Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development: a qualitative focus group study with European experts
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Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development : a qualitative focus group study with European experts. / Hogervorst, Milou A.; Møllebæk, Mathias; Vreman, Rick A.; Lu, Ting An; Wang, Junfeng; De Bruin, Marie Louise; Leufkens, Hubert G.M.; Mantel-Teeuwisse, Aukje; Goettsch, Wim.
In: BMJ Open, Vol. 13, No. 8, e072309, 2023.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Perspectives on how to build bridges between regulation, health technology assessment and clinical guideline development
T2 - a qualitative focus group study with European experts
AU - Hogervorst, Milou A.
AU - Møllebæk, Mathias
AU - Vreman, Rick A.
AU - Lu, Ting An
AU - Wang, Junfeng
AU - De Bruin, Marie Louise
AU - Leufkens, Hubert G.M.
AU - Mantel-Teeuwisse, Aukje
AU - Goettsch, Wim
N1 - Publisher Copyright: © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2023
Y1 - 2023
N2 - 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.
AB - 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.
KW - Decision Making
KW - Health Equity
KW - Health policy
KW - Organisational development
KW - PUBLIC HEALTH
KW - QUALITATIVE RESEARCH
U2 - 10.1136/bmjopen-2023-072309
DO - 10.1136/bmjopen-2023-072309
M3 - Journal article
C2 - 37640462
AN - SCOPUS:85168927445
VL - 13
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 8
M1 - e072309
ER -
ID: 366497317