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Schölin Bywall, KarinORCID iD iconorcid.org/0000-0002-5865-5590
Publications (8 of 8) Show all publications
van Overbeeke, E., Janssens, R., Whichello, C., Schölin Bywall, K., Sharpe, J., Nikolenko, N., . . . Huys, I. (2019). Design, Conduct, and Use of Patient Preference Studies in the Medical Product Life Cycle: A Multi-Method Study. Frontiers in Pharmacology, 10(1395)
Open this publication in new window or tab >>Design, Conduct, and Use of Patient Preference Studies in the Medical Product Life Cycle: A Multi-Method Study
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2019 (English)In: Frontiers in Pharmacology, ISSN 1663-9812, E-ISSN 1663-9812, Vol. 10, no 1395Article in journal (Refereed) Published
Abstract [en]

Objectives: To investigate stakeholder perspectives on how patient preference studies (PPS) should be designed and conducted to allow for inclusion of patient preferences in decision-making along the medical product life cycle (MPLC), and how patient preferences can be used in such decision-making.

Methods: Two literature reviews and semi-structured interviews (n = 143) with healthcare stakeholders in Europe and the US were conducted; results of these informed the design of focus group guides. Eight focus groups were conducted with European patients, industry representatives and regulators, and with US regulators and European/Canadian health technology assessment (HTA) representatives. Focus groups were analyzed thematically using NVivo.

Results: Stakeholder perspectives on how PPS should be designed and conducted were as follows: 1) study design should be informed by the research questions and patient population; 2) preferred treatment attributes and levels, as well as trade-offs among attributes and levels should be investigated; 3) the patient sample and method should match the MPLC phase; 4) different stakeholders should collaborate; and 5) results from PPS should be shared with relevant stakeholders. The value of patient preferences in decision-making was found to increase with the level of patient preference sensitivity of decisions on medical products. Stakeholders mentioned that patient preferences are hardly used in current decision-making. Potential applications for patient preferences across industry, regulatory and HTA processes were identified. Four applications seemed most promising for systematic integration of patient preferences: 1) benefit-risk assessment by industry and regulators at the marketing-authorization phase; 2) assessment of major contribution to patient care by European regulators; 3) cost-effectiveness analysis; and 4) multi criteria decision analysis in HTA.

Conclusions: The value of patient preferences for decision-making depends on the level of collaboration across stakeholders; the match between the research question, MPLC phase, sample, and preference method used in PPS; and the sensitivity of the decision regarding a medical product to patient preferences. Promising applications for patient preferences should be further explored with stakeholders to optimize their inclusion in decision-making.

Keywords
patient preferences, medical products, decision-making, health technology assessment, marketing authorization
National Category
Social and Clinical Pharmacy
Identifiers
urn:nbn:se:uu:diva-398215 (URN)10.3389/fphar.2019.01395 (DOI)000505681700001 ()31849657 (PubMedID)
Projects
IMI-PREFER
Note

Jorien Veldwijk and Isabelle Huys share last authorship.

Available from: 2019-12-03 Created: 2019-12-03 Last updated: 2020-01-28Bibliographically approved
Whichello, C., van Overbeeke, E., Janssens, R., Schölin Bywall, K., Russo, S., Weldwijk, J., . . . de Bekker-Grob, E. (2019). Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US. Frontiers in Pharmacology, 10, Article ID 1009.
Open this publication in new window or tab >>Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US
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2019 (English)In: Frontiers in Pharmacology, ISSN 1663-9812, E-ISSN 1663-9812, Vol. 10, article id 1009Article in journal (Refereed) Published
Abstract [en]

Objectives: Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in assessments and decision-making along the medical product lifecycle (MPLC). This study aimed to identify factors and situations that influence the value of patient preference studies (PPS) in decision-making along the MPLC according to different stakeholders.

Methods: Semi-structured interviews (n = 143) were conducted with six different stakeholder groups (physicians, academics, industry representatives, regulators, HTA/payer representatives, and a combined group of patients, caregivers, and patient representatives) from seven European countries (the United Kingdom, Sweden, Italy, Romania, Germany, France, and the Netherlands) and the United States. Framework analysis was performed using NVivo 11 software.

Results: Fifteen factors affecting the value of PPS in the MPLC were identified. These are related to: study organization (expertise, financial resources, study duration, ethics and good practices, patient centeredness), study design (examining patient and/or other preferences, ensuring representativeness, matching method to research question, matching method to MPLC stage, validity and reliability, cognitive burden, patient education, attribute development), and study conduct (patients’ ability/willingness to participate and preference heterogeneity). Three types of situations affecting the use of PPS results were identified (stakeholder acceptance, market situations, and clinical situations).

Conclusion: The factors and situation types affecting the value of PPS, as identified in this study, need to be considered when designing and conducting PPS in order to promote the integration of PPI into decision-making along the MPLC.

Place, publisher, year, edition, pages
Frontiers Media S.A., 2019
Keywords
patient preferences, drug life cycle, decision-making, health technology assessment, benefit risk assessment, market authorization
National Category
Social and Clinical Pharmacy
Identifiers
urn:nbn:se:uu:diva-393365 (URN)10.3389/fphar.2019.01009 (DOI)000486438000001 ()31619989 (PubMedID)
Projects
IMI-PREFER
Funder
EU, Horizon 2020
Available from: 2019-09-20 Created: 2019-09-20 Last updated: 2019-10-31Bibliographically approved
Schölin Bywall, K., Veldwijk, J., Hansson, M. G. & Kihlbom, U. (2019). Patient Perspectives on the Value of Patient Preference Information in Regulatory Decision Making: A Qualitative Study in Swedish Patients with Rheumatoid Arthritis. Patient, 12(3), 297-305
Open this publication in new window or tab >>Patient Perspectives on the Value of Patient Preference Information in Regulatory Decision Making: A Qualitative Study in Swedish Patients with Rheumatoid Arthritis
2019 (English)In: Patient, ISSN 1178-1653, E-ISSN 1178-1661, Vol. 12, no 3, p. 297-305Article in journal (Refereed) Published
Abstract [en]

Background

There is increasing interest in involving patient preferences for benefits and risks in regulatory decision making. Therefore, it is essential to identify patient perspectives regarding the value of patient preference information (PPI).

Objectives

The aim of this study was to explore how patients with rheumatoid arthritis (RA) value the use of PPI in regulatory decision making regarding medical products.

Methods

Regulators and patients with RA were interviewed to gather initial insights into opinions on the use of PPI in regulatory decisions regarding medical products. The interviews were used to draft and validate the interview guide for focus groups with patients with RA. Participants were purposively sampled in collaboration with the Swedish Rheumatism Association in Stockholm and Uppsala. Each focus group consisted of three to six patients (18 in total). All interviews were audio-recorded, transcribed verbatim, and analysed using content analysis.

Results

According to the participants, PPI could lead to regulators considering patients’ needs, lifestyles and well-being when making decisions. PPI was important in all stages of the medical product lifecycle. Participants reported that, when participating in a preference study, it is important to be well-informed about the use of the study and the development, components, administration, and risks related to the medical products.

Conclusions

Patients thought PPI could be valuable to consider in regulatory decisions. It is essential for patients to be well-informed when asked for their preferences. Research on information materials to inform patients in preference studies is needed to increase the value of PPI in regulatory decision making.

National Category
Medical Ethics
Identifiers
urn:nbn:se:uu:diva-366354 (URN)10.1007/s40271-018-0344-2 (DOI)000468375300003 ()30443897 (PubMedID)
Funder
Riksbankens Jubileumsfond, M13-0260:1
Available from: 2018-11-20 Created: 2018-11-20 Last updated: 2019-06-24Bibliographically approved
Janssens, R., Russo, S., van Overbeeke, E., Whichello, C., Harding, S., Kübler, J., . . . Huys, I. (2019). Patient Preferences in the Medical Product Life Cycle: What do Stakeholders Think? Semi-Structured Qualitative Interviews in Europe and the USA. Patient, 12(5), 513-526
Open this publication in new window or tab >>Patient Preferences in the Medical Product Life Cycle: What do Stakeholders Think? Semi-Structured Qualitative Interviews in Europe and the USA
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2019 (English)In: Patient, ISSN 1178-1653, E-ISSN 1178-1661, Vol. 12, no 5, p. 513-526Article in journal (Refereed) Published
Abstract [en]

Background

Patient preferences (PP), which are investigated in PP studies using qualitative or quantitative methods, are a growing area of interest to the following stakeholders involved in the medical product lifecycle: academics, health technology assessment bodies, payers, industry, patients, physicians, and regulators. However, the use of PP in decisions along the medical product lifecycle remains limited. As the adoption of PP heavily relies on these stakeholders, knowledge of their perceptions of PP is critical.

Objective

This study aimed to characterize stakeholders’ attitudes, needs, and concerns with respect to PP in decision making along the medical product lifecycle.

Methods

Semi-structured interviews (n = 143) were conducted with academics (n = 24), health technology assessment/payer representatives (n = 24), industry representatives (n = 24), patients, caregivers and patient representatives (n = 24), physicians (n = 24), and regulators (n = 23) from seven European countries and the USA. Interviews were conducted between April and August 2017. The framework method was used to organize the data and identify themes and key findings in each interviewed stakeholder group.

Results

Interviewees reported being unfamiliar (43%), moderately familiar (42%), or very familiar (15%) with preference methods and studies. Interviewees across stakeholder groups generally supported the idea of using PP in the medical product lifecycle but expressed mixed opinions about the feasibility and impact of using PP in decision making. Interviewees from all stakeholder groups stressed the importance of increasing stakeholders’ understanding of the concept of PP and preference methods and ensuring patients’ understanding of the questions asked in PP studies. Key concerns and needs in each interviewed stakeholder group were as follows: (1) academics: investigating the validity, reliability, reproducibility, and generalizability of preference methods; (2) health technology assessment/payer representatives: developing quality criteria for evaluating PP studies and gaining insights into how to weigh them in reimbursement/payer decision making; (3) industry representatives: obtaining guidance on PP studies and recognition on the importance of PP from decision makers; (4) patients, caregivers, and patient representatives: providing an incentive and adequate information towards patients when participating in PP studies; (5) physicians: avoiding bias as a result of commercial agendas in PP studies and clarifying how to deal with subjective and emotional elements when measuring PP; and (6) regulators: avoiding the misuse of PP study results to overrule the traditional efficacy and safety criteria used for marketing authorization and obtaining robust PP study results.

Conclusions

Despite the interest all interviewed stakeholder groups reported in PP, the effective use of PP in decision making across the medical product lifecycle is currently hampered by a lack of standardization and consensus on how to both measure and use PP.

National Category
Social and Clinical Pharmacy
Identifiers
urn:nbn:se:uu:diva-387688 (URN)10.1007/s40271-019-00367-w (DOI)000481773600007 ()31222436 (PubMedID)
Projects
IMI-PREFER
Funder
EU, Horizon 2020
Available from: 2019-06-25 Created: 2019-06-25 Last updated: 2019-09-30Bibliographically approved
Whichello, C., Schölin Bywall, K., Mauer, J., Watt, S. J., Cleemput, I., Anne, C., . . . Veldwijk, J. (2018). Mapping benefit-risk decision-making processes and identifying decision points with the potential to include patient preference information throughout the medical product lifecycle. Pharmacoepidemiology and Drug Safety, 27(Suppl. 2), 206-206, Article ID 443.
Open this publication in new window or tab >>Mapping benefit-risk decision-making processes and identifying decision points with the potential to include patient preference information throughout the medical product lifecycle
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2018 (English)In: Pharmacoepidemiology and Drug Safety, ISSN 1053-8569, E-ISSN 1099-1557, Vol. 27, no Suppl. 2, p. 206-206, article id 443Article in journal, Meeting abstract (Other academic) Published
Place, publisher, year, edition, pages
WILEY, 2018
National Category
Pharmacology and Toxicology
Identifiers
urn:nbn:se:uu:diva-364841 (URN)10.1002/pds.4629 (DOI)000441893801215 ()
Available from: 2018-11-05 Created: 2018-11-05 Last updated: 2018-11-05Bibliographically approved
van Overbeeke, E., Whichello, C., Janssens, R., de Bekker-Grob, E., Veldwijk, J., Levitan, B., . . . Huys, I. (2017). Conditions And Contextual Factors That Influence The Utility And Application Of Patient Preference Studies: A Study Combining Literature And Focus Groups. Value in Health, 20(9), A690-A691
Open this publication in new window or tab >>Conditions And Contextual Factors That Influence The Utility And Application Of Patient Preference Studies: A Study Combining Literature And Focus Groups
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2017 (English)In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 20, no 9, p. A690-A691Article in journal, Meeting abstract (Other academic) Published
National Category
Health Sciences
Identifiers
urn:nbn:se:uu:diva-345701 (URN)10.1016/j.jval.2017.08.1759 (DOI)000413599902302 ()
Projects
IMI-PREFER
Available from: 2018-03-16 Created: 2018-03-16 Last updated: 2018-09-26Bibliographically approved
Schölin Bywall, K., Veldwijk, J., Hansson, M. G. & Kihlbom, U. (2017). Rheumatoid Arthritis Patients’ Perspectives On The Value Of Patient Preferences In Regulatory Decision-Making During Drug Development: A Qualitative Study. Value in Health, 20(9), A540-A540
Open this publication in new window or tab >>Rheumatoid Arthritis Patients’ Perspectives On The Value Of Patient Preferences In Regulatory Decision-Making During Drug Development: A Qualitative Study
2017 (English)In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 20, no 9, p. A540-A540Article in journal, Meeting abstract (Other academic) Published
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-345691 (URN)10.1016/j.jval.2017.08.801 (DOI)000413599901148 ()
Projects
IMI-PREFER
Available from: 2018-03-16 Created: 2018-03-16 Last updated: 2018-10-04Bibliographically approved
Janssens, R., Huys, I., van Overbeeke, E., Whichello, C., de Bekker-Grob, E., Kuebler, J., . . . Veldwijk, J. (2017). Stakeholder Perspectives On The Integration Of Patient Preferences In The Medical Product Life Cycle: A Multimethod Approach. Value in Health, 20(9), A689-A689
Open this publication in new window or tab >>Stakeholder Perspectives On The Integration Of Patient Preferences In The Medical Product Life Cycle: A Multimethod Approach
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2017 (English)In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733, Vol. 20, no 9, p. A689-A689Article in journal, Meeting abstract (Other academic) Published
National Category
Medical and Health Sciences
Identifiers
urn:nbn:se:uu:diva-345695 (URN)10.1016/j.jval.2017.08.1750 (DOI)000413599902293 ()
Projects
IMI-PREFER
Available from: 2018-03-16 Created: 2018-03-16 Last updated: 2018-10-04Bibliographically approved
Organisations
Identifiers
ORCID iD: ORCID iD iconorcid.org/0000-0002-5865-5590

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