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      Surveying knowledge, practice and attitudes towards intervention fidelity within trials of complex healthcare interventions

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          Abstract

          Background

          Intervention fidelity is the degree to which interventions have been implemented as intended by their developers. Assessing fidelity is crucial for accurate interpretation of intervention effectiveness, but fidelity is often poorly addressed within trials of complex healthcare interventions. The reasons for this are unclear, and information on the use of methods to enhance and assess fidelity in trials of complex interventions remains insufficient. This study aimed to explore the knowledge, practice and attitudes towards intervention fidelity amongst researchers, triallists and healthcare professionals involved with the design and conduct of trials of complex healthcare interventions.

          Methods

          An online survey consisting of closed and open-ended questions exploring four sections (Demographics, Fidelity knowledge, Practice and Attitudes) was conducted. This was an opportunistic sample of individuals with experience of direct involvement in trials of complex healthcare interventions (e.g. design/development, conduct, evaluation).

          Results

          Data from 264 participants representing 15 countries were analysed. The majority (65.9%, n = 174) of participants identified themselves as ‘Researchers’. The majority of participants were familiar with the term “intervention fidelity” (69.7%, n = 184) and indicated that fidelity is important (89.7%, n = 236). Mean self-reported understanding of fidelity was moderate. Although 68% ( n = 182) had previously used strategies to assess (e.g. audio/video-recording sessions) and enhance (e.g. training manual) fidelity in trials of complex interventions, only a limited proportion of participants indicated always reporting these strategies in subsequent publications (30.9%, n = 56). Poor knowledge or understanding was the most commonly cited barrier to addressing intervention fidelity in trials (77.4%, n = 202). Over half of respondents (52.1%, n = 137) had never completed specific fidelity training or research, and the vast majority (89.7%, n = 236) would welcome specific training in this area.

          Conclusion

          Despite good awareness of intervention fidelity and its importance, poor knowledge and understanding appears to be a key factor limiting how intervention fidelity is addressed in trials of complex interventions. Participants identified a need for further training and education in this area. Additionally, clarification of the terminology, definition and components of intervention fidelity would facilitate better understanding of the concept. A discrepancy between participants’ use of fidelity strategies and subsequent reporting raises concerns around inadequate fidelity reporting in the trials literature.

          Electronic supplementary material

          The online version of this article (10.1186/s13063-018-2838-6) contains supplementary material, which is available to authorized users.

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          Most cited references23

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          Implementation fidelity in community-based interventions.

          Implementation fidelity is the degree to which an intervention is delivered as intended and is critical to successful translation of evidence-based interventions into practice. Diminished fidelity may be why interventions that work well in highly controlled trials may fail to yield the same outcomes when applied in real life contexts. The purpose of this paper is to define implementation fidelity and describe its importance for the larger science of implementation, discuss data collection methods and current efforts in measuring implementation fidelity in community-based prevention interventions, and present future research directions for measuring implementation fidelity that will advance implementation science. (c) 2010 Wiley Periodicals, Inc.
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            How can we improve guideline use? A conceptual framework of implementability

            Background Guidelines continue to be underutilized, and a variety of strategies to improve their use have been suboptimal. Modifying guideline features represents an alternative, but untested way to promote their use. The purpose of this study was to identify and define features that facilitate guideline use, and examine whether and how they are included in current guidelines. Methods A guideline implementability framework was developed by reviewing the implementation science literature. We then examined whether guidelines included these, or additional implementability elements. Data were extracted from publicly available high quality guidelines reflecting primary and institutional care, reviewed independently by two individuals, who through discussion resolved conflicts, then by the research team. Results The final implementability framework included 22 elements organized in the domains of adaptability, usability, validity, applicability, communicability, accommodation, implementation, and evaluation. Data were extracted from 20 guidelines on the management of diabetes, hypertension, leg ulcer, and heart failure. Most contained a large volume of graded, narrative evidence, and tables featuring complementary clinical information. Few contained additional features that could improve guideline use. These included alternate versions for different users and purposes, summaries of evidence and recommendations, information to facilitate interaction with and involvement of patients, details of resource implications, and instructions on how to locally promote and monitor guideline use. There were no consistent trends by guideline topic. Conclusions Numerous opportunities were identified by which guidelines could be modified to support various types of decision making by different users. New governance structures may be required to accommodate development of guidelines with these features. Further research is needed to validate the proposed framework of guideline implementability, develop methods for preparing this information, and evaluate how inclusion of this information influences guideline use.
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              Defining, Conceptualizing, and Measuring Fidelity of Implementation and Its Relationship to Outcomes in K-12 Curriculum Intervention Research

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                Author and article information

                Contributors
                Daraghmcg@gmail.com
                F.lorencatto@ucl.ac.uk
                Karen.msikar@ucc.ie
                Elaine.toomey@nuigalway.ie
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                19 September 2018
                19 September 2018
                2018
                : 19
                : 504
                Affiliations
                [1 ]ISNI 0000 0004 0488 0789, GRID grid.6142.1, School of Medicine, Clinical Science Institute, , National University of Ireland Galway, ; University Road, Galway, Ireland H91 TK33
                [2 ]ISNI 0000000121901201, GRID grid.83440.3b, Centre for Behaviour Change, , University College London, ; 1-19 Torrington Place, London, WC1E 7HB UK
                [3 ]ISNI 0000000123318773, GRID grid.7872.a, School of Public Health, Western Gateway Building, , University College Cork, ; Cork, Ireland T12 YN60
                [4 ]ISNI 0000 0004 0488 0789, GRID grid.6142.1, Health Behaviour Change Research Group, Room 2058, School of Psychology, Arts Millennium Building, , National University of Ireland Galway, ; University Road, Galway, Ireland H91 TK33
                Author information
                http://orcid.org/0000-0001-5941-0838
                Article
                2838
                10.1186/s13063-018-2838-6
                6147031
                30231917
                ab50f053-082a-4aa6-82cf-0734584b6a2e
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 10 January 2018
                : 4 August 2018
                Funding
                Funded by: Health Research Board Trials Methodology Research Network
                Categories
                Research
                Custom metadata
                © The Author(s) 2018

                Medicine
                intervention fidelity,complex interventions,randomised control trials,research methods,survey

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