A patient-derived and patient-reported outcome measure for assessing psoriatic arthritis: Elaboration and preliminary validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, a 13-country EULAR initiative

Annals of the Rheumatic Diseases

Volumn 73, Issue 6, 2014, Pages 1012-1019

  Gossec, Laure ^a   De Wit, Maarten ^b   Kiltz, Uta ^c   Braun, Juergen ^c   Kalyoncu, Umut ^d   Scrivo, Rossana ^e   Maccarone, Mara ^f   Carton, Laurence ^g   Otsa, Kati ^h   Sooäär, Imre ⁱ   Heiberg, Turid ^j   Bertheussen, Heidi ^k   Cañete, Juan D ^l   Lombarte, Anselm Sánchez ^m   Balanescu, Andra ⁿ   Dinte, Alina ^o   De Vlam, Kurt ^p   Smolen, Josef S ^q,r   Stamm, Tanja ^q,r   Niedermayer, Dora ^s   Békés, Gabor ^t   Veale, Douglas ^u   Helliwell, Philip ^v   Parkinson, Andrew ^w   Luger, Thomas ^x   Kvien, Tore K ^y   more..

^a SORBONNE UNIVERSITÉ   (France)

^b Patient Research Partner   (Switzerland)

^c RUHR UNIVERSITY BOCHUM   (Germany)

^d HACETTEPE UNIVERSITY   (Turkey)

^e SAPIENZA UNIVERSITY OF ROME   (Italy)

^f Patient Research Partner ADIPSO PEPsoPOF   (Italy)

^g Patient Research Partner Aflar Patient Association   (France)

^h WEST TALLINN CENTRAL HOSPITAL   (Estonia)

ⁱ Patient Research Partner   (Estonia)

^j OSLO UNIVERSITY HOSPITAL   (Norway)

^k Patient Research Partner   (Norway)

^l HOSPITAL CLÍNIC   (Spain)

^m Patient Research Partner   (Spain)

ⁿ CAROL DAVILA UNIVERSITY OF MEDICINE AND PHARMACY   (Romania)

^o Patient Research Partner   (Romania)

^p UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^q MEDICAL UNIVERSITY OF VIENNA   (Austria)

^r HIETZING HOSPITAL   (Austria)

^s NATIONAL INSTITUTE OF RHEUMATOLOGY AND PHYSIOTHERAPY   (Hungary)

^t Patient Research Partner   (Hungary)

^u ST VINCENT S UNIVERSITY HOSPITAL   (Ireland)

^v UNIVERSITY OF LEEDS   (United Kingdom)

^w Patient Research Partner   (United Kingdom)

^x UNIVERSITY HOSPITAL MÜNSTER   (Germany)

^y DIAKONHJEMMET HOSPITAL   (Norway)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; METHOTREXATE;

ADULT; ARTICLE; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); CORRELATION ANALYSIS; CROSS-SECTIONAL STUDY; FATIGUE; FEASIBILITY STUDY; FEMALE; HUMAN; LONGITUDINAL STUDY; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; PAIN; PRIORITY JOURNAL; PSA IMPACT OF DISEASE QUESTIONNAIRE; PSORIATIC ARTHRITIS; PSYCHOMETRY; QUESTIONNAIRE; RATING SCALE; RELIABILITY; SCORING SYSTEM; SELF REPORT; SENSITIVITY ANALYSIS; SKIN DISEASE; TEST RETEST RELIABILITY; VALIDATION STUDY;

COMPOSITE CRITERIA; FATIGUE; OUTCOME MEASURE; PAIN; PATIENT PERSPECTIVE; PATIENT RESEARCH PARTNER; QUALITY OF LIFE; QUESTIONNAIRE; RESPONSE CRITERIA;

ADULT; AGED; AGED, 80 AND OVER; ARTHRITIS, PSORIATIC; CROSS-SECTIONAL STUDIES; FATIGUE; FEMALE; FOCUS GROUPS; HUMANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PAIN MEASUREMENT; PSORIASIS; PSYCHOMETRICS; QUESTIONNAIRES; REPRODUCIBILITY OF RESULTS; SELF REPORT; SEVERITY OF ILLNESS INDEX; YOUNG ADULT;

EID: 84899825889     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2014-205207     Document Type: Article

References (47)

1. Scoggins JF, Patrick DL. The use of patients reported outcomes instruments in registered clinical trials: evidence from ClinicalTrials.gov. Contemp Clin Trials 2009;30: 289-92.
2. Kalyoncu U, Dougados M, Gossec L, et al. Reporting of patient-reported outcomes in recent trials in rheumatoid arthritis: a systematic literature review. Ann Rheum Dis 2009;68: 183-90.
3. Kirwan JR, Minnock P, Adebajo A, et al. Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol 2007;34: 1174-7. (Pubitemid 46774870)
4. Kirwan JR, Bartlett SJ, Beaton DE, et al. Updating the OMERACT filter: implications for patient-reported outcomes. J Rheumatol 2014. [Epub ahead of print 1 Mar 2014].
5. Acquadro C, Berzon R, Dubois D, et al. Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health 2003;6: 522-31. (Pubitemid 37187713)
6. McLeod LD, Coon CD, Martin SA, et al. Interpreting patient-reported outcome results: US FDA guidance and emerging methods. Expert Rev Pharmacoecon Outcomes Res 2011;11: 163-9.
7. Strand V, Sharp V, Koenig AS, et al. Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment. Ann Rheum Dis 2012;71: 1143-50.
8. Mease PJ, Antoni CE, Gladman DD, et al. Psoriatic arthritis assessment tools in clinical trials. Ann Rheum Dis 2005;64:ii49-54. (Pubitemid 40288522)
9. Armstrong AW, Schupp C, Wu J, et al. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003-2011. PLoS ONE 2012;7:e52935.
10. MacKenzie H, Thavaneswaran A, Chandran V, et al. Patient-reported outcome in psoriatic arthritis: a comparison of Web-based versus paper-completed questionnaires. J Rheumatol 2011;38: 2619-24.
11. Mease PJ, Woolley JM, Bitman B, et al. Minimally important difference of Health Assessment Questionnaire in psoriatic arthritis: relating thresholds of improvement in functional ability to patient-rated importance and satisfaction. J Rheumatol 2011;38: 2461-5.
12. Kwok T, Pope JE. Minimally important difference for patient-reported outcomes in psoriatic arthritis: Health Assessment Questionnaire and pain, fatigue, and global visual analog scales. J Rheumatol 2010;37: 1024-8.
13. Gladman DD, Helliwell P, Mease PJ, et al. Assessment of patients with psoriatic arthritis: a review of currently available measures. Arthritis Rheum 2004;50: 24-35. (Pubitemid 38084284)
14. Brodszky V, Péntek M, Bálint PV, et al. Comparison of the Psoriatic Arthritis Quality of Life (PsAQoL) questionnaire, the functional status (HAQ) and utility (EQ-5D) measures in psoriatic arthritis: results from a cross-sectional survey. Scand J Rheumatol 2010;39: 303-9.
15. Gladman DD, Mease PJ, Strand V, et al. Consensus on a core set of domains for psoriatic arthritis. J Rheumatol 2007;34: 1167-70. (Pubitemid 46774868)
16. Husted JA, Tom BD, Farewell VT, et al. Longitudinal analysis of fatigue in psoriatic arthritis. J Rheumatol 2010;37: 1878-84.
17. Palominos PE, Gaujoux-Viala C, Fautrel B, et al. Clinical outcomes in psoriatic arthritis: A systematic literature review. Arthritis Care Res (Hoboken) 2012;64: 397-406.
18. Bruce B, Fries JF. The Stanford health assessment questionnaire (HAQ): a review of its history, issues, progress, and documentation. J Rheumatol 2003;30: 167-78. (Pubitemid 36077790)
19. Stamm TA, Nell V, Mathis M, et al. Concepts important to patients with psoriatic arthritis are not adequately covered by standard measures of functioning. Arthritis Rheum 2007;57: 487-94. (Pubitemid 46682538)
20. Dandorfer SW, Rech J, Manger B, et al. Differences in the patient's and the physician's perspective of disease in psoriatic arthritis. Semin Arthritis Rheum 2012;42: 32-41.
21. Gossec L, Smolen JS, Gaujoux-Viala C, et al. European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies. Ann Rheum Dis 2012;71: 4-12.
22. Gossec L, Dougados M, Rincheval N, et al. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis 2009;68: 1680-5.
23. Gossec L, Paternotte S, Aanerud GJ, et al. Finalisation and validation of the rheumatoid arthritis impact of disease score, a patient-derived composite measure of impact of rheumatoid arthritis: a EULAR initiative. Ann Rheum Dis 2011;70: 935-42.
24. de Wit MP, Berlo SE, Aanerud GJ, et al. European League Against Rheumatism recommendations for the inclusion of patient representatives in scientific projects. Ann Rheum Dis 2011;70: 722-6.
25. de Wit MP, Elberse JE, Broerse JE, et al. Do not forget the professional-the value of the FIRST model for guiding the structural involvement of patients in rheumatology research. Health Expect 2013. doi:10.1111/hex. 12048. [Epub ahead of print].
26. Katz PP. Introduction to special issue: patient outcomes in rheumatology, 2011. Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S1-3.
27. Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol 1993;46: 1417-32. (Pubitemid 24017263)
28. Beaton DE, Bombardier C, Guillemin F, et al. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine 2000;25: 3186-91. (Pubitemid 32042951)
29. Taylor W, Gladman D, Helliwell P, et al.; CASPAR Study Group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 2006;54: 2665-73. (Pubitemid 44205029)
30. Boers M, Brooks P, Strand CV, et al. The OMERACT filter for outcome measures in rheumatology. J Rheumatol 1998;25: 198-9.
31. Jenkinson C, Coulter A, Wright L. Short form 36 (SF36) health survey questionnaire: normative data for adults of working age. BMJ 1993;306: 1437-40. (Pubitemid 23154745)
32. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use. Clin Exp Dermatol 1994;19: 210-16. (Pubitemid 24194579)
33. Hurst NP, Kind P, Ruta D, et al. Measuring health-related quality of life in rheumatoid arthritis: validity, responsiveness and reliability of EuroQol (EQ-5D). Br J Rheumatol 1997;36: 551-9.
34. Cauli A, Gladman DD, Mathieu A, et al.; GRAPPA 3PPsA Study Group. Patient global assessment in psoriatic arthritis: a multicenter GRAPPA and OMERACT study. J Rheumatol 2011;38: 898-903.
35. Helliwell PS, Fitzgerald O, Strand CV, et al. Composite Measures in Psoriatic Arthritis: a report from the GRAPPA 2009 annual meeting. J Rheumatol 2011;38: 540-5.
36. Aletaha D, Funovits J, Ward MM, et al. Perception of improvement in patients with rheumatoid arthritis varies with disease activity levels at baseline. Arthritis Rheum 2009;61: 313-20.
37. Wells G, Anderson J, Boers M, et al. MCID/Low Disease Activity State Workshop: summary, recommendations, and research agenda. J Rheumatol 2003;30: 1115-18. (Pubitemid 36529645)
38. Tubach F, Ravaud P, Beaton D, et al. Minimal clinically important improvement and patient acceptable symptom state for subjective outcome measures in rheumatic disorders. J Rheumatol 2007;34: 1188-93. (Pubitemid 46774873)
39. Heiberg T, Kvien TK, Mowinckel P, et al. Identification of disease activity and health status cut-off points for the symptom state acceptable to patients with rheumatoid arthritis. Ann Rheum Dis 2008;67: 967-71. (Pubitemid 351956659)
40. Cronbach LJ, Meehl PE. Construct validity in psychological tests. Psychol Bull 1955;52: 281-302.
41. Bland JM, Altman DG. Agreement between methods of measurement with multiple observations per individual. J Biopharm Stat 2007;17: 571-82. (Pubitemid 47027010)
42. Kvamme MK, Kristiansen IS, Lie E, et al. Identification of cutpoints for acceptable health status and important improvement in patient-reported outcomes, in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. J Rheumatol 2010;37: 26-31.
43. Escorpizo R, Kostanjsek N, Kennedy C, et al. Harmonizing WHO's International Classification of Diseases (ICD) and International Classification of Functioning, Disability and Health (ICF): importance and methods to link disease and functioning. BMC Public Health 2013;13:742.
44. Skare TL, Bortoluzzo AB, Gonçalves CR, et al. Ethnic influence in clinical and functional measures of Brazilian patients with spondyloarthritis. J Rheumatol 2012;39: 141-7.
45. Heiberg T, Nordby T, Kvien TK, et al. Development and preliminary validation of the pancreatic cancer disease impact score. Support Care Cancer 2013;21: 1677-84.
46. Meenan RF, Mason JH, Anderson JJ, et al. AIMS2. The content and properties of a revised and expanded Arthritis Impact Measurement Scales Health Status Questionnaire. Arthritis Rheum 1992;35: 1-10.
47. Helliwell PS, FitzGerald O, Fransen J, et al. The development of candidate composite disease activity and responder indices for psoriatic arthritis (GRACE project). Ann Rheum Dis 2013;72: 986-91.