Methodological issues in designing and reporting health-related quality of life in cancer clinical trials: The challenge of brain cancer studies

Journal of Neuro-Oncology

Volumn 108, Issue 2, 2012, Pages 221-226

  Efficace, Fabio ^a   Taphoorn, Martin ^b,c  

^a GIMEMA Data Center   (Italy)

^b VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^c MEDICAL CENTER HAAGLANDEN   (Netherlands)

Author keywords

Brain cancer; Clinical trial; Quality of life

Indexed keywords

LOMUSTINE; PROCARBAZINE; TEMOZOLOMIDE; VINCRISTINE;

ADJUVANT THERAPY; ANOREXIA; ARTICLE; BRAIN CANCER; CANCER PROGNOSIS; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); CONSTIPATION; DROWSINESS; GLIOBLASTOMA; HUMAN; METHODOLOGY; NAUSEA; OLIGODENDROGLIOMA; PATIENT REPORTED OUTCOME; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL (TOPIC); SELF REPORT; STUDY DESIGN; TREATMENT OUTCOME; VOMITING;

BRAIN NEOPLASMS; CLINICAL TRIALS AS TOPIC; HEALTH STATUS; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); QUALITY OF LIFE; RESEARCH DESIGN;

EID: 84864034717     PISSN: 0167594X     EISSN: 15737373     Source Type: Journal    
DOI: 10.1007/s11060-012-0819-2     Document Type: Article

References (41)

1. Moher D, Jones A, Lepage L (2001) Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA 285:1992-1995 (Pubitemid 32366952)
2. Portney LG, Watkins MP (eds) (2000) Foundations of clinical research: applications to practice. Prentice Hall, Upper Saddle River
3. Osoba D (1994) Lessons learned from measuring health-related quality of life in oncology. J Clin Oncol 12:608-616 (Pubitemid 24079906)
4. Schumacher M, Olschewski M, Schulgen G (1991) Assessment of quality of life in clinical trials. Stat Med 10:1915-1930
5. Osoba D (2007) Translating the science of patient-reported outcomes assessment into clinical practice. J Natl Cancer Inst Monogr 37:5-11
6. US Food and Drug Administration (2009) Guidance for industry. patient-reported outcome measures: use in medical product development to support labeling claims. U.S. Department of Health and Human Services Food and Drug Administration. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatory Information/Guidances/UCM193282.pdf. Accessed 13 Feb 2012
7. Bottomley A, Therasse P (2002) Quality of life in patients undergoing systemic therapy for advanced breast cancer. Lancet Oncol 3:620-628 (Pubitemid 35174680)
8. Bottomley A, Efficace F, Thomas R, Vanvoorden V, Ahmedzai S (2003) Health-related quality of life in non small-cell lung cancer: methodologic issues in randomized controlled trials. J Clin Oncol 21:2982-2992 (Pubitemid 46621851)
9. Efficace F, Bottomley A, Vanvoorden V, Blazeby JM (2004) Methodological issues in assessing health-related quality of life of colorectal cancer patients in randomized controlled trials. Eur J Cancer 40:187-197 (Pubitemid 38077020)
10. Efficace F, Bottomley A, van Andel G (2003) Health-related quality of life in prostate carcinoma patients: a systematic review of randomized controlled trials. Cancer 97:377-388 (Pubitemid 36133805)
11. Fitzpatrick R, Davey C, Buxton MJ et al (1998) Evaluating patient-based outcome measures for use in clinical trials. Health Technol Assess 2:1-74
12. Fayers P, Hays R (2005) Assessing quality of life in clinical trials. Oxford University Press, New York
13. de Haes J, Curran D, Young T, Bottomley A, Flechtner H, Aaronson N, Blazeby J, EORTC Quality of Life Study Group (2000) Quality of life evaluation in oncological clinical trials-the EORTC model. Eur J Cancer 36:821-825 (Pubitemid 30214130)
14. Fayers PM, Hopwood P, Harvey A et al (1997) Quality of life assessment in clinical trials-guidelines and a checklist for protocol writers: the U.K. Medical Research Council experience. MRC Cancer Trials Office. Eur J Cancer 33:20-28 (Pubitemid 27099561)
15. Sloan J, Symonds T, Vargas-Chanes D et al (2003) Practical guidelines for assessing the clinical significance of health-related quality of life changes within clinical trials. Drug Inf J 37:23-32
16. Osoba D, Rodrigues G, Myles J et al (1998) Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 16:139-144 (Pubitemid 28041591)
17. Gotay CC, Korn EL, McCabe MS et al (1992) Quality-of-life assessment in cancer treatment protocols: research issues in protocol development. J Natl Cancer Inst 84:575-579
18. Chassany O, Sagnier P, Marquis P et al (2002) 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 36:209-238 (Pubitemid 34208219)
19. Efficace F, Bottomley A, Osoba D et al (2003) 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 21:3502-3511 (Pubitemid 46594084)
20. Efficace F, Osoba D, Gotay C, Sprangers M, Coens C, Bottomley A (2007) 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 18:775-781 (Pubitemid 46523284)
21. Cocks K, King MT, Velikova G et al (2008) Quality, interpretation and presentation of European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 data in randomised controlled trials. Eur J Cancer 44:1793-1798
22. van Meerbeeck JP, Gaafar R, Manegold C et al (2005) Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol 23:6881-6889
23. Blazeby JM, Avery K, Sprangers M et al (2006) Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol 24:3178-3186 (Pubitemid 46646225)
24. Taphoorn MJ, Sizoo EM, Bottomley A (2010) Review on quality of life issues in patients with primary brain tumors. Oncologist 15:618-626
25. Henriksson R, Asklund T, Poulsen HS (2011) Impact of therapy on quality of life, neurocognitive function and their correlates in glioblastoma multiforme: a review. J Neurooncol 104:639-646
26. Stupp R, Mason WP, van den Bent MJ et al (2005) Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 352:987-996 (Pubitemid 40349501)
27. Brandsma D, van den Bent MJ (2007) Molecular targeted therapies and chemotherapy in malignant gliomas. Curr Opin Oncol 19:598-605
28. Taphoorn MJ, Stupp R, Coens C et al (2005) Health-related quality of life in patients with glioblastoma: a randomised controlled trial. Lancet Oncol 6:937-944 (Pubitemid 41685226)
29. Aaronson NK, Ahmedzai S, Bergman B et al (1993) The European Organization for Research and Treatment of Cancer QLQC30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376 (Pubitemid 23073154)
30. Taphoorn MJ, Claassens L, Aaronson NK et al (2010) An international validation study of the EORTC brain cancer module (EORTC QLQ BN-20) for assessing health-related quality of life and symptoms in brain cancer patients. Eur J Cancer 46:1033-1040
31. Weitzner MA, Meyers CA, Gelke CK et al (1995) 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 75:1151-1161
32. Armstrong TS, Mendoza T, Gring I et al (2006) Validation of the M.D. Anderson symptom inventory brain tumor module (MDASI-BT). J Neurooncol 80:27-35 (Pubitemid 44473259)
33. Armstrong TS, Gring I, Mendoza T et al (2009) Clinical utility of the MDASI-BT in patients with brain metastases. J Pain Symptom Manag 37:331-340
34. Sneeuw KC, Sprangers MA, Aaronson NK (2002) The role of health care providers and significant others in evaluating the quality of life of patients with chronic disease. J Clin Epidemiol 55:1130-1143 (Pubitemid 36043991)
35. Brown PD, Decker PA, Rummans TA et al (2008) 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 31:163-168 (Pubitemid 351519168)
36. Taphoorn MJ, van den Bent MJ, Mauer ME et al (2007) Healthrelated 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 25:5723-5730
37. Keime-Guibert F, Chinot O, Taillandier L et al (2007) Radiotherapy for glioblastoma in the elderly. N Engl J Med 356:1527-1535 (Pubitemid 46588417)
38. van den Bent MJ, Carpentier AF, Brandes AA et al (2006) Adjuvant procarbazine, lomustine, and vincristine improves progression-free survival but not overall survival in newly diagnosed anaplastic oligodendrogliomas and oligoastrocytomas: a randomized European Organisation for Research and Treatment of Cancer phase III trial. J Clin Oncol 24:2715-2722 (Pubitemid 46630567)
39. Velikova G, Awad N, Coles-Gale R et al (2008) The clinical value of quality of life assessment in oncology practice-a qualitative study of patient and physician views. Psychooncology 17:690-698
40. Mauer M, Taphoorn MJB, Bottomley A et al (2007) The prognostic value of health-related quality of life data in predicting survival in anaplastic oligodendrogliomas cancer patients: results from an international randomized phase III EORTC Brain Cancer Group study. J Clin Oncol 25:5731-5737
41. Mauer M, Stupp R, Taphoorn MJ et al (2007) The prognostic value of health-related quality-of-life data in predicting survival in glioblastoma cancer patients: results from an international randomised phase III EORTC Brain Tumor and Radiation Oncology Groups, and NCIC Clinical Trials Group study. Br J Cancer 97:302-307 (Pubitemid 47196748)