Assessing the Symptoms of Cancer Using Patient-Reported Outcomes (ASCPRO): Searching for Standards

Journal of Pain and Symptom Management

Volumn 39, Issue 6, 2010, Pages 1077-1085

  Cleeland, Charles S ^a   Sloan, Jeff A ^b  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b Mayo Clinic   (United States)

Author keywords

clinical trials; outcomes; Patient report; quality of life; symptoms

Indexed keywords

ANOREXIA; ARTICLE; CANCER SCREENING; CLINICAL RESEARCH; COGNITIVE DEFECT; DECISION MAKING; DEPRESSION; DISEASE SEVERITY; DYSPNEA; EVIDENCE BASED PRACTICE; FATIGUE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE QUALITY; HUMAN; OUTCOME ASSESSMENT; SLEEP DISORDER; STATISTICAL ANALYSIS; STUDY DESIGN; TREATMENT RESPONSE;

CLINICAL TRIALS AS TOPIC; COST OF ILLNESS; ENDPOINT DETERMINATION; GUIDELINES AS TOPIC; HUMANS; NEOPLASMS; PATIENTS; QUALITY OF LIFE; TERMINOLOGY AS TOPIC; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77953110741     PISSN: 08853924     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpainsymman.2009.05.025     Document Type: Article

References (31)

1. US Food and Drug Administration. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling iclaims. Available from:. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071975.pdf Accessed May 6, 2010
2. Marquis P., Arnould B., Acquadro C., and Roberts W.M. Patient-reported outcomes and health-related quality of life in effectiveness studies: pros and cons. Drug Dev Res 67 (2006) 193-201
3. Lipscomb J., Gotay C.C., and Snyder C.E. Patient-reported outcomes in cancer: a review of recent research and policy initiatives. CA Cancer J Clin 57 (2007) 278-300
4. Bottomley A., Jones D., and Claassens L. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer 45 (2009) 347-353
5. Sloan J.A., Halyard M.Y., Frost M.H., et al., Mayo/FDA Patient-Reported Outcomes Consensus Meeting Group. The Mayo Clinic manuscript series relative to the discussion, dissemination, and operationalization of the Food and Drug Administration guidance on patient-reported outcomes. Value Health 10 Suppl 2 (2007) S59-S63
6. Webster's Third New International Dictionary of the English Language, unabridged (2002), Merriam-Webster, Inc., Springfield, MA
7. Sloan J.A., Frost M.H., Berzon R., et al. The clinical significance of quality of life assessments in oncology: a summary for clinicians. Support Care Cancer 14 (2006) 988-998
8. Leplege A., and Hunt S. The problem of quality of life in medicine. JAMA 278 (1997) 47-50
9. Buchanan D.R., O'Mara A.M., Kelaghan J.W., and Minasian L.M. Quality-of-life assessment in the symptom management trials of the National Cancer Institute-supported Community Clinical Oncology Program. J Clin Oncol 23 (2005) 591-598
10. Taphoorn M.J., Stupp R., Coens C., et al., European Organisation for Research and Treatment of Cancer Brain Tumour Group, EORTC Radiotherapy Group, National Cancer Institute of Canada Clinical Trials Group. Health-related quality of life in patients with glioblastoma: a randomised controlled trial. Lancet Oncol 6 (2005) 937-944
11. van Meerbeeck J.P., Gaafar R., Manegold C., et al., European Organisation for Research and Treatment of Cancer Lung Cancer Group, National Cancer Institute of Canada. 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 (2005) 6881-6889
12. Cella D., Yount S., Rothrock N., et al., PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care 45 5 Suppl 1 (2007) S3-S11
13. Fayers P.M., Hopwood P., Harvey A., et al. 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 (1997) 20-28
14. Reeve B.B., Hays R.D., Bjorner J.B., et al., PROMIS Cooperative Group. Psychometric evaluation and calibration of health-related quality of life item banks: plans for the Patient-Reported Outcomes Measurement Information System (PROMIS). Med Care 45 5 Suppl 1 (2007) S22-S31
15. Cella D., Bullinger M., Scott C., and Barofsky I. The Clinical Significance Consensus Meeting Group. Group vs. individual approaches to understanding the clinical significance of differences or changes in quality of life. Mayo Clin Proc 77 (2002) 384-392
16. Nekolaichuk C.L., Bruera E., Spachynski K., et al. A comparison of patient and proxy symptom assessments in advanced cancer patients. Palliat Med 13 (1999) 311-323
17. Teske K., Daut R.L., and Cleeland C.S. Relationships between nurses' observations and patients' self-reports of pain. Pain 16 (1983) 289-296
18. Parsaie F.A., Golchin M., and Asvadi I. A comparison of nurse and patient perceptions of chemotherapy treatment stressors. Cancer Nurs 23 (2000) 371-374
19. Puntillo K., Neighbor M., O'Neil N., and Nixon R. Accuracy of emergency nurses in assessment of patients' pain. Pain Manag Nurs 4 (2003) 171-175
20. Cleeland C.S. Symptom burden: multiple symptoms and their impact as patient-reported outcomes. J Natl Cancer Inst Monogr 37 (2007) 16-21
21. de Haes J.C. Quality of life: conceptual and theoretical considerations. In: Watson M., Greer S., and Thomas C. (Eds). Psychosocial oncology (1988), Pergamon Press, Oxford, UK 61-70
22. Jatoi A., Kumar S., Sloan J.A., and Nguyen P.L. On appetite and its loss. J Clin Oncol 18 (2000) 2930-2932
23. National Cancer Institute. Common terminology criteria for adverse events v3.0 (CTCAE). Available from. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf Accessed May 6, 2010
24. Fromme E.K., Eilers K.M., Mori M., Hsieh Y.C., and Beer T.M. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol 22 (2004) 3485-3490
25. Huschka M.M., Mandrekar S.J., Schaefer P.L., Jett J.R., and Sloan J.A. A pooled analysis of quality of life measures and adverse events data in North Central Cancer Treatment Group lung cancer clinical trials. Cancer 109 (2007) 787-795
26. Morton R.F., Sloan J.A., Grothey A., et al. A comparison of simple single-item measures and the common toxicity criteria in detecting the onset of oxaliplatin-induced peripheral neuropathy in patients with colorectal cancer. [abstract]. J Clin Oncol 23 Suppl 16 (2005) 750S. Abstract # 8087
27. National Cancer Institute. Patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Available from. http://outcomes.cancer.gov/tools/pro-ctcae.html Accessed February 19, 2009
28. Sloan J.A., Cella D., and Hays R.D. Clinical significance of patient-reported questionnaire data: another step toward consensus. J Clin Epidemiol 58 (2005) 1217-1219
29. Sloan J.A., and Dueck A. Issues for statisticians in conducting analyses and translating results for quality of life endpoints in clinical trials. J Biopharm Stat 14 (2004) 73-96
30. Turk D.C., Dworkin R.H., Allen R.R., et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain 106 (2003) 337-345
31. Turk D.C., and Dworkin R.H. What should be the core outcomes in chronic pain clinical trials?. Arthritis Res Ther 6 (2004) 151-154