Keywords:

2009, Attitude to Health, Center-Authored Paper, Clinical Trials as Topic, Depression, Humans, Internet, Patients, Public Health Sciences Division, Quality of Life, Registries

Abstract:

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.