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Adolescents perspectives on spectacle wear and adherence following a school-based outreach programme in Indonesia: a qualitative study

Por: Rahayu · T. · Barliana · J. D. · Lestari · Y. · Chandra · A. P. · Nadira · D.
Objective

The aim of this study is to explore in depth adolescents’ insights regarding experiences of spectacle lens wear and its correlation with self-perception, quality of life, social interactions, adherence and barriers.

Design

Qualitative design through individual interviews and thematic analysis.

Setting

Middle school students in five regions of Jakarta Province.

Participants

31 middle school adolescents who participated and received free spectacle wear by the Indonesian Ophthalmologist Association.

Methods

A set of semistructured questionnaires exploring adolescents’ perception regarding spectacle lens wear, adapted from the PedEyeQ. Interviews were conducted on site or through Zoom and were then transcribed.

Findings

Thematic analysis identified three themes, as follows: (1) experience with eyeglasses, (2) motivation and encouragement and (3) barriers to usage. This study found that more than half of adolescents received their first spectacles during the outreach programme, with most reporting improved vision and academic performance after spectacle wear. However, adherence varied, as some participants—particularly those with moderate to high myopia and astigmatism—did not use their new glasses due to discomfort, poor fit or dissatisfaction with visual clarity. While initial adaptation often involved dizziness or soreness, most adjusted within a week. The majority recognised the importance of spectacle wear, describing clearer vision, reduced eye strain and improved confidence, though a minority viewed it as unnecessary. Parents played a central role in influencing health-seeking behaviour, and limited prior access to eye examinations and geographic challenges restricted care for several adolescents. Financial concerns were reported by a small proportion, while psychological barriers such as fear of teasing or negative self-perception were the major barrier. Overall, adolescents highlighted both the benefits and challenges of spectacle wear, with motivation shaped by personal experience, parental influence and accessibility of eye care services.

Conclusions

Findings showed insight that adolescent understanding regarding eye health is imperative to support adherence. However, psychological barriers act as a major factor that impedes lens wear. Involving parents and teachers in understanding urgency and severity of eye health in adolescents, specifically refractive error and its long-term negative impact, as well as the prominent psychological barriers, may improve adolescent perception and adherence.

Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol

Por: Douin · D. J. · Rice · J. D. · Xiao · M. · Beaty · L. · Guo · C. · Withers · C. · Sullivan · A. · Anderson · E. L. · Cheng · A. C. · Banasiewicz · M. K. · Semler · M. W. · Lloyd · B. D. · Maiga · A. · Gibbs · K. W. · Stettler · G. R. · Khan · A. · Sally · M. B. · Wright · F. L. · Aggarwal
Introduction

Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO2) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO2 90%–96%) compared with usual care.

Methods and analysis

The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO2 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO22 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.

Ethics and dissemination

The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.

Trial registration number

NCT06374225.

Intradialytic kinetics of cardiac biomarkers during high-flux haemodialysis and postdilution haemodiafiltration: study protocol for a randomised crossover trial

Por: Drivsholm · C. L. · Nygaard · L. · Glerup · R. I. · Birnum · A. T. S. · Jensen · J. D. · Svensson · M.
Introduction

Cardiovascular disease (CVD) is the leading cause of mortality in patients undergoing chronic haemodialysis (HD). However, relatively few data exist regarding the influence of dialysis treatment on cardiac biomarkers such as high-sensitivity cardiac troponin I and T (hs-cTnI and hs-cTnT) and N-terminal pro-B-type natriuretic peptide (NT-proBNP), complicating their interpretation in the diagnosis of acute coronary syndrome and heart failure. This study aims to investigate the intradialytic kinetics of hs-cTnT, hs-cTnI and NT-proBNP, during HD and haemodiafiltration (HDF), in patients treated with chronic HD.

Methods and analysis

Single-centre, randomised, open-label, crossover study, comparing high-flux HD (FX 100 dialyser) and postdilution HDF (FX 1000 dialyser), regarding their potential clearance of hs-cTnI, hs-cTnT and NT-proBNP, in 24 stable patients treated with in-centre HD without acute CVD. The study will investigate changes in concentrations during and after high-flux HD and postdilution HDF and calculate reduction ratios, dialyser clearance and clearance by adsorption to the membrane of the selected cardiac biomarkers. Blood samples will be collected at baseline, after 10, 30, 60, 120, 180 and 240 min of dialysis and 30 min postdialysis. After 120 min of dialysis, dialysate will also be collected from the dialyser outlet line. The primary outcome is change from baseline in concentrations of hs-cTnI, hs-cTnT and NT-proBNP during high-flux HD and postdilution HDF.

Ethics and dissemination

The study has been approved by the North Denmark Region Committee on Health Research Ethics (N-20240016). Results will be published in an international peer-reviewed journal and disseminated at national and international research meetings.

Trial registration number

NCT06526702.

Effectiveness of poliovirus environmental surveillance in Ghana: an indicator-based performance evaluation across seven regions, 2018-2022

Por: Obodai · E. · Asante Ntim · N. A. · Duker · E. O. · Gberbi · E. · Antwi · C. N. · Mensah · J. Y. · Odame · D. · Boakye · J. D. · Bimpong · S. A. · Agbotse · G. D. · Odoom · N. · Adams · P. L. · Acquah · N. K. · Dickson · A. E. · Odoom · C. · Achempem · K. K. · Baffoe-Nyarko · I. · Egbi
Objective

To evaluate the performance of Ghana’s environmental surveillance (ES) system for poliovirus (PV) detection from 2018 to 2022 using standardised indicators developed by the WHO and the US Centers for Disease Control and Prevention.

Design

A retrospective performance evaluation using 10 key indicators benchmarked against global targets for PV surveillance.

Setting

Seven regions across Ghana, participating in the national ES programme implemented under the Global Polio Eradication Initiative.

Surveillance coverage

Wastewater sampling was conducted at designated ES sites, supported by field collection teams and laboratory personnel responsible for sample acquisition, processing and reporting of PV detection results.

Outcome measures

Detection rates of PV and non-polio enteroviruses (NPEVs), timeliness of sample collection and reporting, data quality and system stability.

Results

A total of 738 wastewater samples were collected. The system demonstrated high sensitivity, detecting circulating vaccine-derived PV type 2 in 51 (6.9%) of samples, Sabin PV types 1 and 3 in 61 (9.5%) and 114 (17.8%), respectively, and NPEVs in 491 (66.5%) of samples. Over 80% of samples met the recommended 21-day collection-to-reporting time frame. Data quality exceeded the ≥80% threshold, and workflows remained stable throughout the evaluation period.

Conclusions

Ghana’s ES system for PV was found to be flexible, stable and effective in generating high-quality data for early detection and public health response. These findings underscore the system’s critical role in supporting polio eradication efforts and highlight its potential as a model for surveillance in similar settings.

Is practice variation determined in the needs assessments performed by Dutch home care nurses? A cross-sectional multilevel analysis

Por: van Dorst · J. I. · Schwenke · M. · Hameleers · N. · Bleijenberg · N. · Brabers · A. E. · de Jong · J. D. · de Vries · E. · van den Bulck · A. O. · Zwakhalen · S. M.
Objectives

While needs assessment is the starting point of good quality care, there is anecdotal evidence of patients receiving different care in similar circumstances. This study aims to investigate whether practice variation exists in needs assessments conducted by home care nurses and to identify the factors influencing these assessments.

Design

A cross-sectional, quantitative retrospective study.

Setting

Primary care; home care nursing in the Netherlands in 2023.

Participants

Sampling was based on criterion sampling. Home care organisations were approached based on the following inclusion criteria: organisations providing home care nursing in the Netherlands, organisations from various regions of the country and organisations offering different types of home care nursing (eg, paediatric or palliative care), funded under the Dutch Health Insurance Act (Zvw). Organisations were excluded if they provided home care nursing funded by sources other than the Dutch Health Insurance Act. Home care nurses were recruited from participating organisations, each of whom had recently assessed the care needs of at least five patients. In total, 28 organisations and 258 home care nurses participated in this study, thereby yielding data from 1615 patients.

Primary and secondary outcome measures

Assessed and delivered minutes of home care per patient per week.

Results

Variation was primarily associated with patient-related factors. After accounting for these factors, 83% (assessed minutes) and 88% (delivered minutes) of the total variation was attributed to the patient level, 8% (assessed minutes) and 10% (delivered minutes) to the home care nurses’ level and 9% (assessed minutes) and 2% (delivered minutes) to the organisational level. Due to inadequate documentation in electronic health records, many missing values were identified.

Conclusions

The lack of nursing documentation suggests that missing factors may have contributed to variations in needs assessments. Thus, further research should comprehensively explore the patient-related factors currently absent from nursing documentation.

Effectiveness of protein supplementation combined with resistance training to counteract disproportional fat-free mass loss following metabolic bariatric surgery: rationale and design of the ENRICHED randomised controlled trial

Por: de Roos · B. M. · Yeh · L.-L. Y. · van den Hooff · P. S. · Nuijten · M. A. H. · Twisk · J. W. R. · Liem · R. S. L. · van Acker · G. J. D. · Severens · J. L. · Kambic · T. · Serlie · M. J. M. · Monpellier · V. M. · Eijsvogels · T. M. H. · Hopman · M. T. E. · Karregat · J. H. M.
Introduction

Metabolic bariatric surgery (MBS) can lead to substantial fat-free mass loss (FFML) due to malnutrition, decreased protein intake and insufficient physical activity. Disproportional FFML has been associated with an increased risk for adverse health outcomes. Resistance training (RT) combined with protein intake contributes to maintenance and increase of fat-free mass (FFM) in healthy individuals. However, it is unclear whether RT and protein supplementation can prevent FFML after MBS.

Methods and analysis

In the EffectiveNess of pRotein supplementatIon Combined witH resistance Exercise training to counteract Disproportional fat-free mass loss following metabolic bariatric surgery (ENRICHED) randomised controlled trial, 400 patients scheduled to undergo MBS will be randomised in a 1:1 ratio to the ENRICHED perioperative care programme (intervention group) or the standard perioperative care programme of the Dutch Obesity Clinic (control group). The study is currently recruiting participants at two centres in the Netherlands: Nieuwegein and Amsterdam. The postoperative standard programme consists of 13 group sessions spread over a period of 18 months. As part of the ENRICHED programme, RT and protein supplementation will be added 3 weeks after MBS. Additional whole-body RT consists of home-based training sessions two to three times a week, and supervised RT sessions of 45–60 min once weekly, performed at 60–75% of one-repetition maximum (1-RM). Protein supplementation will start by adding 20 g of whey protein to the daily intake. The supplementation will be gradually increased with 20 g every 4 weeks until a total of 60 g whey protein a day is reached. After 12 weeks of protein supplementation, the focus shifts towards incorporating protein-rich food products into the daily dietary intake. The primary endpoint is the prevalence of disproportional FFM loss, defined as FFML/total weight loss ≥30%, at 3 months post-MBS. Secondary endpoints are differences in body composition, muscle strength and function, cardiorespiratory fitness, (cardio)metabolic health, health-related quality of life, gastrointestinal discomfort, cost-effectiveness of the intervention and treatment satisfaction. Outcomes will be assessed preoperatively and at 3, 6 and 12 months postoperatively.

Ethics and dissemination

The study protocol V.2.0 was approved by the Medical Research Ethics Committee Oost-Nederland (NL-OMON57119) on 9 April 2025. All participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations. Insights gained in this study will provide evidence for a patient-tailored intervention that could be implemented in clinical practice.

Trial registration number

NCT07156552.

Effect size and event rate estimation in neurocritical care randomised clinical trials: a protocol for a systematic review

Por: Shrestha · G. S. · Kitisin · N. · Talbot · P. · Linke · N. · Taylor · J. D. · Battistuzzo · C. R. · Serpa Neto · A. · Higgins · A. · Jeffcote · T. · Cooper · D. J. · Udy · A. A.
Introduction

Effect size and event rate estimation is necessary for sample size calculation in randomised clinical trials. Overestimation of the effect size and event rate can lead to inadequately powered studies and increased probability of false negative results. This is common in trials involving critically ill patients. However, such overestimation has not been systematically evaluated in trials involving neurocritical care. We aimed to conduct a systematic review of published randomised clinical trials involving critically ill neurological patients, to determine the accuracy of effect size and event rate estimation.

Methods and analysis

We will review randomised clinical trials involving adult critically ill neurological patients that were published from 2015 onwards in selected clinically useful and high-impact journals. We will include randomised clinical trials reporting a binary or time to event outcome, using two study groups, and a superiority design testing the efficacy of diagnostic, monitoring, therapeutic or process interventions. All eligible studies must report an estimated event rate in the control group and estimated effect size. All relevant studies will be identified through database searches. All study selection and data extraction will be conducted by two independent reviewers. We will use a random-effects model for pooling data. This review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines. Accuracy of effect size and event rate estimation will be evaluated by comparing the estimated and observed values. The association between the accuracy of the individual randomised clinical trial effect size and event rate estimation and rejection of the null hypothesis will be evaluated using logistic regression analysis. Multivariable linear regression analysis will be used to explore the factors associated with accuracy of effect size and event rate estimation. In addition, we will perform subgroup analysis by impact factor of the published journals, sample size of the studies and risk of bias.

Ethics and dissemination

As this systematic review will use data from previously published studies, it does not require ethics approval. Findings of this systematic review will be published in a peer-reviewed journal and will be presented at specialty-based conferences. The study will be included in the higher degree research thesis of the primary author.

PROSPERO registration number

CRD420251106394.

Promising solution for standardised length of hospital stay based on time-to-event models and contemporary Australian administrative data

Por: Duke · G. J. · Hirth · S. · Santamaria · J. D. · Li · Z. · Read · C. · Hamilton · A. · Lapiz · E. · Le · T. · Fernando · T. · Merlo · R.
Objective

Hospital length of stay (LOS) is a key indicator of hospital efficiency and quality of care, but a reliable metric for benchmarking LOS remains problematic. This report describes a time-to-event methodology to generate a hospital standardised LOS ratio (HSLR).

Design

Retrospective observational analysis of LOS from a jurisdictional administrative dataset using a time-to-event (hazard of discharge) analytic approach to generate risk-adjusted LOS (predicted LOS—pLOS), and the HSLR (= (sum observed LOS)/(sum total pLOS)).

Setting

219 (public and private) acute-care hospitals in the State of Victoria, Australia, adult population 5.28 million.

Participants

2.73 million adult multiday separations and 15.53 million bed-days from July 2019 to June 2024.

Interventions

Nil.

Outcome measures

Descriptive statistics for annual mean LOS (aLOS), pLOS and HSLR at the hospital level with model fit assessed for calibration (Cox-Snell residuals), classification (aLOS and HSLR results for hospital-years compared to benchmark), variance (intraclass correlation coefficient (ICC) at provider level) and model dispersion (value () and random effect SD ()) characteristics.

Results

Observed LOS was markedly right skewed and autocorrelated (p3 SD of benchmark); whereas 936 (99.5%) HSLR values were inliers (

Conclusions

aLOS is a simple descriptor but poor comparator. Time-to-event survival analytic models furnish risk-adjusted pLOS and HSLR metrics which indicate that the majority of LOS variation is due to patient-related, not hospital, factors.

Percutaneous coronary intervention, coronary artery bypass grafting and mortality from acute myocardial infarction in EU15+ countries, 2006-2020: a secondary analysis of the OECD database

Por: Ojha · U. · Marshall · D. C. · Hammond-Haley · M. · Salciccioli · J. D. · Shalhoub · J. · Hartley · A.
Objective

Coronary revascularisation practices have evolved over the last three decades. This study sought to examine the variations in percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) rates, alongside mortality from acute myocardial infarction (AMI) across a group of 16 high-income countries between 2006 and 2020.

Design

Retrospective observational analysis using data from the Organisation for Economic Co-operation and Development (OECD) database between 2006 and 2020. Estimated annual percent change in revascularisation was analysed using Joinpoint regression model, and mortality rates were evaluated using the locally weighted scatterplot smoothing model.

Setting

Publicly available data on PCI and CABG procedure rates alongside AMI mortality rate from 2006 to 2020.

Participants

16 countries from the OECD database.

Interventions

Not applicable.

Main outcome measures

Standardised PCI and CABG procedure rates and AMI age-standardised mortality rate (ASMR) from 2006 to 2020.

Results

Over the 15 year period, 14.0 million PCI and 2.8 million CABG procedures were collectively recorded across 16 countries. PCI rates varied among nations, but from 2006 to 2020 increased in 11 of the 16 nations overall, led by Finland (+36.0%), Ireland (+34.5%) and France (+31.5%). Meanwhile, CABG rates declined in 14 out of the 16 countries, with Luxembourg (–71.3%), the UK (–62.6%) and Finland (–60.6%) experiencing the most substantial decreases. Throughout the study period, the PCI-to-CABG ratio increased, while AMI ASMR decreased consistently across all countries.

Conclusions

Despite evidence supporting CABG over PCI in specific scenarios, CABG rates have declined, and PCI rates have increased. Possible factors for this trend may include patient preference and advancement in interventional techniques. The varied use of PCI among these nations, alongside a sustained decline in AMI mortality rates, may be expected given the importance of optimal medical therapy in the management of ischaemic heart disease. The results further suggest the significance of factors beyond revascularisation in driving improved outcomes.

Influence of subnational contextual factors on demand for family planning satisfied by modern methods: a multilevel approach in 46 surveys from low- and middle-income countries

Por: Lima · N. P. · Blumenberg · C. · Hellwig · F. · Barros · A. J. D. · Wehrmeister · F. C.
Objectives

Understanding contextual drivers of family planning is crucial for designing effective, context-specific policies and programmes. This study aimed to assess (1) the extent to which province-level contextual factors are associated with both coverage and wealth-related inequalities in demand for family planning satisfied by modern methods (mDFPS) across provinces in low- and middle-income countries (LMICs), and (2) whether these factors influence mDFPS at women’s level.

Design

Observational study using multilevel modelling at both ecological and individual levels.

Setting

We analysed data from Demographic and Health Surveys between 2011 and 2022 in 46 LMICs.

Participants

Ecological analysis included 621 provinces. Individual-level analysis included 302 493 women aged 15–49 years, currently married or in union, and in need of contraception (unweighted).

Primary and secondary outcome measures

Demand for family planning satisfied by modern methods (mDFPS) and wealth-related inequalities in mDFPS, assessed using the slope index of inequality (SII) and the concentration index (CIX).

Results

In both income groups, at the province level, higher mean women’s schooling and greater proportion of employed women were positively associated with mDFPS coverage. In contrast, higher male-to-female educational attainment ratios were inversely associated with mDFPS. Provinces with higher means of women’s schooling also showed lower wealth-related inequalities in mDFPS. At the individual level, women residing in provinces with higher male-to-female educational attainment ratios were found to have lower odds of mDFPS, regardless of the income group. Additionally, the factors influencing individual women’s mDFPS varied depending on the income level of the country’s provinces.

Conclusion

Women’s empowerment and gender equality in education at the province level significantly influence family planning outcomes. Targeted interventions that address each region’s specific educational, economic and demographic contexts are crucial for improving coverage and reducing disparities in family planning services.

Barriers and strategies for pain management in non-verbal people with dementia in residential care facilities: protocol for an e-Delphi study

Por: Felix · I. B. · Ramos · C. · Guerreiro · R. · Hughes · J. D. · Hoti · K. · Andrade · T. · Guerreiro · M.
Introduction

Pain is a prevalent symptom in people living with dementia. Evidence shows that pain frequently remains unrecognised and untreated in this vulnerable population, leading to avoidable suffering. Effective pain management is hindered by multifactorial barriers at the individual, organisational and policy level. This study aims to achieve expert consensus on the key barriers to pain management in non-verbal people living with dementia and strategies to address these barriers within Portuguese residential care facilities.

Methods and analysis

An e-Delphi study will be conducted using two rounds of online questionnaires. The Behaviour Change Wheel (BCW) framework guided the development of e-Delphi statements by linking identified determinants (i.e., barriers and facilitators) to intervention functions. Barriers were extracted from the literature reviews and mapped into the capability, opportunity and motivation–behaviour model. Intervention functions were then selected using the BCW linkage matrices and operationalised into practical strategies. A purposive and snowball sampling approach will be used to recruit a heterogeneous panel of experts across national residential care facilities, including nurses, physicians, managers and policymakers with relevant experience in dementia. During the e-Delphi rounds, participants will be invited to rate the relevance of each barrier and associated strategy(ies) on a five-point Likert scale and provide comments or suggestions. Consensus will be defined as ≥75% agreement on each statement.

Ethics and dissemination

Ethical approval for this study was obtained from the Egas Moniz Ethics Committee (Ref. 1586), and all procedures will comply with the Declaration of Helsinki. Informed consent will be obtained from all participants. The findings will be disseminated through a peer-reviewed publication, scientific events and stakeholder networks, including residential care facilities, to inform future practice and policy in dementia care.

Feasibility of an AI-assisted transcranial duplex sonography protocol for early detection of intracerebral haemorrhage: the HYPER-AI-SCAN single-centre prospective study

Por: Simonetti · R. · Canals · P. · Gonzalez Riveros · J. D. · Alanis-Bernal · M. · Pancorbo · O. · Rodriguez-Luna · D.
Introduction

Intracerebral haemorrhage (ICH) is associated with high early mortality and morbidity. Early clinical deterioration is common and influenced by haematoma expansion, which can occur within the first hours after symptom onset. Transcranial duplex sonography (TCD) is a rapid, non-invasive tool that may aid in early ICH detection but is highly operator-dependent. Artificial intelligence (AI)-based analysis of ultrasound images has shown promise in other fields but has not yet been validated in acute ICH.

Methods and analysis

This is a single-centre, prospective feasibility study involving 500 patients with acute ischaemic and haemorrhagic stroke (

Ethics and dissemination

Ethical approval has been obtained. Informed consent will be collected. Data will be coded and stored securely. Results will be disseminated through peer-reviewed journals and conferences.

Trial registration number

Not applicable at this stage (observational AI study).

COVID-19 antibody testing study: a nested substudy within Albertas Tomorrow Project (ATP) in Alberta, Canada

Por: Nejatinamini · S. · Charlton · C. · Harman · S. · Kanji · J. N. · Kellner · J. D. · Lines · K. · Murdoch · K. · Powell · W. · Roberts · J. · Rosner · W. · Shen-Tu · G. · Tipples · G. · Xu · J.-Y. · Vena · J. E.
Purpose

The Alberta’s Tomorrow Project (ATP) prospective cohort study was established in 2000 to investigate the causes of cancer and chronic disease. The cohort consists of almost 55 000 participants aged 35–69 years at the time of recruitment. From 2020 to 2022, ATP conducted a longitudinal substudy, the COVID-19 Antibody Testing (CAT) study, nested in this existing cohort, to understand the spread and impact of the SARS-CoV-2. In this cohort profile, we describe the CAT study design, recruitment and initial findings.

Participants

In this prospective cohort substudy, ~4000 participants completed online surveys and provided blood samples at a study centre every 4 months for 1 year, across four cities in Alberta, Canada. The study was launched on a rolling basis beginning in September 2020 and data collection was completed in May 2022. The surveys collected information on health and lifestyle factors, COVID-19 (testing, symptoms, vaccination, public health recommendations) and impacts of the pandemic (including economic, health services, mental health). Blood samples were tested for antinucleocapsid and antispike protein SARS-CoV-2 antibodies.

Findings to date

A total of 4102 participants consented and attended a study centre at baseline, and almost 90% of these completed the study. Overall, participants were aged 61±10 years, 60% female, 12% came from rural areas, 45% had at least a bachelor’s degree, 24% reported a household income 4 weeks). By the end of the study, 96% of participants had received at least one COVID-19 vaccine dose. Through investigating other outcomes, it was observed that participants under 50 years of age were more likely to be assessed to have mild or moderate-to-severe anxiety and depressive symptoms compared with older participants. In addition, approximately 15% of participants reported a moderate to major impact on their ability to meet financial obligations.

Future plans

Serology results, together with health, lifestyle and sociodemographic data, and the continued follow-up of these participants as part of the broader ATP cohort study (planned through 2065), will provide opportunities to investigate the long-term sequelae of COVID-19 infection as well as the broader impacts of the pandemic on physical, mental and emotional health. Data are available to researchers on request through the ATP access process.

Emerging concepts and practices in health disparities implementation science in the United States: a scoping review protocol

Por: Earland · D. E. · Andreae · L. J. · Austin · J. D. · Gollust · S. E. · Japuntich · S. J. · Theis-Mahon · N. · Reardon · E. · Abdikeir · K. · Crusan · A. · Overcash · F. · Allen · M. L.
Introduction

Implementation science research increases the uptake of evidence-based interventions, which may improve health equity among racial and ethnic minorities. However, it is unclear how anti-racism and anti-colonialism practices have been integrated into implementation science research. The objectives of this scoping review are to describe the current conceptualisations of racism and colonialism within the USA, examine racism or colonialism-conscious approaches and analyse gaps in the operationalisation of anti-racism or anti-colonialism within implementation science studies.

Methods and analysis

This scoping review will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews guidelines. The Center for Chronic Disease Reduction and Equity Promotion Across Minnesota conceptual framework and an implementation science anti-racism lens will guide the study design and analysis. To determine study eligibility for the scoping review, articles will undergo abstract and full-text screening by two independent reviewers and discrepancies will be settled together. Data charting will be extracted from included articles by eight independent reviewers. The search strategy will use controlled vocabulary and natural language keywords related to health equity, health disparities and anti-racism/colonialism on six databases. The scoping review will include studies that applied implementation science theories, models or frameworks among US-based populations. Additionally, included studies will report any of the following implementation activities: implementation strategies, implementation outcomes, adaptations to evidence-based interventions, or evaluations of pre-implementation or implementation context.

Ethics and dissemination

No ethical approval was required for the scoping review. Dissemination will be through publication in a peer-reviewed journal and conference presentations.

Pragmatic paradigm for patient-reported outcome measure selection in lymphoma clinical trials: a rapid review study

Por: Guo · J. D. · Hartzema · A. · Cohen · J. B. · Tunstall · N. · Gehchan · A.
Objectives

Lymphoma is a haematologic malignancy affecting cells of the immune system. With numerous treatment options available, clinicians and patients frequently face difficulty in selecting the most appropriate therapy. Patient-reported Outcome (PRO) offers valuable patients’ insight that may support treatment differentiation. A PRO measure (PROM) is a questionnaire or survey measuring a PRO. Despite many efforts to guide the selection of PROMs in clinical trials, choosing the appropriate ones remains a challenge. This study aims to develop a pragmatic paradigm for selecting PROMs in clinical trials involving adult patients with lymphoma through the collaboration and communication between clinical investigators involved in trials and Health Economics and Outcomes Research (HEOR) scientists specialised in research methodologies.

Design

A rapid review was conducted to identify existing PROMs for adult patients with lymphoma in clinical trials and guidelines supporting PROM selection.

Data sources

PubMed, Google Scholar and websites for regulatory and health technology assessment (HTA) bodies in eight countries of interest were searched from 2009 to July 2024.

Eligibility criteria

Publications with PROMs were identified for adult patients in lymphoma trials. The most relevant guidelines supporting the development of the pragmatic paradigm were selected.

Data extraction and synthesis

The initial search and data extraction were conducted by one author. All authors participated in an in-depth review process.

Results

We categorise 31 applicable PROMs for lymphoma into four distinct groups, streamlining the PROM selection process to facilitate effective communication among clinical investigators, HEOR scientists, patients and others. Additionally, a five-step pragmatic paradigm is developed for identifying appropriate PROM(s).

Conclusions

The pragmatic paradigm presents a practical approach for selecting PROM(s) in lymphoma clinical trials. An appropriate PROM should conceptually align with the treatment goals and be acceptable to regulatory and HTA bodies. Thus, lymphoma clinical trials can generate more patient-focused data, contributing to improving patients’ quality of life and advancing lymphoma care.

Community participatory approaches in infectious disease dynamic transmission modelling: a scoping review protocol

Por: Tahmo · N. B. · Idemili · C. · Noah · A. · Odhiambo · B. · Kyalo · C. · Ligare · F. · Wanjiku · J. · Kong · J. D. · Chan · A. K. · Baral · S. · Walimbwa · J. · Lazarus · L. · Puchalski Ritchie · L. M. · Mishra · S.
Introduction

Community participatory modelling merges participatory research approaches with mathematical modelling. Participatory approaches are grounded in the engagement of people with lived experience (eg, who are affected by the health condition under study) throughout the research process. Mathematical modelling of infectious disease (ID) dynamic transmissions is increasingly used as a tool for public health decision-making, generating predictions, inferring mechanisms and estimating the impact of potential interventions—all of which guide policies, strategies and resource allocation as part of the preparation and response to ID epidemics. However, little is known about the engagement of people with lived experience and affected communities in the ID modelling process. We will map the literature to explore participatory approaches undertaken in ID modelling (practical aspects of formalising participatory modelling), levels of participation and the potential influence from the perspective of communities engaged.

Methods and analysis

The scoping review will follow the Joanna Briggs Institute Manual for Evidence Synthesis. The search strategy includes three electronic bibliographic databases (MEDLINE, Scopus and Embase), no language restrictions and sources published from 2000 to present. We will implement the search with and without the participatory keyword, as we recognise that some studies do not explicitly term community engagement as participatory modelling. After deduplication, two authors will independently screen the titles, abstracts and full texts, with discrepancies resolved with a third team member. We will extract the relevant information from the main text, parameter tables, supplemental files, bibliography, acknowledgment and author affiliation sections. The data extraction will follow a deductive content analysis where we draw from community-based participatory research approaches and established mathematical modelling steps. We will also extract data to assess whether there was equitable engagement of knowledge users by checking for indicators of three equitable engagement domains as outlined by the Ward framework (equity within partnership (eg, whether knowledge user influenced modelling decisions or remuneration), capacity to engage in future partnerships and shift in power/influence (eg, coauthorship). We will supplement our narrative analyses with summaries in tabular format and using appropriate data visualisations.

Ethics and dissemination

No ethics approval will be required for this scoping review because we will map evidence from publicly available literature sources. We will develop multilingual abstracts or one-page lay summaries of the findings (English, French and Swahili), a policy brief and will coauthor an open-access journal article. A summary of the findings will be shared via knowledge user-led presentations at the Maisha HIV and AIDS Conference and with other community-based organisations at the quarterly peer-to-peer support meetings.

Registration

The protocol has been registered in Open Science Framework, DOI: https://doi.org/10.17605/OSF.IO/XQ2WP (December 2024).

Evaluating a co-created model for video consultations in cardiac rehabilitation: impact on health literacy, quality of life and family support--a study protocol

Por: Rosenstrom · S. · Cecilie Tjustrup · N. · Kallemose · T. · Risom · S. S. · Hove · J. D. · Brodsgaard · A.
Introduction

Cardiac rehabilitation has traditionally been administered through face-to-face consultations with a specialised team of nurses, medical doctors and physiotherapists. However, the healthcare system is undergoing a significant digital transformation, which may lead to telemedicine (TM) becoming a cornerstone of healthcare. However, successful TM requires digital competencies among both patients and health professionals. This trial will examine the best methods of onboarding patients to TM by way of a co-designed cardiac telerehabilitation model with a family-focused approach.

Aim

The aim is to investigate how patients and family members could benefit from using TM, including video consultations and home monitoring, for cardiac rehabilitation. We ask how patients’ health literacy, digital health literacy, health-related quality of life and family support would be affected by a shift to TM.

Methods and analysis

The primary outcome is the Health Literacy Questionnaire, and secondary outcomes are the eHealth Literacy Questionnaire, European Quality of Life—Five Dimensions Scale, and the Iceland—Family Perceived Support Questionnaire. The sample size is 73 patients in each group. Data will be analysed with 2 or Fisher’s exact tests, a t-test or a Wilcoxon signed-rank test, depending on the distribution.

Ethics and dissemination

Approval for this trial was obtained from the Danish Data Protection Agency (P-2023-65) and the National Committee on Health Research Ethics (F-23075094). The trial will be conducted in compliance with the Declaration of Helsinki. The trial results—whether positive, neutral or negative—will be submitted for publication. The trial has been registered at ClinicalTrials.gov (NCT06320652).

Trial registration number

(NCT06320652).

MINMON-J: a hybrid implementation pilot study evaluating a low-barrier hepatitis C treatment model in a jail setting

Por: Berk · J. · Fu · E. S. · Murphy · M. · Akiyama · M. J. · Sulkowski · M. · Rich · J. D. · Frank · H. E.
Introduction

Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.

Methods and analysis

MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.

Ethics and dissemination

This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.

Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.

Trial registration number

NCT06953479.

Cardiovascular effects of incretin-based drugs in patients with and without a history of heart failure: a protocol for a systematic review, meta-analysis and trial sequential analysis of randomised controlled trials

Por: El-Sheikh · M. · Sillassen · C. D. B. · Wisborg · F. D. · Hove · J. D. · Dirksen · C. · Lee · M. M. Y. · Jakobsen · J. C. · Grand · J.
Background

Incretin-based drugs, including glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RAs, are increasingly used in the management of type 2 diabetes mellitus and obesity. While these agents have shown cardiovascular benefits, their effects on both cardiovascular outcomes and cardiac structure and function remain uncertain—particularly in patients with and without a history of heart failure (HF).

Methods and analysis

We will conduct a systematic review and search major medical databases (Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), Latin American and Caribbean Health Sciences Literature (LILACS), Science Citation Index Expanded (SCI-EXPANDED) and Conference Proceedings Citation Index-Science (CPCI-S)), as well as clinical trial registries from their inception and onwards to identify relevant randomised trials. The literature search is scheduled for July 2025. Two review authors will independently extract data and assess risk of bias. We will include randomised controlled trials assessing the effects of cagrilintide/semaglutide, liraglutide, semaglutide and tirzepatide in patients with and without a history of HF. The primary outcome will be cardiovascular mortality. Secondary outcomes will include HF hospitalisation, myocardial infarction, stroke, heart rate, systolic blood pressure, N-terminal pro B-type natriuretic peptide, left ventricular ejection fraction, left ventricular end-diastolic volume and left ventricular end-systolic volume. Data will be synthesised by aggregate data meta-analyses and trial sequential analysis. Risk of bias will be assessed with the Cochrane Risk of Bias tool, version 2, and the certainty of the evidence will be assessed by Grading of Recommendations, Assessment, Development and Evaluations (GRADE).

Ethics and dissemination

As this study is a systematic review based on secondary analysis of published data, ethical approval is not required. Findings will be published in international peer-reviewed scientific journals.

PROSPERO registration number

CRD420251003374.

Developing an approach to enhance recruitment for a cluster-randomised implementation trial: leveraging deliberative participation and credible messengers

Por: Vaughn · V. M. · Horowitz · J. · Gandhi · T. · Neetz · R. A. · Petty · L. · Hersh · A. · Lindenauer · P. · Bernstein · S. J. · Flanders · S. A. · Harrison · J. D. · Smith · J. D. · White · A. T. · Szymczak · J. E.
Objectives

To evaluate an innovative approach to recruit 40 hospitals to a cluster randomised controlled trial (RCT) to improve discharge antibiotic prescribing.

Design

This study describes the design, implementation and impact of a theory-informed recruitment approach for hospitals participating in the Reducing Overuse of Antibiotics at Discharge (ROAD) Home trial.

Setting

An inperson meeting of a quality improvement collaborative of acute care hospitals in the state of Michigan.

Participants

Representatives from acute care hospitals that are part of the Michigan Hospital Medicine Safety Consortium.

Interventions

Small group recruitment sessions that combined deliberative participation and credible messengers to recruit hospitals to participate in a cluster RCT on a single date (1 November 2023).

Primary and secondary outcomes

The primary outcome was the number of hospitals which agreed to participate in the trial. We also assessed participant feedback, effectiveness of recruitment methods and resources required for implementation of this approach.

Results

We recruited 51 (74%) of 69 eligible hospitals. Survey participants reported: sessions made clear the purpose of the trial (94%, 64/68) and time commitment required (87%, 59/68); agreed deliberative participation was helpful (82%, 56/68) and were ‘very satisfied’ with the session (82%, 56/68). Investigators largely reported credible messengers were a positive influence, though this varied across sessions. Hospital recruitment was time intensive, taking 179.5 total person hours. The recruitment process involved 3 months of preparation for the sessions and 2 months of follow-up prior to closing recruitment.

Conclusions

We demonstrated the feasibility and impact of a novel approach to recruit hospitals from an existing collaborative to a cluster RCT using the principles of deliberative participation and credible messengers. While the approach was time-consuming, we achieved success at over-recruiting hospitals in a relatively short period of time. Strategies presented here may assist future trial organisers in implementing hospital-based cluster RCTs.

Trial registration number

The ROAD Home trial is registered on Clinical.Trials.gov (NCT06106204).

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