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MSc in Global Healthcare Leadership student Isra AlBastaki shares a thought-provoking reflection on a conversation with a mentor that led to the discovery of a transformative book, ‘The Fifth Discipline’ by Peter M. Senge. Isra offers a rich perspective on leadership and organisational dynamics. Understanding complex health systems is a key theme of the MSc in Global Healthcare Leadership, jointly run by the Nuffield Department of Primary Care Health Sciences and the Saïd Business School. Read more about Isra’s learning journey within the programme below.
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.
Group-Based Interventions for Carers of People With Dementia: A Systematic Review.
Background and objectivesIt is well documented that caring for someone with dementia is associated with many negative mental health outcomes, such as depression, anxiety, and a reduction in quality of life. Group-based interventions are one strategy for improving well-being for carers, but previous systematic reviews have reported inconsistent findings about the efficacy of group-based interventions for carers of people with dementia.Research design and methodsThis systematic review investigates the qualitative and quantitative evidence for the effectiveness of group-based interventions and identifies targets for future research. Narrative synthesis was used to analyze the data.ResultsA comprehensive search of 4 databases revealed 117 potentially relevant studies, 19 of which met the full inclusion criteria. Five studies investigated group cognitive behavioral therapy, 8 investigated psycho-educational interventions, and 6 investigated support groups. The effectiveness of the interventions varied widely, even within subcategories. No type of intervention was consistently shown to improve well-being, though qualitative data and data about participant satisfaction was generally very positive.Discussion and implicationsBased on the quality and quantity of the evidence currently available, there is not enough evidence to reach firm conclusions about the impact of group-based interventions on well-being. In order to establish the effectiveness of group-based interventions there needs to be more high-quality studies with larger sample sizes about this topic. Future research may benefit from the use of mixed methods data collection to explore the disparity between qualitative and quantitative findings in the literature.
Audiovisual integration improves task performance in AD and bvFTD
AbstractBackgroundComplex analysis of sensory inputs, such as auditory scene analysis and spatial localisation, is impaired in Alzheimer’s disease (AD) and behavioural variant frontotemporal dementia (bvFTD). Multisensory integration research demonstrates that synchronous stimulation in one sense (e.g. vision) can modify processing of suboptimal sensory inputs from another sense (e.g. hearing) in the healthy brain. However, the potential benefit of multisensory stimulation to reduce common symptoms in dementia has not been fully examined.MethodPatients living with AD (n = 20) or bvFTD (n = 12), and healthy age‐matched controls (n = 18) were recruited to perform three brief cognitive tasks: 1. Cocktail party effect, identify a name spoken in a noisy environment; 2. Spatial ventriloquism, discriminate the location of an auditory stimulus (left/right of centre); and 3. Detect a suboptimal visual stimulus. Task performance was compared between unisensory, audiovisual congruent, and audiovisual incongruent conditions, and between groups.Result1. Identification of spoken names in a noisy auditory environment was significantly worse for both patient groups than controls. All groups performed significantly better when viewing an accompanying video of congruent lip movements. The AD group showed some improvement for incongruent videos that cued the onset of the spoken name. 2. Auditory spatial discrimination was significantly worse in the AD group than controls, but both groups were significantly biased by the locations of the accompanying visual stimulus. The bvFTD group was only influenced by spatially incongruent visual stimulation. 3. Detection of a near‐threshold peripheral visual stimulus was improved by a synchronous auditory stimulus, irrespective of spatial congruency, in the bvFTD and control groups. In the AD group, only spatially congruent or neutral auditory stimuli benefitted visual stimulus detection.ConclusionCongruent audiovisual stimulation improves the ability of people living with AD or bvFTD to understand voices in a noisy environment, locate auditory sounds, and detect unreliable visual events. Congruency of audiovisual stimulation in different domains (e.g. semantic, spatial) provides evidence for disease‐specific stratification of multisensory integration profiles. As such, multisensory integration provides a mechanism to improve reliability of sensory inputs and the potential to alleviate symptoms in daily life if tailored according to disease.
A mixed methods protocol for an impact and implementation evaluation of the Pharmacy First Services for management of common conditions in England
Objectives: In response to high levels of demand for primary medical services in England, characterized by longer appointment waiting times and delayed referrals, the Government developed its National Health Service (NHS) Primary Care Recovery Plan. A key component of the plan is Pharmacy First (PF), which involves participating community pharmacies supplying prescription-only medicine after consultation with a pharmacist for seven common conditions: earache, uncomplicated urinary tract infections in women, sore throat, sinusitis, impetigo, shingles, and infected insect bites. The study aims to evaluate the implementation of the PF service and its impact on the volume of prescribing, case mix of General Practitioner consultations, accident and emergency department and other hospital use, equity of access, and cost for different groups of patients in different contexts, as well as its acceptability and fidelity. Methods: A 36-month, mixed methods evaluation with five elements, namely evidence synthesis, semi-structured interviews, focus groups, quantitative analysis of impacts before and after implementation (e.g. using interrupted time series analysis) using routine data, and an economic evaluation. Findings will be synthesized and interpreted using the Consolidated Framework for Implementation Research supplemented by Proctor’s Implementation Outcomes Framework. Conclusions: The evaluation should have service level, policy, professional, and research impact both in England and beyond. This includes generating evidence to show: whether PF contributes to improving primary healthcare access, assessing the quality of antimicrobial use, identifying the scope for refinements to PF, and, overall, informing better implementation of PF. The findings will also provide robust evidence to enable policymakers to determine how to enhance the role of community pharmacy in England in the future. Furthermore, the evaluation will develop a data dashboard, and the methods and codes used to interrogate it (though not the patient data), will be made publicly available that could support other similar evaluations in England and internationally.
Erratum: Correction: Evaluation of the impact of COVID-19 pandemic on hospital admission related to common infections: Risk prediction models to tackle antimicrobial resistance in primary care (PloS one (2024) 19 12 DOI: 10.1371/journal.pone.0311515.)
[This corrects the article DOI: 10.1371/journal.pone.0311515.].
Influence of context on engagement with COVID-19 testing: a scoping review of barriers and facilitators to testing for healthcare workers, care homes and schools in the UK.
ObjectiveThe UK government's response to the COVID-19 pandemic included a 'test, trace and isolate' strategy. Testing services for healthcare workers, care homes and schools accounted for the greatest spend and volume of tests. We reviewed relevant literature to identify common and unique barriers and facilitators to engaging with each of these testing services.DesignScoping review.Search strategyPubMed, Scopus and the WHO COVID-19 Research Database were searched for evidence published between 1 January 2020 and 7 November 2022. This was supplemented by evidence identified via free-text searches on Google Scholar and provided by the UK Health Security Agency (UKHSA).Data extraction and synthesisData were extracted by a team of reviewers and synthesised thematically under the broad headings of perceptions, experiences, barriers and facilitators to engaging with the COVID-19 testing programme.ResultsThis study included 40 sources, including 17 from projects that informed UKHSA's decisions during the pandemic. Eight themes emerged and were used to categorise barriers and facilitators to engaging with the testing services for healthcare workers, care homes and schools: (1) perceived value, (2) trust in the tests and public bodies, (3) importance of infrastructure, (4) impact of media and social networks, (5) physical burden of the test, (6) perceived capability to undertake testing, (7) importance of relevant information and 8) consequences of testing.ConclusionsUniversal barriers and facilitators to engagement with the testing programme related to the core elements of each testing service, such as uncomfortable specimen collection and the influence of media and peers; these could be mitigated or leveraged to increase engagement across settings. However, the individuals involved, perceptions of value and available resources differed across services, leading to unique experiences between settings. Thus, consideration of context is crucial when designing and implementing a testing programme in response to a pandemic.
Impact of the COVID-19 pandemic on antidepressant prescribing with a focus on people with learning disability and autism: an interrupted time series analysis in England using OpenSAFELY-TPP.
BACKGROUND: COVID-19 restrictions led to increased reports of depressive symptoms in the general population and impacted health and social care services. We explored whether these changes affected antidepressant prescribing trends in the general population and those with learning disability or autism. METHODS: With the approval of NHS England, we used >24 million patients' primary care data from the OpenSAFELY-TPP platform. We used interrupted time series analysis to quantify trends in those prescribed and newly prescribed an antidepressant across key demographic and clinical subgroups, comparing pre-COVID-19 (January 2018-February 2020), COVID-19 restrictions (March 2020-February 2021) and recovery (March 2021-December 2022) periods. RESULTS: Prior to COVID-19 restrictions, antidepressant prescribing was increasing in the general population and in those with learning disability or autism. We did not find evidence that the pandemic was associated with a change in antidepressant prescribing trend in the general population (relative risk (RR) 1.00 (95% CI 0.97 to 1.02)), in those with autism (RR 0.99 (95% CI 0.97 to 1.01)) or in those with learning disability (RR 0.98 (95% CI 0.96 to 1.00)).New prescribing post restrictions was 13% and 12% below expected had COVID-19 not happened in both the general population and those with autism (RR 0.87 (95% CI 0.83 to 0.93), RR 0.88 (95% CI 0.83 to 0.92)), but not learning disability (RR 0.96 (95% CI 0.87 to 1.05)). CONCLUSIONS AND IMPLICATIONS: In this England study, we did not see an impact of COVID-19 on overall antidepressant prescribing, although unique trends were noted, such as trends in new antidepressant prescriptions which increased in care homes over the pandemic and decreased in the general population and those with autism since recovery.