Health-related quality of life in patients with brain tumors: Limitations and additional outcome measures

Current Neurology and Neuroscience Reports

Volumn 13, Issue 7, 2013, Pages

  Dirven, Linda ^a   Reijneveld, Jacob C ^a   Aaronson, Neil K ^b   Bottomley, Andrew ^c   Uitdehaag, Bernard M J ^a   Taphoorn, Martin J B ^a,d  

^a VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^b NETHERLANDS CANCER INSTITUTE   (Netherlands)

^c EORTC DATA CENTER   (Belgium)

^d MEDICAL CENTER HAAGLANDEN   (Netherlands)

Author keywords

Brain tumors; Cognitive deterioration; Differential item functioning; Health related quality of life; Methodological limitations; Missing data; Response shift

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; BRAIN CANCER; BRAIN TUMOR; CANCER CHEMOTHERAPY; CANCER RESEARCH; CLINICAL ASSESSMENT TOOL; COGNITIVE DEFECT; DAILY LIFE ACTIVITY; FUNCTIONAL ASSESSMENT; GLIOMA; GOLD STANDARD; HUMAN; MENTAL DETERIORATION; NEUROPSYCHOLOGICAL TEST; OUTCOME ASSESSMENT; PSYCHOLOGICAL WELL BEING; QUALITY OF LIFE; QUESTIONNAIRE; SELF REPORT; TUMOR GROWTH; HEALTH STATUS; PSYCHOLOGICAL ASPECT; REVIEW; COMPLICATION; PSYCHOLOGY;

ACTIVITIES OF DAILY LIVING; BRAIN NEOPLASMS; COGNITION DISORDERS; HEALTH STATUS; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); QUALITY OF LIFE;

EID: 84879466480     PISSN: 15284042     EISSN: 15346293     Source Type: Journal    
DOI: 10.1007/s11910-013-0359-y     Document Type: Article

References (94)

1. Kamangar F, Dores GM, Anderson WF. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol. 2006;24:2137-50. (Pubitemid 46655601)
2. Behin A, Hoang-Xuan K, Carpentier AF, Delattre JY. Primary brain tumours in adults. Lancet. 2003;361:323-31. (Pubitemid 36126198)
3. Ranjan T, Abrey LE. Current management of metastatic brain disease. Neurotherapeutics. 2009;6:598-603.
4. Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352:987-96. (Pubitemid 40349501)
5. Efficace F, Taphoorn M. Methodological issues in designing and reporting health-related quality of life in cancer clinical trials: the challenge of brain cancer studies. J Neurooncol. 2012;108:221-6.
6. Efficace F, Bottomley A. Health related quality of life assessment methodology and reported outcomes in randomised controlled trials of primary brain cancer patients. Eur J Cancer. 2002;38:1824-31. (Pubitemid 35247467)
7. Aaronson NK. Quality of life: what is it? How should it be measured? Oncology (Williston Park). 1988;2:69-76.
8. Aaronson NK, Taphoorn MJ, Heimans JJ, Postma TJ, Gundy CM, Beute GN, et al. Compromised health-related quality of life in patients with low-grade glioma. J Clin Oncol. 2011;29:4430-5.
9. Caissie A, Nguyen J, Chen E, Zhang L, Sahgal A, Clemons M, et al. Quality of life in patients with brain metastases using the EORTC QLQ-BN20+2 and QLQ-C15-PAL. Int J Radiat Oncol Biol Phys. 2012;83:1238-45.
10. Gronberg BH, Ciuleanu T, Flotten O, Knuuttila A, Abel E, Langer SW, et al. A placebo-controlled, randomized phase II study of maintenance enzastaurin following whole brain radiation therapy in the treatment of brain metastases from lung cancer. Lung Cancer. 2012;78:63-9.
11. Ma S, Xu Y, Deng Q, Yu X. Treatment of brain metastasis from non-small cell lung cancer with whole brain radiotherapy and Gefitinib in a Chinese population. Lung Cancer. 2009;65:198-203.
12. Steinmann D, Paelecke-Habermann Y, Geinitz H, Aschoff R, Bayerl A, Bolling T, et al. Prospective evaluation of quality of life effects in patients undergoing palliative radiotherapy for brain metastases. BMC Cancer. 2012;12:283.
13. Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, et al. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012;48:2192-202.
14. Taphoorn MJ, Stupp R, Coens C, Osoba D, Kortmann R, van den Bent MJ, et al. Health-related quality of life in patients with glioblastoma: a randomised controlled trial. Lancet Oncol. 2005;6:937-44. (Pubitemid 41685226)
15. Taphoorn MJ, van den Bent MJ, Mauer ME, Coens C, Delattre JY, Brandes AA, et al. Health-related quality of life in patients treated for anaplastic oligodendroglioma with adjuvant chemotherapy: results of a European Organisation for Research and Treatment of Cancer randomized clinical trial. J Clin Oncol. 2007;25:5723-30.
16. Yaneva MP, Semerdjieva MA. Assessment of the effect of palliative radiotherapy for cancer patients with intracranial metastases using EORTC-QOL-C30 questionnaire. Folia Med (Plovdiv). 2006;48:23-9.
17. Yavas C, Zorlu F, Ozyigit G, Gurkaynak M, Yavas G, Yuce D, et al. Health-related quality of life in high-grade glioma patients: a prospective single-center study. Support Care Cancer. 2012;20:2315-25.
18. Kirkbride P, Tannock IF. Trials in palliative treatment-have the goal posts been moved? Lancet Oncol. 2008;9:186-7. (Pubitemid 351722934)
19. Arpinelli F, Bamfi F. The FDA guidance for industry on PROs: the point of view of a pharmaceutical company. Health Qual Life Outcomes. 2006;4:85. (Pubitemid 44774181)
20. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-76. (Pubitemid 23073154)
21. Osoba D, Aaronson NK, Muller M, Sneeuw K, Hsu MA, Yung WK, et al. The development and psychometric validation of a brain cancer quality-of-life questionnaire for use in combination with general cancer-specific questionnaires. Qual Life Res. 1996;5:139-50. (Pubitemid 26100512)
22. Taphoorn MJ, Claassens L, Aaronson NK, Coens C, Mauer M, Osoba D, et al. An international validation study of the EORTC brain cancer module (EORTC QLQ-BN20) for assessing health-related quality of life and symptoms in brain cancer patients. Eur J Cancer. 2012;46:1033-40.
23. Weitzner MA, Meyers CA, Gelke CK, Byrne KS, Cella DF, Levin VA. The Functional Assessment of Cancer Therapy (FACT) scale. Development of a brain subscale and revalidation of the general version (FACT-G) in patients with primary brain tumors. Cancer. 1995;75:1151-61.
24. Armstrong TS, Mendoza T, Gning I, Coco C, Cohen MZ, Eriksen L, et al. Validation of the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT). J Neurooncol. 2006;80:27-35. (Pubitemid 44473259)
25. Armstrong TS, Gning I, Mendoza TR, Weinberg JS, Gilbert MR, Tortorice ML, et al. Clinical utility of the MDASI-BT in patients with brain metastases. J Pain Symptom Manage. 2009;37:331-40.
26. Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002;288:3027-34. (Pubitemid 35471165)
27. Hilarius DL, Kloeg PH, Gundy CM, Aaronson NK. Use of health-related quality-of-life assessments in daily clinical oncology nursing practice: a community hospital-based intervention study. Cancer. 2008;113:628-37.
28. Taphoorn MJ, Sizoo EM, Bottomley A. Review on quality of life issues in patients with primary brain tumors. Oncologist. 2010;15:618-26.
29. Cheng JX, Zhang X, Liu BL. Health-related quality of life in patients with high-grade glioma. Neuro Oncol. 2009;11:41-50.
30. Vordermark D. Avoiding bias in the prospective evaluation of patients with brain metastases. J Clin Oncol. 2007;25:4023-5. (Pubitemid 47477288)
31. Gallego Perez-Larraya J, Ducray F, Chinot O, Catry-Thomas I, Taillandier L, Guillamo JS, et al. Temozolomide in elderly patients with newly diagnosed glioblastoma and poor performance status: an ANOCEF phase II trial. J Clin Oncol. 2011;29:3050-5.
32. Levin VA, Phuphanich S, Yung WK, Forsyth PA, Maestro RD, Perry JR, et al. Randomized, double-blind, placebo-controlled trial of marimastat in glioblastoma multiforme patients following surgery and irradiation. J Neurooncol. 2006;78:295-302. (Pubitemid 44018824)
33. Mauer ME, Bottomley A, Taphoorn MJ. Evaluating health-related quality of life and symptom burden in brain tumour patients: instruments for use in experimental trials and clinical practice. Curr Opin Neurol. 2008;21:745-53.
34. Reijneveld JC, Klein M, Taphoorn MJ, Postma TJ, Heimans JJ. Improved, personalized treatment of glioma necessitates long-term follow-up of cognitive functioning. Pharmacogenomics. 2012;13:1667-9.
35. Osoba D. What has been learned from measuring health-related quality of life in clinical oncology. Eur J Cancer. 1999;35:1565-70. (Pubitemid 29454528)
36. Hakamies-Blomqvist L, Luoma ML, Sjostrom J, Pluzanska A, Sjodin M, Mouridsen H, et al. Timing of quality of life (QoL) assessments as a source of error in oncological trials. J Adv Nurs. 2001;35:709-16. (Pubitemid 33609440)
37. Klee MC, King MT, Machin D, Hansen HH. A clinical model for quality of life assessment in cancer patients receiving chemotherapy. Ann Oncol. 2000;11:23-30. (Pubitemid 30084575)
38. Pater J, Osoba D, Zee B, Lofters W, Gore M, Dempsey E, et al. Effects of altering the time of administration and the time frame of quality of life assessments in clinical trials: an example using the EORTC QLQ-C30 in a large anti-emetic trial. Qual Life Res. 1998;7:273-8. (Pubitemid 28180047)
39. Ediebah DE, Coens C, Maringwa JT, Quinten C, Zikos E, Ringash J, et al. Effect of completion-time windows in the analysis of health-related quality of life outcomes in cancer patients. Ann Oncol. 2013;24:231-7.
40. Osoba D. Rationale for the timing of health-related quality-of-life (HQL) assessments in oncological palliative therapy. Cancer Treat Rev. 1996;22(A):69-73. (Pubitemid 26158435)
41. Fairclough DL, Cella DF. Functional Assessment of Cancer Therapy (FACT-G): non-response to individual questions. Qual Life Res. 1996;5:321-9. (Pubitemid 26228465)
42. Walker M, Brown J, Brown K, Gregor A, Whittle IR, Grant R. Practical problems with the collection and interpretation of serial quality of life assessments in patients with malignant glioma. J Neurooncol. 2003;63:179-86. (Pubitemid 36705687)
43. Rubin DB. Inference and missing data. Biometrika. 1976;63:581-92.
44. Little R, Rubin D. Statistical Analysis with Missing Data. New York: Wiley; 1987.
45. Post WJ, Buijs C, Stolk RP, de Vries EG, le Cessie S. The analysis of longitudinal quality of life measures with informative drop-out: a pattern mixture approach. Qual Life Res. 2010;19:137-48.
46. Walther B, Hossin S, Townend J, Abernethy N, Parker D, Jeffries D. Comparison of electronic data capture (EDC) with the standard data capture method for clinical trial data. PLoS One. 2011;6:e25348.
47. Maringwa J, Quinten C, King M, Ringash J, Osoba D, Coens C, et al. Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Ann Oncol. 2011;22:2107-12.
48. Kvam AK, Wisloff F, Fayers PM. Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma. Health Qual Life Outcomes. 2010;8:79.
49. Schwartz CE, Bode R, Repucci N, Becker J, Sprangers MA, Fayers PM. The clinical significance of adaptation to changing health: a meta-analysis of response shift. Qual Life Res. 2006;15:1533-50. (Pubitemid 44736786)
50. Schwartz CE, Sprangers MA. Methodological approaches for assessing response shift in longitudinal health-related quality-of-life research. Soc Sci Med. 1999;48:1531-48. (Pubitemid 29254112)
51. Sprangers MA, Schwartz CE. Integrating response shift into health-related quality of life research: a theoretical model. Soc Sci Med. 1999;48:1507-15. (Pubitemid 29254110)
52. Rapkin BD, Schwartz CE. Toward a theoretical model of quality-of-life appraisal: Implications of findings from studies of response shift. Health Qual Life Outcomes. 2004;2:14. (Pubitemid 39115369)
53. Barclay-Goddard R, Epstein JD, Mayo NE. Response shift: a brief overview and proposed research priorities. Qual Life Res. 2009;18:335-46.
54. Hamidou Z, Dabakuyo TS, Bonnetain F. Impact of response shift on longitudinal quality-of-life assessment in cancer clinical trials. Expert Rev Pharmacoecon Outcomes Res. 2011;11:549-59.
55. Ubel PA, Peeters Y, Smith D. Abandoning the language of «response shift»: a plea for conceptual clarity in distinguishing scale recalibration from true changes in quality of life. Qual Life Res. 2010;19:465-71.
56. Nolte S, Elsworth GR, Sinclair AJ, Osborne RH. The inclusion of 'then-test' questions in post-test questionnaires alters post-test responses: a randomized study of bias in health program evaluation. Qual Life Res. 2012;21:487-94.
57. Schwartz CE, Sprangers MA. Guidelines for improving the stringency of response shift research using the thentest. Qual Life Res. 2010;19:455-64.
58. McPhail S, Haines T. Response shift, recall bias and their effect on measuring change in health-related quality of life amongst older hospital patients. Health Qual Life Outcomes. 2010;8:65.
59. Groenvold M, Petersen M. The role and use of differential item functioning (DIF) analysis of quality of life data in clinical trials. In: Fayers P, Hays R, editors. Assessing Quality of Life in Clinical Trials. 2nd ed. Oxford: Oxford University Press; 2008. p. 195-208.
60. Scott NW, Fayers PM, Bottomley A, Aaronson NK, de Graeff A, Groenvold M, et al. Comparing translations of the EORTC QLQ-C30 using differential item functioning analyses. Qual Life Res. 2006;15:1103-15. (Pubitemid 44221463)
61. Scott NW, Fayers PM, Aaronson NK, Bottomley A, de Graeff A, Groenvold M, et al. The relationship between overall quality of life and its subdimensions was influenced by culture: analysis of an international database. J Clin Epidemiol. 2008;61:788-95.
62. King MT. The interpretation of scores from the EORTC quality of life questionnaire QLQ-C30. Qual Life Res. 1996;5:555-67. (Pubitemid 27006967)
63. 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;16:139-44. (Pubitemid 28041591)
64. Scott NW, Fayers PM, Aaronson NK, Bottomley A, de Graeff A, Groenvold M, et al. The practical impact of differential item functioning analyses in a health-related quality of life instrument. Qual Life Res. 2009;18:1125-30.
65. Oberndorfer S, Lindeck-Pozza E, Lahrmann H, Struhal W, Hitzenberger P, Grisold W. The end-of-life hospital setting in patients with glioblastoma. J Palliat Med. 2008;11:26-30.
66. Pace A, Di LC, Guariglia L, Jandolo B, Carapella CM, Pompili A. End of life issues in brain tumor patients. J Neurooncol. 2009;91:39-43.
67. Sizoo EM, Braam L, Postma TJ, Pasman HR, Heimans JJ, Klein M, et al. Symptoms and problems in the end-of-life phase of high-grade glioma patients. Neuro Oncol. 2010;12:1162-6.
68. Taphoorn MJ, Klein M. Cognitive deficits in adult patients with brain tumours. Lancet Neurol. 2004;3:159-68. (Pubitemid 38229950)
69. Fayers P, Machin D. Quality of life. Assessment, analysis and interpretation. Chichester: Wiley; 2000.
70. Sneeuw KC, Sprangers MA, Aaronson NK. The role of health care providers and significant others in evaluating the quality of life of patients with chronic disease. J Clin Epidemiol. 2002;55:1130-43. (Pubitemid 36043991)
71. Brown PD, Decker PA, Rummans TA, Clark MM, Frost MH, Ballman KV, et al. A prospective study of quality of life in adults with newly diagnosed high-grade gliomas: comparison of patient and caregiver ratings of quality of life. Am J Clin Oncol. 2008;31:163-8. (Pubitemid 351519168)
72. Sneeuw KC, Aaronson NK, Osoba D, Muller MJ, Hsu MA, Yung WK, et al. The use of significant others as proxy raters of the quality of life of patients with brain cancer. Med Care. 1997;35:490-506. (Pubitemid 127455047)
73. Sneeuw KC, Aaronson NK, Sprangers MA, Detmar SB, Wever LD, Schornagel JH. Comparison of patient and proxy EORTC QLQ-C30 ratings in assessing the quality of life of cancer patients. J Clin Epidemiol. 1998;51:617-31. (Pubitemid 28376971)
74. Stephens RJ, Hopwood P, Girling DJ, Machin D. Randomized trials with quality of life endpoints: are doctors' ratings of patients' physical symptoms interchangeable with patients' self-ratings? Qual Life Res. 1997;6:225-36. (Pubitemid 27293869)
75. Moinpour CM, Lyons B, Schmidt SP, Chansky K, Patchell RA. Substituting proxy ratings for patient ratings in cancer clinical trials: an analysis based on a Southwest Oncology Group trial in patients with brain metastases. Qual Life Res. 2000;9:219-31.
76. • Quinten C, Maringwa J, Gotay CC, Martinelli F, Coens C, Reeve BB, et al. Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst. 2011;103:1851-8. This study examined the extent to which HRQOL scores of cancer patients and clinicians corresponded and if both contributed to the estimation of overall survival. Patient- and clinician-reported HRQOL scores did differ, but contributed independently and positively to survival prognostication. The subjective measure of a patient thus complements clinician scoring in predicting overall survival.
77. Wilson KA, Dowling AJ, Abdolell M, Tannock IF. Perception of quality of life by patients, partners and treating physicians. Qual Life Res. 2000;9:1041-52. (Pubitemid 32289941)
78. Milne DJ, Mulder LL, Beelen HC, Schofield P, Kempen GI, Aranda S. Patients' self-report and family caregivers' perception of quality of life in patients with advanced cancer: how do they compare? Eur J Cancer Care (Engl). 2006;15:125-32. (Pubitemid 43542753)
79. Giesinger JM, Golser M, Erharter A, Kemmler G, Schauer-Maurer G, Stockhammer G, et al. Do neurooncological patients and their significant others agree on quality of life ratings? Health Qual Life Outcomes. 2009;7:87.
80. McPhail S, Beller E, Haines T. Two perspectives of proxy reporting of health-related quality of life using the Euroqol-5D, an investigation of agreement. Med Care. 2008;46:1140-8.
81. Sprangers MA, Aaronson NK. The role of health care providers and significant others in evaluating the quality of life of patients with chronic disease: a review. J Clin Epidemiol. 1992;45:743-60.
82. Pickard AS, Knight SJ. Proxy evaluation of health-related quality of life: a conceptual framework for understanding multiple proxy perspectives. Med Care. 2005;43:493-9. (Pubitemid 40694611)
83. Gundy CM, Aaronson NK. The influence of proxy perspective on patient-proxy agreement in the evaluation of health-related quality of life: an empirical study. Med Care. 2008;46:209-16.
84. Ruge MI, Ilmberger J, Tonn JC, Kreth FW. Health-related quality of life and cognitive functioning in adult patients with supratentorial WHO grade II glioma: status prior to therapy. J Neurooncol. 2011;103:129-36.
85. Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969;9:179-86.
86. Sikkes SA, de Lange-de Klerk ES, Pijnenburg YA, Gillissen F, Romkes R, Knol DL, et al. A new informant-based questionnaire for instrumental activities of daily living in dementia. Alzheimers Dement. 2012;8:536-43.
87. Osoba D, Bezjak A, Brundage M, Zee B, Tu D, Pater J. Analysis and interpretation of health-related quality-of-life data from clinical trials: basic approach of The National Cancer Institute of Canada Clinical Trials Group. Eur J Cancer. 2005;41:280-7. (Pubitemid 40126961)
88. Bottomley A, Efficace F, Thomas R, Vanvoorden V, Ahmedzai SH. Health-related quality of life in non-small-cell lung cancer: methodologic issues in randomized controlled trials. J Clin Oncol. 2003;21:2982-92. (Pubitemid 46621851)
89. Efficace F, Bottomley A, Vanvoorden V, Blazeby JM. Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomised controlled trials. Eur J Cancer. 2004;40:187-97. (Pubitemid 38077020)
90. Efficace F, Osoba D, Gotay C, Sprangers M, Coens C, Bottomley A. Has the quality of health-related quality of life reporting in cancer clinical trials improved over time? Towards bridging the gap with clinical decision making. Ann Oncol. 2007;18:775-81. (Pubitemid 46523284)
91. Mauer ME, Taphoorn MJ, Bottomley A, Coens C, Efficace F, Sanson M, et al. Prognostic value of health-related quality-of-life data in predicting survival in patients with anaplastic oligodendrogliomas, from a phase III EORTC brain cancer group study. J Clin Oncol. 2007;25:5731-7.
92. Efficace F, Bottomley A, Osoba 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;21:3502-11. (Pubitemid 46594084)
93. Sprangers MA, Moinpour CM, Moynihan TJ, Patrick DL, Revicki DA. Assessing meaningful change in quality of life over time: a users' guide for clinicians. Mayo Clin Proc. 2002;77:561-71. (Pubitemid 34587346)
94. Staquet M, Berzon R, Osoba D, Machin D. Guidelines for reporting results of quality of life assessments in clinical trials. Qual Life Res. 1996;5:496-502. (Pubitemid 26382284)