Making sense of complexity in context and implementation: the Context and Implementation of Complex Interventions (CICI) framework
Open accessAbstract
BACKGROUND: The 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. METHODS: The 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. RESULTS: The 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. CONCLUSIONS: The 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.
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TL;DR
The paper presents the Context and Implementation of Complex Interventions (CICI) framework, which integrates context, implementation, and setting for complex interventions. It was developed iteratively through literature searches, concept analysis, and extensive application in systematic reviews, HTA, and applicability assessment.
Key findings
- The CICI framework comprises three interacting dimensions: context, implementation, and setting. Context has seven domains (geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political); implementation has five domains (implementation theory, process, strategies, agents, outcomes); setting refers to the specific physical location where the intervention is put into practice.
- Development included systematic searches yielding 35 publications on implementation and 17 on context, followed by pragmatic utility concept analysis that distinguished context, implementation, and setting.
- The revised framework was applied in three rapid assessments, a demonstration HTA of reinforced home-based palliative care, quantitative and qualitative systematic reviews, and an applicability assessment with semi-structured consultations with palliative care experts from three European countries; it was also externally peer-reviewed by three experts.
- Tools developed include a generic checklist, data extraction tools for qualitative and quantitative reviews, and a consultation guide; a worked example applied CICI, CFIR, and PARiHS to the Irish Air Pollution Act, finding CFIR and PARiHS had difficulty capturing public health context.
Methods
- The CICI framework was developed in a three-step iterative process within the INTEGRATE-HTA project: initial framework from purposive literature searches and three rapid assessments; pragmatic utility concept analysis using systematic searches for context in EMBASE/MEDLINE and forward tracking for implementation in Google Scholar; revision and extensive application.
- Applications included a demonstration HTA, quantitative systematic reviews, a qualitative systematic review using CICI as a best-fit framework, and an applicability assessment; appraisal used seven pre-specified criteria and external peer review.
- A worked example applied CICI, CFIR, and PARiHS to the Air Pollution Act on the Marketing, Sale and Distribution of Coal, using the primary study and grey literature searches.
Limitations
- The paper states that searches lacked explicit coverage of management and organisational studies; the setting dimension is less well conceptualised because the search strategy targeted context and implementation; no formal consensus method such as Delphi was used; and the latest framework version has not yet been fully tested.
- The paper states that primary studies report little detail on context and implementation, limiting population of the framework, and that extracting data on context and implementation imposes additional workload in quantitative reviews, potentially substantial if further sources are consulted.
- Evident from the text: the generic framework does not display relationships between dimensions or domains; applications noted overlaps between context and implementation dimensions and discomfort with the original ethical domain definition; peer reviewers questioned practical uptake given additional workload and called for clearer distinction between context and implementation and greater elaboration of domain definitions.
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Claims the paper makes
0 of 46 cited sources checked · 0 supported · 0 flagged
- Findingown data
The rapid assessments unveiled inconsistencies in the interpretation of the terms context and implementation and the characteristics assigned to each of these among members of the research team.
“The rapid assessments unveiled inconsistencies in the interpretation of the terms context and implementation and the characteristics assigned to each of these among members of the research team.”
Quote in the paperSubstantial claim - Findingown data
The test cases revealed that selected aspects under specific domains of context and implementation had been missing.
“The test cases did, however, also reveal that selected aspects under specific domains of context and implementation had been missing.”
Quote in the paperSubstantial claim - Findingown data
The concept of reinforced home-based palliative care, as defined for the HTA, did not fit the German context, where reinforcement (e.g., carer support) is integrated in every palliative care construct available.
“In particular, the concept of reinforced home-based palliative care, as defined for the HTA, did not fit the German context, where reinforcement (e.g., carer support) is integrated in every palliative care construct available.”
Quote in the paperNot a substantial claim - Findingreasoning
The framework was assessed as compatible with other methods developed and applied within INTEGRATE-HTA as a consequence of their development taking place side-by-side.
“The framework was assessed as compatible with other methods developed and applied within INTEGRATE-HTA (i.e., assessments of ethical or socio-cultural issues, logic model and the INTEGRATE-HTA model) as a consequence of their development taking place side-by-side.”
Quote in the paperNot a substantial claim - Findingcitation
In the applicability assessment, the framework partly missed the complexity and adaptability of the intervention.
“In the applicability assessment, the framework partly missed the complexity and adaptability of the intervention [14].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [14] Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4. source
Not checked in the free run.
- Findingnone given
The application of the revised CICI framework in quantitative reviews does not make relationships between dimensions or domains explicit.
“In line with the tradition of previous implementation frameworks, the application of the revised CICI framework in quantitative reviews does not make relationships between dimensions or domains explicit.”
Quote in the paperNot a substantial claim - Findingnone given
To our knowledge, no concept analysis of implementation has been undertaken to date.
“To our knowledge, no concept analysis of implementation has been undertaken to date.”
Quote in the paperNot a substantial claim - Findingcitation
Damschroder's CFIR, Greenhalgh's landmark review, Roger's Diffusion of Innovation Theory, Klein and Sorra's Theory of Innovation and Ajzen's Theory of Planned Behaviour were particularly influential in the development of the CICI framework.
“In terms of previous frameworks, models or theories, Damschroder’s Consolidated Framework for advancing Implementation Research, Greenhalgh’s landmark review, Roger’s Diffusion of Innovation Theory, and Klein and Sorra’s Theory of Innovation [17] and Ajzen’s Theory of Planned Behaviour were particularly influential in the development of the CICI framework.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [17] Klein KJ, Sorra JS. The challenge of innovation implementation. Acad Manag Rev. 1996;21:1055–80. source
Not checked in the free run.
- Findingown data
In the authors' various applications of the CICI framework and in the worked example, primary studies reported little detail on context and implementation.
“In our various applications of the framework as well as in the worked example, a significant problem was that primary studies reported little detail on context and implementation; this was less problematic when using primary qualitative or mixed-method studies.”
Quote in the paperSubstantial claim - Findingcitation
Reporting of information on context and implementation of health interventions is consistently poor.
“Unfortunately, our experience confirms what is known from the literature: reporting of information on context and implementation of health interventions is consistently poor [93].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [93] Luoto J, Shekelle PG, Maglione MA, Johnsen B, Perry T. Reporting of context and implementation in studies of global health interventions: a pilot study. Implement Sci. 2014;9:1–9. source
Not checked in the free run.
- Findingown data
In the authors' applications of the CICI framework, the complex and interdependent relationships between the various domains of context and implementation can be tracked and made transparent using the tools presented in the paper.
“although we found that these can be tracked and made transparent using the tools presented in this paper.”
Quote in the paperSubstantial claim- Rests on an assumption: An intervention and its implementation interact in multiple ways within any given setting and context, with these interactions taking place at multiple levels.
- Findingreasoning
A further difficulty related to the terminology used, where terms used by the CFIR and PARiHS frameworks are grounded in a clinical and/or health services perspective and only partially applicable to public health interventions.
“A further difficulty related to the terminology used, where terms used by the CFIR and PARiHS frameworks (e.g., patients) are grounded in a clinical and/or health services perspective and only partially applicable to public health interventions.”
Quote in the paperSubstantial claim - Findingown data
From our application of the CICI framework, we learnt that context as a versatile, dynamic construct evolves over time, as the intervention unfolds and as implementation strategies change.
“Importantly, from our application of the CICI framework, we learnt that context as a versatile, dynamic construct evolves over time, as the intervention unfolds and as implementation strategies change, e.g., the issuing of additional taxes or grants.”
Quote in the paperSubstantial claim - Findingown data
In the authors' applications, the problem of primary studies reporting little detail on context and implementation was less problematic when using primary qualitative or mixed-method studies.
“In our various applications of the framework as well as in the worked example, a significant problem was that primary studies reported little detail on context and implementation; this was less problematic when using primary qualitative or mixed-method studies.”
Quote in the paperNot a substantial claim - Findingown data
The worked example demonstrates that the CICI framework can be readily applied to a complex public health intervention that operates across multiple settings and engages multiple implementation agents across different organisations and sectors.
“The worked example of the CICI framework, available in Additional file 7 and also including a simple logic model of the intervention, demonstrates that the framework can be readily applied to a complex public health intervention that operates across multiple settings and engages multiple implementation agents across different organisations and sectors.”
Quote in the paperSubstantial claim - Premisenone given
Apart from the intervention of direct interest, the context and the way the intervention of interest is implemented may be advanced or compromised by other interventions occurring independently.
“Apart from the intervention of direct interest, the context and the way the intervention of interest is implemented may be advanced or compromised by other interventions occurring independently.”
Quote in the paperNot a substantial claim - Premisenone given
Individual implementation agents are usually embedded in an organisation or community that critically influences their attitudes and behaviours.
“Individual implementation agents, or teams that are actively involved in funding, administering or implementing an intervention, are usually embedded in an organisation or community that critically influences their attitudes and behaviours (see description of meso level above).”
Quote in the paperNot a substantial claim - Premisecitation
All community or organisational characteristics jointly influence implementation climate, system readiness for change and capacity for change and thus the chances of an intervention being implemented successfully.
“All of these community or organisational characteristics jointly influence implementation climate [14, 15], system readiness for change [14, 17, 67] and capacity for change [15, 62, 68, 69] and thus the chances of an intervention being implemented successfully.”
Quote in the paperSubstantial claim0 of 7 sources checked- cites [14] Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4. source
Not checked in the free run.
- cites [15] Greenhalgh T, Robert G, Macfarlane F, Bate P, Kyriakidou O. Diffusion of Innovations in Service Organizations: systematic review and recommendations. Milbank Q. 2004;82:581–629. source
Not checked in the free run.
- cites [17] Klein KJ, Sorra JS. The challenge of innovation implementation. Acad Manag Rev. 1996;21:1055–80. source
Not checked in the free run.
- cites [67] Weiner BJ, Lewis MA, Linnan LA. Using organization theory to understand the determinants of effective implementation of worksite health promotion programs. Health Educ Res. 2009;24:292–305. source
Not checked in the free run.
- cites [62] Packard T. Organizational change: a conceptual framework to advance the evidence base. J Hum Behav Soc Environ. 2013;23. source
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- cites [68] Emmons KM, Weiner B, Fernandez ME, Tu S-P. Systems antecedents for dissemination and implementation: a review and analysis of measures. Health Educ Behav. 2012;39:87–105. source
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- cites [69] Flottorp SA, Oxman AD, Krause J, Musila NR, Wensing M, Godycki-Cwirko M, Baker R, Eccles MP. A checklist for identifying determinants of practice: a systematic review and synthesis of frameworks and taxonomies of factors that prevent or enable improvements in healthcare professional practice. Implement Sci. 2013;8. source
Not checked in the free run.
- Interpretationreasoning
As the framework builds on a systematic review of previously published conceptual frameworks, theories and models of context and implementation, it can also be considered compatible with the literature.
“As the framework builds on a systematic review of previously published conceptual frameworks, theories and models of context and implementation, it can also be considered compatible with the literature.”
Quote in the paperNot a substantial claim - Interpretationreasoning
The successful application of the framework to very different types of health interventions suggests that the criterion applicability is met.
“The successful application of the framework to very different types of health interventions suggests that the criterion applicability is met.”
Quote in the paperSubstantial claim - Premisecitation
The success of implementation is highly dependent on the buy-in of individuals who become key stakeholders in both the intervention and the implementation effort.
“The success of implementation is highly dependent on the buy-in of individuals who become key stakeholders in both the intervention and the implementation effort [89].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [89] Chaudoir SR, Dugan AG, Barr CHI. Measuring factors affecting implementation of health innovations: a systematic review of structural, organizational, provider, patient, and innovation level measures. Implement Sci. 2013;8. source
Not checked in the free run.
- Premisecitation
Primary research, evidence synthesis and evidence-based policy and practise are inextricably linked.
“However, given that primary research, evidence synthesis and evidence-based policy and practise are inextricably linked [32], the framework is likely to be equally relevant for primary research.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [32] Rehfuess EA, Durao S, Kyamanywa P, Meerpohl JJ, Young T, Rohwer A, Cebha, consortium. An approach for setting evidence-based and stakeholder-informed research priorities in low- and middle-income countries. Bull World Health Organ. 2016;94:297–305. source
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- Premisecitation
Additional information regarding context can be found in process evaluations that attest to the evolving, adaptive dynamics of context.
“Additional information regarding context can moreover be found in process evaluations that attest to the evolving, adaptive dynamics of context [97].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [97] Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O’Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015;350. source
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- Interpretationreasoning
The organisational or community level plays a significant role in implementing an intervention successfully.
“As such, it plays a significant role in implementing an intervention successfully.”
Quote in the paperSubstantial claim - Premisereasoning
The organisational or community level determines the overall implementation climate and capacity for change and thus the ability of individual implementation agents to contribute to an implementation effort.
“This organisational or community level determines the overall implementation climate and capacity for change and thus the ability of individual implementation agents to contribute to an implementation effort.”
Quote in the paperSubstantial claim - Study design and conductnone given
The CICI framework underwent extensive testing across different types of interventions and using a range of methodological approaches (i.e., HTA, effectiveness reviews, qualitative review and applicability assessment).
“Another considerable strength of the CICI framework is that it underwent extensive testing across different types of interventions and using a range of methodological approaches (i.e., HTA, effectiveness reviews, qualitative review and applicability assessment).”
Quote in the paperSubstantial claim - Interpretationreasoning
When used in conjunction with a logic model, the CICI framework can help researchers and research organisations that undertake systematic reviews and HTAs, such as Cochrane and the European network for HTA (EUnetHTA), make sense of complexity and develop, prioritise and answer some of the many questions that arise when implementing complex interventions.
“When used in conjunction with a logic model, the CICI framework can help researchers and research organisations that undertake systematic reviews and HTAs, such as Cochrane and the European network for HTA (EUnetHTA), make sense of complexity and develop, prioritise and hopefully answer some of the many questions that arise when implementing complex interventions.”
Quote in the paperSubstantial claim - Premisecitation
Respective subdomains within the implementation strategy domain of the CICI framework align with the work of Proctor and colleagues.
“For example, respective subdomains within the implementation strategy domain of the CICI framework align with the work of Proctor and colleagues [83].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [83] Proctor EK, Powell BJ, McMillen JC. Implementation strategies: recommendations for specifying and reporting. Implement Sci. 2013;8. source
Not checked in the free run.
- Premisecitation
Context and implementation interact in a complex adaptive system, where significant changes at a micro, meso or macro level can become manifest over time.
“It is important to note that these interact in a complex adaptive system, where significant changes at a micro, meso or macro level can become manifest over time [92].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [92] May CR, Johnson M, Finch T. Implementation, context and complexity. Implement Sci. 2016;11:141. source
Not checked in the free run.
- Classified as probably not a substantial claim. 50
- May combine two claims. 46
Classified as probably not a substantial claim. May combine two claims.
Findingnone givenThe initial framework comprised two dimensions-context and implementation-with eight domains (locational, geographical, epidemiological, socio-cultural, socio-economic, ethical, legal and political) and four domains (provider, organisation and structure, funding and policy).
“The initial framework comprised two dimensions—context and implementation—with eight domains (i.e., locational, geographical, epidemiological, socio-cultural, socio-economic, ethical, legal and political) and four domains (i.e., provider, organisation and structure, funding and policy), respectively.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataThe CICI framework was considered feasible to apply across all the different applications; ease of use was ensured through clear terminology, step-by-step guidance and ready-to-use data extraction tools.
“The framework was considered feasible to apply across all the different applications; ease of use was ensured through clear use of terminology, step-by-step guidance and the provision of ready-to-use data extraction tools.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Findingnone givenThe CICI framework addresses and graphically presents context, implementation and setting in an integrated way.
“The CICI framework addresses and graphically presents context, implementation and setting in an integrated way.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataIn the qualitative systematic review, the framework facilitated the assessment of relationships through data extracts being attributed to several domains; for example, 'access to healthcare' emerged as a relevant aspect under three context domains (geographical, political, ethical and socio-economic).
“On the other hand, in the qualitative systematic review, the framework facilitated the assessment of relationships through data extracts being attributed to several domains, for example, ‘access to healthcare’ emerged as a relevant aspect under three context domains (geographical, political, ethical and socio-economic).”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataThe framework was appraised as largely consistent, with significant overlaps between the context and implementation dimensions noted.
“In terms of coherence, the framework was appraised as largely consistent; significant overlaps between the context and implementation dimensions were noted.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingnone givenThe additional time required for extracting data on context and implementation is limited when extraction is only performed on the included study, but may be substantial if further sources are also consulted.
“The additional time required is limited, where extraction is only performed on the included study; it may be substantial if further sources (e.g., qualitative studies or process evaluations cited in the included study) are also consulted.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationBased on systematic searches, 35 publications developing, proposing or describing theories, models or conceptual frameworks for implementation and 17 publications doing the same for context were included.
“Based on the systematic searches, we included 35 publications developing, proposing or describing theories, models or conceptual frameworks for implementation (see Additional file 1) and 17 publications doing the same for context (see Additional file 2) [37].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [37] Pfadenhauer LM, Mozygemba K, Gerhardus A, Hofmann B, Booth A, Lysdahl KB, Tummers M, Burns J, Rehfuess EA. Context and implementation: a concept analysis towards conceptual maturity. Z Evid Fortbild Qual Gesundhwes. 2015;109:103–14. source
Not checked in the free run.
Classified as probably not a substantial claim. May combine two claims.
FindingreasoningThe framework was considered helpful in guiding the formulation of questions about links between domains and dimensions, which inspires advancement of theory regarding interactions.
“The framework was also considered helpful in guiding the formulation of questions about these links, which in return inspires the advancement of theory regarding interactions between domains as well as context and implementation dimensions.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
FindingcitationThe forward tracking search based on Damschroder et al. (2009) resulted in considerably improved efficiency of searches without a significant loss of information.
“This resulted in considerably improved efficiency of our searches without a significant loss of information [37].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [37] Pfadenhauer LM, Mozygemba K, Gerhardus A, Hofmann B, Booth A, Lysdahl KB, Tummers M, Burns J, Rehfuess EA. Context and implementation: a concept analysis towards conceptual maturity. Z Evid Fortbild Qual Gesundhwes. 2015;109:103–14. source
Not checked in the free run.
May combine two claims.
Findingown dataThe CICI framework has proven methodologically flexible, applicable in quantitative and qualitative systematic reviews and primary studies, though data extraction was sometimes limited by poor reporting.
“Generally, the framework has proven to be methodologically flexible due to its good applicability in quantitative and qualitative systematic reviews and the primary qualitative, quantitative or mixed-method studies included in these, although data extraction was sometimes limited by poor reporting.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenIn quantitative reviews, extracting data on context and implementation imposes an additional workload on researchers.
“In quantitative reviews, extracting data on context and implementation imposes an additional workload on researchers.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataThe high granularity of the CICI framework facilitated extraction of often scarcely reported information on context and implementation and supported structuring this information.
“The high granularity of the framework proved capable of facilitating extraction of—often scarcely—reported information on context and implementation and supported the structuring of this information.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenData extractors were not comfortable with the original definition of the ethical domain.
“Also, data extractors were not comfortable with our original definition of the ethical domain.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Findingnone givenContext comprises seven domains: geographical, epidemiological, socio-cultural, socio-economic, ethical, legal, political.
“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.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Findingnone givenThe concept of context is less studied and applied in diverse ways across different fields, among them implementation science.
“The concept of context, on the other hand, is less studied and applied in diverse ways across different fields, among them implementation science.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
Findingnone givenThe concept of implementation is situated within an advancing and well-connected field of implementation science.
“The concept of implementation is situated within an advancing and well-connected field of implementation science.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Findingown dataThe concept analysis led to a clear conceptual distinction between context and setting as well as a more comprehensive formulation of characteristics for each of the domains of context and implementation.
“The concept analysis led to a clear conceptual distinction between context and setting as well as a more comprehensive formulation of characteristics for each of the domains of context and implementation.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Findingnone givenThe CICI framework comprises three dimensions-context, implementation and setting-which interact with one another and with the intervention dimension.
“The CICI framework comprises three dimensions—context, implementation and setting—which interact with one another and with the intervention dimension.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Findingnone givenA certain degree of adaptation with regard to the domains to be considered in relation to a specific intervention is a strength of the framework.
“A certain degree of adaptation with regard to the domains to be considered in relation to a specific intervention is clearly a strength of the framework.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim.
Findingown dataSetting emerged as an additional and distinct concept of interest, sometimes used synonymously with context.
“Setting—a term that is sometimes used synonymously with context—emerged as an additional and distinct concept of interest.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown dataIn the qualitative review, issues arose in relation to the attribution of text extracts to specific domains (e.g., provider vs. organisational domain).
“In the qualitative review, issues arose in relation to the attribution of text extracts to specific domains (e.g., provider vs. organisational domain).”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Findingnone givenImplementation consists of five domains: implementation theory, process, strategies, agents and outcomes.
“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.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Findingnone givenWhile its generic version does not display relationships, the framework allows for their assessment when applied to a complex intervention.
“While its generic version does not display relationships, the framework allows for their assessment when applied to a complex intervention.”
Quote in the paperSubstantial claimMay combine two claims.
Findingnone givenStudies looking at policy and environmental interventions reported more details on the macro context, while studies evaluating educational, psychoeducational, psychological, social as well as spiritual interventions reported more details on the meso level relating to context or setting.
“While studies looking at policy and environmental interventions reported more details on the macro context, studies evaluating educational, psychoeducational, psychological, social as well as spiritual interventions reported more details on the meso level relating to context or setting.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Findingnone givenThe intervention, informed by theory, lies at the heart of the CICI framework with its reach and effectiveness being affected by context and implementation.
“The intervention, informed by theory, lies at the heart of the CICI framework with its reach and effectiveness being affected by context and implementation.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based).
Findingnone givenThe intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level.
“The intervention and the way it is implemented in a given setting and context can occur on a micro, meso and macro level.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Findingnone givenTools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments.
“Tools to operationalise the framework comprise a checklist, data extraction tools for qualitative and quantitative reviews and a consultation guide for applicability assessments.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataThe revised framework showed good internal coherence and completeness, applicability and user-friendliness and was found to contribute to theory advancement and development.
“Overall, as summarised in Table 3, the revised framework showed good internal coherence and completeness, applicability and user-friendliness and was found to contribute to theory advancement and development.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenThe graphical display arising from the framework's use highlights how dimensions and domains interact within a complex system.
“Moreover, the graphical display arising from its use highlights how dimensions and domains interact within a complex system.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown dataResearchers considered the framework complete at the level of the domains but not with respect to the aspects covered.
“In relation to completeness, researchers considered the framework complete at the level of the domains but not with respect to the aspects covered.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingreasoningThrough systematic literature searches and concept analysis, the CICI framework builds on previous knowledge and presents a strong theoretical basis; through empirical applications across several distinct complex health interventions, it has proven its value across a range of different methodological approaches.
“Through systematic literature searches and concept analysis, the CICI framework builds on previous knowledge and presents a strong theoretical basis; through empirical applications across several distinct complex health interventions, it has proven its value across a range of different methodological approaches (e.g., qualitative and quantitative systematic reviews, primary qualitative research).”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based).
Findingnone givenNumerous frameworks, theories and models assessing implementation and, to a lesser extent, context have been published over the past decades.
“Numerous frameworks, theories and models assessing implementation and, to a lesser extent, context have been published over the past decades.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown dataIssues identified in scientific articles and grey literature documents could easily be categorised under relevant domains, and the CICI framework facilitated explicit consideration of potential interactions occurring between domains and dimensions and across various levels.
“Issues identified in scientific articles and grey literature documents could easily be categorised under relevant domains, and the CICI framework also facilitated explicit consideration of potential interactions occurring between domains and dimensions and across various levels.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based).
Findingnone givenThe ethical, socio-economic or epidemiological context, concepts that are regularly used in HTA and are known to have a considerable impact on the uptake, reach and effectiveness of an intervention, are rarely considered.
“Moreover, the ethical, socio-economic or epidemiological context, concepts that are regularly used in HTA and are known to have a considerable impact on the uptake, reach and effectiveness of an intervention, are rarely considered.”
Quote in the paperNot a substantial claim- Rests on an assumption: The ethical, socio-economic or epidemiological context have a considerable impact on the uptake, reach and effectiveness of an intervention.
Classified as probably not a substantial claim. May combine two claims.
FindingreasoningAll of these settings involve different implementation agents, require different implementation strategies and allow the assessment of different implementation outcomes.
“All of these settings involve different implementation agents, require different implementation strategies and allow the assessment of different implementation outcomes.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based). May combine two claims.
Findingnone givenThe CICI framework includes step-by-step pragmatic guidance, a generic checklist to be adapted for different purposes and data extraction tools as well as a graphical representation to facilitate its application in practise.
“The CICI framework includes step-by-step pragmatic guidance, a generic checklist to be adapted for different purposes and data extraction tools as well as a graphical representation to facilitate its application in practise.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based). May combine two claims.
Findingnone givenFew of these frameworks address implementation and context in an integrated fashion, and very few offer pragmatic guidance and worked examples of how to apply the framework, theory or model in practise.
“Few of these frameworks address implementation and context in an integrated fashion, and very few offer pragmatic guidance and worked examples of how to apply the framework, theory or model in practise.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingreasoningAs we applied the CFIR and PARiHS to the Air Pollution Act, many relevant aspects of context and implementation were not captured at all, while a substantial proportion of the CFIR and PARiHS domains remained unpopulated.
“Consequently, as we applied the CFIR and PARiHS to the Air Pollution Act, many relevant aspects of context and implementation were not captured at all, while a substantial proportion of the CFIR and PARiHS domains remained unpopulated.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone givenAccording to the feedback received, the CICI framework performed well against seven pre-specified criteria.
“In summary, according to the feedback received, the framework performed well against seven pre-specified criteria.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingreasoningWe had difficulties with applying the CFIR and PARiHS to our intervention of choice, as both assume that those delivering and those receiving the intervention are nested within the organisation implementing the change; consequently, the detailed assessment of context exclusively relates to this organisational context.
“In contrast, we had difficulties with applying the CFIR and PARiHS to our intervention of choice, as both assume that those delivering and those receiving the intervention (e.g., doctors, nurses) are nested within the organisation implementing the change (e.g., hospitals, health centres); consequently, the detailed assessment of context exclusively relates to this organisational context.”
Quote in the paperSubstantial claimMay combine two claims.
Findingown dataPreviously published theories, frameworks or models, as identified from our systematic searches, are based on different theoretical underpinnings, although these are often not made explicit.
“Previously published theories, frameworks or models, as identified from our systematic searches are based on different theoretical underpinnings, although these are often not made explicit.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationThe effectiveness of complex interventions, and their success in reaching all relevant target populations, is critically influenced by their implementation in a given context; effectiveness, implementation and context are inextricably linked.
“The effectiveness of complex interventions, as well as their success in reaching all relevant target populations, is critically influenced by their implementation in a given context; indeed, effectiveness, implementation and context are inextricably linked [1, 2].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [1] Waters E, Hall BJ, Armstrong R, Doyle J, Pettman TL, de Silva-Sanigorski A. Essential components of public health evidence reviews: capturing intervention complexity, implementation, economics and equity. J Public Health (Oxf). 2011;33:462–5. source
Not checked in the free run.
- cites [2] Wells M, Williams B, Treweek S, Coyle J, Taylor J. Intervention description is not enough: evidence from an in-depth multiple case study on the untold role and impact of context in randomised controlled trials of seven complex interventions. Trials. 2012;13:95. source
Not checked in the free run.
May combine two claims.
InterpretationreasoningThe 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.
“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.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationAn implementation effort can be promoted and facilitated by single implementation leaders and/or implementation teams.
“An implementation effort can be promoted and facilitated by single implementation leaders [14, 15] and/or implementation teams [82].”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [14] Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4. source
Not checked in the free run.
- cites [15] Greenhalgh T, Robert G, Macfarlane F, Bate P, Kyriakidou O. Diffusion of Innovations in Service Organizations: systematic review and recommendations. Milbank Q. 2004;82:581–629. source
Not checked in the free run.
- cites [82] Metz A, Bartley L. Active implementation frameworks for program success. Zero to One. 2012;32:11–8.
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
InterpretationcitationThe CICI framework is likely to be equally relevant for primary research.
“However, given that primary research, evidence synthesis and evidence-based policy and practise are inextricably linked [32], the framework is likely to be equally relevant for primary research.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductown dataThe searches had not been designed to capture all relevant aspects, which precluded a formal concept analysis.
“Our searches had not been designed to capture all relevant aspects, which precluded a formal concept analysis.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
PremisecitationImplementation is considered to be a process, a constellation of processes, efforts or the means or methods of fitting, assimilating or putting into use an intervention-either evidence-based or theory-based-in an organisation or a setting.
“Implementation is considered to be a process, a constellation of processes, efforts or the means or methods of fitting, assimilating or putting into use an intervention—either evidence-based or theory-based—in an organisation or a setting [14, 30, 31].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [14] Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4. source
Not checked in the free run.
- cites [30] Rabin BA, Brownson RC, Haire-Joshu D, Kreuter MW, Weaver NL. A glossary for dissemination and implementation research in health. J Public Health Manag Pract. 2008;14:117–23. source
Not checked in the free run.
- cites [31] Simpson DD. A framework for implementing sustainable oral health promotion interventions. J Public Health Dent. 2011;71:S84–94. source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe framework was externally peer-reviewed by three experts with intentions to apply the framework.
“At the same time, the framework was externally peer-reviewed by three experts with intentions to apply the framework.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationreasoningThe CICI framework helps to review all sources of complexity in relation to a given intervention and to examine the interactions between them.
“It therefore helps to review all sources of complexity in relation to a given intervention and to examine the interactions between them.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationUses of the terms 'context' and 'implementation' and their meanings vary widely in the health literature, lacking consensual definitions and descriptions as well as clearly delineated boundaries.
“Importantly, uses of the terms ‘context’ and ‘implementation’ and their meanings vary widely in the health literature, lacking consensual definitions and descriptions as well as clearly delineated boundaries.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [13] Kitson A, Harvey G, McCormack B. Enabling the implementation of evidence based practice: a conceptual framework. Quality in Health Care. 1998;7:149–58. source
Not checked in the free run.
- cites [28] McCormack B, Kitson A, Harvey G, Rycroft-Malone J, Titchen A, Seers K. Getting evidence into practice: the meaning of ‘context’. J Adv Nurs. 2002;38:94–104. source
Not checked in the free run.
Classified as probably not a substantial claim.
PremisecitationContext is often used synonymously with setting and environment, embracing static and dynamic aspects as well as the theory underpinning the intervention and its implementation.
“Context is often used synonymously with setting and environment [13, 28], embracing static (e.g., physical environment) and dynamic aspects (e.g., relationships, networks) as well as the theory underpinning the intervention and its implementation [29].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [13] Kitson A, Harvey G, McCormack B. Enabling the implementation of evidence based practice: a conceptual framework. Quality in Health Care. 1998;7:149–58. source
Not checked in the free run.
- cites [28] McCormack B, Kitson A, Harvey G, Rycroft-Malone J, Titchen A, Seers K. Getting evidence into practice: the meaning of ‘context’. J Adv Nurs. 2002;38:94–104. source
Not checked in the free run.
- cites [29] Pawson R, Greenhalgh T, Harvey G, Walshe K. Realist review—a new method of systematic review designed for complex policy interventions. J Health Serv Res Policy. 2005;10 Suppl 1:21–34. source
Not checked in the free run.
May combine two claims.
PremisecitationContext and implementation are rarely assessed in an integrated way, although selected frameworks have attempted to do so.
“The two aspects are rarely assessed in an integrated way, although selected frameworks have attempted to do so (e.g., [14, 27]).”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [14] Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4. source
Not checked in the free run.
- cites [27] Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011;6. source
Not checked in the free run.
Probably not a substantial claim: may not pass S4 (based).
PremisereasoningThese other interventions are likely to influence the reach and effectiveness of the intervention under investigation in a specific setting.
“These other interventions are likely to influence the reach and effectiveness of the intervention under investigation in a specific setting.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningOperationalised as a checklist and/or graphical representation, the CICI framework can help researchers and research organisations to communicate with the policy and practise audiences they intend to reach.
“Operationalised as a checklist and/or graphical representation, the framework can help researchers and research organisations to communicate with the policy and practise audiences they intend to reach.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationMcCormack and colleagues looked at context as part of the PARiHS framework; Squires and colleagues have not yet published their concept analysis.
“McCormack and colleagues looked at context as part of the Promoting Action on Research Implementation in Health Services (PARiHS) framework [37]; Squires and colleagues have not yet published their concept analysis [90].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [37] Pfadenhauer LM, Mozygemba K, Gerhardus A, Hofmann B, Booth A, Lysdahl KB, Tummers M, Burns J, Rehfuess EA. Context and implementation: a concept analysis towards conceptual maturity. Z Evid Fortbild Qual Gesundhwes. 2015;109:103–14. source
Not checked in the free run.
- cites [90] Squires JE, Graham ID, Hutchinson AM, Linklater S, Brehaut JC, Curran J, Ivers N, Lavis JN, Michie S, Sales AE, et al. Understanding context in knowledge translation: a concept analysis study protocol. J Adv Nurs. 2015;71:1146–55. source
Not checked in the free run.
May combine two claims.
PremisecitationPreviously published approaches primarily focus on implementation, although the details of implementation theory, implementation strategy or a comprehensive implementation process are often neglected.
“Previously published approaches primarily focus on implementation, although the details of implementation theory, implementation strategy or a comprehensive implementation process are often neglected (e.g., [14, 53, 84, 85]).”
Quote in the paperSubstantial claim0 of 4 sources checked- cites [14] Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009;4. source
Not checked in the free run.
- cites [53] Aarons GA, Hurlburt M, Horwitz SM. Advancing a conceptual model of evidence-based practice implementation in public service sectors. Adm Policy Ment Health. 2011;38:4–23. source
Not checked in the free run.
- cites [84] May CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, Rapley T, Ballini L, Ong BN, Rogers A, et al. Development of a theory of implementation and integration: normalization process theory. Implement Sci. 2009;4. source
Not checked in the free run.
- cites [85] May C. Towards a general theory of implementation. Implement Sci. 2013;8. source
Not checked in the free run.
May combine two claims.
InterpretationreasoningIntegrating insights gained in previously published frameworks, theories or models, the CICI framework adds a macro perspective that seeks to capture all aspects of complex interventions.
“Integrating insights gained in previously published frameworks, theories or models, it adds a macro perspective that seeks to capture all aspects of complex interventions.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
InterpretationreasoningThe CICI framework highlights the breadth and depth of the influence of context from a societal perspective and shows that context can act at one or several different levels (micro, meso and macro), thereby adding granularity and flexibility to the assessment of a complex intervention.
“The CICI framework highlights this breadth and depth of the influence of context from a societal perspective and shows that context can act at one or several different levels (micro, meso and macro), thereby adding granularity and flexibility to the assessment of a complex intervention.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown dataThe authors did not employ any formal method of consensus building, such as a Delphi approach, in developing the CICI framework.
“Importantly, we did not employ any formal method of consensus building, such as a Delphi approach.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationWe are aware of at least two other concept analyses of context.
“We are aware of at least two other concept analyses of context [90].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [90] Squires JE, Graham ID, Hutchinson AM, Linklater S, Brehaut JC, Curran J, Ivers N, Lavis JN, Michie S, Sales AE, et al. Understanding context in knowledge translation: a concept analysis study protocol. J Adv Nurs. 2015;71:1146–55. source
Not checked in the free run.
May combine two claims.
PremisecitationContext often plays a subordinate role; where it is considered explicitly, it is usually restricted to an organisational context.
“Context often plays a subordinate role; where it is considered explicitly, it is usually restricted to an organisational context [27, 44, 91].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [27] Stetler CB, Damschroder LJ, Helfrich CD, Hagedorn HJ. A guide for applying a revised version of the PARIHS framework for implementation. Implement Sci. 2011;6. source
Not checked in the free run.
- cites [44] Kitson AL, Rycroft-Malone J, Harvey G, McCormack B, Seers K, Titchen A. Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implementation science : IS. 2008;3:1–1. source
Not checked in the free run.
- cites [91] Rycroft-Malone J, Seers K, Chandler J, Hawkes CA, Crichton N, Allen C, Bullock I, Strunin L. The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework. Implement Sci. 2013;8. source
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
PremisecitationIt is impossible to look for and discover everything.
“while keeping in mind that it is impossible to look for and discover everything [99].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [99] Peters M, Harmsen M, Laurant M, Wensing M. Ruimte voor verandering? Knelpunten en mogelijkheden voor verbeteringen in de patiëntenzorg [Room for improvement? Barriers to and facilitators for improvement of patient care]. Nijmegen: Centre for Quality of Care Research (WOK), Radboud University Nijmegen Medical Centre; 2002.
Not checked in the free run.
May combine two claims.
InterpretationreasoningFor public health/complex interventions, there is often an organisational or even sectoral disconnection between the implementing organisation(s) and those receiving the intervention, and context is concerned with the society at large.
“Instead, for public health/complex interventions, there is often an organisational or even sectoral disconnection between the implementing organisation(s) and those receiving the intervention, and context is concerned with the society at large.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone givenThe CICI framework pays tribute to competing interventions that might have a considerable impact on the uptake, reach and effectiveness of the intervention being investigated.
“Lastly, the CICI framework pays tribute to competing interventions that might have a considerable impact on the uptake, reach and effectiveness of the intervention being investigated.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductreasoningThe setting dimension of the CICI framework is less well conceptualised, mostly because the search strategy was designed to yield insights into the concepts of context and implementation.
“It must also be noted that the setting dimension is less well conceptualised, mostly because our search strategy was designed to yield insights into the concepts of context and implementation.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitationA limitation of the searches is the lack of explicit searches in databases of management and organisational studies.
“Some limitations pertaining to the searches are described elsewhere, for example the lack of explicit searches in databases of management and organisational studies [37].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [37] Pfadenhauer LM, Mozygemba K, Gerhardus A, Hofmann B, Booth A, Lysdahl KB, Tummers M, Burns J, Rehfuess EA. Context and implementation: a concept analysis towards conceptual maturity. Z Evid Fortbild Qual Gesundhwes. 2015;109:103–14. source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe literature tends to conceptualise setting as having physical boundaries, which may fall short of acknowledging developments during the last decade such as telemedicine and Internet- or smart phone-based interventions.
“While the literature tends to conceptualise setting as having physical boundaries [98], this may fall short of acknowledging developments during the last decade (e.g., telemedicine, Internet- or smart phone-based interventions).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [98] World Health Organization, Division of Health Promotion Education and Communication. Health promotion glossary. Geneva: World Health Organization; 1998.
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningThe CICI framework constitutes one way of structuring this complexity in order to advance our understanding of whether and how interventions work.
“The CICI framework constitutes one way of structuring this complexity in order to advance our understanding of whether and how interventions work, while keeping in mind that it is impossible to look for and discover everything [99].”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationreasoningIn moving beyond the organisational context, the framework is particularly suitable for public health and other interventions that are assessed or analysed on a macro level or on several levels concurrently.
“In moving beyond the organisational context, the framework is particularly suitable for public health and other interventions that are assessed or analysed on a macro level or on several levels concurrently.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based). May combine two claims.
Interpretationnone givenComplexity is not only inherent in the intervention but also a consequence of interactions between the intervention and its implementation in context.
“Complexity is not only inherent in the intervention but also a consequence of interactions between the intervention and its implementation in context.”
Quote in the paperNot a substantial claim- Rests on an assumption: An intervention and its implementation interact in multiple ways within any given setting and context, with these interactions taking place at multiple levels.
May combine two claims.
InterpretationreasoningThe CICI framework can serve both as a determinant framework that seeks to conceptualise, describe and understand the multiple influences on implementation outcomes, and as an evaluation framework that clarifies the context, setting and implementation aspects to be assessed when examining implementation success or lack thereof.
“It can serve both as a determinant framework that seeks to conceptualise, describe and understand the multiple influences on implementation outcomes, and as an evaluation framework that clarifies the context, setting and implementation aspects to be assessed when examining implementation success or lack thereof.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningTo our knowledge, the CICI framework is the first attempt to provide guidance for assessing setting, context and implementation of complex interventions in a comprehensive manner, for integrating the views of different disciplines and for adapting a concept of context that is embedded in a broad public health perspective rather than a narrower organisational perspective.
“To our knowledge, the CICI framework is the first attempt to provide guidance for assessing setting, context and implementation of complex interventions in a comprehensive manner, for integrating the views of different disciplines (economics, ethics, sociology, law) and for adapting a concept of context that is embedded in a broad public health perspective rather than a narrower organisational”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductnone givenThe latest version of the CICI framework has not yet been fully tested.
“A limitation is, however, that the latest version of the framework has not yet been fully tested.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationOver the last few decades, considerable work has been undertaken to elaborate and define elements of organisational context as well as behaviours that influence an implementation effort.
“Over the last few decades, considerable work has been undertaken to elaborate and define elements of organisational context as well as behaviours that influence an implementation effort (REFS).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites REFS
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.
InterpretationreasoningThe CICI framework can serve as a comprehensive starting point for examining context and implementation; where useful, granularity within specific domains can be added by bringing in insights from previously published frameworks.
“In this way, the CICI framework can serve as a comprehensive starting point for examining context and implementation; where useful, granularity within specific domains can be added by bringing in insights from previously published frameworks.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationreasoningWhile developed primarily for evidence synthesis, the usefulness of the CICI framework depends on the evidence available.
“Finally, while developed primarily for evidence synthesis, the usefulness of the framework depends on the evidence available.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductreasoningThe combination of systematic searches to identify existing frameworks, theories and models of context and implementation and formal methods to derive definitions and detailed characteristics of the relevant concepts provides a strong theoretical basis for the CICI framework and constitutes one of its major strengths.
“The combination of systematic searches to identify existing frameworks, theories and models of context and implementation and formal methods to derive definitions and detailed characteristics of the relevant concepts provides a strong theoretical basis for the CICI framework and constitutes one of its major strengths.”
Quote in the paperSubstantial claim
The paper relies on this without support.
Many existing frameworks, theories and models are specific rather than generic, e.g., focussing only on organisational context, and therefore do not lend themselves to application across diverse health interventions.
“Moreover, many of these frameworks, theories and models are specific rather than generic, e.g., focussing only on organisational context, and therefore do not lend themselves to application across diverse health interventions.”
The paper relies on this without support.
Few existing frameworks appear suitable for use within systematic reviews and HTAs.
“Furthermore, few of these frameworks appear suitable for use within systematic reviews and HTAs.”
The paper relies on this without support.
Many existing frameworks, models and theories are relatively abstract in nature and lack guidance on how to operationalise them in practise.
“Indeed, many of these frameworks, models and theories are relatively abstract in nature and lack guidance on how to operationalise them in practise.”
The paper relies on this without support.
Context, implementation and the intervention interact with one another and often co-evolve over time in a setting.
“In the setting dimension, context, implementation and the intervention, which are described according to intervention theory, design and delivery characteristics [46], interact with one another and often co-evolve over time.”
The paper relies on this without support.
Interventions are typically implemented simultaneously within different settings and at multiple levels.
“Interventions are typically implemented simultaneously within different settings and at multiple levels.”
The paper relies on this without support.
The ethical, socio-economic or epidemiological context have a considerable impact on the uptake, reach and effectiveness of an intervention.
“Moreover, the ethical, socio-economic or epidemiological context, concepts that are regularly used in HTA and are known to have a considerable impact on the uptake, reach and effectiveness of an intervention, are rarely considered.”
The paper relies on this without support.
An intervention and its implementation interact in multiple ways within any given setting and context, with these interactions taking place at multiple levels.
“As stated repeatedly throughout this paper, an intervention and its implementation interact in multiple ways within any given setting and context, with these interactions taking place at multiple levels.”
The paper relies on this without support.
The success in populating the dimensions and domains of the CICI framework with evidence critically depends on detailed assessment and reporting of information in primary studies.
“The success in populating the dimensions and domains of the CICI framework with evidence critically depends on detailed assessment and reporting of information in primary studies.”
The paper relies on this without support.
Many widely used reporting guidelines acknowledge context but most only require researchers to report on the setting.
“While many of the widely used reporting guidelines, such as STROBE, SQUIRE, TREND and the extension of CONSORT for Pragmatic Trials, acknowledge context, most only require researchers to report on the setting.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Effectiveness of healthcare interventions such as bubble CPAP is critically influenced by the context in which they are delivered.
“Effectiveness of healthcare interventions such as bubble CPAP is critically influenced by the context in which these interventions are being delivered [14].”
From Barriers and enablers of implementing bubble Continuous Positive Airway Pressure (CPAP): Perspectives of health professionals in Malawi (2020) · cites this paper as [14]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Four context domains are described as three
MinorThe parenthetical list names four domains, contradicting the stated count of three.
“under three context domains”
“(geographical, political, ethical and socio-economic)”
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BackgroundMaking sense of implementation theories, models and frameworks
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Theories of the Policy Process
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Changing Behavior Using Ecological Models
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Development of an integrative coding framework for evaluating context within implementation science
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- Authors
- Pfadenhauer, L. M., Gerhardus, A., Mozygemba, K., Lysdahl, K. B., Booth, A., Hofmann, B., Wahlster, P., Polus, S., Burns, J., Brereton, L., & Rehfuess, E.
- Affiliations
- Ludwig-Maximilians-Universität München (DE)
- University of Bremen (DE)
- University of Oslo (NO)
- University of Sheffield (GB)
- Corresponding author
- Pfadenhauer, Lisa M.
- ORCID
- Venue
- Implementation Science
- Published
- 2017-02-15
- Volume
- 12
- Issue
- 1
- Pages
- 21-21
- ISSN
- 1748-5908 (ISSN-L)
- PMC
- PMC5312531
- OpenAlex
- W2588392437
- Semantic Scholar
- 141e96cb1d6c8ef8f904f5f1d32a0ff22718e8f1
- Cited by
- 1,016
- References
- 99
- Citations by year
- 2026: 91 · 2025: 112 · 2024: 153 · 2023: 108 · 2022: 148 · 2021: 125 · 2020: 151 · 2019: 66 · 2018: 45 · 2017: 15 · 2016: 2
- FWCI
- 13.33
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Implementation Science (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion)
- Open access LMU (Ludwid Maxmilian's Universitat Munchen) (submittedVersion)
- NORA - Norwegian Open Research Archives (submittedVersion, cc-by)
- Zenodo (CERN European Organization for Nuclear Research) (submittedVersion, cc-by)
- Funders
- Seventh Framework Programme (306141)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Social Sciences › Decision Sciences › Management Science and Operations Research › Evaluation and Performance Assessment
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Keywords
- complex interventions, context, implementation, conceptual framework, implementation theory, setting, applicability assessment, health technology assessment, intervention effectiveness, stakeholder communication
- MeSH terms
- Bioethics, Diffusion of Innovation, Health Policy, Legislation as Topic, Socioeconomic Factors, Technology Assessment, Biomedical, Organizational Culture, Checklist
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-06.
Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-06.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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