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) The logic of logic models The Logic of Logic Modelling Complexity of health technologies and systems Describes components of complex interventions and relationships between them Strong assumptions about the Logic Models Makes underlying theories of a graphic structure, content and “… objectives of description of a system … change and assumptions about to identify important a health technology asdesigned well as its causal pathways elements and relationships within that explicit implementation system”. Negligence of system within which the intervention is intended to act and the potential interplay and coevolution Describes interactions between the intervention and the system within which it is implemented Added value of using logic models in systematic reviews Scoping the review Defining and conducting the review Making the review relevant to policy and practice • Refining review question • Deciding on lumping or splitting a review topic • Identifying intervention components • • • • 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) • • • • 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) 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 systembased and process-orientated logic models and • (iv) application of these templates in three SRs and one HTA of different complex health technologies. 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 A-priori logic model Iterative logic model Staged logic model Subtype of logic model Process-based logic model System-based logic model Three types of logic model Label Meaning A priori logic A logic model that is specified as close to the inception of an HTA or SR as scoping the model literature and/or stakeholder consultation permit and that remains unchanged during the Type HTA/SR process. Iterative A logic model that is subject to continual modification and revision throughout the course logic model of an HTA or SR. Staged logic A type of iterative logic model that pre-specifies points at which major data inputs are model anticipated to prompt a subsequent version of the logic model, thereby increasing transparency and minimising problems with version control. Subtype: System-based logic model Subtype: Process-oriented logic model Populating the logic model template Literature review SAP and expert input Discussion within team Logic models in the INTEGRATEHTA Process INTEGRATE-HTA model Step 1: HTA Objectives and Technology Decision-making body, HTA commissioning agency Selection of theme for assessment e.g. palliative care Definition of functional requirements of the decision-making body Definition of stakeholder advisory panel (SAP) Create logic model architecture and attributes for specific technologies according to a generic logic model template Create specific logic model regarding the theme e.g. palliative care based on the data from step 1 Identify and assess patient preferences, moderators, context and implementation Specific requirements and evidence needs according to the specific logic model, context, implemantation and patient groups (moderators/ preferences), relevant issues Literature review, SAP consultations Evidence collection for all assessed aspects (effectiveness, economics, ethical, legal, cultural, and social aspects, relevant issues) Step 4: Mapping of the evidence Step 5: HTA decision-making Evidence summaries about different assessment aspects (e.g. effectiveness, ethics) Presentation of HTA results obtained from steps 3 and 4 to a decision committee comprising stakeholders/decision-makers Selecting a tool to structure a deliberative discussion (in cooperation with the decision committee) Summarizing and structuring the assessment results into specific assessment criteria of the HTA research question HTA researchers Scoping literature overview Specific scoping procedures for each assessment aspect considered Definition of relevant issues and assessment criteria regarding the assessment theme (e.g. access, continuity) Result Step 3: Evidence assessment Step 2: Logic Model to define evidence needs Definition of HTA research question, assessment criteria and preliminary definition of technologies e.g. models of care and relevant issues Scientific assessment of evidence Review and adaptaptation of specific model by SAPs and HTA researchers Review of the assessment results by HTA researchers and SAPs Refinement of A,B,C,D, E: A) Definition of specific technologies B) Relevant issues C) Outcome parameter D) Relevant patient characteristics (preferences, moderators) E) Context and implementation issues Result Specific logic model to start evidence collection including A,B,C,D,E Construction of the ELMMAR (Extended Logic Model to Map the Assessment Results) Model: Integration of the assessment results (effectiveness, ethics etc.) Deliberative reflections of stakeholders/decision-makers about unanswered issues/ uncertainty/ limitations of the assessment process (steps 1- 4) Review by stakeholders (HTA researchers, SAPs, decision-maker) Completing evidence summary templates about different assessment aspects (e.g. effectiveness, ethics) Result Evidence reports and evidence summaries for each assessment aspect Deriving conclusions from the ELMMAR Model (HTA researchers, SAPs, decision-maker) Result ELMMAR Model and synthesised evidence according to the HTA research question Result HTA decision/ recommendation Ideal application of Logic Models in INTEGRATE-HTA: Staged system-based logic model 1 Based on the agreed HTA question and a combination of team discussions, literature and SAPs. Initial Logic Model 2 3 4 Based on an analysis of context and implementation, patient preferences and moderators of treatment. Based on the results of the effectiveness review and economic assessment, as well as insights generated through the sociocultural, ethical and legal assessments. Based on any additional findings generated through an assessment of context and implementation. Iteration 2 Final Logic Model Iteration 1 Systembased logic model of reinforced and nonreinforced home-based palliative care (Brereton et al. 2015) 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 Conflict of Interest • The authors have no conflicts of interest to declare <DISCLAIMER: The sole responsibility for the content of this presentation lies with the authors. It does not necessarily reflect the opinion of the European Union. The European Commission is not responsible for any use that may be made of the information contained therein.> 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.integratehta.eu/downloads/