Outcome measures for balneotherapy

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Outcome measures for balneotherapy
Recommendations
Dr. LÁSZLÓ HODINKA

• NATIONAL INSTITUTE OF RHEUMATOLOGY AND
  PHYSIOTHERAPYBudapest, Hungary

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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?

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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?

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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)
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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) Fibromyal
gia 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)
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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

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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

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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 ESR RADAI
  (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 threshold FIQ, fatigue
  psychosocial incl, cognitive tests

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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)

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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

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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 efficacy in
  terms of health economy