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Published in: Current Oncology Reports 1/2013

01-02-2013 | Neuro-oncology (MR Gilbert, Section Editor)

Measuring Clinical Benefit: Use of Patient-Reported Outcomes (PRO) in Primary Brain Tumor Clinical Trials

Author: Terri S. Armstrong

Published in: Current Oncology Reports | Issue 1/2013

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Abstract

Primary brain tumors and their treatment are associated with a significant impact on function and quality of life (QOL). Patient-reported outcomes (PROs) are measures that allow report of the impact directly from the patient. Instruments to measure both QOL and symptom burden have been developed for use in the primary brain tumor patient population. Use of these instruments coupled with tumor response assessment and other objective measures will allow for evaluation of the net clinical benefit for the patient.
Literature
1.
go back to reference Armstrong TS. Head's up on the treatment of malignant glioma patients. Oncol Nurs Forum. 2009;36:E232–40.PubMedCrossRef Armstrong TS. Head's up on the treatment of malignant glioma patients. Oncol Nurs Forum. 2009;36:E232–40.PubMedCrossRef
2.
go back to reference Cahill JE, Armstrong TS. Caring for an adult with a malignant primary brain tumor. Nursing. 2011;41:28–33. quiz 33-4.PubMed Cahill JE, Armstrong TS. Caring for an adult with a malignant primary brain tumor. Nursing. 2011;41:28–33. quiz 33-4.PubMed
3.
go back to reference Armstrong TS, Vera-Bolanos E, Gilbert MR. Clinical course of adult patients with ependymoma: results of the Adult Ependymoma Outcomes Project. Cancer. 2011;117:5133–41.PubMedCrossRef Armstrong TS, Vera-Bolanos E, Gilbert MR. Clinical course of adult patients with ependymoma: results of the Adult Ependymoma Outcomes Project. Cancer. 2011;117:5133–41.PubMedCrossRef
4.
go back to reference Bradley SE, Sherwood PR, Kuo J, et al. Perceptions of economic hardship and emotional health in a pilot sample of family caregivers. J Neurooncol. 2009;93:333–42.PubMedCrossRef Bradley SE, Sherwood PR, Kuo J, et al. Perceptions of economic hardship and emotional health in a pilot sample of family caregivers. J Neurooncol. 2009;93:333–42.PubMedCrossRef
5.
go back to reference Mackworth N, Fobair P, Prados MD. Quality of life self-reports from 200 brain tumor patients: comparisons with Karnofsky performance scores. J Neurooncol. 1992;14:243–53.PubMedCrossRef Mackworth N, Fobair P, Prados MD. Quality of life self-reports from 200 brain tumor patients: comparisons with Karnofsky performance scores. J Neurooncol. 1992;14:243–53.PubMedCrossRef
6.
go back to reference Salander P, Bergenheim AT, Henriksson R. How was life after treatment of a malignant brain tumour? Soc Sci Med. 2000;51:589–98.PubMedCrossRef Salander P, Bergenheim AT, Henriksson R. How was life after treatment of a malignant brain tumour? Soc Sci Med. 2000;51:589–98.PubMedCrossRef
7.
go back to reference Strang S, Strang P. Spiritual thoughts, coping and 'sense of coherence' in brain tumour patients and their spouses. Palliat Med. 2001;15:127–34.PubMedCrossRef Strang S, Strang P. Spiritual thoughts, coping and 'sense of coherence' in brain tumour patients and their spouses. Palliat Med. 2001;15:127–34.PubMedCrossRef
8.
go back to reference Strang S, Strang P, Ternestedt BM. Existential support in brain tumour patients and their spouses. Support Care Cancer. 2001;9:625–33.PubMedCrossRef Strang S, Strang P, Ternestedt BM. Existential support in brain tumour patients and their spouses. Support Care Cancer. 2001;9:625–33.PubMedCrossRef
9.
go back to reference Bradley S, Sherwood PR, Donovan HS, et al. I could lose everything: understanding the cost of a brain tumor. J Neurooncol. 2007;85:329–38.PubMedCrossRef Bradley S, Sherwood PR, Donovan HS, et al. I could lose everything: understanding the cost of a brain tumor. J Neurooncol. 2007;85:329–38.PubMedCrossRef
10.
go back to reference • Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352:987–96. Important paper establishing level 1 evidence of the impact of chemo-radiation on outcome in GBM.PubMedCrossRef • Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352:987–96. Important paper establishing level 1 evidence of the impact of chemo-radiation on outcome in GBM.PubMedCrossRef
11.
go back to reference Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009;10:459–66.PubMedCrossRef Stupp R, Hegi ME, Mason WP, et al. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009;10:459–66.PubMedCrossRef
12.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
13.
go back to reference Lamborn KR, Yung WK, Chang SM, et al. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol. 2008;10:162–70.PubMedCrossRef Lamborn KR, Yung WK, Chang SM, et al. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol. 2008;10:162–70.PubMedCrossRef
14.
go back to reference Polley MY, Lamborn KR, Chang SM, et al. Six-month progression-free survival as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma patients receiving temozolomide. Neuro Oncol. 2010;12:274–82.PubMedCrossRef Polley MY, Lamborn KR, Chang SM, et al. Six-month progression-free survival as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma patients receiving temozolomide. Neuro Oncol. 2010;12:274–82.PubMedCrossRef
15.
16.
go back to reference Meyers CA, Rock EP, Fine HA. Refining endpoints in brain tumor clinical trials. J Neurooncol. 2012;108:227–30.PubMedCrossRef Meyers CA, Rock EP, Fine HA. Refining endpoints in brain tumor clinical trials. J Neurooncol. 2012;108:227–30.PubMedCrossRef
17.
go back to reference Wen PY, Macdonald DR, Reardon DA, et al. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010;28:1963–72.PubMedCrossRef Wen PY, Macdonald DR, Reardon DA, et al. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol. 2010;28:1963–72.PubMedCrossRef
18.
go back to reference Chamberlain MC. Pseudoprogression in glioblastoma. J Clin Oncol. 2008;26:4359. author reply 4359-60.PubMedCrossRef Chamberlain MC. Pseudoprogression in glioblastoma. J Clin Oncol. 2008;26:4359. author reply 4359-60.PubMedCrossRef
19.
go back to reference Fink J, Born D, Chamberlain MC. Pseudoprogression: relevance with respect to treatment of high-grade gliomas. Curr Treat Options Oncol. 2011;12:240–52.PubMedCrossRef Fink J, Born D, Chamberlain MC. Pseudoprogression: relevance with respect to treatment of high-grade gliomas. Curr Treat Options Oncol. 2011;12:240–52.PubMedCrossRef
20.
go back to reference Norden AD, Young GS, Setayesh K, et al. Bevacizumab for recurrent malignant gliomas: efficacy, toxicity, and patterns of recurrence. Neurology. 2008;70:779–87.PubMedCrossRef Norden AD, Young GS, Setayesh K, et al. Bevacizumab for recurrent malignant gliomas: efficacy, toxicity, and patterns of recurrence. Neurology. 2008;70:779–87.PubMedCrossRef
21.
go back to reference Chamberlain MC. MRI in patients with high-grade gliomas treated with bevacizumab and chemotherapy. Neurology. 2006;67:2089. author reply 2089.PubMedCrossRef Chamberlain MC. MRI in patients with high-grade gliomas treated with bevacizumab and chemotherapy. Neurology. 2006;67:2089. author reply 2089.PubMedCrossRef
22.
go back to reference Lucas J, Zada G. Radiology: criteria for determining response to treatment and recurrence of high-grade gliomas. Neurosurg Clin N Am. 2012;23:269–76. viii.PubMedCrossRef Lucas J, Zada G. Radiology: criteria for determining response to treatment and recurrence of high-grade gliomas. Neurosurg Clin N Am. 2012;23:269–76. viii.PubMedCrossRef
23.
go back to reference Lassman AB, Holland EC. Incorporating molecular tools into clinical trials and treatment for gliomas? Curr Opin Neurol. 2007;20:708–11.PubMedCrossRef Lassman AB, Holland EC. Incorporating molecular tools into clinical trials and treatment for gliomas? Curr Opin Neurol. 2007;20:708–11.PubMedCrossRef
24.
go back to reference Nelson SJ. Assessment of therapeutic response and treatment planning for brain tumors using metabolic and physiological MRI. NMR Biomed. 2011;24:734–49.PubMed Nelson SJ. Assessment of therapeutic response and treatment planning for brain tumors using metabolic and physiological MRI. NMR Biomed. 2011;24:734–49.PubMed
25.
go back to reference •• 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. Paper outlining FDA position on the use of PRO instruments.PubMedCrossRef •• 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. Paper outlining FDA position on the use of PRO instruments.PubMedCrossRef
26.
go back to reference DeMuro C, Clark M, Mordin M, et al. Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006-2010. Value Health. 2012;15:443–8.PubMedCrossRef DeMuro C, Clark M, Mordin M, et al. Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006-2010. Value Health. 2012;15:443–8.PubMedCrossRef
27.
go back to reference Gnanasakthy A, Mordin M, Clark M, et al. A review of patient-reported outcome labels in the United States: 2006 to 2010. Value Health. 2012;15:437–42.PubMedCrossRef Gnanasakthy A, Mordin M, Clark M, et al. A review of patient-reported outcome labels in the United States: 2006 to 2010. Value Health. 2012;15:437–42.PubMedCrossRef
28.
go back to reference Rock EP, Kennedy DL, Furness MH, et al. Patient-reported outcomes supporting anticancer product approvals. J Clin Oncol. 2007;25:5094–9.PubMedCrossRef Rock EP, Kennedy DL, Furness MH, et al. Patient-reported outcomes supporting anticancer product approvals. J Clin Oncol. 2007;25:5094–9.PubMedCrossRef
29.
go back to reference Patrick DL, Burke LB, Powers JH, et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health. 2007;10 Suppl 2:S125–37.PubMedCrossRef Patrick DL, Burke LB, Powers JH, et al. Patient-reported outcomes to support medical product labeling claims: FDA perspective. Value Health. 2007;10 Suppl 2:S125–37.PubMedCrossRef
30.
go back to reference Galanis E, Wu W, Cloughesy T, et al. Phase 2 trial design in neuro-oncology revisited: a report from the RANO group. Lancet Oncol. 2012;13:e196–204.PubMedCrossRef Galanis E, Wu W, Cloughesy T, et al. Phase 2 trial design in neuro-oncology revisited: a report from the RANO group. Lancet Oncol. 2012;13:e196–204.PubMedCrossRef
31.
go back to reference • Armstrong TS, Mendoza T, Gning I, et al. Validation of the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT). J Neurooncol. 2006;80:27–35. PRO instrument developed for report of symtpom burden in brain tumor patients.PubMedCrossRef • Armstrong TS, Mendoza T, Gning I, et al. Validation of the M.D. Anderson Symptom Inventory Brain Tumor Module (MDASI-BT). J Neurooncol. 2006;80:27–35. PRO instrument developed for report of symtpom burden in brain tumor patients.PubMedCrossRef
32.
go back to reference Armstrong TS, Cohen MZ, Eriksen L, et al. Content validity of self-report measurement instruments: an illustration from the development of the Brain Tumor Module of the M.D. Anderson Symptom Inventory. Oncol Nurs Forum. 2005;32:669–76.PubMedCrossRef Armstrong TS, Cohen MZ, Eriksen L, et al. Content validity of self-report measurement instruments: an illustration from the development of the Brain Tumor Module of the M.D. Anderson Symptom Inventory. Oncol Nurs Forum. 2005;32:669–76.PubMedCrossRef
33.
go back to reference Armstrong TS, Gning I, Mendoza TR, et al. Clinical utility of the MDASI-BT in patients with brain metastases. J Pain Symptom Manag. 2009;37:331–40.CrossRef Armstrong TS, Gning I, Mendoza TR, et al. Clinical utility of the MDASI-BT in patients with brain metastases. J Pain Symptom Manag. 2009;37:331–40.CrossRef
34.
go back to reference Armstrong TS, Vera-Bolanos E, Gning I, et al. The impact of symptom interference using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) on prediction of recurrence in primary brain tumor patients. Cancer. 2011;117:3222–8.PubMedCrossRef Armstrong TS, Vera-Bolanos E, Gning I, et al. The impact of symptom interference using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) on prediction of recurrence in primary brain tumor patients. Cancer. 2011;117:3222–8.PubMedCrossRef
35.
go back to reference Lien K, Zeng L, Nguyen J, et al. FACT-Br for assessment of quality of life in patients receiving treatment for brain metastases: a literature review. Expert Rev Pharmacoecon Outcomes Res. 2011;11:701–8.PubMedCrossRef Lien K, Zeng L, Nguyen J, et al. FACT-Br for assessment of quality of life in patients receiving treatment for brain metastases: a literature review. Expert Rev Pharmacoecon Outcomes Res. 2011;11:701–8.PubMedCrossRef
36.
go back to reference • Weitzner MA, Meyers CA, Gelke CK, et al. 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. Validation of Quality of life instrument for primary brain tumor patients.PubMedCrossRef • Weitzner MA, Meyers CA, Gelke CK, et al. 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. Validation of Quality of life instrument for primary brain tumor patients.PubMedCrossRef
37.
go back to reference • Taphoorn MJ, Claassens L, Aaronson NK, 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. 2010;46:1033–40. Validation of Quality of life instrument for primary brain tumor patients.PubMedCrossRef • Taphoorn MJ, Claassens L, Aaronson NK, 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. 2010;46:1033–40. Validation of Quality of life instrument for primary brain tumor patients.PubMedCrossRef
38.
go back to reference Mauer M, Stupp R, Taphoorn MJ, et al. 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 Tumour and Radiation Oncology Groups, and NCIC Clinical Trials Group study. Br J Cancer. 2007;97:302–7.PubMedCrossRef Mauer M, Stupp R, Taphoorn MJ, et al. 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 Tumour and Radiation Oncology Groups, and NCIC Clinical Trials Group study. Br J Cancer. 2007;97:302–7.PubMedCrossRef
39.
go back to reference Mauer ME, Taphoorn MJ, Bottomley A, 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.PubMedCrossRef Mauer ME, Taphoorn MJ, Bottomley A, 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.PubMedCrossRef
40.
go back to reference • Cleeland CS, Sloan JA. Assessing the Symptoms of Cancer Using Patient-Reported Outcomes (ASCPRO): searching for standards. J Pain Symptom Manag. 2010;39:1077–85. Paper reviewing position of ASCPRO committee on issues related to standards for use of PROs.CrossRef • Cleeland CS, Sloan JA. Assessing the Symptoms of Cancer Using Patient-Reported Outcomes (ASCPRO): searching for standards. J Pain Symptom Manag. 2010;39:1077–85. Paper reviewing position of ASCPRO committee on issues related to standards for use of PROs.CrossRef
41.
go back to reference Reyes-Gibby CC, Aday L, Cleeland C. Impact of pain on self-rated health in the community-dwelling older adults. Pain. 2002;95:75–82.PubMedCrossRef Reyes-Gibby CC, Aday L, Cleeland C. Impact of pain on self-rated health in the community-dwelling older adults. Pain. 2002;95:75–82.PubMedCrossRef
42.
go back to reference Schwartz CE, Bode R, Repucci N, et al. The clinical significance of adaptation to changing health: a meta-analysis of response shift. Qual Life Res. 2006;15:1533–50.PubMedCrossRef Schwartz CE, Bode R, Repucci N, et al. The clinical significance of adaptation to changing health: a meta-analysis of response shift. Qual Life Res. 2006;15:1533–50.PubMedCrossRef
43.
go back to reference Tierney DK, Facione N, Padilla G, et al. Response shift: a theoretical exploration of quality of life following hematopoietic cell transplantation. Cancer Nurs. 2007;30:125–38.PubMedCrossRef Tierney DK, Facione N, Padilla G, et al. Response shift: a theoretical exploration of quality of life following hematopoietic cell transplantation. Cancer Nurs. 2007;30:125–38.PubMedCrossRef
44.
go back to reference Armstrong TS, Cron SG, Bolanos EV, et al. Risk factors for fatigue severity in primary brain tumor patients. Cancer. 2010;116:2707–15.PubMed Armstrong TS, Cron SG, Bolanos EV, et al. Risk factors for fatigue severity in primary brain tumor patients. Cancer. 2010;116:2707–15.PubMed
45.
go back to reference Fox SW, Lyon D, Farace E. Symptom clusters in patients with high-grade glioma. J Nurs Scholarsh. 2007;39:61–7.PubMedCrossRef Fox SW, Lyon D, Farace E. Symptom clusters in patients with high-grade glioma. J Nurs Scholarsh. 2007;39:61–7.PubMedCrossRef
46.
go back to reference Gleason Jr JF, Case D, Rapp SR, et al. Symptom clusters in patients with newly-diagnosed brain tumors. J Support Oncol. 2007;5:427–33. 436.PubMed Gleason Jr JF, Case D, Rapp SR, et al. Symptom clusters in patients with newly-diagnosed brain tumors. J Support Oncol. 2007;5:427–33. 436.PubMed
47.
go back to reference Cleeland CS: Symptom burden: multiple symptoms and their impact as patient-reported outcomes. J Natl Cancer Inst Monogr:16-21, 2007 Cleeland CS: Symptom burden: multiple symptoms and their impact as patient-reported outcomes. J Natl Cancer Inst Monogr:16-21, 2007
48.
go back to reference Armstrong TS, Wefel JS, Won M, et al: Abstract 2016: Clinical utility of neurocognitive function (NCF), quality of life (QOL), and symptom assessment as prognostic factors for survival and measures of treatment effects on RTOG 0525. Journal of Clinical Oncology 29 2011 Armstrong TS, Wefel JS, Won M, et al: Abstract 2016: Clinical utility of neurocognitive function (NCF), quality of life (QOL), and symptom assessment as prognostic factors for survival and measures of treatment effects on RTOG 0525. Journal of Clinical Oncology 29 2011
49.
go back to reference Witgert ME, Meyers CA. Neurocognitive and quality of life measures in patients with metastatic brain disease. Neurosurg Clin N Am. 2011;22:79–85. vii.PubMedCrossRef Witgert ME, Meyers CA. Neurocognitive and quality of life measures in patients with metastatic brain disease. Neurosurg Clin N Am. 2011;22:79–85. vii.PubMedCrossRef
50.
go back to reference Nekolaichuk CL, Maguire TO, Suarez-Almazor M, et al. Assessing the reliability of patient, nurse, and family caregiver symptom ratings in hospitalized advanced cancer patients. J Clin Oncol. 1999;17:3621–30.PubMed Nekolaichuk CL, Maguire TO, Suarez-Almazor M, et al. Assessing the reliability of patient, nurse, and family caregiver symptom ratings in hospitalized advanced cancer patients. J Clin Oncol. 1999;17:3621–30.PubMed
51.
go back to reference Nekolaichuk CL, Bruera E, Spachynski K, et al. A comparison of patient and proxy symptom assessments in advanced cancer patients. Palliat Med. 1999;13:311–23.PubMedCrossRef Nekolaichuk CL, Bruera E, Spachynski K, et al. A comparison of patient and proxy symptom assessments in advanced cancer patients. Palliat Med. 1999;13:311–23.PubMedCrossRef
52.
go back to reference Teske K, Daut RL, Cleeland CS. Relationships between nurses' observations and patients' self-reports of pain. Pain. 1983;16:289–96.PubMedCrossRef Teske K, Daut RL, Cleeland CS. Relationships between nurses' observations and patients' self-reports of pain. Pain. 1983;16:289–96.PubMedCrossRef
53.
go back to reference Parsaie FA, Golchin M, Asvadi I. A comparison of nurse and patient perceptions of chemotherapy treatment stressors. Cancer Nurs. 2000;23:371–4.PubMedCrossRef Parsaie FA, Golchin M, Asvadi I. A comparison of nurse and patient perceptions of chemotherapy treatment stressors. Cancer Nurs. 2000;23:371–4.PubMedCrossRef
54.
go back to reference Puntillo K, Neighbor M, O'Neil N, et al. Accuracy of emergency nurses in assessment of patients' pain. Pain Manag Nurs. 2003;4:171–5.PubMedCrossRef Puntillo K, Neighbor M, O'Neil N, et al. Accuracy of emergency nurses in assessment of patients' pain. Pain Manag Nurs. 2003;4:171–5.PubMedCrossRef
55.
go back to reference Barsevick AM, Cleeland CS, Manning DC, et al. ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials. J Pain Symptom Manag. 2010;39:1086–99.CrossRef Barsevick AM, Cleeland CS, Manning DC, et al. ASCPRO recommendations for the assessment of fatigue as an outcome in clinical trials. J Pain Symptom Manag. 2010;39:1086–99.CrossRef
56.
go back to reference Cella D, Bullinger M, Scott C, et al. Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clin Proc. 2002;77:384–92.PubMedCrossRef Cella D, Bullinger M, Scott C, et al. Group vs individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clin Proc. 2002;77:384–92.PubMedCrossRef
57.
go back to reference Tait RC, Chibnall JT, Kalauokalani D. Provider judgments of patients in pain: seeking symptom certainty. Pain Med. 2009;10:11–34.PubMedCrossRef Tait RC, Chibnall JT, Kalauokalani D. Provider judgments of patients in pain: seeking symptom certainty. Pain Med. 2009;10:11–34.PubMedCrossRef
58.
go back to reference 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.PubMedCrossRef 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.PubMedCrossRef
59.
go back to reference Davies E, Clarke C. Views of bereaved relatives about quality of survival after radiotherapy for malignant cerebral glioma. J Neurol Neurosurg Psychiatry. 2005;76:555–61.PubMedCrossRef Davies E, Clarke C. Views of bereaved relatives about quality of survival after radiotherapy for malignant cerebral glioma. J Neurol Neurosurg Psychiatry. 2005;76:555–61.PubMedCrossRef
60.
go back to reference Armstrong TS, Wefel JS, Gning I, et al: Congruence of primary brain tumor patient and caregiver symptom report. Cancer, 2012 Armstrong TS, Wefel JS, Gning I, et al: Congruence of primary brain tumor patient and caregiver symptom report. Cancer, 2012
61.
go back to reference Brown PD, Decker PA, Rummans TA, 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.PubMedCrossRef Brown PD, Decker PA, Rummans TA, 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.PubMedCrossRef
63.
go back to reference Corkrey R, Parkinson L. Interactive voice response: review of studies 1989-2000. Behav Res Methods Instrum Comput. 2002;34:342–53.PubMedCrossRef Corkrey R, Parkinson L. Interactive voice response: review of studies 1989-2000. Behav Res Methods Instrum Comput. 2002;34:342–53.PubMedCrossRef
64.
go back to reference Corkrey R, Parkinson L. A comparison of four computer-based telephone interviewing methods: getting answers to sensitive questions. Behav Res Methods Instrum Comput. 2002;34:354–63.PubMedCrossRef Corkrey R, Parkinson L. A comparison of four computer-based telephone interviewing methods: getting answers to sensitive questions. Behav Res Methods Instrum Comput. 2002;34:354–63.PubMedCrossRef
65.
go back to reference Lustria ML, Cortese J, Noar SM, et al. Computer-tailored health interventions delivered over the Web: review and analysis of key components. Patient Educ Couns. 2009;74:156–73.PubMedCrossRef Lustria ML, Cortese J, Noar SM, et al. Computer-tailored health interventions delivered over the Web: review and analysis of key components. Patient Educ Couns. 2009;74:156–73.PubMedCrossRef
66.
go back to reference Dumrongpakapakorn P, Hopkins K, Sherwood P, et al. Computer-mediated patient education: opportunities and challenges for supporting women with ovarian cancer. Nurs Clin North Am. 2009;44:339–54.PubMedCrossRef Dumrongpakapakorn P, Hopkins K, Sherwood P, et al. Computer-mediated patient education: opportunities and challenges for supporting women with ovarian cancer. Nurs Clin North Am. 2009;44:339–54.PubMedCrossRef
67.
go back to reference Alvina AA, Gilbert MR, Armstrong TS: Feasibility of Use of Electronic Data Capture in Primary Brain Tumor Patients Neuro-Oncology, In Press Alvina AA, Gilbert MR, Armstrong TS: Feasibility of Use of Electronic Data Capture in Primary Brain Tumor Patients Neuro-Oncology, In Press
68.
go back to reference Snyder CF, Watson ME, Jackson JD, et al. Patient-reported outcome instrument selection: designing a measurement strategy. Value Health. 2007;10 Suppl 2:S76–85.PubMedCrossRef Snyder CF, Watson ME, Jackson JD, et al. Patient-reported outcome instrument selection: designing a measurement strategy. Value Health. 2007;10 Suppl 2:S76–85.PubMedCrossRef
69.
go back to reference Burris H, Storniolo AM. Assessing clinical benefit in the treatment of pancreas cancer: gemcitabine compared to 5-fluorouracil. Eur J Cancer. 1997;33 Suppl 1:S18–22.PubMedCrossRef Burris H, Storniolo AM. Assessing clinical benefit in the treatment of pancreas cancer: gemcitabine compared to 5-fluorouracil. Eur J Cancer. 1997;33 Suppl 1:S18–22.PubMedCrossRef
70.
go back to reference Burris 3rd HA, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997;15:2403–13.PubMed Burris 3rd HA, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997;15:2403–13.PubMed
Metadata
Title
Measuring Clinical Benefit: Use of Patient-Reported Outcomes (PRO) in Primary Brain Tumor Clinical Trials
Author
Terri S. Armstrong
Publication date
01-02-2013
Publisher
Current Science Inc.
Published in
Current Oncology Reports / Issue 1/2013
Print ISSN: 1523-3790
Electronic ISSN: 1534-6269
DOI
https://doi.org/10.1007/s11912-012-0276-2

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