Department of Health Service Research Head: Prof. Dr. Ansgar Gerhardus Interactive session: Presentation of the INTEGRATE-HTA Model and short discussion after each step of the model Philip Wahlster, Ansgar Gerhardus, University of Bremen INTEGRATE-HTA Conference, , Amsterdam INTEGRATE-HTA

The ingredients of the INTEGRATE-HTA Model The INTEGRATE-HTA Model is built on a)the experiences of traditional HTA which mainly provides side-by-side assessments of the different aspects; b)the methodological guidances developed in the INTEGRATE-HTA-project; c)the dimension of information in HTA; d)the literature review on approaches for integration; e)the involvement of stakeholder panels in each step of the assessment process INTEGRATE-HTA

Step 1 INTEGRATE-HTA

Step 1:Bring the generation of evidence into perspective Example: Continuity of care Example: COPE intervention Example: Ethical complexity assessment

Separating the HTA into clearly defined assessment criteria Assessment criteria can be obtained from different sources Should be in line with stakeholder values INTEGRATE-HTA Output: Definition of HTA objective and the definition of technologies Step 1:Bring the generation of evidence into perspective

Example: HTA research question of the case study INTEGRATE-HTA Are reinforced models of home-based palliative care acceptable, feasible, appropriate, meaningful, effective, and cost-effective for providing patient-centred home-based palliative care [compared to usual home-based care models of palliative care] in adults (defined as those aged 18 years and above) and their families?”

Discussion of step 1 Bring the generation of evidence into perspective INTEGRATE-HTA Is the involvement of stakeholders feasible? If yes: Who should be involved? Is the operationalization of the HTA research question into different assessment criteria (e.g. acceptable, appropriate, meaningful) which are not along the lines of effectiveness, economic, ethical, etc. issues feasible?

Step 2 INTEGRATE-HTA

Step 2: Specific logic model to define evidence needs Examples: Patients with preference for place of death Implemented by generalized palliative care team or specialist palliative care team Rural or urban area (context) INTEGRATE-HTA

Step 2: Specific logic model to define evidence needs Illustrate the results in the specific logic model Review of the specific logic model by HTA researches and SAPs INTEGRATE-HTA Example: Specific logic model of reinforced and non-reinforced home-based palliative care

Example: System- based logic model of reinforced and non- reinforced home- based palliative care (Brereton et al. 2015)

INTEGRATE-HTA Outcomes Intermediate outcomes Process outcomes: e.g. Hospitalisation Surrogate outcomes (of patients and carers) e.g. Mastering Health outcomes Patients e.g. Good dead Family Carers/Family e.g. Psychological health Non-health outcomes e.g. Acceptability of models of care Outcomes Intermediate outcomes Process outcomes: Quality of care Hospitalisation Reach Professional caregiver outcomes Surrogate outcomes (of patients and carers) Coping Mastery Self-efficacy Health outcomes Patients: Quality of life Physical well-being (reduced symptoms) Psychological well-being Spiritual well-being Good death/achieving preferred place of death Survival Family Carers/Family: Psychological health Physical health Quality of life Non-health outcomes Economic costs Non-economic costs Acceptability of models of care

Discussion of step 2 Specific logic model to define evidence needs INTEGRATE-HTA Apart from the HTA-assessment issues and patient characteristics, context and implementation issues: Do you miss any parameter? Have you considered using logic models (or other means of modelling) in HTA before? Do you think it is feasible from e.g. an HTA-agency´s perspective?

Step 3 INTEGRATE-HTA

Step 3: Assessing the Evidence INTEGRATE-HTA

Step 3: Assessing the Evidence Separation of the infomation according to their Importance e.g. pain reduction an essential aspect for terminal conditions Relevance e.g. improvement in manageability for reinforced compared to home-based models Internal validity e.g. evidence obtained from two observational studies with limited statistical power External validity e.g. results from a palliative care study for children transferred to the care of adults INTEGRATE-HTA

Discussion Step 3: Assessing the Evidence INTEGRATE-HTA The HTA-Core-Model assumes a distinction between parameter that are “fix” across different settings and others that are variable. In our approach all parameter are variable as they depend on patients, context, implementation. Is this feasible?

Step 4 INTEGRATE-HTA

Step 4 Processing the evidence INTEGRATE-HTA

Example: Aggregating the evidence obtained from different assessment aspects INTEGRATE-HTA Patient autonomy and shared decision-making (Part 1 - preferences) Patient autonomy and shared decision-making (Part 2 - Legal perspective) Patient autonomy and shared decision- making (Part 3 – ethical perspective) Patient autonomy and shared decision-making (Part 4 – socio- cultural perspective) There is a desire for autonomy for end-of-life choices. However, the most important factors of treatment are reduction of emotional, physical burden on family, reduction of symptoms and especially adequate communications The legal issue of autonomy of the patient might be of higher relevance for reinforced care models. This applies to the three aspects of patient's autonomy, namely the legal requirement: 1. to acquire the patient's informed consent; 2. to substitute this informed consent where the patient can not consent him-/herself, 3. to protect the patient's data. There may be differences in patient and informal carer choice / preferences (e.g. the patient may prefer to be cared for at home, but the informal carer may prefer care to be provided in an institution). This can result in a conflict of interest between patients and carers. Hence, ensuring patient and caregiver autonomy, self determination and valid consent for both patients and carers is challenging given their different needs. Informed consent and autonomy of the patient and relatives are central. This approach is challenged if user don’t understand the information or prefer another culture of decision making (e.g. to be directed by professionals). The needs assessment should be characterized by a two way procedure and talks between patient and professional(s). Patient autonomy and shared decision-making

Example: HTA objective in the case study INTEGRATE-HTA Are reinforced models of home-based palliative care acceptable, feasible, appropriate, meaningful, effective, and cost-effective for providing patient-centred home-based palliative care [compared to usual home-based care models of palliative care] in adults (defined as those aged 18 years and above) and their families?”

Example: Assignment of the assessment results INTEGRATE-HTA Effectiveness Caregiver Quality of life Response Outcomes Satisfaction with care Psychological health (plus preferences) Patients Pain Symptom control Quality of life Psycological health Hospitalisatio n Response Satiscfaction with care Death at home (plus preferences) Cost effectiveness Costs per patient Resources impact (e.g. Specialist Nurse time) Budget impact Acceptability Changing roles and relationship for caregiver (ethics) Changing roles and relationship for patients (ethics) Autonomy and shared decision- making (legal, ethics, socio- cultural, preferences) Location of death (preferences) Preference for survival Meaningfulness Vulnerability (ethics) Perceived usefulness and the idea of benefit (socio- cultural) Knowledge and understanding of the technology (i.e. home-based palliative care, socio-cultural) User- professionals- relation and decision making (socio-cultural) Feasibility Context and implemantation issues Appropriateness Access and availability (ethics) Voluntariness (ethics)

Step 4 Processing the evidence INTEGRATE-HTA

Assessment results Assessment criteria Specific logic Model

INTEGRATE-HTA Assessment criteria Assessment results

INTEGRATE-HTA Locating Autonomy and shared decision- making Patient preferences Legal context Ethical context Socio-cultural context Acceptability

Discussion step 4 Processing the evidence INTEGRATE-HTA Would you find the structuring of the results by this (or a similar) model feasible and helpful?

Step 5 INTEGRATE-HTA

Step 5: HTA decision-making INTEGRATE-HTA Considerung the delibaration and decision- making process in HTA-agencies and decision- making bodies: Could the INTEGRATE-HTA- process be “integrated”?

This project is co-funded by the European Union under the Seventh Framework Programme (Grant Agreement No ) INTEGRATE-HTA