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

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 influence any biological / pathological response in disease states?

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 living ADL / HAQ, AIMS, Keitel index (Yurtkuran, Sukenik, Franke, Elkayam) A. psor. morning stiffness, grip strenght, activity VAS (pat), active joints, Ritchie, vertebral pain + ROM, PASI, tender point pain (Dolorimeter) (Sukenik, Elkayam) SPA morning pain and stiffness, spine ROM, activity (pat + doctor - 3 / +3 grade) (Tubengen, Tischler) RA Pain VAS, (pat) activity vAS (pat), activity VAS (doctor), morning stiffness, Ritchie, painful and swollen joints, walking distance, PIP circumference, activities of daily living ADL / HAQ, AIMS, Keitel index (Yurtkuran, Sukenik, Franke, Elkayam) A. psor. morning stiffness, grip strenght, activity VAS (pat), active joints, Ritchie, vertebral pain + 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) 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. Evaluation of 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 measuresEvaluative measures chareacterize groupsmeasure response sensitive for groupsensitive for changes means, medians, etcindicates differences over time Measures should be valid, differentiating, easily applicable Discriminative measuresEvaluative measures chareacterize groupsmeasure response sensitive for groupsensitive for changes means, 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 ESR RADAI (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 threshold FIQ, fatigue + psychosocial incl, cognitive tests 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 ESR RADAI (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 threshold FIQ, 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 [OMERACT workshop report J. Rheumatology 24 (1997)] Depression, anxiety, health cognition, fatigue, coping skills, positive mood, helplessness, stress, somatization, sleep, social support Reviewed by Brooks et al, Wolfe [OMERACT workshop 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 of disease specific QALYs or QALDays based on EuroQoL Health States SF-36, EuroQoL5D, less Nottingham Health Pofile Psychosocial outcomes Utility calculations:direct and indirect costs of disease specific QALYs or QALDays based on EuroQoL Health States

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