Philip Wahlster

Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework

BackgroundThe effectiveness of complex interventions, as well as their success in reaching relevant populations, is critically influenced by their implementation in a given context. Current conceptual frameworks often fail to address context and implementation in an integrated way and, where addressed, they tend to focus on organisational context and are mostly concerned with specific health fields. Our objective was to develop a framework to facilitate the structured and comprehensive conceptualisation and assessment of context and implementation of complex interventions.MethodsThe Context and Implementation of Complex Interventions (CICI) framework was developed in an iterative manner and underwent extensive application. An initial framework based on a scoping review was tested in rapid assessments, revealing inconsistencies with respect to the underlying concepts. Thus, pragmatic utility concept analysis was undertaken to advance the concepts of context and implementation. Based on these findings, the framework was revised and applied in several systematic reviews, one health technology assessment (HTA) and one applicability assessment of very different complex interventions. Lessons learnt from these applications and from peer review were incorporated, resulting in the CICI framework.ResultsThe CICI framework comprises three dimensions—context, implementation and setting—which interact with one another and with the intervention dimension. Context comprises seven domains (i.e., geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political); implementation consists of five domains (i.e., implementation theory, process, strategies, agents and outcomes); setting refers to the specific physical location, in which the intervention is put into practise. The intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level. Tools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments.ConclusionsThe CICI framework addresses and graphically presents context, implementation and setting in an integrated way. It aims at simplifying and structuring complexity in order to advance our understanding of whether and how interventions work. The framework can be applied in systematic reviews and HTA as well as primary research and facilitate communication among teams of researchers and with various stakeholders.

Identifying stakeholder opinion regarding access to “high-cost medicines”: A systematic review of the literature

Objective: To identify the viewpoints and perceptions of different stakeholders regarding high cost medicines (HCMs). Methods: A systematic review of the literature was performed to identify original research articles. Using predefined categories, data related to the viewpoints of different stakeholders was systematically extracted and analyzed. Results: Thirty seven original research articles matched the criteria. The main stakeholders identified include physicians, patients, public and health funding authorities. The influence of media and other economic and ethical issues were also identified in the literature. A large number of stakeholders were concerned about lack of access to HCMs. Physicians have difficulty balancing the the rational use of expensive drugs while at the same time acting as “patients’ advocate”. Patients would like to know about all treatment options, even if they may not be able to afford them. The process and criteria for reimbursement should be transparent and access has to be equitable across patient groups. Conclusion: Access to HCMs could be improved through transparency and involvement of all stakeholders, especially patients and the public. Moral issues and the “rule of rescue” could influence decision-making process significantly. At system level, objectivity is important to ensure that the system is equitable and transparent.

Structured methodology review identified seven (RETREAT) criteria for selecting qualitative evidence synthesis approaches

OBJECTIVE To compare and contrast different methods of qualitative evidence synthesis (QES) against criteria identified from the literature and to map their attributes to inform selection of the most appropriate QES method to answer research questions addressed by qualitative research. STUDY DESIGN AND SETTING Electronic databases, citation searching, and a study register were used to identify studies reporting QES methods. Attributes compiled from 26 methodological papers (2001-2014) were used as a framework for data extraction. Data were extracted into summary tables by one reviewer and then considered within the author team. RESULTS We identified seven considerations determining choice of methods from the methodological literature, encapsulated within the mnemonic Review question-Epistemology-Time/Timescale-Resources-Expertise-Audience and purpose-Type of data. We mapped 15 different published QES methods against these seven criteria. The final framework focuses on stand-alone QES methods but may also hold potential when integrating quantitative and qualitative data. CONCLUSION These findings offer a contemporary perspective as a conceptual basis for future empirical investigation of the advantages and disadvantages of different methods of QES. It is hoped that this will inform appropriate selection of QES approaches.

A consultation guide for assessing the applicability of health technologies: a case study

OBJECTIVES The translation of research findings into policy and practice is crucially dependent on the applicability of such findings in a given decision-making context. We explored in a case study whether a generic consultation guide to assess the applicability of a health technology could be rapidly deployed and deliver useful insights. METHODS A consultation guide based on the context and implementation for complex interventions (CICI) framework was developed and piloted to assess the applicability of reinforced home-based palliative care in three European countries. Individual consultations in England and Germany and a panel discussion in Poland were completed. RESULTS Various barriers may hinder successful implementation of reinforced home-based palliative care in the three countries. Whilst the experts across all countries emphasized the lack of funding along with organization and structure as major barriers, information varied by country for many of the other identified barriers and facilitators. Participants in the pilot study provided positive feedback in terms of understanding the topic and purpose of the consultation, and both individual and panel consultations could be easily implemented. CONCLUSIONS In this case study, the consultation guide presented a pragmatic, ready-to-use tool to assess the applicability of a health technology. As shown here, it can be used in a generic manner without discrete empirical information on the technology in question or, ideally, makes use of specific information collected as part of a HTA. Further studies are needed to validate this guide and apply it to other types of health technologies and more diverse decision-making contexts.

AN INTEGRATED PERSPECTIVE ON THE ASSESSMENT OF TECHNOLOGIES: INTEGRATE-HTA

OBJECTIVES Current health technology assessment (HTA) is not well equipped to assess complex technologies as insufficient attention is being paid to the diversity in patient characteristics and preferences, context, and implementation. Strategies to integrate these and several other aspects, such as ethical considerations, in a comprehensive assessment are missing. The aim of the European research project INTEGRATE-HTA was to develop a model for an integrated HTA of complex technologies. METHODS A multi-method, four-stage approach guided the development of the INTEGRATE-HTA Model: (i) definition of the different dimensions of information to be integrated, (ii) literature review of existing methods for integration, (iii) adjustment of concepts and methods for assessing distinct aspects of complex technologies in the frame of an integrated process, and (iv) application of the model in a case study and subsequent revisions. RESULTS The INTEGRATE-HTA Model consists of five steps, each involving stakeholders: (i) definition of the technology and the objective of the HTA; (ii) development of a logic model to provide a structured overview of the technology and the system in which it is embedded; (iii) evidence assessment on effectiveness, economic, ethical, legal, and socio-cultural aspects, taking variability of participants, context, implementation issues, and their interactions into account; (iv) populating the logic model with the data generated in step 3; (v) structured process of decision-making. CONCLUSIONS The INTEGRATE-HTA Model provides a structured process for integrated HTAs of complex technologies. Stakeholder involvement in all steps is essential as a means of ensuring relevance and meaningful interpretation of the evidence.