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      Enhancing the experience and outcomes of children with complex care needs in acute paediatric settings: a realist review protocol

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          Abstract

          Abstract
          Introduction

          The number of babies, children and young people with complex care needs (henceforth children with complex care needs (CCCN)) in England has increased in recent decades, and this has also been recognised globally. CCCN may have frequent and lengthy hospital admissions, but during these episodes, their needs are not always met, potentially resulting in suboptimal experiences and outcomes. Despite increased numbers of CCCN accessing acute care and displaying greater complexity, much of the contemporary literature has focused on primary care coordination between health, education and social care. Research specifically focused on CCCN in the acute care setting is largely absent. This realist review aims to understand how optimal experience and outcomes are achieved for CCCN during acute care, in different settings, for whom and why.

          Methods and analysis

          This realist review will proceed through six steps: (1) clarifying the scope of the review, (2) searching for evidence, (3) data selection and quality appraisal, (4) data extraction, (5) analysis and synthesis and (6) dissemination. We will search Medline, Cumulated Index in Nursing and Allied Health Literature and PsycINFO, alongside grey literature and other sources and will carry out citation tracking. Patient and public involvement and engagement have aided in the development of this protocol and will be maintained through regular consultations with a stakeholder group throughout the review. The review will result in a programme theory which will include context-mechanism-outcome configurations and provide data to support claims of generative causation.

          Ethics and dissemination

          Ethical approval is not required for this review as it does not involve primary research. The programme theory developed will be disseminated through peer-reviewed publications and relevant conferences. It will subsequently inform the development of an intervention to improve acute care for CCCN.

          PROSPERO registration number

          CRD42024591231.

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          Most cited references51

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          A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance

          The UK Medical Research Council’s widely used guidance for developing and evaluating complex interventions has been replaced by a new framework, commissioned jointly by the Medical Research Council and the National Institute for Health Research, which takes account of recent developments in theory and methods and the need to maximise the efficiency, use, and impact of research.
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            Realist review--a new method of systematic review designed for complex policy interventions.

            Evidence-based policy is a dominant theme in contemporary public services but the practical realities and challenges involved in using evidence in policy-making are formidable. Part of the problem is one of complexity. In health services and other public services, we are dealing with complex social interventions which act on complex social systems--things like league tables, performance measures, regulation and inspection, or funding reforms. These are not 'magic bullets' which will always hit their target, but programmes whose effects are crucially dependent on context and implementation. Traditional methods of review focus on measuring and reporting on programme effectiveness, often find that the evidence is mixed or conflicting, and provide little or no clue as to why the intervention worked or did not work when applied in different contexts or circumstances, deployed by different stakeholders, or used for different purposes. This paper offers a model of research synthesis which is designed to work with complex social interventions or programmes, and which is based on the emerging 'realist' approach to evaluation. It provides an explanatory analysis aimed at discerning what works for whom, in what circumstances, in what respects and how. The first step is to make explicit the programme theory (or theories)--the underlying assumptions about how an intervention is meant to work and what impacts it is expected to have. We then look for empirical evidence to populate this theoretical framework, supporting, contradicting or modifying the programme theories as it goes. The results of the review combine theoretical understanding and empirical evidence, and focus on explaining the relationship between the context in which the intervention is applied, the mechanisms by which it works and the outcomes which are produced. The aim is to enable decision-makers to reach a deeper understanding of the intervention and how it can be made to work most effectively. Realist review does not provide simple answers to complex questions. It will not tell policy-makers or managers whether something works or not, but will provide the policy and practice community with the kind of rich, detailed and highly practical understanding of complex social interventions which is likely to be of much more use to them when planning and implementing programmes at a national, regional or local level.
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              RAMESES publication standards: realist syntheses

              Background There is growing interest in realist synthesis as an alternative systematic review method. This approach offers the potential to expand the knowledge base in policy-relevant areas - for example, by explaining the success, failure or mixed fortunes of complex interventions. No previous publication standards exist for reporting realist syntheses. This standard was developed as part of the RAMESES (Realist And MEta-narrative Evidence Syntheses: Evolving Standards) project. The project's aim is to produce preliminary publication standards for realist systematic reviews. Methods We (a) collated and summarized existing literature on the principles of good practice in realist syntheses; (b) considered the extent to which these principles had been followed by published syntheses, thereby identifying how rigor may be lost and how existing methods could be improved; (c) used a three-round online Delphi method with an interdisciplinary panel of national and international experts in evidence synthesis, realist research, policy and/or publishing to produce and iteratively refine a draft set of methodological steps and publication standards; (d) provided real-time support to ongoing realist syntheses and the open-access RAMESES online discussion list so as to capture problems and questions as they arose; and (e) synthesized expert input, evidence syntheses and real-time problem analysis into a definitive set of standards. Results We identified 35 published realist syntheses, provided real-time support to 9 on-going syntheses and captured questions raised in the RAMESES discussion list. Through analysis and discussion within the project team, we summarized the published literature and common questions and challenges into briefing materials for the Delphi panel, comprising 37 members. Within three rounds this panel had reached consensus on 19 key publication standards, with an overall response rate of 91%. Conclusion This project used multiple sources to develop and draw together evidence and expertise in realist synthesis. For each item we have included an explanation for why it is important and guidance on how it might be reported. Realist synthesis is a relatively new method for evidence synthesis and as experience and methodological developments occur, we anticipate that these standards will evolve to reflect further methodological developments. We hope that these standards will act as a resource that will contribute to improving the reporting of realist syntheses. To encourage dissemination of the RAMESES publication standards, this article is co-published in the Journal of Advanced Nursing and is freely accessible on Wiley Online Library (http://www.wileyonlinelibrary.com/journal/jan). Please see related article http://www.biomedcentral.com/1741-7015/11/20 and http://www.biomedcentral.com/1741-7015/11/22
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2025
                12 March 2025
                : 15
                : 3
                : e097328
                Affiliations
                [1 ]departmentNottingham Children’s Hospital , Nottingham University Hospitals NHS Trust , Nottingham, UK
                [2 ]departmentSchool of Healthcare , University of Leicester , Leicester, UK
                [3 ]departmentCentre for Children and Young Peoples Health Research , University of Nottingham School of Health Sciences , Nottingham, UK
                [4 ]departmentCentre for Care Excellence , University Hospitals Coventry and Warwickshire , Coventry, UK
                [5 ]departmentPediatrics , Hospital for Sick Kids , Toronto, Ontario, Canada
                [6 ]SickKids Research Institute , Toronto, Ontario, Canada
                [7 ]departmentInstitute of Medical Science , University of Toronto , Toronto, Ontario, Canada
                [8 ]University of Exeter , Exeter, UK
                [9 ]Nottingham University Hospitals NHS Trust , Nottingham, UK
                Author notes

                Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

                None declared.

                Author information
                http://orcid.org/0000-0003-1733-8676
                http://orcid.org/0000-0003-0112-7188
                http://orcid.org/0000-0002-6077-4169
                Article
                bmjopen-2024-097328
                10.1136/bmjopen-2024-097328
                11904347
                40074263
                6094e045-5137-40ed-96be-084efd82eeb5
                Copyright © Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/.

                History
                : 29 November 2024
                : 14 February 2025
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000272, National Institute for Health and Care Research;
                Award ID: NIHR304196
                Funded by: Health Education England / National Institute for Health and Care Research;
                Award ID: Post-Doctoral Bridging Programme – East Midlands
                Categories
                Protocol
                Paediatrics
                1719
                1506

                Medicine
                paediatrics,hospitals,review
                Medicine
                paediatrics, hospitals, review

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