RESUMO
BACKGROUND: In 2017, The French National Authority for Health (HAS) created an open, online, systematic contribution process to enable patient and consumer groups (PCGs) to contribute to health technology assessment (HTA) carried out to aid public authorities in reimbursement and pricing decision making. OBJECTIVES: This retrospective study analyzes how French PCGs contributed to the HTA process within the HAS for the first 2 years of this new mechanism. METHODS: PCG contributions received between 01 January 2017 and 31 December 2018 and the recording of deliberations leading to reports of the corresponding HTAs were included. Analysis grids were designed by the investigators with 5 rounds of refinement tests on 10 random PCG contributions and the reports. Systematic data extraction was then performed separately by two investigators. PCG answers to the open-question templates and the related final HTA report published by the HAS were analyzed. RESULTS: Seventy-nine contributions from 44 PCGs were received and analyzed by the HAS for 78 out of the 592 HTAs performed for drugs or medical devices during the 2-year period. Twenty-five percent of the HTAs performed for drugs received at least one contribution. The contributions covered quality-of-life aspects, access to care, and personal and family impact. Membership and budget of the contributing PCGs varied greatly. CONCLUSIONS: The experience gained in the first 2 years demonstrates the feasibility of the process and the fact that PCG contribution actually provides relevant input on the patient perspective for HTAs used for reimbursement decisions. The challenges identified on the side of PCGs were time constraints and human resources.
Assuntos
Pesquisadores , Avaliação da Tecnologia Biomédica , Custos e Análise de Custo , Humanos , Estudos RetrospectivosRESUMO
The term incidentaloma, created in 1982, has spread throughout medical literature. However, there does not seem to be a precise definition to describe what an incidentaloma is. In the initial uses, the word incidentaloma systematically designated a mass that was detected during an imaging examination prescribed for diagnostic purposes unrelated to the reason for carrying out the examination. Naming this mass "incidentaloma" did not give any precision on its nature as it can be located in many anatomical zones, secreting or not, benign or malignant, etc. Today, the term "incidentaloma" carries a much broader dimension which seems to cover the notion of incidental discovery, whether radiological, biological or genetic. The evolution of the term "incidentaloma" demonstrates its heuristic nature. It is a sign of a change in modern medicine which hesitates between a patient clinic and a data clinic. Fortuitous discoveries are a phenomenon known and anticipated by radiologists. Thus, these discoveries are no longer fortuitous, or even unexpected, but secondary to the use of health technology.
TITLE: De l'incidentalome à la découverte secondaire. ABSTRACT: Le terme incidentalome, créé en 1982, s'est, depuis, diffusé dans la littérature médicale. Il ne semble cependant pas exister de définition précise pour décrire ce qu'est un incidentalome. Dans les usages initiaux, l'incidentalome désignait une masse détectée à l'occasion d'un examen d'imagerie prescrit à visée diagnostique sans qu'un lien ne soit déterminé avec le motif de réalisation de l'examen. La qualification d'« incidentalome ¼ de cette masse n'apportait aucune précision sur sa nature, celle-ci pouvant être située dans de nombreuses zones anatomiques, être sécrétante ou non, être bénigne ou maligne Aujourd'hui, le terme d'incidentalome porte une dimension beaucoup plus large, semblant recouvrir la notion de découverte fortuite, qu'elle soit radiologique, biologique ou génétique. Cet usage évolutif du terme démontre son caractère heuristique. Il est le signe d'une modification de la médecine moderne qui hésite entre une clinique des patients et une clinique des données. Les découvertes fortuites sont un phénomène connu et anticipé par les radiologues. Ces découvertes ne sont donc plus fortuites, ni même inattendues, mais bien secondaires à l'usage de la technologie en santé.