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Using reference equations to standardise incremental shuttle walk test performance in children and young people with chronic conditions and facilitate the evaluation of exercise capacity and disease severity

Por: Filipow · N. · Bladen · M. · Raywood · E. · Robinson · E. · Chugh · D. · Douglas · H. · Thorpe · N. · O'Connor · R. · Murray · N. · Main · E.
Aims

The aim was to evaluate whether standardised exercise performance during the incremental shuttle walk test (ISWT) can be used to assess disease severity in children and young people (CYP) with chronic conditions, through (1) identifying the most appropriate paediatric normative reference equation for the ISWT, (2) assessing how well CYP with haemophilia and cystic fibrosis (CF) perform against the values predicted by the best fit reference equation and (3) evaluating the association between standardised ISWT performance and disease severity.

Methods

A cross-sectional analysis was carried out using existing data from two independent studies (2018–2019) at paediatric hospitals in London,UK. CYP with haemophilia (n=35) and CF (n=134) aged 5–18 years were included. Published reference equations for standardising ISWT were evaluated through a comparison of populations, and Bland-Altman analysis was used to assess the level of agreement between distances predicted by each equation. Associations between ISWT and disease severity were assessed with linear regression.

Results

Three relevant reference equations were identified for the ISWT that standardised performance based on age, sex and body mass index (Vardhan, Lanza, Pinho). A systematic proportional bias of standardised ISWT was observed in all equations, most pronounced with Vardhan and Lanza; the male Pinho equation was identified as most appropriate. On average, CYP with CF and haemophilia performed worse than predicted by the Pihno equation, although the range was wide. Standardised ISWT, and not ISWT distance alone, was significantly associated with forced expiratory volume in 1 s in CYP with CF. Standardised ISWT in CYP with haemophilia was slightly associated with haemophilia joint health score, but this was not significant.

Conclusions

ISWT performance may be useful in a clinic to identify those with worsening disease, but only when performance is standardised against a healthy reference population. The development of validated global reference equations is necessary for more robust assessment.

Developing blood-brain barrier arterial spin labelling as a non-invasive early biomarker of Alzheimers disease (DEBBIE-AD): a prospective observational multicohort study protocol

Por: Padrela · B. · Mahroo · A. · Tee · M. · Sneve · M. H. · Moyaert · P. · Geier · O. · Kuijer · J. P. A. · Beun · S. · Nordhoy · W. · Zhu · Y. D. · Buck · M. A. · Hoinkiss · D. C. · Konstandin · S. · Huber · J. · Wiersinga · J. · Rikken · R. · de Leeuw · D. · Grydeland · H. · Tippett · L. · Caw
Introduction

Loss of blood-brain barrier (BBB) integrity is hypothesised to be one of the earliest microvascular signs of Alzheimer’s disease (AD). Existing BBB integrity imaging methods involve contrast agents or ionising radiation, and pose limitations in terms of cost and logistics. Arterial spin labelling (ASL) perfusion MRI has been recently adapted to map the BBB permeability non-invasively. The DEveloping BBB-ASL as a non-Invasive Early biomarker (DEBBIE) consortium aims to develop this modified ASL-MRI technique for patient-specific and robust BBB permeability assessments. This article outlines the study design of the DEBBIE cohorts focused on investigating the potential of BBB-ASL as an early biomarker for AD (DEBBIE-AD).

Methods and analysis

DEBBIE-AD consists of a multicohort study enrolling participants with subjective cognitive decline, mild cognitive impairment and AD, as well as age-matched healthy controls, from 13 cohorts. The precision and accuracy of BBB-ASL will be evaluated in healthy participants. The clinical value of BBB-ASL will be evaluated by comparing results with both established and novel AD biomarkers. The DEBBIE-AD study aims to provide evidence of the ability of BBB-ASL to measure BBB permeability and demonstrate its utility in AD and AD-related pathologies.

Ethics and dissemination

Ethics approval was obtained for 10 cohorts, and is pending for 3 cohorts. The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study)

Por: Kong · Y. · Chen · R. · Xu · M. · Zhang · J. · Chen · G. · Hong · Z. · Zhang · H. · Dai · X. · Ma · Y. · Zhao · X. · Peng · Y. · Zhang · C. · Xing · P. · Zhang · L.
Introduction

The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.

Objective

The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.

Methods and analysis

The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.

Trial registration number

NCT05790447.

Landscape of Metis health and wellness: protocol for a scoping review

Por: Boutros · H. M. · Koprich · S. · Simms · A. J. · Tsui · N. · Boyle · R.-A. · Harrison · J. · Riddell · M. · Sanftenberg · S. · Cripps · S. · Edwards · S. A. · Metis Nation of Ontario (MNO)
Introduction

In Canada, Métis people are one of three distinct Indigenous peoples whose rights are recognised and affirmed in Section 35 of the federal Constitution Act, 1982. In line with Métis people having a unique culture, history, language and way of life, a distinctions-based approach is critical to understand the current landscape of Métis-specific health. In this paper, we present a scoping review protocol to describe this research landscape in Canada led by the Métis Nation of Ontario (MNO).

Methods and analysis

This scoping review protocol is reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews reporting guidelines and follows Arksey and O’Malley’s scoping review methodology. We will search electronic databases (Scopus, MEDLINE, Embase, Web of Science, CINAHL, APA PsycINFO, Anthropology Plus, Bibliography of Indigenous Peoples of North America, Canadian Business and Current Affairs, Indigenous Studies Portal, Informit Indigenous Collection, Collaborative Indigenous Garden, PubMed, ProQuest), grey literature sources and reference lists from selected papers. Two reviewers (HMB and SK) will double-blind screen all titles/abstracts and full-text studies for inclusion. Any health-related study or health report that includes a Métis-specific health, well-being or Métis social determinant of health outcome will be included. Relevant variables will be extracted following an iterative process whereby the data charting will be reviewed and updated.

Ethics and dissemination

Findings from this scoping review will be shared back through the MNO’s existing community-based communication channels. Traditional academic dissemination will also be pursued. Research ethics board approval is not required, since data are from peer-reviewed publications or publicly shared health reports and knowledge translation products.

Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol

Por: Vahid · F. · Dessenne · C. · Tur · J. A. · Bouzas · C. · Devaux · Y. · Malisoux · L. · Monserrat-Mesquida · M. · Sureda · A. · Desai · M. S. · Turner · J. D. · Lamy · E. · Perez-Jimenez · M. · Ravn-Haren · G. · Andersen · R. · Forberger · S. · Nagrani · R. · Ouzzahra · Y. · Fontefrancesc
Introduction

Despite international efforts, the number of individuals struggling with obesity is still increasing. An important aspect of obesity prevention relates to identifying individuals at risk at early stage, allowing for timely risk stratification and initiation of countermeasures. However, obesity is complex and multifactorial by nature, and one isolated (bio)marker is unlikely to enable an optimal risk stratification and prognosis for the individual; rather, a combined set is required. Such a multicomponent interpretation would integrate biomarkers from various domains, such as classical markers (eg, anthropometrics, blood lipids), multiomics (eg, genetics, proteomics, metabolomics), lifestyle and behavioural attributes (eg, diet, physical activity, sleep patterns), psychological traits (mental health status such as depression) and additional host factors (eg, gut microbiota diversity), also by means of advanced interpretation tools such as machine learning. In this paper, we will present a protocol that will be employed for a scoping review that attempts to summarise and map the state-of-the-art in the area of multicomponent (bio)markers related to obesity, focusing on the usability and effectiveness of such biomarkers.

Methods and analysis

PubMed, Scopus, CINAHL and Embase databases will be searched using predefined key terms to identify peer-reviewed articles published in English until January 2024. Once downloaded into EndNote for deduplication, CADIMA will be employed to review and select abstracts and full-text articles in a two-step procedure, by two independent reviewers. Data extraction will then be carried out by several independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Peer Review of Electronic Search Strategies guidelines will be followed. Combinations employing at least two biomarkers from different domains will be mapped and discussed.

Ethics and dissemination

Ethical approval is not required; data will rely on published articles. Findings will be published open access in an international peer-reviewed journal. This review will allow guiding future directions for research and public health strategies on obesity prevention, paving the way towards multicomponent interventions.

Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol

Por: Ho · C. · Ha · N. T. · Youens · D. · Abhayaratna · W. P. · Bulsara · M. K. · Hughes · J. D. · Mishra · G. · Pearson · S.-A. · Preen · D. B. · Reid · C. M. · Ruiter · R. · Saunders · C. M. · Stricker · B. H. · van Rooij · F. J. A. · Wright · C. · Moorin · R.
Introduction

Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.

Methods and analysis

The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.

Ethics and dissemination

Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.

Trial registration number

NCT05972785.

Sex-specific Impact of the first COVID-19 Lockdown on Age Structure and Case Acuity at Admission in a Patient Population in southwestern Germany: a retrospective comparative Study in Neuroradiology

Por: Reder · S. R. · Herrlich · N. · Grauhan · N. F. · Othman · A. E. · Müller-Eschner · M. · Brockmann · C. · Brockmann · M. A.
Objectives

A hard lockdown was presumed to lead to delayed diagnosis and treatment of serious diseases, resulting in higher acuity at admission. This should be elaborated based on the estimated acuity of the cases, changes in findings during hospitalisation, age structure and biological sex.

Design

Retrospective monocentric cross-sectional study.

Setting

German Neuroradiology Department at a .

Participants

In 2019, n=1158 patients were admitted in contrast to n=884 during the first hard lockdown in 2020 (11th–13th week).

Main outcome measures

Three radiologists evaluated the initial case acuity, classified them into three groups (not acute, subacute and acute), and evaluated if there was a relevant clinical deterioration. The data analysis was conducted using non-parametric methods and multivariate regression analysis.

Results

A 24% decrease in the number of examinations from 2019 to 2020 (p=0.025) was revealed. In women, the case acuity increased by 21% during the lockdown period (p=0.002). A 30% decrease in acute cases in men was observable (in women 5% decrease). Not acute cases decreased in both women and men (47%; 24%), while the subacute cases remained stable in men (0%) and decreased in women (28%). Regression analysis revealed the higher the age, the higher the acuity (p

Conclusion

The lockdown led to a decrease in neuroradiological consultations, with delays in seeking medical care. In women, the number of most severe cases remained stable, whereas the mean case acuity and age increased. This could be due to greater pandemic-related anxiety among women, however, with severe symptoms they were seeking for medical help. In contrast in men, the absolute number of most severe cases decreased, whereas the mean acuity and age remained nearly unaffected. This could be attributable to a reduced willingness to seek for medical consultation.

Prevalence and correlates of paediatric guideline non-adherence for initial empirical care in six low and middle-income settings: a hospital-based cross-sectional study

Por: Shawon · R. A. · Denno · D. · Tickell · K. D. · Atuhairwe · M. · Bandsma · R. · Mupere · E. · Voskuijl · W. · Mbale · E. · Ahmed · T. · Chisti · M. J. · Saleem · A. F. · Ngari · M. · Diallo · A. H. · Berkley · J. · Walson · J. · Means · A. R.
Objectives

This study evaluated the prevalence and correlates of guideline non-adherence for common childhood illnesses in low-resource settings.

Design and setting

We used secondary cross-sectional data from eight healthcare facilities in six Asian and African countries.

Participants

A total of 2796 children aged 2–23 months hospitalised between November 2016 and January 2019 with pneumonia, diarrhoea or severe malnutrition (SM) and without HIV infection were included in this study.

Primary outcome measures

We identified children treated with full, partial or non-adherent initial inpatient care according to site-specific standard-of-care guidelines for pneumonia, diarrhoea and SM within the first 24 hours of admission. Correlates of guideline non-adherence were identified using generalised estimating equations.

Results

Fully adherent care was delivered to 32% of children admitted with diarrhoea, 34% of children with pneumonia and 28% of children with SM when a strict definition of adherence was applied. Non-adherence to recommendations was most common for oxygen and antibiotics for pneumonia; fluid, zinc and antibiotics for diarrhoea; and vitamin A and zinc for SM. Non-adherence varied by site. Pneumonia guideline non-adherence was more likely among patients with severe disease (OR 1.82; 95% CI 1.38, 2.34) compared with non-severe disease. Diarrhoea guideline non-adherence was more likely among lower asset quintile groups (OR 1.16; 95% CI 1.01, 1.35), older children (OR 1.10; 95% CI 1.06, 1.13) and children presenting with wasting (OR 6.44; 95% CI 4.33, 9.57) compared with those with higher assets, younger age and not wasted.

Conclusions

Non-adherence to paediatric guidelines was common and associated with older age, disease severity, and comorbidities, and lower household economic status. These findings highlight opportunities to improve guidelines by adding clarity to specific recommendations.

Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) - protocol for a multi-centre open-label randomised trial

Por: Hudson · E. M. · Noutch · S. · Webster · J. · Brown · S. R. · Boele · F. W. · Al-Salihi · O. · Baines · H. · Bulbeck · H. · Currie · S. · Fernandez · S. · Hughes · J. · Lilley · J. · Smith · A. · Parbutt · C. · Slevin · F. · Short · S. · Sebag-Montefiore · D. · Murray · L.
Introduction

Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.

Methods and analysis

BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.

Ethics and dissemination

BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.

Trial registration number

ISRCTN60524.

Examining the impact of COVID-19 on Maori:non-Maori health inequities in Aotearoa, New Zealand: an observational study protocol

Por: Curtis · E. · Jaung · R. · Paine · S.-J. · McLeod · M. · Tamatea · J. · Atkinson · J. · Jiang · Y. · Robson · B. · Reid · P. · Harris · R. B.
Introduction

The COVID-19 pandemic has had both direct and indirect impacts on the health of populations worldwide. While racial/ethnic health inequities in COVID-19 infection are now well known (and ongoing), knowledge about the impact of COVID-19 pandemic management on non-COVID-19-related outcomes for Indigenous peoples is less well understood. This article presents the study protocol for the Health Research Council of New Zealand funded project ‘Mā te Mōhio ka Mārama: Impact of COVID-19 on Māori:non-Māori inequities’. The study aims to explore changes in access to healthcare, quality of healthcare and health outcomes for Māori, the Indigenous peoples of Aotearoa New Zealand (NZ) and non-Māori during the COVID-19 outbreak period across NZ.

Methods and analysis

This observational study is framed within a Kaupapa Māori research positioning that includes Kaupapa Māori epidemiology. National datasets will be used to report on access to healthcare, quality of healthcare and health outcomes between Māori and non-Māori during the COVID-19 pandemic in NZ. Study periods are defined as (a) prepandemic period (2015–2019), (b) first pandemic year without COVID-19 vaccines (2020) and (c) pandemic period with COVID-19 vaccines (2021 onwards). Regional and national differences between Māori and non-Māori will be explored in two phases focused on identified health priority areas for NZ including (1) mortality, cancer, long-term conditions, first 1000 days, mental health and (2) rheumatic fever.

Ethics and dissemination

This study has ethical approval from the Auckland Health Research Ethics Committee (AHREC AH26253). An advisory group will work with the project team to disseminate the findings of this project via project-specific meetings, peer-reviewed publications and a project-specific website. The overall intention of the project is to highlight areas requiring health policy and practice interventions to address Indigenous inequities in health resulting from COVID-19 pandemic management (both historical and in the future).

Randomised trials conducted using cohorts: a scoping review

Por: Nickolls · B. J. · Relton · C. · Hemkens · L. · Zwarenstein · M. · Eldridge · S. · McCall · S. J. · Griffin · X. L. · Sohanpal · R. · Verkooijen · H. M. · Maguire · J. L. · McCord · K. A.
Introduction

Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.

Objective

To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.

Design

Scoping review.

Data sources

Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews—Cochrane Methodology Registry (Final issue, third Quarter 2012).

Eligibility criteria

Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs.

Data extraction and synthesis

Data were extracted on the condition being studied, age group, setting, country/continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology.

Results

A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers.

The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions.

Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers.

Conclusion

This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts.

Determinants of iron-rich food deficiency among children under 5 years in sub-Saharan Africa: a comprehensive analysis of Demographic and Health Surveys

Por: Osei Bonsu · E. · Addo · I. Y. · Boadi · C. · Boadu · E. F. · Okeke · S. R.
Background

Iron deficiency is a major public health problem that affects the physical and cognitive development of children under 5 years of age (under-5 children) in sub-Saharan Africa (SSA). However, the factors associated with the limited consumption of iron-rich foods in the region are poorly understood.

Objective

This study examined the prevalence and determinants of iron-rich food deficiency among under-5 children in 26 SSA countries.

Design

This nationally representative quantitative study employed pooled data from Demographic and Health Surveys conducted between 2010 and 2019.

Methods

Representative samples comprising 296 850 under-5 children from the various countries were used. Bivariate and multivariate logistic regression models were used to determine the associations between the lack of iron-rich food uptake and various sociodemographic factors.

Result

The overall prevalence of iron-rich food deficiency among the children in the entire sample was 56.75%. The prevalence of iron-rich food deficiency varied widely across the 26 countries, ranging from 42.76% in Congo Democratic Republic to 77.50% in Guinea. Maternal education, particularly primary education (OR 0.62, 95% CI 0.57 to 0.68) and higher education (OR 0.58, 95% CI 0.52 to 0.64), demonstrated a reduced likelihood of iron-rich food deficiency in the sample. Likewise, paternal education, with both primary education (OR 0.69, 95% CI 0.63 to 0.75) and higher education (OR 0.66, 95% CI 0.60 to 0.73) showed decreased odds of iron-rich food deficiency. Postnatal visits contributed significantly to reducing the odds of iron-rich food deficiency (OR 0.90, 95% CI 0.83 to 0.95), along with antenatal visits, which also had a positive impact (OR 0.84, 95% CI 0.74 to 0.95). Finally, residents in rural areas showed slightly higher odds of iron-rich food deficiency (OR 1.12, 95% CI 1.10 to 1.28).

Conclusion

Based on the findings, interventions targeting iron-food deficiency in the SSA region should take into strong consideration the key determinants highlighted in this study.

National cross-sectional cluster survey of tuberculosis prevalence in Timor-Leste: a study protocol

Por: Lopes · C. · Joao · J. C. · Lowbridge · C. · Martins · N. · dos Santos · R. I. G. · da Silva · E. · Dias · J. · Ramalingam · S. · Amaral · S. · Oakley · T. · Ico · L. d. C. · Sarmento · N. · Yan · J. · Francis · J. R.
Introduction

Timor-Leste has one of the world’s highest estimated tuberculosis (TB) incidences, yet the data which informs this estimate is limited and the true burden of TB disease is not known. TB prevalence surveys offer the best means of determining robust estimates of disease burden. This study aims to provide an estimate of the prevalence of bacteriologically confirmed pulmonary TB in Timor-Leste and provide additional insights into diagnostic coverage and health-seeking behaviour of persons with symptoms suggestive of TB.

Methods and analysis

A national population-based cross-sectional cluster survey will be conducted in which participants aged 15 years and older will be screened for pulmonary TB using an algorithm consisting of symptom screening and digital X-ray of the chest with computer-aided detection software for X-ray interpretation. Xpert Ultra and liquid culture methods will be used to confirm survey TB cases. Additional data will be collected from persons reporting symptoms suggestive of TB to assess health-seeking behaviour and access to TB diagnosis and care. The survey aims to screen a target sample population of 20 068 people, living within 50 clusters, representing every municipality of Timor-Leste. Bacteriologically confirmed pulmonary TB prevalence will be estimated using WHO-recommended methods.

Ethics and dissemination

Research ethics approval has been granted by the human research ethics committee of the Northern Territory, Australia, and the Instituto Nacional da Saúde, Timor-Leste. The results will be published in a peer-reviewed scientific journal and disseminated with relevant stakeholders.

Trial registration number

ACTRN12623000718640.

Effectiveness of shared medical appointments delivered in primary care for improving health outcomes in patients with long-term conditions: a systematic review of randomised controlled trials

Por: Tang · M. Y. · Graham · F. · O'Donnell · A. · Beyer · F. · Richmond · C. · Dhami · R. · Sniehotta · F. F. · Kaner · E. F. S.
Objectives

To examine the effectiveness of shared medical appointments (SMAs) compared with one-to-one appointments in primary care for improving health outcomes and reducing demand on healthcare services by people with one or more long-term conditions (LTCs).

Design

A systematic review of the published literature.

Data sources

Six databases, including MEDLINE and Web of Science, were searched 2013–2023. Relevant pre-2013 trials identified by forward and backward citation searches of the included trials were included.

Eligibility criteria

Randomised controlled trials of SMAs delivered in a primary care setting involving adults over 18 years with one or more LTCs. Studies were excluded if the SMA did not include one-to-one patient-clinician time. All countries were eligible for inclusion.

Data extraction and synthesis

Data were extracted and outcomes narratively synthesised, meta-analysis was undertaken where possible.

Results

Twenty-nine unique trials were included. SMA models varied in terms of components, mode of delivery and target population. Most trials recruited patients with a single LTC, most commonly diabetes (n=16). There was substantial heterogeneity in outcome measures. Meta-analysis showed that participants in SMA groups had lower diastolic blood pressure than those in usual care (d=–0.086, 95% CI=–0.16 to –0.02, n=10) (p=0.014). No statistically significant differences were found across other outcomes. Compared with usual care, SMAs had no significant effect on healthcare service use. For example, no difference between SMAs and usual care was found for admissions to emergency departments at follow-up (d=–0.094, 95% CI=–0.27 to 0.08, n=6, p=0.289).

Conclusions

There was a little difference in the effectiveness of SMAs compared with usual care in terms of health outcomes or healthcare service use in the short-term (range 12 weeks to 24 months). To strengthen the evidence base, future studies should include a wider array of LTCs, standardised outcome measures and more details on SMA components to help inform economic evaluation.

PROSPERO registration number

CRD42020173084.

Feasibility of quality indicators on prehospital advanced airway management in a physician-staffed emergency medical service: survey-based assessment of the provider point of view

Por: Kottmann · A. · Pasquier · M. · Carron · P.-N. · Maudet · L. · Rouve · J.-D. · Suppan · L. · Caillet-Bois · D. · Riva · T. · Albrecht · R. · Krüger · A. · Sollid · S. J. M.
Objective

We aimed to determine the feasibility of quality indicators (QIs) for prehospital advanced airway management (PAAM) from a provider point of view.

Design

The study is a survey based feasibility assessment following field testing of QIs for PAAM.

Setting

The study was performed in two physician staffed emergency medical services in Switzerland.

Participants

42 of the 44 emergency physicians who completed at least one case report form (CRF) dedicated to the collection of the QIs on PAAM between 1 January 2019 and 31 December 2021 participated in the study.

Intervention

The data required to calculate the 17 QIs was systematically collected through a dedicated electronic CRF.

Primary and secondary outcome measures

Primary outcomes were provider-related feasibility criteria: relevance and acceptance of the QIs, as well as reliability of the data collection. Secondary outcomes were effort to collect specific data and to complete the CRF.

Results

Over the study period, 470 CRFs were completed, with a median of 11 per physician (IQR 4–17; range 1–48). The median time to complete the CRF was 7 min (IQR 3–16) and was considered reasonable by 95% of the physicians. Overall, 75% of the physicians assessed the set of QIs to be relevant, and 74% accepted that the set of QIs assessed the quality of PAAM. The reliability of data collection was rated as good or excellent for each of the 17 QIs, with the lowest rated for the following 3 QIs: duration of preoxygenation, duration of laryngoscopy and occurrence of desaturation during laryngoscopy.

Conclusions

Collection of QIs on PAAM appears feasible. Electronic medical records and technological solutions facilitating automatic collection of vital parameters and timing during the procedure could improve the reliability of data collection for some QIs. Studies in other services are needed to determine the external validity of our results.

Descriptive study of the challenges when implementing an app for patients with neovascular age-related macular degeneration to monitor their vision at home

Por: Reeves · B. C. · Wickens · R. · OConnor · S. R. · Gidman · E. A. · Ward · E. · Treanor · C. · Peto · T. · Burton · B. J. L. · Knox · P. C. · Lotery · A. · Sivaprasad · S. · Donnelly · M. · Rogers · C. A. · Hogg · R. E.
Objectives

Remote monitoring of health has the potential to reduce the burden to patients of face-to-face appointments and make healthcare more efficient. Apps are available for patients to self-monitor vision at home, for example, to detect reactivation of age-related macular degeneration (AMD). Describing the challenges when implementing apps for self-monitoring of vision at home was an objective of the MONARCH study to evaluate two vision-monitoring apps on an iPod Touch (Multibit and MyVisionTrack).

Design

Diagnostic Test Accuracy study.

Setting

Six UK hospitals.

Methods

The study provides an example of the real-world implementation of such apps across health sectors in an older population. Challenges described include the following: (1) frequency and reason for incoming calls made to a helpline and outgoing calls made to participants; (2) frequency and duration of events responsible for the tests being unavailable; and (3) other technical and logistical challenges.

Results

Patients (n=297) in the study were familiar with technology; 252/296 (85%) had internet at home and 197/296 (67%) had used a smartphone. Nevertheless, 141 (46%) called the study helpline, more often than anticipated. Of 435 reasons for calling, all but 42 (10%) related to testing with the apps or hardware, which contributed to reduced adherence. The team made at least one call to 133 patients (44%) to investigate why data had not been transmitted. Multibit and MyVisionTrack apps were unavailable for 15 and 30 of 1318 testing days for reasons which were the responsibility of the app providers. Researchers also experienced technical challenges with a multiple device management system. Logistical challenges included regulations for transporting lithium-ion batteries and malfunctioning chargers.

Conclusions

Implementation of similar technologies should incorporate a well-resourced helpline and build in additional training time for participants and troubleshooting time for staff. There should also be robust evidence that chosen technologies are fit for the intended purpose.

Trial registration number

ISRCTN79058224.

Attrition from longitudinal ageing studies and performance across domains of cognitive functioning: an individual participant data meta-analysis

Por: Hernandez · R. · Jin · H. · Lee · P.-J. · Schneider · S. · Junghaenel · D. U. · Stone · A. A. · Meijer · E. · Gao · H. · Maupin · D. · Zelinski · E. M.
Objectives

This paper examined the magnitude of differences in performance across domains of cognitive functioning between participants who attrited from studies and those who did not, using data from longitudinal ageing studies where multiple cognitive tests were administered.

Design

Individual participant data meta-analysis.

Participants

Data are from 10 epidemiological longitudinal studies on ageing (total n=209 518) from several Western countries (UK, USA, Mexico, etc). Each study had multiple waves of data (range of 2–17 waves), with multiple cognitive tests administered at each wave (range of 4–17 tests). Only waves with cognitive tests and information on participant dropout at the immediate next wave for adults aged 50 years or older were used in the meta-analysis.

Measures

For each pair of consecutive study waves, we compared the difference in cognitive scores (Cohen’s d) between participants who dropped out at the next study wave and those who remained. Note that our operationalisation of dropout was inclusive of all causes (eg, mortality). The proportion of participant dropout at each wave was also computed.

Results

The average proportion of dropouts between consecutive study waves was 0.26 (0.18 to 0.34). People who attrited were found to have significantly lower levels of cognitive functioning in all domains (at the wave 2–3 years before attrition) compared with those who did not attrit, with small-to-medium effect sizes (overall d=0.37 (0.30 to 0.43)).

Conclusions

Older adults who attrited from longitudinal ageing studies had lower cognitive functioning (assessed at the timepoint before attrition) across all domains as compared with individuals who remained. Cognitive functioning differences may contribute to selection bias in longitudinal ageing studies, impeding accurate conclusions in developmental research. In addition, examining the functional capabilities of attriters may be valuable for determining whether attriters experience functional limitations requiring healthcare attention.

Evaluations of virtual exercise programmes for adults with mobility limitations: a scoping review protocol incorporating an equity lens to inform the development of strategies to optimise participation of under-represented groups

Por: dos Santos · R. B. · Lin · J. · Badwal · A. · Singh · H. · Jaglal · S. B. · Sperling · C. · Salbach · N. M.
Introduction

For individuals with mobility limitations, virtual exercise programmes can address the challenges of in-person participation in community exercise programmes. A synthesis of studies of virtual exercise programmes targeting mobility limitations provided outside of conventional rehabilitation services and strategies used to optimise equitable access and inclusivity in these programmes is lacking. We aim to characterise evaluations of virtual exercise programmes for adults with mobility limitations, and the nature of and extent to which equity, diversity and inclusion considerations are integrated in the research process.

Methods and analysis

A scoping review following a six-stage methodological framework, including a consultation exercise, is proposed. A comprehensive strategy will be used to search Medline, Embase, PEDro, CINAHL and Scopus to identify peer-reviewed studies evaluating virtual exercise programmes for adults with mobility limitations living in the community. Three trained reviewers will select studies independently. Data (eg, study methodology, programme structure and content, participant characteristics) will be extracted using a standardised form, and collated and summarised using quantitative and qualitative methods. The PROGRESS-Plus and International Classification of Functioning, Disability and Health frameworks will be used to classify participant characteristics and study outcomes, respectively. During the consultation exercise, key knowledge users, including exercise participants, programme providers and coordinators, and members of community organisations for persons living with disabilities and under-represented groups, will be asked to provide insights regarding the applicability of review findings. A directed content analysis of data from the consultation exercise will be performed.

Ethics and dissemination

The research ethics board at the University of Toronto approved the consultation exercise. Findings will be disseminated through peer-reviewed publications and conference presentations. Findings will enhance understanding of current research evaluating virtual exercise programmes and inform future research and strategies for promoting equitable access and outcomes for individuals with mobility limitations.

Registration details

https://doi.org/10.17605/OSF.IO/X5JMA.

Prevalence and population characteristics associated with frailty in a rural low socioeconomic area in Denmark: the Lolland-Falster Health Study

Por: Christensen · M. G. · Jacobsen · K. K. · Nilsson · C. · Jepsen · R. · Thygesen · L. · Suetta · C. · Holm · E. A.
Background

Frailty is a major geriatric syndrome that predicts increased vulnerability to minor stressor events and adverse outcomes such as falls, fractures, disability and death. The prevalence of frailty among individuals above the age of 65 varies widely with an overall weighted prevalence of 10.7%.

Objectives

The purpose of this study was to examine the prevalence of prefrailty and frailty in community-dwelling older adults from the regions of Lolland-Falster, which is one of the most socioeconomically disadvantaged areas of Denmark with lower income and lower life expectancy compared with the general Danish population. Moreover, the objective was to find selected individual characteristics associated with frailty.

Design

An observational, cross-sectional registry-based population study with data from the regions of Lolland-Falster collected between February 2016 and February 2020.

Results

The study included 19 000 individuals. There were 10 154 above the age of 50 included for analysis. Prevalence of frailty in the age group of 50–64 years was 4.7% and 8.7% in the age group of 65 years and above.

The study demonstrates associations between frailty and high age, female gender, low education level, low income, smoking, living alone, frequency of seeing one’s children and getting help when needed. These associations are comparable with findings from other studies.

Conclusion

The syndrome of frailty consists of not only physiological and medical issues but also education, life conditions such as living alone and living in poverty and how you evaluate your own health.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

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