Retour

AIXIAL Review #2

Why should RWE’s health research integrate the notion of health pathways and increase the place of PRO?

 

In the field of chronic diseases, French health policy, like that of many countries, is now focused on the care/health path of individuals. As the LEEM indicates, medicine has thus become a medicine of pathways[1].

This new medicine makes it possible to pay better attention to the suffering individual, to his difficulties, his possibilities, his expectations, and his choices throughout the hardships he endures during his often painful and complex pathway.

Such a perspective, which a posteriori seems so natural, nevertheless greatly modifies the pre-existing, compartmentalized organization of care and potentially research in RWE[2] while better corresponding to the reality experienced by patients.

To preserve/improve the health of people with chronic diseases, the quality of care (which will include the quality of the relationship between caregivers and patients) has always been and remains decisive. Within the framework of the pathways, two important levers for improving quality deserve to be highlighted: individualized support for patients, and the coordination of the pathway’s caregivers:

  • The place and role of care providers and patient caregivers have been reconsidered within particular efforts made on the training of the various stakeholders. The ability of the latter to take into account the possibilities of patients, to understand their obstacles and motivations, to engage in their care path has become essential. In contrast to blind standardization, support has thus developed that is adapted to the individual needs of patients throughout their pathway
  • The growing complexity of the care provided and the multiplicity of actors require coordination, but this necessary coordination, institutionalized in France by the coordinated course of care in the 2004 law reforming health insurance[3], requires information sharing.

Certain information already exists, medical, social, and medico-social, it is collected routinely throughout the journey but in a dispersed manner, is not yet perfectly linked and the possibility of sharing it needs to be improved. Others are to be collected on a case-by-case basis depending on the questions that arise. Such information must of course be used first and foremost to be shared in the context of clinical practice, but it should also, in addition to ad hoc studies, make it possible to acquire better health knowledge.

RWE research must now take into account this longitudinal and panoramic perspective of the pathways.

Far from excluding the usual essential analytical approach from the evaluation of health acts and products, this new perspective should lead us to conduct research to better measure the impact on the health of the population of health procedures and products concerned with chronic diseases in this new framework.

And as one of the primary objectives of the care of patients with chronic diseases is, let us remember, to improve their quality of life in all its dimensions[4], PROs [5] must take a very special place within this new research approach; any improvement in the quality of life of patients demonstrated in a methodologically acceptable manner, deserving to be considered as real progress.

Likewise, knowing the difficulties and critical points of the care pathways, will it be possible to measure the impact of innovations on the care pathway itself; a simplification of the course or an improvement of the conditions of access to care under the effect of its actions or its products requiring to be, likewise, recognized or even valued.

Also, in such an upheaval in the organization of care, one would not be surprised if the health authorities seek to supplement their request for documentation of the impact of reimbursable health procedures or products on the health of the population by that of the impact they will have on the care pathway in medical and organizational terms as well as on PRO.

But such a change in the perspective of care calls for a change in the way of thinking of all those involved in health, including researchers and the health industry. Thus, when a new health technology emerges in chronic diseases, let us see it as part of a real health pathway during which the conditions for its success will be conditioned by global care and coordinated, where the patient is an actor of his own care and where their possibilities and needs are integrated.

Industrials wishing to assess the impact of the use of their drug or medical device will then have to integrate this dimension of personalized pathways into the framework of the RWE studies that they promote.

This is why AIXIAL has set up, with the help of health assessment specialists, PRO specialists, and patient association representatives, a consultation system open to industrials to reflect with them on how the most appropriate way to answer the questions they have or are asked by Health Authorities about their drugs or medical devices. 

— Written by Jacques Massol, MD, PhD, Prof of Therapeutics, Consultant AIXIAL

[1] https://www.leem.org/de-loffre-de-soins-au-parcours-de-sante

[2] Real-World Evidence

[3] https://www.ameli.fr/fileadmin/user_upload/documents/cp08122004.pdf

[4] https://solidarites-sante.gouv.fr/IMG/pdf/plan2007_2011.pdf

[5] Patient-Reported Outcome: results reported by patients, Patient-Reported Outcome Measures – PROM and Patient-Reported Experience Measures – PREM. Within PRO’S are the Health-Related Quality of Life measurements by the patient.

Déposez votre CV
close

Candidature spontanée








    AIXIAL vous informe que les informations recueillies dans ce présent formulaire font l’objet d’un traitement informatique destiné à la gestion des candidatures. Vos données à caractère personnel sont susceptibles d’être communiquées aux différentes entités du groupe pour les mêmes finalités. Nous vous rappelons que vous disposez d'un droit d'accès, de modification et de suppression sur vos données, d’un droit de limitation, à la portabilité, à l’effacement et d’opposition pour des motifs légitimes que vous pouvez exercer en adressant un e-mail à notre DPO à l’adresse suivante : dpo-france@aixial.com.
    Les données collectées sont indispensables à ces traitements et sont destinées aux services habilités d’AIXIAL. Elles seront conservées pendant 2 ans à compter de notre dernier contact.
    Pour en savoir plus, consultez la politique de Protection des Données Personnelles d’AIXIAL