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Outcome measures for balneotherapy

Outcome measures for balneotherapy. R ecommendations. NATIONAL INSTITUTE OF RHEUMATOLOGY AND PHYSIOTHERAPY Budapest, Hungary. Dr. LÁSZLÓ HODINKA. Fundamental q uestions of balneotherapy (I.). Definition of curative water: hy g ienic / administrative: suitable for therapeutic use

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Outcome measures for balneotherapy

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  1. Outcome measures for balneotherapy Recommendations NATIONAL INSTITUTE OF RHEUMATOLOGY AND PHYSIOTHERAPYBudapest, Hungary Dr. LÁSZLÓ HODINKA

  2. Fundamental questions of balneotherapy (I.) Definition of curative water: • hygienic / administrative: suitable for therapeutic use • evidence based: beneficial / curative effects What are the physiological effects of immersion into thermal / mineral water? Are these different from the effects of normal water? Does immersion into thermal / mineral water influenceany biological/ pathological response in diseasestates?

  3. Fundamental questions of balneotherapy (II.) Is the immersion effective itself, or when combined with any activity or climatical factor? How can we measure / prove the changes? Are these changes beneficial / curative ? What are the main domains of the benefit?

  4. Measures applied in balneotherapy trials (I) • RA • Pain VAS, (pat) activity vAS (pat), activity VAS (doctor), morning stiffness, Ritchie,painful and swollen joints, walking distance, PIP circumference, activities of daily livingADL / HAQ, AIMS, Keitel index (Yurtkuran, Sukenik, Franke, Elkayam) • A. psor. • morning stiffness, grip strenght, activity VAS (pat), active joints, Ritchie, vertebralpain + ROM,PASI, tender point pain (Dolorimeter) (Sukenik, Elkayam) • SPA • morning pain and stiffness, spine ROM, activity (pat + doctor - 3 / +3 grade) (Tubengen, Tischler)

  5. Measures applied in balneotherapy trials (II) • OA • Pain VAS (pat), severity (pat + doctor - 3 / +3 grade), ROM, Lequesne index, step-walk time, funcional state, AIMS, walking distance, QoL (Duke Health Profile (Wigler, Elkayam, Kovács, Sukenik, Nguyen, Forester, Guillemin • Back pain • Pain VAS (pat), Laségue, spine ROM, drug need, function (Roland-Morris), QoL (Duket Health Profile) (Konrád, Constant, Guillemin) • Fibromyalgia • Pain, fatigue, anxiety, Sleep disturbance (VAS, pat) tender points, dolorimetry(Fischer), HAQ (FDI), SF-36, AIMS, FIQ, Beck EI (Yurtkuran, Ervcik, Neuman,Buskila) • (reviewed by: I. Tefner, Natl.Inst. Rheum. Phys.Med. Budapest)

  6. Evaluationof randomized clinical trials in balneotherapy Strengths: Evidence based protocol settings Efforts to apply relevant indicators Weaknesses: Use of arbitrary, „home made” or less known parameters Focus on disease activity and pain Rarely apply functional tests Almost complete lack of QoL and psychosocial measures No effort for health economy argumentation

  7. OMERACT requirements on outcome measures Discriminative measures Evaluative measures chareacterize groupsmeasure response sensitive for groupsensitive for changesmeans, medians, etcindicates differences over time Measures should be valid, differentiating, easily applicable

  8. Recommended disease specific outcome measures for balneotherapy RAEULAR core set / DAS 28: (pain VAS-pat, activity VAS-pat, ESR, swollen and tender points)Simplified disease activity index (SDAI-swollen) as above+ activity VAS-doctor, CRP instead of ESRRADAI (Stucki)RA QoL, HAQ (less ClinHAQ, MHAQ, MDHAQ)ACR or EULAR improvement 9ACR 20, 50, 70, DAS 28 limits A.psorPASI, PsorHAQ, ApsorQoL SpABASDAI, BASFI, BASMI, ASAS improvement criteria OAWomac scales, Lequesne index Low back pain:ROM, Oswestry index, Roland and Morris index Fibromyalgia:tender points + Fischer dolorimetry + pain thresholdFIQ, fatigue + psychosocial incl, cognitive tests

  9. Psychosocial measures are highly recommended in musculoskeletal trials Depression, anxiety, health cognition, fatigue, coping skills, positive mood, helplessness, stress, somatization, sleep, social support Reviewed by Brooks et al, Wolfe [OMERACTworkshop report J.Rheumatology 24 (1997)]

  10. Generic health state and QoL measures and health economy SF-36, EuroQoL5D, less Nottingham Health Pofile Psychosocial outcomes Utility calculations:direct and indirect costs ofdisease specificQALYs or QALDays based onEuroQoL Health States

  11. Conclusion Effectiveness of balneotherapy should be proven by Evidence Based Medicineapproved indicators and instruments Focus on rehabilitation, functional and QoL improvement Based on QoL improvements, prove efficacyin terms of health economy

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