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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
The potential of programme theory in bridging the evidence into practice gap in implementation science: a worked example of integrating palliative care into heart failure management
Abstract Implementation science has been defined as the scientific study of methods focused on promoting the systematic uptake of research findings into routine practice in order to improve the quality and effectiveness of healthcare services. However, a recent critique of the science has highlighted a research to practice gap paradox suggesting that rather than closing the gap, implementation science may be reinventing it. Others have more recently provided a further critique focusing on the promises and pitfalls of implementation science, arguing that the field needs to further develop and grow. Our paper aims to contribute to this call by suggesting one possible way forward. To do this we first explore the ideas and assumptions underpinning implementation science, before we introduce the benefits of realist approaches - which are increasingly recognised as crucial for addressing the research to practice gap paradox as they deal with real world complexity. Whilst realist approaches may help move the field of implementation science forward, we also point out that the theories within this field can also help to improve understanding in realist research. In summary, our paper challenges the growing reliance on implementation theories, models and frameworks as the only starting point for research in this field, and we argue that realist programme theory may be equally useful.
The impact of patient enrolment in primary care on continuity and quality of care around the world, 2014-2024, and lessons for Australia: a scoping review.
OBJECTIVES: To identify publications examining the enablers of and barriers to patient enrolment in primary care and its impact on continuity and quality of care; to assess the likely effectiveness of voluntary patient enrolment (MyMedicare) in Australia with regard to improving continuity of care and supporting other health care reforms. STUDY DESIGN: Scoping review of peer-reviewed journal article published in English during 1 January 2014 - 12 July 2024 that evaluated primary care enrolment models, including patient enrolment enablers and barriers. DATA SOURCES: PubMed, Cochrane Database of Systematic Reviews, Embase, CINAHL (Cumulated Index in Nursing and Allied Health Literature), PsycINFO, PAIS (Public Affairs Information Service), Web of Science, Scopus. The bibliographies of included articles were checked for further relevant publications. DATA SYNTHESIS: The database searches and bibliography checks identified 508 potentially relevant articles; we reviewed the full text of 66 articles after title and abstract screening, of which 24 publications met our inclusion criteria. Twenty-two of the included studies were undertaken in fifteen countries, including eleven in Canada, four in Australia, and two each in the United Kingdom and New Zealand; one publication compared schemes in twelve countries, one was a rapid review. The characteristics of patient enrolment models differ greatly between countries in both form and implementation, including the mandatory and voluntary components. We found little evidence that enrolment improved continuity of care. However, existing patient engagement with usual general practitioners was high among participants in many studies, and some studies involved patients who may already have had high levels of continuity of care. There is evidence that enrolment can support primary care reforms, including preventive care and the management of chronic conditions, and that other reforms, such as incentives and increased access to services can affect the enrolment of patients and practices. People in marginalised groups or with complex care needs are less likely to enrol with practices or practitioners. CONCLUSIONS: The Australian voluntary patient enrolment scheme should be continuously evaluated to assess levels of engagement by patients and general practices, drawing on the experiences of other countries in which similar schemes operate. Further assessment of overseas enrolment systems could identify reasons for the different experiences reported, as well as enablers of and barriers to successful implementation and better health outcomes.
SPIRIT 2025 statement: Updated guideline for protocols of randomised trials.
IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.
SPIRIT 2025 statement: updated guideline for protocols of randomized trials.
The protocol of a randomized trial is the foundation for study planning, conduct, reporting and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. Here, we aimed to systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomized trial. We completed a scoping review and developed a project-specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct and reporting. The updated SPIRIT 2025 statement consists of an evidence-based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrollment, interventions and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators and other reviewers.
SPIRIT 2025 statement: updated guideline for protocols of randomised trials.
IMPORTANCE: The protocol of a randomised trial is the foundation for study planning, conduct, reporting, and external review. However, trial protocols vary in their completeness and often do not address key elements of design and conduct. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was first published in 2013 as guidance to improve the completeness of trial protocols. Periodic updates incorporating the latest evidence and best practices are needed to ensure that the guidance remains relevant to users. OBJECTIVE: To systematically update the SPIRIT recommendations for minimum items to address in the protocol of a randomised trial. DESIGN: We completed a scoping review and developed a project specific database of empirical and theoretical evidence to generate a list of potential changes to the SPIRIT 2013 checklist. The list was enriched with recommendations provided by lead authors of existing SPIRIT/CONSORT (Consolidated Standards of Reporting Trials) extensions (Harms, Outcomes, Non-pharmacological Treatment) and other reporting guidelines (TIDieR). The potential modifications were rated in a three-round Delphi survey followed by a consensus meeting. FINDINGS: Overall, 317 individuals participated in the Delphi consensus process and 30 experts attended the consensus meeting. The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines. Notable changes include a new open science section, additional emphasis on the assessment of harms and description of interventions and comparators, and a new item on how patients and the public will be involved in trial design, conduct, and reporting. The updated SPIRIT 2025 statement consists of an evidence based checklist of 34 minimum items to address in a trial protocol, along with a diagram illustrating the schedule of enrolment, interventions, and assessments for trial participants. To facilitate implementation, we also developed an expanded version of the SPIRIT 2025 checklist and an accompanying explanation and elaboration document. CONCLUSIONS AND RELEVANCE: Widespread endorsement and adherence to the updated SPIRIT 2025 statement have the potential to enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, funders, research ethics committees, journals, trial registries, policymakers, regulators, and other reviewers.
Formulating outputs from a mixed-methods study of access to general practice: a series of collaborative stakeholder workshops.
BACKGROUND: Access to general practice is a concern for policy-makers, politicians, service providers and the public. We conducted a study to examine what happens in the long term to general practices that have introduced innovations designed to improve access to appointments. Recognising the importance of ensuring research findings are transferable to those using them, we used collaborative workshops to aid the development of our study outputs. METHODS: We held three sequential interactive workshops. These covered (1) early findings of the study, (2) what evidence-based resources attendees use and (3) what resources they would like to see produced. We sought to include 6-12 people from staff from practices participating in the wider research study, from primary care networks, from partnership boards of integrated care systems, clinical commissioners, professional bodies, National Health Service bodies and independent think tanks. The first two workshops were online, the final was in-person. Workshops were facilitated by the research team, including the patient and public involvement lead. A research team member took detailed notes. RESULTS: Workshop 1 had 12 attendees; workshop 2 had 9 attendees, of which 7 were also at the previous workshop; workshop 3 had 7 attendees, of whom 6 had attended a previous workshop. From these workshops, we gained insights that helped us to validate our interpretation of the study data. We observed the competing interests and needs of different groups, who have different perspectives on the value of research evidence. Outputs that are brief, written in lay terms and widely publicised appear to be of especial value. LIMITATIONS: The range of stakeholders included was less varied than intended; this was in part due to the commitment involved in attending, and this may limit the inclusivity of the findings. FUTURE WORK: This approach could be used in future studies to ensure that stakeholder interests are included in study dissemination plans. FUNDING: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR133620.
A service evaluation of the implementation of a novel digital intervention for hypertension self-monitoring and management system in primary care (SHIP): protocol for a mixed methods study
Background: Hypertension is a key risk factor for death and disability, and blood pressure reduction is associated with significant reductions in cardiovascular risk. Large trials have shown that interventions including self-monitoring of blood pressure can reduce blood pressure but real-world data from wider implementation are lacking. Aim: The self-monitoring and management service evaluation in primary care (SHIP) study will evaluate a novel digital intervention for hypertension management and medication titration platform (“Hypertension-Plus”) that is currently undergoing initial implementation into primary care in several parts of the UK. Methods and analyses: The study will use a mixed methods approach including both quantitative analysis of anonymised electronic health record data and qualitative analyses of interview and customer support log data. Pseudonymised data will be extracted from electronic health records and outcomes compared between those using the digital intervention and their own historical data, as well as to those not registered to the system. The primary outcome will be difference in systolic blood pressure in the 12 months before and after implementation. A further analysis will utilise self-monitored blood pressure data from the Hypertension-Plus system itself. Semi-structured qualitative interviews will be completed with implementation and clinical leads, staff and patients in six general practices located in two different geographical areas in England. Informed by the non-adoption, abandonment, scale-up, spread, and sustainability (NASSS) framework, our analysis will identify the challenges to successful implementation and sustainability of the digital intervention in routine clinical practice and in patients’ homes. Ethics and dissemination: The analyses of pseudonymised data were assessed by the sponsor (The University of Oxford) as service evaluation not requiring individual consent and hence did not require ethical approval. Ethics approval for the qualitative analyses was provided by Wales REC 4 (21/WA/0280) and individual written informed consent will be gained for all participants. Results will be published in peer-reviewed journals, presented at national and international conferences and disseminated via patient and health service organisations. Discussion: This study will provide an in-depth analysis of the impact and acceptance of initial implementation of a novel digital intervention, enhancing our understanding and supporting more effective implementation of telemonitoring based hypertension management systems for blood pressure control in England.
Videoconferencing support groups for people affected by dementia: a systematic narrative review.
ObjectivesThis systematic review aimed to examine the impact of videoconferencing peer support groups on individuals living with dementia and their caregivers.MethodA narrative synthesis of articles identified via searches of five databases (MEDLINE, PsycINFO, EMBASE, CINAHL, and Web of Science). The search was carried out in January 2024. The review included qualitative, quantitative, and mixed methods research reporting the experiences of dementia patients and/or their caregivers participating in online support groups that took place through video call.Results16 studies met the inclusion criteria for the review. In all studies, participants indicated that taking part in a virtual support group was beneficial, as they valued being able to connect with others in a similar situation, receive advice, and learn coping strategies. Videoconferencing support groups were seen as convenient to attend, even though participants sometimes experienced technical difficulties (e.g. internet connectivity issues). The provision of IT training and support helped participants access this type of support effectively.ConclusionVideoconferencing support groups can be beneficial for caregivers of people living with dementia, especially when groups meet frequently and provide some manner of IT support. More research is needed to understand the potential benefits of videoconferencing for people with dementia.
Online support groups for carers of people living with dementia: An investigation of videoconferencing support groups in lockdown.
BACKGROUND: This study aimed to explore the experiences of carers of people living with dementia who participated in videoconferencing support groups during the COVID-19 pandemic to investigate their preferences and experiences with online, hybrid, and face-to-face support. METHODS: This convergent mixed methods design study utilised an online questionnaire and semi-structured interviews. Interviews took place over videoconferencing software and were analysed through thematic analysis. Participants were recruited from support groups based in the UK and Ireland. RESULTS: 39 carers of people living with dementia completed the questionnaire and 16 carers participated in interviews. Participants found videoconferencing support groups more convenient, but face-to-face groups more enjoyable. Participants who had found it difficult to access face-to-face groups prior to COVID-19 expressed more positive perceptions of videoconference-based groups. Many felt that hybrid groups would make it easier for more people to attend. However, some carers described lacking the resources and technological skills to participate in online support groups effectively. Some suggested making IT training available may improve the capacity of carers to access support online. CONCLUSION: Videoconferencing support groups can be an appropriate way of supporting carers of people with dementia, especially for those who do not have access to face-to-face support groups. However, face-to-face support remains important to carers and should be made available when it can be implemented safely. Hybrid support groups could allow for increased accessibility while still providing the option of face-to-face contact for those who prefer it or are not adept with technology.