In general it's just a copy paste from the lecture slides without any context or further additions from the suggested literature. Waist of money in my opinion
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Case 6: Patient involvement in healthcare decisions/ HTA
Learning goals
1. Why do we need to include the patient perspective in healthcare decisions/regulatory
decisions about healthcare?
2. When do we need to include patients in healthcare decisions/ regulatory decision making for
healthcare?
3. What are the possible patient roles in patient involvement?
4. Provide some examples/initiatives about patient involvement and the use of patients’
preferences in healthcare decisions
5. How can we facilitate optimal patient engagement in regulatory decisions about healthcare?
6. What are the benefits of patient preferences research?
7. What are the methods to elicit preferences?
Keywords of the case
Patient involvement, preference research, conjoint analysis / discrete choice experiment, best worst
scaling, patient engagement, roles of patient in patient involvement and patients in regulatory
decisions.
Literature
- Borup et al. (2016). A Paradigm Shift Towards Patient Involvement in Medicines Development and
Regulatory Science: Workshop Proceedings and Commentary. Ther Innov Regul Sci 2016
May;50(3):304-311
- Bridges JP, et al. (2007). Patient Preference Methods - A Patient Centered Evaluation Paradigm.
Available from URL https://www.ispor.org/docs/default- source/sig-documents/Patient-Preference-
Methods.pdf
- De Wit M, et al. (2019). Practical guidance for engaging patients in health research, treatment
guidelines and regulatory processes: results of an expert group meeting organized by the World
Health Organization (WHO) and the European Society for Clinical and Economic Aspects of
Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO). Aging Clin Exp Res.31(7):905-915
- De Wit M, et al. (2017). Successful Stepwise Development of Patient Research Partnership: 14
Years’ Experience of Actions and Consequences in Outcome Measures in Rheumatology (OMERACT)
Patient; 10:141–152
- Fraenkel L (2013). Incorporating Patients’ Preferences into Medical Decision Making. Med Care Res
Rev.; 70(1 0): 80S–93S
,- Hunter A et al. (2018). EUPATI Guidance for Patient Involvement in Medicines Research and
Development: Health Technology Assessment. Front Med (Lausanne); 5: 231.
- Soekhai et al. (2019). Methods for exploring and eliciting patient preferences in the medical product
lifecycle: a literature review. Drug Discovery 24, 7, 1359-64
1. Why do we need to include the patient perspective in healthcare decisions/regulatory decisions
about healthcare?
Patient perspective:
- Increasingly important in healthcare decisions and HTA
- Key in the development, conduct and evaluation of health intervention
Important for clinical decisions
- Can help health professionals to improve disease management
- Facilitate SDM
- Improve medication adherence
- More active role of patients in clinical decision-making
Important for policy decisions
- 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 insights, 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.
Importance of patient involvement
Emphasis on patient-centered 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
o Patient report adverse events (without bias)
- 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.
Hunter et al., rationale to include patients
- Democratic right to be involved
2. 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.
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