outcome measures for balneotherapy national institute of rheumatology and physiotherapy budapest,...
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Outcome measures for balneotherapyOutcome measures for balneotherapy
NATIONAL INSTITUTE OF RHEUMATOLOGY AND PHYSIOTHERAPYNATIONAL INSTITUTE OF RHEUMATOLOGY AND PHYSIOTHERAPYBudapest, HungaryBudapest, Hungary
Dr. LÁSZLÓ HODINKADr. LÁSZLÓ HODINKA
RecommendationsRecommendations
Fundamental questions of balneotherapy (I.)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?
Fundamental questions of balneotherapy (II.)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?
Measures applied in balneotherapy trials (I) 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)
Measures applied in balneotherapy trials (II) 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)
Evaluation of randomized clinical trials in balneotherapy
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
OMERACT requirements on outcome measures
OMERACT requirements on outcome measures
Discriminative measures Evaluative measures
chareacterize groups measure response
sensitive for group sensitive for changesmeans, medians, etc indicates differences over time
Measures should be valid, differentiating, easily applicable
Discriminative measures Evaluative measures
chareacterize groups measure response
sensitive for group sensitive for changesmeans, medians, etc indicates differences over time
Measures should be valid, differentiating, easily applicable
Recommended disease specific outcome measures for balneotherapy
Recommended disease specific outcome measures for balneotherapy
RA EULAR 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. psor PASI, PsorHAQ, ApsorQoL
SpA BASDAI, BASFI, BASMI, ASAS improvement criteria
OA Womac 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
RA EULAR 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. psor PASI, PsorHAQ, ApsorQoL
SpA BASDAI, BASFI, BASMI, ASAS improvement criteria
OA Womac 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
Psychosocial measures are highly recommended in musculoskeletal trials
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)]
Generic health state and QoL measures and health economy
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
SF-36, EuroQoL5D, less Nottingham Health Pofile
Psychosocial outcomes
Utility calculations: direct and indirect costs ofdisease specificQALYs or QALDays based onEuroQoL Health States
ConclusionConclusion
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