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Ayer — Abril 19th 2024Tus fuentes RSS

Rationale and protocol for a prospective cohort study of respiratory viral infections in patients admitted from emergency departments of community hospitals: Effect of respiratory Virus infection on EmeRgencY admission (EVERY) study

Por: Morimoto · T. · Morikawa · T. · Imura · H. · Nezu · M. · Hamazaki · K. · Sakuma · M. · Chaumont · A. · Moitinho de Almeida · M. · Moreno · V. P. · Ho · Y. · Harrington · L. · Matsuki · T. · Nakamura · T.
Introduction

Respiratory syncytial virus (RSV) is a causative virus for the common cold worldwide and can result in hospitalisations and even death in patients with high-risk conditions and older adults. However, the relationship between RSV or other incidental respiratory infections and acute exacerbations of underlying conditions has not been well investigated. The primary objective of this study is to estimate RSV prevalence, risk factors for adverse outcomes or hospitalisation and their effect on the hospital course of patients with acute respiratory symptoms admitted from emergency departments. Furthermore, we evaluate the prevalence of other respiratory viruses associated with respiratory symptoms.

Methods and analysis

We are conducting a multicentre prospective cohort study in Japan. We plan to enrol 3000 consecutive patients admitted from emergency departments with acute respiratory symptoms or signs from 1 July 2023 to 30 June 2024. A nasopharyngeal swab is obtained within 24 hours of admission and the prevalence of RSV and other respiratory viruses is measured using the FilmArray Respiratory 2.1 panel. Paired serum samples are collected from patients with suspected lower respiratory infections to measure RSV antibodies at admission and 30 days later. Information on patients’ hospital course is retrieved from the electronic medical records at discharge, death or 30 days after admission. Furthermore, information on readmission to the hospital and all-cause mortality is collected 180 days after admission. We assess the differences in clinical outcomes between patients with RSV or other respiratory viruses and those without, adjusting for baseline characteristics. Clinical outcomes include in-hospital mortality, length of hospital stay, disease progression, laboratory tests and management of respiratory symptoms or underlying conditions.

Ethics and dissemination

The study protocol was approved by the institutional review boards of participating hospitals. Our study reports will be published in academic journals as well as international meetings.

Trial registration number

NCT05913700.

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Using explainable AI to investigate electrocardiogram changes during healthy aging—From expert features to raw signals

by Gabriel Ott, Yannik Schaubelt, Juan Miguel Lopez Alcaraz, Wilhelm Haverkamp, Nils Strodthoff

Cardiovascular diseases remain the leading global cause of mortality. Age is an important covariate whose effect is most easily investigated in a healthy cohort to properly distinguish the former from disease-related changes. Traditionally, most of such insights have been drawn from the analysis of electrocardiogram (ECG) feature changes in individuals as they age. However, these features, while informative, may potentially obscure underlying data relationships. In this paper we present the following contributions: (1) We employ a deep-learning model and a tree-based model to analyze ECG data from a robust dataset of healthy individuals across varying ages in both raw signals and ECG feature format. (2) We use explainable AI methods to identify the most discriminative ECG features across age groups.(3) Our analysis with tree-based classifiers reveals age-related declines in inferred breathing rates and identifies notably high SDANN values as indicative of elderly individuals, distinguishing them from younger adults. (4) Furthermore, the deep-learning model underscores the pivotal role of the P-wave in age predictions across all age groups, suggesting potential changes in the distribution of different P-wave types with age. These findings shed new light on age-related ECG changes, offering insights that transcend traditional feature-based approaches.

Improving leadership skills of infection prevention and control teams by psychological empowerment: study protocol for a cluster randomised controlled trial (IP-POWER)

Por: Keil · V. · Schaumburg · T. · Buchta · F. · Luz · J. K. · Kolbe-Busch · S. · Chaberny · I. F. · von Lengerke · T.
Introduction

Infection prevention and control (IPC) teams are routinely confronted with intense emotions in their daily work, as they are involved in many change processes with front-line medical staff, for example, when promoting compliance with basic IPC measures. In addition, they are confronted with challenges due to their role as intermediaries. Based on former research, this study aims to empower IPC teams to promote clinicians’ compliance through interventions focusing on the IPC teams’ leadership skills.

Methods and analysis

The IP-POWER study (Infection Prevention with head and heart: Psychological empowerment of IPC teams), a multicentre, two-arm, non-blinded, cluster-randomised controlled trial with a parallel waiting control group, is planned to be conducted in Germany as of February to November 2024. A group of 10 voluntary hospitals is going to participate in a multistage intervention programme, including 2 days of intense psychological training; 5 hospitals will be randomly assigned to the waiting control group. After the workshops, there will be a 12-week follow-up period during which the contents learnt within the workshops can be applied and internalised into IPC practice. The proposed outcomes (both self-assessed and other-assessed leadership competencies of IPC team members and their task profiles, perceived workload, motivation to act in order to implement IP measures and goal attainment) are going to be collected with an online questionnaire, followed by an analysis with IBM SPSS (Statistics 29 (or later)) using descriptive analyses and multiple linear regressions. Additionally, as external data sources, hand hygiene compliance rates from the study hospitals’ monitoring systems will be analysed using ² tests.

Ethics and dissemination

This study was reviewed and approved by the ethics committee of the University of Leipzig (184/23-ek; vote from 4 July 2023). Findings will be disseminated via peer-review publications, and national and international conference presentations.

Trial registration number

DRKS00031879.

Physician and nurse well-being, patient safety and recommendations for interventions: cross-sectional survey in hospitals in six European countries

Por: Aiken · L. H. · Sermeus · W. · McKee · M. · Lasater · K. B. · Sloane · D. · Pogue · C. A. · Kohnen · D. · Dello · S. · Maier · C. B. B. · Drennan · J. · McHugh · M. D. · For the Magnet4Europe Consortium · Sermeus · Bruyneel · Witte · Schaufeli · Dello · Kohnen · Aiken · McHugh · Smith
Objectives

To determine the well-being of physicians and nurses in hospital practice in Europe, and to identify interventions that hold promise for reducing adverse clinician outcomes and improving patient safety.

Design

Baseline cross-sectional survey of 2187 physicians and 6643 nurses practicing in 64 hospitals in six European countries participating in the EU-funded Magnet4Europe intervention to improve clinicians’ well-being.

Setting

Acute general hospitals with 150 or more beds in six European countries: Belgium, England, Germany, Ireland, Sweden and Norway.

Participants

Physicians and nurses with direct patient contact working in adult medical and surgical inpatient units, including intensive care and emergency departments.

Main outcome measures

Burnout, job dissatisfaction, physical and mental health, intent to leave job, quality of care and patient safety and interventions clinicians believe would improve their well-being.

Results

Poor work/life balance (57% physicians, 40% nurses), intent to leave (29% physicians, 33% nurses) and high burnout (25% physicians, 26% nurses) were prevalent. Rates varied by hospitals within countries and between countries. Better work environments and staffing were associated with lower percentages of clinicians reporting unfavourable health indicators, quality of care and patient safety. The effect of a 1 IQR improvement in work environments was associated with 7.2% fewer physicians and 5.3% fewer nurses reporting high burnout, and 14.2% fewer physicians and 8.6% fewer nurses giving their hospital an unfavourable rating of quality of care. Improving nurse staffing levels (79% nurses) and reducing bureaucracy and red tape (44% physicians) were interventions clinicians reported would be most effective in improving their own well-being, whereas individual mental health interventions were less frequently prioritised.

Conclusions

Burnout, mental health morbidities, job dissatisfaction and concerns about patient safety and care quality are prevalent among European hospital physicians and nurses. Interventions to improve hospital work environments and staffing are more important to clinicians than mental health interventions to improve personal resilience.

Allogeneic limbo-deep anterior lamellar keratoplasty (Limbo-DALK)—A novel surgical technique in corneal stromal disease and limbal stem cell deficiency

by Verena Schöneberger, Volkan Tahmaz, Mario Matthaei, Sigrid Roters, Simona L. Schlereth, Friederike Schaub, Claus Cursiefen, Björn O. Bachmann

Purpose

To describe a novel corneal surgical technique combining Deep Anterior Lamellar Keratoplasty (DALK) with grafting of allogeneic limbus (Limbo-DALK) for the treatment of eyes with corneal stromal pathology and limbal stem cell deficiency (LSCD).

Methods

Clinical records of six Limbo-DALKs performed in five patients diagnosed with LSCD and corneal stromal pathology requiring keratoplasty were retrospectively reviewed. All patients were diagnosed with LSCD due to various pathologies including thermal and chemical burns, congenital aniridia or chronic inflammatory ocular surface disease. Parameters analysed included demographics, diagnoses, clinical history, thickness measurements using anterior segment OCT, visual acuity, and epithelial status. Regular follow-up visits were scheduled at 6 weeks as well as 3, 6, 9, and 12 and 18 months postoperatively. Main outcome measures were time to graft epithelialisation and the occurrence of corneal endothelial decompensation.

Results

Two grafts showed complete epithelial closure at 2 days, two at 14 days. In one eye, complete epithelial closure was not achieved after the first Limbo-DALK, but was achieved one month after the second Limbo-DALK. No endothelial decompensation occurred except in one patient with silicone oil associated keratopathy. Endothelial graft rejection was not observed in any of the grafts.

Conclusion

Based on the data from this pilot series, limbo-DALK appears to be a viable surgical approach for eyes with severe LSCD and corneal stromal pathology, suitable for emergency situations (e.g. corneal ulceration with impending corneal perforation), while minimising the risk of corneal endothelial decompensation.

Role of modifiable organisational factors in decreasing barriers to mental healthcare: a longitudinal study of mission meaningfulness, team relatedness and leadership trust among Canadian military personnel deployed on Operation LASER

Por: Born · J. · Liu · A. · Sudom · K. · Michaud · K. · Xi · M. · Fikretoglu · D.
Objectives

The literature presents complex inter-relationships among individual-factors and organisational-factors and barriers to seeking mental health support after deployment. This study aims to quantify longitudinal associations between such factors and barriers to mental health support.

Design

A longitudinal online survey of Canadian Armed Forces (CAF) personnel collected data at 3 months post-deployment (T1), 6 months post-deployment (T2) and 1 year post-deployment (T3).

Setting

In 2020, as part of Canada’s response to the COVID-19 pandemic, 2595 CAF personnel deployed on Operation LASER to support civilian long-term care facilities in Québec and Ontario.

Participants

All Operation LASER personnel were invited to participate: 1088, 582 and 497 responded at T1, T2 and T3, respectively. Most respondents were young, male, non-commissioned members.

Main outcome measures

Barriers to mental health support were measured using 25 self-reported items and grouped into theory-based factors, including eight factors exploring care-seeking capabilities, opportunities and motivations; and two factors exploring moral issues. Logistic regressions estimated the crude and adjusted associations of individual and organisational characteristics (T1) with barriers (T2 and T3).

Results

When adjusting for sex, military rank and mental health status, increased meaningfulness of deployment was associated with lower probability of endorsing barriers related to conflicts with career goals and moral discomfort in accessing support at T2. Higher scores in trust in leadership were associated with lower probability of endorsing four barriers at T2, and five barriers at T3.

Conclusions

We identified several modifiable organisational-level characteristics that may help reduce perceived barriers to mental health support in military and other high-risk occupational populations. Results suggest that promoting individuals’ sense of purpose, instilling trust in leadership and promoting relatedness among team members may improve perceptions of access to mental health supports in the months following a domestic deployment or comparable occupational exposure.

Sepsis policy, guidelines and standards in Canada: a jurisdictional scoping review protocol

Por: Sheikh · F. · Chechulina · V. · Daneman · N. · Garber · G. E. · Hendrick · K. · Kissoon · N. · Loubani · O. · Russell · K. · Fox-Robichaud · A. · Schwartz · L. · Barrett · K.
Introduction

To our knowledge, this study is the first to identify and describe current sepsis policies, clinical practice guidelines, and health professional training standards in Canada to inform evidence-based policy recommendations.

Methods and analysis

This study will be designed and reported according to the Arksey and O’Malley framework for scoping reviews and the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews. EMBASE, CINAHL, Medline, Turning Research Into Practice and Policy Commons will be searched for policies, clinical practice guidelines and health professional training standards published or updated in 2010 onwards, and related to the identification, management or reporting of sepsis in Canada. Additional sources of evidence will be identified by searching the websites of Canadian organisations responsible for regulating the training of healthcare professionals and reporting health outcomes. All potentially eligible sources of evidence will be reviewed for inclusion, followed by data extraction, independently and in duplicate. The included policies will be collated and summarised to inform future evidence-based sepsis policy recommendations.

Ethics and dissemination

The proposed study does not require ethics approval. The results of the study will be submitted for publication in a peer-reviewed journal and presented at local, national and international forums.

Assessing the basic knowledge and awareness of dengue fever prevention among migrant workers in Klang Valley, Malaysia

by Maryam N. Chaudhary, Voon-Ching Lim, Erwin Martinez Faller, Pramod Regmi, Nirmal Aryal, Siti Nursheena Mohd Zain, Adzzie Shazleen Azman, Norhidayu Sahimin

Background

Globally, 390 million dengue virus infections occur per year. In Malaysia, migrant workers are particularly vulnerable to dengue fever (DF) due to mosquito breeding sites exposure and poor health literacy. Therefore, this study aimed to (i) assess the current DF knowledge, attitudes and practices (KAP), and (ii) identify strategies to promote DF awareness, among migrant workers in Klang Valley.

Method

A survey was conducted with 403 Nepali, Filipino and Indonesian migrant workers through phone interviews and online self-administered questionnaires. Piecewise structural equation modelling was applied to identify predictor variables for DF KAP.

Results

Most respondents were male, working in the services industry, had completed high school, aged between 30–39 years and with less than ten years work experience in Malaysia. Overall, respondents’ knowledge was positively correlated with attitude but negatively with practices. Older respondents, who had completed higher education, obtained higher knowledge scores. Similarly, those with working experience of >20 years in Malaysia obtained higher attitude scores. Respondents with a previous history of DF strongly considered the removal of mosquito breeding sites as their own responsibility, hence tended to frequently practise DF preventive measures. Respondents’ knowledge was also positively correlated to their understanding of DF information sourced from social media platforms.

Conclusion

These findings highlighted: (i) the need for targeted DF educational intervention among younger and newly arrived workers with lower levels of education and (ii) maximising the usage of social media platforms to improve DF public awareness.

Characterization and comparison of human and mouse milk cells

by Rose Doerfler, Saigopalakrishna Yerneni, Alexandra Newby, Namit Chaudhary, Ashley Shu, Katherine Fein, Juliana Hofstatter Azambuja, Kathryn A. Whitehead

Recent data has characterized human milk cells with unprecedented detail and provided insight into cell populations. While such analysis of freshly expressed human milk has been possible, studies of cell functionality within the infant have been limited to animal models. One commonly used animal model for milk research is the mouse; however, limited data are available describing the composition of mouse milk. In particular, the maternal cells of mouse milk have not been previously characterized in detail, in part due to the difficulty in collecting sufficient volumes of mouse milk. In this study, we have established a method to collect high volumes of mouse milk, isolate cells, and compare the cell counts and types to human milk. Surprisingly, we found that mouse milk cell density is three orders of magnitude higher than human milk. The cell types present in the milk of mice and humans are similar, broadly consisting of mammary epithelial cells and immune cells. These results provide a basis of comparison for mouse and human milk cells and will inform the most appropriate uses of mouse models for the study of human phenomena.

Supporting regional pandemic management by enabling self-service reporting—A case report

by Richard Gebler, Martin Lehmann, Maik Löwe, Mirko Gruhl, Markus Wolfien, Miriam Goldammer, Franziska Bathelt, Jens Karschau, Andreas Hasselberg, Veronika Bierbaum, Toni Lange, Katja Polotzek, Hanns-Christoph Held, Michael Albrecht, Jochen Schmitt, Martin Sedlmayr

Background

The COVID-19 pandemic revealed a need for better collaboration among research, care, and management in Germany as well as globally. Initially, there was a high demand for broad data collection across Germany, but as the pandemic evolved, localized data became increasingly necessary. Customized dashboards and tools were rapidly developed to provide timely and accurate information. In Saxony, the DISPENSE project was created to predict short-term hospital bed capacity demands, and while it was successful, continuous adjustments and the initial monolithic system architecture of the application made it difficult to customize and scale.

Methods

To analyze the current state of the DISPENSE tool, we conducted an in-depth analysis of the data processing steps and identified data flows underlying users’ metrics and dashboards. We also conducted a workshop to understand the different views and constraints of specific user groups, and brought together and clustered the information according to content-related service areas to determine functionality-related service groups. Based on this analysis, we developed a concept for the system architecture, modularized the main services by assigning specialized applications and integrated them into the existing system, allowing for self-service reporting and evaluation of the expert groups’ needs.

Results

We analyzed the applications’ dataflow and identified specific user groups. The functionalities of the monolithic application were divided into specific service groups for data processing, data storage, predictions, content visualization, and user management. After composition and implementation, we evaluated the new system architecture against the initial requirements by enabling self-service reporting to the users.

Discussion

By modularizing the monolithic application and creating a more flexible system, the challenges of rapidly changing requirements, growing need for information, and high administrative efforts were addressed.

Conclusion

We demonstrated an improved adaptation towards the needs of various user groups, increased efficiency, and reduced burden on administrators, while also enabling self-service functionalities and specialization of single applications on individual service groups.

MISSION ABC: transforming respiratory care through one-stop multidisciplinary clinics - an observational study

Por: Heiden · E. · Longstaff · J. · Chauhan · M. J. A. · DeVos · R. · Lanning · E. · Neville · D. · Jones · T. L. · Begum · S. · Amos · M. · Mottershaw · M. · Micklam · J. · Holdsworth · B. · Rupani · H. · Brown · T. · Chauhan · A. J. · Mission ABC Collaborators · Baghammar · Bannell · Domin
Objectives

The Modern Innovative Solutions to Improve Outcomes in Asthma, Breathlessness and Chronic Obstructive Pulmonary Disease (COPD) (MABC) service aimed to enhance disease management for chronic respiratory conditions through specialist multidisciplinary clinics, predominantly in the community. This study assesses the outcomes of these clinics.

Design

This study used a prospective, longitudinal, participatory action research approach.

Setting

The study was conducted in primary care practices across Hampshire, UK.

Participants

Adults aged 16 years and above with poorly controlled asthma or COPD, as well as those with undifferentiated breathlessness not under specialist care, were included.

Interventions

Participants received care through the multidisciplinary, specialist-led MABC clinics.

Primary and secondary outcome measures

Primary outcomes included disease activity, quality of life and healthcare utilisation. Secondary outcomes encompassed clinic attendance, diagnostic changes, patient activation, participant and healthcare professional experiences and cost-effectiveness.

Results

A total of 441 participants from 11 general practitioner practices were recruited. Ninety-six per cent of participants would recommend MABC clinics. MABC assessments led to diagnosis changes for 64 (17%) participants with asthma and COPD and treatment adjustments for 252 participants (57%). Exacerbations decreased significantly from 236 to 30 after attending the clinics (p

Conclusions

Specialist-supported multidisciplinary teams in MABC clinics improved diagnosis accuracy and adherence to guidelines. High patient satisfaction, disease control improvements and reduced exacerbations resulted in decreased unscheduled healthcare use and cost savings.

Trial registration number

NCT03096509.

An examination of factorial invariance of the Asthma Control Questionnaire among adults with severe asthma

by Ronald McDowell, Liam Heaney, Thomas Brown, Brendan Bunting, Hassan Burhan, Rekha Chaudhuri, Paddy Dennison, Shoaib Faruqi, Robin Gore, David J. Jackson, Andrew Menzies-Gow, Thomas Pantin, Mitesh Patel, Paul Pfeffer, Salman Siddiqui, John Busby, on behalf of the UK Severe Asthma Registry

Background

The Asthma Control Questionnaire (ACQ) is used to assess asthma symptom control. The relationship between the questionnaire items and symptom control has not been fully studied in severe asthmatic patients, and its validity for making comparisons between subgroups of patients is unknown.

Methods

Data was obtained from patients in the United Kingdom Severe Asthma Registry whose symptom control was assessed using the five-item ACQ (ACQ5) (n = 2,951). Confirmatory factor analysis determined whether a latent factor for asthma symptom control, as measured by the ACQ5, was consistent with the data. Measurement invariance was examined in relation to ethnicity, sex and age; this included testing for approximate measurement invariance using Bayesian Structural Equation Modelling (BSEM). The fitted models were used to estimate the internal consistency reliability of the ACQ5. Invariance of factor means across subgroups was assessed.

Results

A one-factor construct with residual correlations for the ACQ5 was an excellent fit to the data in all subgroups (Root Mean Square Error Approximation 0.03 [90%CI 0.02,0.05], p-close fit 0.93, Comparative Fit Index 1.00, Tucker Lewis Index 1.00}. Expected item responses were consistent for Caucasian and non-Caucasian patients with the same absolute level of symptom control. There was some evidence that females and younger adults reported wakening more frequently during the night than males and older adults respectively with the same absolute level of symptom control (p Conclusion

The ACQ5 is informative in comparing levels of symptom control between severe asthmatic patients of different ethnicities, sexes and ages. It is important that analyses are replicated in other severe asthma registries to determine whether measurement invariance is observed.

Ecolabels and the economic recession

by Jibonayan Raychaudhuri, Ada Wossink

We examine the effect of the 2008 economic recession on consumers’ observed expenditures for eco-labelled grocery products. Traditional price theory predicts that consumers change their spending during an economic downturn and we would expect the sales share of eco-labelled products to fall since these are relatively more expensive than non-labelled products. We use supermarket loyalty card data from the UK and show that the recession had widely different effects on the expenditure share of different eco-labelled grocery products. We confirm, empirically, that expenditure shares on organic products declined over the time period under study but the expenditures share for fair-trade products increased over the same period. We evaluate alternative models of decision making to explain our results, viz., a salience model and a model of reputation signalling. We find that both of these models give a plausible explanation of our empirical results.

Aquaporin splice variation differentially modulates channel function during marine teleost egg hydration

by Alba Ferré, François Chauvigné, Cinta Zapater, Roderick Nigel Finn, Joan Cerdà

Aquaporin-mediated oocyte hydration is a developmentally regulated adaptive mechanism that co-occurs with meiosis resumption in marine teleosts. It provides the early embryos with vital water until osmoregulatory systems develop, and in the majority of marine teleosts causes their eggs to float. Recent studies have shown that the subdomains of two water channels (Aqp1ab1 and Aqp1ab2) encoded in a teleost-specific aquaporin-1 cluster (TSA1C) co-evolved with duplicated Ywhaz-like (14-3-3ζ-like) binding proteins to differentially control their membrane trafficking for maximal egg hydration. Here, we report that in species that encode the full TSA1C, in-frame intronic splice variants of Aqp1ab1 result in truncated proteins that cause dominant-negative inhibition of the canonical channel trafficking to the plasma membrane. The inhibition likely occurs through hetero-oligomerization and retention in the endoplasmic reticulum (ER) and ultimate degradation. Conversely, in species that only encode the Aqp1ab2 channel we found an in-frame intronic splice variant that results in an intact protein with an extended extracellular loop E, and an out-of frame intronic splice variant with exon readthrough that results in a truncated protein. Both isoforms cause dominant-negative enhancement of the degradation pathway. However, the extended and truncated Aqp1ab2-type variants can also partially escape from the ER to reach the oocyte plasma membrane, where they dominantly-negatively inhibit water flux. The ovarian follicular expression ratios of the Aqp1ab2 isoforms in relation to the canonical channel are lowest during oocyte hydration, but subsequently highest when the canonical channel is recycled, thus leaving the eggs endowed with >90% water. These findings suggest that the expression of inhibitory isoforms of Aqp1ab1 and Aqp1ab2 may represent a new regulatory mechanism through which the cell-surface expression and the activity of the canonical channels can be physiologically modulated during oocyte hydration in marine teleosts.

What are the perceptions and concerns of people living with diabetes and National Health Service staff around the potential implementation of AI-assisted screening for diabetic eye disease? Development and validation of a survey for use in a secondary car

Por: Willis · K. · Chaudhry · U. A. R. · Chandrasekaran · L. · Wahlich · C. · Olvera-Barrios · A. · Chambers · R. · Bolter · L. · Anderson · J. · Barman · S. A. · Fajtl · J. · Welikala · R. · Egan · C. · Tufail · A. · Owen · C. G. · Rudnicka · A. · On behalf of the ARIAS Research Group · S
Introduction

The English National Health Service (NHS) Diabetic Eye Screening Programme (DESP) performs around 2.3 million eye screening appointments annually, generating approximately 13 million retinal images that are graded by humans for the presence or severity of diabetic retinopathy. Previous research has shown that automated retinal image analysis systems, including artificial intelligence (AI), can identify images with no disease from those with diabetic retinopathy as safely and effectively as human graders, and could significantly reduce the workload for human graders. Some algorithms can also determine the level of severity of the retinopathy with similar performance to humans. There is a need to examine perceptions and concerns surrounding AI-assisted eye-screening among people living with diabetes and NHS staff, if AI was to be introduced into the DESP, to identify factors that may influence acceptance of this technology.

Methods and analysis

People living with diabetes and staff from the North East London (NEL) NHS DESP were invited to participate in two respective focus groups to codesign two online surveys exploring their perceptions and concerns around the potential introduction of AI-assisted screening.

Focus group participants were representative of the local population in terms of ages and ethnicity. Participants’ feedback was taken into consideration to update surveys which were circulated for further feedback. Surveys will be piloted at the NEL DESP and followed by semistructured interviews to assess accessibility, usability and to validate the surveys.

Validated surveys will be distributed by other NHS DESP sites, and also via patient groups on social media, relevant charities and the British Association of Retinal Screeners. Post-survey evaluative interviews will be undertaken among those who consent to participate in further research.

Ethics and dissemination

Ethical approval has been obtained by the NHS Research Ethics Committee (IRAS ID: 316631). Survey results will be shared and discussed with focus groups to facilitate preparation of findings for publication and to inform codesign of outreach activities to address concerns and perceptions identified.

Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes

Por: Bailey · S. C. · Pack · A. P. · Wismer · G. · Calderon · N. · Velazquez · E. · Batio · S. · Ekong · A. · Eggleston · A. · Wallia · A. · Wolf · M. S. · Schauer · J. M. · Tenfelde · S. · Liebovitz · D. M. · Grobman · W. A.
Introduction

Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care.

Methods and analysis

We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to ‘hardwire’ preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18–44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic’s assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects.

Ethics and dissemination

This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request.

Trial registration number

ClinicalTrials.gov Registry (NCT04976881).

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