Health-related quality of life in cancer patients treated with immune checkpoint inhibitors: A systematic review on reporting of methods in randomized controlled trials


Autoři: Stéphane Faury aff001;  Jérôme Foucaud aff002
Působiště autorů: Laboratory Handicap, Activity, Cognition, Health, EA, University of Bordeaux, Bordeaux, France aff001;  INCa, Institut National du Cancer, Boulogne Billancourt, France aff002
Vyšlo v časopise: PLoS ONE 15(1)
Kategorie: Research Article
doi: 10.1371/journal.pone.0227344

Souhrn

Objective

Immune checkpoint inhibitors (ICIs) have recently shown tremendous promise in the treatment of diverse cancers. The available data suggests that ICIs are well tolerated in terms of health-related quality of life (HRQOL) compared to other anticancer therapies. However, it appears that instruments currently used to evaluate HRQOL in this context may fail to capture important symptomatology unique to ICIs. This systematic review was designed to assess the adequacy of methods used to report HRQOL in cancer patients treated with ICIs and to identify the quality of life scales used.

Method

A systematic review was performed (systematic registration number: PROSPERO: CRD42019121427). A search of the PubMed, PsycINFO, PsycARTICLES, Psychology and Behavioral Sciences collection, and SocINDEX databases was carried out for publications in English and in French. Relevant databases were searched from the earliest records through to March 2019. Publications were selected if they reported on HRQOL in patients with cancer treated by ICIs. Risk of bias was scored using the Cochrane Collaboration bias assessment tool.

Results

Our search identified 144 publications between 2012 and 2019, of which 15 RCTs met the inclusion criteria. The results suggest that even though the overall reporting of HRQOL was deemed to be of good quality, the data available was marred by methodological aspects such as the lack of HRQOL research hypotheses and the lack of questionnaires validated for cancer patients treated with immunotherapy.

Conclusion

This study provides a comprehensive analysis of the current state of the art and identifies gaps in knowledge on HRQOL analysis with respect to ICIs. It also suggests avenues for further research.

Klíčová slova:

Cancer immunotherapy – Cancer treatment – Clinical trials – Clinical trials (cancer treatment) – Database searching – Psychometrics – Quality of life – Systematic reviews


Zdroje

1. Gálffy G, Puskás R. Role of pembrolizumab in the treatment of non-small cell lung cancer (NSCLC). Magy Onkol. 2017;61(1): 107–110. 28273195

2. Emens LA, Ascierto PA, Darcy PK, Demaria S, Eggermont AMM, Redmond WL, et al. Cancer immunotherapy: opportunities and challenges in the rapidly evolving clinical landscape. Eur J Cancer 2017;81: 116–129. doi: 10.1016/j.ejca.2017.01.035 28623775

3. Morrissey KM, Yuraszeck TM, Li CC, Zhang Y, Kasichayanula S. Immunotherapy and novel combinations in Oncology: current Landscape; challenges and opportunities. Clin Transl Sci. 2016;9(2): 89–104. doi: 10.1111/cts.12391 26924066

4. Dine J, Gordon R, Shames Y, Kasler MK, Barton-Burke M. Immune Checkpoint Inhibitors: An innovation on Immunotherapy for the Treatment and Management of Patients with Cancer. Asia Pac J Oncol Nurs. 2017;4(2): 127–135. doi: 10.4103/apjon.apjon_4_17 28503645

5. Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012;366(26): 2443–2454. doi: 10.1056/NEJMoa1200690 22658127

6. Administration, U.S.F.a.D. Drugs@FDA: FDA approved drug products. 2018 february 28th; Available from: https://www.accessdata.fda.gov/scripts/cder/daf/.

7. Puzanov I, Diab A, Abdallah K, Bingham CO, Brogdon C, Dadu R, et al. Managing toxicities associated with immune checkpoint inhibitors: consensus recommendations from the Society for Immunotherapy of Cancer (SITC) Toxicity Management Working Group. J Immunither Cancer 2017;5(1): 95. doi: 10.1186/s40425-017-0300-z 29162153

8. Voudouri D, Nikolalaou V, Laschos K, Charpidou A, Soupos N, Triantafyllopoulou, et al. Anti-PD1/PDL1 induced psoriasis. Curr Probl Cancer 2017;41(6): 407–412. doi: 10.1016/j.currproblcancer.2017.10.003 29096940

9. Brahmer J, Lacchetti C, Schneider BJ, Atkins MB, Brassil KJ, Caterino JM, et al. Management of Immune-Related Adverse Events in patients treated with immunce checkpoint inhibitor therapy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2018;36(17): 1714–1768. doi: 10.1200/JCO.2017.77.6385 29442540

10. Ghislain I, Zikos E, Coens C, Quinten C, Balta V, Tryfonidis K, et al. Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials. Lancet Oncol. 2016;17(7): 294–304.

11. Abdel-Rahman O, Oweira H, Giryes A. Health-related quality of life in cancer patients treated with PD-(L)1 inhibitors: A systematic review. Expert Rev Anticancer 2018;18(12): 1231–1239.

12. Hall ET, Singhal S, Dickerson J, Gabster B, Wong HN, Aslakson RA et al. Patient-reported outcomes for cancer patients receiving checkpoint inhibitors: Opportunities for palliative care- A systematic review. JPSM 2019. https://doi.org/10.1016/j.jpainsymman.2019.03.015

13. Ferris RL, Blumenschein G, Fayette J, Guigay J, Colevas AD, Licitra L, et al. Nivolumab for recurrent squamous-Cell carcinoma of the head and neck. N Engl J Med. 2016;375: 1856–1867. doi: 10.1056/NEJMoa1602252 27718784

14. Downing A, Morris EJ, Richards M, Corner J, Wright P, Sebag-Montefiore D, et al. Health- related quality of life after colorectal cancer in England: A patient-reported outcomes study of individuals 12 to 36 months after diagnosis. J Clin Oncol. 2015;33(6): 616–624. doi: 10.1200/JCO.2014.56.6539 25559806

15. Ramsey SD, Andersen MR, Etzioni R, Moinpour C, Peacock S, Potosky A, et al. Quality of life in survivors of colorectal carcinoma. Cancer 2000;88(6): 1294–1303. 10717609

16. Kopp I, Bauhofer A, Koller M. Understanding quality of life in patients with colorectal cancer: Comparison of data from a randomised controlled trial, a population based cohort study and the norm reference population. Inflamm Res. 2004;53 (Suppl 2): 130–135.

17. Bottomley A, Flechtner H, Efficace F, Vanvoorden V, Coens C, Therasse P, et al. Health related quality of life outcomes in cancer clinical trials. Eur J Cancer 2005;41(12): 1697–1709. doi: 10.1016/j.ejca.2005.05.007 16043345

18. Au HJ, Ringash J, Brundage M, Palmer M, Richardson H, Meyer RM, et al. Added value of health-related quality of life measurement in cancer clinical trials: the experience of the NCIC CTG. Expert Rev Pharmacoecon Outcomes Res. 2010;10(2): 119–128. doi: 10.1586/erp.10.15 20384559

19. Fielding S, Ogbuagu A, Sivasubramaniam S, MacLennan G, Ramsay CR. Reporting and dealing with missing quality of life data in RCTs: has the picture changed in the last decade? Qual Life Res.2016;25(12): 2977–2983. doi: 10.1007/s11136-016-1411-6 27650288

20. Zikos E, Ghislain I, Coens C, Ediebah DE, Sloan E, Quinten C, et al. Health-related quality of life in small-cell lung cancer: a systematic review on reporting of methods and clinical issues in randomised controlled trials. Lancet Oncol. 2014;15(2): 78–89.

21. Jacobsen PB, Davis K, Cella D. Assessing quality of life in research and clinical practice. Oncology 2002;16 (9 Suppl 10): 133–139.

22. Bottomley A, Therasse P. Quality of life in patients undergoing systemic therapy for advanced breast cancer. Lancet Oncol. 2002;3(10): 620–628. doi: 10.1016/s1470-2045(02)00876-8 12372724

23. Sanders C, Egger M, Donovan J, Tallon D, Frankel S. Reporting on quality of life in randomised controlled trials: Bibliographic study. BMJ 1998;317(7167):1191–1194. doi: 10.1136/bmj.317.7167.1191 9794853

24. Lee CW, Chi KN. The standard of reporting of health-related quality of life in clinical cancer trials. J Clin Epidemiol. 2000;53(5):451–458. doi: 10.1016/s0895-4356(99)00221-8 10812316

25. Efficace F, Bottomley A, Osaba D, Gotay C, Flechtner H, D’haese S, et al. Beyond the development of Health-Related Quality-of-life (HRQOL) measures: A checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials-Does HRQOL Evaluation in Prostate Cancer Research Inform Clinical Decision Making? J Clin Oncol. 2003; 21(18): 3502–3511. doi: 10.1200/JCO.2003.12.121 12972527

26. Moher D, Jones A, Lepage L, CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. Jama 2001;285:1992–1995. doi: 10.1001/jama.285.15.1992 11308436

27. http://www.crd.york.ac.uk/PROSPERO/

28. Shamseer L, Moher D, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation. BMJ 2015;350. doi: 10.1136/bmj.g7647 25555855

29. Liberati A, Petticrew M, Shekelle P, Stewart LA. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015;4:1. doi: 10.1186/2046-4053-4-1 25554246

30. Higgins JPT, Green S, eds. Cochrane handbook for systematic reviews of interventions version 5.1.0. Cochrane Collab, 2011. Julian PT Higgins and Sally Green.

31. Staquet M, Berzon R, Osoba D, Machin D. Guidelines for reporting results of quality of life assessments in clinical trials. Qual Life Res. 1996;5(5): 496–502. doi: 10.1007/bf00540022 8973129

32. Chassany O, Sagnier P, Marquis P, Fullerton S, Aaronson N, ERIQA. Patient-reported outcomes: The example of health related quality of life—A European guidance document for the improved integration of health related quality of life assessment in the drug regulatory process. Drug Inf J. 2002;36(1): 209–238.

33. de Haes J, Curran D, Young T, Bottomley A, Flechtner H, Aaronson N, et al. Quality of life evaluation in oncological clinical trials: The EORTC model—The EORTC Quality of Life Study Group. Eur J Cancer 2000;36(7): 821–825. doi: 10.1016/s0959-8049(00)00007-1 10785585

34. Sprangers MA, Moinpour CM, Moynihan TJ, Patrick DL, Revicki DA, Clinical Significance Consensus Meeting Group. Assessing meaningful change in quality of life over time: A users’ guide for clinicians. Mayo Clin Proc. 2002;77(6): 561–571. doi: 10.4065/77.6.561 12059127

35. Higgins JPT, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. BMJ 2011;343. doi: 10.1136/bmj.d5928 22008217

36. Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, et al. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, pen-label, multicentre randomised controlled trial. Lancet 2017;389(10066): 255–65. doi: 10.1016/S0140-6736(16)32517-X 27979383

37. Reck M, Rodríguez-Abreu D, Robinson AG, Hui R, Csöszi T, Fülöp A et al. Pembrolizumab versus chemotherapy for PD-L1-Positive Non-Small-Cell lung cancer. N Engl J Med. 2016;375: 1823–1833. doi: 10.1056/NEJMoa1606774 27718847

38. Motzer RJ, Escudier B, McDermott DF, George S, Hammers HJ, Srinivas S, et al. Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med. 2015;373: 1803–1813. doi: 10.1056/NEJMoa1510665 26406148

39. Motzer RJ, Tannir NM, McDermott DF, Arén Frontera O, Melichar B, Choueiri TK et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. N Engl J Med. 2018;378(14): 1277–1290. doi: 10.1056/NEJMoa1712126 29562145

40. Eggermont A, Chiarion-Sileni V, Grob Jean-Jacques, Dummer R, Wolchok JD, Schmidt H et al. Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial. Lancer Oncol. 2015;16: 522–530.

41. Weber JS, D’Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015;16: 375–384. doi: 10.1016/S1470-2045(15)70076-8 25795410

42. Robert C, Long G, Brady B, Dutriaux C, Maio M, Mortier L et al. Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med. 2015;372: 320–330. doi: 10.1056/NEJMoa1412082 25399552

43. Robert C, Schachter J, Long G, Arance A, Grob JJ, Mortier L et al. Pembrolizumab versus Ipilimumab in advanced melanoma. N Engl J Med.2015;372: 2521–2532. doi: 10.1056/NEJMoa1503093 25891173

44. Brahmer J, Reckamp K, Baas P, Crinò L, Eberhardt EE, Poddubskaya E, et al. Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer. N Engl J Med.2015;373: 123–135. doi: 10.1056/NEJMoa1504627 26028407

45. Hodi FS, O’Day S, McDermott DF, Weber RW, Sosman JA, Haanen JB et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363(8): 711–723. doi: 10.1056/NEJMoa1003466 20525992

46. Ribas A, Puzonov I, Dummer R, Schadendorf D, Hamid O, Robert C, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol. 2015;16(8): 908–918. doi: 10.1016/S1470-2045(15)00083-2 26115796

47. Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med. 2015;373: 23–34. doi: 10.1056/NEJMoa1504030 26027431

48. Bellmunt J, de Wit R, Vaughn DJ, Fradet Y, Lee JL, Fong L, et al. Pembrolizumab as second-line therapy for advanced urothelial carcinoma. N Engl J Med. 2017;376(11): 1015–1026. doi: 10.1056/NEJMoa1613683 28212060

49. Bordoni R, Ciardiello F, von Pawel J, Cortinovis D, Karagiannis T, Ballinger M, 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. doi: 10.1016/j.cllc.2018.05.011 30017645

50. Cella D, Grünwald V, Nathan P, Doan J, Dastani H, Taylor F, et al. Quality of life in patients with advanced renal cell carcinoma given nivolumab versus everolimus in CheckMate 025: a randomised, open-label, phase 3 trial. Lancet Oncol. 2016;17(7): 994–1003. doi: 10.1016/S1470-2045(16)30125-5 27283863

51. Coens C, Suciu S, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, et al. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial. Lancet Oncol. 2017;18(3): 393–403. doi: 10.1016/S1470-2045(17)30015-3 28162999

52. Larkin J, Minor D, D’Angelo S, Neyns B, Smylie M, Miller WH, et al. Overall survival in patients with advanced melanoma who received nivolumab versus investigator’s choice chemotherapy in CheckMate 037: a randomized, controlled, open-label phase III Trial. J Clin Oncol. 2018;36(4): 383–393. doi: 10.1200/JCO.2016.71.8023 28671856

53. Long GV, Atkinson V, Ascierto PA, Robert C, Hassel JC, Rutkowski P, et al. Effect of nivolumab on health-related quality of life in patients with treatment-naïve advanced melanoma: results from the phase III CheckMate 066 study. Ann Oncol. 2016; 27(10): 1940¬¬—1946. doi: 10.1093/annonc/mdw265 27405322

54. Petrella T.M, Robert C, Richtig E, Miller WH, Masucci GV, Walpole E, et al. Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma. Eur JCancer 2017; 86: 115–124.

55. Reck M, Taylor F, Penrod J, DeRosa M, Morrissey L, Dastani H, et al. Impact of Nivolumab Versus Docetaxel on Health-Related Quality of Life and Symptoms in Patients With Advanced Squamous Non-Small Cell Lung Cancer: Results From the CheckMate 017 Study. J Thorac Oncol. 2018;13(2): 194–204. doi: 10.1016/j.jtho.2017.10.029 29129758

56. Schadendorf D, Larkin J, Wolchok J, Hodi FS, Chiarion-Sileni V, Gonzalez R, et al. Health-related quality of life results from the phase III CheckMate 067 study. Eur J cancer 2017;82: 80–91. doi: 10.1016/j.ejca.2017.05.031 28651159

57. Weber J, Mandala M, Del Vecchio M, Gogas HJ, Arance AM, Cowey CL, et al. Adjuvant Nivolumab versus ipilimumab in resected stage III or IV melanoma. N Engl J Med. 2017; 377: 1824–1835. doi: 10.1056/NEJMoa1709030 28891423

58. Brahmer JR, Rodriguez-Abreu D, Robinson AG, Hui R, Csöszi T, Fülöp A, 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. doi: 10.1016/S1470-2045(17)30690-3 29129441

59. Cella D, Grünwald V, Escudier B, Hammers HJ, George S, Nathan P, et al. Patient-reported outcomes of patients with advanced renal cell carcinoma treated with nivolumab plus ipilimumab versus sunitinib (CheckMate 214): a randomised, phase 3 trial. Lancet Oncol. 2019; 20: 297–310. doi: 10.1016/S1470-2045(18)30778-2 30658932

60. Harrington K, Ferris R, Blumenschein G, Colevas AD, Fayette J, Licitra L, et al. Nivolumab versus standard, single-agent therapy of investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised phase 3 trial. Lancet Oncol. 2017;18(8): 1104–1115. doi: 10.1016/S1470-2045(17)30421-7 28651929

61. Schadendorf D, Dummer R, Hauschild A, Robert C, Hamid O, Daud A, et al. Health-related quality of life in the randomised KEYNOTE-002 study of pembrolizumab versus chemotherapy in patients with ipilimumab-refractory melanoma. Eur J cancer 2016;67: 46–54. doi: 10.1016/j.ejca.2016.07.018 27596353

62. Vaughn DJ, Bellmunt J, Fradet Y, Lee JL, Fong L, Vogelzang NJ, et al. Health-related quality of life analysis from keynote-45: A phase III study of pembrolizumab versus chemotherapy for previously treated advanced urothelial cancer. J Clin Oncol 2018; 16(1): 1579–1587.

63. Revicki DA, van den Eertwegh AJM, Lorigan P, Lebbe C, Linette G, Ottensmeier CH, et al. Health related quality of life outcomes for unresectable stage III or IV melanoma patients receiving ipilimumab treatment. Health Qual Life outcomes 2012;10: 66. doi: 10.1186/1477-7525-10-66 22694829

64. Efficace F, Fayers P, Pusic A, Cemal Y, Yanagawa J, Jacobs M, 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. doi: 10.1002/cncr.29489 26079197

65. Hamel JF, Saulnier P, Pe M, Zikos E, Musoro J, Coens C, et al. A systematic review of the quality of statistical methods employed for analysing quality of life data in cancer randomised controlled trials. Eur J Cancer 2017;83: 166–176. doi: 10.1016/j.ejca.2017.06.025 28738257

66. European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal productshttps://www.ispor.org/workpaper/emea-hrql-guidance.pdf (accessed mars 8, 2018).

67. Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998; 16: 139–144. doi: 10.1200/JCO.1998.16.1.139 9440735

68. Maringwa JT, Quinten C, King M, Ringash J, Osoba D, Coens C, et al. Minimal important differences for interpreting health related quality of life scores from the EORTC QLQC30 in lung cancer patients participating in randomized controlled trials. Support Care Cancer 2011;19(11): 1753–1760. doi: 10.1007/s00520-010-1016-5 20886240

69. Schadendorf D, Amonkar MM, Milhem M, Grotzinger K, Demidov LV, Rutkowski P, et al. Functional and symptom impact of trametinib versus chemotherapy in BRAF V600E advanced or metastatic melanoma: Quality-of-life analyses of the METRIC study. Ann Oncol. 2014;25: 700–706. doi: 10.1093/annonc/mdt580 24504441

70. Singer S. Quality of life after Nivolumab treatment for head and neck cancer. Lancet Oncol. 2017;18(8): 993–994. doi: 10.1016/S1470-2045(17)30463-1 28651926

71. Campbell A, Converse PE, Rodgers WL. The quality of American life: Perceptions, evaluations, and satisfactions: RSF. 1976.

72. Hosseini B, Nedjat S, Zendehdel K, Majdzadeh R, Nourmohammadi A, Montazer A. Response shift in quality of life assessment among cancer patients: A study from Iran. Med J Islam Repub Iran 2017;31:120. doi: 10.14196/mjiri.31.120 29951421

73. Sprangers M, Schwartz C. The challenge of response shift for quality- of-life-based clinicaloncology research. Ann Oncol. 1999;10(7): 747–749. doi: 10.1023/a:1008305523548 10470418

74. Sprangers MA, Schwartz CE. Integrating response shift into health- related quality of life research: a theoretical model. Soc. Sci. Med. 1999;48(11): 1507–1515. doi: 10.1016/s0277-9536(99)00045-3 10400253

75. Breetvelt I, Van Dam F. Underreporting by cancer patients: the case of response-shift. Soc. Sci. Med. 1991;32(9): 981–987. doi: 10.1016/0277-9536(91)90156-7 2047902

76. Andrykowski MA, Hunt JW. Positive psychosocial adjustment in potential bone marrow transplant recipients: Cancer as a psychosocial transition. Psychooncology. 1993;2(4): 261–276.

77. Kagawa-Singer M. Redefining health: living with cancer. Soc. Sci. Med. 1993;37(3): 295–304. doi: 10.1016/0277-9536(93)90261-2 8356479

78. Leventhal H, Meyer D, Nerenz D. The common sense representation of illness danger. In Rachman S, ed. Contributions to Medical Psychology. New York: pergamon press 1980; 7–30.

79. Richardson E, Schüz N, Sanderson K, Scott JL, Schüz B. Illness representations, coping and illness outcomes in people with cancer: a systematic review and meta-analysis. Psychoncology 2016;26(6): 724–737.

80. Day SJ, Altman DG. Blinding in clinical trials and other studies. BMJ 2000;321: 504. doi: 10.1136/bmj.321.7259.504 10948038

81. Sparano F, Aaronson NK, Sprangers MAG, Fayers P, Pusic A, Kieffer JM et al. Does the quality of patient-reported outcomes (PROs) assessment in randomized controlled trials (RCTs) differ across cancer types and over time? A pooled analysis of 610 RCTs published between 2004 and 2018. J. Clin. Oncol. 2019;37(15). doi: 10.1200/JCO.2019.37.15_suppl.e18218

82. Patel KK, Veenstra DL, Patrick DL. A review of selected patient-generated outcome measures and their application in clinical trials. Value Health. 2003; 6(5): 595–603. doi: 10.1046/j.1524-4733.2003.65236.x 14627066

83. Aburub AS, Gagnon B, Rodriguez AM, Mayo NE. Using a personalized measure (Patient Generated Index (PGI)) to identify what matters to people with cancer. Support Care Cancer. 2016;24(1):437–445. doi: 10.1007/s00520-015-2821-7 26099901

84. Tang JA, Taemin OH, Scheer JK, Parsa AT. The Current Trend of Administering a Patient-Generated Index in the Oncological Setting: A Systematic Review. Oncol Rev. 2014;8(1): 245. doi: 10.4081/oncol.2014.245 25992233


Článek vyšel v časopise

PLOS One


2020 Číslo 1