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Background The theoretical framework of acceptability (TFA) was developed in response to recommendations that acceptability should be assessed in the design, evaluation and implementation phases of healthcare interventions. The TFA consists of seven component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy) that can help to identify characteristics of interventions that may be improved. The aim of this study was to develop a generic TFA questionnaire that can be adapted to assess acceptability of any healthcare intervention. Methods Two intervention-specific acceptability questionnaires based on the TFA were developed using a 5-step pre-validation method for developing patient-reported outcome instruments: 1) item generation; 2) item de-duplication; 3) item reduction and creation; 4) assessment of discriminant content validity against a pre-specified framework (TFA); 5) feedback from key stakeholders. Next, a generic TFA-based questionnaire was developed and applied to assess prospective and retrospective acceptability of the COVID-19 vaccine. A think-aloud method was employed with two samples: 10 participants who self-reported intention to have the COVID-19 vaccine, and 10 participants who self-reported receiving a first dose of the vaccine. Results 1) The item pool contained 138 items, identified from primary papers included in an overview of reviews. 2) There were no duplicate items. 3) 107 items were discarded; 35 new items were created to maximise coverage of the seven TFA constructs. 4) 33 items met criteria for discriminant content validity and were reduced to two intervention-specific acceptability questionnaires, each with eight items. 5) Feedback from key stakeholders resulted in refinement of item wording, which was then adapted to develop a generic TFA-based questionnaire. For prospective and retrospective versions of the questionnaire, no participants identified problems with understanding and answering items reflecting four TFA constructs: affective attitude, burden, perceived effectiveness, opportunity costs. Some participants encountered problems with items reflecting three constructs: ethicality, intervention coherence, self-efficacy. Conclusions A generic questionnaire for assessing intervention acceptability from the perspectives of intervention recipients was developed using methods for creating participant-reported outcome measures, informed by theory, previous research, and stakeholder input. The questionnaire provides researchers with an adaptable tool to measure acceptability across a range of healthcare interventions.

Background It is increasingly acknowledged that ‘acceptability’ should be considered when designing, evaluating and implementing healthcare interventions. However, the published literature offers little guidance on how to define or assess acceptability. The purpose of this study was to develop a multi-construct theoretical framework of acceptability of healthcare interventions that can be applied to assess prospective (i.e. anticipated) and retrospective (i.e. experienced) acceptability from the perspective of intervention delivers and recipients. Methods Two methods were used to select the component constructs of acceptability. 1) An overview of reviews was conducted to identify systematic reviews that claim to define, theorise or measure acceptability of healthcare interventions. 2) Principles of inductive and deductive reasoning were applied to theorise the concept of acceptability and develop a theoretical framework. Steps included (1) defining acceptability; (2) describing its properties and scope and (3) identifying component constructs and empirical indicators. Results From the 43 reviews included in the overview, none explicitly theorised or defined acceptability. Measures used to assess acceptability focused on behaviour (e.g. dropout rates) (23 reviews), affect (i.e. feelings) (5 reviews), cognition (i.e. perceptions) (7 reviews) or a combination of these (8 reviews). From the methods described above we propose a definition: Acceptability is a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention. The theoretical framework of acceptability (TFA) consists of seven component constructs: affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy. Conclusion Despite frequent claims that healthcare interventions have assessed acceptability, it is evident that acceptability research could be more robust. The proposed definition of acceptability and the TFA can inform assessment tools and evaluations of the acceptability of new or existing interventions.

Background Implementation research may play an important role in reducing research waste by identifying strategies that support translation of evidence into practice. Implementation of healthcare interventions is influenced by multiple factors including the organisational context, implementation strategies and features of the intervention as perceived by people delivering and receiving the intervention. Recently, concepts relating to perceived features of interventions have been gaining traction in published literature, namely, acceptability, fidelity, feasibility, scalability and sustainability. These concepts may influence uptake of healthcare interventions, yet there seems to be little consensus about their nature and impact. The aim of this paper is to develop a testable conceptual framework of implementability of healthcare interventions that includes these five concepts. Methods A multifaceted approach was used to develop and refine a conceptual framework of implementability of healthcare interventions. An overview of reviews identified reviews published between January 2000 and March 2021 that focused on at least one of the five concepts in relation to a healthcare intervention. These findings informed the development of a preliminary framework of implementability of healthcare interventions which was presented to a panel of experts. A nominal group process was used to critique, refine and agree on a final framework. Results A total of 252 publications were included in the overview of reviews. Of these, 32% were found to be feasible, 4% reported sustainable changes in practice and 9% were scaled up to other populations and/or settings. The expert panel proposed that scalability and sustainability of a healthcare intervention are dependent on its acceptability, fidelity and feasibility. Furthermore, acceptability, fidelity and feasibility require re-evaluation over time and as the intervention is developed and then implemented in different settings or with different populations. The final agreed framework of implementability provides the basis for a chronological, iterative approach to planning for wide-scale, long-term implementation of healthcare interventions. Conclusions We recommend that researchers consider the factors acceptability, fidelity and feasibility (proposed to influence sustainability and scalability) during the preliminary phases of intervention development, evaluation and implementation, and iteratively check these factors in different settings and over time.

Background Designing implementation interventions to change the behaviour of healthcare providers and other professionals in the health system requires detailed specification of the behaviour(s) targeted for change to ensure alignment between intervention components and measured outcomes. Detailed behaviour specification can help to clarify evidence-practice gaps, clarify who needs to do what differently, identify modifiable barriers and enablers, design interventions to address these and ultimately provides an indicator of what to measure to evaluate an intervention’s effect on behaviour change. An existing behaviour specification framework proposes four domains (Target, Action, Context, Time; TACT), but insufficiently clarifies who is performing the behaviour (i.e. the Actor). Specifying the Actor is especially important in healthcare settings characterised by multiple behaviours performed by multiple different people. We propose and describe an extension and re-ordering of TACT to enhance its utility to implementation intervention designers, practitioners and trialists: the Action, Actor, Context, Target, Time (AACTT) framework. We aim to demonstrate its application across key steps of implementation research and to provide tools for its use in practice to clarify the behaviours of stakeholders across multiple levels of the healthcare system. Methods and results We used French et al.’s four-step implementation process model to describe the potential applications of the AACTT framework for (a) clarifying who needs to do what differently, (b) identifying barriers and enablers, (c) selecting fit-for-purpose intervention strategies and components and (d) evaluating implementation interventions. Conclusions Describing and detailing behaviour using the AACTT framework may help to enhance measurement of theoretical constructs, inform development of topic guides and questionnaires, enhance the design of implementation interventions and clarify outcome measurement for evaluating implementation interventions.

Behaviour change is key to increasing the uptake of evidence into healthcare practice. Designing behaviour-change interventions first requires problem analysis, ideally informed by theory. Yet the large number of partly overlapping theories of behaviour makes it difficult to select the most appropriate theory. The need for an overarching theoretical framework of behaviour change was addressed in research in which 128 explanatory constructs from 33 theories of behaviour were identified and grouped. The resulting Theoretical Domains Framework (TDF) appears to be a helpful basis for investigating implementation problems. Research groups in several countries have conducted TDF-based studies. It seems timely to bring together the experience of these teams in a thematic series to demonstrate further applications and to report key developments. This overview article describes the TDF, provides a brief critique of the framework, and introduces this thematic series. In a brief review to assess the extent of TDF-based research, we identified 133 papers that cite the framework. Of these, 17 used the TDF as the basis for empirical studies to explore health professionals’ behaviour. The identified papers provide evidence of the impact of the TDF on implementation research. Two major strengths of the framework are its theoretical coverage and its capacity to elicit beliefs that could signify key mediators of behaviour change. The TDF provides a useful conceptual basis for assessing implementation problems, designing interventions to enhance healthcare practice, and understanding behaviour-change processes. We discuss limitations and research challenges and introduce papers in this series.

Background Providing health professionals with quantitative summaries of their clinical performance when treating specific groups of patients (“feedback”) is a widely used quality improvement strategy, yet systematic reviews show it has varying success. Theory could help explain what factors influence feedback success, and guide approaches to enhance effectiveness. However, existing theories lack comprehensiveness and specificity to health care. To address this problem, we conducted the first systematic review and synthesis of qualitative evaluations of feedback interventions, using findings to develop a comprehensive new health care-specific feedback theory. Methods We searched MEDLINE, EMBASE, CINAHL, Web of Science, and Google Scholar from inception until 2016 inclusive. Data were synthesised by coding individual papers, building on pre-existing theories to formulate hypotheses, iteratively testing and improving hypotheses, assessing confidence in hypotheses using the GRADE-CERQual method, and summarising high-confidence hypotheses into a set of propositions. Results We synthesised 65 papers evaluating 73 feedback interventions from countries spanning five continents. From our synthesis we developed Clinical Performance Feedback Intervention Theory (CP-FIT), which builds on 30 pre-existing theories and has 42 high-confidence hypotheses. CP-FIT states that effective feedback works in a cycle of sequential processes; it becomes less effective if any individual process fails, thus halting progress round the cycle. Feedback’s success is influenced by several factors operating via a set of common explanatory mechanisms: the feedback method used, health professional receiving feedback, and context in which feedback takes place. CP-FIT summarises these effects in three propositions: (1) health care professionals and organisations have a finite capacity to engage with feedback, (2) these parties have strong beliefs regarding how patient care should be provided that influence their interactions with feedback, and (3) feedback that directly supports clinical behaviours is most effective. Conclusions This is the first qualitative meta-synthesis of feedback interventions, and the first comprehensive theory of feedback designed specifically for health care. Our findings contribute new knowledge about how feedback works and factors that influence its effectiveness. Internationally, practitioners, researchers, and policy-makers can use CP-FIT to design, implement, and evaluate feedback. Doing so could improve care for large numbers of patients, reduce opportunity costs, and improve returns on financial investments. Trial registration PROSPERO, CRD42015017541

Background Decreasing ineffective or harmful healthcare practices (de-implementation) may require different approaches than those used to promote uptake of effective practices (implementation). Few psychological theories differentiate between processes involved in decreasing, versus increasing, behaviour. However, it is unknown whether implementation and de-implementation interventions already use different approaches. We used the behaviour change technique (BCT) taxonomy (version 1) (which includes 93 BCTs organised into 12 groupings) to investigate whether implementation and de-implementation interventions for clinician behaviour change use different BCTs. Methods Intervention descriptions in 181 articles from three systematic reviews in the Cochrane Library were coded for (a) implementation versus de-implementation and (b) intervention content (BCTs) using the BCT taxonomy (v1). BCT frequencies were calculated and compared using Pearson’s chi-squared ( χ 2 ), Yates’ continuity correction and Fisher’s exact test, where appropriate. Identified BCTs were ranked according to frequency and rankings for de-implementation versus implementation interventions were compared and described. Results Twenty-nine and 25 BCTs were identified in implementation and de-implementation interventions respectively. Feedback on behaviour was identified more frequently in implementation than de-implementation ( Χ 2 (2, n =178) = 15.693, p = .000057). Three BCTs were identified more frequently in de-implementation than implementation: Behaviour substitution ( Χ 2 (2, n =178) = 14.561, p = .0001; Yates’ continuity correction); Monitoring of behaviour by others without feedback ( Χ 2 (2, n =178) = 16.187, p = .000057; Yates’ continuity correction); and Restructuring social environment ( p = .000273; Fisher’s 2-sided exact test). Conclusions There were some significant differences between BCTs reported in implementation and de-implementation interventions suggesting that researchers may have implicit theories about different BCTs required for de-implementation and implementation. These findings do not imply that the BCTs identified as targeting implementation or de-implementation are effective, rather simply that they were more frequently used. These findings require replication for a wider range of clinical behaviours. The continued accumulation of additional knowledge and evidence into whether implementation and de-implementation is different will serve to better inform researchers and, subsequently, improve methods for intervention design.

Background Over 60 implementation frameworks exist. Using multiple frameworks may help researchers to address multiple study purposes, levels, and degrees of theoretical heritage and operationalizability; however, using multiple frameworks may result in unnecessary complexity and redundancy if doing so does not address study needs. The Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF) are both well-operationalized, multi-level implementation determinant frameworks derived from theory. As such, the rationale for using the frameworks in combination (i.e., CFIR + TDF) is unclear. The objective of this systematic review was to elucidate the rationale for using CFIR + TDF by (1) describing studies that have used CFIR + TDF, (2) how they used CFIR + TDF, and (2) their stated rationale for using CFIR + TDF. Methods We undertook a systematic review to identify studies that mentioned both the CFIR and the TDF, were written in English, were peer-reviewed, and reported either a protocol or results of an empirical study in MEDLINE/PubMed, PsycInfo, Web of Science, or Google Scholar. We then abstracted data into a matrix and analyzed it qualitatively, identifying salient themes. Findings We identified five protocols and seven completed studies that used CFIR + TDF. CFIR + TDF was applied to studies in several countries, to a range of healthcare interventions, and at multiple intervention phases; used many designs, methods, and units of analysis; and assessed a variety of outcomes. Three studies indicated that using CFIR + TDF addressed multiple study purposes. Six studies indicated that using CFIR + TDF addressed multiple conceptual levels. Four studies did not explicitly state their rationale for using CFIR + TDF. Conclusions Differences in the purposes that authors of the CFIR (e.g., comprehensive set of implementation determinants) and the TDF (e.g., intervention development) propose help to justify the use of CFIR + TDF. Given that the CFIR and the TDF are both multi-level frameworks, the rationale that using CFIR + TDF is needed to address multiple conceptual levels may reflect potentially misleading conventional wisdom. On the other hand, using CFIR + TDF may more fully define the multi-level nature of implementation. To avoid concerns about unnecessary complexity and redundancy, scholars who use CFIR + TDF and combinations of other frameworks should specify how the frameworks contribute to their study. Trial registration PROSPERO CRD42015027615

Background There is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research. Methods The intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood? Results A complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change. Conclusions We have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.

Background The provision of healthcare is complex. When evidence-practice gaps are identified, interventions to improve practice across multi-level systems are required. These interventions often consist of multiple interacting components and behaviours. To effectively address these complexities, it is crucial to first identify the specific roles and actions required at each stage of the intervention. This approach enables a thorough examination of what is working well and what needs to be optimised. The action , actor , context , target, time (AACTT) framework provides a consistent approach to identifying key elements such as ‘who’ (actor) does ‘what’ (action), ‘where’ (context), ‘to or with whom’ (target) and ‘when’ (time). To our knowledge the AACTT has not yet been applied: 1) to specify complex interventions across patient journeys; and 2) to investigate consumer views, despite the importance of patient-centred care. Aim Using advance care planning (ACP) as an exemplar complex healthcare process, we describe a method for using the AACTT framework to 1) map a complex model of care across a patient journey 2) capture the consumer perspective; and 3) operationalise these perspectives by comparing across groups and identifying alignments or misalignments. Methods Two groups were recruited (healthcare professionals and consumers). Informed by the AACTT framework, four focus groups discussed the process of ACP across existing care pathways. Maps visually representing the perspectives and preferences of healthcare professionals and consumers were co-created iteratively. Qualitative data was deductively coded to the AACTT framework and inductively coded to identify themes within domains. Maps were circulated for critical feedback and refined. Results Healthcare professional (n-13) and consumer perspectives ( n  = 11) highlighted what is ‘currently occurring’ in practice, what is ‘not occurring’, and what ‘should be occurring’ to align practice with consumer preferences of care. Comparing participant perspectives identified that most misalignment occurred within the actor , context , and time domains. Misalignment was found predominantly in actions ‘occurring sometimes’, with no converging perspectives reported for the context and time domains. Conclusion This novel application of the AACTT framework systematically brings in the consumer voice in ways that may influence the delivery of care. This approach to specifying healthcare professional and consumer perspectives across a complex care pathway identifies barriers that are not found with traditional mapping methods or in current applications of the AACTT framework.