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Study protocol for a prospective diagnostic accuracy study to assess the feasibility and diagnostic accuracy of serial ankle handheld Doppler waveform assessment (Ankle HHD) for surveillance after lower-limb revascularisation: WAVE study

Por: Alodayni · H. M. · Smith · S. · Poushpas · S. · Swagell · K. · Mandic · D. · Johnson · N. A. · Jaffer · U. · Davies · A. · Normahani · P.
Introduction

Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

Methods and analysis

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

Ethics and dissemination

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

Trial registration number

ClinicalTrials.gov, NCT06619223.

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Scalability evaluation of a complex community-based falls prevention intervention in Australian stroke rehabilitation

Por: Lin · I. · Day · S. · Dean · C. M. · Clemson · L. M. · Glinsky · J. V. · Cusick · A. · Lannin · N. A. · Scrivener · K.
Objectives

To investigate the scalability of the multi-component Falls After Stroke Trial (FAST) intervention tailored to community-dwelling adults with stroke to enable post-trial implementation.

Design

A mixed-methods formative evaluation of FAST data guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework.

Setting

Community settings across three states in Australia.

Participants

Stroke participants were a subset of FAST trial participants (n=50) who were community-dwelling adults who had experienced a stroke up to 5 years prior and were at risk of falling. Therapists who delivered the intervention in the trial (interventionists) were physiotherapists and occupational therapists, trained in the FAST intervention.

Interventions

The FAST intervention is an individually tailored home safety and functional exercise programme designed to reduce falls and improve community mobility. It is offered over a 6-month period using 10 home visits, two telephone calls and programme resources, for example, manual and worksheets.

Primary and secondary outcome measures

Trial data, including interventionist training records and delivery data, resources and stroke participants’ adherence data were used to assess the Adoption, Implementation and Maintenance dimensions of the RE-AIM framework.

Results

The FAST intervention was delivered by 22 interventionists. High implementation fidelity was shown with 90% of the stroke participants receiving FAST dose and content. Effective strategies supporting implementation included standardised programme resources, comprehensive pre-programme training, regular interventionist feedback and interventionist mentoring from experts. Online training and peer support networks will be required for scale up.

Conclusions

This study identifies how a complex intervention to prevent falls after stroke was successfully delivered. The AIM dimensions provided insights to FAST features essential for scale-up. Interventionist training, resources and mentoring/feedback were essential for adoption within the trial. Training and resources should be accessible in an online format for scale up (maintenance).

Trial registration number

ACTRN12619001114134.

Prevalence of workplace bullying among healthcare workers in hospitals in Greater Beirut: effects on psychological well-being, burnout and sick leaves

Por: Makarem · N. N. · Tavitian-Elmadjian · L. R. · Brome · D. · Soubra · N. A.
Introduction

Interest in workplace bullying (WPB) has been steadily growing with a focus on understanding its consequences as well as prevalence rates in different occupations and across different countries with varying cultural contexts. Research in the Middle East remains limited, especially in Lebanon. The scarcity of data from the Lebanese healthcare sector underscores the need to better understand WPB in this unique sociocultural and organisational environment.

Objectives

The primary aim of this study is to investigate the prevalence of WPB among healthcare providers and hospital staff in Greater Beirut. The secondary aim is to investigate the relationship between WPB, psychological well-being, burnout and sick leaves in the Lebanese cultural context.

Design

A cross-sectional study design was conducted.

Setting

Seven hospitals in Greater Beirut took part in the study, including six private hospitals and one public hospital.

Participants

A total of 958 participants aged 18–64 were recruited using stratified proportionate non-random sampling. Stratification by hospital size and department aimed to ensure broad representation of nursing and support staff across institutions. The participants included nursing and supporting staff, of which 26.3% were males and 73.7% were females. Those employed for less than 6 months were excluded.

Primary and secondary outcome measures

The Arabic versions of each of the Negative Acts Questionnaire-Revised (NAQ-R), the General Health Questionnaire (GHQ-12) and the Copenhagen Burnout Inventory (CBI) were administered. These instruments were selected for their established reliability and widespread use in cross-cultural occupational health research. Surveys were administered via paper-and-pencil (six hospitals) and online (one hospital). Prevalence of bullying using the NAQ-R cut-off scores was first calculated and then their respective thresholds identified using receiver operating characteristic analysis. Pearson’s correlation coefficient was used to evaluate the relationship between the NAQ-R and the GHQ-12, CBI and number of sick leaves.

Results

Using the lower threshold as a cut-off on the NAQ-R, 35.1% of participants were classified as bullied. When applying the higher threshold as a cut-off, the percentage was slightly lower but remained comparable at 32.4%. Results showed that across the two outcomes, those who were bullied both when using a lower threshold and upper threshold were significantly more distressed and burnt out (pt(df) = –8.43, p±1.96; Upper threshold: ² (4, N=902)=9.963, p=0.019, Standardised residual for 6–10 days=2.2>±1.96).

Conclusion

Findings yielded lower prevalence rates of WPB among nurses and the entire sample as compared with research carried out in the Arab region. Our study further supports the impact of culture on the perpetuation of WPB and the uniqueness of Lebanon’s culture on influencing this prevalence. Results indicated that participants who were bullied were significantly more distressed, more burnt out and reported taking up more sick leaves. These findings highlight the need to consider local workplace culture when addressing bullying and reinforce the significant psychological and occupational toll bullying takes on affected individuals. Healthcare institutions are encouraged to implement and reinforce clear antibullying policies, WPB prevention strategies and confidential reporting mechanisms. Future research should explore longitudinal patterns of bullying, obtain a more nationally representative sample and examine the effectiveness of targeted interventions to create safer, more supportive work environments.

Structural equation analysis on the inter-relationships between optimal antenatal care, health facility delivery and early postnatal care among women in Ethiopia: EDHS 2016

Por: Feleke · S. F. · Tesfa · N. A. · Geto · A. K. · Habtie · T. E. · Ahmed · S. S. · Ashagrie · G. · Kassa · M. A. · Yayeh · B. M. · Emagneneh · T.
Objective

This study employs structural equation modelling to explore the inter-relationships among optimal antenatal care (ANC), health facility delivery and early postnatal care (EPNC) in Ethiopia. By identifying both direct and indirect influencing factors, the study offers valuable insights to support integrated maternal health strategies and guide informed decision-making by policymakers and women alike.

Design

The secondary analysis of the Ethiopian Demographic and Health Survey 2016 was performed to investigate inter-relationships between optimal ANC, health facility delivery and postnatal care (PNC) among women in Ethiopia. Data were analysed with R software V.4.3.2. The study used binary logistic regression to examine differences in optimal ANC, health facility delivery and EPNC, focusing on variables with a p value of 0.1 or less. Selected variables were incorporated into a generalised structural equation model (GSEM) using the LAVAAN package to explore both direct and indirect effects. The GSEM method assessed the impact of exogenous variables on endogenous variables, all binary, using a logistic link and binomial family. Missing data were handled with the multiple imputation by chained equations package, and sampling weights were applied to ensure national and regional representativeness.

Setting and participant

The source population comprised all women of reproductive age (15–49 years) who gave birth in the 5 years preceding the survey. From 16 650 interviewed households (98% response rate), we identified 7590 eligible women with recent births. Finally, we included 2415 women who had attended four or more ANC visits.

Result

Media exposure significantly boosts the likelihood of using ANC (OR=1.8, 95% CI (1.04 to 3.23), p=0.04), health facility delivery (OR=1.7, 95% CI (1.23 to 2.45), p=0.05) and PNC (OR=2.0, 95% CI (1.6 to 4.01), p=0.01). Urban residence and secondary education also enhance ANC (OR=1.2, 95% CI (1.01 to 2.88), p=0.022; OR=1.3, 95% CI (1.20 to 3.01), p=0.018), health facility delivery (OR=1.1, 95% CI (1.01 to 3.24), p=0.035; OR=1.5, 95% CI (1.22 to 3.45), p=0.03) and PNC (OR=1.6, 95% CI (1.01 to 4.32), p=0.03). ANC directly affects health facility delivery (OR=1.4, 95% CI (1.28 to 3.09), p=0.01) and PNC (OR=1.6, 95% CI (1.01 to 3.80), p=0.03). Additionally, women aged 20–34 years and those from male-headed households positively impact health facility delivery (OR=1.5, 95% CI (1.20 to 4.80), p=0.01; OR=1.3, 95% CI (1.07 to 3.45), p=0.014) and PNC (OR=1.4, 95% CI (1.10 to 2.90), p=0.01; OR=1.2, 95% CI (1.07 to 3.08), p=0.025).

Conclusions

Optimal ANC is vital for encouraging health facility delivery and EPNC. To enhance maternal and neonatal health, policies should integrate these services. Key predictors include being aged 20–34, having secondary and higher education, media exposure, male-headed households and living in urban areas. Improving education and media exposure can boost maternal healthcare service use.

Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlled trial in the USA: A protocol

Por: Tellor Pennington · B. R. · Janda · A. M. · Colquhoun · D. A. · Neuman · M. D. · Kidwell · K. M. · Spino · C. · Thelen-Perry · S. · Krambrink · A. · Huang · S. · Ignacio · R. · Wu · Z. · Swisher · L. · Cloyd · C. · Vaughn · M. T. · Pescatore · N. A. · Bollini · M. L. · Mashour · G. A.
Introduction

Millions of patients receive general anaesthesia every year with either propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA). It is currently unknown which of these techniques is superior in relation to patient experience, safety and clinical outcomes. The primary aims of this trial are to determine (1) whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and (2) whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA.

Methods and analysis

This protocol was co-created by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 13 000-patient, multicentre, patient-blinded, randomised, comparative effectiveness trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to one of two anaesthetic approaches, TIVA or INVA, using minimisation. The primary effectiveness endpoints are Quality of Recovery-15 (QOR-15) score on postoperative day (POD) 1 in patients undergoing (1) major inpatient surgery, (2) minor inpatient surgery or (3) outpatient surgery, and the primary safety endpoint is the incidence of unintended definite intraoperative awareness with recall in all patients, assessed on POD1 or POD30. Secondary endpoints include QOR-15 score on POD0, POD2 and POD7; incidence of delirium on POD0 and POD1; functional status on POD30 and POD90; health-related quality of life on POD30, POD90, POD180 and POD365; days alive and at home at POD30; patient satisfaction with anaesthesia at POD2; respiratory failure on POD0; kidney injury on POD7; all-cause mortality at POD30 and POD90; intraoperative hypotension; moderate-to-severe intraoperative movement; unplanned hospital admission after outpatient surgery in a free-standing ambulatory surgery centre setting; propofol-related infusion syndrome and malignant hyperthermia.

Ethics and dissemination

This study is approved by the ethics board at Washington University, serving as the single Institutional Review Board for all participating sites. Recruitment began in September 2023. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.

Trial registration number

NCT05991453.

What factors influence nutrition-related information-seeking behaviour among pregnant women attending antenatal care at public hospitals in Bahir Dar City, northwest Ethiopia: a cross-sectional study

Por: Bitacha · G. K. · Asemahagn · M. A. · Mekonnen · Z. A. · Chekol · T. M. · Ahmed · M. H. · Meshesha · N. A. · Guadie · H. A. · Dube · G. N.
Objective

This study aimed to assess the proportion of nutrition-related information-seeking behaviour and its associated factors among pregnant women attending antenatal care at public hospitals in Bahir Dar City, northwest Ethiopia, 2023.

Method

A cross-sectional quantitative supplemented with qualitative study design was conducted from March to April 2023 among 406 pregnant women. Pre-tested structured interviewer-administered and semistructured open-ended questionnaires were used to collect quantitative and qualitative data, respectively. Data were collected using the Kobo toolbox, and SPSS V.25 was used for analysis. Descriptive statistics were used to describe study subjects, and multivariate logistic regression analysis was employed to investigate the associated factors. The strength of associations was described using the OR with the corresponding 95% CI.

Result

The study included 406 pregnant mothers with a median age of 28 with an IQR of 8 and 212 (52.2%) from rural settings. Of the total respondents, 173 (42.6%; 95% CI 37.7 to 47.6) of pregnant mothers were nutrition-related information seekers. Educational status, residence, monthly income and nutrition information literacy were significantly associated with nutrition-related information-seeking behaviour.

Conclusion

The proportion of nutrition information seeking among pregnant mothers in Bahir Dar City public hospitals was low. Lower educational status, low nutrition information literacy level, being from a rural residence and low monthly income are significantly associated factors.

Recommendation

Awareness creation for pregnant mothers from rural areas and with low educational status and improving nutrition information literacy of pregnant mothers are important activities to improve their nutrition information-seeking behaviour.

Effect of medical-grade honey (L-Mesitran) for cervical intraepithelial neoplasia II: protocol for a multicentre cohort pilot study (HONEY FOR CIN II study)

Por: Prop · J. · De Vos van Steenwijk · P. · Lardenoije · C. M. J. G. · Cremers · N. A. J. · Morre · S. A. · Mongula · J.
Introduction

High-grade squamous intraepithelial lesions are caused by persistent high-risk human papillomavirus (hr-HPV) infections and are subdivided into cervical intraepithelial neoplasia (CIN) lesions: CIN II (moderate) and CIN III (severe). Current treatment options for CIN II include large loop excision of the transformation zone, imiquimod and expectant management. Each treatment option has its drawbacks, and therefore, a non-invasive treatment is desirable. Preliminary evidence shows that medical-grade honey (MGH) has antiviral activity and might be able to modulate the vaginal microbiome, reduce local inflammation or directly influence the intralesional immune response within cervical tissues. Therefore, this study aims to investigate the possible effect of MGH on hr-HPV clearance and to investigate the possible underlying mechanisms contributing to the regression of CIN II lesions.

Methods and analysis

This study is performed in the Zuyderland Medical Centre and Maastricht University Medical Centre+. A total of 60 eligible women with newly histologically confirmed CIN II will receive MGH (L-Mesitran Soft) for intravaginal use for 6 months. The primary objective is to investigate the effect of MGH on the hr-HPV clearance after 6 months. Secondary aims are the effect of MGH on the regression of CIN II lesions, clearance of hr-HPV at 12 and 24 months and the role of the vaginal microbiome, local immune system and intravaginal inflammatory status in response to MGH. Moreover, data on quality of life, side effects and compliance will be collected.

Ethics and dissemination

Ethical approval from the Medical Ethics Review Committee of the Zuyderland Medical Centre Heerlen has been obtained (NL86044.096.24 on 24 April 2024). The results will be presented to researchers and healthcare professionals through conferences, meetings and publications in international journals.

Trial registration number

NCT06219018.

Mis- and disinformation and perceptions of healthcare policy among Latinos in the USA: protocol for a multi-method social media sentiment analysis study

Por: Wilson · F. A. · Stimpson · J. P. · Young · M.-E. D. T. · Bustamante · A. V. · Ponce · N. A. · Ortega · A. N.
Introduction

It is unclear how mis- and disinformation regarding healthcare policy changes propagate throughout Latino communities via social media. This may lead to chilling effects that dissuade eligible individuals from enrolling in critical safety net programmes such as Medicaid. This study will examine pathways and mechanisms by which sentiment in response to mis- and disinformation regarding healthcare policies on social media differentially impact health disparity populations, thus supporting the design of tailored social media interventions to mitigate this.

Methods and analysis

We will search social media from X/Twitter, Facebook/Instagram and Reddit for keywords relating to health benefit programmes. Demographic, geographical location and other characteristics of users will be used to stratify social media data. Posts will be classified as fake-news-related or fact-related based on curated lists of fake-news-related websites. The number, temporal dissemination and positive or negative sentiment in reacting to posts and threads will be examined using the Python-based Valence Aware Dictionary and sEntiment Reasoner (VADER). Using a crowd-sourcing methodology, a novel Spanish-language VADER (S-VADER) will be created to rate sentiment to social media among Spanish-speaking Latinos. With the proposed approach, we will explore reactions to the dissemination of fake-news- or fact-related social media tweets and posts and their sources. Analyses of social media posts in response to healthcare-related policies will provide insights into fears faced by Latinos and Spanish speakers, as well as positive or negative perceptions relating to the policy over time among social media users.

Ethics and dissemination

Our study protocol was approved by the University of California, Los Angeles IRB (IRB#23–0 01 123). Results from this study will be disseminated in peer-reviewed journals and conference presentations, and S-VADER will be disseminated to public repositories such as GitHub.

Evaluation of the outpatient parenteral antimicrobial therapy (OPAT) service in Malaysian public hospitals: a mixed-methods study protocol

Por: Lim · A. H. · Ab Rahman · N. · Nor · A. N. M. · Misnan · N. A. · Tok · P. S. K.
Introduction

Outpatient parenteral antimicrobial therapy (OPAT) is an innovative approach to manage infections that require extended courses of intravenous antibiotics by enabling patients to receive treatment in an outpatient setting. In Malaysia, there has yet to be a systematic evaluation of the OPAT service. This study aims to describe the safety, clinical indications and treatment outcomes of the OPAT service in Malaysia, assess patients’ satisfaction and experiences and determine the facilitators and barriers associated with the provision of the OPAT service in Malaysia.

Methods and analysis

A mixed-methods approach combining qualitative and quantitative methods will be employed for a comprehensive understanding of the provision of the OPAT service in Malaysian public hospitals. The study consists of four distinct parts: systematic review, retrospective cohort analysis of clinical outcomes, patients’ satisfaction survey and focus group discussions on providers’ experiences. A longitudinal analysis of the clinical outcomes (treatment success/failure, infection cure, adverse events, readmission and mortality) of the OPAT patients’ cohort will be conducted using descriptive and conclusive statistics, in addition to rates of patients’ satisfaction and evaluation of providers’ experiences.

Ethics and dissemination

This study is registered in the National Medical Research Register (NMRR ID-24-00941-2C8) and approved by the Medical Research and Ethics Committee, Ministry of Health Malaysia (Ref: 24-00941-2C8). Written informed consent will be obtained from all participants. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences.

Skills for adolescent WELLbeing (SWELL): protocol for a preventive effectiveness randomised controlled trial for young people at high-familial risk of depression with treatment optimisation for parents with depression at study entry comparing online group

Por: Rice · F. · Powell · V. · Eyre · O. · Bevan Jones · R. · Michelson · D. · Airdrie · J. · Collishaw · S. · Thapar · A. · Grozeva · D. · Munnery · K. · Randell · E. · Brookes-Howell · L. · Garber · J. · Thapar · A. · Moore · G. · Harrison · N. A. · Playle · R. · Bisson · J. · McNamara · R.
Introduction

Young people (YP) whose parents have depression are at elevated risk for developing depression themselves and could benefit from preventive interventions. However, when parents are in a depressive episode, this reduces the effects of psychological interventions for depression in YP. Moreover, parental depression is often managed suboptimally in usual care. There is, therefore, a case for identifying and optimising parental depression treatment to enhance the effectiveness of psychological preventive interventions for depression in YP.

Methods and analysis

This is a randomised controlled trial (Skills for adolescent WELLbeing) to determine the effectiveness of a cognitive behavioural therapy (CBT) intervention compared with usual care in increasing the time to a major depressive episode in YP by 9-month follow-up (primary outcome). The intervention offers a 12-week treatment-optimisation phase for parents depressed at study entry, followed by randomisation of the young person to a small group manualised online CBT programme facilitated by a therapist. YP allocated to the intervention will receive eight weekly sessions plus three monthly continuation sessions. Secondary outcomes include the number of depression-free weeks, mental health symptoms and functioning. Mechanisms of intervention action will be assessed with mediation analysis of quantitative data and thematic analysis of qualitative interviews. Participants (parents/carers with depression and their children aged 13–19 years) will be identified through existing cohorts of adults with depression, from primary care through health boards in Wales and England, UK, schools and advertising including via social media.

Ethics and dissemination

The trial has received ethical approval from Wales NHS Research Ethics Committee (REC) 5, the Health Research Authority and Health and Care Research Wales (IRAS 305331; REC 22/WA/0254). This manuscript is based on V.5.7 of the protocol (17 January 2025). Findings will be disseminated in peer-reviewed journals and conferences. Reports and social media messages will be used to disseminate findings to the wider public.

Trial registration number

ISRCTN13924193 (date registered: 15 March 2023).

Nursing research landscape in Malaysia: a systematic scoping review protocol on journal publications from 2015 to 2024

Por: Lim · A. H. S. · Danial · M. · Jolly · A. M. A. · Norudin · N. B. · Eu · A. S. H. · Molly · A. M. A. · Mohidin · R. B. · Kim · A. R. J. · Main · S. A. · Lai · W. H. · Muhamad · N. A. B.
Introduction

The nursing profession has undergone significant evolution over the past century, shifting from a role traditionally viewed as an auxiliary to physicians to one of autonomous healthcare professionals equipped with specialised skills and expertise. This shift is driven by the increasing recognition of the importance of evidence-based practice in enhancing patient outcomes and advancing the field of nursing. Consequently, nursing research has emerged as a critical priority in the profession. This study seeks to explore the nursing research landscape in Malaysia, where data remain limited, by examining trends before, during and after the COVID-19 pandemic.

Methods and analysis

This scoping review will be conducted following the Arksey and O'Malley framework, using four electronic databases: PubMed, Scopus and CINAHL for journal articles published between 2015 and 2024, and Web of Science for conference proceedings from the same period.

Ethics and dissemination

The findings from this scoping review will provide an overview of the nursing research landscape in the Malaysian context, offering insights that could guide the future advancement of nursing research in the country. The results will be disseminated through submission to a peer-reviewed scientific journal for publication. Ethical approval is not required for this scoping review, as it involves the synthesis of data from available published literature.

The effect of dietary micronutrient intake on abdominal aortic calcification: a study protocol for systematic review and meta-analysis

Por: Tsegay · E. W. · Hailu · N. A. · Mengesha · M. B. · Gufue · Z. H.
Introduction

Healthy dietary choices have an important role in preventing chronic diseases such as cardiovascular disease (CVD). Increasing evidence suggests micronutrient intake (essential minerals and vitamins) is associated with abdominal aortic calcification (AAC), which is an advanced marker of CVD. However, the existing reports seem inconsistent. Some studies reported micronutrients are associated with a lower risk of AAC, while others have reported an increased risk. Therefore, this systematic review and meta-analysis sought to summarise the available evidence on the association of dietary micronutrient intake on AAC.

Methods and analysis

A comprehensive systematic search of the PubMed/MEDLINE, EMBASE, Web of Science and Google Scholar databases from their inception up to September 1, 2024, will be conducted. All clinical studies that report eligible exposure/s (dietary micronutrient intake) and outcome/s (presence/severity of AAC) will be included, and this systematic review and meta-analysis protocol will be reported following the revised Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines. The risk of bias for observational studies will be assessed using the Newcastle-Ottawa Scale and publication bias will be evaluated through visual inspection of funnel plots and the Egger’s and Begg’s regression tests. The Der Simonian and Laird random-effects model meta-analysis will be calculated to provide pooled results, and the weighted risk ratio with their 95% confidence intervals will be presented.

Ethics and dissemination

The results will be disseminated through publishing in a peer-reviewed journal and public presentations at relevant local, national and international conferences, workshops and symposiums. Ethical approval is not required as this is a systematic review of publicly available data.

PROSPERO registration number

CRD42024575902

Estimating the effect of South Africa travel restrictions in November 2021 on the SARS-CoV-2 Omicron outbreak in the Netherlands: a descriptive analysis and modelling study

Por: Wynberg · E. · Lee · S. · Bavalia · R. · Eijrond · V. · Coffeng · L. E. · de Vries · A. · van Egmond · S. · Brals · L. · Schel · N. A. J. · Harbers · L. · Kolen · B. · De Vlas · S. · Schreijer · A.
Background

Governments used travel bans during the COVID-19 pandemic to limit the introduction of new variant of concern (VoC). In the Netherlands, direct flights from South Africa were banned from 26 November 2021 onwards to curb Omicron (B.1.1.529) importation.

Objectives

This study retrospectively evaluated the effect of the South African travel ban and the timing of its implementation on subsequent Omicron infections in the Netherlands and, in order to help inform future decision-making, assessed alternative scenarios in which the reproduction number (Re) and volume of indirectly imported cases were varied.

Design

Descriptive analysis and modelling study.

Outcome measure

Time (days) from 26 November 2021 to reach 10 000 cumulative Omicron infections in the Netherlands.

Methods

To benchmark the direct importation rate of Omicron from South Africa, we used the proportion (n/N, %) of passengers arriving on two direct flights from South Africa to the Netherlands on 26 November 2021 with a positive PCR sequencing result for Omicron VoC infection. We scaled the number of directly-imported Omicron infections before and after the travel ban to the incidence in South Africa. We assumed that 10% of all cases continued to arrive via indirect routes, a ‘failure rate’ of 2% (ie, incoming Dutch citizens not adhering to quarantine on arrival) and an effective reproduction number (Re) of Omicron of 1.3. In subsequent analyses, we varied, within plausible limits, the Re (1.1–2.0) and proportion of indirectly-imported cases (0–20%).

Results

Compared with no travel ban, the travel ban achieved a 14-day delay in reaching 10 000 Omicron cases, with an additional day of delay if initiated 2 days earlier. If all indirect importation had been prevented (eg, European-wide travel ban), a 21-day delay could have been achieved. The travel ban’s effect was negligible if Re was ≥2.0 and with a greater volume of ongoing importation.

Conclusions

Travel bans can delay the calendar timing of an outbreak but are substantially less effective for pathogens where importation cannot be fully controlled and tracing every imported case is unfeasible. When facing future disease outbreaks, we urge policy-makers to critically weigh up benefits against the known socioeconomic drawbacks of international travel restrictions.

Qualitative exploration of the acceptability of a 12-week intervention to reduce sedentary behaviour among ethnically diverse older adults

Por: Meghani · N. A. A. · Hudson · J. · Straton · G. · Mullins · J.
Objective

The population of ethnically diverse older adults (OAs) is increasing in the UK; this group faces complex health challenges that are exacerbated by language difficulties, socioeconomic status and acculturation experiences. Moreover, this diverse group is the least active and sedentary subgroup within the wider population, which raises a major concern for their health and highlights the need for effective behaviour change interventions to motivate this group to be less sedentary. Therefore, this study aims to explore the acceptability of a 12-week intervention to reduce sedentary behaviour (SB) for ethnically diverse sedentary OAs.

Design

The study employed a qualitative approach to assess the acceptability of the 12-week single-arm intervention for reducing SB.

Setting

The study participants were recruited on a rolling basis from January to May 2024. The recruitment process was conducted through social community organisations and local religious groups in Swansea that provided leisure, sports and recreational activities for ethnically diverse OAs.

Participants

The target population for this study was ethnically diverse OAs aged ≥65 years (including women and men) among (n=20) OAs using in-depth interviews.

Intervention

The intervention consisted of a 40–60 minute personalised one-to-one in-person health coaching session, a wearable activity tracker to remind participants to take breaks from prolonged sitting time, a pamphlet and weekly reminder messages via a mobile phone.

Primary outcome

To assess the acceptability of the intervention.

Results

Reflexive thematic analysis was performed using a deductive approach by integrating four predetermined MRC framework themes. Four overarching themes were included in our analysis: (1) acceptability, (2) usability, (3) functionality and (4) recruitment and retention. OAs were satisfied with the intervention and found it effective and acceptable. The multicomponent intervention provided users with strategies to achieve the goal of reducing their sitting time and provided them with opportunities to be active and independent. In addition, there were personal (eg, health) and social (eg, family) factors that influenced their decision to participate in the intervention.

Conclusion

The findings of this study support the acceptability of the intervention with an ethnically diverse group of OAs. Initial evidence also suggests that the intervention has the potential to increase activity and minimise sitting time in ethnically diverse OAs and therefore will inform a future effectiveness trial. The inclusion of an ethnically diverse population in this study has helped us to understand the needs and challenges of these groups to identify how to design culturally sensitive interventions that are tailored according to their needs. These insights will be incorporated into the planned effectiveness trial.

How to improve the transferability of a 12-week home-space sedentary behaviour intervention for ethnically diverse older adults: a qualitative study protocol of key stakeholder perspectives

Por: Meghani · N. A. A. · Hudson · J. · Stratton · G. · Mullins · J.
Introduction

In the UK, the number of ethnically diverse older adults (OA) is growing. These individuals suffer complex health issues that are made worse by socioeconomic status, acculturation experiences and language barriers. Additionally, this varied group is the least active and a highly sedentary subgroup in the general population, which poses serious health concerns. Various interventions have been implemented with OAs to reduce their sedentary behaviour (SB) and enhance their physical activity (PA). However, there is still limited research that implements stakeholders’ perceptions in translating the interventions into real-life settings, particularly for ethnically diverse OAs. Therefore, the current study aims to explore stakeholders’ perceptions of the transferability of a 12-week home space intervention for ethnically diverse sedentary OAs, that is, aimed at reducing their SB and increasing their PA.

Methods

Exploratory qualitative research using in-depth interviews (IDIs) and a purposive sampling technique will be employed to recruit stakeholders. Before conducting the IDIs, the primary researcher (NAAM) will discuss the findings of the 12-week home space intervention study for ethnically diverse OAs to explain the intervention, and then the interview will revolve around the transferability of the intervention to transfer the intervention into real-world practice into the stakeholder contexts. A diverse group of stakeholders from Swansea, Wales, UK, representing a range of roles including health promotion professionals, programme leads, service providers, policymakers and researchers will be included. The qualitative data obtained will be analysed using reflexive thematic analysis.

Ethics and dissemination

Stakeholders will be required to provide written informed consent prior to initiation of the study. Ethical approval for this study has been obtained from the College of Engineering Research Ethics Committee (320249732903), Swansea University. The study’s results will be shared with the scientific community through a peer-reviewed journal publication and with study participants through seminars and workshops.

Personalised selection of medication for newly diagnosed adult epilepsy: study protocol of a first-in-class, double-blind, randomised controlled trial

Por: Thom · D. · Chang · R. S.-k. · Lannin · N. A. · Ademi · Z. · Ge · Z. · Reutens · D. · OBrien · T. · DSouza · W. · Perucca · P. · Reeder · S. · Nikpour · A. · Wong · C. · Kiley · M. · Saw · J.-L. · Nicolo · J.-P. · Seneviratne · U. · Carney · P. · Jones · D. · Somerville · E. · Stapleton · C.
Introduction

Selection of antiseizure medications (ASMs) for newly diagnosed epilepsy remains largely a trial-and-error process. We have developed a machine learning (ML) model using retrospective data collected from five international cohorts that predicts response to different ASMs as the initial treatment for individual adults with new-onset epilepsy. This study aims to prospectively evaluate this model in Australia using a randomised controlled trial design.

Methods and analysis

At least 234 adult patients with newly diagnosed epilepsy will be recruited from 14 centres in Australia. Patients will be randomised 1:1 to the ML group or usual care group. The ML group will receive the ASM recommended by the model unless it is considered contraindicated by the neurologist. The usual care group will receive the ASM selected by the neurologist alone. Both the patient and neurologists conducting the follow-up will be blinded to the group assignment. Both groups will be followed up for 52 weeks to assess treatment outcomes. Additional information on adverse events, quality of life, mood and use of healthcare services and productivity will be collected using validated questionnaires. Acceptability of the model will also be assessed.

The primary outcome will be the proportion of participants who achieve seizure-freedom (defined as no seizures during the 12-month follow-up period) while taking the initially prescribed ASM. Secondary outcomes include time to treatment failure, time to first seizure after randomisation, changes in mood assessment score and quality of life score, direct healthcare costs, and loss of productivity during the treatment period.

This trial will provide class I evidence for the effectiveness of a ML model as a decision support tool for neurologists to select the first ASM for adults with newly diagnosed epilepsy.

Ethics and dissemination

This study is approved by the Alfred Health Human Research Ethics Committee (Project 130/23). Findings will be presented in academic conferences and submitted to peer-reviewed journals for publication.

Trial registration number

ACTRN12623000209695.

Insights into the provision of physical therapy services at public sector hospitals in Pakistan: an exploratory qualitative study

Por: Muhammad Hanif · Q. A. · Pradhan · N. A. · Hameed · W. · Zafar · B. · Khowaja · B. M. H.
Objectives

Although physical therapy services are a part of the Essential Package of Health Services in Pakistan, they do not receive their due importance. This qualitative study aimed to explore the in-depth insights regarding the factors that influence the provision of physical therapy services in public sector hospitals of Karachi, Pakistan using the WHO’s health systems framework.

Design

Exploratory qualitative study.

Setting and participants

Three public sector hospitals located in Karachi, Pakistan were selected for this study. In-depth interviews were conducted with a total of 12 physical therapists working in the outpatient departments of the selected hospitals.

Results

Findings were categorised into six major themes within the health systems framework, shedding light on various factors influencing the quality of care provided to the patients. These encompass issues such as inappropriate facility infrastructure, limited staff availability and competency, challenges with equipment adequacy and functionality, insufficient financial support, low staff incentivisation and the absence of a regulatory council.

Conclusion

The findings exhibited that the physical therapy services are constrained by various factors at the public sector hospitals in Pakistan. Improvement is recommended at various levels to increase the adequate staffing, financial support, provide the necessary equipment and ensure its functionality. The development of the regulatory council for physical therapy services is the need of the time to address the above solutions.

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