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