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Inter-reviewer reliability of human literature reviewing and implications for the introduction of machine-assisted systematic reviews: a mixed-methods review

Por: Hanegraaf · P. · Wondimu · A. · Mosselman · J. J. · de Jong · R. · Abogunrin · S. · Queiros · L. · Lane · M. · Postma · M. J. · Boersma · C. · van der Schans · J.
Objectives

Our main objective is to assess the inter-reviewer reliability (IRR) reported in published systematic literature reviews (SLRs). Our secondary objective is to determine the expected IRR by authors of SLRs for both human and machine-assisted reviews.

Methods

We performed a review of SLRs of randomised controlled trials using the PubMed and Embase databases. Data were extracted on IRR by means of Cohen’s kappa score of abstract/title screening, full-text screening and data extraction in combination with review team size, items screened and the quality of the review was assessed with the A MeaSurement Tool to Assess systematic Reviews 2. In addition, we performed a survey of authors of SLRs on their expectations of machine learning automation and human performed IRR in SLRs.

Results

After removal of duplicates, 836 articles were screened for abstract, and 413 were screened full text. In total, 45 eligible articles were included. The average Cohen’s kappa score reported was 0.82 (SD=0.11, n=12) for abstract screening, 0.77 (SD=0.18, n=14) for full-text screening, 0.86 (SD=0.07, n=15) for the whole screening process and 0.88 (SD=0.08, n=16) for data extraction. No association was observed between the IRR reported and review team size, items screened and quality of the SLR. The survey (n=37) showed overlapping expected Cohen’s kappa values ranging between approximately 0.6–0.9 for either human or machine learning-assisted SLRs. No trend was observed between reviewer experience and expected IRR. Authors expect a higher-than-average IRR for machine learning-assisted SLR compared with human based SLR in both screening and data extraction.

Conclusion

Currently, it is not common to report on IRR in the scientific literature for either human and machine learning-assisted SLRs. This mixed-methods review gives first guidance on the human IRR benchmark, which could be used as a minimal threshold for IRR in machine learning-assisted SLRs.

PROSPERO registration number

CRD42023386706.

Hierarchy of demographic and social determinants of mental health: analysis of cross-sectional survey data from the Global Mind Project

Por: Bala · J. · Newson · J. J. · Thiagarajan · T. C.
Objectives

To understand the extent to which various demographic and social determinants predict mental health status and their relative hierarchy of predictive power in order to prioritise and develop population-based preventative approaches.

Design

Cross-sectional analysis of survey data.

Setting

Internet-based survey from 32 countries across North America, Europe, Latin America, Middle East and North Africa, Sub-Saharan Africa, South Asia and Australia, collected between April 2020 and December 2021.

Participants

270 000 adults aged 18–85+ years who participated in the Global Mind Project.

Outcome measures

We used 120+ demographic and social determinants to predict aggregate mental health status and scores of individuals (mental health quotient (MHQ)) and determine their relative predictive influence using various machine learning models including gradient boosting and random forest classification for various demographic stratifications by age, gender, geographical region and language. Outcomes reported include model performance metrics of accuracy, precision, recall, F1 scores and importance of individual factors determined by reduction in the squared error attributable to that factor.

Results

Across all demographic classification models, 80% of those with negative MHQs were correctly identified, while regression models predicted specific MHQ scores within ±15% of the position on the scale. Predictions were higher for older ages (0.9+ accuracy, 0.9+ F1 Score; 65+ years) and poorer for younger ages (0.68 accuracy, 0.68 F1 Score; 18–24 years). Across all age groups, genders, regions and language groups, lack of social interaction and sufficient sleep were several times more important than all other factors. For younger ages (18–24 years), other highly predictive factors included cyberbullying and sexual abuse while not being able to work was high for ages 45–54 years.

Conclusion

Social determinants of traumas, adversities and lifestyle can account for 60%–90% of mental health challenges. However, additional factors are at play, particularly for younger ages, that are not included in these data and need further investigation.

Subphenotypes of self-reported symptoms and outcomes in long COVID: a prospective cohort study with latent class analysis

Por: Kitsios · G. D. · Blacka · S. · Jacobs · J. J. · Mirza · T. · Naqvi · A. · Gentry · H. · Murray · C. · Wang · X. · Golubykh · K. · Qurashi · H. · Dodia · A. · Risbano · M. · Benigno · M. · Emir · B. · Weinstein · E. · Bramson · C. · Jiang · L. · Dai · F. · Szigethy · E. · Mellors · J. W. · Met
Objective

To characterise subphenotypes of self-reported symptoms and outcomes (SRSOs) in postacute sequelae of COVID-19 (PASC).

Design

Prospective, observational cohort study of subjects with PASC.

Setting

Academic tertiary centre from five clinical referral sources.

Participants

Adults with COVID-19 ≥20 days before enrolment and presence of any new self-reported symptoms following COVID-19.

Exposures

We collected data on clinical variables and SRSOs via structured telephone interviews and performed standardised assessments with validated clinical numerical scales to capture psychological symptoms, neurocognitive functioning and cardiopulmonary function. We collected saliva and stool samples for quantification of SARS-CoV-2 RNA via quantitative PCR.

Outcomes measures

Description of PASC SRSOs burden and duration, derivation of distinct PASC subphenotypes via latent class analysis (LCA) and relationship with viral load.

Results

We analysed baseline data for 214 individuals with a study visit at a median of 197.5 days after COVID-19 diagnosis. Participants reported ever having a median of 9/16 symptoms (IQR 6–11) after acute COVID-19, with muscle-aches, dyspnoea and headache being the most common. Fatigue, cognitive impairment and dyspnoea were experienced for a longer time. Participants had a lower burden of active symptoms (median 3 (1–6)) than those ever experienced (p

Conclusions

We identified three distinct PASC subphenotypes. We highlight that although most symptoms progressively resolve, specific PASC subpopulations are impacted by either high burden of constitutional symptoms or persistent olfactory/gustatory dysfunction, requiring prospective identification and targeted preventive or therapeutic interventions.

Implementation of an intervention to reduce urine dipstick testing in aged care homes: a qualitative study of enablers and barriers, and strategies to enhance delivery

Por: Lim · L.-l. · Williams · K. · Francis · J. J. · Wroth · M. · Breen · J.
Objective

The ‘To Dip or Not to Dip’ (TDONTD) intervention aims to reduce antibiotic prescribing for urinary tract infection (UTI) by reducing low-value dipstick testing. The aims of this study were to use a qualitative approach to (1) evaluate potential influences on the delivery of the TDONTD intervention in Australian residential aged care homes (RACHs) by identifying perceived barriers and enablers to delivery and acceptance; and (2) propose intervention strategies to address barriers and enhance enablers.

Design

A qualitative before–after process evaluation of a multisite implementation study using interviews with nurse and pharmacist implementers.

Setting

This study was conducted in 12 Australian RACHs.

Participants

Participants included 17 on-site nurse champions and 4 pharmacists (existing contracted providers).

Intervention

Resources from England’s TDONTD intervention were adapted for an Australian context. Key resources delivered were case-based education, staff training video, clinical pathway and an audit tool.

Results

Key barriers to TDONTD were beliefs about nursing capabilities in diagnosing infection, beliefs about consequences (fear of missing infection) and social influences (pressure from family, doctors and hospitals). Key enablers were perceived increased nurse and carer knowledge (around UTI and asymptomatic bacteriuria), resources from a credible source, empowerment of nurse champions to apply knowledge and skills in delivering operational change initiatives, pharmacist-delivered education and organisational policy or process change. Of TDONTD’s key components, the clinical pathway substituted dipstick testing in diagnosing UTI, delivery of case-based education was enhanced by their attendance and support of the intervention and the antibiotic audit tool generated feedback that champions shared with staff.

Conclusions

Our study confirms the core components of TDONTD and strategies to enhance delivery and overcome barriers. To further reduce barriers to TDONTD, broader advocacy work is required to raise awareness of dipstick testing as a low-value test in older persons and by linking it to healthcare professionals and consumer education.

Protocol of a scoping review of outcome domains in dermatology

Por: Nadir · U. · Ahmed · A. · Yi · M. D. · Hisham · F. I. · Dave · L. · Kottner · J. · Ezzedine · K. · Garg · A. · Ingram · J. R. · Jemec · G. B. E. · Spuls · P. I. · Kirkham · J. J. · Cahn · B. · Alam · M.
Introduction

Core outcome sets (COSs) are agreed outcomes (domains (subdomains) and instruments) that should be measured as a minimum in clinical trials or practice in certain diseases or clinical fields. Worldwide, the number of COSs is increasing and there might be conceptual overlaps of domains (subdomains) and instruments within disciplines. The aim of this scoping review is to map and to classify all outcomes identified with COS projects relating to skin diseases.

Methods and analysis

We will conduct a scoping review of outcomes of skin disease-related COS initiatives to identify all concepts and their definitions. We will search PubMed, Embase and Cochrane library. The search dates will be 1 January 2010 (the point at which Core Outcome Measures in Effectiveness Trials (COMET) was established) to 1 January 2024. We will also review the COMET database and C3 website to identify parts of COSs (domains and/or instruments) that are being developed and published. This review will be supplemented by querying relevant stakeholders from COS organisations, dermatology organisations and patient organisations for additional COSs that were developed. The resulting long lists of outcomes will then be mapped into conceptually similar concepts.

Ethics and dissemination

This study was supported by departmental research funds from the Department of Dermatology at Northwestern University. An ethics committee review was waived since this protocol was done by staff researchers with no involvement of patient care. Conflicts of interests, if any, will be addressed by replacing participants with relevant conflicts or reassigning them. The results will be disseminated through publication in peer-reviewed journals, social media posts and promotion by COS organisations.

Priming transcranial direct current stimulation for improving hemiparetic upper limb in patients with subacute stroke: study protocol for a randomised controlled trial

Por: Zhu · F. · Xu · X. · Jin · M. · Chen · J. · Feng · X. · Wang · J. · Yu · D. · Wang · R. · Lian · Y. · Huai · B. · Lou · X. · Shi · X. · He · T. · Lu · J. · Zhang · J. J. · Bai · Z.
Introduction

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that modulates brain states by applying a weak electrical current to the brain cortex. Several studies have shown that anodal stimulation of the ipsilesional primary motor cortex (M1) may promote motor recovery of the affected upper limb in patients with stroke; however, a high-level clinical recommendation cannot be drawn in view of inconsistent findings. A priming brain stimulation protocol has been proposed to induce stable modulatory effects, in which an inhibitory stimulation is applied prior to excitatory stimulation to a brain area. Our recent work showed that priming theta burst magnetic stimulation demonstrated superior effects in improving upper limb motor function and neurophysiological outcomes. However, it remains unknown whether pairing a session of cathodal tDCS with a session of anodal tDCS will also capitalise on its therapeutic effects.

Methods and analysis

This will be a two-arm double-blind randomised controlled trial involving 134 patients 1–6 months after stroke onset. Eligible participants will be randomly allocated to receive 10 sessions of priming tDCS+robotic training, or 10 sessions of non-priming tDCS+robotic training for 2 weeks. The primary outcome is the Fugl-Meyer Assessment-upper extremity, and the secondary outcomes are the Wolf Motor Function Test and Modified Barthel Index. The motor-evoked potentials, regional oxyhaemoglobin level and resting-state functional connectivity between the bilateral M1 will be acquired and analysed to investigate the effects of priming tDCS on neuroplasticity.

Ethics and dissemination

The study has been approved by the Research Ethics Committee of the Shanghai Yangzhi Rehabilitation Center (reference number: Yangzhi2023-022) and will be conducted in accordance with the Declaration of Helsinki of 1964, as revised in 2013.

Trial registration number

ChiCTR2300074681.

Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

Por: Al-Hendy · A. · Segars · J. H. · Taylor · H. S. · Gonzalez · F. · Siblini · H. · Zamah · M. · Alkelani · H. · Singh · B. · Flores · V. A. · Christman · G. M. · Johnson · J. J. · Huang · H. · Zhang · H.
Introduction

Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

Methods and analysis

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

Ethics and dissemination

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

Trial registration number

NCT05364008.

Impact of multimorbidity and complex multimorbidity on healthcare utilisation in older Australian adults aged 45 years or more: a large population-based cross-sectional data linkage study

Por: Kabir · A. · Conway · D. P. · Ansari · S. · Tran · A. · Rhee · J. J. · Barr · M.
Objectives

As life expectancy increases, older people are living longer with multimorbidity (MM, co-occurrence of ≥2 chronic health conditions) and complex multimorbidity (CMM, ≥3 chronic conditions affecting ≥3 different body systems). We assessed the impacts of MM and CMM on healthcare service use in Australia, as little was known about this.

Design

Population-based cross-sectional data linkage study.

Setting

New South Wales, Australia.

Participants

248 496 people aged ≥45 years who completed the Sax Institute’s 45 and Up Study baseline questionnaire.

Primary outcome

High average annual healthcare service use (≥2 hospital admissions, ≥11 general practice visits and ≥2 emergency department (ED) visits) during the 3-year baseline period (year before, year of and year after recruitment).

Methods

Baseline questionnaire data were linked with hospital, Medicare claims and ED datasets. Poisson regression models were used to estimate adjusted and unadjusted prevalence ratios for high service use with 95% CIs. Using a count of chronic conditions (disease count) as an alternative morbidity metric was requested during peer review.

Results

Prevalence of MM and CMM was 43.8% and 15.5%, respectively, and prevalence increased with age. Across three healthcare settings, MM was associated with a 2.02-fold to 2.26-fold, and CMM was associated with a 1.83-fold to 2.08-fold, increased risk of high service use. The association was higher in the youngest group (45–59 years) versus the oldest group (≥75 years), which was confirmed when disease count was used as the morbidity metric in sensitivity analysis.

When comparing impact using three categories with no overlap (no MM/CMM, MM with no CMM, and CMM), CMM had greater impact than MM across all settings.

Conclusion

Increased healthcare service use among older adults with MM and CMM impacts on the demand for primary care and hospital services. Which of MM or CMM has greater impact on risk of high healthcare service use depends on the analytic method used. Ageing populations living longer with increasing burdens of MM and CMM will require increased Medicare funding and provision of integrated care across the healthcare system to meet their complex needs.

Factors associated with dietary behaviour change support in patients: A qualitative study among community nurses

Abstract

Aim

To explore which factors, influencing dietary behaviour change support among patients by Dutch community nurses (CNs; nurses), are key focal points in training programmes.

Background

Nurses have an important role in counselling patients towards healthier dietary behaviour to prevent or delay long-term complications from chronic lifestyle-related diseases. Most nurses do not incorporate dietary behaviour change support in their routines to the fullest potential.

Design

A qualitative descriptive study.

Methods

Data were collected in the Netherlands in 2018–2019 via semi-structured face-to-face interviews with 18 nurses. Interview guide themes were informed by the COM-B model, using validated descriptions in Dutch. Data were recorded, transcribed and analysed using inductive thematic analysis.

Results

Factors that affected dietary behaviour change support were linked to (1) the nurse (role identity, dietary knowledge and competences such as methodical approach, behaviour change techniques and communication techniques), (2) nurse–patient encounter (building a relationship with a patient, supporting patient autonomy and tailoring the approach) and (3) cooperation and organizational context.

Conclusion

It is of utmost importance to pay attention to nurses' role identity regarding dietary behaviour change support, as this underlies professional behaviour. This should be accompanied by improving competences on dietary behaviour change support. Focus on competences regarding the application of behaviour change technique is crucial. Furthermore, having a relationship of trust with a patient was important for discussing sensitive topics such as diet.

Impact

The promotion of a healthy diet provides opportunities to contribute to patient autonomy and self-management. Well-fitted training offers for (senior) nurses will lead to improved professional practice of nurses, leading to healthier dietary behaviour of patients.

Patient or Public Contribution

A nurse provided feedback on the interview guide.

Elements of organisation of integrated maternity care and their associations with outcomes: a scoping review protocol

Por: Liebregts · J. · Goodarzi · B. · Valentijn · P. P. · Downe · S. · Erwich · J. J. · Burchell · G. · Batenburg · R. · de Vries · E. F. · de Jonge · A. · Verhoeven · C. J. M. · VOICE study group · Graaf · Heemstra · Rippen · Struijs · Zuidhof · Boesveld · Kaiser · Fransen · Berks · Haga
Introduction

Integrated care is seen as an enabling strategy in organising healthcare to improve quality, finances, personnel and sustainability. Developments in the organisation of maternity care follow this trend. The way care is organised should support the general aims and outcomes of healthcare systems. Organisation itself consists of a variety of smaller ‘elements of organisation’. Various elements of organisation are implemented in different organisations and networks. We will examine which elements of integrated maternity care are associated with maternal and neonatal health outcomes, experiences of women and professionals, healthcare spending and care processes.

Methods and analysis

We will conduct this review using the JBI methodology for scoping reviews and the reporting guideline PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews). We will undertake a systematic search in the databases PubMed, Scopus, Cochrane and PsycINFO. A machine learning tool, ASReview, will be used to select relevant papers. These papers will be analysed and classified thematically using the framework of the Rainbow Model of Integrated Care (RMIC). The Population Concept Context framework for scoping reviews will be used in which ‘Population’ is defined as elements of the organisation of integrated maternity care, ‘Context’ as high-income countries and ‘Concepts’ as outcomes stated in the objective of this review. We will include papers from 2012 onwards, in Dutch or English language, which describe both ‘how the care is organised’ (elements) and ‘outcomes’.

Ethics and dissemination

Since this is a scoping review of previously published summary data, ethical approval for this study is not needed. Findings will be published in a peer-reviewed international journal, discussed in a webinar and presented at (inter)national conferences and meetings of professional associations.

The findings of this scoping review will give insight into the nature and effectiveness of elements of integrated care and will generate hypotheses for further research.

Key factors for effective implementation of healthcare workers support interventions after patient safety incidents in health organisations: a scoping review

Por: Guerra-Paiva · S. · Lobao · M. J. · Simoes · D. G. · Fernandes · J. · Donato · H. · Carrillo · I. · Mira · J. J. · Sousa · P.
Objectives

This study aims to map and frame the main factors present in support interventions successfully implemented in health organisations in order to provide timely and adequate response to healthcare workers (HCWs) after patient safety incidents (PSIs).

Design

Scoping review guided by the six-stage approach proposed by Arksey and O’Malley and by PRISMA-ScR.

Data sources

CINAHL, Cochrane Library, Embase, Epistemonikos, PsycINFO, PubMed, SciELO Citation Index, Scopus, Web of Science Core Collection, reference lists of the eligible articles, websites and a consultation group.

Eligibility criteria for selecting studies

Empirical studies (original articles) were prioritised. We used the Mixed Methods Appraisal Tool Version 2018 to conduct a quality assessment of the eligible studies.

Data extraction and synthesis

A total of 9766 records were retrieved (last update in November 2022). We assessed 156 articles for eligibility in the full-text screening. Of these, 29 earticles met the eligibility criteria. The articles were independently screened by two authors. In the case of disagreement, a third author was involved. The collected data were organised according to the Organisational factors, People, Environment, Recommendations from other Audies, Attributes of the support interventions. We used EndNote to import articles from the databases and Rayyan to support the screening of titles and abstracts.

Results

The existence of an organisational culture based on principles of trust and non-judgement, multidisciplinary action, leadership engagement and strong dissemination of the support programmes’ were crucial factors for their effective implementation. Training should be provided for peer supporters and leaders to facilitate the response to HCWs’ needs. Regular communication among the implementation team, allocation of protected time, funding and continuous monitoring are useful elements to the sustainability of the programmes.

Conclusion

HCWs’ well-being depends on an adequate implementation of a complex group of interrelated factors to support them after PSIs.

Associations of eHealth literacy and knowledge with preventive behaviours and psychological distress during the COVID-19 pandemic: a population-based online survey

Por: Lee · J. J. · Poon · C. Y. · O'Connor · S. · Wong · J. Y. H. · Kwok · J. Y. Y. · Choi · E. P. H. · Tsang · W. N. · Wang · M. P.
Objectives

To compare the associations of COVID-19 preventive behaviours and depressive and anxiety symptoms with eHealth literacy and COVID-19 knowledge among Korean adults.

Design

A cross-sectional online survey was conducted in April 2020.

Setting

Seoul metropolitan area in South Korea.

Participants

1057 Korean adults were recruited.

Main outcome measures

Associations between eHealth literacy, COVID-19 knowledge, COVID-19 preventive behaviours and psychological distress were computed using Pearson’s correlation and logistic regression analyses. eHealth literacy, COVID-19 knowledge, COVID-19 preventive behaviours and psychological distress were weighted by sex and age distribution of the general population in Seoul Metropolitan area.

Results

68.40% (n=723) perceived high eHealth literacy level (eHEALS ≥26), while 57.43% (n=605) had high levels of COVID-19 knowledge (score ≥25). No significant association between eHealth literacy and COVID-19 knowledge was identified (r=0.05, p=0.09). eHealth literacy and COVID-19 knowledge were significantly associated with COVID-19 preventive behaviours (aOR=1.99, 95% CI 1.51 to 2.62 L; aOR=1.81, 95% CI 1.40 to 2.34, respectively). High eHealth literacy was significantly associated with anxiety symptom (aOR=1.71, 95% CI 1.18 to 2.47) and depressive symptom (aOR=1.69, 95% CI 1.24 to 2.30). COVID-19 knowledge had negative and no associations with the symptoms (aOR=0.62, 95% CI 0.46 to 0.86; aOR=0.79, 95% CI 0.60 to 1.03, respectively). High eHealth literacy with low COVID-19 knowledge was positively and significantly associated with COVID-19 preventive behaviours (aOR=2.30, 95% CI 1.52 to 3.43), and anxiety (aOR=1.81, 95% CI 1.09 to 3.01) and depressive symptoms (aOR=2.24, 95% CI 1.41 to 3.55). High eHealth literacy with high COVID-19 knowledge were significantly associated with more preventive behaviours (aOR=3.66, 95% CI 2.47 to 5.42) but no significant associations with anxiety and depressive symptoms.

Conclusion

We identified that eHealth literacy and COVID-19 knowledge were not associated each other, and differently associated with individuals’ COVID-19 preventive behaviours and psychological well-being. Public health strategies should pay attention to enhancing both eHealth literacy and COVID-19 knowledge levels in the public to maximise their COVID-19 preventive behaviours and mitigate their psychological distress during COVID-19 pandemic.

NIMBUS study protocol: a single-centre feasibility study of non-invasive monitoring with bowel ultrasound in paediatric inflammatory bowel disease

Por: Green · Z. · Mayberry · E. · Ashton · J. J. · Beattie · R. M. · Evans · A. · Wahid · A. · Edwards · M. O.
Introduction

Incidence of inflammatory bowel disease (IBD) is increasing in childhood and treatment increasingly targets mucosal healing. Monitoring bowel inflammation requires endoscopy or MRI enterography which are invasive, expensive and have long waiting lists.

We aim to examine the feasibility of a non-invasive monitoring tool—bowel ultrasound (BUS)—in children with IBD and explore correlations with inflammatory markers and disease activity measures. Some BUS criteria have been found to correlate with these markers; however, this has not been validated in children.

We aim to examine the feasibility of BUS for monitoring inflammation in this population; highlighting useful parameters for this purpose. We aim to inform a larger scale randomised controlled trial using BUS.

Methods and analysis

This prospective observational feasibility study will be carried out over 24 months at the Noah’s Ark Children’s Hospital for Wales, Cardiff; with the endpoint recruitment of 50 participants. Children aged 2–18 years with a modified Porto criteria diagnosis of IBD will be included.

Patients without IBD or who have previously undergone IBD-related surgery will be excluded; as will families unable to give informed consent.

Ultrasound scan images and reports will be collected, as well as laboratory results and clinical outcomes.

The primary aim will assess the feasibility of targeted BUS for disease monitoring; including recruitment statistics. The secondary aims will involve data collection and correlation analysis for targeted ultrasound parameters, biomarkers, disease activity scores and prediction of changes in treatment. The statistical methods will include: feasibility metrics, descriptive statistics, cross-tabulation and 2 analysis, correlation analysis, regression analysis.

Ethics and dissemination

Ethical approval is granted by NHS Research Ethics Committee. The sponsor is Cardiff and Vale University Health Board. We will publish the results in a peer-reviewed medical journal.

Trial registration number

NCT05673278.

Methodology and application of three-dimensional technology for brace design and production for treatment in patients with adolescent idiopathic scoliosis: a scoping review protocol

Por: Hoelen · T.-C. A. · de Bie · R. A. · Arts · J. J. · Willems · P. C.
Introduction

Conservative treatment for adolescent idiopathic scoliosis (AIS) using bracing has proven to be effective at reducing curve progression. However, variation in brace design and lack of brace specificity hamper clinical treatment outcomes as well as the predictability and comparison hereof. To overcome this, recent technological developments aim to generate transparent and objective criteria for brace manufacturing by applying computer-aided design software and additive manufacturing to produce braces for scoliosis treatment. Yet, the extent of its applicability and clinical implementation are to be determined. This study will identify and map the available evidence for the methodology and application of three-dimensional technology for the design and production of clinical braces used for treatment in patients with AIS.

Methods and analysis

This scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. This scoping review will consider studies on methodology of three-dimensional technological methodology and applications that have been or are currently being applied in brace treatment of AIS. The following databases will be searched: MEDLINE, Web of Science, Cochrane Database of Systematic Reviews and Embase (OVID). Search limits will be applied; for example, only articles written in the English language published after 2000 will be included. The retrieved articles will be screened independently by two researchers. A third researcher will be consulted in case of disagreement. Data from relevant articles will be independently extracted by two researchers and presented in a tabular manner accompanied by a descriptive narration.

Ethics and dissemination

Considering the nature of the study, no ethical approval needed to be requested. The study result will be submitted to a peer-reviewed journal.

Polyethylene glycol precipitation is an efficient method to obtain extracellular vesicle-depleted fetal bovine serum

by Peng Wang, Onno J. Arntz, Johanna F. A. Husch, Van der Kraan P. M., Jeroen J. J. P. van den Beucken, Fons A. J. van de Loo

Mesenchymal stromal/stem cell derived-extracellular vesicles (MSC-EVs) have gained interest as drug delivery nanoparticles, having immunoregulatory and potentiating tissue repair property. To maintain growth of MSCs and obtain pure MSC-derived EVs, the culture media should contain fetal bovine serum (FBS) devoid of EVs, as the presence of FBS EVs confounds the properties of MSC-EVs. Therefore, we tested three methods: 18h ultracentrifugation (UC) and ultrafiltration (UF), which are common FBS EV depletion methods in current MSC-EV research, and polyethylene glycol (PEG) precipitation to obtain three EV depleted FBS (EVdFBS) batches, and compared them to FBS and commercial (Com) EVdFBS on human adipose stem cell (hADSC) growth, differentiation, enrichment of EVs in hADSC supernatant and their biological function on collagen metabolism. Our comparative study showed UC and UF vary in terms of depletion efficiency and do not completely deplete EVs and affects the growth-promoting quality of FBS. Specifically, FBS EV depletion was comparable between PEG (95.6%) and UF (96.6%) but less by UC (82%), as compared to FBS. FBS protein loss was markedly different among PEG (47%), UF (87%), and UC (51%), implying the ratio of EV depletion over protein loss was PEG (2.03), UF (1.11), and UC (1.61). A significant decrease of TGFβ/Smad signaling, involving in MSC growth and physiology, was observed by UF. After 96 hours of exposure to 5% FBS or 5% four different EVdFBS cell growth media, the osteogenesis ability of hADSCs was not impaired but slightly lower mRNA expression level of Col2a observed in EVdFBS media during chondrogenesis. In consistent with low confluency of hADSCs observed by optical microscope, cell proliferation in response to 5% UF EVdFBS media was inhibited significantly. Importantly, more and purer ADSCs EVs were obtained from ADSCs cultured in 5% PEG EVdFBS media, and they retained bioactive as they upregulated the expression of Col1a1, TIMP1 of human knee synovial fibroblast. Taken together, this study showed that PEG precipitation is the most efficient method to obtain EV depleted FBS for growth of MSCs, and to obtain MSC EVs with minimal FBS EV contamination.

Workplace-based learning about health promotion in individual patient care: a scoping review

Por: Verhees · M. J. M. · Engbers · R. · Landstra · A. M. · Bremer · A. E. · van de Pol · M. · Laan · R. F. J. M. · Assendelft · W. J. J.
Objective

To outline current knowledge regarding workplace-based learning about health promotion in individual patient care.

Design

Scoping review.

Data sources

PubMed, ERIC, CINAHL and Web of Science from January 2000 to August 2023.

Eligibility criteria

We included articles about learning (activities) for healthcare professionals (in training), about health promotion in individual patient care and in the context of workplace-based learning.

Data extraction and synthesis

The studies were evaluated using a charting template and were analysed thematically using a template based on Designable Elements of Learning Environments model.

Results

From 7159 studies, we included 31 that described evaluations of workplace-based learning about health promotion, around a variety of health promotion topics, for different health professions. In the articles, health promotion was operationalised as knowledge, skills or attitudes related to specific lifestyle factors or more broadly, with concepts such as health literacy, advocacy and social determinants of health. We assembled an overview of spatial and instrumental, social, epistemic and temporal elements of learning environments in which health promotion is learnt.

Conclusions

The studies included in our analysis varied greatly in their approach to health promotion topics and the evaluation of learning outcomes. Our findings suggest the importance of providing opportunities for health profession learners to engage in authentic practice situations and address potential challenges they may experience translating related theory into practice. Additionally, our results highlight the need for conscious and articulated integration of health promotion in curricula and assessment structures. We recommend the exploration of opportunities for health profession students, professionals and patients to learn about health promotion together. Additionally, we see potential in using participatory research methods to study future health promotion learning.

Study registration

Open Science Framework, https://doi.org/10.17605/OSF.IO/6QPTV.

How prevalent is COVID-19 vaccine hesitancy in low-income and middle-income countries and what are the key drivers of hesitancy? Results from 53 countries

Por: Dayton Eberwein · J. · Edochie · I. N. · Newhouse · D. · Cojocaru · A. · Bopahbe · G. D. · Kakietek · J. J. · Kim · Y. S. · Montes · J.
Objectives

This study aims to estimate the levels of COVID-19 vaccine hesitancy in 53 low-income and middle-income countries, differences across population groups in hesitancy, and self-reported reasons for being hesitant to take the COVID-19 vaccine.

Methods

This paper presents new evidence on levels and trends of vaccine hesitancy in low-income and middle-income countries based on harmonised high-frequency phone surveys from more than 120 000 respondents in 53 low-income and middle-income countries collected between October 2020 and August 2021. These countries represent a combined 53% of the population of low-income and middle-income countries excluding India and China.

Results

On average across countries, one in five adults reported being hesitant to take the COVID-19 vaccine, with the most cited reasons for hesitancy being concerns about the safety of the vaccine, followed by concerns about its efficacy. Between late 2020 and the first half of 2021, there tended to be little change in hesitancy rates in 11 of the 14 countries with available data, while hesitancy increased in Iraq, Malawi and Uzbekistan. COVID-19 vaccine hesitancy was higher among female, younger adults and less educated respondents, after controlling for selected observable characteristics.

Conclusions

Country estimates of vaccine hesitancy from the high-frequency phone surveys are correlated with but lower than those from earlier studies, which often relied on less representative survey samples. The results suggest that vaccine hesitancy in low-income and middle-income countries, while less prevalent than previously thought, will be an important and enduring obstacle to recovery from the pandemic.

Supporting adolescents participation in muscle-strengthening physical activity: protocol for the 'Resistance Training for Teens (RT4T) hybrid type III implementation-effectiveness trial

Por: Kelly · H. T. · Smith · J. J. · Verdonschot · A. · Kennedy · S. G. · Scott · J. J. · McKay · H. · Nathan · N. · Sutherland · R. · Morgan · P. J. · Salmon · J. · Penney · D. · Boyer · J. · Lloyd · R. S. · Oldmeadow · C. · Reeves · P. · Pursey · K. · Hua · M. · Longmore · S. · Norman · J. · Vo
Introduction

In Australia, only 22% of male and 8% of female adolescents meet the muscle-strengthening physical activity guidelines, and few school-based interventions support participation in resistance training (RT). After promising findings from our effectiveness trial, we conducted a state-wide dissemination of the ‘Resistance Training for Teens’ (RT4T) intervention from 2015 to 2020. Despite high estimated reach, we found considerable variability in programme delivery and teachers reported numerous barriers to implementation. Supporting schools when they first adopt evidence-based programmes may strengthen programme fidelity, sustainability, and by extension, programme impact. However, the most effective implementation support model for RT4T is unclear.

Objective

To compare the effects of three implementation support models on the reach (primary outcome), dose delivered, fidelity, sustainability, impact and cost of RT4T.

Methods and analysis

We will conduct a hybrid type III implementation–effectiveness trial involving grade 9 and 10 (aged 14–16 years) students from 90 secondary schools in New South Wales (NSW), Australia. Schools will be recruited across one cohort in 2023, stratified by school type, socioeconomic status and location, and randomised in a 1:1:1 ratio to receive one of the following levels of implementation support: (1) ‘low’ (training and resources), (2) ‘moderate’ (training and resources+external support) or ‘high’ (training and resources+external support+equipment). Training includes a teacher workshop related to RT4T programme content (theory and practical sessions) and the related resources. Additional support will be provided by trained project officers from five local health districts. Equipment will consist of a pack of semiportable RT equipment (ie, weighted bars, dumbbells, resistance bands and inverted pull up bar stands) valued at ~$A1000 per school. Study outcomes will be assessed at baseline (T0), 6 months (T1) and 18 months (T2). A range of quantitative (teacher logs, observations and teacher surveys) and qualitative (semistructured interviews with teachers) methods will be used to assess primary (reach) and secondary outcomes (dose delivered, fidelity, sustainability, impact and cost of RT4T). Quantitative analyses will use logistic mixed models for dichotomous outcomes, and ordinal or linear mixed effects regression models for continuous outcomes, with alpha levels set at p

Ethics and dissemination

Ethics approval has been obtained from the University of Newcastle (H-2021-0418), the NSW Department of Education (SERAP:2022215), Hunter New England Human Research Ethics Committee (2023/ETH00052) and the Catholic Schools Office. The design, conduct and reporting will adhere to the Consolidated Standards of Reporting Trials statement, the Standards for Reporting Implementation Studies statement and the Template for Intervention Description and Replication checklist. Findings will be published in open access peer-reviewed journals, key stakeholders will be provided with a detailed report. We will support ongoing dissemination of RT4T in Australian schools via professional learning for teachers.

Trial registration number

ACTRN12622000861752.

Home-based model is an important cost-effective alternative to centre-based cardiac rehabilitation

Por: Batalik · L. · Su · J. J.

Commentary on: Shields GE, Rowlandson A, Dalal G, Nickerson S, Cranmer H, Capobianco L, Doherty P. Cost-effectiveness of home-based cardiac rehabilitation: a systematic review. Heart. 2023 Feb 27:heartjnl-2021-320459. doi: 10.1136/heartjnl-2021-320459. Epub ahead of print.

Implications for practice and research

  • Home-based cardiac rehabilitation (CR) is a cost-effective alternative/supplementary model to increase CR accessibility, improve health benefits and reduce health service use.

  • More robust clinical trials are needed as the heterogeneity in design, particularly the intervention dosage, staffing models, telehealth features, hybrid approach and individual costs, challenges the evidence base.

  • The psychological care component is missing in the current cost-effectiveness analysis of home-based CR.

  • Context

    Despite evidence that exercise-based cardiovascular rehabilitation (CR) is an effective intervention, patient uptake and adherence are uncertain. Recent research suggests that home-based CR interventions are as effective and safe as those supervised in a centre.1 Therefore, home-based telemedicine...

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