Discriminant validity, responsiveness and reliability of the arthritis-specific Work Productivity Survey assessing workplace and household productivity in patients with psoriatic arthritis

Jane T Osterhaus, Oana Purcaru, Jane T Osterhaus, Oana Purcaru

Abstract

Introduction: The novel arthritis-specific Work Productivity Survey (WPS) was developed to estimate patient productivity limitations associated with arthritis within and outside the home, which is an unmet need in psoriatic arthritis (PsA). The WPS has been validated in rheumatoid arthritis. This report assesses the discriminant validity, responsiveness and reliability of the WPS in adult-onset PsA.

Methods: Psychometric properties were assessed using data from the RAPID-PsA trial (NCT01087788) investigating certolizumab pegol (CZP) efficacy and safety in PsA. WPS was completed at baseline and every 4 weeks until Week 24. Validity was evaluated at baseline via known-groups defined using first and third quartiles of patients' Disease Activity Score 28 based on C-reactive protein (DAS28(CRP)), Health Assessment Questionnaire-Disability Index (HAQ-DI), Short Form-36 (SF-36) items and PsA Quality of Life (PsAQoL) scores. Responsiveness and reliability were assessed by comparing WPS mean changes at Week 12 in American College of Rheumatology 20% improvement criteria (ACR20) or HAQ-DI Minimal Clinically Important Difference (MCID) 0.3 responders versus non-responders, as well as using standardized response means (SRM). All comparisons were conducted on the observed cases in the Randomized Set, regardless of the randomization group, using a non-parametric bootstrap-t method.

Results: Compared with patients with a better health state, patients with a worse health state had on average 2 to 6 times more household work days lost, more days with reduced household productivity, more days missed of family/social/leisure activities, more days with outside help hired and a significantly higher interference of arthritis per month. Among employed patients, those with a worse health state had 2 to 4 times more workplace days lost, more days with patient workplace productivity reduced, and a significantly higher interference of arthritis on patient workplace productivity versus patients with a better health state. WPS was also responsive to clinical changes, with responders having significantly larger improvements at Week 12 in WPS scores versus non-responders. The effect sizes for changes in productivity in ACR20 or HAQ-DI MCID responders were moderate (0.5 < SRM < 0.8) or small.

Conclusions: These analyses demonstrate the validity, responsiveness and reliability of the WPS, as an instrument for the measurement of patient productivity within and outside the home in an adult-onset PsA population.

Figures

Figure 1
Figure 1
Mean changes from baseline in the Work Productivity Survey by American College of Rheumatology 20% improvement criteria clinical response at week 12. Change from baseline in the Work Productivity Survey by American College of Rheumatology 20% improvement criteria (ACR20) clinical response at week 12 (randomized set, observed cases). **P ≤ 0.001, *P < 0.01 responders versus nonresponders; P-values were obtained using the nonparametric bootstrap t method. Rate of interference is a score on a scale of 0 to 10 points (0 = no interference and 10 = complete interference). WP, work productivity.
Figure 2
Figure 2
Effect size of mean changes from baseline in the Work Productivity Survey at week 12 (randomized set, observed cases). Effect size (standardized response mean (SRM)) of mean changes from baseline in the Work Productivity Survey (WPS) are presented by the (a) American College of Rheumatology 20% improvement criteria (ACR20) clinical response, (b) American College of Rheumatology 50% improvement criteria (ACR50) clinical response, and (c) Health Assessment Questionnaire – Disability Index (HAQ-DI) minimal clinically important difference (MCID of 0.3) clinical response. SRM (absolute values) thresholds: small, from 0.2 to 0.5 (below the dashed line); moderate, from 0.5 to 0.8 (between the two lines); and large, >0.8 (above the solid line).

References

    1. Nograles KE, Brasington RD, Bowcock AM. New insights into the pathogenesis and genetics of psoriatic arthritis. Nat Clin Pract Rheumatol. 2009;5:83–91.
    1. Boonen A, Severens JL. Worker participation in rheumatic disease: the socioeconomic perspective. ACR Topical Rev. 2009;6:12.
    1. Wallenius M, Skomsvoll JF, Koldingsnes W, Rodevand E, Mikkelsen K, Kaufmann C, Kvien TK. Work disability and health-related quality of life in males and females with psoriatic arthritis. Ann Rheum Dis. 2009;68:685–689.
    1. Tillett W, de-Vries C, McHugh NJ. Work disability in psoriatic arthritis: a systematic review. Rheumatology (Oxford) 2012;51:275–283.
    1. Mau W, Listing J, Huscher D, Zeidler H, Zink A. Employment across chronic inflammatory rheumatic diseases and comparison with the general population. J Rheumatol. 2005;32:721–728.
    1. Huscher D, Merkesdal S, Thiele K, Zeidler H, Schneider M, Zink A. Cost of illness in rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and systemic lupus erythematosus in Germany. Ann Rheum Dis. 2006;65:1175–1183.
    1. Moreno JC, Daudén E, Rodriguez-Valverde V, Gomez-Reino J, Gratacos J, Sabater FJ, Casado MA. A cost-of-illness study of psoriatic arthritis in Spain. Value Health. 2009;12:A437.
    1. Olivieri I, de Portu S, Salvarani C, Cauli A, Lubrano E, Spadaro A, Cantini F, Cutro MS, Mathieu A, Matucci-Cerinic M, Pappone N, Punzi L, Scarpa R, Mantovani LG. The psoriatic arthritis cost evaluation study: a cost-of-illness study on tumour necrosis factor inhibitors in psoriatic arthritis patients with inadequate response to conventional therapy. Rheumatology (Oxford) 2008;47:1664–1670.
    1. Shbeeb M, Uramoto KM, Gibson LE, O'Fallon WM, Gabriel SE. The epidemiology of psoriatic arthritis in Olmsted County, Minnesota, USA, 1982–1991. J Rheumatol. 2000;27:1247–1250.
    1. Wilson FC, Icen M, Crowson CS, McEvoy MT, Gabriel SE, Kremers HM. Time trends in epidemiology and characteristics of psoriatic arthritis over 3 decades: a population-based study. J Rheumatol. 2009;36:361–367.
    1. Kaipiainen-Seppanen O, Aho K. Incidence of chronic inflammatory joint diseases in Finland in 1995. J Rheumatol. 2000;27:94–100.
    1. Hu SW, Holt EW, Husni ME, Qureshi AA. Willingness-to-pay stated preferences for 8 health-related quality-of-life domains in psoriatic arthritis: a pilot study. Semin Arthritis Rheum. 2010;39:384–397.
    1. McKenna SP, Doward LC, Whalley D, Tennant A, Emery P, Veale DJ. Development of the PsAQoL: a quality of life instrument specific to psoriatic arthritis. Ann Rheum Dis. 2004;63:162–169.
    1. Gladman DD, Strand V, Mease PJ, Antoni C, Nash P, Kavanaugh A. OMERACT 7 psoriatic arthritis workshop: synopsis. Ann Rheum Dis. 2005;64:ii115–ii116.
    1. Mease PJ. Assessment tools in psoriatic arthritis. J Rheumatol. 2008;35:1426–1430.
    1. Kavanaugh A. Health economics: implications for novel antirheumatic therapies. Ann Rheum Dis. 2005;64:iv65–iv69.
    1. Escorpizo R, Bombardier C, Boonen A, Hazes JM, Lacaille D, Strand V, Beaton D. Worker productivity outcome measures in arthritis. J Rheumatol. 2007;34:1372–1380.
    1. Prasad M, Wahlqvist P, Shikiar R, Shih YC. A review of self-report instruments measuring health-related work productivity: a patient-reported outcomes perspective. PharmacoEconomics. 2004;22:225–244.
    1. Mattke S, Balakrishnan A, Bergamo G, Newberry SJ. A review of methods to measure health-related productivity loss. Am J Manag Care. 2007;13:211–217.
    1. Lofland JH, Pizzi L, Frick KD. A review of health-related workplace productivity loss instruments. PharmacoEconomics. 2004;22:165–184.
    1. Osterhaus JT, Purcaru O, Richard L. Discriminant validity, responsiveness and reliability of the rheumatoid arthritis-specific Work Productivity Survey (WPS-RA) Arthritis Res Ther. 2009;11:R73.
    1. Beaton D, Bombardier C, Escorpizo R, Zhang W, Lacaille D, Boonen A, Osborne RH, Anis AH, Strand CV, Tugwell PS. Measuring worker productivity: frameworks and measures. J Rheumatol. 2009;36:2100–2109.
    1. Mease PJ, Fleischmann R, Deodhar AA, Wollenhaupt J, Khraishi M, Kielar D, Woltering F, Stach C, Hoepken B, Arledge T, van der Heijde D. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24 week results of a phase 3 double blind randomized placebo-controlled study (RAPID-PsA) Ann Rheum Dis. 2014;73:48–55.
    1. Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, Furst D, Goldsmith C, Kieszak S, Lightfoot R, Paulus H, Tugwell P, Weinblatt M, Widmark R, Williams HJ, Wolfe F. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum. 1993;36:729–740.
    1. Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum. 1992;35:498–502.
    1. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23:137–145.
    1. Bruce B, Fries JF. The Health Assessment Questionnaire (HAQ) Clin Exp Rheumatol. 2005;23:S14–S18.
    1. Mease PJ, Ganguly R, Wanke L, Yu E, Singh A. How much improvement in functional status is considered important by patients with active psoriatic arthritis: applying the Outcome Measures in Rhuematoid Arthritis Clinical Trials (OMERACT) group guidelines [abstract] Ann Rheum Dis. 2004;63 SAT0015.
    1. Wells G, Becker JC, Teng J, Dougados M, Schiff M, Smolen J, Aletaha D, van Riel PL. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis. 2009;68:954–960.
    1. Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64:ii65–ii68. discussion ii69-ii73.
    1. Fredriksson T, Pettersson U. Severe psoriasis – oral therapy with a new retinoid. Dermatologica. 1978;157:238–244.
    1. Clegg DO, Reda DJ, Mejias E, Cannon GW, Weisman MH, Taylor T, Budiman-Mak E, Blackburn WD, Vasey FB, Mahowald ML, Cush JJ, Schumacher HR, Silverman SL, Alepa FP, Luggen ME, Cohen MR, Makkena R, Haakenson CM, Ward RH, Manaster BJ, Anderson RJ, Ward JR, Henderson WG. Comparison of sulfasalazine and placebo in the treatment of psoriatic arthritis. A department of veterans affairs cooperative study. Arthritis Rheumatism. 1996;39:2013–2020.
    1. Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) – a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994;19:210–216.
    1. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–483.
    1. Brooks R. EuroQol: the current state of play. Health Policy. 1996;37:53–72.
    1. EuroQol G. EuroQol – a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.
    1. Fayers PM, Machin D. Quality of Life: Assessment, Analysis and Interpretation. Chichester, UK: John Wiley & Sons, Ltd; 2000.
    1. Barber JA, Thompson SG. Analysis of cost data in randomized trials: an application of the non-parametric bootstrap. Stat Med. 2000;19:3219–3236.
    1. Cohen MR, Reda DJ, Clegg DO. Baseline relationships between psoriasis and psoriatic arthritis: analysis of 221 patients with active psoriatic arthritis. Department of Veterans Affairs Cooperative Study Group on Seronegative Spondyloarthropathies. J Rheumatol. 1999;26:1752–1756.
    1. Hazes JM, Taylor P, Strand V, Purcaru O, Coteur G, Mease P. Physical function improvements and relief from fatigue and pain are associated with increased productivity at work and at home in rheumatoid arthritis patients treated with certolizumab pegol. Rheumatology (Oxford) 2010;49:1900–1910.
    1. Kavanaugh A, Smolen JS, Emery P, Purcaru O, Keystone E, Richard L, Strand V, van Vollenhoven RF. Effect of certolizumab pegol with methotrexate on home and work place productivity and social activities in patients with active rheumatoid arthritis. Arthritis Rheum. 2009;61:1592–1600.
    1. Kirwan J, Heiberg T, Hewlett S, Hughes R, Kvien T, Ahlmen M, Boers M, Minnock P, Saag K, Shea B, Suarez Almazor M, Taal E. Outcomes from the Patient Perspective Workshop at OMERACT 6. J Rheumatol. 2003;30:868–872.
    1. Kirwan JR, Hewlett SE, Heiberg T, Hughes RA, Carr M, Hehir M, Kvien TK, Minnock P, Newman SP, Quest EM, Taal E, Wale J. Incorporating the patient perspective into outcome assessment in rheumatoid arthritis – progress at OMERACT 7. J Rheumatol. 2005;32:2250–2256.
    1. Tang K, Escorpizo R, Beaton DE, Bombardier C, Lacaille D, Zhang W, Anis AH, Boonen A, Verstappen SM, Buchbinder R, Osborne RH, Fautrel B, Gignac MA, Tugwell PS. Measuring the impact of arthritis on worker productivity: perspectives, methodologic issues, and contextual factors. J Rheumatol. 2011;38:1776–1790.
    1. Lerner DJ, Lee J. In: Health and Work Productivity: Making the Business Case for Quality Health Care. Kessler RC, Stang PE, editor. Chicago, IL: University of Chicago Press; 2006. Measuring health related work productivity with self-reports; pp. 67–87.

Source: PubMed

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