Monaco 020909
-
Upload
sfaangeiologie -
Category
Documents
-
view
443 -
download
2
description
Transcript of Monaco 020909
Epidemiologie sociale de la maladie veineuse
Pr Francois André ALLAERT
Président de la Société Française d'Angiologie. Vice Président de la société Française de phlébologie
Secrétaire général de la Société Française Des docteurs en pharmacie
Pr CHRU Dijon & McGill University Montreal. Canada.
Pr Francois André ALLAERT
Président de la Société Française d'Angiologie.
Vice Président de la société Française de phlébologie
Titulaire de la Chaire d’Evaluation des allégations de santé Ceren ESC Dijon
Evaluation tools for venoactive drug : Does the future lies in patients’ satisfaction evaluation ?
INTRODUCTION
De-reimbursement has discredited the efficacy of the venoactive drugs
For most of them their efficacy was not in question
According to the evidence based standards, one of them was able to claim for a level A evidence of efficacy and some other a level B
It was the medical utility which appeared insufficient to the French Health authorities
An evolution of the drug registration
A new approach of the drug registration
Where efficacy is a sine qua none condition
But which is not sufficient by itself
To allow its registration and its reimbursement by the social insurance system.
The added medical value : a flexible paradigme
Its fuzzy definition lets the commissions to interpret it as they whish by associating depending on the circumstances :
« Effectiveness » « Efficacy »
« Efficiency »
«Utility»
« Safety »
An anglosaxon terminology« Efficacy » measures how well it works in clinical trials or laboratory studies.
« Effectiveness »» relates to how well a treatment works in practice
« Efficiency »» is doing things in the most economical way
« Safety » is the security in use
«Utility» is a measure of the relative satisfaction from, consumption of various goods and services
Efficacy evaluation tools
Indirect evidences :
an explanatory approach
Direct evidences :
a conclusive approach
Efficacy evaluation tools
Explanatory approach
in vitro studies or animal studiesOn microcirculation On N0 production
On inflammatory markerOn pain mediator
Interest : to explain the effects on functional and physical symptoms
Difficulty : to démonstrate the link with the venous disease
Conclusive approach
Clinical studies
56 studies fulfilling the criteria to get a level A evidence were analysed in the cochrane 2005 review and that we complete with a personal bibliography review after 2005 using the same key words
Frequencyof evaluation criteria54/56 Symptoms evaluation 96,4%28/56 ankle or calf circumference 50,0%13/56 Pléthysmographies 23,2%4/56 leg volume measure using water displacement 7,1%4/56 Venous reflux with doppler 7,1%4/56 Venous pressure measure 7,1%3/56 PO2 et PCO2 measure 5,4%2/56 Echodoppler measure of oedema 3,8%
Conclusive approach
Functional symptoms Visual analogic scales are better than qualitative or semi quantitative scales
Oedema measures : Measure with measuring tape must be conducted with constant force and attention must be paid to do the measure at the exact same level.
Pléthysmography :The most valuable measure except the photoplethysmography. Plethysmography using mercury strain-gauge are forbidden in many countries do to the restriction of using mercury. The most frequent is now air Plethysmography. Volume measurement and venous refilling time.
Water displacement: The best way to measure oedema but only oedema.
Conclusive approach
Reflux measure with echodopplerDemonstrate the reflux and its duration But some studies shows that only 20% of patients with a chronic venous disease avec a deep venous reflux Deep venous reflux are not very sensitive to medical treatment..
Mesure of the venous pressure at the ankle . Lack of standard or definition of a pathological threshold. Not very sensitive to medical treatment..
PCO2 et PO2 Measure Reflect the tissular stress induced by the venous stase But what is the correlation with the clinical symptoms?
Oedema measure with echodpoppler. Requires a mathematical 3 dimensional reconstruction of the oedema and only gives a measure of oedema.
Conclusive approach
Quality of life scales
Generic scale : SF12
Specific scales : CIVIQ
Show a patients’ quality of life benefit
Health authorities do no pay a great attention to their results
May re-enforce the opinion of health authorities that venous disease is a comfort troubles
It could have been more interesting to compare the
quality of life decrease induced by venous disease and those induced by some more « recognized » pathology
A lack of recognition
Its a disease without real pathological status till some complications appear.
Trophic troubles
Varicose
Ulcer
Even not recognised as a risk factor of complications as phlebitis
Venous disease status
A painful heaviness Whose physiopathological mechanisms have
been partially elucidated
whose symptoms are relieved by venoactive drugs
But its severity is not perceived by authorities in the same
manner than arthritic pain
or headache.
What should we do ?
Studies must be targeted in two directions.
Health authorities
Patients
To convince health authorities
Long term clinical trials Long term cohorts studies
Targeting new indications Not making reference to the venous disease
But to the prevention of its complication who are acknowledge as « real » pathologies
Requires many years
A willingness to pay of the health authorities
But what happens in italy is interesting :
After venoactive de-reimbursement : frequency of varicose and ulcer increases inducing heath costs increase
To convince patients
Because patients become consummersWhen they are paying for their own health
expenses
To bring evidence of their venous disease relief
Functional symptoms +++
Physical symptoms (oedema)
Quality of life
And in the next future
Patients’ satisfaction
To evaluate patients’ satisfaction
VAS or Lickert scalesbut
Some specific questionnaire Already exist in some other disease and
especially in rheumatology
They concern 1) The answer to the patients’ expectations
2) Its posology3) Its safety
4) The patients decision to buy it again5) Its satisfaction/price
A questionnaire should be soon validated In the venous disease
CONCLUSION
Perhaps are we faced to a turning point of the evaluation of venoactive drugs?
Because patients are now paying the venoactive drugs, should we pay more attention to the patienst satisfaction?
Perhaps the consumer patient will require a specific metrology for OTC drug in general and venoactive particularly ?
Utility is a measure of the relative satisfaction from,
consumption of various goods and services