Reporting quality and influencing factors of patient-reported outcomes in randomized controlled trials of lung cancer: 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 randomized controlled trials (RCTs) of lung cancer. Methods RCTs of lung cancer with PRO as either primary or secondary endpoints were searched from PubMed, EMbase, Medline, CNKI, Wanfang Data, and VIP databases between January 1, 2010 and April 20, 2024. Reporting quality of included RCTs 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 RCTs of lung cancer 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 (98.11%) studies whose PRO measured the domain of "symptom management of cough, dyspnea, fatigue, pain, etc.", and 45 (84.91%) studies 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 25.00% to 93.00%. 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 2018 had a 67.2% higher completeness of reporting compared to those published in or before 2018 (SE=17.8, 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 PRO measures reliability and validity, PRO assumptions, applicability, and handling of missing data need further improvement. Future research should emphasize comprehensive adherence to the CONSORT-PRO guidelines.

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. 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.
33.	Wu YL, Lu S, Lu Y, et al. Results of PROFILE 1029, a phase Ⅲ comparison of first-line crizotinib versus chemotherapy in east Asian patients with ALK-positive advanced non-small cell lung cancer. J Thorac Oncol, 2018, 13(10): 1539-1548.
34.	Reck M, Schenker M, Lee KH, et al. Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: Patient-reported outcomes results from the randomised, open-label, phase Ⅲ CheckMate 227 trial. Eur J Cancer, 2019, 116: 137-147.
35.	Pérol M, Pavlakis N, Levchenko E, et al. Patient-reported outcomes from the randomized phase Ⅲ ALEX study of alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer. Lung Cancer, 2019, 79-87.
36.	Hui R, Özgüroğlu M, Villegas A, et al. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage Ⅲ, unresectable non-small-cell lung cancer (PACIFIC): A randomised, controlled, phase 3 study. Lancet Oncol, 2019, 20(12): 1670-1680.
37.	Sio TT, Atherton PJ, Pederson LD, et al. Daily lisinopril vs placebo for prevention of chemoradiation-induced pulmonary distress in patients with lung cancer (Alliance MC1221): A pilot double-blind randomized trial. Int J Radiat Oncol Biol Phys, 2019, 103(3): 686-696.
38.	Kuo JC, Graham DM, Salvarrey A, et al. A randomized trial of the electronic Lung Cancer Symptom Scale for quality-of-life assessment in patients with advanced non-small-cell lung cancer. Curr Oncol, 2020, 27(2): e156-e162.
39.	Goldman JW, Garassino MC, Chen Y, et al. Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): A randomized, controlled, open-label, phase Ⅲ study. Lung Cancer, 2020, 149: 46-52.
40.	Mazieres J, Kowalski D, Luft A, et al. Health-related quality of life with carboplatin-paclitaxel or nab-paclitaxel with or without pembrolizumab in patients with metastatic squamous non-small-cell lung cancer. J Clin Oncol, 2020, 38(3): 271-280.
41.	Yoh K, Atagi S, Reck M, et al. Patient-reported outcomes in RELAY, a phase 3 trial of ramucirumab plus erlotinib versus placebo plus erlotinib in untreated EGFR-mutated metastatic non-small-cell lung cancer. Curr Med Res Opin, 2020, 36(10): 1667-1675.
42.	Garassino MC, Gadgeel S, Esteban E, et al. Patient-reported outcomes following pembrolizumab or placebo plus pemetrexed and platinum in patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189): A multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol, 2020, 21(3): 387-397.
43.	Reck M, Wehler T, Orlandi F, et al. Safety and patient-reported outcomes of atezolizumab plus chemotherapy with or without bevacizumab versus bevacizumab plus chemotherapy in non-small-cell lung cancer. J Clin Oncol, 2020, 38(22): 2530-2542.
44.	Garon EB, Cho BC, Reinmuth N, et al. Patient-reported outcomes with durvalumab with or without tremelimumab versus standard chemotherapy as first-line treatment of metastatic non-small-cell lung cancer (MYSTIC). Clin Lung Cancer, 2021, 22(4): 301-312.
45.	Scott JM, Thomas SM, Herndon JE, et al. Effects and tolerability of exercise therapy modality on cardiorespiratory fitness in lung cancer: A randomized controlled trial. J Cachexia Sarcopenia Muscle, 2021, 12(6): 1456-1465.
46.	Socinski MA, Özgüroğlu M, Villegas A, et al. Durvalumab after concurrent chemoradiotherapy in elderly patients with unresectable stage Ⅲ non-small-cell lung cancer (PACIFIC). Clin Lung Cancer, 2021, 22(6): 549-561.
47.	Reck M, Ciuleanu TE, Lee JS, et al. First-Line nivolumab plus ipilimumab versus chemotherapy in advanced NSCLC with 1% or greater tumor PD-L1 expression: Patient-reported outcomes from CheckMate 227 Part 1. J Thorac Oncol, 2021, 16(4): 665-676.
48.	Hollen PJ, Gralla RJ, Gentzler RD, et al. Do patients regret having received systemic treatment for advanced non-small cell lung cancer: A prospective evaluation. Oncologist, 2021, 26(3): 224-230.
49.	马睿晨. 基于ADOPT模式的瑜伽呼吸训练对肺癌手术患者康复效果的研究. 吉林大学, 2021.Ma RC. Effects of yoga breathing exercises based on the ADOPT mode on lung cancer patients with surgical resection. Jilin University, 2021.
50.	Cooley ME, Mazzola E, Xiong N, et al. Clinical decision support for symptom management in lung cancer patients: A group RCT. J Pain Symptom Manage, 2022, 63(4): 572-580.
51.	Dai W, Feng W, Zhang Y, et al. Patient-reported outcome-based symptom management versus usual care after lung cancer surgery: A multicenter randomized controlled trial. J Clin Oncol, 2022, 40(9): 988-996.
52.	Wang J, Yu X, Barnes G, et al. The effects of tislelizumab plus chemotherapy as first-line treatment on health-related quality of life of patients with advanced squamous non-small cell lung cancer: Results from a phase 3 randomized clinical trial. Cancer Treat Res Commun, 2022, 30: 100501.
53.	Singh J, Bourke S, Dyer M, et al. An analysis of 5-level version of EQ-5D adjusting for treatment switching: The case of patients with epidermal growth factor receptor T790M-positive nonsmall cell lung cancer treated with osimertinib. Value Health, 2022, 25(7): 1205-1211.
54.	Chang J, Wu YL, Lu S, et al. Three-year follow-up and patient-reported outcomes from CheckMate 078: Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer. Lung Cancer, 2022, 165: 71-81.
55.	Mazieres J, Iadeluca L, Shaw AT, et al. Patient-reported outcomes from the randomized phase 3 CROWN study of first-line lorlatinib versus crizotinib in advanced ALK-positive non-small cell lung cancer. Lung Cancer, 2022, 174: 146-156.
56.	King-Kallimanis BL, Bhatnagar V, Horodniceanu EG, et al. Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events. Clin Trials, 2022, 19(3): 267-273.
57.	Lim E, Harris RA, McKeon HE, et al. Impact of video-assisted thoracoscopic lobectomy versus open lobectomy for lung cancer on recovery assessed using self-reported physical function: VIOLET RCT. Health Technol Assess, 2022, 26(48): 1-162.
58.	Lu S, Yu Y, Barnes G, et al. Examining the impact of tislelizumab added to chemotherapy on health-related quality-of-life outcomes in previously untreated patients with nonsquamous non-small cell lung cancer. Cancer J, 2022, 28(2): 96-104.
59.	Patel MI, Banks L, Das M. Improving supportive care for patients with thoracic malignancies—A randomized controlled trial. Contemp Clin Trials Commun, 2022, 28: 100929.
60.	Huang D, Zhou C, Barnes G, et al. The effects of tislelizumab treatment on the health-related quality of life of patients with advanced non-small cell lung cancer. Cancer Med, 2023, 12(16): 17403-17412.
61.	Garon EB, Cho BC, Luft A, et al. Patient-reported outcomes with durvalumab, with or without tremelimumab, plus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (POSEIDON). Lung Cancer, 2023, 186: 107422.
62.	Gümüş M, Chen CI, Ivanescu C, et al. Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of ≥50%: The EMPOWER-Lung 1 study. Cancer, 2023, 129(1): 118-129.
63.	Unger JM, Qian L, Redman MW, et al. Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I. J Natl Cancer Inst, 2023, 115(4): 437-446.
64.	Kim HR, Awad MM, Navarro A, et al. Patient-reported health-related quality of life in KEYNOTE-604: Pembrolizumab or placebo added to etoposide and platinum as first-line therapy for extensive-stage SCLC. JTO Clin Res Rep, 2023, 4(11): 100572.
65.	Billingy NE, Tromp VNMF, Aaronson NK, et al. Quality of life after patient-initiated vs physician-initiated response to symptom monitoring: The SYMPRO-Lung trial. J Natl Cancer Inst, 2023, 115(12): 1515-1525.
66.	Makharadze T, Quek RGW, Melkadze T, et al. Quality of life with cemiplimab plus chemotherapy for first-line treatment of advanced non-small cell lung cancer: Patient-reported outcomes from phase 3 EMPOWER-Lung 3. Cancer, 2023, 129(14): 2256-2265.
67.	Wu Y, Liu H, Zhong M, et al. Enhanced patient comfort and satisfaction with early oral feeding after thoracoscopic lung cancer resection. Med Sci Monit, 2023, 29: e941577.
68.	张馨元. 分级运动想象应用于胸腔镜肺癌术后恐动症患者效果的混合方法研究. 南方医科大学, 2023.Zhang XY. Effects of graded motor imagery on patients with kinesiophobia after video-assisted thoracoscopic surgery for lung cancer: A mixed methods study. Southern Medical University, 2023.
69.	Tan DSW, Felip E, de Castro G, et al. Canakinumab versus placebo in combination with first-line pembrolizumab plus chemotherapy for advanced non-small-cell lung cancer: Results from the CANOPY-1 trial. J Clin Oncol, 2024, 42(2): 192-204.
70.	Dai W, Wang Y, Liao J, et al. Electronic patient-reported outcome-based symptom management versus usual care after lung cancer surgery: Long-term results of a multicenter, randomized, controlled trial. J Clin Oncol, 2024, 42(18): 2126-2131.
71.	Banks LC, Kapphahn K, Das M, et al. Randomized trial of a volunteer-led symptom assessment intervention on documentation, patient-reported outcomes, and health care use among veterans with lung cancer. JCO Oncol Pract, 2024, 20(3): 419-428.
72.	Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. Int J Surg, 2012, 10(1): 28-55.
73.	Mack DE, Wilson PM, Santos E, et al. Standards of reporting: The use of CONSORT PRO and CERT in individuals living with osteoporosis. Osteoporos Int, 2018, 29(2): 305-313.
74.	Efficace F, Fayers P, Pusic A, et al. Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials. Cancer, 2015, 121(18): 3335-3342.
75.	van der Vet P, Wilson S, Houwert RM, et al. Quality and reporting of patient-reported outcomes in elderly patients with hip fracture: A systematic review. BMJ Open, 2022, 12(12): e058197.
76.	Ladd C, Jacobsen SM, Snider K, et al. Evaluating the underreporting of patient-reported outcomes in carpal tunnel syndrome randomized controlled trials. J Osteopath Med, 2023, 123(6): 301-308.
77.	Goorts K, Dizon J, Milanese S. The effectiveness of implementation strategies for promoting evidence informed interventions in allied healthcare: A systematic review. BMC Health Serv Res, 2021, 21(1): 241.
78.	Clancy CJ, Buehrle D, Vu M, et al. Impact of revised Infectious Diseases Society of America and Society for Healthcare Epidemiology of America clinical practice guidelines on the treatment of clostridium difficile infections in the United States. Clin Infect Dis, 2021, 72(11): 1944-1949.
79.	Zhou J, Qi H, Hu J, et al. Low-quality of patient-reported outcome reporting in randomized clinical trials of major depressive disorder—A meta-epidemiological review. Front Psychiatry, 2023, 14: 1246938.
80.	Fabian A, Domschikowski J, Letsch A, et al. Use and reporting of patient-reported outcomes in trials of palliative radiotherapy: A systematic review. JAMA Netw Open, 2022, 5(9): e2231930.
81.	Anderson RM, Streck S, Hughes G, et al. Evaluating reporting of patient-reported outcomes in peptic ulcer disease: A meta-epidemiological study of randomized controlled trials. Expert Rev Pharmacoecon Outcomes Res, 2022, 22(8): 1253-1260.
82.	Khan T, Khalid M, Dunford B, et al. Incomplete reporting of patient-reported outcomes in multiple sclerosis: A meta-epidemiological study of randomized controlled trials. Mult Scler Relat Disord, 2022, 63: 103819.
83.	Brock L, Hightower B, Moore T, et al. Reporting of patient-reported outcome measures in randomized controlled trials on shoulder rotator cuff injuries is suboptimal and requires standardization. Arthrosc Sports Med Rehabil, 2022, 4(4): e1429-e1436.

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. 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.
33. Wu YL, Lu S, Lu Y, et al. Results of PROFILE 1029, a phase Ⅲ comparison of first-line crizotinib versus chemotherapy in east Asian patients with ALK-positive advanced non-small cell lung cancer. J Thorac Oncol, 2018, 13(10): 1539-1548.
34. Reck M, Schenker M, Lee KH, et al. Nivolumab plus ipilimumab versus chemotherapy as first-line treatment in advanced non-small-cell lung cancer with high tumour mutational burden: Patient-reported outcomes results from the randomised, open-label, phase Ⅲ CheckMate 227 trial. Eur J Cancer, 2019, 116: 137-147.
35. Pérol M, Pavlakis N, Levchenko E, et al. Patient-reported outcomes from the randomized phase Ⅲ ALEX study of alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer. Lung Cancer, 2019, 79-87.
36. Hui R, Özgüroğlu M, Villegas A, et al. Patient-reported outcomes with durvalumab after chemoradiotherapy in stage Ⅲ, unresectable non-small-cell lung cancer (PACIFIC): A randomised, controlled, phase 3 study. Lancet Oncol, 2019, 20(12): 1670-1680.
37. Sio TT, Atherton PJ, Pederson LD, et al. Daily lisinopril vs placebo for prevention of chemoradiation-induced pulmonary distress in patients with lung cancer (Alliance MC1221): A pilot double-blind randomized trial. Int J Radiat Oncol Biol Phys, 2019, 103(3): 686-696.
38. Kuo JC, Graham DM, Salvarrey A, et al. A randomized trial of the electronic Lung Cancer Symptom Scale for quality-of-life assessment in patients with advanced non-small-cell lung cancer. Curr Oncol, 2020, 27(2): e156-e162.
39. Goldman JW, Garassino MC, Chen Y, et al. Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): A randomized, controlled, open-label, phase Ⅲ study. Lung Cancer, 2020, 149: 46-52.
40. Mazieres J, Kowalski D, Luft A, et al. Health-related quality of life with carboplatin-paclitaxel or nab-paclitaxel with or without pembrolizumab in patients with metastatic squamous non-small-cell lung cancer. J Clin Oncol, 2020, 38(3): 271-280.
41. Yoh K, Atagi S, Reck M, et al. Patient-reported outcomes in RELAY, a phase 3 trial of ramucirumab plus erlotinib versus placebo plus erlotinib in untreated EGFR-mutated metastatic non-small-cell lung cancer. Curr Med Res Opin, 2020, 36(10): 1667-1675.
42. Garassino MC, Gadgeel S, Esteban E, et al. Patient-reported outcomes following pembrolizumab or placebo plus pemetrexed and platinum in patients with previously untreated, metastatic, non-squamous non-small-cell lung cancer (KEYNOTE-189): A multicentre, double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol, 2020, 21(3): 387-397.
43. Reck M, Wehler T, Orlandi F, et al. Safety and patient-reported outcomes of atezolizumab plus chemotherapy with or without bevacizumab versus bevacizumab plus chemotherapy in non-small-cell lung cancer. J Clin Oncol, 2020, 38(22): 2530-2542.
44. Garon EB, Cho BC, Reinmuth N, et al. Patient-reported outcomes with durvalumab with or without tremelimumab versus standard chemotherapy as first-line treatment of metastatic non-small-cell lung cancer (MYSTIC). Clin Lung Cancer, 2021, 22(4): 301-312.
45. Scott JM, Thomas SM, Herndon JE, et al. Effects and tolerability of exercise therapy modality on cardiorespiratory fitness in lung cancer: A randomized controlled trial. J Cachexia Sarcopenia Muscle, 2021, 12(6): 1456-1465.
46. Socinski MA, Özgüroğlu M, Villegas A, et al. Durvalumab after concurrent chemoradiotherapy in elderly patients with unresectable stage Ⅲ non-small-cell lung cancer (PACIFIC). Clin Lung Cancer, 2021, 22(6): 549-561.
47. Reck M, Ciuleanu TE, Lee JS, et al. First-Line nivolumab plus ipilimumab versus chemotherapy in advanced NSCLC with 1% or greater tumor PD-L1 expression: Patient-reported outcomes from CheckMate 227 Part 1. J Thorac Oncol, 2021, 16(4): 665-676.
48. Hollen PJ, Gralla RJ, Gentzler RD, et al. Do patients regret having received systemic treatment for advanced non-small cell lung cancer: A prospective evaluation. Oncologist, 2021, 26(3): 224-230.
49. 马睿晨. 基于ADOPT模式的瑜伽呼吸训练对肺癌手术患者康复效果的研究. 吉林大学, 2021.Ma RC. Effects of yoga breathing exercises based on the ADOPT mode on lung cancer patients with surgical resection. Jilin University, 2021.
50. Cooley ME, Mazzola E, Xiong N, et al. Clinical decision support for symptom management in lung cancer patients: A group RCT. J Pain Symptom Manage, 2022, 63(4): 572-580.
51. Dai W, Feng W, Zhang Y, et al. Patient-reported outcome-based symptom management versus usual care after lung cancer surgery: A multicenter randomized controlled trial. J Clin Oncol, 2022, 40(9): 988-996.
52. Wang J, Yu X, Barnes G, et al. The effects of tislelizumab plus chemotherapy as first-line treatment on health-related quality of life of patients with advanced squamous non-small cell lung cancer: Results from a phase 3 randomized clinical trial. Cancer Treat Res Commun, 2022, 30: 100501.
53. Singh J, Bourke S, Dyer M, et al. An analysis of 5-level version of EQ-5D adjusting for treatment switching: The case of patients with epidermal growth factor receptor T790M-positive nonsmall cell lung cancer treated with osimertinib. Value Health, 2022, 25(7): 1205-1211.
54. Chang J, Wu YL, Lu S, et al. Three-year follow-up and patient-reported outcomes from CheckMate 078: Nivolumab versus docetaxel in a predominantly Chinese patient population with previously treated advanced non-small cell lung cancer. Lung Cancer, 2022, 165: 71-81.
55. Mazieres J, Iadeluca L, Shaw AT, et al. Patient-reported outcomes from the randomized phase 3 CROWN study of first-line lorlatinib versus crizotinib in advanced ALK-positive non-small cell lung cancer. Lung Cancer, 2022, 174: 146-156.
56. King-Kallimanis BL, Bhatnagar V, Horodniceanu EG, et al. Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events. Clin Trials, 2022, 19(3): 267-273.
57. Lim E, Harris RA, McKeon HE, et al. Impact of video-assisted thoracoscopic lobectomy versus open lobectomy for lung cancer on recovery assessed using self-reported physical function: VIOLET RCT. Health Technol Assess, 2022, 26(48): 1-162.
58. Lu S, Yu Y, Barnes G, et al. Examining the impact of tislelizumab added to chemotherapy on health-related quality-of-life outcomes in previously untreated patients with nonsquamous non-small cell lung cancer. Cancer J, 2022, 28(2): 96-104.
59. Patel MI, Banks L, Das M. Improving supportive care for patients with thoracic malignancies—A randomized controlled trial. Contemp Clin Trials Commun, 2022, 28: 100929.
60. Huang D, Zhou C, Barnes G, et al. The effects of tislelizumab treatment on the health-related quality of life of patients with advanced non-small cell lung cancer. Cancer Med, 2023, 12(16): 17403-17412.
61. Garon EB, Cho BC, Luft A, et al. Patient-reported outcomes with durvalumab, with or without tremelimumab, plus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (POSEIDON). Lung Cancer, 2023, 186: 107422.
62. Gümüş M, Chen CI, Ivanescu C, et al. Patient-reported outcomes with cemiplimab monotherapy for first-line treatment of advanced non-small cell lung cancer with PD-L1 of ≥50%: The EMPOWER-Lung 1 study. Cancer, 2023, 129(1): 118-129.
63. Unger JM, Qian L, Redman MW, et al. Quality-of-life outcomes and risk prediction for patients randomized to nivolumab plus ipilimumab vs nivolumab on LungMAP-S1400I. J Natl Cancer Inst, 2023, 115(4): 437-446.
64. Kim HR, Awad MM, Navarro A, et al. Patient-reported health-related quality of life in KEYNOTE-604: Pembrolizumab or placebo added to etoposide and platinum as first-line therapy for extensive-stage SCLC. JTO Clin Res Rep, 2023, 4(11): 100572.
65. Billingy NE, Tromp VNMF, Aaronson NK, et al. Quality of life after patient-initiated vs physician-initiated response to symptom monitoring: The SYMPRO-Lung trial. J Natl Cancer Inst, 2023, 115(12): 1515-1525.
66. Makharadze T, Quek RGW, Melkadze T, et al. Quality of life with cemiplimab plus chemotherapy for first-line treatment of advanced non-small cell lung cancer: Patient-reported outcomes from phase 3 EMPOWER-Lung 3. Cancer, 2023, 129(14): 2256-2265.
67. Wu Y, Liu H, Zhong M, et al. Enhanced patient comfort and satisfaction with early oral feeding after thoracoscopic lung cancer resection. Med Sci Monit, 2023, 29: e941577.
68. 张馨元. 分级运动想象应用于胸腔镜肺癌术后恐动症患者效果的混合方法研究. 南方医科大学, 2023.Zhang XY. Effects of graded motor imagery on patients with kinesiophobia after video-assisted thoracoscopic surgery for lung cancer: A mixed methods study. Southern Medical University, 2023.
69. Tan DSW, Felip E, de Castro G, et al. Canakinumab versus placebo in combination with first-line pembrolizumab plus chemotherapy for advanced non-small-cell lung cancer: Results from the CANOPY-1 trial. J Clin Oncol, 2024, 42(2): 192-204.
70. Dai W, Wang Y, Liao J, et al. Electronic patient-reported outcome-based symptom management versus usual care after lung cancer surgery: Long-term results of a multicenter, randomized, controlled trial. J Clin Oncol, 2024, 42(18): 2126-2131.
71. Banks LC, Kapphahn K, Das M, et al. Randomized trial of a volunteer-led symptom assessment intervention on documentation, patient-reported outcomes, and health care use among veterans with lung cancer. JCO Oncol Pract, 2024, 20(3): 419-428.
72. Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and elaboration: Updated guidelines for reporting parallel group randomised trials. Int J Surg, 2012, 10(1): 28-55.
73. Mack DE, Wilson PM, Santos E, et al. Standards of reporting: The use of CONSORT PRO and CERT in individuals living with osteoporosis. Osteoporos Int, 2018, 29(2): 305-313.
74. Efficace F, Fayers P, Pusic A, et al. Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials. Cancer, 2015, 121(18): 3335-3342.
75. van der Vet P, Wilson S, Houwert RM, et al. Quality and reporting of patient-reported outcomes in elderly patients with hip fracture: A systematic review. BMJ Open, 2022, 12(12): e058197.
76. Ladd C, Jacobsen SM, Snider K, et al. Evaluating the underreporting of patient-reported outcomes in carpal tunnel syndrome randomized controlled trials. J Osteopath Med, 2023, 123(6): 301-308.
77. Goorts K, Dizon J, Milanese S. The effectiveness of implementation strategies for promoting evidence informed interventions in allied healthcare: A systematic review. BMC Health Serv Res, 2021, 21(1): 241.
78. Clancy CJ, Buehrle D, Vu M, et al. Impact of revised Infectious Diseases Society of America and Society for Healthcare Epidemiology of America clinical practice guidelines on the treatment of clostridium difficile infections in the United States. Clin Infect Dis, 2021, 72(11): 1944-1949.
79. Zhou J, Qi H, Hu J, et al. Low-quality of patient-reported outcome reporting in randomized clinical trials of major depressive disorder—A meta-epidemiological review. Front Psychiatry, 2023, 14: 1246938.
80. Fabian A, Domschikowski J, Letsch A, et al. Use and reporting of patient-reported outcomes in trials of palliative radiotherapy: A systematic review. JAMA Netw Open, 2022, 5(9): e2231930.
81. Anderson RM, Streck S, Hughes G, et al. Evaluating reporting of patient-reported outcomes in peptic ulcer disease: A meta-epidemiological study of randomized controlled trials. Expert Rev Pharmacoecon Outcomes Res, 2022, 22(8): 1253-1260.
82. Khan T, Khalid M, Dunford B, et al. Incomplete reporting of patient-reported outcomes in multiple sclerosis: A meta-epidemiological study of randomized controlled trials. Mult Scler Relat Disord, 2022, 63: 103819.
83. Brock L, Hightower B, Moore T, et al. Reporting of patient-reported outcome measures in randomized controlled trials on shoulder rotator cuff injuries is suboptimal and requires standardization. Arthrosc Sports Med Rehabil, 2022, 4(4): e1429-e1436.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

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

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