Patient-reported outcome measures for systemic lupus erythematosus clinical trials: A review of content validity, face validity and psychometric performance

Health and Quality of Life Outcomes

Volumn 12, Issue 1, 2014, Pages

  Holloway, Laura ^a   Humphrey, Louise ^b   Heron, Louise ^a   Pilling, Claire ^a   Kitchen, Helen ^c   Højbjerre, Lise ^d   Strandberg Larsen, Martin ^d   Hansen, Brian B ^d  

^a ADELPHI REAL WORLD   (United Kingdom)

^b Decision Resources Group   (United Kingdom)

^c UNIVERSITY OF MANCHESTER   (United Kingdom)

^d NOVO NORDISK A S   (Denmark)

Author keywords

Conceptual model; Fatigue; Health related quality of life; Patient reported outcomes; Systemic lupus erythematosus

Indexed keywords

ARTICLE; BRIEF PAIN INVENTORY; COGNITION; CONTENT VALIDITY; DAILY LIFE ACTIVITY; DEPRESSION; EMOTION; FACE VALIDITY; FATIGUE; FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY FATIGUE SCALE; HOSPITAL ANXIETY AND DEPRESSION SCALE; HUMAN; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; OUTCOME ASSESSMENT; PAIN; PATIENT PARTICIPATION; PSYCHOMETRY; QUALITY OF LIFE; SHORT FORM 36; SOCIAL INTERACTION; SYSTEMIC LUPUS ERYTHEMATOSUS; WELLBEING; WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT QUESTIONNAIRE; CLINICAL TRIAL (TOPIC); COMPLICATION; COST OF ILLNESS; DISABILITY; ECONOMICS; HEALTH STATUS INDICATOR; LUPUS ERYTHEMATOSUS, SYSTEMIC; PSYCHOLOGY; QUESTIONNAIRE; REPRODUCIBILITY; THEORETICAL MODEL;

CLINICAL TRIALS AS TOPIC; COST OF ILLNESS; DISABILITY EVALUATION; HEALTH STATUS INDICATORS; HUMANS; LUPUS ERYTHEMATOSUS, SYSTEMIC; MODELS, THEORETICAL; PATIENT OUTCOME ASSESSMENT; PSYCHOMETRICS; QUALITY OF LIFE; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS;

EID: 84906823228     PISSN: None     EISSN: 14777525     Source Type: Journal    
DOI: 10.1186/s12955-014-0116-1     Document Type: Article

References (112)

1. Jakes RW, Bae SC, Louthrenoo W, Mok CC, Navarra SV, Kwon N. Systematic review of the epidemiology of systemic lupus erythematosus in the Asia-Pacific region: prevalence, incidence, clinical features, and mortality. Arthritis Care Res 2012, 64:159-168.
2. Danchenko N, Satia JA, Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus 2006, 15:308-318. 16761508.
3. Chakravarty EF, Bush TM, Manzi S, Clarke AE, Ward MM. Prevalence of adult systemic lupus erythematosus in California and Pennsylvania in 2000: estimates obtained using hospitalization data. Arthritis Rheum 2007, 56:2092-2094. 17530651.
4. Borchers AT, Naguwa SM, Shoenfeld Y, Gershwin ME. The geoepidemiology of systemic lupus erythematosus [abstract]. Autoimmun Rev 2010, 9:A277-A287. 20036343.
5. Zhu TY, Tam LS, Li EK. Cost-of-illness studies in systemic lupus erythematosus: a systematic review. Arthritis Care Res (Hoboken) 2011, 63:751-760.
6. Manson JJ, Rahman A. Systemic lupus erythematosus. Orphanet J Rare Dis 2006, 1:6. 16722594.
7. Ruperto N, Hanrahan LM, Alarcon GS, Belmont HM, Brey RL, Brunetta P, Buyon JP, Costner MI, Cronin ME, Dooley MA, Filocamo G, Fiorentino D, Fortin PR, Franks AG, Gilkeson G, Ginzler E, Gordon C, Grossman J, Hahn B, Isenberg DA, Kalunian KC, Petri M, Sammaritano L, Sa´nchez-Guerrero J, Sontheimer RD, Strand V, Urowitz M, von Feldt JM, Werth VP, Merrill JT. International consensus for a definition of disease flare in lupus. Lupus 2011, 20:453-462. 21148601.
8. Lahita RG. Systemic Lupus Erythematosus 2004, Elsevier, London.
9. Lupus: Statistics on Lupus. Foundation of America. http://www.lupus.org/about/statistics-on-lupus
10. Jolly M, Pickard AS, Wilke C, Mikolaitis RA, Teh LS, McElhone K, Fogg L, Block J. Lupus-specific health outcome measure for US patients: the LupusQoL-US version. Ann Rheum Dis 2010, 69:29-33. 19126561.
11. Guidance For Industry: Patient-Reported Outcome Measures: Use In Medical Product Development To Support Labelling Claims 2009,
12. Reflection Paper on the Regulatory Guidance for the use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products 2005,
13. Equity and Excellence: Liberating the NHS 2010,
14. Guidance for Industry: Systemic Lupus Erythematosus - Developing Medical Products for Treatment 2010,
15. Guideline on Clinical Investigation of Medicinal Products for the Treatment of Systemic Lupus Erythematosus, Cutaneous Lupus and Lupus Nephritis (Draft) 2013,
16. Strand V, Gladman D, Isenberg D, Petri M, Smolen J, Tugwell P. Outcome measures to be used in clinical trials in systemic lupus erythematosus. J Rheumatol 1999, 26:490-497. 9972993.
17. Smolen JS, Strand V, Cardiel M, Edworthy S, Furst D, Gladman D, Gordon C, Isenberg DA, Klippel JH, Petri M, Simon L, Tugwell P, Wolfe F. Randomized clinical trials and longitudinal observational studies in systemic lupus erythematosus: consensus on a preliminary core set of outcome domains. J Rheumatol 1999, 26:504-507. 9972996.
18. Moher D, Liberati A, Tetzlaff J, Altman DG. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement [abstract]. BMJ 2009, 339:b2535. 19622551.
19. Systematic Reviews: CRD's guidance for undertaking systematic reviews in health care. http://www.york.ac.uk/inst/crd/pdf/Systematic_Reviews.pdf
20. Earp JA, Ennett ST. Conceptual models for health education research and practice. Health Educ Res 1991, 6:163-171. 10148689.
21. Rothman ML, Beltran P, Cappelleri JC, Lipscomb J, Teschendorf B. Patient-reported outcomes: conceptual issues. Value Health 2007, 10:S66-S75. 17995476.
22. Gallop K, Nixon A, Swinburn P, Sterling KL, Naegeli AN, Silk ME. Development of a conceptual model of health-related quality of life for systemic lupus erythematosus (SLE) from the patients' perspective. Lupus 2012, 21:934-943. 22433917.
23. Mokkink L, Terwee C, Patrick D, Alonso J, Stratford P, Knol D, Bouter L, Vet H. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res 2010, 19:539-549. 20169472.
24. Beckerman NL. Living with lupus: a qualitative report. Soc Work Health Care 2011, 50:330-343. 21512954.
25. McElhone K, Abbott J, Gray J, Williams A, Teh LS. Patient perspective of systemic lupus erythematosus in relation to health-related quality of life concepts: a qualitative study. Lupus 2010, 19:1640-1647. 20709719.
26. Robinson J, Aguilar D, Schoenwetter M, Dubois R, Russak S, Ramsey-Goldman R, Navarra S, Hsu B, Revicki D, Cella D, Rapaport MH, Renahan K, Ress R, Wallace D, Weisman M. Impact of systemic lupus erythematosus on health, family, and work: the patient perspective. Arthritis Care Res 2010, 62:266-273.
27. Mattsson M, Moller B, Stamm T, Gard G, Bostrom C. Uncertainty and opportunities in patients with established systemic Lupus Erythematosus: a qualitative study. Musculoskeletal Care 2012, 10:1-12. 22009870.
28. Kosinski M, Gajria K, Fernandes AW, Cella D. Qualitative validation of the FACIT-fatigue scale in systemic lupus erythematosus. Lupus 2013, 22:422-430. 23423250.
29. Schneider M, Schmeding A, Carnarius H, Ager M, McWade V. Systemic lupus erythematosus (SLE): understanding the burden. Value Health 2010, 13:A470.
30. Yee CS, McElhone K, Teh LS, Gordon C. Assessment of disease activity and quality of life in systemic lupus erythematosus - New aspects. Best Pract Res Clin Rheumatol 2009, 23:457-467. 19591777.
31. Aberer E. Epidemiologic, socioeconomic and psychosocial aspects in lupus erythematosus. Lupus 2010, 19:1118-1124. 20693206.
32. Strand V, Galateanu C, Pushparajah DS, Nikai E, Sayers J, Wood R, van Vollenhoven RF. Limitations of current treatments for systemic lupus erythematosus: a patient and physician survey. Lupus 2013, 22:819-826. 23817511.
33. Pettersson S, Lovgren M, Eriksson LE, Moberg C, Svenungsson E, Gunnarsson I, Henriksson EW. An exploration of patient-reported symptoms in systemic lupus erythematosus and the relationship to health-related quality of life. Scand J Rheumatol 2012, 41:383-390. 22646821.
34. Measurement of fatigue in systemic lupus erythematosus: a systematic review. Arthritis Care Res 2007, 57:1348-1357.
35. Cleanthous S, Tyagi M, Isenberg DA, Newman SP. What do we know about self-reported fatigue in systemic lupus erythematosus?. Lupus 2012, 21:465-476. 22345120.
36. Ramsey-Goldman R, Rothrock N. Fatigue in systemic lupus erythematosus and rheumatoid arthritis. PM&R 2010, 2:384-392.
37. Danoff-Burg S, Friedberg F. Unmet needs of patients with systemic lupus erythematosus. Behav Med 2009, 35:5-13. 19297299.
38. Yazdany J, Yelin E. Health-related quality of life and employment among persons with systemic Lupus Erythematosus. Rheum Dis Clin North Am 2010, 36:15-32. 20202589.
39. Robinson M, Sheets CS, Currie LM. Systemic lupus erythematosus: a genetic review for advanced practice nurses. J Am Acad Nurse Pract 2011, 23:629-637. 22145653.
40. Doward LC, McKenna SP, Whalley D, Tennant A, Griffiths B, Emery P, Veale DJ. The development of the L-QoL: a quality-of-life instrument specific to systemic lupus erythematosus. Ann Rheum Dis 2009, 68:196-200. 18385276.
41. Johnsson PM, Sandqvist G, Bengtsson A, Nived O. Hand function and performance of daily activities in systemic lupus erythematosus. Arthritis Rheum 2008, 59:1432-1438.
42. Carls G, Li T, Panopalis P, Wang S, Mell AG, Gibson TB, Goetzel RZ. Direct and indirect costs to employers of patients with systemic lupus erythematosus with and without nephritis. J Occup Environ Med 2009, 51:66-79. 19136875.
43. Zhu TY, Tam LS, Li EK. The socioeconomic burden of systemic lupus erythematosus: state-of-the-art and prospects. Expert Rev Pharmacoecon Outcomes Res 2012, 12:53-69. 22280197.
44. Yelin E, Katz P. Introduction to special section: cost and social and psychological impact of rheumatic diseases. Arthritis Rheum 2008, 59:457. 18383402.
45. Zhu TY, Tam LS, Lee VWY, Lee KKC, Li EK. The impact of flare on disease costs of patients with systemic lupus erythematosus. Arthritis Rheum 2009, 61:1159-1167. 19714597.
46. Aghdassi E, Zhang W, St Pierre Y, Clarke AE, Morrison S, Peeva V, Landolt-Marticorena C, Su J, Reich H, Scholey J, Herzenberg A, Pope JE, Peschken C, Lunnet Canios I, Wither JE, Fortin PR. Healthcare cost and loss of productivity in a Canadian population of patients with and without lupus nephritis. J Rheumatol 2011, 38:658-666. 21159829.
47. Yazdany J, Yelin EH, Panopalis P, Trupin L, Julian L, Katz PP. Validation of the systemic lupus erythematosus activity questionnaire in a large observational cohort. Arthritis Rheum 2008, 59:136-143. 18163398.
48. Askanase AD, Castrejon I, Pincus T. Quantitative data for care of patients with systemic lupus erythematosus in usual clinical settings: a patient multidimensional health assessment questionnaire and physician estimate of noninflammatory symptoms. J Rheumatol 2011, 38:1309-1316. 21459938.
49. Moldovan I, Katsaros E, Carr FN, Cooray D, Torralba K, Shinada S, Ishimori ML, Jolly M, Wallace DJ, Weisman MH, Nicassio PM. The Patient Reported Outcomes in Lupus (PATROL) study: role of depression in health-related quality of life in a Southern California lupus cohort. Lupus 2011, 20:1285-1292. 21813589.
50. McElhone K, Abbott J, Shelmerdine J, Bruce IN, Ahmad Y, Gordon C, Peers K, Isenberg D, Ferenkeh-Koroma A, Griffiths B, Akil M, Maddison P, Teh LS. Development and validation of a disease-specific health-related quality of life measure, the LupusQoL, for adults with systemic lupus erythematosus. Arthritis Rheum 2007, 57:972-979. 17665467.
51. Strand V, Chu AD. Generic versus disease-specific measures of health-related quality of life in systemic lupus erythematosus. J Rheumatol 2011, 38:1821-1823. 21885504.
52. Jolly M, Pickard AS, Block JA, Kumar RB, Mikolaitis RA, Wilke CT, Rodby RA, Fogg L, Sequeira W, Utset TO, Cash TF, Moldovan I, Katsaros E, Nicassio P, Ishimori ML, Kosinsky M, Merrill JT, Weisman MH, Wallace DJ. Disease-specific patient reported Outcome tools for systemic lupus erythematosus. Semin Arthritis Rheum 2012, 42:56-65. 22480408.
53. Jolly M, Garris CP, Jhingran PM, Mikolaitis RA, Dennis G, Wallace DJ, Clarke A, Dooley MA, Parke A, Strand V, Ala´rcon GS, Kosinski M. Development of the lupus impact tracker: a tool for patients and physicians to assess and monitor the impact of systemic lupus erythematosus (SLE). Arthritis Care Res (Hoboken) 2011, 14:A65-A66.
54. Strand V, Chu AD. Measuring outcomes in systemic lupus erythematosus clinical trials. Expert Rev Pharmacoecon Outcomes Res 2011, 11:455-468. 21831027.
55. Leong KP, Kong KO, Thong BYH, Koh ET, Lian TY, Teh CL, Cheng YK, Chng HH, Badsha H, Law WG, Lau TC, Chew LC, Ho HJ, Pong LY, Hoi LS, Sangeetha N, Chan SP, Howe HS. Development and preliminary validation of a systemic lupus erythematosus-specific quality-of-life instrument (SLEQOL). Rheumatology 2005, 44:1267-1276. 15797980.
56. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992, 30:473-483. 1593914.
57. Almehed K, Carlsten H, Forsblad-D'Elia H. Health-related quality of life in systemic lupus erythematosus and its association with disease and work disability. Scand J Rheumatol 2010, 39:58-62. 20132072.
58. Benitha R, Tikly M. Functional disability and health-related quality of life in South Africans with rheumatoid arthritis and systemic lupus erythematosus. Clin Rheumatol 2007, 26:24-29. 16538390.
59. Kulczycka L, Sysa-Jedrzejowska A, Robak E. Quality of life and satisfaction with life in SLE patients-the importance of clinical manifestations. Clin Rheumatol 2010, 29:991-997. 20532577.
60. Kuriya B, Gladman DD, Ibañez D, Urowitz MB. Quality of life over time in patients with systemic lupus erythematosus. Arthritis Care Res 2008, 59:181-185.
61. Mok CC, Ho LY, Cheung MY, Yu KL, To CH. Effect of disease activity and damage on quality of life in patients with systemic lupus erythematosus: a 2-year prospective study. Scand J Rheumatol 2009, 38:121-127. 18991189.
62. Sliem H, Tawfik G, Khalil KA, Ibrahim N. Pattern of systemic lupus erythematosus in Egyptian patients: the impact of disease activity on the quality of life. Pan Afr Med J 2010, 6:14. 21734922.
63. Zhu TY, Tam LS, Lee VWY, Lee KK, Li EK. Relationship between flare and health-related quality of life in patients with systemic lupus erythematosus. J Rheumatol 2010, 37:568-573. 20110519.
64. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
65. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011, 20:1727-1736. 21479777.
66. Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage 1997, 13:63-74. 9095563.
67. Smets EM, Garssen B, Bonke B, De Haes JC. The Multidimensional Fatigue Inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosom Res 1995, 39:315-325. 7636775.
68. Belza BL, Henke CJ, Yelin EH, Epstein WV, Gilliss CL. Correlates of fatigue in older adults with rheumatoid arthritis. Nurs Res 1993, 42:93-99. 8455994.
69. Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain 1975, 1:277-299. 1235985.
70. Ozel F, Argon G. The effects of fatigue and pain on daily life activities in systemic lupus erythematosus. 2011Abstracts from 10th Congress of the European Federation of Internal Medicine [abstract. Eur J Intern Med 2011, 22:S70.
71. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994, 23:129-138. 8080219.
72. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry 1961, 4:561-571. 13688369.
73. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370. 6880820.
74. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics 1993, 4:353-365. 10146874.
75. Konig HH, Ulshofer A, Gregor M, von Tirpitz C, Reinshagen M, Adler G, Leidl R. Validation of the EuroQol questionnaire in patients with inflammatory bowel disease. Eur J Gastroenterol Hepatol 2002, 14:1205-1215. 12439115.
76. Aggarwal R, Wilke CT, Pickard AS, Vats V, Mikolaitis R, Fogg L, Block JA, Jolly M. Psychometric properties of the EuroQol-5D and short form-6D in patients with systemic lupus erythematosus. J Rheumatol 2009, 36:1209-1216. 19369452.
77. Lai JS, Beaumont JL, Ogale S, Brunetta P, Cella D. Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial. J Rheumatol 2011, 38:672-679. 21239746.
78. Karlson EW, Daltroy LH, Rivest C, Ramsey-Goldman R, Wright EA, Partridge AJ, Liang MH, Fortin PR. Validation of a Systemic Lupus Activity Questionnaire (SLAQ) for population studies. Lupus 2003, 12:280-286. 12729051.
79. Beaumont J, Lai JS, Cella D, Brunetta P, Ogale S. Validation of the SF-36 in Patients with Systemic Lupus Erythematosus (SLE). Arthritis Rheum 2009, 60:296.
80. Busija L, Pausenberger E, Haines TP, Haymes S, Buchbinder R, Osborne RH. Adult measures of general health and health-related quality of life: Medical Outcomes Study Short Form 36-Item (SF-36) and Short Form 12-Item (SF-12) Health Surveys, Nottingham Health Profile (NHP), Sickness Impact Profile (SIP), Medical Outcomes Study Short Form 6D (SF-6D), Health Utilities Index Mark 3 (HUI3), Quality of Well-Being Scale (QWB), and Assessment of Quality of Life (AQOL) [abstract]. Arthritis Care Res 2011, 63:S383-S412.
81. User's Manual for the SF-36v2 Health Survey 2011,
82. Gignac MAM, Cao X, McAlpine J, Badley EM. Measures of disability: Arthritis Impact Measurement Scales 2 (AIMS2), Arthritis Impact Measurement Scales 2-Short Form (AIMS2-SF), The Organization for Economic Cooperation and Development (OECD) Long-Term Disability (LTD) Questionnaire, EQ-5D, World Health Organization Disability Assessment Schedule II (WHODASII), Late-Life Function and Disability Instrument (LLFDI), and Late-Life Function and Disability Instrument-Abbreviated Version (LLFDI-Abbreviated) [abstract]. Arthritis Care Res 2011, 63:S308-S324.
83. Chandran V, Bhella S, Schentag C, Gladman DD. Functional assessment of chronic illness therapy-fatigue scale is valid in patients with psoriatic arthritis. Ann Rheum Dis 2007, 66:936-939. 17324972.
84. Goodchild CE, Treharne GJ, Booth DA, Kitas GD, Bowman SJ. Measuring fatigue among women with Sjogren's syndrome or rheumatoid arthritis: a comparison of the Profile of Fatigue (ProF) and the Multidimensional Fatigue Inventory (MFI). Musculoskeletal Care 2008, 6:31-48. 18085596.
85. Lin J-M, Brimmer D, Maloney E, Nyarko E, BeLue R, Reeves W. Further validation of the Multidimensional Fatigue Inventory in a US adult population sample. Popul Health Metrics 2009, 7:18.
86. Barendregt PJ, Visser MR, Smets EM, Tulen JH, van den Meiracker AH, Boomsma F, Markusse HM. Fatigue in primary Sjogren's syndrome. Ann Rheum Dis 1998, 57:291-295. 9741313.
87. Smets E, Garssen B, Cull A, De Haes J. Application of the multidimensional fatigue inventory (MFI-20) in cancer patients receiving radiotherapy. Br J Cancer 1996, 73:241. 8546913.
88. Meek PM, Nail LM, Barsevick A, Schwartz AL, Stephen S, Whitmer K, Beck SL, Jones LS, Walker BL. Psychometric Testing of Fatigue Instruments for Use With Cancer Patients. Nurs Res 2000, 49:181-190. 10929689.
89. Wolfe F. Fatigue assessments in rheumatoid arthritis: comparative performance of visual analog scales and longer fatigue questionnaires in 7760 patients. Arthritis Rheumatol 2004, 31:1896-1902.
90. Jump RL, Fifield J, Tennen H, Reisine S, Giuliano AJ. History of affective disorder and the experience of fatigue in rheumatoid arthritis. Arthritis Care Res 2004, 51:239-245.
91. Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J. Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol 2005, 32:811-819. 15868614.
92. Roche PA, Klestov AC, Heim HM. Description of stable pain in rheumatoid arthritis: a 6 year study. Arthritis Rheumatol 2003, 30:1733-1738.
93. Creamer P, Lethbridge-Cejku M, Hochberg M. Determinants of pain severity in knee osteoarthritis: effect of demographic and psychosocial variables using 3 pain measures. Arthritis Rheumatol 1999, 26:1785.
94. Jenkinson C, Carroll D, Egerton M, Frankland T, McQuay H, Nagle C. Comparison of the sensitivity to change of long and short form pain measures. Qual Life Res 1995, 4:353-357. 7550184.
95. Cleeland CS, Gonin R, Hatfield AK, Edmonson JH, Blum RH, Stewart JA, Pandya KJ. Pain and its treatment in outpatients with metastatic cancer. N Engl J Med 1994, 330:592-596. 7508092.
96. Mendoza T, Mayne T, Rublee D, Cleeland C. Reliability and validity of a modified Brief Pain Inventory short form in patients with osteoarthritis. Eur J Pain 2006, 10:353-361. 16051509.
97. Atkinson TM, Rosenfeld BD, Sit L, Mendoza TR, Fruscione M, Lavene D, Shaw M, Li Y, Hay J, Cleeland CS, Scher HI, Breitbart WS, Basch E. Using confirmatory factor analysis to evaluate construct validity of the Brief Pain Inventory (BPI). J Pain Symptom Manage 2011, 41:558-565. 21131166.
98. Williams VSL, Smith MY, Fehnel SE. The validity and utility of the BPI interference measures for evaluating the impact of osteoarthritic pain. J Pain Symptom Manag 2006, 31:48-57.
99. Keller S, Bann CM, Dodd SL, Schein J, Mendoza TR, Cleeland CS. Validity of the brief pain inventory for use in documenting the outcomes of patients with noncancer pain. Clin J Pain 2004, 20:309-318. 15322437.
100. Daut RL, Cleeland CS, Flannery RC. Development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain 1983, 17:197-210. 6646795.
101. Mease PJ, Spaeth M, Clauw DJ, Arnold LM, Bradley LA, Russell IJ, Kajdasz DK, Walker DJ, Chappell AS. Estimation of minimum clinically important difference for pain in fibromyalgia. Arthritis Care Res 2011, 63:821-826.
102. Beck AT, Steer RA, Carbin MG. Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clin Psychol Rev 1988, 8:77-100.
103. Hiroe T, Kojima M, Yamamoto I, Nojima S, Kinoshita Y, Hashimoto N, Watanabe N, Maeda T, Furukawa TA. Gradations of clinical severity and sensitivity to change assessed with the Beck Depression Inventory-II in Japanese patients with depression. Psychiatry Res 2005, 135:229-235. 15996749.
104. Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale: An updated literature review. J Psychosom Res 2002, 52:69-77. 11832252.
105. Herrmann C. International experiences with the Hospital Anxiety and Depression Scale-A review of validation data and clinical results. J Psychosom Res 1997, 42:17-41. 9055211.
106. Silverstone PH. Poor efficacy of the hospital anxiety and depression scale in the diagnosis of major depressive disorder in both medical and psychiatric patients. J Psychosom Res 1994, 38:441-450. 7965933.
107. Reilly MC, Gooch KL, Wong RL, Kupper H, van der Heijde D. Validity, reliability and responsiveness of the Work Productivity and Activity Impairment Questionnaire in ankylosing spondylitis. Rheumatology (Oxford) 2010, 49:812-819.
108. Zhang W, Bansback N, Boonen A, Young A, Singh A, Anis A. Validity of the work productivity and activity impairment questionnaire - general health version in patients with rheumatoid arthritis [abstract]. Arthritis Res Ther 2010, 12:R177. 20860837.
109. Tang R, Groshen SG, Piatek CI, Desai BB, Pinski JK, Acosta F, Raghavan D, Dorff TB, Quinn DI. Sequential active chemotherapy schema in castration-resistant prostate cancer [abstract]. J Clin Oncol 2011, 29:e15191.
110. Krupp L, LaRocca N, Muir-Nash J, Steinberg A. The fatigue severity scale: Application to patients with multiple sclerosis and systemic lupus erythematosus. Arch Neurol 1989, 46:1121-1123. 2803071.
111. Mattsson M, Moller B, Lundberg IE, Gard G, Bostrom C. Reliability and validity of the Fatigue Severity Scale in Swedish for patients with systemic lupus erythematosus. Scand J Rheumatol 2008, 37:269-277. 18612927.
112. Refolo P, Minacori R, Mele V, Sacchini D, Spagnolo AG. Patient-reported outcomes (PROs): the significance of using humanistic measures in clinical trial and clinical practice. Eur Rev Med Pharmacol Sci 2012, 16:1319-1323. 23104647.