Reporting health related quality of life in critical care RCTs

Article type
Authors
Roth D1, Tscherny K1, Heidinger B1, Havel C1, Arrich J1, Gamper G2, Herkner H1
1Medical University of Vienna, Department of Emergency Medicine, Austria
2Universitätsklinikum St. Pölten, Austria
Abstract
Background: Health-related quality of life (HRQoL), defined as “the functional effect of an illness and its treatment upon a patient as perceived by the patient”, might provide better information about the actual impact of a therapy; detect less obvious or unexpected effects; and is among the most relevant outcomes. A Cochrane Methods Group focusing on patient-reported outcome measures has been formed in 1999, and analysis of the reporting of quality of life has been recommended for all Cochrane Reviews since 2003. The frequency of reporting HRQoL in randomized controlled trials (RCTs) on critical care in general has however not been yet evaluated.
Objectives: To assess how many Cochrane Reviews on critical care included HRQoL as an outcome, evaluate the frequency of reporting of HRQoL in RCTs in critical care medicine, and to analyze the differences in study characteristics between those reporting HRQoL and those not.
Methods: To access a cohort of studies, the Cochrane Database of Systematic Reviews was searched for reviews on critical care published after 2000. All reviews in the RCTs contained therein were included in our analysis. Study characteristics such as sample size, type of intervention, disease spectrum, intensive care unit (ICU) setting, hospital setting, funding, effect size, number and type of outcomes, risk of bias, were extracted. HRQoL-specific data included whether HRQoL was reported, and which instrument was used.
Results: The reference lists of 136 reviews, 53 (39%) of which mentioned HRQoL as an outcome, were reviewed. A total of 468 individual studies representing 88,585 patients were included; 39 (8%) reported HRQoL as an outcome, one (0.2%) study as a primary outcome. Most commonly used scores were the Glasgow Outcome Scale (8; 21%), Modified Rankin Score (6; 15%), Rankin Score (4; 10%) and Barthel Index (3; 8%). No differences were found between studies reporting HRQoL and those not.
Conclusions: Although measuring HRQoL is recommended for all Cochrane Reviews, only 39% defined it as an outcome. Reporting HRQoL is even less common in individual studies of critical care, with only 8% of studies including measures of HRQoL.