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

13 (QLQ-LC13) covers 13 typical symptoms of lung cancer patients and was the first module developed in conjunction with the EORTC core qualityof-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 5 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 5 89) or in the abstract (n 5 92); and, in half of the articles, QL results were presented in the form of tables (n 5 53) or figures (n 5 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.

Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension

“…Again, these are knowledge transfer concerns requiring intervention to improve reporting practices and to ensure PRO results are interpreted accurately so they can appropriately inform patient care. Recent reviews confirm that reporting of PRO endpoints remains unsatisfactory overall; particularly regarding the reporting of PRO hypotheses, methodology, missing data, and generalisability of results [19][20][21][22][23][24][25][26]. Failing to report this information is wasteful as it limits the potential for readers to appraise the effect of interventions on patient health status, and the potential for PRO systematic reviews to impact clinical recommendations and health policy [27,28].…”

The Humanistic Burden of Small Cell Lung Cancer (SCLC): A Systematic Review of Health-Related Quality of Life (HRQoL) Literature

“…The most frequently used PRO to assess HRQoL was the EORTC QLQ-C30 core cancer instruments, the lung cancer specific module the EORTC QLQ-LC13, LCSS, and EQ-5D. The EORTC instruments, while considered by some authors as the standard for HRQoL measurement in lung cancer (Koller et al, 2015), were developed prior regulatory PRO guidance. The LCSS appears to be face and content valid for this patient population (Hollen et al, 1993).…”

The humanistic burden of small cell lung cancer (SCLC): a systematic review of health-related quality of life (HRQoL) literature

“…A review of literature summarizing the use of the EORTC QLQ-LC13 in clinical trials supports this finding, reporting that of the 109 trials found to have included the instrument, 83 reported results and only 69 publications (63%) provided numerical values (Koller et al, 2015). The lack of published HRQoL data may be due to a publication bias, with researchers not publishing findings in cases where the data does not present favorable outcomes (decline in HRQoL) in relation to the treatment being investigated.…”

“…The most frequently used PRO to assess HRQoL was the EORTC QLQ-C30 core cancer instruments, the lung cancer specific module the EORTC QLQ-LC13, LCSS, and EQ-5D. The EORTC instruments, while considered by some authors as the standard for HRQoL measurement in lung cancer (Koller et al, 2015), were developed prior regulatory PRO guidance. The LCSS appears to be face and content valid for this patient population (Hollen et al, 1993).…”

“…The lack of opportunity for obtain a labeling claim by using these instruments may play a part in why HRQoL and specific domains of HRQoL are not receiving significant focus in the literature, despite their frequent use as a secondary endpoint in clinical trials. These instruments are currently being updated; however it is unclear if this is in consideration of FDA guidance (Koller et al, 2015).…”