10 research outputs found
Patient Perspectives on the Value of Patient Preference Information in Regulatory Decision Making: A Qualitative Study in Swedish Patients with Rheumatoid Arthritis.
Background There is increasing interest in involving patient preferences for benefts 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 mak
Patient Perspectives on the Value of Patient Preference Information in Regulatory Decision Making: A Qualitative Study in Swedish Patients with Rheumatoid Arthritis.
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
Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US
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 representa
Patient Preferences in the Medical Product Life Cycle: What do Stakeholders Think? Semi-Structured Qualitative Interviews in Europe and the USA.
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,
Factors and situations affecting the value of patient preference studies: semi-structured interviews in Europe and the US.
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 tha
Design, Conduct and Use of Patient Preference Studies in the Medical Product Life Cycle
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 sen
Exploring preferences of at-risk individuals for preventive treatments for rheumatoid arthritis
Objective: Some immunomodulatory drugs have been shown to delay the onset of, or lower the risk of developing, rheumatoid arthritis (RA), if given to individuals at risk. Several trials are ongoing in this area; however, little evidence is currently available about the views of those at risk of RA regarding preventive treatment. Method: Three focus groups and three interviews explored factors that are relevant to first degree relatives (FDRs) of RA patients and members of the general public when considering taking preventive treatment for RA. The semi-structured qualitative interview prompts explored participant responses to hypothetical attributes of preventive RA medicines. Transcripts of focus group/interview proceedings were inductively coded and analysed using a framework approach. Results: Twenty-one individuals (five FDRs, 16 members of the general public) took part in the study. Ten broad themes were identified describing factors that participants felt would influence their decisions about whether to take preventive treatment if they were at increased risk of RA. These related either directly to features of the specific treatment or to other factors, including personal characteristics, attitude towards taking medication, and an individual’s actual risk of developing RA. Conclusion: This research highlights the importance of non-treatment factors in the decision-making process around preventive treatments, and will inform recruitment to clinical trials as well as information to support shared decision making by those considering preventive treatment. Studies of treatment preferences in individuals with a confirmed high risk of RA would further inform clinical trial design
sj-docx-1-mdm-10.1177_0272989X231218265 – Supplemental material for Can the General Public Be a Proxy for an “At-Risk” Group in a Patient Preference Study? A Disease Prevention Example in Rheumatoid Arthritis
Supplemental material, sj-docx-1-mdm-10.1177_0272989X231218265 for Can the General Public Be a Proxy for an “At-Risk” Group in a Patient Preference Study? A Disease Prevention Example in Rheumatoid Arthritis by R. L. DiSantostefano, G. Simons, M. Englbrecht, Jennifer H. Humphreys, Ian N. Bruce, K. Schölin Bywall, C. Radawski, K. Raza, M. Falahee and J. Veldwijk in Medical Decision Making</p
Exploring preferences of at-risk individuals for preventive treatments for rheumatoid arthritis
Some immunomodulatory drugs have been shown to delay the onset of, or lower the risk of developing, rheumatoid arthritis (RA), if given to individuals at risk. Several trials are ongoing in this area; however, little evidence is currently available about the views of those at risk of RA regarding preventive treatment. Three focus groups and three interviews explored factors that are relevant to first degree relatives (FDRs) of RA patients and members of the general public when considering taking preventive treatment for RA. The semi-structured qualitative interview prompts explored participant responses to hypothetical attributes of preventive RA medicines. Transcripts of focus group/interview proceedings were inductively coded and analysed using a framework approach. Twenty-one individuals (five FDRs, 16 members of the general public) took part in the study. Ten broad themes were identified describing factors that participants felt would influence their decisions about whether to take preventive treatment if they were at increased risk of RA. These related either directly to features of the specific treatment or to other factors, including personal characteristics, attitude towards taking medication, and an individual’s actual risk of developing RA. This research highlights the importance of non-treatment factors in the decision-making process around preventive treatments, and will inform recruitment to clinical trials as well as information to support shared decision making by those considering preventive treatment. Studies of treatment preferences in individuals with a confirmed high risk of RA would further inform clinical trial design.</p
Factors and situations affecting the utility of patient preference studies: semi-structured interviews in Europe and the US
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 diff