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

Laura Holloway, Louise Humphrey, Louise Heron, Claire Pilling, Helen Kitchen, Lise Højbjerre, Martin Strandberg-Larsen, Brian Bekker Hansen, Laura Holloway, Louise Humphrey, Louise Heron, Claire Pilling, Helen Kitchen, Lise Højbjerre, Martin Strandberg-Larsen, Brian Bekker Hansen

Abstract

Background: Despite overall progress in treatment of autoimmune diseases, patients with systemic lupus erythematosus (SLE) experience many inflammatory symptoms representing an unmet medical need. This study aimed to create a conceptual model of the humanistic and economic burden of SLE, and review the patient-reported outcomes (PROs) used to measure such concepts in SLE clinical trials.

Methods: A conceptual model for SLE was developed from structured review of published articles from 2007 to August 2013 identified from literature databases (MEDLINE, EMBASE, PsycINFO, EconLit) plus other sources (PROLabels, FDA/EMA websites, Clinicaltrials.gov). PROs targeting key symptoms/impacts were identified from the literature. They were reviewed in the context of available guidance and assessed for face and content validity and psychometric properties to determine appropriateness for use in SLE trials.

Results: The conceptual model identified fatigue, pain, cognition, daily activities, emotional well-being, physical/social functioning and work productivity as key SLE concepts. Of the 68 articles reviewed, 38 reported PRO data. From these and the other sources, 15 PROs were selected for review, including SLE-specific health-related quality of life (HRQoL) measures (n = 5), work productivity (n = 1), and generic measures of fatigue (n = 3), pain (n = 2), depression (n = 2) and HRQoL (n = 2). The Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue), Brief Pain Inventory (BPI-SF) and LupusQoL demonstrated the strongest face validity, conceptual coverage and psychometric properties measuring key concepts in the conceptual model. All PROs reviewed, except for three Lupus-specific measures, lacked qualitative SLE patient involvement during development. The Hospital Anxiety and Depression Scale (HADS), Short Form [36 item] Health Survey version 2 (SF-36v2), EuroQoL 5-dimensions (EQ-5D-3L and EQ-5D-5L) and Work Productivity and Activity Impairment Questionnaire: Lupus (WPAI:Lupus) showed suitability for SLE economic models.

Conclusions: Based on the identification of key symptoms and impacts of SLE using a scientifically sound conceptual model, we conclude that SLE is a condition associated with high unmet need and considerable burden to patients. This review highlights the availability and need for disease-specific and generic patient-reported measures of relevant domains of disease signs and symptoms, HRQoL and work productivity, providing useful insight for SLE clinical trial design.

Figures

Figure 1
Figure 1
Systemic lupus erythematosus conceptual model.

References

    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.
    1. Danchenko N, Satia JA, Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus. 2006;15:308–318.
    1. 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.
    1. Borchers AT, Naguwa SM, Shoenfeld Y, Gershwin ME. The geoepidemiology of systemic lupus erythematosus [abstract] Autoimmun Rev. 2010;9:A277–A287.
    1. 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.
    1. Manson JJ, Rahman A. Systemic lupus erythematosus. Orphanet J Rare Dis. 2006;1:6.
    1. 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 Jr, Gilkeson G, Ginzler E, Gordon C, Grossman J, Hahn B, Isenberg DA, Kalunian KC, Petri M, Sammaritano L, Sánchez-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.
    1. Lahita RG. Systemic Lupus Erythematosus. Elsevier, London; 2004.
    1. Lupus: Statistics on Lupus. Foundation of America. []
    1. 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.
    1. Guidance For Industry: Patient-Reported Outcome Measures: Use In Medical Product Development To Support Labelling Claims. 2009.
    1. Reflection Paper on the Regulatory Guidance for the use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products. 2005.
    1. Equity and Excellence: Liberating the NHS. 2010.
    1. Guidance for Industry: Systemic Lupus Erythematosus - Developing Medical Products for Treatment. 2010.
    1. Guideline on Clinical Investigation of Medicinal Products for the Treatment of Systemic Lupus Erythematosus, Cutaneous Lupus and Lupus Nephritis (Draft) 2013.
    1. 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.
    1. 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.
    1. 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.
    1. Systematic Reviews: CRD’s guidance for undertaking systematic reviews in health care..
    1. Earp JA, Ennett ST. Conceptual models for health education research and practice. Health Educ Res. 1991;6:163–171.
    1. Rothman ML, Beltran P, Cappelleri JC, Lipscomb J, Teschendorf B. Patient-reported outcomes: conceptual issues. Value Health. 2007;10:S66–S75.
    1. 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.
    1. 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.
    1. Beckerman NL. Living with lupus: a qualitative report. Soc Work Health Care. 2011;50:330–343.
    1. 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.
    1. 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.
    1. 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.
    1. Kosinski M, Gajria K, Fernandes AW, Cella D. Qualitative validation of the FACIT-fatigue scale in systemic lupus erythematosus. Lupus. 2013;22:422–430.
    1. Schneider M, Schmeding A, Carnarius H, Ager M, McWade V. Systemic lupus erythematosus (SLE): understanding the burden. Value Health. 2010;13:A470.
    1. 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.
    1. Aberer E. Epidemiologic, socioeconomic and psychosocial aspects in lupus erythematosus. Lupus. 2010;19:1118–1124.
    1. 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.
    1. 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.
    1. Measurement of fatigue in systemic lupus erythematosus: a systematic review. Arthritis Care Res. 2007;57:1348–1357.
    1. 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.
    1. Ramsey-Goldman R, Rothrock N. Fatigue in systemic lupus erythematosus and rheumatoid arthritis. PM&R. 2010;2:384–392.
    1. Danoff-Burg S, Friedberg F. Unmet needs of patients with systemic lupus erythematosus. Behav Med. 2009;35:5–13.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. Yelin E, Katz P. Introduction to special section: cost and social and psychological impact of rheumatic diseases. Arthritis Rheum. 2008;59:457.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. Jolly M, Garris CP, Jhingran PM, Mikolaitis RA, Dennis G, Wallace DJ, Clarke A, Dooley MA, Parke A, Strand V, Alárcon 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.
    1. Strand V, Chu AD. Measuring outcomes in systemic lupus erythematosus clinical trials. Expert Rev Pharmacoecon Outcomes Res. 2011;11:455–468.
    1. 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.
    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. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy. 1990;16:199–208.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975;1:277–299.
    1. 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.
    1. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore. 1994;23:129–138.
    1. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry. 1961;4:561–571.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370.
    1. Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993;4:353–365.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. Beaumont JLL J, Cella D, Brunetta P, Ogale S. Validation of the SF-36 in Patients with Systemic Lupus Erythematosus (SLE) Arthritis Rheum. 2009;60:296.
    1. 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.
    1. User’s Manual for the SF-36v2 Health Survey. 2011.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. Roche PA, Klestov AC, Heim HM. Description of stable pain in rheumatoid arthritis: a 6 year study. Arthritis Rheumatol. 2003;30:1733–1738.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.
    1. 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.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren