Danish Physicians’ Views on the Appropriateness of the Involvement of Patients with Type 2 Diabetes in Regulatory Decision Making: A Qualitative Study

Mikkel Lindskov Sachs; Morten Colding-Jørgensen; Per Helboe; Sofia Kälvemark Sporrong; Sven Frøkjær; Katarina Jelic; Susanne Kaae

Danish Physicians’ Views on the Appropriateness of the Involvement of Patients with Type 2 Diabetes in Regulatory Decision Making: A Qualitative Study

Mikkel Lindskov Sachs, Morten Colding-Jørgensen, Per Helboe, Sofia Kälvemark Sporrong, Sven Frøkjær, Katarina Jelic, Susanne Kaae

Social and Clinical Pharmacy

Abstract

Background: Regulators, the pharmaceutical industry, and patient organizations expect an increased inclusion of patients’ risk preferences in medical regulatory decisions, for example, with regard to market approval. Merging of input from patients with, for example, multiple sclerosis, with expertise from health professionals in regulatory decisions has already occurred. The complex task of involving larger and more heterogeneous patient populations (e.g. with diabetes mellitus, asthma), however, remains. Objective: This study aimed to understand physicians’ experiences with factors influencing patients with diabetes mellitus perceived risks of their medicines and to explore how physicians, based on these experiences, perceive patients with diabetes to be suited for involvement in regulatory decisions. This study will provide knowledge that can improve the inclusion of heterogeneous patient groups in regulatory decisions. Methods: We conducted five semi-structured interviews with physicians with different types of experiences with patients’ risk perceptions (for example, being in contact with individual patients vs. being involved in developing guidelines at the population level) and one focus group interview with eight general practitioners in Sjælland, Denmark. We applied a thematic analysis to explore physicians’ experiences of the risk perceptions of patients with type 2 diabetes and their perceptions of patients’ fitness for involvement in regulatory decisions. Results: The risk perceptions and preferences of patients with diabetes were perceived to be rather diverse. Four drivers behind this diversity were described: past experiences, personality, prognosis ability, and knowledge. The legitimacy of patient preferences was not questioned, but the diversity of risk perceptions made the respondents question the existence of a uniform ‘patient voice’ useful for regulatory decision making. Conclusion: The respondents acknowledged the relevance and legitimacy of the patient perspective, but it was a concern that patient risk perceptions, at present, are too diverse to be included in regulatory decisions. Whether patients make regulatory decisions as perceived by physicians needs to be confirmed by future studies.

Original language	English
Journal	Pharmaceutical Medicine
Volume	33
Issue number	2
ISSN	1178-2595
Publication status	Published - 1 Apr 2019

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Danish Physicians’ Views on the Appropriateness of the Involvement of Patients with Type 2 Diabetes in Regulatory Decision Making: A Qualitative Study. / Sachs, Mikkel Lindskov; Colding-Jørgensen, Morten; Helboe, Per et al.

In: Pharmaceutical Medicine, Vol. 33, No. 2, 01.04.2019.

Research output: Contribution to journal › Journal article › Research › peer-review

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title = "Danish Physicians{\textquoteright} Views on the Appropriateness of the Involvement of Patients with Type 2 Diabetes in Regulatory Decision Making: A Qualitative Study",

abstract = "Background: Regulators, the pharmaceutical industry, and patient organizations expect an increased inclusion of patients{\textquoteright} risk preferences in medical regulatory decisions, for example, with regard to market approval. Merging of input from patients with, for example, multiple sclerosis, with expertise from health professionals in regulatory decisions has already occurred. The complex task of involving larger and more heterogeneous patient populations (e.g. with diabetes mellitus, asthma), however, remains. Objective: This study aimed to understand physicians{\textquoteright} experiences with factors influencing patients with diabetes mellitus perceived risks of their medicines and to explore how physicians, based on these experiences, perceive patients with diabetes to be suited for involvement in regulatory decisions. This study will provide knowledge that can improve the inclusion of heterogeneous patient groups in regulatory decisions. Methods: We conducted five semi-structured interviews with physicians with different types of experiences with patients{\textquoteright} risk perceptions (for example, being in contact with individual patients vs. being involved in developing guidelines at the population level) and one focus group interview with eight general practitioners in Sj{\ae}lland, Denmark. We applied a thematic analysis to explore physicians{\textquoteright} experiences of the risk perceptions of patients with type 2 diabetes and their perceptions of patients{\textquoteright} fitness for involvement in regulatory decisions. Results: The risk perceptions and preferences of patients with diabetes were perceived to be rather diverse. Four drivers behind this diversity were described: past experiences, personality, prognosis ability, and knowledge. The legitimacy of patient preferences was not questioned, but the diversity of risk perceptions made the respondents question the existence of a uniform {\textquoteleft}patient voice{\textquoteright} useful for regulatory decision making. Conclusion: The respondents acknowledged the relevance and legitimacy of the patient perspective, but it was a concern that patient risk perceptions, at present, are too diverse to be included in regulatory decisions. Whether patients make regulatory decisions as perceived by physicians needs to be confirmed by future studies.",

author = "Sachs, {Mikkel Lindskov} and Morten Colding-J{\o}rgensen and Per Helboe and {K{\"a}lvemark Sporrong}, Sofia and Sven Fr{\o}kj{\ae}r and Katarina Jelic and Susanne Kaae",

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AU - Sachs, Mikkel Lindskov

AU - Colding-Jørgensen, Morten

AU - Helboe, Per

AU - Kälvemark Sporrong, Sofia

AU - Frøkjær, Sven

AU - Jelic, Katarina

AU - Kaae, Susanne

PY - 2019/4/1

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N2 - Background: Regulators, the pharmaceutical industry, and patient organizations expect an increased inclusion of patients’ risk preferences in medical regulatory decisions, for example, with regard to market approval. Merging of input from patients with, for example, multiple sclerosis, with expertise from health professionals in regulatory decisions has already occurred. The complex task of involving larger and more heterogeneous patient populations (e.g. with diabetes mellitus, asthma), however, remains. Objective: This study aimed to understand physicians’ experiences with factors influencing patients with diabetes mellitus perceived risks of their medicines and to explore how physicians, based on these experiences, perceive patients with diabetes to be suited for involvement in regulatory decisions. This study will provide knowledge that can improve the inclusion of heterogeneous patient groups in regulatory decisions. Methods: We conducted five semi-structured interviews with physicians with different types of experiences with patients’ risk perceptions (for example, being in contact with individual patients vs. being involved in developing guidelines at the population level) and one focus group interview with eight general practitioners in Sjælland, Denmark. We applied a thematic analysis to explore physicians’ experiences of the risk perceptions of patients with type 2 diabetes and their perceptions of patients’ fitness for involvement in regulatory decisions. Results: The risk perceptions and preferences of patients with diabetes were perceived to be rather diverse. Four drivers behind this diversity were described: past experiences, personality, prognosis ability, and knowledge. The legitimacy of patient preferences was not questioned, but the diversity of risk perceptions made the respondents question the existence of a uniform ‘patient voice’ useful for regulatory decision making. Conclusion: The respondents acknowledged the relevance and legitimacy of the patient perspective, but it was a concern that patient risk perceptions, at present, are too diverse to be included in regulatory decisions. Whether patients make regulatory decisions as perceived by physicians needs to be confirmed by future studies.

AB - Background: Regulators, the pharmaceutical industry, and patient organizations expect an increased inclusion of patients’ risk preferences in medical regulatory decisions, for example, with regard to market approval. Merging of input from patients with, for example, multiple sclerosis, with expertise from health professionals in regulatory decisions has already occurred. The complex task of involving larger and more heterogeneous patient populations (e.g. with diabetes mellitus, asthma), however, remains. Objective: This study aimed to understand physicians’ experiences with factors influencing patients with diabetes mellitus perceived risks of their medicines and to explore how physicians, based on these experiences, perceive patients with diabetes to be suited for involvement in regulatory decisions. This study will provide knowledge that can improve the inclusion of heterogeneous patient groups in regulatory decisions. Methods: We conducted five semi-structured interviews with physicians with different types of experiences with patients’ risk perceptions (for example, being in contact with individual patients vs. being involved in developing guidelines at the population level) and one focus group interview with eight general practitioners in Sjælland, Denmark. We applied a thematic analysis to explore physicians’ experiences of the risk perceptions of patients with type 2 diabetes and their perceptions of patients’ fitness for involvement in regulatory decisions. Results: The risk perceptions and preferences of patients with diabetes were perceived to be rather diverse. Four drivers behind this diversity were described: past experiences, personality, prognosis ability, and knowledge. The legitimacy of patient preferences was not questioned, but the diversity of risk perceptions made the respondents question the existence of a uniform ‘patient voice’ useful for regulatory decision making. Conclusion: The respondents acknowledged the relevance and legitimacy of the patient perspective, but it was a concern that patient risk perceptions, at present, are too diverse to be included in regulatory decisions. Whether patients make regulatory decisions as perceived by physicians needs to be confirmed by future studies.

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ER -

Danish Physicians’ Views on the Appropriateness of the Involvement of Patients with Type 2 Diabetes in Regulatory Decision Making: A Qualitative Study

Abstract

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