Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts.
BMJ Open
; 13(8): e072309, 2023 08 28.
Article
em En
| MEDLINE
| ID: mdl-37640462
ABSTRACT
OBJECTIVE:
Improving synergy among regulation, health technology assessment (HTA) and clinical guideline development is relevant as these independent processes are building on shared evidence-based grounds. The two objectives were first to assess how convergence of evidentiary needs among stakeholders may be achieved, and second, to determine to what extent convergence can be achieved.DESIGN:
Qualitative study using eight online dual-moderator focus groups.SETTING:
Discussions had a European focus and were contextualised in four case studies on head and neck cancer, diabetes mellitus, multiple sclerosis and myelodysplastic syndromes.PARTICIPANTS:
Forty-two experienced (over 10 years) European regulators, HTA representatives and clinicians participated in the discussion.INTERVENTIONS:
Participants received information on the case study and research topic in advance. An introductory background presentation and interview guide for the moderators were used to steer the discussion.RESULTS:
Convergence may be achieved through improved communication institutionalised in multistakeholder early dialogues, shared definitions and shared methods. Required data sets should be inclusive rather than aligned. Deliberation and decision-making should remain independent. Alignment could be sought for pragmatic clinical trial designs and patient registries. Smaller and lower-income countries should be included in these efforts.CONCLUSION:
Actors in the field expressed that improving synergy among stakeholders always involves trade-offs. A balance needs to be found between the convergence of processes and the institutional remits or geographical independence. A similar tension exists between the involvement of more actors, for example, patients or additional countries, and the level of collaboration that may be achieved. Communication is key to establishing this balance.Palavras-chave
Texto completo:
1
Temas:
ECOS
/
Aspectos_gerais
/
Avaliacao_tecnologia
/
Equidade_desigualdade
Bases de dados:
MEDLINE
Assunto principal:
Avaliação da Tecnologia Biomédica
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Comunicação
Tipo de estudo:
Guideline
/
Health_technology_assessment
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Prognostic_studies
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Qualitative_research
Aspecto:
Equity_inequality
Limite:
Humans
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Holanda