The standard of reporting of health-related quality of life in clinical cancer trials

The standard of reporting of randomized controlled trials (RCTs) is important to the interpretation of outcomes such as health-related quality of life (HRQL). HRQL is used increasingly as an outcome in clinical cancer trials. Design: All 1997 issues of 36 selected journals were hand searched to identify original articles that included the term "quality of life" in the title, abstract, keywords or methods. Studies were included if they were RCTs and addressed cancer-related topics. A checklist to assess the adequacy of reporting of HRQL was developed based on a guideline previously published by an expert panel. Two unblinded reviewers applied the quality of life reporting (QLR) and CONSORT checklists, along with an instrument to assess the likelihood of bias to each selected RCT. Results: 72 articles were identified of which 20 were RCTs and cancer-related. For these 20 reports the median number of items in the QLR checklist that were adequately reported is 42% (range 15% to 85%). The median number of items in the CONSORT checklist that were adequately reported is 70% (range 47% to 95%). The mean score for the instrument to assess the likelihood for bias is 2.6 (95% CI 2.08-3.12). Conclusions: The current standard of reporting of HRQL needs to be improved. Major deficiencies that should be addressed are failure to provide a rationale for HRQL assessment and inadequate description of methodology. Development and application of structured formats for presentation of HRQL may help to improve the standard of reporting of HRQL in the literature. (C) 2000 Elsevier Science Inc. All rights reserved.