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Evidence for clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications among adults with peripheral artery disease: protocol for a systematic review and meta-analysis

Por: de Launay · D. · Paquet · M. · Kirkham · A. M. · Graham · I. D. · Fergusson · D. A. · Nagpal · S. K. · Shorr · R. · Grimshaw · J. M. · Roberts · D. J.
Introduction

International guidelines recommend that adults with peripheral artery disease (PAD) be prescribed antiplatelet, statin and antihypertensive medications. However, it is unclear how often people with PAD are underprescribed these drugs, which characteristics predict clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications, and whether underprescription and non-adherence are associated with adverse health and health system outcomes.

Methods and analysis

We will search MEDLINE, EMBASE and Evidence-Based Medicine Reviews from 2006 onwards. Two investigators will independently review abstracts and full-text studies. We will include studies that enrolled adults and reported the incidence and/or prevalence of clinician underprescription of or patient non-adherence to guideline-recommended cardiovascular medications among people with PAD; adjusted risk factors for underprescription of/non-adherence to these medications; and adjusted associations between underprescription/non-adherence to these medications and outcomes. Outcomes will include mortality, major adverse cardiac and limb events (including revascularisation procedures and amputations), other reported morbidities, healthcare resource use and costs. Two investigators will independently extract data and evaluate study risk of bias. We will calculate summary estimates of the incidence and prevalence of clinician underprescription/patient non-adherence across studies. We will also conduct subgroup meta-analyses and meta-regression to determine if estimates vary by country, characteristics of the patients and treating clinicians, population-based versus non-population-based design, and study risks of bias. Finally, we will calculate pooled adjusted risk factors for underprescription/non-adherence and adjusted associations between underprescription/non-adherence and outcomes. We will use Grading of Recommendations, Assessment, Development and Evaluation to determine estimate certainty.

Ethics and dissemination

Ethics approval is not required as we are studying published data. This systematic review will synthesise existing evidence regarding clinician underprescription of and patient non-adherence to guideline-recommended cardiovascular medications in adults with PAD. Results will be used to identify evidence-care gaps and inform where interventions may be required to improve clinician prescribing and patient adherence to prescribed medications.

PROSPERO registration number

CRD42022362801.

Pancreatic quantitative sensory testing to predict treatment response of endoscopic therapy or surgery for painful chronic pancreatitis with pancreatic duct obstruction: study protocol for an observational clinical trial

Por: Phillips · A. E. · Afghani · E. · Akshintala · V. S. · Benos · P. Y. · Das · R. · Drewes · A. M. · Easler · J. · Faghih · M. · Gabbert · C. · Halappa · V. · Khashab · M. A. · Olesen · S. S. · Saloman · J. L. · Sholosh · B. · Slivka · A. · Wang · T. · Yadav · D. · Singh · V. K.
Introduction

Treatment for abdominal pain in patients with chronic pancreatitis (CP) remains challenging in the setting of central nervous system sensitisation, a phenomenon of remodelling and neuronal hyperexcitability resulting from persistent pain stimuli. This is suspected to render affected individuals less likely to respond to conventional therapies. Endotherapy or surgical decompression is offered to patients with pancreatic duct obstruction. However, the response to treatment is unpredictable. Pancreatic quantitative sensory testing (P-QST), an investigative technique of standardised stimulations to test the pain system in CP, has been used for phenotyping patients into three mutually exclusive groups: no central sensitisation, segmental sensitisation (pancreatic viscerotome) and widespread hyperalgesia suggestive of supraspinal central sensitisation. We will test the predictive capability of the pretreatment P-QST phenotype to predict the likelihood of pain improvement following invasive treatment for painful CP.

Methods and analysis

This observational clinical trial will enrol 150 patients from the University of Pittsburgh, Johns Hopkins and Indiana University. Participants will undergo pretreatment phenotyping with P-QST. Treatment will be pancreatic endotherapy or surgery for clearance of painful pancreatic duct obstruction. Primary outcome: average pain score over the preceding 7 days measured by Numeric Rating Scale at 6 months postintervention. Secondary outcomes will include changes in opioid use during follow-up, and patient-reported outcomes in pain and quality of life at 3, 6 and 12 months after the intervention. Exploratory outcomes will include creation of a model for individualised prediction of response to invasive treatment.

Ethics and dissemination

The trial will evaluate the ability of P-QST to predict response to invasive treatment for painful CP and develop a predictive model for individualised prediction of treatment response for widespread use. This trial was approved by the University of Pittsburgh Institutional Review Board. Data and results will be reported and disseminated in conjunction with National Institutes of Health policies.

Trial registration number

NCT04996628.

Using the Power Wheel as a transformative tool to promote equity through spaces and places of patient engagement

Por: Sayani · A. · Cordeaux · E. · Wu · K. · Awil · F. · Garcia · V. · Hinds · R. · Jeji · T. · Khan · O. · Soh · B.-L. · Mensah · D. · Monteith · L. · Musawi · M. · Rathbone · M. · Robinson · J. · Sterling · S. · Wardak · D. · Amsdr · I. · Khawari · M. · Niwe · S. · Hussain · A. · Forster · V. · May
Background

Patient engagement is the active collaboration between patient partners and health system partners towards a goal of making decisions that centre patient needs—thus improving experiences of care, and overall effectiveness of health services in alignment with the Quintuple Aim. An important but challenging aspect of patient engagement is including diverse perspectives particularly those experiencing health inequities. When such populations are excluded from decision-making in health policy, practice and research, we risk creating a healthcare ecosystem that reinforces structural marginalisation and perpetuates health inequities.

Approach

Despite the growing body of literature on knowledge coproduction, few have addressed the role of power relations in patient engagement and offered actionable steps for engaging diverse patients in an inclusive way with a goal of improving health equity. To fill this knowledge gap, we draw on theoretical concepts of power, our own experience codesigning a novel model of patient engagement that is equity promoting, Equity Mobilizing Partnerships in Community, and extensive experience as patient partners engaged across the healthcare ecosystem. We introduce readers to a new conceptual tool, the Power Wheel, that can be used to analyse the interspersion of power in the places and spaces of patient engagement.

Conclusion

As a tool for ongoing praxis (reflection +action), the Power Wheel can be used to report, reflect and resolve power asymmetries in patient-partnered projects, thereby increasing transparency and illuminating opportunities for equitable transformation and social inclusion so that health services can meet the needs and priorities of all people.

Examining the relationship between the oral microbiome, alcohol intake and alcohol-comorbid neuropsychological disorders: protocol for a scoping review

Por: Maki · K. A. · Crayton · C. B. · Butera · G. · Wallen · G. R.
Introduction

Heavy alcohol use and alcohol use disorder (AUD) continues to rise as a public health problem and increases the risk for disease. Elevated rates of anxiety, depression, sleep disruption and stress are associated with alcohol use. Symptoms may progress to diagnosed neurophysiological conditions and increase risk for relapse if abstinence is attempted. Research on mechanisms connecting the gastrointestinal microbiome to neuropsychological disorders through the gut-brain axis is well-established. Less is known how the oral microbiome and oral microbial-associated biomarkers may signal to the brain. Therefore, a synthesis of research studying relationships between alcohol intake, alcohol-associated neurophysiological symptoms and the oral microbiome is needed to understand the state of the current science. In this paper, we outline our protocol to collect, evaluate and synthesise research focused on associations between alcohol intake and AUD-related neuropsychological disorders with the oral microbiome.

Methods and analysis

The search strategy was developed and will be executed in collaboration with a medical research librarian. Studies will be screened by two independent investigators according to the aim of the scoping review, along with the outlined exclusion and inclusion criteria. After screening, data will be extracted and synthesised from the included papers according to predefined demographic, clinical and microbiome methodology metrics.

Ethics and dissemination

A scoping review of primary sources is needed to synthesise the data on relationships between alcohol use, neuropsychological conditions associated with AUD and the oral microbiome. The proposed scoping review is based on the data from publicly available databases and does not require ethical approval. We expect the results of this synthesis will identify gaps in the growing literature and highlight potential mechanisms linking the oral-brain axis to addiction and other associated neuropsychological conditions. The study findings and results will be disseminated through journals and conferences related to psychology, neuroscience, dentistry and the microbiome.

Comprehensive quality assessment for aphasia rehabilitation after stroke: protocol for a multicentre, mixed-methods study

Por: Harvey · S. · Stone · M. · Zingelman · S. · Copland · D. A. · Kilkenny · M. F. · Godecke · E. · Cadilhac · D. A. · Kim · J. · Olaiya · M. T. · Rose · M. L. · Breitenstein · C. · Shrubsole · K. · OHalloran · R. · Hill · A. J. · Hersh · D. · Mainstone · K. · Mainstone · P. · Unsworth · C. A
Introduction

People with aphasia following stroke experience disproportionally poor outcomes, yet there is no comprehensive approach to measuring the quality of aphasia services. The Meaningful Evaluation of Aphasia SeRvicES (MEASuRES) minimum dataset was developed in partnership with people with lived experience of aphasia, clinicians and researchers to address this gap. It comprises sociodemographic characteristics, quality indicators, treatment descriptors and outcome measurement instruments. We present a protocol to pilot the MEASuRES minimum dataset in clinical practice, describe the factors that hinder or support implementation and determine meaningful thresholds of clinical change for core outcome measurement instruments.

Methods and analysis

This research aims to deliver a comprehensive quality assessment toolkit for poststroke aphasia services in four studies. A multicentre pilot study (study 1) will test the administration of the MEASuRES minimum dataset within five Australian health services. An embedded mixed-methods process evaluation (study 2) will evaluate the performance of the minimum dataset and explore its clinical applicability. A consensus study (study 3) will establish consumer-informed thresholds of meaningful change on core aphasia outcome constructs, which will then be used to establish minimal important change values for corresponding core outcome measurement instruments (study 4).

Ethics and dissemination

Studies 1 and 2 have been registered with the Australian and New Zealand Clinical Trial Registry (ACTRN12623001313628). Ethics approval has been obtained from the Royal Brisbane and Women’s Hospital (HREC/2023/MNHB/95293) and The University of Queensland (2022/HE001946 and 2023/HE001175). Study findings will be disseminated through peer-reviewed publications, conference presentations and engagement with relevant stakeholders including healthcare providers, policy-makers, stroke and rehabilitation audit and clinical quality registry custodians, consumer support organisations, and individuals with aphasia and their families.

What impact has the Centre of Research Excellence in Digestive Health made in the field of gastrointestinal health in Australia and internationally? Study protocol for impact evaluation using the FAIT framework

Por: Koloski · N. · Duncanson · K. · Ramanathan · S. A. · Rao · M. · Holtmann · G. · Talley · N. J.
Introduction

The need for public research funding to be more accountable and demonstrate impact beyond typical academic outputs is increasing. This is particularly challenging and the science behind this form of research is in its infancy when applied to collaborative research funding such as that provided by the Australian National Health and Medical Research Council to the Centre for Research Excellence in Digestive Health (CRE-DH).

Methods and analysis

In this paper, we describe the protocol for applying the Framework to Assess the Impact from Translational health research to the CRE-DH. The study design involves a five-stage sequential mixed-method approach. In phase I, we developed an impact programme logic model to map the pathway to impact and establish key domains of benefit such as knowledge advancement, capacity building, clinical implementation, policy and legislation, community and economic impacts. In phase 2, we have identified and selected appropriate, measurable and timely impact indicators for each of these domains and established a data plan to capture the necessary data. Phase 3 will develop a model for cost–consequence analysis and identification of relevant data for microcosting and valuation of consequences. In phase 4, we will determine selected case studies to include in the narrative whereas phase 5 involves collation, data analysis and completion of the reporting of impact.

We expect this impact evaluation to comprehensively describe the contribution of the CRE-DH for intentional activity over the CRE-DH lifespan and beyond to improve outcomes for people suffering with chronic and debilitating digestive disorders.

Ethics and dissemination

This impact evaluation study has been registered with the Hunter New England Human Research Ethics Committee as project 2024/PID00336 and ethics application 2024/ETH00290. Results of this study will be disseminated via medical conferences, peer-reviewed publications, policy submissions, direct communication with relevant stakeholders, media and social media channels such as X (formely Twitter).

Online survey exploring researcher experiences of research funding processes in the UK: the effort and burden of applying for funding and fulfilling reporting requirements

Por: Fackrell · K. · Church · H. · Crane · K. · Recio-Saucedo · A. · Blatch-Jones · A. · Meadmore · K.
Objective

To explore researchers’ experiences of funding processes, the effort and burden involved in applying for funding, obtaining funding and/or fulfilling reporting requirements with a UK health and social care research funder.

Design/Setting

A cross-sectional online survey study with open (free-text) and closed questions (August to November 2021).

Participants

Researchers with experience of applying for/obtaining funding and/or experience of fulfilling reporting requirements for UK health and social care research funded between January 2018 and June 2021.

Results

The survey was completed by 182 researchers, of which 176 had experience with applying for/obtaining funding, and 143 had experience with fulfilling reporting requirements during the timeframe. The majority of the 176 respondents (58%) completed between 7 and 13 key processes in order to submit an application and 69% felt that it was critically important to undertake these key processes. Respondents (n=143) reported submitting an average of 17 reports as part of research monitoring to a range of organisations (eg, funders, Higher Education Institutions). However, only 33% of respondents felt it was critically important to provide the requested reporting information to the different organisations. Thematic analysis of free-text questions on application and reporting identified themes relating to process inefficiencies including streamlining and alignment of systems, lack of understanding of processes including a need for improved communication and feedback from organisations with clear explanations about what information is needed, when and why, the support required by respondents and the time, effort and impact on workload and well-being.

Conclusions

Through this study, we were able to identify funding processes that are considered by some to be effortful, but necessary, as well as those that were perceived as unnecessary, complex and repetitive, and may waste some researchers time and effort and impact on well-being. Possible solutions to increase efficiency and enhance value in these processes were identified.

Predictors of recovery time from severe community-acquired pneumonia among paediatrics patients in selected hospitals in Addis Ababa, Ethiopia: an institution-based retrospective cohort study

Por: Sinishaw · K. M. · Sebsbie · G. · Kebede · M. A.
Objective

Severe community-acquired pneumonia (SCAP) is a significant cause of morbidity worldwide and a major cause of morbidity and mortality in developing countries. Ethiopia ranks 6th out of 15 countries with the highest mortality rate due to pneumonia in children under 5 years of age. The aim of this study was to determine the recovery time from SCAP and factors in paediatric patients in selected hospitals in Addis Ababa.

Design, participants and setting

A retrospective cohort study was conducted among 407 randomly selected paediatric patients admitted with SCAP in Addis Ababa public hospitals from 1 January 2018 to 31 December 2020.

Primary and secondary outcomes

Recovery time and recovery rate from SCAP were estimated using Kaplan-Meier and simple frequency statistics, respectively, and the adjusted HR with a 95% CI was used to identify associated factors for recovery.

Results

91.5% (95% CI: 88.3% to 94.1%) of children recovered from SCAP with an overall recovery rate of 11.5 (95% CI: 10.37 to 12.76) per 100 person-day observation, and the median recovery time was 6 days. In the multivariable analysis, older age and the absence of comorbidities were protective factors for early recovery, while stunting and late utilisation of medical care were risk factors.

Conclusion

The median recovery time after SCAP was very long compared with the optimal recovery time of 3 days given in the British Thoracic Society guidelines. Older age and absence of comorbidities were found to shorten recovery time, whereas stunting and late initiation of treatment delayed recovery. Therefore, measures that increase the recovery rate and shorten the recovery time, such as primary prevention to eliminate malnutrition and increase the utilisation of medical care in the community, should be strengthened, and health workers should focus on the early detection and treatment of comorbid diseases.

Maternal and household factors affecting the dietary diversity of preschool children in eastern Ethiopia: a cross-sectional study

Por: Roba · A. A. · Basdas · O. · Brewis · A. · Roba · K. T.
Objective

Investigate the association between the dietary diversity of preschool children and proximate factors including household food insecurity, maternal food choice, preferences, khat use, and levels of depressive symptoms.

Design

Cross-sectional survey of randomly selected households.

Setting

Haramaya Health and Demographic Surveillance site in Eastern Ethiopia, predominantly smallholder farming households.

Participants

678 preschool children (24–59 months) and their mothers.

Methods

The key outcome, the adequacy of dietary diversity of preschool children, was calculated using a 24-hour parental dietary recall. Binary logistic regression was then used to identify maternal and household factors associated with dietary adequacy versus inadequacy.

Results

The majority (80.53%) of surveyed children had low dietary diversity (mean Dietary Diversity (MDD)) score of 3.06±1.70 on a 7-point scale). Approximately 80% of households exhibited food insecurity. Households with greater food security (adjusted OR (AOR)=1.96, 95% CI 1.19 to 3.23), healthier maternal food choice (AOR=2.19, 95% CI 1.12 to 4.31) and broader maternal food preferences (AOR=4.95, 95% CI 1.11 to 21.95) were all associated with higher dietary diversity of their preschool children (p≤0.05). Other covariates associated with adequate child dietary diversity included improved household drinking water sources (AOR=1.84, 95% CI 1.16 to 2.92) and family planning use (AOR=1.69, 95% CI 1.00 to 2.86). Despite predictions, however, maternal depression and khat consumption were not identified as factors.

Conclusions

The dietary diversity of preschool children is extremely low—a pattern observed in both food-secure and food-insecure households. Key factors include maternal selection of food for convenience and ease, preferences that do not include animal protein or healthier food choices, and lack of access to improved drinking water sources. Interventions around maternal food choice and preferences could improve preschool children’s nutritional health.

Identifying provider, patient and practice factors that shape long-term opioid prescribing for cancer pain: a qualitative study of American and Australian providers

Por: Fereydooni · S. · Lorenz · K. · Azarfar · A. · Luckett · T. · Phillips · J. L. · Becker · W. · Giannitrapani · K.
Introduction

Prescribing long-term opioid therapy is a nuanced clinical decision requiring careful consideration of risks versus benefits. Our goal is to understand patient, provider and context factors that impact the decision to prescribe opioids in patients with cancer.

Methods

We conducted a secondary analysis of the raw semistructured interview data gathered from 42 prescribers who participated in one of two aligned concurrent qualitative studies in the USA and Australia. We conducted a two-part analysis of the interview: first identifying all factors influencing long-term prescribing and second open coding-related content for themes.

Results

Factors that influence long-term opioid prescribing for cancer-related pain clustered under three key domains (patient-related, provider-related and practice-related factors) each with several themes. Domain 1: Patient factors related to provider–patient continuity, patient personality, the patient’s social context and patient characteristics including racial/ethnic identity, housing and socioeconomic status. Domain 2: Provider-related factors centred around provider ‘personal experience and expertise’, training and time availability. Domain 3: Practice-related factors included healthcare interventions to promote safer opioid practices and accessibility of quality alternative pain therapies.

Conclusion

Despite the differences in the contexts of the two countries, providers consider similar patient, provider and practice-related factors when long-term prescribing opioids for patients with cancer. Some of these factors may be categorised as cognitive biases that may intersect in an already disadvantaged patient and exacerbate disparities in the treatment of their pain. A more systematic understanding of these factors and how they impact the quality of care can inform appropriate interventions.

Cohort profile: The Health, Food, Purchases and Lifestyle (SMIL) cohort - a Danish open cohort

Por: Sorensen · K. K. · Andersen · M. P. · Moller · F. T. · Eves · C. · Junker · T. G. · Zareini · B. · Torp-Pedersen · C.
Purpose

The Health, Food, Purchases and Lifestyle (SMIL) cohort is a prospective open Danish cohort that collects electronic consumer purchase data, which can be linked to Danish nationwide administrative health and social registries. This paper provides an overview of the cohort’s baseline characteristics and marginal differences in the monetary percentage spent on food groups by sex, age and hour of the day.

Participants

As of 31 December 2022, the cohort included 11 214 users of a smartphone-based receipt collection application who consented to share their unique identification number for linkage to registries in Denmark. In 2022, the composition of the cohort was as follows: 62% were men while 24% were aged 45–55. The cohort had a median of 63 (IQR 26–116) unique shopping trips. The cohort included participants with a range of health statuses. Notably, 21% of participants had a history of cardiovascular disease and 8% had diabetes before donating receipts.

Findings to date

The feasibility of translating consumer purchase data to operationalisable food groups and merging with registers has been demonstrated. We further demonstrated differences in marginal distributions which revealed disparities in the amount of money spent on various food groups by sex and age, as well as systematic variations by the hour of the day. For example, men under 30 spent 8.2% of their total reported expenditure on sugary drinks, while women under 30 spent 6.5%, men over 30 spent 4.3% and women over 30 spent 3.9%.

Future plans

The SMIL cohort is characterised by its dynamic, continuously updated database, offering an opportunity to explore the relationship between diet and disease without the limitations of self-reported data. Currently encompassing data from 2018 to 2022, data collection is set to continue. We expect data collection to continue for many years and we are taking several initiatives to increase the cohort.

Health-related quality of life after 12 months post discharge in patients hospitalised with COVID-19-related severe acute respiratory infection (SARI): a prospective analysis of SF-36 data and correlation with retrospective admission data on age, disease

Por: Wright · G. · Senthil · K. · Zadeh-Kochek · A. · Au · J. H.-s. · Zhang · J. · Huang · J. · Saripalli · R. · Khan · M. · Ghauri · O. · Kim · S. · Mohammed · Z. · Alves · C. · Koduri · G.

Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.

Objective

To assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI at 1 year post discharge, focusing on the potential impact of age, frailty, and disease severity.

Method

Routinely collected outcome data on 1207 patients admitted with confirmed COVID-19 related SARI across all three secondary care sites in our NHS trust over 3 months were assessed in this retrospective cohort study. Of those surviving 1 year, we prospectively collected 36-item short form (SF-36) HRQoL questionnaires, comparing three age groups (

Results

Overall mortality was 46.5% in admitted patients. In our SF-36 cohort (n=169), there was a significant reduction in all HRQoL domains versus normative data; the most significant reductions were in the physical component (pemotional component (physical well-being versus CFS (the correlation coefficient=–0.37, p

Conclusion

There was a significant reduction in all SF-36 domains at 1 year. Poor CFS at admission was associated with a significant and prolonged impact on physical parameters at 1 year. Age had little impact on the severity of HRQoL, except in the domains of physical functioning and the overall physical component.

SCALE-UP II: protocol for a pragmatic randomised trial examining population health management interventions to increase the uptake of at-home COVID-19 testing in community health centres

Por: Del Fiol · G. · Orleans · B. · Kuzmenko · T. V. · Chipman · J. · Greene · T. · Martinez · A. · Wirth · J. · Meads · R. · Kaphingst · K. K. · Gibson · B. · Kawamoto · K. · King · A. J. · Siaperas · T. · Hughes · S. · Pruhs · A. · Pariera Dinkins · C. · Lam · C. Y. · Pierce · J. H. · Benson
Introduction

SCALE-UP II aims to investigate the effectiveness of population health management interventions using text messaging (TM), chatbots and patient navigation (PN) in increasing the uptake of at-home COVID-19 testing among patients in historically marginalised communities, specifically, those receiving care at community health centres (CHCs).

Methods and analysis

The trial is a multisite, randomised pragmatic clinical trial. Eligible patients are >18 years old with a primary care visit in the last 3 years at one of the participating CHCs. Demographic data will be obtained from CHC electronic health records. Patients will be randomised to one of two factorial designs based on smartphone ownership. Patients who self-report replying to a text message that they have a smartphone will be randomised in a 2x2x2 factorial fashion to receive (1) chatbot or TM; (2) PN (yes or no); and (3) repeated offers to interact with the interventions every 10 or 30 days. Participants who do not self-report as having a smartphone will be randomised in a 2x2 factorial fashion to receive (1) TM with or without PN; and (2) repeated offers every 10 or 30 days. The interventions will be sent in English or Spanish, with an option to request at-home COVID-19 test kits. The primary outcome is the proportion of participants using at-home COVID-19 tests during a 90-day follow-up. The study will evaluate the main effects and interactions among interventions, implementation outcomes and predictors and moderators of study outcomes. Statistical analyses will include logistic regression, stratified subgroup analyses and adjustment for stratification factors.

Ethics and dissemination

The protocol was approved by the University of Utah Institutional Review Board. On completion, study data will be made available in compliance with National Institutes of Health data sharing policies. Results will be disseminated through study partners and peer-reviewed publications.

Trial registration number

ClinicalTrials.gov: NCT05533918 and NCT05533359.

Temporal trends of ambulance time intervals for suspected stroke/transient ischaemic attack (TIA) before and during the COVID-19 pandemic in Ireland: a quasi-experimental study

Por: Burton · E. · Quinn · R. · Crosbie-Staunton · K. · Deasy · C. · Masterson · S. · O'Donnell · C. · Merwick · A. · Willis · D. · Kearney · P. M. · Mc Carthy · V. J. C. · Buckley · C. M.
Objectives

Time is a fundamental component of acute stroke and transient ischaemic attack (TIA) care, thus minimising prehospital delays is a crucial part of the stroke chain of survival. COVID-19 restrictions were introduced in Ireland in response to the pandemic, which resulted in major societal changes. However, current research on the effects of the COVID-19 pandemic on prehospital care for stroke/TIA is limited to early COVID-19 waves. Thus, we aimed to investigate the effect of the COVID-19 pandemic on ambulance time intervals and suspected stroke/TIA call volume for adults with suspected stroke and TIA in Ireland, from 2018 to 2021.

Design

We conducted a secondary data analysis with a quasi-experimental design.

Setting

We used data from the National Ambulance Service in Ireland. We defined the COVID-19 period as ‘1 March 2020–31 December 2021’ and the pre-COVID-19 period ‘1 January 2018–29 February 2020’.

Primary and secondary outcome measures

We compared five ambulance time intervals: ‘allocation performance’, ‘mobilisation performance’, ‘response time’, ‘on scene time’ and ‘conveyance time’ between the two periods using descriptive and regression analyses. We also compared call volume for suspected stroke/TIA between the pre-COVID-19 and COVID-19 periods using interrupted time series analysis.

Participants

We included all suspected stroke/TIA cases ≥18 years who called the National Ambulance Service from 2018 to 2021.

Results

40 004 cases were included: 19 826 in the pre-COVID-19 period and 19 731 in the COVID-19 period. All ambulance time intervals increased during the pandemic period compared with pre-COVID-19 (p

Conclusions

A ’shock' like a pandemic has a negative impact on the prehospital phase of care for time-sensitive conditions like stroke/TIA. System evaluation and public awareness campaigns are required to ensure maintenance of prehospital stroke pathways amidst future healthcare crises. Thus, this research is relevant to routine and extraordinary prehospital service planning.

Predictive machine learning models for ascending aortic dilatation in patients with bicuspid and tricuspid aortic valves undergoing cardiothoracic surgery: a prospective, single-centre and observational study

Por: Gaye · B. · Vignac · M. · Gadin · J. R. · Ladouceur · M. · Caidahl · K. · Olsson · C. · Franco-Cereceda · A. · Eriksson · P. · Björck · H. M.
Objectives

The objective of this study was to develop clinical classifiers aiming to identify prevalent ascending aortic dilatation in patients with bicuspid aortic valve (BAV) and tricuspid aortic valve (TAV).

Design and setting

A prospective, single-centre and observational cohort.

Participants

The study involved 543 BAV and 491 TAV patients with aortic valve disease and/or ascending aortic dilatation, excluding those with coronary artery disease, undergoing cardiothoracic surgery at the Karolinska University Hospital (Sweden).

Main outcome measures

Predictors of high risk of ascending aortic dilatation (defined as ascending aorta with a diameter above 40 mm) were identified through the application of machine learning algorithms and classic logistic regression models.

Exposures

Comprehensive multidimensional data, including valve morphology, clinical information, family history of cardiovascular diseases, prevalent diseases, demographic details, lifestyle factors, and medication.

Results

BAV patients, with an average age of 60.4±12.4 years, showed a higher frequency of aortic dilatation (45.3%) compared with TAV patients, who had an average age of 70.4±9.1 years (28.9% dilatation, p

Conclusion and recommendation

Cardiovascular risk profiles appear to be more predictive of aortopathy in TAV patients than in patients with BAV. This adds evidence to the fact that BAV-associated and TAV-associated aortopathy involves different pathways to aneurysm formation and highlights the need for specific aneurysm preventions in these patients. Further, our results highlight that machine learning approaches do not outperform classical prediction methods in addressing complex interactions and non-linear relations between variables.

Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol

Por: Grant · S. J. · Kay · S. · Lacey · J. · Kumar · S. · Kerin-Ayres · K. · Stehn · J. · Gonzalez · M. · Templeton · S. · Heller · G. · Cockburn · J. · Wahlroos · S. · Malalasekera · A. · Mak · C. · Graham · S.
Introduction

Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.

During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.

Methods and analysis

This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.

Ethics and dissemination

The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.

Trial registration number

ACTRN12622000584730.

REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement - feasibility study for a randomised controlled trial

Por: Bertram · W. · Penfold · C. · Glynn · J. · Johnson · E. · Burston · A. · Rayment · D. · Howells · N. · White · S. · Wylde · V. · Gooberman-Hill · R. · Blom · A. · Whale · K.
Objectives

To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement.

Design

Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study.

Setting

Two National Health Service (NHS) secondary care hospitals in England and Wales.

Participants

Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0–28 on the Sleep Condition Indicator questionnaire.

Intervention

The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals.

Outcome measures

The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients.

Results

Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable.

Conclusions

This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible.

Trial registration number

ISRCTN14233189.

Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives

Por: Chatters · R. · Dimairo · M. · Cooper · C. · Ditta · S. · Woodward · J. · Biggs · K. · Ogunleye · D. · Thistlethwaite · F. · Yap · C. · Rothman · A.
Objectives

To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials.

Design

Qualitative interviews analysed using thematic analysis.

Setting and participants

Five professionals (clinical researchers and methodologists) and three patient and public representatives (those with experience of early-phase clinical trials and/or those from ethnic minority backgrounds) were interviewed between June and August 2022. Participants were identified via their institutional web page, existing contacts or social media (eg, X, formerly known as Twitter).

Results

Professionals viewed that diversity is not currently considered in all early-phase clinical trials but felt that it should always be taken into account. Such trials are primarily undertaken at a small number of centres, thus limiting the populations they can access. Referrals from clinicians based in the community may increase diversity; however, those referred are often not from underserved groups. Referrals may be hindered by the extra resources required to approach and recruit underserved groups and participants often having to undertake ‘self-driven’ referrals. Patient and public representatives stated that diversity is important in research staff and that potential participants should be informed of the need for diversity. Those from underserved groups may require clarification regarding the potential harms of a treatment, even if these are unknown. Education may improve awareness and perception of early-phase clinical trials. We provide 14 recommendations to improve diversity in early-phase clinical trials.

Conclusions

Diversity should be considered in all early-phase trials. Consideration is required regarding the extent of diversity and how it is addressed. The increased resources needed to recruit those from underserved groups may warrant funders to increase the funds to support the recruitment of such participants. The potential harms and societal benefits of the research should be presented to potential participants in a balanced but accurate way to increase transparency.

Co-creating a new Charter for equitable and inclusive co-creation: insights from an international forum of academic and lived experience experts

Por: Mulvale · G. · Moll · S. · Phoenix · M. · Buettgen · A. · Freeman · B. · Murray-Leung · L. · Micsinszki · S. K. · Mulalu · L. · Vrzovski · A. · Foisy · C.
Background

Co-creation approaches, such as co-design and co-production, aspire to power-sharing and collaboration between service providers and service users, recognising the specific insights each group can provide to improve health and other public services. However, an intentional focus on equity-based approaches grounded in lived experience and epistemic justice is required considering entrenched structural inequities between service-users and service-providers in public and institutional spaces where co-creation happens.

Objectives

This paper presents a Charter of tenets and principles to foster a new era of ‘Equity-based Co-Creation’ (EqCC).

Methods

The Charter is based on themes heard during an International Forum held in August 2022 in Ontario, Canada, where 48 lived experience experts and researchers were purposively invited to deliberate challenges and opportunities in advancing equity in the co-creation field.

Results

The Charter’s seven tenets—honouring worldviews, acknowledging ongoing and historical harms, operationalising inclusivity, establishing safer and brave spaces, valuing lived experiences, ‘being with’ and fostering trust, and cultivating an EqCC heartset/mindset—aim to promote intentional inclusion of participants with intersecting social positions and differing historic oppressions. This means honouring and foregrounding lived experiences of service users and communities experiencing ongoing structural oppression and socio-political alienation—Black, Indigenous and people of colour; disabled, Mad and Deaf communities, women, 2S/LGBTQIA+ communities, people perceived to be mentally ill and other minoritised groups—to address epistemic injustice in co-creation methodologies and practice, thereby providing opportunities to begin to dismantle intersecting systems of oppression and structural violence.

Conclusions

Each Charter tenet speaks to a multilayered, multidimensional process that is foundational to shifting paradigms about redesigning our health and social systems and changing our relational practices. Readers are encouraged to share their reactions to the Charter, their experiences implementing it in their own work, and to participate in a growing international EqCC community of practice.

Perceptions and experiences of paramedics managing people with non-traumatic low back pain: a qualitative study of Australian paramedics

Por: Vella · S. P. · Simpson · P. · Bendall · J. C. · Pickles · K. · Copp · T. · Swain · M. S. · Maher · C. G. · Machado · G. C.
Background

Paramedics are often first providers of care to patients experiencing non-traumatic low back pain (LBP), though their perspectives and experiences with managing these cases remain unclear.

Objectives

This study explored paramedic views of the management of non-traumatic LBP including their role and experience with LBP management, barriers to referral and awareness of ambulance service guidelines.

Design

Qualitative study using semistructured interviews conducted between January and April 2023.

Setting

New South Wales Ambulance service.

Participants

A purposive sample of 30 paramedics of different specialities employed by New South Wales Ambulance were recruited.

Results

Paramedic accounts demonstrated the complexity, challenge, frustration and reward associated with managing non-traumatic LBP. Paramedics perceived that their primary role focused on the assessment of LBP, and that calls to ambulance services were often driven by misconceptions surrounding the management of LBP, and a person’s pain severity. Access to health services, patient factors, defensive medicine, paramedic training and education and knowledge of guidelines influenced paramedic management of LBP.

Conclusion

Paramedics often provide care to non-traumatic LBP cases yet depending on the type of paramedic speciality find these cases to be frustrating, challenging or rewarding to manage due to barriers to referral including access to health services, location, patient factors and uncertainty relating to litigation. Future research should explore patient perspectives towards ambulance service use for the management of their LBP.

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