Pharmaceutical Medicine

, Volume 33, Issue 2, pp 99–107 | Cite as

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 Frøkjaer
  • Katarina Jelic
  • Susanne KaaeEmail author
Original Research Article



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.


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.


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.


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.


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.


Compliance with Ethical Standards


Funding for this study was provided by Innovation Fund Denmark (Department of the Ministry of Higher Education and Science) and Novo Nordisk A/S as part of a public-industrial co-funded Ph.D. project. Publication of the study results was not dependent on the approval of either funder.

Conflict of Interest

Mikkel Lindskov Sachs was employed as a full-time industrial Ph.D. student at the University of Copenhagen and Novo Nordisk A/S during this study. Morten Colding-Jørgensen is a consultant and shareholder of Novo Nordisk A/S. Katarina Jelic is a full-time employee and shareholder of Novo Nordisk A/S. Per Helboe is a shareholder of multiple pharmaceutical companies, including Novo Nordisk A/S. Sven Frokjaer, Sofia Kälvemark Sporrong, and Susanne Kaae have no conflicts of interest that are directly relevant to the content of this article.

Ethics Approval

The study and the related data management were approved by the Data Management Unit of the Faculty of Health and Medicines, University of Copenhagen. The Danish Data Protection Agency approved the study (Reference: SUND-2016-47).

Consent to Participate

Participants were informed about the study and its aim and signed informed consent forms at the start of each interview. All participants were introduced to the purpose of the study. No financial incentives were offered or transacted. The confidentiality and anonymity of the data were ensured according to national standards.


  1. 1.
    Muhlbacher AC, Juhnke C, Beyer AR, Garner S. Patient-focused benefit-risk analysis to inform regulatory decisions: the European Union perspective. Value Health. 2016;19(6):734–40.PubMedGoogle Scholar
  2. 2.
    Adamo JE, Wilhelm EE, Steele SJ. Advancing a vision for regulatory science training. Clin Transl Sci. 2015;8(5):615–8.PubMedGoogle Scholar
  3. 3.
    Sacristan JA, Aguaron A, Avendaño C, Garrido P, Carrion J, Gutierrez A, et al. Patient involvement in clinical research: why, when, and how. Patient Pref Adher. 2016;10:631.Google Scholar
  4. 4.
    Gallivan J, Kovacs Burns K, Bellows M, Eigenseher C. The many faces of patient engagement. J Participatory Med. 2012;4:e32.Google Scholar
  5. 5.
    Ocloo J, Matthews R. From tokenism to empowerment: progressing patient and public involvement in healthcare improvement. BMJ Qual Saf. 2016;25(8):626–32.PubMedGoogle Scholar
  6. 6.
    Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, et al. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012;27(10):1361–7.PubMedGoogle Scholar
  7. 7.
    Charles C, Gafni A, Whelan T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Soc Sci Med. 1997;44(5):681–92.PubMedGoogle Scholar
  8. 8.
    Coulter A. Partnerships with patients: the pros and cons of shared clinical decision-making. J Health Serv Res Policy. 1997;2(2):112–21.PubMedGoogle Scholar
  9. 9.
    Arnstein SR. A ladder of citizen participation. J Am Inst Plann. 1969;35(4):216–24.Google Scholar
  10. 10.
    Tritter JQ, McCallum A. The snakes and ladders of user involvement: moving beyond Arnstein. Health Policy. 2006;76(2):156–68.PubMedGoogle Scholar
  11. 11.
    Kelty C, Panofsky A, Currie M, Crooks R, Erickson S, Garcia P, et al. Seven dimensions of contemporary participation disentangled. J Assoc Inf Sci Technol. 2015;66(3):474–88.Google Scholar
  12. 12.
    Beresford P. User involvement in research and evaluation: liberation or regulation? Soc Policy Soc. 2002;1(2):95–105.Google Scholar
  13. 13.
    Groot Koerkamp B, Weinstein MC, Stijnen T, Heijenbrok-Kal MH, Hunink MG. Uncertainty and patient heterogeneity in medical decision models. Med Decis Making. 2010;30(2):194–205.PubMedGoogle Scholar
  14. 14.
    van der Pouw Kraan TC, van Gaalen FA, Kasperkovitz PV, Verbeet NL, Smeets TJ, Kraan MC, et al. Rheumatoid arthritis is a heterogeneous disease: evidence for differences in the activation of the STAT-1 pathway between rheumatoid tissues. Arthritis Rheum. 2003;48(8):2132–45.PubMedGoogle Scholar
  15. 15.
    Drazen JM. Asthma: the paradox of heterogeneity. J Allergy Clin Immunol. 2012;129(5):1200–1.PubMedGoogle Scholar
  16. 16.
    Sachs ML, Sporrong SK, Colding-Jorgensen M, Frokjaer S, Helboe P, Jelic K, et al. Risk perceptions in diabetic patients who have experienced adverse events: implications for patient involvement in regulatory decisions. Pharm Med. 2017;31(4):245–55.Google Scholar
  17. 17.
    Shreck E, Gonzalez JS, Cohen HW, Walker EA. Risk perception and self-management in urban, diverse adults with type 2 diabetes: the improving diabetes outcomes study. Int J Behav Med. 2014;21(1):88–98.PubMedGoogle Scholar
  18. 18.
    Kvale S. Interviews: an introduction to qualitative research interviewing. London: Sage Publications; 1996.Google Scholar
  19. 19.
    Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.Google Scholar
  20. 20.
    Botzen WJW, Kunreuther H, Michel-Kerjan E. Divergence between individual perceptions and objective indicators of tail risks: evidence from floodplain residents in New York City. Judgm Decis Mak. 2015;10(4):365–85.Google Scholar
  21. 21.
    Knuth D, Kehl D, Hulse L, Schmidt S. Risk perception, experience, and objective risk: a cross-national study with European emergency survivors. Risk Anal. 2014;34(7):1286–98.PubMedGoogle Scholar
  22. 22.
    Svensson S, Kjellgren KI. Adverse events and patients’ perceptions of antihypertensive drug effectiveness. J Hum Hypertens. 2003;17(10):671–5.PubMedGoogle Scholar
  23. 23.
    Slovic P. Perception of risk. Science. 1987;236(4799):280–5.PubMedGoogle Scholar
  24. 24.
    Fischhoff B, Slovic P, Lichtenstein S, Read S, Combs B. How safe is safe enough? A psychometric study of attitudes towards technological risks and benefits. Policy Sci. 1978;9:127–52.Google Scholar
  25. 25.
    Bouyer M, Bagdassarian S, Chaabanne S, Mullet E. Personality correlates of risk perception. Risk Anal. 2001;21(3):457–65.PubMedGoogle Scholar
  26. 26.
    Chauvin B, Hermand D, Mullet E. Risk perception and personality facets. Risk Anal. 2007;27(1):171–85.PubMedGoogle Scholar
  27. 27.
    Finucane ML, Slovic P, Mertz CK, Flynn J, Satterfield TA. Gender, race, and perceived risk: the ‘white male’ effect. Health Risk Society. 2000;2(2):159–72.Google Scholar
  28. 28.
    Kahan DM, et al. Culture and identity-protective cognition: explaining the white male. J Empir Legal Stud. 2007;4(3):465–505.Google Scholar
  29. 29.
    Johnson FR, Zhou M. Patient preferences in regulatory benefit-risk assessments: a US prspective. Value Health. 2016;19(6):741–5.PubMedGoogle Scholar
  30. 30.
    Siegrist M, Keller C, Kiers HAL. A new look at the psychometric paradigm of perception of hazards. Risk Anal. 2005;25(1):211–22.PubMedGoogle Scholar
  31. 31.
    Rouyard T, Kent S, Baskerville R, Leal J, Gray A. Perceptions of risks for diabetes-related complications in type 2 diabetes populations: a systematic review. Diabet Med. 2017;34(4):467–77.PubMedGoogle Scholar
  32. 32.
    Tawfik MY, Mohamed RA. The impact of communicating cardiovascular risk in type 2 diabetics on patient risk perception, diabetes self-care, glycosylated hemoglobin, and cardiovascular risk. J Public Health. 2016;24(2):153–64.Google Scholar
  33. 33.
    Huang ES, Brown SE, Ewigman BG, Foley EC, Meltzer DO. Patient perceptions of quality of life with diabetes-related complications and treatments. Diabetes Care. 2007;30(10):2478–83.PubMedGoogle Scholar
  34. 34.
    Pilnick A, Dingwall R. On the remarkable persistence of asymmetry in doctor/patient interaction: a critical review. Soc Sci Med. 2011;72(8):1374–82.PubMedGoogle Scholar
  35. 35.
    EUPATI. Patient education! The A to Z of medicines development. 2018. Accessed 9 Mar 2018.
  36. 36.
    Bryant J, Saxton M, Madden A, Bath N, Robinson S. Consumers’ and providers’ perspectives about consumer participation in drug treatment services: is there support to do more? What are the obstacles? Drug Alcohol Rev. 2008;27(2):138–44.PubMedGoogle Scholar
  37. 37.
    Thompson SC, Pitts JS, Schwankovsky L. Preferences for involvement in medical decision-making: situational and demographic influences. Patient Educ Couns. 1993;22(3):133–40.PubMedGoogle Scholar
  38. 38.
    Leonhardt JM, Keller LR, Pechmann C. Avoiding the risk of responsibility by seeking uncertainty: responsibility aversion and preference for indirect agency when choosing for others. J Consum Psychol. 2011;21(4):405–13.Google Scholar
  39. 39.
    Klein AV, Hardy S, Lim R, Marshall DA. Regulatory decision making in Canada: exploring new frontiers in patient involvement. Value Health. 2016;19(6):730–3.PubMedGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.University of CopenhagenCopenhagenDenmark
  2. 2.Novo NordiskSøborgDenmark

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