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Summary HPI4001 Case 1
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Lecture Case 6 Patient involvement in healthcaredecisions/HTA EH
Nowadays patient involvement is becoming more important for both clinical and policy decisions.
1.Background (rationale why we need to involve patients in R&D)
Patient is always the key healthcare factor and therefore is important in development, conduction
and evaluation of health interventions
Involving patients at all stages of healthcare delivery and evaluation
Patients have a key role in all aspects of health-related research
Trial protocol design, informed consent, ethical review, market authorization, value
assessment and health policy (patients get invited to say something about this)
Why is patient involvement important in clinical decisions?
Can help health professionals to improve disease management (understand what is
important for patients)
Facilitate shared-decision making (=choice for treatment is based on deliberation process
between patient and clinician -> patient wants to be more active nowadays)
Improve medication adherence (since they partly choose for this treatment themselves)
Why is patient involvement important in policy decisions?
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
treatment on their daily lives that is not available elsewhere
Patients are in a unique position to describe the outcomes that matter to them, to challenge
presumptions about their health
o The importance of patient involvement in HTA is becoming widely recognized.
There is an emphasis on patient-centred research through engagement of patients in:
1. Identifying unmet needs
2. The design and conduct of clinical studies
3. Subsequent regulatory assessments
4. Post-marketing vigilance and data collection
5. 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 healthcare 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
An example of an organization in which patients are involved is the EMA: They are involved in a
wide range of activities at the agency (e.g. members of management board or scientific committees)
1
, 2. Patient involvement in research (patient roles and initiatives)
Patient-centered model: illustrating how patients/patient organizations can interact and bring
invaluable first-hand knowledge into the medicine’s R&D process.
Patient involvement in different steps in R&D:
Can be involved in (Geissler, 2016):
1. Research priorities (identify needs of patients)
2. Research design and planning (protocol)
3. Research conduct and operations (trial committee)
4. Dissemination (=spreading), communication and post-
approval (regulatory affairs)
Other overview of potential patient involvement in R&D can be
found in the article of Borup et al (2016): Pre-study/submission -> Research design and planning ->
study conduct -> analysis and dissemination -> marketing
and post marketing
Patient involvement in R&D:
o Different levels of patient engagement
o All equally valuable and complementary
o Degree of patient participation and level of
power/authority should not be mandatory
Patient roles in patient involvement:
- Consultation: involves participation of patients
and/or their representatives as study participants
- Advise: provided by an informed patient (e.g. by
discussing new developments and sharing personal knowledge and experience) -> advise
research team and policy maker
- Collaboration: taking active role in research team as patient research partner/patient expert
Patient expert: ‘expert’ in their own disease and its management, and someone who
is equipped to look further than their own personal experience of the disease
Patient collaboration takes place on a collective level and influences the aims, design
and conduct of a study through dialogue (two-way communication with other
stakeholders)
- Control: when patient organization takes lead and determines the research gap or research
questions, controls the study and own the data
Patient definition:
2
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