A Guide for applying a revised version of the PARIHS framework for implementation

1In October 2010, a critical synthesis of literature on the use of the Promoting Action on Research Implementation in Health Services (PARIHS) framework was published in Implementation Science. PARIHS is a widely cited conceptual framework that conceives of three key, interacting elements that influence successful implementation of evidence-based practices (EBPs): Evidence (E), Context (C), and Facilitation (F). The literature synthesis identified key strengths and issues as regards the framework.

2A subgroup of the synthesis authors drew upon the above results to revise PARIHS for use by researchers in the Veteran's Health Administration (VA); that is, in trials or evaluations focused on implementation of targeted EBPs. A companion document, or Guide, also was developed to provide direction on how this revised version could be operationalized. Together, the framework modifications and Guide addressed barriers to the use of PARIHS previously encountered by VA researchers, in part due to the framework's limitations. It is important to note that although we propose a number of revisions and comment on how best to use PARIHS, we have built on the original work of the PARIHS team; and while we have shared our work with members of that team, this version of PARIHS and our related Guide were developed independently. It does not necessarily reflect the PARIHS team's views. This work further reflects our efforts to operationalize the PARIHS framework based on our VA research context, our VA experience with PARIHS, and our critical review. Were others to follow the same process, they might come to different interpretations and conclusions.

3Our Guide is intended to enhance and optimize the efforts of those choosing to use PARIHS as their theoretical framework. It is designed to enable users to more clearly and consistently define and apply relevant terms. Further, it is designed to facilitate diagnostic analysis of framework elements, selection of an appropriate implementation strategy, and measurement of Successful Implementation. It is hoped that similar syntheses and guides will be developed for other implementation theories, models, and frameworks. Within the VA, where no single theory takes precedence over any other, efforts are underway to enhance operationalization of other frameworks and models by mapping their elements to constructs identified through a Consolidated Framework for Implementation Research (CFIR).

4Since the intent of this paper is to provide others interested in using PARIHS with tool-based, practical guidance, we rely heavily on additional files. These files equip users of the framework with the following: a set of definitions for elements/sub-elements, tips in the form of observations about use of elements/sub-elements, and a set of questions for diagnostic analysis and planning. All of the separate components of the actual Guide are contained in additional files (see Additional Files 1, 2, 3 and 4). The main narrative provides only overview information and pointers regarding various Guide components. Specifically, this overview briefly describes the basic underlying PARIHS framework, its limitations and related issues, the structured process and frames of reference used to identify modifications and create the Guide, and the revisions to the original framework. It also provides sample material from additional files to give readers a better feel for their content and potential usefulness.

5PARIHS can be characterized as an impact or explanatory framework, originally developed in 1998 and refined over time based on concept analyses and exploratory research.

6Before using our Guide, it is important that users be familiar with the underlying framework of PARIHS (e.g., see Rycroft-Malone et al. for a recent depiction of the framework, including its key sub-elements and explanatory material; also see Kitson et al.'s discussion regarding theoretical issues in general and PARIHS' status specifically, noting the potential diagnostic and evaluative questions they provide in a related appendix). Another, more recent publication provides an overview of the framework, its underlying assumptions, developmental work, and its use by others. Key aspects of the PARIHS framework are herein summarized in Table 1. Figure 1 outlines the sub-elements of each of the core elements, as described in the PARIHS team's 2004 refinement.

7In summary, PARIHS can be selected as a broad framework to guide development of a program of implementation interventions that effectively enable EBP-related changes. Specifically, it can be used to diagnose critical elements related to implementation of an EBP (E and C) and thence development of an implementation strategy (F) to enable successful and sustained change. A PARIHS-based diagnostic analysis can additionally engage stakeholders in self-reflection regarding critical aspects of implementation and the related nature of needed change.

8Strengths of the PARIHS framework identified through our published synthesis included the following: its intuitive appeal, provision of a basic "to-do" list, flexibility in application, and inclusion of Successful Implementation as the desired outcome. Of particular importance to development of the Guide were its identified limitations and related issues. These included the following, which are further described in Table 2:

9• Lack of conceptual clarity, specificity, and transparency, which results in different interpretations of PARIHS concepts by different researchers

10• Lack of inclusion of relevant elements perceived to be critical to implementation and congruent with the main intent of PARIHS

11• Lack of well-developed instrumentation and evaluation measures, as well as limited evaluation of actual use or perceived usefulness of the framework.

12No published studies were identified that used the framework comprehensively and prospectively to develop an implementation project. The ability to fully evaluate its usefulness thus has been limited.

13Our objective in developing the Guide was to meet the needs of VA researchers interested in understanding the nuts and bolts of operationalizing PARIHS. More specifically, our objective was two-fold: (1) provide guidance on how best to apply/operationalize the framework within QUERI's [Quality Enhancement Research Initiative] action-oriented approach and (2) enable more effective use of the framework by addressing identified barriers (Table 2). (Note: Italicized sentences here and in the next section come from our internal PARIHS synthesis/application project plan.)

14Given this practical need, after completion of the synthesis groundwork, the authors used a planned, structured process to organize and bring together into a coherent whole the substance of our critiques, related discussions, and potential recommendations for refinements/adaptations of the PARIHS framework--for use within the context of QUERI-like implementation projects. Specifically, the authors did the following:

151) Utilizing finalized critiques from the published synthesis, each author independently recorded key components for each reviewed paper on a templated form. This form focused on the study's definition of elements, perceived strengths/limitations of PARIHS highlighted by the study, other observations regarding key PARIHS issues, and recommendations regarding refinements consistent with the intent of the basic framework... in light of the QUERI framework, QUERI experience and current science.

162) Each author independently reviewed selected components of two other published syntheses that analyzed the concept of Context.

173) As a group, the authors critically reviewed, discussed, and themed the above information at a two-day intensive face-to-face meeting.)

184) As a group, the authors reached consensus on the above key components, including the clarity/lack of clarity of language found in various definitions, and then identified opportunities to improve the framework.

19Information from step 4 was used to draft a Guide. Critical to this draft was the original PARIHS framework, primarily its two most recent versions and the 2008 paper and Appendix. Feedback was obtained from VA implementation researchers and others familiar with PARIHS, and minor refinements made.

20Critical to understanding the general implementation approach embedded within this Guide is the nature of QUERI's action-oriented paradigm. This implementation/research paradigm served as an implicit background or frame of reference for overall author deliberations. It distinguishes two general types of implementation situations and emphasizes a set of innovative concepts.

21We distinguish two general types of implementation situations:

22• one with a task-oriented purpose, where a specific intervention is being implemented within a relatively short timeframe (such as implementing a new procedure or care process)

23• one with a broader "organizational" purpose, where implementation strategies are targeted at transformational change within one or more levels of an institution (such as changing culture to be more receptive to using EBPs on a routine basis).

24The primary focus of QUERI projects, and thus the purpose of this Guide, is to assist with more short-term, targeted EBP implementation studies with a strong task orientation. We highlight this distinction because it influenced how we approached framework refinements and identified observations/tips in the reference tools.

25In short-term, task-oriented situations, implementation efforts are unlikely to target broad changes in the multiple sub-elements related to culture, evaluation, or leadership. We therefore focused on defining and highlighting only those aspects of PARIHS elements that might realistically be modified in a relatively short period of time.

26It is important to further distinguish our use of the terms task versus organizational purpose from the PARIHS framework's approach to Facilitation. The latter envisages the purpose of Facilitation to occur along a continuum from primarily "task" to "holistic." The former focuses on "a 'doing for others' role... [and is] more discrete, practical, technical and task driven," while the latter focuses on "an 'enabling and empowering' role which is more developmental". In most cases, task-oriented EBP implementation situations will rely more heavily on task-focused or "mixed" Facilitation methods; on the other hand, transformational initiatives that have an organizational redesign goal will rely more heavily on holistic Facilitation.

27As QUERI developed over time, a set of concepts guided its implementation research activities. Some of these concepts relate to QUERI innovations or contributions, others to the Stetler model of EBP, and yet others to the general implementation science literature spanning the last decade. Such concepts include, for example, strength of evidence, theoretical underpinnings, attributes of innovations, appropriate variation and qualifiers for use of evidence, social marketing and other recognized implementation interventions, sustainability, cost considerations for implementation, and critical leadership behaviors. Such concepts were familiar to the authors, were implicitly part of our decision-making, and ultimately influenced our development of the Guide's content in general and construction of the files' "Related Observations/Tips" most specifically.

28Based on the above process and frames of reference, a number of modifications were made to the original PARIHS framework. Emphasis was placed on modifiable sub-elements or ones that might be buffered to reduce negative influences. This revised version of PARIHS is outlined in Table 3. Of particular note are the following:

29• Changes were made both to wording and ordering of a few elements/sub-elements, as can be seen in comparing Table 3 to Figure 1. For example, the name of the Context element was amended (Contextual Readiness for Targeted EBP Implementation) to clearly indicate our task-oriented focus; and Leadership became the first sub-element under Context, indicating its prime importance in implementation. Nonetheless, it is important to note that the original PARIHS sub-elements of transformational leadership are still reflected within the Guide (e.g., role clarity and effective teamwork).

30• A few items were added to core elements to reflect relevant features critical to implementation but missing from the framework (Table 2); for example, EBP Characteristics within Evidence now highlights attributes of an implementable form of "evidence" (i.e., the full form of an "EBP" innovation, such as a policy, procedure, or program). These additions were drawn from Roger's diffusion of innovation work and the CFIR. Some of these additions were already implicit within other Evidence sub-elements. As a result there may appear to be some overlap. However, these attributes were considered important enough to be expanded and made explicit, thus ensuring their consideration. This is particularly important because implementation decisions flow first from the nature of the implementable form of the Evidence and its characteristics.

31Additionally, for Facilitation, implementation interventions beyond that of a facilitator role were inserted. This modification speaks in part to the 2008 PARIHS paper's comment regarding development of a "programme of change," that is, "task based, planned change programme approaches that meet the individual and team's learning needs...."--and, we would add, that meet contextual needs identified through diagnostic analysis. As these programmes of change are likely to require "a range of different techniques", we now make such techniques more explicit. This ties "Facilitation as an intervention" to implementation interventions in general, which facilitators and others employ to enhance adoption.

32• Successful Implementation is now visualized as an explicit part of the revised PARIHS "figure" (Table 3), with detailed definitions provided in the Guide (Additional File 4). This first effort at explicating the meaning of Successful Implementation is only preliminary and will benefit from ongoing attempts to operationalize it.

33Finally, based on our synthesis, our frames of reference, and our framework modifications, we were able to construct a Guide (Table 4). Again, its intent is to enhance and optimize efforts of those using PARIHS as their theoretical framework. Within the Guide, the team used active, pragmatic language for each element/sub-element--and, again, tied these changes to the original PARIHS framework material and its perceived intent. Such language focuses on recognizable, measurable behaviors and minimizes what to us was abstract language less familiar to our researchers. The content of all additional files provides the following:

34• Conceptual and operational definitions: This includes refined meanings of constructs within the framework, reflecting the team's interpretation of each element and related sub-element. These definitions are intended to facilitate in-depth understanding of each concept, guide application of the various elements, and identify potential questions for diagnostic analysis and planning.

35• Observations and tips: This additional information, from the implementation literature and authors' experiences, is designed to enhance researchers' nuanced understanding of PARIHS elements/sub-elements. Tips also may facilitate design decisions.

36As stated previously, the material contained across the additional files (i.e., the revised PARIHS Guide) is the meat of this publication. It is intended to be used as an active reference tool for planning implementation research and evaluation. Tables 5, 6 and 7 provide the reader with a preview of these reference tools. Table 5 points out how we describe the potential use of an individual tool; Table 6 illustrates our approach to defining each of the core elements; and Table 7 demonstrates how an individual sub-element is presented in terms of its definitions, tips on use, and measurement.

37Based on a systematic, structured process, the authors have revised PARIHS and provided a detailed reference Guide to help researchers apply this framework. When using the Guide, readers should keep the following points in mind:

38• The Guide relies on basic elements of PARIHS, as well as updates provided in Kitson and colleagues' 2008 paper and its appendix, specifically its diagnostic approach.

39• A key revision objective was to minimize the original framework's limitations and related issues (Table 2).

40• Our modifications are consistent with the general nature and intent of the PARIHS framework.

41• Basic expectations for applying any framework, theory, or model were a guiding influence, that is, the need for clear conceptual and operational definitions, measurement approaches, and additional practical information about the realities of application.

42• QUERI frames of reference and concepts affected development of Guide content, as did supplemental information from complementary theories such as Rogers, the Stetler model of EBP, and other selected concepts from implementation science. Modifications are thus responsive to the PARIHS team's suggestion to draw on other theoretical perspectives; for example, "What theories would inform the way evidence has been conceptualized within the PARIHS framework?"

43• The implementation knowledge and experience-based lessons of the author team (published implementation scientists in the VA) influenced consensual judgments underlying the Guide.

44• Our addition of "other implementation interventions" to the Facilitation element draws, in part, from a QUERI evaluation on facilitation wherein data suggested the following: "external facilitators were likely to use or integrate other implementation interventions, while performing this problem-solving and supportive role".

45The Guide has been disseminated within the VA as a resource for implementation scientists. Individuals familiar to the authors (personal communications) have reported using the modified framework in their studies or intending to put it to use in the near future. Such uses included the following:

46• Guiding new investigators looking for "theoretical" assistance

47• Simplifying selection of diagnostic/evaluative questions relevant to a targeted EBP, followed by organization of those questions into a semi-structured interview

48• Defining specifics of an external facilitation intervention (e.g., the level of interaction and type of external facilitator needed), thus making formative evaluation easier

49• Facilitating thinking about what Successful Implementation would look like in a study and how that would be measured

50• Assisting in the preparation of a proposal wherein use of a theoretical framework and related design decisions could more clearly be explained to reviewers.

51In conclusion, the PARIHS synthesis paper suggested that "the single greatest need for researchers using PARIHS, and other implementation models, is to use the framework prospectively and comprehensively, and evaluate that use relative to its perceived strengths and issues for enhancing successful implementation". Those using this manuscript to either implement a targeted EBP or study such an implementation thus are encouraged to use the Guide prospectively/comprehensively and to evaluate its use. Formal evaluations and critical reflections regarding the usefulness and limitations of our revised PARIHS and Guide could thereby promote continued evolution of this promising framework.

52The authors declare that they have no competing interests.

53CBS conceived the design of a Guide and drafted both the initial manuscript and Guide. All authors contributed to development of its content, reviewed drafts, and provided major input and revisions. All authors approved the final manuscript.