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Evaluating patient factors, operative management and postoperative outcomes in trauma laparotomy patients worldwide: a protocol for a global observational multicentre trauma study

Por: Bath · M. F. · Kohler · K. · Hobbs · L. · Smith · B. G. · Clark · D. J. · Kwizera · A. · Perkins · Z. · Marsden · M. · Davenport · R. · Davies · J. · Amoako · J. · Moonesinghe · R. · Weiser · T. · Leather · A. J. M. · Hardcastle · T. · Naidoo · R. · Nördin · Y. · Conway Morris · A. · Lak
Introduction

Trauma contributes to the greatest loss of disability-adjusted life-years for adolescents and young adults worldwide. In the context of global abdominal trauma, the trauma laparotomy is the most commonly performed operation. Variation likely exists in how these patients are managed and their subsequent outcomes, yet very little global data on the topic currently exists. The objective of the GOAL-Trauma study is to evaluate both patient and injury factors for those undergoing trauma laparotomy, their clinical management and postoperative outcomes.

Methods

We describe a planned prospective multicentre observational cohort study of patients undergoing trauma laparotomy. We will include patients of all ages who present to hospital with a blunt or penetrating injury and undergo a trauma laparotomy within 5 days of presentation to the treating centre. The study will collect system, patient, process and outcome data, following patients up until 30 days postoperatively (or until discharge or death, whichever is first). Our sample size calculation suggests we will need to recruit 552 patients from approximately 150 recruiting centres.

Discussion

The GOAL-Trauma study will provide a global snapshot of the current management and outcomes for patients undergoing a trauma laparotomy. It will also provide insight into the variation seen in the time delays for receiving care, the disease and patient factors present, and patient outcomes. For current standards of trauma care to be improved worldwide, a greater understanding of the current state of trauma laparotomy care is paramount if appropriate interventions and targets are to be identified and implemented.

Effectiveness of an anti-inflammatory diet versus low-fat diet for knee osteoarthritis: the FEAST randomised controlled trial protocol

Por: Law · L. · Heerey · J. L. · Devlin · B. L. · Brukner · P. · Kemp · J. L. · Attanayake · A. · Hulett · M. D. · De Livera · A. · Mosler · A. B. · Morris · H. G. · White · N. P. · Culvenor · A. G.
Introduction

Chronic inflammation plays a key role in knee osteoarthritis pathophysiology and increases risk of comorbidities, yet most interventions do not typically target inflammation. Our study will investigate if an anti-inflammatory dietary programme is superior to a standard care low-fat dietary programme for improving knee pain, function and quality-of-life in people with knee osteoarthritis.

Methods and analysis

The eFEct of an Anti-inflammatory diet for knee oSTeoarthritis study is a parallel-group, assessor-blinded, superiority randomised controlled trial. Following baseline assessment, 144 participants aged 45–85 years with symptomatic knee osteoarthritis will be randomly allocated to one of two treatment groups (1:1 ratio). Participants randomised to the anti-inflammatory dietary programme will receive six dietary consultations over 12 weeks (two in-person and four phone/videoconference) and additional educational and behaviour change resources. The consultations and resources emphasise nutrient-dense minimally processed anti-inflammatory foods and discourage proinflammatory processed foods. Participants randomised to the standard care low-fat dietary programme will receive three dietary consultations over 12 weeks (two in-person and one phone/videoconference) consisting of healthy eating advice and education based on the Australian Dietary Guidelines, reflecting usual care in Australia. Adherence will be assessed with 3-day food diaries. Outcomes are assessed at 12 weeks and 6 months. The primary outcome will be change from baseline to 12 weeks in the mean score on four Knee injury and Osteoarthritis Outcome Score (KOOS4) subscales: knee pain, symptoms, function in daily activities and knee-related quality of life. Secondary outcomes include change in individual KOOS subscale scores, patient-perceived improvement, health-related quality of life, body mass and composition using dual-energy X-ray absorptiometry, inflammatory (high-sensitivity C reactive protein, interleukins, tumour necrosis factor-α) and metabolic blood biomarkers (glucose, glycated haemoglobin (HbA1c), insulin, liver function, lipids), lower-limb function and physical activity.

Ethics and dissemination

The study has received ethics approval from La Trobe University Human Ethics Committee. Results will be presented in peer-reviewed journals and at international conferences.

Trial registration number

ACTRN12622000440729.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients musculoskeletal pain and enablement

Por: Bishop · F. L. · Cross · N. · Dewar-Haggart · R. · Teasdale · E. · Herbert · A. · Robinson · M. E. · Ridd · M. J. · Mallen · C. · Clarson · L. · Bostock · J. · Becque · T. · Stuart · B. · Garfield · K. · Morrison · L. · Pollet · S. · Vennik · J. · Atherton · H. · Howick · J. · Leydon · G. M
Introduction

Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.

Methods and analysis

A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.

Ethics approval and dissemination

Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.

Trial registration number

ISRCTN18010240.

Codesigning enhanced models of care for Northern Australian Aboriginal and Torres Strait Islander youth with type 2 diabetes: study protocol

Por: Kirkham · R. · Puszka · S. · Titmuss · A. · Freeman · N. · Weaver · E. · Morris · J. · Mack · S. · O'Donnell · V. · Boffa · J. · Dowler · J. · Ellis · E. · Corpus · S. · Graham · S. · Scott · L. · Sinha · A. K. · Connors · C. · Shaw · J. E. · Azzopardi · P. · Brown · A. · Davis · E. · Wicklow
Introduction

Premature onset of type 2 diabetes and excess mortality are critical issues internationally, particularly in Indigenous populations. There is an urgent need for developmentally appropriate and culturally safe models of care. We describe the methods for the codesign, implementation and evaluation of enhanced models of care with Aboriginal and Torres Strait Islander youth living with type 2 diabetes across Northern Australia.

Methods and analysis

Our mixed-methods approach is informed by the principles of codesign. Across eight sites in four regions, the project brings together the lived experience of Aboriginal and Torres Strait Islander young people (aged 10–25) with type 2 diabetes, their families and communities, and health professionals providing diabetes care through a structured yet flexible codesign process. Participants will help identify and collaborate in the development of a range of multifaceted improvements to current models of care. These may include addressing needs identified in our formative work such as the development of screening and management guidelines, referral pathways, peer support networks, diabetes information resources and training for health professionals in youth type 2 diabetes management. The codesign process will adopt a range of methods including qualitative interviews, focus group discussions, art-based methods and healthcare systems assessments. A developmental evaluation approach will be used to create and refine the components and principles of enhanced models of care. We anticipate that this codesign study will produce new theoretical insights and practice frameworks, resources and approaches for age-appropriate, culturally safe models of care.

Ethics and dissemination

The study design was developed in collaboration with Aboriginal and Torres Strait Islander and non-Indigenous researchers, health professionals and health service managers and has received ethical approval across all sites. A range of outputs will be produced to disseminate findings to participants, other stakeholders and the scholarly community using creative and traditional formats.

Clinical and cost-effectiveness of DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people living with dementia and their carers: a study protocol for a parallel multicentre randomised controlled trial

Por: Rapaport · P. · Amador · S. · Adeleke · M. · Banerjee · S. · Barber · J. · Charlesworth · G. · Clarke · C. · Connell · C. · Espie · C. · Gonzalez · L. · Horsley · R. · Hunter · R. · Kyle · S. D. · Manela · M. · Morris · S. · Pikett · L. · Raczek · M. · Thornton · E. · Walker · Z. · Webster
Introduction

Many people living with dementia experience sleep disturbance and there are no known effective treatments. Non-pharmacological treatment options should be the first-line sleep management. For family carers, relatives’ sleep disturbance leads to interruption of their sleep, low mood and breakdown of care. Our team developed and delivered DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives), a multimodal non-pharmacological intervention, showing it to be feasible and acceptable. The aim of this randomised controlled trial is to establish whether DREAMS START is clinically cost-effective in reducing sleep disturbances in people living with dementia living at home compared with usual care.

Methods and analysis

We will recruit 370 participant dyads (people living with dementia and family carers) from memory services, community mental health teams and the Join Dementia Research Website in England. Those meeting inclusion criteria will be randomised (1:1) either to DREAMS START or to usual treatment. DREAMS START is a six-session (1 hour/session), manualised intervention delivered every 1–2 weeks by supervised, non-clinically trained graduates. Outcomes will be collected at baseline, 4 months and 8 months with the primary outcome being the Sleep Disorders Inventory score at 8 months. Secondary outcomes for the person with dementia (all proxy) include quality of life, daytime sleepiness, neuropsychiatric symptoms and cost-effectiveness. Secondary outcomes for the family carer include quality of life, sleep disturbance, mood, burden and service use and caring/work activity. Analyses will be intention-to-treat and we will conduct a process evaluation.

Ethics and dissemination

London—Camden & Kings Cross Ethics Committee (20/LO/0894) approved the study. We will disseminate our findings in high-impact peer-reviewed journals and at national and international conferences. This research has the potential to improve sleep and quality of life for people living with dementia and their carers, in a feasible and scalable intervention.

Trial registration number

ISRCTN13072268.

Implementation of a Scalable Online Weight Management Programme in Clinical Settings: Protocol for the PROPS 2.0 Programme (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0)

Por: Cho · J. · Noonan · S. H. · Fay · R. · Apovian · C. M. · McCarthy · A. C. · Blood · A. J. · Samal · L. · Fisher · N. · Orav · J. E. · Plutzky · J. · Block · J. P. · Bates · D. W. · Rozenblum · R. · Tucci · M. · McPartlin · M. · Gordon · W. J. · McManus · K. D. · Morrison-Deutsch · C. · Sci
Introduction

There is an urgent need for scalable strategies for treating overweight and obesity in clinical settings. PROPS 2.0 (Partnerships for Reducing Overweight and Obesity with Patient-Centered Strategies 2.0) aims to adapt and implement the combined intervention from the PROPS Study at scale, in a diverse cross-section of patients and providers.

Methods and analysis

We are implementing PROPS 2.0 across a variety of clinics at Brigham and Women’s Hospital, targeting enrolment of 5000 patients. Providers can refer patients or patients can self-refer. Eligible patients must be ≥20 years old and have a body mass index (BMI) of ≥30 kg/m2 or a BMI of 25–29.9 kg/m2 plus another cardiovascular risk factor or obesity-related condition. After enrolment, patients register for the RestoreHealth online programme/app (HealthFleet Inc.) and participate for 12 months. Patients can engage with the programme and receive personalized feedback from a coach. Patient navigators help to enrol patients, enter updates in the electronic health record, and refer patients to additional resources. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is guiding the evaluation.

Ethics and dissemination

The Mass General Brigham Human Research Committee approved this protocol. An implementation guide will be created and disseminated, to help other sites adopt the intervention in the future.

Trial registration number

NCT0555925.

Research priorities for childrens cancer: a James Lind Alliance Priority Setting Partnership in the UK

Por: Aldiss · S. · Hollis · R. · Phillips · B. · Ball-Gamble · A. · Brownsdon · A. · Chisholm · J. · Crowther · S. · Dommett · R. · Gower · J. · Hall · N. J. · Hartley · H. · Hatton · J. · Henry · L. · Langton · L. · Maddock · K. · Malik · S. · McEvoy · K. · Morgan · J. E. · Morris · H. · Parke
Objectives

To engage children who have experienced cancer, childhood cancer survivors, their families and professionals to systematically identify and prioritise research questions about childhood cancer to inform the future research agenda.

Design

James Lind Alliance Priority Setting Partnership.

Setting

UK health service and community.

Methods

A steering group oversaw the initiative. Potential research questions were collected in an online survey, then checked to ensure they were unanswered. Shortlisting via a second online survey identified the highest priority questions. A parallel process with children was undertaken. A final consensus workshop was held to determine the Top 10 priorities.

Participants

Children and survivors of childhood cancer, diagnosed before age 16, their families, friends and professionals who work with this population.

Results

Four hundred and eighty-eight people submitted 1299 potential questions. These were refined into 108 unique questions; 4 were already answered and 3 were under active study, therefore, removed. Three hundred and twenty-seven respondents completed the shortlisting survey. Seventy-one children submitted questions in the children’s surveys, eight children attended a workshop to prioritise these questions. The Top 5 questions from children were taken to the final workshop where 23 questions in total were discussed by 25 participants (young adults, carers and professionals). The top priority was ‘can we find effective and kinder (less burdensome, more tolerable, with fewer short and long-term effects) treatments for children with cancer, including relapsed cancer?’

Conclusions

We have identified research priorities for children’s cancer from the perspectives of children, survivors, their families and the professionals who care for them. Questions reflect the breadth of the cancer experience, including diagnosis, relapse, hospital experience, support during/after treatment and the long-term impact of cancer. These should inform funding of future research as they are the questions that matter most to the people who could benefit from research.

Investigating Scottish Long COVID community rehabilitation service models from the perspectives of people living with Long COVID and healthcare professionals: a qualitative descriptive study

Por: Duncan · E. · Alexander · L. · Cowie · J. · Love · A. · Morris · J. H. · Moss · R. · Ormerod · J. · Preston · J. · Shim · J. · Stage · E. · Tooman · T. · Cooper · K.
Objectives

This study aimed to explore the perceptions and experiences of barriers and facilitators to accessing Long COVID community rehabilitation.

Design

We used a qualitative descriptive design over two rounds of data collection with three participant groups: (1) people with experience of rehabilitation for Long COVID (PwLC); (2) National Health Service (NHS) staff delivering and/or managing community rehabilitation services (allied health professionals (AHPs)) and (3) NHS staff involved in strategic planning around Long COVID in their health board (Long COVID leads).

Setting

Four NHS Scotland territorial health boards.

Participants

51 interviews: eight Long COVID leads (11 interviews); 15 AHPs (25 interviews) and 15 PwLC (15 interviews).

Results

Three key themes were identified: (1) accessing care for PwLC, (2) understanding Long COVID and its management and (3) strengths and limitations of existing Long COVID rehabilitation services.

Conclusions

Organisational delivery of Long COVID community rehabilitation is complex and presents multiple challenges. In addition, access to Long COVID community rehabilitation can be challenging. When accessed, these services are valued by PwLC but require adequate planning, publicity and resource. The findings presented here can be used by those developing and delivering services for people with Long COVID.

Assessment of the Global Fund-supported procurement and supply chain reforms at the Ethiopian Pharmaceuticals Supply Agency: a mixed-methods study

Por: Lesego · A. · Tsegaye · T. · Were · L. P. O. · Sakvarelidze · G. · Garg · S. · Morrison · L. · Nigussie · S. · Githendu · P. · Achoki · T.
Objective

The Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) partnered with the Ethiopian Pharmaceutical Supply Agency (EPSA) in 2018–2019 to reform procurement and supply chain management (PSCM) procedures within the Ethiopian healthcare system. This assessment sought to determine the impact of the reforms and document the lessons learnt.

Design

Mixed-methods study incorporating qualitative and quantitative analysis. Purposive and snowballing sampling techniques were applied for the qualitative methods, and the data collected was transcribed in full and subjected to thematic content analysis. Descriptive analysis was applied to quantitative data.

Setting

The study was based in Ethiopia and focused on the EPSA operations nationally between 2017 and 2021.

Participants

Twenty-five Ethiopian healthcare decision-makers and health workers.

Intervention

Global Fund training programme for health workers and infrastructural improvements

Outcomes

Operational and financial measures for healthcare PSCM.

Results

The availability of antiretrovirals, tuberculosis and malaria medicines, and other related commodities, remained consistently high. Line fill rate and forecast accuracy were average. Between 2018 and 2021, procurement lead times for HIV and malaria-related orders reduced by 43.0% relative to other commodities that reported an increase. Many interview respondents recognised the important role of the Global Fund support in improving the performance of EPSA and provided specific attributions to the observed successes. However, they were also clear that more needs to be done in specific critical areas such as financing, strategic reorganisation, data and information management systems.

Conclusion

The Global Fund-supported initiatives led to improvements in the EPSA performance, despite several persistent challenges. To sustain and secure the gains achieved so far through Global Fund support and make progress, it is important that various stakeholders, including the government and the donor community, work together to support EPSA in delivering on its core mandate within the Ethiopian health system.

The Oxford Needle Experience (ONE) scale: a UK-based and US-based online mixed-methods psychometric development and validation study of an instrument to assess needle fear, attitudes and expectations in the general public

Por: Kantor · J. · Vanderslott · S. · Morrison · M. · Pollard · A. J. · Carlisle · R. C.
Objectives

To develop and validate the Oxford Needle Experience (ONE) scale, an instrument to assess needle fear, attitudes and expectations in the general population.

Design

Cross-sectional validation study.

Setting

Internet-based with participants in the UK and USA.

Participants

UK and US representative samples stratified by age, sex, and ethnicity using the Prolific Academic platform.

Main outcome measures

Exploratory factor analysis with categorical variables and a polychoric correlation matrix followed by promax oblique rotation on the UK sample for the ONE scale. Confirmatory factor analysis (CFA) with a Satorra-Bentler scaled test statistic evaluating the root mean squared error of approximation (RMSEA), standardised root mean squared residual (SRMR) and comparative fit index (CFI) on the US sample. Reliability as internal consistency using McDonald’s omega. Convergent validity using the Pearson correlation coefficient. Predictive and discriminant validity using logistic regression ORs of association (OR).

Results

The population included 1000 respondents, 500 in the UK and 500 in the USA. Minimum average partial correlation and a scree plot suggested four factors should be retained: injection hesitancy, blood-related hesitancy, recalled negative experiences and perceived benefits, yielding a 19-question scale. On CFA, the RMSEA was 0.070 (90% CI, 0.064 to 0.077), SRMR 0.053 and CFI 0.925. McDonald’s omega was 0.92 and 0.93 in the UK and US samples, respectively. Convergent validity with the four-item Oxford Coronavirus Explanations, Attitudes and Narratives Survey (OCEANS) needle fear scale demonstrated a strong correlation (r=0.83). Predictive validity with a single-question COVID-19 vaccination status question demonstrated a strong association, OR (95% CI) 0.97 (0.96 to 0.98), p

Conclusions

The ONE scale is a reliable and valid multidimensional scale that may be useful in predicting vaccine hesitancy, designing public health interventions to improve vaccine uptake and exploring alternatives to needles for medical procedures.

Measuring the success of programmes of care for people living with dementia: a protocol for consensus building with consumers to develop a set of Core Outcome Measures for Improving Care (COM-IC)

Por: Comans · T. · Nguyen · K. · Gray · L. · Flicker · L. · Williamson · P. · Dodd · S. · Kearney · A. · Cunningham · C. · Morris · T. · Nunn · J. · Trepel · D. · Almeida · O. P. · Kenny · D. · Welch · A. · Lowthian · J. A. · Quinn · J. · Petrie · G. · Dao-Tran · T.-H. · Manchha · A. · Kurrle · S.
Introduction

The Core Outcome Measures for Improving Care (COM-IC) project aims to deliver practical recommendations on the selection and implementation of a suite of core outcomes to measure the effectiveness of interventions for dementia care.

Methods and analysis

COM-IC embeds a participatory action approach to using the Alignment–Harmonisation–Results framework for measuring dementia care in Australia. Using this framework, suitable core outcome measures will be identified, analysed, implemented and audited. The methods for analysing each stage will be codesigned with stakeholders, through the conduit of a Stakeholder Reference Group including people living with dementia, formal and informal carers, aged care industry representatives, researchers, clinicians and policy actors. The codesigned evaluation methods consider two key factors: feasibility and acceptability. These considerations will be tested during a 6-month feasibility study embedded in aged care industry partner organisations.

Ethics and dissemination

COM-IC has received ethical approval from The University of Queensland (HREC 2021/HE001932). Results will be disseminated through networks established over the project, and in accordance with both the publication schedule and requests from the Stakeholder Reference Group. Full access to publications and reports will be made available through UQ eSpace (https://espace.library.uq.edu.au/), an open access repository hosted by The University of Queensland.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK

Por: Walsh · T. S. · Aitken · L. M. · McKenzie · C. A. · Boyd · J. · Macdonald · A. · Giddings · A. · Hope · D. · Norrie · J. · Weir · C. · Parker · R. A. · Lone · N. I. · Emerson · L. · Kydonaki · K. · Creagh-Brown · B. · Morris · S. · McAuley · D. F. · Dark · P. · Wise · M. P. · Gordon · A. C.
Introduction

Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care.

Methods and analysis

Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of –2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.

The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40–50 UK ICUs.

Ethics and dissemination

The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines.

Trial registration number

ClinicalTrials.gov NCT03653832.

Protocol for the Tallaght University Hospital Institute for Memory and Cognition-Biobank for Research in Ageing and Neurodegeneration

Por: Dyer · A. H. · Dolphin · H. · OConnor · A. · Morrison · L. · Sedgwick · G. · McFeely · A. · Killeen · E. · Gallagher · C. · Davey · N. · Connolly · E. · Lyons · S. · Young · C. · Gaffney · C. · Ennis · R. · McHale · C. · Joseph · J. · Knight · G. · Kelly · E. · OFarrelly · C. · Bourke · N. M.
Introduction

Alzheimer’s disease and other dementias affect >50 million individuals globally and are characterised by broad clinical and biological heterogeneity. Cohort and biobank studies have played a critical role in advancing the understanding of disease pathophysiology and in identifying novel diagnostic and treatment approaches. However, further discovery and validation cohorts are required to clarify the real-world utility of new biomarkers, facilitate research into the development of novel therapies and advance our understanding of the clinical heterogeneity and pathobiology of neurodegenerative diseases.

Methods and analysis

The Tallaght University Hospital Institute for Memory and Cognition Biobank for Research in Ageing and Neurodegeneration (TIMC-BRAiN) will recruit 1000 individuals over 5 years. Participants, who are undergoing diagnostic workup in the TIMC Memory Assessment and Support Service (TIMC-MASS), will opt to donate clinical data and biological samples to a biobank. All participants will complete a detailed clinical, neuropsychological and dementia severity assessment (including Addenbrooke’s Cognitive Assessment, Repeatable Battery for Assessment of Neuropsychological Status, Clinical Dementia Rating Scale). Participants undergoing venepuncture/lumbar puncture as part of the clinical workup will be offered the opportunity to donate additional blood (serum/plasma/whole blood) and cerebrospinal fluid samples for longitudinal storage in the TIMC-BRAiN biobank. Participants are followed at 18-month intervals for repeat clinical and cognitive assessments. Anonymised clinical data and biological samples will be stored securely in a central repository and used to facilitate future studies concerned with advancing the diagnosis and treatment of neurodegenerative diseases.

Ethics and dissemination

Ethical approval has been granted by the St. James’s Hospital/Tallaght University Hospital Joint Research Ethics Committee (Project ID: 2159), which operates in compliance with the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 and ICH Good Clinical Practice Guidelines. Findings using TIMC-BRAiN will be published in a timely and open-access fashion.

Maternal exposure to SSRIs or SNRIs and the risk of congenital abnormalities in offspring: A systematic review and meta-analysis

by Weiyi Huang, Robin L. Page, Theresa Morris, Susan Ayres, Alva O. Ferdinand, Samiran Sinha

Background

The association of maternal exposure to selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) with the risk of system-specific congenital malformations in offspring remains unclear. We conducted a meta-analysis to examine this association and the risk difference between these two types of inhibitors.

Methods

A literature search was performed from January 2000 to May 2023 using PubMed and Web of Science databases. Cohort and case-control studies that assess the association of maternal exposure to SSRIs or SNRIs with the risk of congenital abnormalities were eligible for the study.

Results

Twenty-one cohort studies and seven case-control studies were included in the meta-analysis. Compared to non-exposure, maternal exposure to SNRIs is associated with a higher risk of congenital cardiovascular abnormalities (pooled OR: 1.64 with 95% CI: 1.36, 1.97), anomalies of the kidney and urinary tract (pooled OR: 1.63 with 95% CI: 1.21, 2.20), malformations of nervous system (pooled OR: 2.28 with 95% CI: 1.50, 3.45), anomalies of digestive system (pooled OR: 2.05 with 95% CI: 1.60, 2.64) and abdominal birth defects (pooled OR: 2.91 with 95%CI: 1.98, 4.28), while maternal exposure to SSRIs is associated with a higher risk of congenital cardiovascular abnormalities (pooled OR: 1.25 with 95%CI: 1.20, 1.30), anomalies of the kidney and urinary tract (pooled OR: 1.14 with 95%CI: 1.02, 1.27), anomalies of digestive system (pooled OR: 1.11 with 95%CI: 1.01, 1.21), abdominal birth defects (pooled OR: 1.33 with 95%CI: 1.16, 1.53) and musculoskeletal malformations (pooled OR: 1.44 with 95%CI: 1.32, 1.56).

Conclusions

SSRIs and SNRIs have various teratogenic risks. Clinicians must consider risk-benefit ratios and patient history when prescribing medicines.

'Thats how we got around it: a qualitative exploration of healthcare professionals experiences of care provision for asylum applicants with limited English proficiency in UK contingency accommodation

Por: Tomkow · L. · Prager · G. · Drinkwater · J. · Morris · R. L. · Farrington · R.
Objectives

The inadequate provision of language interpretation for people with limited English proficiency (LEP) is a determinant of poor health, yet interpreters are underused. This research explores the experiences of National Health Service (NHS) staff providing primary care for people seeking asylum, housed in contingency accommodation during COVID-19. This group often have LEP and face multiple additional barriers to healthcare access. Language discrimination is used as a theoretical framework. The potential utility of this concept is explored as a way of understanding and addressing inequities in care.

Design

Qualitative research using semistructured interviews and inductive thematic analysis.

Setting

An NHS primary care service for people seeking asylum based in contingency accommodation during COVID-19 housing superdiverse residents speaking a wide spectrum of languages.

Participants

Ten staff including doctors, nurses, mental health practitioners, healthcare assistants and students participated in semistructured online interviews. Some staff were redeployed to this work due to the pandemic.

Results

All interviewees described patients’ LEP as significant. Inadequate provision of interpretation services impacted the staff’s ability to provide care and compromised patient safety. Discrimination, such as that based on migration status, was recognised and challenged by staff. However, inequity based on language was not articulated as discrimination. Instead, insufficient and substandard interpretation was accepted as the status quo and workarounds used, such as gesticulating or translation phone apps. The theoretical lens of language discrimination shows how this propagates existing social hierarchies and further disadvantages those with LEP.

Conclusions

This research provides empirical evidence of how the inadequate provision of interpreters forces the hand of healthcare staff to use shortcuts. Although this innovative ‘tinkering’ allows staff to get the job done, it risks normalising structural gaps in care provision for people with LEP. Policy-makers must rethink their approach to interpretation provision which prioritises costs over quality. We assert that the concept of language discrimination is a valuable framework for clinicians to better identify and articulate unfair treatment on the grounds of LEP.

Stratification of risk for emergent intracranial abnormalities in children with headaches: a Pediatric Emergency Care Applied Research Network (PECARN) study protocol

Por: Tsze · D. S. · Kuppermann · N. · Casper · T. C. · Barney · B. J. · Richer · L. P. · Liberman · D. B. · Okada · P. J. · Morris · C. R. · Myers · S. R. · Soung · J. K. · Mistry · R. D. · Babcock · L. · Spencer · S. P. · Johnson · M. D. · Klein · E. J. · Quayle · K. S. · Steele · D. W. · Cr
Introduction

Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%–1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables.

Methods and analysis

Prospective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2–17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score

Ethics and dissemination

Ethics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.

'Its the stuff they can do better than us: case studies of general practice surgeries experiences of optimising the skill-mix contribution of practice-based pharmacists in Wales

Por: Bartlett · S. · Bullock · A. · Morris · F.
Objective

Pharmacists are increasingly joining the general practice skill-mix. Research is still in relative infancy, but barriers and facilitators to their integration are emerging, as well as indications that pharmacists’ skillset remain underutilised. This study explores first-hand experiences and perspectives among general practice teams of the processes that underpin the effective integration and sustained contribution of pharmacists in general practice.

Design and setting

This research employed a qualitative case study approach involving general practice teams in Wales. Data were collected from eight general practices where each practice represented one case study. Data were collected via online interviews (one-to-one or group) and written feedback. Data were pattern coded and analysed thematically through a constant comparative approach. Data interpretations were confirmed with participants and wider general practice teams.

Participants

Eight general practice teams across Wales (comprising combinations of practice and business managers, general practitioners (GPs) and general practice pharmacists) represented eight case studies. Cases were required to have had experience of working with a general practice pharmacist.

Results

Data were yielded from five practice managers, two GPs, three general practice pharmacists and a business manager. A total of 3 hours and 2 min of interview data was recorded as well as 2038 words of written feedback. Three foundations to pharmacists’ effective contribution to general practice were identified: defining the role (through identifying the right pharmacist, mapping skillset to demand and utilising the increasing need for specialist skills), appropriate infrastructure and workforce review, and an appropriate employment model.

Conclusion

Pharmacists are becoming increasingly critical to the general practice skill-mix and utilisation of their specialist skillset is crucial. This paper identifies how to enable the effective integration and sustained contribution of pharmacists to general practice.

Organisation and delivery of supportive services for patients with prostate cancer in the National Health Service in England and Wales: a national cross-sectional hospital survey and latent class analysis

Por: Dodkins · J. · Cook · A. · Morris · M. · Nossiter · J. · Prust · S. · Waller · S. · van der Meulen · J. · Aggarwal · A. · Clarke · N. · Payne · H. A.
Objectives

We assessed how often National Health Service (NHS) hospitals reported that they had specific supportive services for patients with prostate cancer available onsite, including nursing support, sexual function and urinary continence services, psychological and genetic counselling, and oncogeriatric services. We identified groups of hospitals with similar patterns of supportive services.

Design/setting

We conducted an organisational survey in 2021 of all NHS hospitals providing prostate cancer services in England and Wales. Latent class analysis grouped hospitals with similar patterns of supportive services.

Results

In 138 hospitals, an advanced prostate cancer nurse was available in 125 hospitals (90.6%), 107 (77.5%) had a clinical nurse specialist (CNS) attending all clinics, 103 (75.7%) had sexual function services, 111 (81.6%) had continence services and 93 (69.4%) psychological counselling. The availability of genetic counselling (41 hospitals, 30.6%) and oncogeriatric services (15 hospitals, 11.0%) was lower. The hospitals could be divided into three groups. The first and largest group of 85 hospitals provided the most comprehensive supportive services onsite: all hospitals had a CNS attending all clinics, 84 (98.8%) sexual function services and 73 (85.9%) continence services. A key characteristic of the second group of 31 hospitals was that none had a CNS attending all clinics. A key characteristic of the third group of 22 hospitals was that none had sexual function services available. The hospitals in the largest group were more likely to run joint clinics (p

Conclusions

There is considerable variation in supportive services for prostate cancer available onsite in NHS hospitals in England and Wales. Availability of genetic counselling and oncogeriatric services is low. The different patterns of supportive services among hospitals demonstrate that initiatives to improve the availability of the entire range of supportive services to all patients should be carefully targeted.

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