Case 6 – patient involvement in healthcare decisions (HTA)
1.Why do we need to include the patient perspective in healthcare
decisions/regulatory decisions about healthcare?
Article of hunter et al
The extent of patient involvement in HTA varies considerably across Europe. There is an interest in
understanding patients’ experiences and preferences is increasing.
Patient perspective is becoming more important in healthcare decisions and HTA. The key in the
development, conduct and evaluation of health interventions.
1) Patients bring an unique perspective that researchers don’t have
2) Research have shown that the involvement of patients has been rewarding for both patients
and researchers
3) 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 (De Wit et al., 2019)
4) Patient involvement increases transparency, trust and mutual respect between patients and
stakeholders (Hunter, 2018)
I. 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.
II. Patients can provide information and insight about the impact of their condition and
treatments on their daily lives that is not available elsewhere.
III. 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.
Important 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
Nog toevoegen van college
,Patient centred research
- Patient participation can identify needs
- Design and conduct clinical studies
- Post-marketing religions
- Data collection afterwards
- Clinical practice development
= the same as under:
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.
2.When do we need to include patients in healthcare decisions/ regulatory
decision making for healthcare?
Hunter et al
Eupati guidance covers the interaction between HTA bodies and patients in relation to medicines for
human use. HTA processes are applied to interventions other than medicines, but they are not the
focus of this guidance, in line with the remit EUPATI. Figure 1 indicates where patients can be
involved throughout the R&D lifecycle.
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.
, Hta main aim is to inform decision making by health care policy makers. It is a systematic process
that considers health technologies and involve a review of:
1) clinical effectiveness
2) cost effectiveness
3) social and ethical impacts on the health care system and the lives of individual patients
Why do we need to include patients in HTA
they are the ones that are effected by the HTA.
efficiently allocate resources on technology by HTA and reimbursement. Reimbursement is
highly relevant for every person; the HTA can affect every patient.
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
3. Research Conduct and operations (carrying out the research): let them participate in the research
in the form of a RCT. Do a member check in qualitative research.
4. Dissemination, communication, post-approval; discuss results and outcomes with patient/study
group
The research discuss it with the patients.
For HTA bodies that are new to patient involvement, a step-wise approach to introducing new
working methods and activities may be the most successful. Prioritization of specific working
methods and activities should be decided on by individual HTA bodies with patients and other
stakeholders.
Patient involvement in HTA
you sometimes need high skills as a patient and sometimes not.
The importance of patient involvement in HTA is becoming widely recognized. Patients are directly
affected by HTA decisions to patients should have the democratic right to be involved. Patients can
provide information about the impact of their condition and treatments on their daily lives that
should be used within a HTA.
- Fair compensation for time, and reimbursement of expenses, is an essential part of facilitating
patient involvement.
- Patients need training and support that is carefully designed with their needs in mind, to build
understanding, confidence and effectiveness and be useful for involvement
Borup et al
Patient involvement in R&D
The patient-centered model illustrates how patients can interact and bring invaluable first-hand
knowledge into the medicine’s R&D process.
- Different levels of patient engagement in R&D
- All equally valuable and complementary (!)
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