title: Use of the lung cancer-specific Quality of Life Questionnaire EORTC QLQ-LC13 in clinical trials: A systematic review of the literature 20 years after its development.
abstract: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) covers 13 typical symptoms of lung cancer patients and was the first module developed in conjunction with the EORTC core quality-of-life (QL) questionnaire. This review investigates how the module has been used and reported in cancer clinical trials in the 20 years since its publication. Thirty-six databases were searched with a prespecified algorithm. This search plus an additional hand search generated 770 hits, 240 of which were clinical studies. Two raters extracted data using a coding scheme. Analyses focused on the randomized controlled trials (RCTs). Of the 240 clinical studies that were identified using the LC13, 109 (45%) were RCTs. More than half of the RCTs were phase 3 trials (n = 58). Twenty RCTs considered QL as the primary endpoint, and 68 considered it as a secondary endpoint. QL results were addressed in the results section of the article (n = 89) or in the abstract (n = 92); and, in half of the articles, QL results were presented in the form of tables (n = 53) or figures (n = 43). Furthermore, QL results had an impact on the evaluation of the therapy that could be clearly demonstrated in the 47 RCTs that yielded QL differences between treatment and control groups. The EORTC QLQ-LC13 fulfilled its mission to be used as a standard instrument in lung cancer clinical trials. An update of the LC13 is underway to keep up with new therapeutic trends and to ensure optimized and relevant QL assessment in future trials.
authors.affiliation: Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Koller
authors.affiliation: Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
authors.forename: Sophie
authors.initials: S
authors.lastname: Warncke
authors.affiliation: Regional Centre for Excellence in Palliative Care, Department of Oncology, Oslo University Hospital and European Palliative Care Research Centre, Department of Cancer and Molecular Medicine, Norwegian University of Science and Technology, Norway.
authors.forename: Marianne J
authors.initials: MJ
authors.lastname: Hjermstad
authors.affiliation: Oncology Departments, Navarra Hospital Complex, Pamplona, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Arraras
authors.affiliation: Division of Thoracic Surgery, St. James's University Hospital, Leeds, United Kingdom.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Pompili
authors.affiliation: The Christie National Health Service Foundation Trust, Manchester, United Kingdom.
authors.forename: Amelie
authors.initials: A
authors.lastname: Harle
authors.affiliation: University Surgical Unit, University Hospital Southampton, Hampshire, United Kingdom.
authors.forename: Colin D
authors.initials: CD
authors.lastname: Johnson
authors.affiliation: Institute of Epidemiology and Preventive Medicine, National Taiwan University, Taipei, Taiwan.
authors.forename: Wei-Chu
authors.initials: WC
authors.lastname: Chie
authors.affiliation: Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Schulz
authors.affiliation: Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Zeman
authors.affiliation: Thoracic Oncology-MOCA, Antwerp University Hospital, Edegem, Belgium.
authors.forename: Jan P
authors.initials: JP
authors.lastname: van Meerbeeck
authors.affiliation: EORTC Quality of Life Department, Brussels, Belgium.
authors.forename: Dagmara
authors.initials: D
authors.lastname: Kuliś
authors.affiliation: EORTC Quality of Life Department, Brussels, Belgium.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D008175:Lung Neoplasms; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D011795:Surveys and Questionnaires / Q000706:statistics & numerical data
keywords: clinical trials; lung cancer; outcome; quality of life