Case 6 Patient involvement in healthcare decisions 21-10-2022
Why do we need to include the patient perspective in healthcare decisions/regulatory
decisions about healthcare?
The extent of patient involvement in HTA varies considerably across Europe. There is an
interest in understanding patients’ experiences and preferences is increasing. There is a
paradigm shift towards patient involvement in medicine development and regulatory
science. Reasons for this are:
- Patients bring an unique perspective that researchers don’t have. Patients can
provide information and insight about the impact of their condition and treatments
on their daily lives that is not available elsewhere.
o Patients are in a unique position to describe the outcomes that matter to
them, to challenge presumptions about their health aspirations and to inform
HTA processes about the potential positive or negative effects of new existing
technologies.
- Research have shown that the involvement of patients has been rewarding for both
patients and researchers
- Engaging with patients helps to bridge the gap between health research, policy and
patient-centred practice, increases transparency and patient’s adherence to
treatments, reduces waste and leads to more meaningful regulatory outcomes
- Patient involvement increases transparency, trust and mutual respect between
patients and stakeholders
- Patients are directly affected by HTA decisions – they are key stakeholders, and have
a democratic right to be involved.
Importance for clinical decision
- Can help health professionals to improve disease management
- Facilitate shared-decision making
- Improve medication adherence
- More active role of patients in clinical decision-making
Important for policy decision
- The importance of patient involvement in HTA is becoming widely recognized
- Patients are directly affected by HTA decisions – they are key stakeholders, and have
a democratic right to be involved
- Patients can provide information and insight, about the impact of their condition and
treatments on their daily lives that is no available elsewhere
- Patients are in a unique position to describe the outcomes that matter to them, to
challenge presumptions about their health
- Can be used for healthcare decisions
Importance of patient involvement
Emphasis on patient-centred research through the engagement of patients in:
- identifying unmet needs - the design and conduct of clinical studies
- subsequent regulatory assessments
- post-marketing vigilance and data collection
- clinical practice guideline development
, Value of patient involvement
- May result in research, clinical, licensing, reimbursement, and policy decisions that
better reflect the preferences of stakeholders, especially patients.
- Could improve the effectiveness of health care interventions by improving adoption
of, satisfaction with, and adherence to clinical treatments or public health programs
- Could improve the quality, relevance and value of HTA.
Challenges to include patients in HTA
- Costly to involve patients (e.g. for OMERACT it was a 100,000 dollars per
conferences).
- Lack of financial compensation for patients participating
- Poor training and support
- Difficult to find suitable patients to participate
- Difficult to get a representative patient base for each step and one of sufficient
quantity (to have a sample representativeness)
- Difficult to quantify the benefits of including patients
- Missing structures make it challenging to properly integrate patients in the process,
and in which role? Info sharer, advisor, collaborator, leader?
- Risk of professionalizing patients which no longer represent the authentic patient
experience
o → critical look
When do we need to include patients in healthcare decisions/regulatory decision making
for healthcare?
Patients need to be involved in ALL stages of healthcare delivery and evaluation.
They are the mostly important part. It doesn’t matter if it is research or communication.
1. Research priorities: involve patients with setting priorities
2. Research design and planning: involve patients to make protocols. Inform patients
about the research and make them able to participate with the research; gain more
information. Make the information readable
Why do we need to include the patient perspective in healthcare decisions/regulatory
decisions about healthcare?
The extent of patient involvement in HTA varies considerably across Europe. There is an
interest in understanding patients’ experiences and preferences is increasing. There is a
paradigm shift towards patient involvement in medicine development and regulatory
science. Reasons for this are:
- Patients bring an unique perspective that researchers don’t have. Patients can
provide information and insight about the impact of their condition and treatments
on their daily lives that is not available elsewhere.
o Patients are in a unique position to describe the outcomes that matter to
them, to challenge presumptions about their health aspirations and to inform
HTA processes about the potential positive or negative effects of new existing
technologies.
- Research have shown that the involvement of patients has been rewarding for both
patients and researchers
- Engaging with patients helps to bridge the gap between health research, policy and
patient-centred practice, increases transparency and patient’s adherence to
treatments, reduces waste and leads to more meaningful regulatory outcomes
- Patient involvement increases transparency, trust and mutual respect between
patients and stakeholders
- Patients are directly affected by HTA decisions – they are key stakeholders, and have
a democratic right to be involved.
Importance for clinical decision
- Can help health professionals to improve disease management
- Facilitate shared-decision making
- Improve medication adherence
- More active role of patients in clinical decision-making
Important for policy decision
- The importance of patient involvement in HTA is becoming widely recognized
- Patients are directly affected by HTA decisions – they are key stakeholders, and have
a democratic right to be involved
- Patients can provide information and insight, about the impact of their condition and
treatments on their daily lives that is no available elsewhere
- Patients are in a unique position to describe the outcomes that matter to them, to
challenge presumptions about their health
- Can be used for healthcare decisions
Importance of patient involvement
Emphasis on patient-centred research through the engagement of patients in:
- identifying unmet needs - the design and conduct of clinical studies
- subsequent regulatory assessments
- post-marketing vigilance and data collection
- clinical practice guideline development
, Value of patient involvement
- May result in research, clinical, licensing, reimbursement, and policy decisions that
better reflect the preferences of stakeholders, especially patients.
- Could improve the effectiveness of health care interventions by improving adoption
of, satisfaction with, and adherence to clinical treatments or public health programs
- Could improve the quality, relevance and value of HTA.
Challenges to include patients in HTA
- Costly to involve patients (e.g. for OMERACT it was a 100,000 dollars per
conferences).
- Lack of financial compensation for patients participating
- Poor training and support
- Difficult to find suitable patients to participate
- Difficult to get a representative patient base for each step and one of sufficient
quantity (to have a sample representativeness)
- Difficult to quantify the benefits of including patients
- Missing structures make it challenging to properly integrate patients in the process,
and in which role? Info sharer, advisor, collaborator, leader?
- Risk of professionalizing patients which no longer represent the authentic patient
experience
o → critical look
When do we need to include patients in healthcare decisions/regulatory decision making
for healthcare?
Patients need to be involved in ALL stages of healthcare delivery and evaluation.
They are the mostly important part. It doesn’t matter if it is research or communication.
1. Research priorities: involve patients with setting priorities
2. Research design and planning: involve patients to make protocols. Inform patients
about the research and make them able to participate with the research; gain more
information. Make the information readable
