HRB open research最新文献

{"title":"Using a digital health intervention \"INTERCEPT\" to improve secondary prevention in coronary heart disease (CHD) patients: protocol for a mixed methods non-randomised feasibility study.","authors":"Irene Gibson, Catriona Jennings, Lis Neubeck, Marissa Corcoran, David Wood, Faisal Sharif, Lisa Hynes, Andrew W Murphy, Molly Byrne, John William McEvoy","doi":"10.12688/hrbopenres.13781.1","DOIUrl":"10.12688/hrbopenres.13781.1","url":null,"abstract":"<p><strong>Background: </strong>Digital health interventions (DHIs) are increasingly used for the secondary prevention of cardiovascular disease (CVD). The aim of this study is to determine the feasibility of \"INTERCEPT\", a co-designed DHI developed to improve secondary prevention in hospitalised coronary heart disease patients (CHD).</p><p><strong>Methods: </strong>This non-randomised, pilot feasibility study with embedded process evaluation will be conducted with a sample of 40 patients in an acute hospital setting. Informed by behaviour change theory, INTERCEPT integrates a smartphone interface, health care professional portal, a fitness wearable and a blood pressure monitor. INTERCEPT is designed to support and motivate patients to set goals, self-monitor lifestyle and medical risk factors, and manage their medications, with the health care professional portal enabling monitoring and communication with patients. Using consecutive sampling, eligible patients will be recruited in two phases, a pre-implementation phase and an implementation phase. Commencing with pre-implementation (1 month duration), participants will not immediately receive INTERCEPT, however, they will be invited to receive INTERCEPT at 3 months follow-up. This will enable early learning about the processes of recruitment and conducting the assessment prior to full scale deployment of INTERCEPT in the next step implementation phase. During the implementation phase (2 months duration), participants will be invited to download INTERCEPT to their smartphone prior to hospital discharge. Qualitative interviews will be conducted among a subset of patients and health care professionals to gain a greater insight into their experience of using INTERCEPT. Primary outcomes will be assessed at baseline and 3-month follow-up. Using pre-defined feasibility criteria, including recruitment, retention and engagement rates, together with data on intervention acceptability, will determine the appropriateness of progressing to a definitive trial.</p><p><strong>Discussion: </strong>This study will provide important insights to help inform the feasibility of conducting a definitive trial of \"INTERCEPT\" among coronary heart disease patients in a critical health care setting.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":" ","pages":"43"},"PeriodicalIF":0.0,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10897504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48168460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the stability of psychobiological stress reactivity during adolescence: mixed-effect modelling of cortisol responses to laboratory stressors.","authors":"Jen O'Shea, Samantha Dockray, Elizabeth Susman","doi":"10.12688/hrbopenres.13874.2","DOIUrl":"https://doi.org/10.12688/hrbopenres.13874.2","url":null,"abstract":"<p><strong>Background: </strong>Puberty has been historically considered as a time of risk and vulnerability for young people. It is associated with rapid development in the hypothalamus, which is central in the production of both stress and sex steroids. While patterns of stress reactivity are calibrated in early life, this time of rapid development may provide a means for these patterns to change. This purpose of this study was to examine whether patterns of cortisol reactivity remained stable across one year of pubertal development, and whether variations in pubertal development impacted on this stability.</p><p><strong>Methods: </strong>This study used a secondary dataset comprised of 102 adolescent-aged children and adolescents. Children and adolescents took part in the Trier Social Stress Test to elicit a physiological stress response. Cortisol reactivity was measured as the increase in salivary cortisol concentration taken at five time points throughout the session. Pubertal stage was measured by nurse report where possible, and parent/self-report otherwise and was used to calculate pubertal timing and tempo relative to peers. Measures of anxiety, BMI, and socio-economic status were taken and included in analysis.</p><p><strong>Results: </strong>Results of a linear mixed-effect model found there to be a significant difference in cortisol reactivity over time, indicating that cortisol stress reactivity did not remain stable during this time (Estimate= 3.39, t=3.67, p<.001, CI[1.56, 5.22]). Additionally, results show children and adolescents who developed slower/quicker than peers displayed decreased stress reactivity (Estimate= -3.59, t=-2.13. p=.03, CI[-6.92, -0.25]).</p><p><strong>Conclusions: </strong>This research contributes to a relatively small but consistent body of research noting pattern of increased cortisol reactivity during pubertal development. While a significant effect was found for pubertal tempo, this finding should not be considered indicative of any true effect.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"7 ","pages":"26"},"PeriodicalIF":0.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11776060/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143069786","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Delirium and Cognitive Screening in National Hip Fracture Registries: Scoping Review Protocol.","authors":"Niamh A Merriman, Rose S Penfold, Louise Brent, Pamela Hickey, Mary E Walsh, Eithne Sexton, Tara Coughlan, Alasdair M J MacLullich, Antony Johansen, Cristina Ojeda-Thies, Andrew J Hall, Catherine Blake","doi":"10.12688/hrbopenres.13996.2","DOIUrl":"10.12688/hrbopenres.13996.2","url":null,"abstract":"<p><strong>Background: </strong>Delirium and cognitive impairment are common in hip fracture populations and are associated with significant adverse patient outcomes. National hip fracture registries facilitate improvements in patient outcomes and care quality, such as reduced mortality and the development of specialist multidisciplinary services. However, there is substantial variation in the data collected and reported in relation to delirium and cognition, which impedes international comparison and may reduce quality of care.</p><p><strong>Objective: </strong>This scoping review aims to identify delirium and cognition data items currently collected by hip fracture registries internationally, to identify associated registry guidance that exists for the administration of delirium and cognitive screening tools, and report outcomes of these data items across the most recently published annual reports of identified hip fracture registries.</p><p><strong>Methods: </strong>This scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews extension for Scoping Reviews (PRISMA-ScR). We will search the following databases: Medline Ovid; Embase; CINAHL EBSCOHost. Relevant websites such as the Fragility Fracture Network (FFN) will also be searched. Study selection and review will be carried out independently by two research team members, with discrepancies resolved by a third member of the research team. Data extraction and synthesis will be conducted by one reviewer and checked for accuracy and omissions by another. The scoping review findings will be informed and validated through engagement with the FFN Hip Fracture Audit Special Interest Group, who will share their knowledge, expertise, and research to achieve consensus over core aspects of the scoping review findings.</p><p><strong>Conclusion: </strong>By identifying existing heterogeneity in delirium and cognitive screening tool use and administration, it is hoped that administration and specific screening tool use will become standardised to optimise comparability across countries and ensure that high quality and reliable data are included across international registry reports.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"7 ","pages":"68"},"PeriodicalIF":0.0,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11773136/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143061616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The short-, medium-, and long-term prevalence of physical health comorbidities in first-episode psychosis: a systematic review and meta-analysis protocol.","authors":"Anna Zierotin, Jennifer Murphy, Brian O'Donoghue, Karen O'Connor, Michael Norton, Mary Clarke","doi":"10.12688/hrbopenres.13810.2","DOIUrl":"10.12688/hrbopenres.13810.2","url":null,"abstract":"<p><strong>Background: </strong>Individuals with first-episode psychosis (FEP) face an increased risk of physical comorbidities, notably cardiovascular diseases, metabolic disorders, respiratory disorders, and certain types of cancer. Previous reviews report pooled physical health prevalence from chronic psychosis and FEP groups. By contrast, this review will focus on antipsychotic-naïve FEP cohorts and incorporate data from observational longitudinal studies and antipsychotic intervention studies to understand the progression of physical health comorbidities from the onset to later stages of psychosis. This review aims to examine the short-, medium-, and long-term period prevalence of these comorbidities in FEP and variations related to demographic factors.</p><p><strong>Methods: </strong>Using the PRISMA and MOOSE guidelines, Medline, Embase, PsycINFO, and CINAHL+, as well as Clinical Trials gov.uk, OpenGrey, WHO International Clinical Trials Registry Platform, Current Controlled Trials, United States National Institute of Health Trials Registry, and the Irish Health Repository, will be searched from inception. Longitudinal studies and antipsychotic intervention studies monitoring health outcomes in antipsychotic naïve FEP individuals will be eligible for inclusion. Two reviewers will independently screen titles, abstracts, and full-text articles. Risk of bias will be assessed using the Joanna Briggs Institute Critical Appraisal Checklist. A meta-analysis of the short-, medium-, and long-term prevalence of cardiovascular, metabolic, cancer, and respiratory outcomes and a narrative synthesis will be conducted. Where feasible, a meta-regression on the impact of demographic variables will be conducted. Potential limitations include the risk of diagnostic heterogeneity across studies and possible underreporting of certain comorbidities.</p><p><strong>Conclusions: </strong>This systematic review will clarify the progression of physical health comorbidities in FEP, informing early intervention strategies and policies. Subsequent findings will be submitted to a leading journal, supplemented by a recovery education module and a lay summary for wider dissemination.</p><p><strong>Registration: </strong>The study was registered in PROSPERO, the International Prospective Register of Systematic Reviews ( CRD42023431072; 17/06/2023).</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"6 ","pages":"75"},"PeriodicalIF":0.0,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757914/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Equality, Diversity and Inclusion characteristics measured or reported in randomised trials of intrapartum interventions: A Scoping Review.","authors":"Susan Hannon, Aoife Smith, John Gilmore, Valerie Smith","doi":"10.12688/hrbopenres.14012.1","DOIUrl":"10.12688/hrbopenres.14012.1","url":null,"abstract":"<p><strong>Background: </strong>Equality, diversity and inclusion (EDI) has gained discursive momentum across multiple arenas, including in maternal health research. As a preliminary exploration for future discussion and development, we undertook a scoping review to identify the types, frequency, and extent of EDI characteristics that were measured and reported in randomised controlled trials (RCTs) of intrapartum interventions specifically.</p><p><strong>Methods: </strong>Joanna Briggs Institute methodological guidance for scoping reviews guided the conduct of the review. The population were women of any parity and risk category who were enrolled in intrapartum RCTs in any birth setting or geographical location. The concept was measured and reported EDI characteristics. CINAHL, MEDLINE, PsycINFO, EMBASE, and CENTRAL were searched from January 2019 to March 2024. Data were extracted using a pre-designed form. The findings were summarised and narratively reported supported by illustrative tables and graphs.</p><p><strong>Results: </strong>Two-hundred and forty-seven RCTs from 49 countries were included. Eleven EDI characteristics were measured or reported in at least one RCT, although frequency varied. Religion, for example, featured in three RCTs only, whereas Age featured in 222 RCTs. How the EDI characteristics featured also varied. Race/Ethnicity, for example, was described in 21 different ways in 25 RCTs. Similarly, Education was reported in 62 different ways across 96 RCTs. Ninety RCTs limited inclusion to nulliparous participants only, six RCTs required participants to have a minimum educational level, 127 RCTs had inclusion age cut-offs although 23 different variations of this were noted and 15 RCTs excluded participants on the grounds of disability.</p><p><strong>Conclusions: </strong>This scoping review highlights EDI characteristic measurement and reporting deficits in intrapartum RCTs. There is a critical need for improvements in designing, conducting, and reporting RCTs to incorporate EDI. By adopting more extensive EDI practices a greater understanding of healthcare treatments and innovations leading to enhanced maternal health equity could be achieved.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"7 ","pages":"78"},"PeriodicalIF":0.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11782935/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143082360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring Breastfeeding Mothers' and Lactation Consultants' Experiences of Lactation Consultancy Throughout the Restrictions Put in Place Due to the COVID-19 Pandemic.","authors":"Anna Connolly, Anne Matthews","doi":"10.12688/hrbopenres.13856.2","DOIUrl":"10.12688/hrbopenres.13856.2","url":null,"abstract":"<p><strong>Background: </strong>Breastfeeding rates in Ireland are among the lowest in the world. Lactation consultancy provides mothers with support and information on how to cope with any challenges they encounter. There is emerging evidence that COVID-19 restrictions impacted access to and the quality of breastfeeding support.The aim of this study was to explore breastfeeding mothers' and lactation consultants' experiences of breastfeeding support throughout the COVID-19 restrictions in Ireland. It also aimed to explore what adaptations had to be made to the delivery of lactation consultancy and how these changes impacted mothers' experiences of breastfeeding support.</p><p><strong>Methods: </strong>A qualitative research design was chosen. Semi-structured interviews were conducted with eight participants, three breastfeeding mothers and five lactation consultants. Interviews were conducted online via Zoom, audio-recorded and transcribed. The data were analysed using thematic analysis.</p><p><strong>Results: </strong>Five key themes were identified: 'Lack of Support', 'Adapting to COVID-19 Restrictions', Emotional Response to COVID-19 and Restrictions', Vaccination against SARS-CoV-2 as a Barrier to and Facilitator of Support' and Inconsistency of Lactation Support Across Ireland'. Both lactation consultants and mothers identified similar issues however, slight variations within lactation consultants' perceptions of mothers' and mothers' attitudes towards online services were seen. An notable finding was the lack of support in hospitals pre-COVID-19.</p><p><strong>Conclusions: </strong>Both mothers' and lactation consultants' experiences of lactation consultancy were impacted by the COVID-19 restrictions. Although exacerbated by COVID-19, the lack of support in hospitals existed before COVID-19. Provision of better breastfeeding support is required.Increased availability of lactation consultants and the implementation of breastfeeding rooms within hospitals is required in addition to debrief counselling sessions for lactation consultants. Further research is required to understand the unavailability of lactation consultants in hospital settings and to identify how to manage breastfeeding support in future emergency situations.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"7 ","pages":"9"},"PeriodicalIF":0.0,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757925/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143048950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A study to explore the role of a low threshold, fitness focussed physical rehabilitation intervention with protein supplementation to target physical function and frailty in people with problematic substance use and homelessness: protocol for a single-arm pre-post intervention study.","authors":"Fiona Kennedy, Clíona Ní Cheallaigh, Roman Romero-Ortuno, Suzanne Doyle, Julie Broderick","doi":"10.12688/hrbopenres.13678.2","DOIUrl":"10.12688/hrbopenres.13678.2","url":null,"abstract":"<p><strong>Background: </strong>People who are homeless are more likely to experience poor mental health and addiction as well as suffering from non-communicable diseases. There is evidence of frailty and accelerated physical ageing among people experiencing homelessness. Appropriate physical rehabilitation and nutritional supplementation strategies can stabilise or reverse frailty and general physical decline, but it is not known how this type of intervention would work in practice in this population.</p><p><strong>Aim: </strong>To evaluate the feasibility and pre-post intervention impact of a low threshold physical rehabilitation intervention with protein supplementation to target physical functioning and frailty in people with problematic substance use who are experiencing homelessness.</p><p><strong>Methods: </strong>The intervention will consist of a 12-week low threshold rehabilitation programme with protein supplementation. Participants will be service users of the Ballyfermot Advance Project, a day services centre for people with addiction issues and experiencing homelessness. Primary outcomes will be feasibility including numbers recruited, retention of participants and adherence to the exercise intervention and protein supplement. Any adverse events will be recorded. Secondary outcomes will be strength and muscular mass, physical performance and lower extremity physical function, pain, frailty and nutritional status.</p><p><strong>Discussion: </strong>An immediate impact may be simply a distraction from difficult circumstances and potentially an improvement of physical health of participants, which can be a conduit for the emergence of other positive behaviours and recovery. Longer term, this study will generate preliminary data on which to inform the design of a definitive randomised controlled trial of physical rehabilitation and protein supplementation, if indicated.</p><p><strong>Ethics and dissemination: </strong>Ethical approval was granted by the Faculty of Health Sciences Research Ethics Committee in TCD. Study findings will be disseminated through publication into an international peer-reviewed journal and presented at national and international conferences.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"6 ","pages":"26"},"PeriodicalIF":0.0,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11576564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142683599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a systematic search and critical discourse analysis of research on national HIV pre-exposure prophylaxis programmes among gay, bisexual, and other men who have sex with men.","authors":"David Comer, Chris Noone","doi":"10.12688/hrbopenres.13841.2","DOIUrl":"10.12688/hrbopenres.13841.2","url":null,"abstract":"<p><strong>Background: </strong>HIV pre-exposure prophylaxis (PrEP) is a medication that prevents the acquisition of HIV, most commonly taken in the form of a pill. PrEP is an efficacious tool for HIV prevention, including among gay, bisexual, and other men who have sex with men (gbMSM). PrEP is often provided through formal PrEP programmes. Research on these programmes may employ discourses shaped by heteronormativity and homophobia. Given that expert language influences how HIV prevention is understood and delivered, problematic discourses in research likely extend into PrEP implementation. This study will use critical discourse analysis (CDA) to explore research on PrEP programme implementation for gbMSM. Within this literature, we will identify interpretive repertoires used to discuss gbMSM; the subject positions afforded to gbMSM; and the implications of these interpretive repertoires and subject positions for gbMSM engaging with HIV PrEP programmes.</p><p><strong>Methods: </strong>Systematic search methods identified relevant articles through timebound searching (2012-2023) in ProQuest ASSIA, EBSCOhost PsycInfo, OVID Medline, OVID Embase, and EBSCOhost CINAHL, with forward and backward citation searching of included studies. Grey literature will be identified through ProQuest and Google Scholar. Screening will be conducted by two independent reviewers, who will conduct random partial double screening for titles and abstracts and for all full text articles. Data will be analysed and synthesised using CDA informed by critical realism (CR). CDA focuses on relationships between language and power, including how language enables inequality. The analytic process will explore the background of included studies, identify themes, and analyse external and internal relations in included studies.</p><p><strong>Conclusions: </strong>Highlighting issues with discourses in PrEP implementation may enhance reflective engagement with assumptions underlying this research, preventing further stigmatisation of gbMSM's sexual and protective practices. As PrEP programmes become more common, diverse and inclusive perspectives in PrEP programme research may inform interventions that enhance their acceptability and implementation.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"7 ","pages":"12"},"PeriodicalIF":0.0,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11532903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142577416","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Altmetric coverage of health research in Ireland 2017-2023: a protocol for a cross-sectional analysis.","authors":"Melissa K Sharp, Patricia Logullo, Pádraig Murphy, Prativa Baral, Sara Burke, David Robert Grimes, Máirín Ryan, Barbara Clyne","doi":"10.12688/hrbopenres.13895.2","DOIUrl":"10.12688/hrbopenres.13895.2","url":null,"abstract":"<p><strong>Background: </strong>Scientific publications have been growing exponentially, contributing to an oversaturated information environment. Quantifying a research output's impact and reach cannot be solely measured by traditional metrics like citation counts as these have a lag time and are largely focused on an academic audience. There is increasing recognition to consider 'alternative metrics' or altmetrics to measure more immediate and broader impacts of research. Better understanding of altmetrics can help researchers better navigate evolving information environments and changing appetites for different types of research.</p><p><strong>Objectives: </strong>Our study aims to: 1) analyse the amount and medium of Altmetric coverage of health research produced by Irish organisations (2017 - 2023), identifying changes over time and 2) investigate differences in the amount of coverage between clinical areas (e.g., nutrition vs. neurology).</p><p><strong>Methods: </strong>Using Altmetric institutional access, we will gather data on research outputs published 1 January 2017 through 31 December 2023 from active Irish organisations with Research Organisation Registry (ROR) IDs. Outputs will be deduplicated and stratified by their Australian and New Zealand Standard Research Classification relating to ≥1 field of health research: Biological Sciences, Biomedical and Clinical Sciences, Chemical Sciences, Health Sciences, and Psychology. We will clean data using R and perform descriptive analyses, establishing counts and frequencies of coverage by clinical area and medium (e.g., traditional news, X, etc.); data will be plotted on a yearly and quarterly basis where appropriate.</p><p><strong>Results and conclusions: </strong>Improved understanding of one's information environment can help researchers better navigate their local landscapes and identify pathways for more effective communication to the public. All R code will be made available open-source, allowing researchers to adapt it to evaluate their local landscapes.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"7 ","pages":"36"},"PeriodicalIF":0.0,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11443184/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142360731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial.","authors":"Linda O'Neill, Fiona Murphy, Derval Reidy, Camille Poisson, Juliette Hussey, Emer Guinan","doi":"10.12688/hrbopenres.13763.2","DOIUrl":"10.12688/hrbopenres.13763.2","url":null,"abstract":"<p><strong>Background: </strong>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 ' <i>Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial'</i>, a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial.</p><p><strong>Registration: </strong>ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"6 ","pages":"46"},"PeriodicalIF":0.0,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11401978/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142302591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}