1. Building a logic model of reinforced models of palliative care Anke Rohwer, Andrew Booth, Lisa Pfadenhauer, Louise Brereton, Ansgar Gerhardus, Kati Mozygemba, Wija Oortwijn, Marcia Tummers, Gert Jan van der Wilt, Eva Rehfuess The INTEGRATE-HTA project is co-funded by the European Union under the Seventh Framework Programme (Grant Agreement No. 306141)

2. The logic of logic models

3. The Logic of Logic Modelling Complexity of health technologies and systems Strong assumptions about the structure, content and objectives of a health technology as well as its implementation Negligence of system within which the intervention is intended to act and the potential interplay and co- evolution Describes components of complex interventions and relationships between them Makes underlying theories of change and assumptions about causal pathways explicit Describes interactions between the intervention and the system within which it is implemented Logic Models “… a graphic description of a system … designed to identify important elements and relationships within that system”. Logic Models “… a graphic description of a system … designed to identify important elements and relationships within that system”.

4. Added value of using logic models in systematic reviews Scoping the review Refining review question Deciding on lumping or splitting a review topic Identifying intervention components Defining and conducting the review Identifying relevant study inclusion/exclusion criteria Guiding the literature search strategy Explaining the rationale behind surrogate outcomes used in the review Justifying need for subgroup analyses (e.g. age, sex/gender, socioeconomic status) Making the review relevant to policy and practice Structuring reporting of results Interpreting results based on intervention theory and systems thinking Illustrating how harms and feasibility are connected with interventions Interpreting results based on intervention theory and systems thinking (Anderson et al, 2011)

5. Method of development of logic models: four step process (i) systematic searches for published examples of logic models (ii) searches for existing guidance on the use of logic models in primary research, SRs and HTAs (iii) development of two draft templates for system- based and process-orientated logic models and (iv) application of these templates in three SRs and one HTA of different complex health technologies.

6. Logic models in HTA and Systematic Reviews HTA/SR research question Check literature for published logic models Adoption of published logic model Adaptation of logic model De novo logic model Type of logic model Subtype of logic model A-priori logic modelIterative logic modelStaged logic model Process-based logic modelSystem-based logic model

7. Three types of logic model LabelMeaning Type A priori logic model A logic model that is specified as close to the inception of an HTA or SR as scoping the literature and/or stakeholder consultation permit and that remains unchanged during the HTA/SR process. Iterative logic model A logic model that is subject to continual modification and revision throughout the course of an HTA or SR. Staged logic model A type of iterative logic model that pre-specifies points at which major data inputs are anticipated to prompt a subsequent version of the logic model, thereby increasing transparency and minimising problems with version control.

8. Subtype: System-based logic model

9. Subtype: Process-oriented logic model

10. Populating the logic model template SAP and expert input Discussion within team Literature review

11. Logic models in the INTEGRATE- HTA Process

12. INTEGRATE-HTA model

13. Ideal application of Logic Models in INTEGRATE-HTA: Staged system-based logic model Based on the agreed HTA question and a combination of team discussions, literature and SAPs. Initial Logic Model 1 1 Based on an analysis of context and implementation, patient preferences and moderators of treatment. Iteration 1 2 2 Based on the results of the effectiveness review and economic assessment, as well as insights generated through the socio- cultural, ethical and legal assessments. Iteration 2 3 3 Based on any additional findings generated through an assessment of context and implementation. Final Logic Model 4 4

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

15. Discussion Added value – Getting team on same page – Integrating various types of evidence/knowledge – Structuring subsequent SR/HTA process – Graphical means of communication Strenghts and limitations: – parallel development of methods and application in demonstration HTA – Empirical testing in various SR – Each type and subtype of logic models has its specific strengths and limitations

16. Conflict of Interest The authors have no conflicts of interest to declare

17. References Anderson LM, Petticrew M, Rehfuess E, Armstrong R, Ueffing E, Baker P, et al. Using logic models to capture complexity in SRs. Research Synthesis Methods. 2011;2(1):33-42. Rohwer, A., Booth, A., Pfadenhauer, L., Brereton, L., Gerhardus, A., Mozygemba, K., Oortwijn, W., Tummers, M., Van Der Wilt, G.J., Rehfuess, E. (2015) Guidance on the use of logic models in health technology assessments of complex interventions [Online]. Available from: http://www.integrate- hta.eu/downloads/