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      Translational framework for implementation evaluation and research: a normalisation process theory coding manual for qualitative research and instrument development

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          Abstract

          Background

          Normalisation Process Theory (NPT) is frequently used to inform qualitative research that aims to explain and evaluate processes that shape late-stage translation of innovations in the organisation and delivery of healthcare. A coding manual for qualitative researchers using NPT will facilitate transparent data analysis processes and will also reduce the cognitive and practical burden on researchers.

          Objectives

          (a) To simplify the theory for the user. (b) To describe the purposes, methods of development, and potential application of a coding manual that translates normalisation process theory (NPT) into an easily usable framework for qualitative analysis. (c) To present an NPT coding manual that is ready for use.

          Method

          Qualitative content analysis of papers and chapters that developed normalisation process theory, selection and structuring of theory constructs, and testing constructs against interview data and published empirical studies using NPT.

          Results

          A coding manual for NPT was developed. It consists of 12 primary NPT constructs and conforms to the Context-Mechanism-Outcome configuration of realist evaluation studies. Contexts are defined as settings in which implementation work is done, in which strategic intentions, adaptive execution, negotiating capability, and reframing organisational logics are enacted. Mechanisms are defined as the work that people do when they participate in implementation processes and include coherence-building, cognitive participation, collective action, and reflexive monitoring. Outcomes are defined as effects that make visible how things change as implementation processes proceed and include intervention mobilisation, normative restructuring, relational restructuring, and sustainment.

          Conclusion

          The coding manual is ready to use and performs three important tasks. It consolidates several iterations of theory development, makes the application of NPT simpler for the user, and links NPT constructs to realist evaluation methods. The coding manual forms the core of a translational framework for implementation research and evaluation.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13012-022-01191-x.

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          Most cited references60

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          Three approaches to qualitative content analysis.

          Content analysis is a widely used qualitative research technique. Rather than being a single method, current applications of content analysis show three distinct approaches: conventional, directed, or summative. All three approaches are used to interpret meaning from the content of text data and, hence, adhere to the naturalistic paradigm. The major differences among the approaches are coding schemes, origins of codes, and threats to trustworthiness. In conventional content analysis, coding categories are derived directly from the text data. With a directed approach, analysis starts with a theory or relevant research findings as guidance for initial codes. A summative content analysis involves counting and comparisons, usually of keywords or content, followed by the interpretation of the underlying context. The authors delineate analytic procedures specific to each approach and techniques addressing trustworthiness with hypothetical examples drawn from the area of end-of-life care.
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            Implementing, Embedding, and Integrating Practices: An Outline of Normalization Process Theory

            C. May, T Finch (2009)
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              Implementation, context and complexity

              Background Context is a problem in research on health behaviour change, knowledge translation, practice implementation and health improvement. This is because many intervention and evaluation designs seek to eliminate contextual confounders, when these represent the normal conditions into which interventions must be integrated if they are to be workable in practice. Discussion We present an ecological model of the ways that participants in implementation and health improvement processes interact with contexts. The paper addresses the problem of context as it affects processes of implementation, scaling up and diffusion of interventions. We extend our earlier work to develop Normalisation Process Theory and show how these processes involve interactions between mechanisms of resource mobilisation, collective action and negotiations with context. These mechanisms are adaptive. They contribute to self-organisation in complex adaptive systems. Conclusion Implementation includes the translational efforts that take healthcare interventions beyond the closed systems of evaluation studies into the open systems of ‘real world’ contexts. The outcome of these processes depends on interactions and negotiations between their participants and contexts. In these negotiations, the plasticity of intervention components, the degree of participants’ discretion over resource mobilisation and actors’ contributions, and the elasticity of contexts, all play important parts. Understanding these processes in terms of feedback loops, adaptive mechanisms and the practical compromises that stem from them enables us to see the mechanisms specified by NPT as core elements of self-organisation in complex systems.
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                Author and article information

                Contributors
                Carl.May@lshtm.ac.uk
                bianca.albers@uzh.ch
                M.J.Bracher@soton.ac.uk
                tracy.finch@northumbria.ac.uk
                anthony.gilbert@nhs.net
                melissa.girling@northumbria.ac.uk
                k.e.greenwood@sussex.ac.uk
                Anne.MacFarlane@ul.ie
                Frances.Mair@glasgow.ac.uk
                chrismay918@gmail.com
                elizabeth.murray@ucl.ac.uk
                sebastian.potthoff@northumbria.ac.uk
                tim.rapley@northumbria.ac.uk
                Journal
                Implement Sci
                Implement Sci
                Implementation Science : IS
                BioMed Central (London )
                1748-5908
                22 February 2022
                22 February 2022
                2022
                : 17
                : 19
                Affiliations
                [1 ]GRID grid.8991.9, ISNI 0000 0004 0425 469X, Department of Health Services Research and Policy, , London School of Hygiene and Tropical Medicine & NIHR North Thames ARC, ; London, UK
                [2 ]Institute for Implementation Science in Healthcare, Zurich, Switzerland
                [3 ]GRID grid.5491.9, ISNI 0000 0004 1936 9297, School of Health Sciences, , University of Southampton, ; Southampton, UK
                [4 ]GRID grid.42629.3b, ISNI 0000000121965555, Department of Nursing, Midwifery & Health, , Northumbria University & NIHR ARC North East-North Cumbria, ; Newcastle, UK
                [5 ]GRID grid.416177.2, ISNI 0000 0004 0417 7890, Royal National Orthopaedic Hospital, London & NIHR North Thames ARC, ; London, UK
                [6 ]GRID grid.12082.39, ISNI 0000 0004 1936 7590, School of Psychology, , University of Sussex, ; Brighton, UK
                [7 ]GRID grid.10049.3c, ISNI 0000 0004 1936 9692, School of Medicine and Health Research Institute, University of Limerick, ; Limerick, Ireland
                [8 ]GRID grid.8756.c, ISNI 0000 0001 2193 314X, Institute of Health and Wellbeing, Glasgow University, ; Glasgow, UK
                [9 ]Southampton, UK
                [10 ]GRID grid.83440.3b, ISNI 0000000121901201, Research Department of Primary Care and Population Health, , University College London & NIHR North Thames ARC, ; London, UK
                [11 ]GRID grid.42629.3b, ISNI 0000000121965555, Department of Social Work, Education and Community Wellbeing, , Northumbria University & NIHR ARC North East- North Cumbria, ; Newcastle, UK
                Author information
                http://orcid.org/0000-0002-0451-2690
                Article
                1191
                10.1186/s13012-022-01191-x
                8861599
                35193611
                425474fb-de25-4cef-993b-43194de21e6c
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.

                History
                : 6 September 2021
                : 18 January 2022
                Categories
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                © The Author(s) 2022

                Medicine
                Medicine

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