HRB open research最新文献

Background: Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ' Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial', a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors.

Methods: This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James's Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit.

Results: The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date.

Conclusion: This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial.

Registration: ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019.

Rationale: The planetary crisis is a serious threat to human health. Healthcare professionals need to be trained to adapt to and mitigate against this crisis. Competencies, curricular frameworks and learning outcomes relating to climate change and sustainability (CC&S) have been proposed for healthcare professionals. A synthesis of these competencies, learning outcomes and frameworks is necessary to identify commonalities and differences, understand the process of their development and highlight areas for future development.

Objective: The objective of this scoping review is to identify and synthesise the evidence on competencies, curricular frameworks and learning outcomes for healthcare professionals in climate change and sustainability.

Inclusion criteria: Sources relating to healthcare professionals and healthcare students, describing competencies, curricular frameworks and learning outcomes in CC&S, will be included. Sources in all healthcare contexts will be included. Sources in the English language, published from 2014 to June 2024 will be considered for inclusion.

Methods: The review will be conducted in line with the Joanna Briggs Institute guidance for scoping reviews. The following electronic databases will be searched: PubMed, Embase, CINAHL, PsycINFO, SocINDEX, Academic Search Complete, Business Source Complete, British Education Index, Australian Education Index, Scopus and ERIC. A search of the grey literature will also be conducted. Two reviewers will independently screen the titles and abstracts and full texts for eligibility. Data extraction will be conducted independently by two reviewers. A narrative summary and tables will be presented. Key stakeholders will be consulted throughout the review.

Discussion: This review will summarise the range of competencies, curricular frameworks and learning outcomes proposed internationally for various healthcare professionals. The findings will be used to inform core competencies for all healthcare professions in CC&S, in addition to highlighting gaps in the literature and areas for future development. The findings will be disseminated at conferences and in a peer-reviewed publication.

Registration: This protocol was registered on 31 ^st July 2024 on the Open Science Framework ( https://osf.io/vnx2g).

Background: The increasing necessity for specialised training in primary care cancer research stems from GPs' pivotal role in cancer detection and holistic care coupled with the unique primary care context. This has led to the development of the PRiCAN Scholars Network, an initiative to enhance the research capabilities of Graduate Entry Medicine (GEM) students in RCSI University of Medicine and Health Sciences, Dublin, Ireland. This protocol outlines a proposal for the systematic development, implementation, and evaluation of a curriculum aimed at improving the primary care cancer research skills of this cohort.

Methods: The curriculum development process will be guided by Kern's six-step approach. Initial stages involve comprehensive needs assessments via surveys and focus groups to identify educational needs. Subsequently, targeted learning objectives and aligned educational strategies will be defined to maximise learning opportunities and impact. The curriculum's impact will be evaluated in a pilot phase with selected students and faculty, utilising both qualitative and quantitative feedback to drive continuous improvements.

Conclusion: This protocol describes a detailed method for establishing a primary care cancer research curriculum within the PRiCAN Scholars Network. Designed with a focus on sustainability and adaptability, the curriculum will be structured to develop and support a generation of medical professionals' literate in primary care research, contributing to the advancement of medical education and cancer research.

Background: Stroke represents a major source of mortality and morbidity globally. The role of a stroke Clinical Nurse Specialist (CNS) as an expert team member in early supported discharge (ESD) for stroke, is not well defined or described although it is well established in other models of after-hospital and out-reach specialist care in the community. A greater focus has been on patients receiving rehabilitation post-stroke, however there is a need for a more holistic approach to care which clinical nurse specialists can offer to patients as part of ESD. Nurses are often the cohesive point of contact for other after-hospital services, managing many aspects of secondary prevention.

Objective: The aim of this scoping review is to explore the evidence in relation to the role of the stroke nurse providing secondary prevention interventions to stroke patients in a community setting.

Methods: We will conduct a scoping review in accordance with the Arksey and O'Malley, 2005 ¹ scoping review framework and the PRISMA-ScR guidelines to map available literature on the role of the stroke nurse in post-stroke care of patients in the community. The Cochrane Central Register of Controlled Trials and Systematic literature searches including databases MEDLINE, EMBASE, CINAHL, google scholar and grey literature will be searched using keyword searches. Data will be charted and synthesised and a narrative synthesis will be conducted.

Conclusions: This scoping review will be used to identify gaps in the current literature and identify areas for future research in the role of the stroke nurse in ESD in relation to secondary prevention for stroke patients and inform the development of a pathway for stroke nursing in ESD.

Background: Childhood obesity is a significant global public health challenge, with significant adverse effects on both mental and physical health outcomes. During the period from birth to one-year, modifiable caregiver behaviours, such as what, how and when infants are fed, can influence obesity development and prevention. The Choosing Healthy Eating for Infant Health (CHErIsH) intervention was developed to support healthy infant feeding practices to prevent childhood obesity in the first year. A feasibility study examined acceptability and feasibility of the CHErIsH intervention in primary care and identified key challenges and possible areas for refinement of the intervention and trial processes. The current project aims to refine delivery of the CHErIsH intervention and trial processes to maximise the likelihood of successful future implementation and evaluation.

Methods: This study will utilise a mixed-methods approach and will be conducted in three phases. In Phase 1 potential refinements to the CHErIsH intervention delivery and trial processes will be developed from a review of the feasibility study findings and input from the multidisciplinary team. An online mixed-methods survey will be conducted in Phase 2 to evaluate caregiver attitudes about the proposed refinements from Phase 1. Participants will be pregnant women, their partners, and/or parents/primary caregivers of infants up to 2-years of age, based in Ireland. Participants will be recruited using convenience and snowball sampling. In Phase 3 a stakeholder consensus meeting, using the nominal group technique, will be conducted to agree the refined intervention and trial processes. Stakeholders will include healthcare professionals, researchers, policymakers, and parents/caregivers, who will discuss and rate refinements in terms of preference.

Conclusions: Findings from this study will address uncertainties in the intervention delivery and trial processes of the CHErIsH intervention, with the potential to maximise the likelihood of successful future implementation and evaluation of a primary-care based obesity prevention intervention.

Background: Sláintecare aims to introduce universal healthcare in Ireland. The COVID-19 pandemic poses both challenges and opportunities to this process. This study explored the impact of COVID-19 on aspects of Irish healthcare during the first nine months of the pandemic and considers the implications for Sláintecare implementation.

Methods: Secondary analysis was undertaken on publicly available data on three key domains of the Irish healthcare system: primary care, community-based allied healthcare, and hospitals. Descriptive statistics were computed using Microsoft Excel 2016.

Results: Up to March 2021, 3.76 million COVID-19 tests were performed by Ireland's public healthcare system, 2.48 million (66.0%) of which were referred from the community. General practitioners delivered 2.31 million telephone triages of COVID-19 symptoms, peaking in December 2020 when 416,607 consultations occurred. Patient numbers across eight allied healthcare specialties fell by 35.1% versus previous years, with the greatest reductions seen in speech and language therapy (49.0%) and audiology (46.1%). Hospital waiting lists increased from 729,937 to 869,676 (or by 19.1%) from January 2019 to January 2021. In January 2021, 629,919 patients awaited a first outpatient clinic appointment, with 170,983 (27.1%) waiting longer than 18 months. The largest outpatient lists were observed in orthopaedic surgery (n=77,257); ear, nose and throat surgery (n=68,073); and ophthalmology (n=47,075). The proportion of patients waiting more than 12 months for a day-case gastrointestinal endoscopy rose from 6.0% in January 2020 to 19.0% in January 2021.

Conclusions: Healthcare activity has been significantly disrupted by COVID-19, leading to increased wait times and greater barriers to healthcare access during the pandemic. Yet, Ireland's health system responses also revealed strong willingness and ability to adapt and to implement novel solutions for healthcare delivery, rapidly and at scale. This has demonstrated what is achievable under Sláintecare and provides a unique opportunity to 'build back better' towards sustainable recovery.

Background: Neurocognitive disorders (NCDs), including delirium, cognitive impairment, or dementia are prevalent in up to 39% of older adults in acute care, particularly older trauma patients. Undiagnosed NCDs result in poor outcomes, such as increased incidence of depressive symptoms, longer length of stay, and mortality.

Objective: This study aims to identify the diagnostic test accuracy of screening tools for the detection of NCDs in older trauma patients in acute settings.

Design: Systematic review protocol.

Literature search: Electronic databases (MEDLINE, Embase, CINAHL, PsycInfo, Cochrane Library) will be searched for journal articles. Search terms related to NCDs, delirium and cognitive screening tools, and diagnostic accuracy will be included.

Study selection criteria: Cross-sectional, prospective, or retrospective cohort studies of adults aged ≥60 post-trauma, in an acute setting, will be included where the study aimed to validate a screening tool for detection of 1) delirium or 2) cognitive impairment, or dementia against a reference standard of a clinical decision, based on standardised diagnostic criteria or a validated tool.

Data synthesis: Two review authors will conduct study selection, data extraction, and appraisal. Data will be extracted based on the Preferred Reporting Items for a Systematic Review and Meta-analysis of Diagnostic Test Accuracy Studies (PRISMA-DTA) checklist. Studies will be assessed for methodological quality by two independent review authors using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Narrative summaries will be generated describing risk of bias and concerns regarding applicability. Quantitative synthesis of study findings will be conducted.

Conclusion: This systematic review will aim to identify screening tools with the best diagnostic accuracy for detection of 1) delirium and 2) cognitive impairment or dementia in adults aged ≥60 post-trauma in acute care settings. Results will inform clinical practice to enhance the probability of patients with NCDs receiving appropriate care and management.

Registration: PROSPERO https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024518730 (11/03/2024).

Background: Following Spinal Cord Injury (SCI), 53% of people develop neuropathic pain (NP). NP can be more debilitating than other consequences of SCI, and a persistent health issue. Pharmacotherapies are commonly recommended for NP management in SCI, although severe pain often remains refractory to these treatments in many sufferers. Furthermore, poor medication adherence exists, stemming from unacceptable side-effects and fear of dependency.Sensorimotor stimulation using active walking with robotic assistance has not been well studied in NP after SCI, despite convincing locomotor-based pre-clinical studies, identifying prevention and reversal of NP.Our primary aim is to assess the impact of exoskeleton-based walking on NP intensity and interference after SCI and examine feasibility outcomes for progression to a definitive trial.

Methods: This is a phase 2 single-blinded, randomised feasibility study. It will test the feasibility and acceptability of exoskeleton-based walking 3 times per week for 12 weeks (intervention), as a mechanistic-based intervention for NP after SCI. The comparator will be an equally dosed, blended relaxation programme devoid of motor imagery prompts. 40 participants with moderate-to-severe NP post SCI will be recruited and randomised to intervention and comparator groups.The primary outcomes are feasibility outcomes for progression to definitive trial which include recruitment and retention rates, adverse events and acceptability of the intervention.Secondary outcomes explore changes in NP intensity and interference as measured by the International Spinal Cord Injury Pain Basic Data Set 3.0 (ISCIPBDS) at baseline, post-intervention (week 13) and at 6-month follow-up.

Conclusions: There is a need to explore non-pharmacological management of NP after SCI. The findings of this feasibility trial will inform the development of a future multicentre, international RCT.

Trial registration: NCT06463418, 08/07/2024, https://clinicaltrials.gov/study/NCT06463418.

Introduction: Internationally, the prevalence of diabetes is increasing, and with this comes an increase in diabetes related complications. Diabetic foot disease is the most common lower extremity complication in people with diabetes causing 2% of the global disease burden. It, is associated with major morbidity, mortality, and costs to health services. Despite this burden, the incidence and prevalence of diabetic foot disease is unknown in Ireland. This paper presents a protocol for a systematic review to examine the incidence and prevalence of diabetic foot disease in the Irish population.

Methods: A systematic review will be performed using the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines. Pubmed, EMBASE, and Lenus, the Irish Health Research repository, will be searched for publications in any language and without restrictions to date. Title, abstract, and full text screening will be carried out independently by two investigators. Publications reporting on the incidence or prevalence of peripheral neuropathy, peripheral artery disease, ulceration, or amputation in people with diabetes in Ireland, from a defined geographical catchment area of Ireland, will be included. Joanna Briggs Institute (JBI) Critical Appraisal tool will be used to assess included studies methodological quality. Results will be reported in line with the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines.

Conclusion: The results of this systematic review can be used to inform appropriate stakeholders on the incidence and prevalence of diabetic foot disease in Irish populations, enabling decision making around appropriate use of resources to help prevent, and improve management of this disease.

Systematic review registration: CRD42023472904.

Background: This study aims to understand and explain the influence of contextual factors on the implementation of Intentional Rounding in acute hospitals using the realist synthesis methodology.Falls of hospital admitted patients are one of the most frequent concerns for patient safety in the acute hospital environment. The reasons why people fall are complex. International guidelines recommend a multifactorial assessment and effective prevention and management of identified risk factors in order to reduce the number of falls. Intentional Rounding (IR) is one approach for delivering this. IR is an umbrella term, understood as a structured process whereby nurses or care staff carry out regular checks with individual patients using a standardised protocol to address such issues as positioning, pain, personal needs and placement of possessions.

Methods: This study will use realist synthesis to understand what works, for whom, in what circumstances, and in what settings. Realist synthesis is a theory driven interpretive approach to evidence synthesis. It is our intention to analyse IR as an intervention, which aims to enhance patient care and safety in hospital settings. The synthesis forms part of a larger implementation study examining interventions that reduce the number of falls that occur in hospitals. Search terms will include intentional rounding, purposeful rounding, comfort rounding and hourly rounding and will encompass search terms beyond IR and falls rates to avoid limiting the synthesis. This synthesis will conform to the RAMESES (realist and meta-narrative evidence synthesis group) publication and reporting quality standards.

Conclusions: The findings will inform the next phase of an implementation study on IR in acute hospital settings, to address evidence informed enablers and barriers to IR. The results will be disseminated in a peer-reviewed journal and through presentations.