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      Developing a Hypothetical Implementation Framework of Expectations for Monitoring Early Signs of Psychosis Relapse Using a Mobile App: Qualitative Study

      research-article
      , MA 1 , , PhD 1 , , PhD 1 , , PhD 2 , , DClinPsy 3 , , PhD 3 , , MSc 1 , EMPOWER Group 1 , , PhD 1 ,
      (Reviewer), (Reviewer)
      Journal of Medical Internet Research
      JMIR Publications
      psychosis, self-management, implementation science

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          Abstract

          Background

          Relapse is a common experience for people diagnosed with psychosis, which is associated with increased service costs and profound personal and familial distress. EMPOWER (Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery) is a peer worker–supported digital intervention that aims to enable service users to self-monitor their mental health with the aim of encouraging self-management and the shared use of personal data to promote relapse prevention. Digital interventions have not been widely used in relapse prevention and, therefore, little is currently known about their likely implementation—both within trials and beyond.

          Objective

          Seeking the perspectives of all relevant stakeholder groups is recommended in developing theories about implementation because this can reveal important group differences in understandings and assumptions about whether and for whom the intervention is expected to work. However, the majority of intervention implementation research has been retrospective. This study aimed to discover and theoretically frame implementation expectations in advance of testing and synthesize these data into a framework.

          Methods

          To develop a hypothetical implementation framework, 149 mental health professionals, carers, and people diagnosed with psychosis participated in 25 focus groups in both Australia and the United Kingdom. An interview schedule informed by the normalization process theory was used to explore stakeholders’ expectations about the implementation of the EMPOWER intervention. Data were analyzed using thematic analysis and then theoretically framed using the Medical Research Council guidelines for understanding the implementation of complex interventions.

          Results

          All groups expected that EMPOWER could be successfully implemented if the intervention generated data that were meaningful to mental health staff, carers, and service users within their unique roles. However, there were key differences between staff, carers, and service users about what facilitators and barriers that stakeholders believe exist for intervention implementation in both the cluster randomized controlled trial stage and beyond. For example, service user expectations mostly clustered around subjective user experiences, whereas staff and carers spoke more about the impact upon staff interactions with service users.

          Conclusions

          A hypothetical implementation framework synthesized from stakeholder implementation expectations provides an opportunity to compare actual implementation data gathered during an ongoing clinical trial, giving valuable insights into the accuracy of these stakeholders’ previous expectations. This is among the first studies to assess and record implementation expectations for a newly developed digital intervention for psychosis in advance of testing in a clinical trial.

          Trial Registration

          ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262

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          Most cited references32

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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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            Frameworks for supporting patient and public involvement in research: Systematic review and co‐design pilot

            Abstract Background Numerous frameworks for supporting, evaluating and reporting patient and public involvement in research exist. The literature is diverse and theoretically heterogeneous. Objectives To identify and synthesize published frameworks, consider whether and how these have been used, and apply design principles to improve usability. Search strategy Keyword search of six databases; hand search of eight journals; ancestry and snowball search; requests to experts. Inclusion criteria Published, systematic approaches (frameworks) designed to support, evaluate or report on patient or public involvement in health‐related research. Data extraction and synthesis Data were extracted on provenance; collaborators and sponsors; theoretical basis; lay input; intended user(s) and use(s); topics covered; examples of use; critiques; and updates. We used the Canadian Centre for Excellence on Partnerships with Patients and Public (CEPPP) evaluation tool and hermeneutic methodology to grade and synthesize the frameworks. In five co‐design workshops, we tested evidence‐based resources based on the review findings. Results Our final data set consisted of 65 frameworks, most of which scored highly on the CEPPP tool. They had different provenances, intended purposes, strengths and limitations. We grouped them into five categories: power‐focused; priority‐setting; study‐focused; report‐focused; and partnership‐focused. Frameworks were used mainly by the groups who developed them. The empirical component of our study generated a structured format and evidence‐based facilitator notes for a “build your own framework” co‐design workshop. Conclusion The plethora of frameworks combined with evidence of limited transferability suggests that a single, off‐the‐shelf framework may be less useful than a menu of evidence‐based resources which stakeholders can use to co‐design their own frameworks.
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              The dark side of coproduction: do the costs outweigh the benefits for health research?

              Background Coproduction, a collaborative model of research that includes stakeholders in the research process, has been widely advocated as a means of facilitating research use and impact. We summarise the arguments in favour of coproduction, the different approaches to establishing coproductive work and their costs, and offer some advice as to when and how to consider coproduction. Debate Despite the multiplicity of reasons and incentives to coproduce, there is little consensus about what coproduction is, why we do it, what effects we are trying to achieve, or the best coproduction techniques to achieve policy, practice or population health change. Furthermore, coproduction is not free risk or cost. Tensions can arise throughout coproduced research processes between the different interests involved. We identify five types of costs associated with coproduced research affecting the research itself, the research process, professional risks for researchers and stakeholders, personal risks for researchers and stakeholders, and risks to the wider cause of scholarship. Yet, these costs are rarely referred to in the literature, which generally calls for greater inclusion of stakeholders in research processes, focusing exclusively on potential positives. There are few tools to help researchers avoid or alleviate risks to themselves and their stakeholders. Conclusions First, we recommend identifying specific motivations for coproduction and clarifying exactly which outcomes are required for whom for any particular piece of research. Second, we suggest selecting strategies specifically designed to enable these outcomes to be achieved, and properly evaluated. Finally, in the absence of strong evidence about the impact and process of coproduction, we advise a cautious approach to coproduction. This would involve conscious and reflective research practice, evaluation of how coproduced research practices change outcomes, and exploration of the costs and benefits of coproduction. We propose some preliminary advice to help decide when coproduction is likely to be more or less useful.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                J. Med. Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications (Toronto, Canada )
                1439-4456
                1438-8871
                September 2019
                24 October 2019
                : 21
                : 10
                : e14366
                Affiliations
                [1 ] Mental Health and Wellbeing Institute of Health & Wellbeing University of Glasgow Glasgow United Kingdom
                [2 ] Department of Psychology and Counselling La Trobe University Melbourne Australia
                [3 ] School of Behavioural and Health Sciences Australian Catholic University Melbourne Australia
                Author notes
                Corresponding Author: Andrew Gumley andrew.gumley@ 123456glasgow.ac.uk
                Author information
                https://orcid.org/0000-0002-1016-0708
                https://orcid.org/0000-0002-0339-1882
                https://orcid.org/0000-0002-4225-1815
                https://orcid.org/0000-0003-2439-2830
                https://orcid.org/0000-0001-8125-0041
                https://orcid.org/0000-0001-7969-492X
                https://orcid.org/0000-0002-4558-3049
                https://orcid.org/0000-0002-8888-938X
                Article
                v21i10e14366
                10.2196/14366
                6838692
                31651400
                ef83e5ff-d7a0-4969-998d-d2f5bb11a29e
                ©Stephanie Allan, Simon Bradstreet, Hamish Mcleod, John Farhall, Maria Lambrou, John Gleeson, Andrea Clark, EMPOWER Group, Andrew Gumley. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.10.2019.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on http://www.jmir.org/, as well as this copyright and license information must be included.

                History
                : 12 April 2019
                : 8 May 2019
                : 10 July 2019
                : 19 July 2019
                Categories
                Original Paper
                Original Paper

                Medicine
                psychosis,self-management,implementation science
                Medicine
                psychosis, self-management, implementation science

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