Validity and reliability of the EULAR instrument RAID.7 as a tool to assess individual domains of impact of disease in rheumatoid arthritis: a cross-sectional study of 671 patients

Catia Duarte, Eduardo José Ferreira Santos, Ricardo J O Ferreira, Tore K Kvien, Maxime Dougados, Maarten de Wit, Jose Antonio Pereira da Silva, Laure Gossec, Catia Duarte, Eduardo José Ferreira Santos, Ricardo J O Ferreira, Tore K Kvien, Maxime Dougados, Maarten de Wit, Jose Antonio Pereira da Silva, Laure Gossec

Abstract

Objective: The rheumatoid arthritis impact of disease (RAID) questionnaire comprises seven patient-important domains of disease impact (pain, function, fatigue, sleep disturbance, emotional well-being, physical well-being, coping). RAID was validated as a pooled-weighted score. Its seven individual items separately could provide a valuable tool in clinical practice to guide interventions targeting the patient's experience of the disease. The aim was to separately assess the psychometric properties of each of the seven numeric rating scale (NRS) of the RAID (RAID.7).

Material and methods: Post hoc analyses of data from the cross-sectional RAID study and from the Rainbow study, an open-label 12-week trial of etanercept in patients with RA. Construct validity of each NRS was assessed cross-sectionally in the RAID data set by Spearman's correlation with the respective external instrument of reference. Using the rainbow data set, we assessed reliability through intraclass correlation coefficient between the screening and the baseline visits and responsiveness (sensitivity to change) by standardised response mean between baseline and 12 weeks.

Results: A total of 671 patients with RA with features of established disease were analysed, 563 and 108 from RAID and Rainbow, respectively. The NRS correlated moderately to strongly with the respective external instrument of reference (r=0.62-0.81). Reliability ranged from 0.64 (0.51-0.74) (pain) to 0.83 (0.76-0.88) (sleep disturbance) and responsiveness from 0.93 (0.73-1.13) (sleep disturbance) to 1.34 (1.01-1.64) (pain).

Conclusion: The separate use of the individual NRS of RAID (RAID.7) is valid, feasible, reliable and sensitive to change, representing an opportunity to improve the assessment and treatment of disease impact with minimal questionnaire burden.

Trial registration number: NCT00768053.

Keywords: arthritis; health care; outcome assessment; patient reported outcome measures; rheumatoid.

Conflict of interest statement

Competing interests: MD and JAPS have received consultancy fees from Pfizer (advisory board) and their departments have received research grants from Pfizer. TKK has received fees for speaking and/or consulting from Abbvie, Biogen, Celgene, Celltrion, Egis, Evapharma, Ewopharma, Eli Lilly, Gilead, Hikma, Hospira, MSD, Mylan, Novartis, Oktal, Orion Pharma, Pfizer, Roche, Sandoz, Sanofi and UCB and received research funding to Diakonhjemmet Hospital from Abbvie, BMS, MSD, Pfizer, Roche and UCB.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Comparison of mean values obtained in each RAID domain between patients in the RAID study (n=563) with different levels of disease activity status (DAS28(3 v)-ESR). *Correspond to p

Figure 2

Mean NRS for each RAID…

Figure 2

Mean NRS for each RAID domain, according to disease activity status (Das28(3v)-ESR) at…

Figure 2
Mean NRS for each RAID domain, according to disease activity status (Das28(3v)-ESR) at week 12 in rainbow study (n=97) * correspond to p

Figure 3

Comparison of change in RAID…

Figure 3

Comparison of change in RAID domains (baseline to week 12 between responders and…

Figure 3
Comparison of change in RAID domains (baseline to week 12 between responders and non-responders (DAS28(3 v)-ESR) to bDMARD, in the Rainbow trial (n=97). *Correspond to p
Similar articles
References
    1. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. . EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis 2020;79:685–99. 10.1136/annrheumdis-2019-216655 - DOI - PubMed
    1. Smolen JS, Breedveld FC, Burmester GR, et al. . Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international Task force. Ann Rheum Dis 2016;75:3–15. 10.1136/annrheumdis-2015-207524 - DOI - PMC - PubMed
    1. Santos EJF, Duarte C, Ferreira RJO, et al. . Determinants of Happiness and quality of life in patients with rheumatoid arthritis: a structural equation modelling approach. Ann Rheum Dis 2018;77:1118–24. 10.1136/annrheumdis-2017-212934 - DOI - PMC - PubMed
    1. Ferreira RJO, Santos E, Gossec L, et al. . The patient global assessment in RA precludes the majority of patients otherwise in remission to reach this status in clinical practice. should we continue to ignore this? Semin Arthritis Rheum 2020;50:583–5. 10.1016/j.semarthrit.2020.03.014 - DOI - PubMed
    1. Ferreira RJO, Welsing PMJ, Jacobs JWG. Revisiting the use of remission criteria for rheumatoid arthritis by excluding patient global assessment: an individual meta-analysis of 5792 patients. Ann Rheum Dis 2020. [Epub ahead of print: 06 Oct 2020]. 10.1136/annrheumdis-2020-217171 - DOI - PubMed
Show all 50 references
Publication types
MeSH terms
Associated data
Related information
Full text links [x]
[x]
Cite
Copy Download .nbib
Format: AMA APA MLA NLM

NCBI Literature Resources

MeSH PMC Bookshelf Disclaimer

The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Unauthorized use of these marks is strictly prohibited.

Follow NCBI
Figure 2
Figure 2
Mean NRS for each RAID domain, according to disease activity status (Das28(3v)-ESR) at week 12 in rainbow study (n=97) * correspond to p

Figure 3

Comparison of change in RAID…

Figure 3

Comparison of change in RAID domains (baseline to week 12 between responders and…

Figure 3
Comparison of change in RAID domains (baseline to week 12 between responders and non-responders (DAS28(3 v)-ESR) to bDMARD, in the Rainbow trial (n=97). *Correspond to p
Similar articles
References
    1. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. . EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis 2020;79:685–99. 10.1136/annrheumdis-2019-216655 - DOI - PubMed
    1. Smolen JS, Breedveld FC, Burmester GR, et al. . Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international Task force. Ann Rheum Dis 2016;75:3–15. 10.1136/annrheumdis-2015-207524 - DOI - PMC - PubMed
    1. Santos EJF, Duarte C, Ferreira RJO, et al. . Determinants of Happiness and quality of life in patients with rheumatoid arthritis: a structural equation modelling approach. Ann Rheum Dis 2018;77:1118–24. 10.1136/annrheumdis-2017-212934 - DOI - PMC - PubMed
    1. Ferreira RJO, Santos E, Gossec L, et al. . The patient global assessment in RA precludes the majority of patients otherwise in remission to reach this status in clinical practice. should we continue to ignore this? Semin Arthritis Rheum 2020;50:583–5. 10.1016/j.semarthrit.2020.03.014 - DOI - PubMed
    1. Ferreira RJO, Welsing PMJ, Jacobs JWG. Revisiting the use of remission criteria for rheumatoid arthritis by excluding patient global assessment: an individual meta-analysis of 5792 patients. Ann Rheum Dis 2020. [Epub ahead of print: 06 Oct 2020]. 10.1136/annrheumdis-2020-217171 - DOI - PubMed
Show all 50 references
Publication types
MeSH terms
Associated data
Related information
Full text links [x]
[x]
Cite
Copy Download .nbib
Format: AMA APA MLA NLM
Figure 3
Figure 3
Comparison of change in RAID domains (baseline to week 12 between responders and non-responders (DAS28(3 v)-ESR) to bDMARD, in the Rainbow trial (n=97). *Correspond to p

References

    1. Smolen JS, Landewé RBM, Bijlsma JWJ, et al. . EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis 2020;79:685–99. 10.1136/annrheumdis-2019-216655
    1. Smolen JS, Breedveld FC, Burmester GR, et al. . Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international Task force. Ann Rheum Dis 2016;75:3–15. 10.1136/annrheumdis-2015-207524
    1. Santos EJF, Duarte C, Ferreira RJO, et al. . Determinants of Happiness and quality of life in patients with rheumatoid arthritis: a structural equation modelling approach. Ann Rheum Dis 2018;77:1118–24. 10.1136/annrheumdis-2017-212934
    1. Ferreira RJO, Santos E, Gossec L, et al. . The patient global assessment in RA precludes the majority of patients otherwise in remission to reach this status in clinical practice. should we continue to ignore this? Semin Arthritis Rheum 2020;50:583–5. 10.1016/j.semarthrit.2020.03.014
    1. Ferreira RJO, Welsing PMJ, Jacobs JWG. Revisiting the use of remission criteria for rheumatoid arthritis by excluding patient global assessment: an individual meta-analysis of 5792 patients. Ann Rheum Dis 2020. [Epub ahead of print: 06 Oct 2020]. 10.1136/annrheumdis-2020-217171
    1. Ferreira RJO, Ndosi M, de Wit M, et al. . Dual target strategy: a proposal to mitigate the risk of overtreatment and enhance patient satisfaction in rheumatoid arthritis. Ann Rheum Dis 2019;78:e109. 10.1136/annrheumdis-2018-214199
    1. Castrejon I, Carmona L, Agrinier N, et al. . The EULAR outcome measures library: development and an example from a systematic review for systemic lupus erythematous instruments. Clin Exp Rheumatol 2015;33:910–6.
    1. Fautrel B, Alten R, Kirkham B, et al. . Call for action: how to improve use of patient-reported outcomes to guide clinical decision making in rheumatoid arthritis. Rheumatol Int 2018;38:935–47. 10.1007/s00296-018-4005-5
    1. Aletaha D, Landewe R, Karonitsch T, et al. . Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum 2008;59:1371–7. 10.1002/art.24123
    1. Kirwan JR, Newman S, Tugwell PS, et al. . Patient perspective on outcomes in rheumatology -- a position paper for OMERACT 9. J Rheumatol 2009;36:2067–70. 10.3899/jrheum.090359
    1. 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. 10.1136/ard.2008.100271
    1. 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. 10.1136/ard.2010.142901
    1. Chew E, Griva K, Cheung PP. Evaluation of coping strategies in established rheumatoid arthritis patients: emergence of concealment in an Asian cohort. Int J Rheum Dis 2016;19:1069–77. 10.1111/1756-185X.12932
    1. Heiberg T, Austad C, Kvien TK, et al. . Performance of the rheumatoid arthritis impact of disease (RAID) score in relation to other patient-reported outcomes in a register of patients with rheumatoid arthritis. Ann Rheum Dis 2011;70:1080–2. 10.1136/ard.2010.143032
    1. Salaffi F, Di Carlo M, Vojinovic J, et al. . Validity of the rheumatoid arthritis impact of disease (RAID) score and definition of cut-off points for disease activity states in a population-based European cohort of patients with rheumatoid arthritis. Joint Bone Spine 2018;85:317–22. 10.1016/j.jbspin.2017.05.020
    1. Dougados M, Brault Y, Logeart I, et al. . Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the rheumatoid arthritis impact of disease (RAID). Arthritis Res Ther 2012;14:R129. 10.1186/ar3859
    1. Avila-Ribeiro P, Brault Y, Dougados M, et al. . Psychometric properties of sleep and coping numeric rating scales in rheumatoid arthritis: a subanalysis of an etanercept trial. Clin Exp Rheumatol 2017;35:786–90.
    1. Boers M, Kirwan JR, Gossec L, et al. . How to choose core outcome measurement sets for clinical trials: OMERACT 11 approves filter 2.0. J Rheumatol 2014;41:1025–30. 10.3899/jrheum.131314
    1. Arnett FC, Edworthy SM, Bloch DA, et al. . The American rheumatism association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315–24. 10.1002/art.1780310302
    1. Prevoo ML, van 't Hof MA, Kuper HH, et al. . Modified disease activity scores that include twenty-eight-joint counts. development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995;38:44–8. 10.1002/art.1780380107
    1. DAS-Score website, 2018. Available: [Accessed 04 Apr 2018].
    1. Cheung PP, Lahiri M, March L, et al. . Patient-Reported outcomes in Asia: evaluation of the properties of the rheumatoid arthritis impact of disease (RAID) score in multiethnic Asian patients with rheumatoid arthritis. Clin Rheumatol 2017;36:1149–54. 10.1007/s10067-016-3522-4
    1. Fleiss JL, Cohen J. The equivalence of weighted kappa and the intraclass correlation coefficient as measures of reliability. Educ Psychol Meas 1973;33:613–9. 10.1177/001316447303300309
    1. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;1:307–10.
    1. Beaton DE, Hogg-Johnson S, Bombardier C. Evaluating changes in health status: reliability and responsiveness of five generic health status measures in workers with musculoskeletal disorders. J Clin Epidemiol 1997;50:79–93. 10.1016/S0895-4356(96)00296-X
    1. Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care 1990;28:632–42. 10.1097/00005650-199007000-00008
    1. Heiberg T, Kvien TK. Preferences for improved health examined in 1,024 patients with rheumatoid arthritis: pain has highest priority. Arthritis Rheum 2002;47:391–7. 10.1002/art.10515
    1. Heiberg T, Finset A, Uhlig T, et al. . Seven year changes in health status and priorities for improvement of health in patients with rheumatoid arthritis. Ann Rheum Dis 2005;64:191–5. 10.1136/ard.2004.022699
    1. Ahlmén M, Nordenskiöld U, Archenholtz B, et al. . Rheumatology outcomes: the patient's perspective. A multicentre focus group interview study of Swedish rheumatoid arthritis patients. Rheumatology 2005;44:105–10. 10.1093/rheumatology/keh412
    1. Stamm TA, Cieza A, Coenen M, et al. . Validating the International classification of functioning, disability and health comprehensive core set for rheumatoid arthritis from the patient perspective: a qualitative study. Arthritis Rheum 2005;53:431–9. 10.1002/art.21159
    1. Englbrecht M, Gossec L, DeLongis A, et al. . The impact of coping strategies on mental and physical well-being in patients with rheumatoid arthritis. Semin Arthritis Rheum 2012;41:545–55. 10.1016/j.semarthrit.2011.07.009
    1. Steed LG A critique of coping scales. Aust Psychol 1998;33:193–202. 10.1080/00050069808257404
    1. Gossec L, de Wit M, Kiltz U, et al. . 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. Ann Rheum Dis 2014;73:1012–9. 10.1136/annrheumdis-2014-205207
    1. Gossec L, Danré A, Combe B, et al. . Improvement in patient-reported outcomes after rituximab in rheumatoid arthritis patients: An open-label assessment of 175 patients. Joint Bone Spine 2015;82:451–4. 10.1016/j.jbspin.2015.02.007
    1. Smolen JS, Kremer JM, Gaich CL, et al. . Patient-Reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann Rheum Dis 2017;76:694–700. 10.1136/annrheumdis-2016-209821
    1. Boyce EG, Vyas D, Rogan EL, et al. . Impact of tofacitinib on patient outcomes in rheumatoid arthritis - review of clinical studies. Patient Relat Outcome Meas 2016;7:1–12. 10.2147/PROM.S62879
    1. Rigby W, Ferraccioli G, Greenwald M, et al. . Effect of rituximab on physical function and quality of life in patients with rheumatoid arthritis previously untreated with methotrexate. Arthritis Care Res 2011;63:711–20. 10.1002/acr.20419
    1. Schoemaker CG, de Wit MPT. Treat-to-Target from the patient perspective is Bowling for a perfect strike. Arthritis Rheumatol 202010.1002/art.41461. [Epub ahead of print: 02 Aug 2020].
    1. Gossec L, Dougados M, Dixon W. Patient-Reported outcomes as end points in clinical trials in rheumatoid arthritis. RMD Open 2015;1:e000019. 10.1136/rmdopen-2014-000019
    1. Radner H, Chatzidionysiou K, Nikiphorou E, et al. . 2017 EULAR recommendations for a core data set to support observational research and clinical care in rheumatoid arthritis. Ann Rheum Dis 2018;77:476–9. 10.1136/annrheumdis-2017-212256
    1. Barber CEH, Mosher DP, Ahluwalia V, et al. . Development of a Canadian core clinical dataset to support high-quality care for Canadian patients with rheumatoid arthritis. J Rheumatol 2017;44:1813–22. 10.3899/jrheum.170421
    1. Ferreira RJO, Carvalho PD, Ndosi M, et al. . Impact of Patient’s Global Assessment on Achieving Remission in Patients With Rheumatoid Arthritis: A Multinational Study Using the METEOR Database. Arthritis Care Res 2019;71:1317–25. 10.1002/acr.23866
    1. Ferreira RJO, Dougados M, Kirwan JR, et al. . Drivers of patient global assessment in patients with rheumatoid arthritis who are close to remission: an analysis of 1588 patients. Rheumatology 2017;56:1573–8. 10.1093/rheumatology/kex211
    1. Cramp F, Hewlett S, Almeida C, et al. . Non-Pharmacological interventions for fatigue in rheumatoid arthritis. Cochrane Database Syst Rev 2013;44:Cd008322. 10.1002/14651858.CD008322.pub2
    1. Cunningham NR, Kashikar-Zuck S. Nonpharmacological treatment of pain in rheumatic diseases and other musculoskeletal pain conditions. Curr Rheumatol Rep 2013;15:306. 10.1007/s11926-012-0306-y
    1. Ndosi M, Vinall K, Hale C, et al. . The effectiveness of nurse-led care in people with rheumatoid arthritis: a systematic review. Int J Nurs Stud 2011;48:642–54. 10.1016/j.ijnurstu.2011.02.007
    1. Prothero L, Barley E, Galloway J, et al. . The evidence base for psychological interventions for rheumatoid arthritis: a systematic review of reviews. Int J Nurs Stud 2018;82:20–9. 10.1016/j.ijnurstu.2018.03.008
    1. Ware JE, Sherbourne CD. The mos 36-item short-form health survey (SF-36). I. conceptual framework and item selection. Med Care 1992;30:473–83.
    1. Pincus T, Summey JA, Soraci SA, et al. . Assessment of patient satisfaction in activities of daily living using a modified Stanford health assessment questionnaire. Arthritis Rheum 1983;26:1346–53. 10.1002/art.1780261107
    1. Wells GA, Li T, Kirwan JR, et al. . Assessing quality of sleep in patients with rheumatoid arthritis. J Rheumatol 2009;36:2077–86. 10.3899/jrheum.090362

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir