Reporting quality and influencing factors of patient-reported outcomes in lung cancer randomized controlled trials: based on the CONSORT-PRO extension_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

ZHANG Guiying ¹ , YOU Yueyuan ¹ , ZHOU Xiaoqin ² ,  LI Jing ¹

1. Research Center of Clinical Epidemiology and Evidence-Based Medicine, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
2. Center of Biostatistics, Design, Measurement and Evaluation (CBDME), Department of Clinical Research Management, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;

Corresponding author：

LI Jing, Email: lijing68@hotmail.com

Keywords：

Lung cancer; patient-reported outcomes; randomized controlled trials; CONSORT-PRO; reporting quality assessment

DOI：

10.7507/1007-4848.202408018

Video：

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Objective To evaluate the reporting quality and influencing factors of patient-reported outcome (PRO) data in lung cancer randomized controlled trials (RCTs) from 2010 to 2024. Methods RCTs of lung cancer with PRO as either primary or secondary endpoints were searched from PubMed, EMbase, Medline, CNKI (China National Knowledge Infrastructure), Wanfang Data Knowledge Service Platform, and VIP Chinese Journal Service Platform between January 1, 2010 and April 20, 2024. Reporting quality of included RCT were assessed based on the CONSORT-PRO extension. Descriptive statistics and bivariate regression analysis were used to describe the reporting quality and analyze the factors influencing the reporting quality. Results A total of 740 articles were retrieved. After screening, 53 eligible lung cancer RCTs with 22 780 patients were included. The patients mainly were non-small cell lung cancer (84.91%), with the median sample size was 364 (160.50, 599.50) patients. The primary PRO tool used was the EORTC QLQ-C30 (60.38%). There were 52 studies (98.11%) whose PRO measured the domain of "symptom management of cough, dyspnea, fatigue, pain, etc.", and 45 studies (84.91%) measured "health-related quality of life." Multicenter studies accounted for 84.91%, and randomized non-blind trials accounted for 62.26%. PRO was used as the primary endpoint in 33.96% of the studies and as secondary endpoints in 66.04%. The reliability and validity of the PRO tools were explicitly mentioned in 11.32% and 7.55% of the studies, respectively. The average completeness of reporting according to the CONSORT-PRO guidelines was 60.00%, ranging from 25% to 93%. The main factors affecting the completeness of CONSORT-PRO reporting included sample size and publication year. For each additional sample size, the completeness of reporting increased by 27.5% (SE=0.000, t=2.04, P=0.046). Additionally, studies published after 2019 had a 67.2% higher completeness of reporting compared to those published in or before 2019 (SE=0.178, t=–3.273, P=0.006). Conclusion The study reveals that the overall reporting quality of PRO in lung cancer RCTs is poor. Particularly, the reporting of patient reported outcome measures reliability and validity, PRO assumptions, applicability, and handling of missing data needs further improvement. Future research should emphasize comprehensive adherence to the CONSORT-PRO guidelines.

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1. Wu F, Wang L, Zhou C. Lung cancer in China: Current and prospect. Curr Opin Oncol, 2021, 33(1): 40-46.
2. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2024, 74(3): 229-263.
3. International Agency for Research on Cancer. (n. d. ). Global Cancer Observatory. Retrieved from https://gco.iarc.fr/en.
4. Luján M, Lema M, Preciado B, et al. Real-world evidence of nivolumab for non-small-cell lung cancer in a developing country. J Investig Med, 2023, 71(5): 502-510.
5. Bade BC, Dela Cruz CS. Lung cancer 2020: Epidemiology, etiology, and prevention. Clin Chest Med, 2020, 41(1): 1-24.
6. Nasim F, Sabath BF, Eapen GA. Lung cancer. Med Clin North Am, 2019, 103(3): 463-473.
7. Mao Y, Yang D, He J, et al. Epidemiology of lung cancer. Surg Oncol Clin N Am, 2016, 25(3): 439-445.
8. Hoy H, Lynch T, Beck M. Surgical treatment of lung cancer. Crit Care Nurs Clin North Am, 2019, 31(3): 303-313.
9. Speight J, Barendse SM. FDA guidance on patient reported outcomes. BMJ, 2010, 340: c2921.
10. Nowinski CJ, Miller DM, Cella D. Evolution of patient-reported outcomes and their role in multiple sclerosis clinical trials. Neurotherapeutics, 2017, 14(4): 934-944.
11. Jenkinson C, Morley D. Patient reported outcomes. Eur J Cardiovasc Nurs, 2016, 15(2): 112-113.
12. Chang SS, Movsas B. How vital are patient-reported outcomes. J Natl Cancer Inst, 2022, 114(3): 347-348.
13. Kaufmann TL, Rocque GB. Pathway to precision patient-reported outcomes. J Clin Oncol, 2021, 39(34): 3770-3772.
14. Asci G, Ok E. Patient-reported outcomes and patient voices. Semin Dial, 2022, 35(5): 457-458.
15. Kyte D, Retzer A, Ahmed K, et al. Systematic evaluation of patient-reported outcome protocol content and reporting in cancer trials. J Natl Cancer Inst, 2019, 111(11): 1170-1178.
16. Marandino L, La Salvia A, Sonetto C, et al. Deficiencies in health-related quality-of-life assessment and reporting: A systematic review of oncology randomized phase Ⅲtrials published between 2012 and 2016. Ann Oncol, 2018, 29(12): 2288-2295.
17. Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: The CONSORT PRO extension. JAMA, 2013, 309(8): 814-822.
18. Mercieca-Bebber R, Rouette J, Calvert M, et al. Preliminary evidence on the uptake, use and benefits of the CONSORT-PRO extension. Qual Life Res, 2017, 26(6): 1427-1437.
19. Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med, 2010, 363(8): 733-742.
20. Rittmeyer A, Gorbunova V, Vikström A, et al. Health-related quality of life in patients with advanced nonsquamous non-small-cell lung cancer receiving bevacizumab or bevacizumab-plus-pemetrexed maintenance therapy in AVAPERL (MO22089). J Thorac Oncol, 2013, 8(11): 1409-1416.
21. Traeger L, McDonnell TM, McCarty CE, et al. Nursing intervention to enhance outpatient chemotherapy symptom management: Patient-reported outcomes of a randomized controlled trial. Cancer, 2015, 121(21): 3905-3913.
22. Geater SL, Xu CR, Zhou C, et al. Symptom and quality of life improvement in LUX-Lung 6: An open-label phase Ⅲ study of afatinib versus cisplatin/gemcitabine in Asian patients with EGFR mutation-positive advanced non-small-cell lung cancer. J Thorac Oncol, 2015, 10(6): 883-889.
23. Novello S, Kaiser R, Mellemgaard A, et al. Analysis of patient-reported outcomes from the LUME-Lung 1 trial: A randomised, double-blind, placebo-controlled, phase Ⅲ study of second-line nintedanib in patients with advanced non-small cell lung cancer. Eur J Cancer, 2015, 51(3): 317-326.
24. Schuler M, Yang JC, Park K, et al. Afatinib beyond progression in patients with non-small-cell lung cancer following chemotherapy, erlotinib/gefitinib and afatinib: Phase Ⅲrandomized LUX-Lung 5 trial. Ann Oncol, 2016, 27(3): 417-423.
25. Boye M, Wang X, Srimuninnimit V, et al. First-line pemetrexed plus cisplatin followed by gefitinib maintenance therapy versus gefitinib monotherapy in east Asian never-smoker patients with locally advanced or metastatic nonsquamous non-small-cell lung cancer: Quality of life results from a randomized phase Ⅲ trial. Clin Lung Cancer, 2016, 17(2): 150-160.
26. Brahmer JR, Rodríguez-Abreu D, Robinson AG, et al. Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): A multicentre, international, randomised, open-label phase 3 trial. Lancet Oncol, 2017, 18(12): 1600-1609.
27. Geerse OP, Hoekstra-Weebers JE, Stokroos MH, et al. Structural distress screening and supportive care for patients with lung cancer on systemic therapy: A randomised controlled trial. Eur J Cancer, 2017, 72: 37-45.
28. Lee CK, Novello S, Rydén A, et al. Patient-reported symptoms and impact of treatment with osimertinib versus chemotherapy in advanced non-small-cell lung cancer: The AURA3 trial. J Clin Oncol, 2018, 36(18): 1853-1860.
29. Felip E, Hirsh V, Popat S, et al. Symptom and quality of life improvement in LUX-Lung 8, an open-label phaseⅢ study of second-line afatinib versus erlotinib in patients with advanced squamous cell carcinoma of the lung after first-line platinum-based chemotherapy. Clin Lung Cancer, 2018, 19(1): 74-83.
30. Reck M, Brahmer J, Bennett B, et al. Evaluation of health-related quality of life and symptoms in patients with advanced non-squamous non-small cell lung cancer treated with nivolumab or docetaxel in CheckMate 057. Eur J Cancer, 2018, 102: 23-30.
31. Sebastian M, Rydén A, Walding A, et al. Patient-reported symptoms possibly related to treatment with osimertinib or chemotherapy for advanced non-small cell lung cancer. Lung Cancer, 2018, 122: 100-106.
32. Bordoni R, Ciardiello F, von Pawel J, et al. Patient-reported outcomes in OAK: A phase Ⅲ study of atezolizumab versus docetaxel in advanced non-small-cell lung cancer. Clin Lung Cancer, 2018, 19(5): 441-449.
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Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Latest ArticlesReporting quality and influencing factors of patient-reported outcomes in lung cancer randomized controlled trials: based on the CONSORT-PRO extension

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