1 / 33

Tore K. Kvien Dept of Rheumatology Diakonhjemmet Hospital Oslo, Norway

‘The house supports the use of patient-driven data as important markers for the evaluation of disease activity’ Tore K Kvien and Paul-Peter Tak. The House Supports the Use of Patient-driven Data as Important Markers for the Evaluation of Disease Activity. Tore K. Kvien

glora
Download Presentation

Tore K. Kvien Dept of Rheumatology Diakonhjemmet Hospital Oslo, Norway

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. ‘The house supports the use of patient-drivendata as important markers for theevaluation of disease activity’ Tore K Kvien and Paul-Peter Tak

  2. The House Supports the Use of Patient-driven Dataas Important Markers for the Evaluation ofDisease Activity Tore K. Kvien Dept of RheumatologyDiakonhjemmet HospitalOslo, Norway

  3. Outcome Measures – Main Dimensions Markers of inflammation Structural damage Patient reported outcomes

  4. Core Set of Disease Activity Measures • Tender joint count • Swollen joint count • Pain • Disability score (HAQ) • Patient global • Physician global • Acute phase reactants • Radiographic damage

  5. Importance of Patient Reported Outcomes (PROs) • Patient questionnaires address the primary concerns of the patients and their families • Validated questionnaires for several outcomes(e.g. functional status, pain, fatigue, psychological distress and global status) • Changes in clinical measurements or imaging results may not translate into recognisable benefits to patients

  6. Dimensions of Health Status • Pain • Physical functioning • Mental health • Social functioning

  7. Which Measures are Being Used? • Generic • SF-36 • Disease specific • Arthritis impact measurement scales (AIMS) • Arthritis impact measurement scales 2 (AIMS2) • Health assessment questionnaire (HAQ) • Modified health assessment questionnaire (MHAQ)

  8. Research Agenda OMERACT6 • Identify novel outcomes and instruments of relevance • Well-being / fatigue / sleep pattern • Low disease activity state • Weighting for priorities or impact • Standardised patient diaries • Use of information technology for repeated measurement • Patient feedback from questionnaires

  9. Importance of Patient Reported Outcomes (PROs)(continued) • The relative efficiency to distinguish active from control treatment is generally greater than that seen for joint counts • The most significant predictors of important long-term outcomes in RA (premature death, costs, replacement surgery etc.) • Feasible tools Pincus. J Rheumatol 2006;33:834–837

  10. Relative Efficiency (Compared with Tender Joint Count) of the Outcome Analysed for Leflunomide vs Placebo (ITT Cohort) MHAQ=Modified Health Assessment Questionnaire; ESR=erythrocyte sedimentation rate; CRP=C-reactive protein, PET=Problem Elicitation Technique; SF36=Medical Outcomes Study Short Form-36; ITT=intent-to-treat Tugwell, et al. Arthritis Rheum 2000;43:506–514

  11. Relative Efficiency Wells G et al. Ann Rheum Dis 2007 (online 10 Sept)

  12. Standardised Response Mean (SRM) Unpublished data (NORDMARD)

  13. Courses of HAQ Disability in Individual RA Patients with Long-term DiseaseWolfe, Arthritis Rheum 2000;43:2751-61

  14. Daily Pain 100 mm VAS (Patient with RA) mm VAS Day Heiberg T et al. Arthritis Rheum 2007;57:454-60

  15. Bland Altman DAS-28 SDD 1.29 Unpublished data (Kvien et al.)

  16. Conclusions Patient questionnaires address the primary concerns of the patients and their families The relative efficiency to distinguish active from control treatment is generally greater than that seen for joint counts The most significant predictors of important long-term outcomes in RA (premature death, costs, replacement surgery etc) Feasible tools Test-retest reliability is a concern (as for other measures of disease activity/health status)

  17. This House Does Not Support the Use ofPatient-driven Data as Important Markers for the Evaluation of Disease Activity Paul P. Tak, MD, PhD Clinical Immunology & Rheumatology Academic Medical Center, University of Amsterdam

  18. Characteristics of Patient Questionnaires in Rheumatic Diseases • Cultural differences in data interpretation • Literacy issues cause difficulty for some patients to complete questionnaires • Motivation • Open to possibility of manipulation by the patient (rare) Pincus, et al. Best Pract Res Clin Rheumatol 2003;17:753–781

  19. Characteristics of Fatigue in Rheumatic Diseases • A common symptom of rheumatoid arthritis • Considerable impact on quality of life (QoL) • More predictive of QoL than pain, joint tenderness or disease activity • Poor correlation with objective measures of disease activity (e.g. number of swollen joints or erythrocyte sedimentation rate) Moreland, et al. Arthritis Rheum 2006;55:287–293

  20. Predictors of Subjective Fatigue Among Individuals with Rheumatoid Arthritis Huyser, et al. Arthritis Rheum 1998;41:2230–2237 *n=33; NS=no significant correlation (p>0.05)

  21. Characteristics of HAQ Scores • Volatility, particularly in early RA when changes in HAQ are of great importance • Lack of sensitivity to change in established RA Scott, et al. Rheumatology 2000;39:122–132 HAQ=Health Assessment Questionnaire

  22. Variability in HAQ is Greater in Early vs Established Rheumatoid Arthritis Scott, et al. Rheumatology 2000;39:122–132 HAQ=Health Assessment Questionnaire

  23. Placebo therapies 1.0 0.5 0 -0.5 -1.0 -1.5 -2.0 -2.5 -3.0 1.0 0.5 0 -0.5 -1.0 -1.5 -2.0 -2.5 -3.0 Six-month analysis Twelve-month analysis Traditional DMARDs Biologics 13 1 9 5 9 5 13 1 HAQ responsiveness (effect size) HAQ responsiveness (effect size) Model: F=7.37 p<0.0001 R2=0.31 Model: F=11.05 p<0.0001 R2=0.61 Mean duration of RA in trial (years) Mean duration of RA in trial (years) Long Standing RA: HAQ Monitoring Might Not be Sensitive Enough! Aletaha, et al. Ann Rheum Dis 2007 (online 20 July) HAQ=Health Assessment Questionnaire

  24. Wide Distribution of HAQ Score Variation Over 2 Months in Patients Reporting No Change in Health in General Median disease duration (range) = 11 (1–29) years; n=40 Number of patients Greenwood, et al. Ann Rheum Dis 2001;60:344–348 HAQ=Health Assessment Questionnaire

  25. Weak Association Between Patient Satisfaction with Disease Control and Disease Activity/severity as Assessed by HAQ Vertical lines at 0.5, 1.0 and 1.625 divide the histograms into compartments of mild, moderate, severe and very severe functional status Wolfe, et al. Arthritis Rheum 2007;56:2135–2142 HAQ=Health Assessment Questionnaire

  26. Weak Association Between Patient Satisfaction with Disease Control and Disease Activity/severity as Assessed by PAS Vertical lines at 1.9, 3.8 and 5.6 divide the histograms into compartments of mild, moderate, severe and very severe disease activity Wolfe, et al. Arthritis Rheum 2007;56:2135–2142 PAS=Patient Activity Score

  27. Sensitivity to Change of Patient-driven Data is Too Low

  28. Patient-driven Data • Too much variability on the individual level • Not sufficiently reliable • Poor correlation with objective measures of disease activity • Lack sensitivity to change

  29. Based on the available evidence: this house does not support the use of patient-driven data as important markers for the evaluation of disease activity

More Related