Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

Aaronson, 1993, The European Organization for Research and Treatment of Cancer QLQ-c30: a quality-of-life instrument of use in international clinical trials in oncology., J Natl Cancer Inst, 85, 365, 10.1093/jnci/85.5.365 Anderson, 1999, Physical symptoms distress index: a sensitive tool to evaluate the impact of pharmacological agents., Arch Int Med, 159, 693, 10.1001/archinte.159.7.693 Anderson, 1994, Symptom distress checklists as a component of quality of life measurement: comparing prompted reports by patient and physician with concurrent adverse event reports via the physician., Drug Inf J, 28, 89, 10.1177/009286159402800112 Banks, 1996, Explaining high rates of depression in chronic pain: a diathesis-stress framework., Psychol Bull, 119, 95, 10.1037/0033-2909.119.1.95 Begg, 1996, Improving the quality of reporting of randomized controlled trials: the CONSORT statement., J Am Med Assoc, 276, 637, 10.1001/jama.1996.03540080059030 Bellamy, 1997, Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis: consensus development at OMERACT III., J Rheumatol, 24, 799 Benzon, 1994, Quality of life bibliography and indexes., Qual Life Res, 6, 547 Brooks, 2001, Outcome measures and classification criteria for the rheumatic diseases: a compilation of data from OMERACT (Outcome Measures for Arthritis Clinical Trials), ILAR (International League of Associations for Rheumatology), regional leagues and other groups., Rheumatology, 40, 896, 10.1093/rheumatology/40.8.896 Caraceni, 2002, Pain measurement tools and methods in clinical research in palliative care: recommendations of an expert working group of the European Association of Palliative Care., J Pain Symptom Mgmt, 23, 239, 10.1016/S0885-3924(01)00409-2 Cella, 1995, Measuring quality of life: update., Oncology, 1995, 47 Collins, 2001, Seeking a simple measure of analgesia for mega-trials: is a single global assessment good enough?, Pain, 91, 189, 10.1016/S0304-3959(00)00435-8 Croog, 1986, The effects of antihypertensive therapy on quality of life., N Engl J Med, 314, 1657, 10.1056/NEJM198606263142602 Dawson, 2002, Probing the paradox of patients satisfaction with inadequate pain management., J Pain Symptom Mgmt, 23, 211, 10.1016/S0885-3924(01)00399-2 De Gagne, 1995, Confirmatory factor analysis of a 4-factor model of chronic pain evaluation., Pain, 60, 195, 10.1016/0304-3959(94)00114-T Deyo, 1998, Outcome measures for low back pain research: a proposal for standardized use., Spine, 23, 2003, 10.1097/00007632-199809150-00018 Dionne, 2003, NIH-FDA analgesic drug development workshop: translating scientific advances into improved pain relief., Clin J Pain, 19, 139, 10.1097/00002508-200305000-00001 Dougados, 2002, A report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials Response Criteria Initiative., Osteoarthritis Cartilage, 8, 395, 10.1053/joca.2000.0361 Farrar, 2001, Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale., Pain, 94, 149, 10.1016/S0304-3959(01)00349-9 Fernandez, 1995, The significance of anger in the experience of chronic pain., Pain, 61, 165, 10.1016/0304-3959(95)00192-U Fischer, 1999, Capturing the patients view of change as a clinical outcome measure., J Am Med Assoc, 282, 1157, 10.1001/jama.282.12.1157 Garratt, 2001, Responsiveness of generic and specific measures of health outcome in low back pain., Spine, 26, 71, 10.1097/00007632-200101010-00014 Holroyd, 1999, The three dimensions of headache impact: pain, disability and affective distress., Pain, 83, 571, 10.1016/S0304-3959(99)00165-7 Just, 1999, Global impressions versus validated measures of treatment effectiveness in patients with chronic nonmalignant pain., Rehab Psychol, 44, 194, 10.1037/0090-5550.44.2.194 Katz, 2002, The impact of pain management on quality of life., J Pain Symptom Mgmt, 24, S38, 10.1016/S0885-3924(02)00411-6 Klein, 2002, Improving clinical trials American Society of Clinical Psychopharmacology recommendations., Arch Gen Psychiatry, 59, 272, 10.1001/archpsyc.59.3.272 Mikail, 1993, A comparative analysis of measures used in the assessment of chronic pain patients., Psychol Assess, 5, 117, 10.1037/1040-3590.5.1.117 Moher, 2001, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials., Ann Int Med, 134, 657, 10.7326/0003-4819-134-8-200104170-00011 Moscucci, 1987, Blinding, unblinding, and the placebo effect: an analysis of patients guesses of treatment assignment in a double-blind clinical trial., Clin Pharmacol Ther, 41, 259, 10.1038/clpt.1987.26 Patrick, 1989, Generic and disease-specific measures in assessing health status and quality of life., Med Care, 27, S217, 10.1097/00005650-198903001-00018 Revicki, 1997, Health-related quality of life assessment and planning for the pharmaceutical industry., Clin Ther, 19, 1101, 10.1016/S0149-2918(97)80063-X Revicki, 2000, Recommendations on health-related quality of life research to support labeling and promotional claims in the United States., Qual Life Res, 8, 887, 10.1023/A:1008996223999 Ross, 1989, Relation of implicit theories to the construction of personal histories., Psychol Rev, 96, 341, 10.1037/0033-295X.96.2.341 Seid, 2000, Pediatric health-related quality-of-life measurement technology: intersections between science, managed care, and clinical care., J Clin Psychol Med Settings, 7, 17, 10.1023/A:1009541218764 Stucki, 1995, Relative responsiveness of condition-specific and generic health status measures in degenerative lumbar stenosis., J Clin Epidemiol, 48, 1369, 10.1016/0895-4356(95)00054-2 Turk, 1991, Neglected factors in chronic pain treatment outcome studiesrelapse, noncompliance, and adherence enhancement., Pain, 44, 528, 10.1016/0304-3959(91)90142-K Varni, 1999, Pediatric health-related quality of life measurement technology: a guide for healthcare decision makers., JCOM, 6, 33