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Exploration of Latina/Hispanic womens experiences living with non-alcoholic fatty liver disease: a qualitative study with patients in Houston

Por: Heredia · N. I. · Mendoza Duque · E. · Ayieko · S. · Averyt · A. · McNeill · L. H. · Hwang · J. P. · Fernandez · M. E.
Objectives

A deeper understanding of the lived experiences of Hispanic patients with non-alcoholic fatty liver disease (NAFLD) can help guide the development of behavioural programmes that facilitate NAFLD management. This paper explores Hispanic women’s experiences living with NAFLD.

Design, setting, participants

We collected brief sociodemographic questionnaires and conducted in-depth interviews with 12 low-income (all had household income ≤USD$55 000 per year) Hispanic women with NAFLD from the Houston area. Transcripts were audio-recorded and transcribed. We developed a coding scheme and used thematic analysis to identify emergent themes, supported by Atlas.ti.

Results

Participants identified physicians as their main information source on NAFLD but also consulted the internet, family, friends and peers. Many were still left wanting more information. Participants identified family history, sedentary lifestyles, poor diet and comorbid conditions as causes for their NAFLD. Participants also reported emotional distress after diagnosis. Participants experienced both successes and challenges in making lifestyle changes in nutrition and physical activity. Some participants received desired social support in managing NAFLD, although there were conflicting feelings about spousal support.

Conclusion

Multifaceted programming that improves patient–provider communication, conveys accurate information and enhances social support is needed to support Hispanic women in managing NAFLD.

Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: a propensity score-matched retrospective cohort study using the SEER database

Por: Ma · X. · Wu · S. · Zhang · X. · Chen · N. · Yang · C. · Yang · C. · Cao · M. · Du · K. · Liu · Y.
Objectives

This study aimed to investigate the impact of adjuvant chemotherapy (ACT) on survival outcomes in older women with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2–) breast cancer (BC).

Design

A retrospective cohort study using data from the Surveillance, Epidemiology, and End Results database, which contains publicly available information from US cancer registries.

Setting and participants

The study included 45 762 older patients with BC aged over 65 years diagnosed between 2010 and 2015.

Methods

Patients were divided into two groups based on age: 65–79 years and ≥80 years. Propensity score matching (PSM) was employed to balance clinicopathological characteristics between patients who received ACT and those who did not. Data analysis used the 2 test and Kaplan-Meier method, with a subgroup analysis conducted to identify potential beneficiaries of ACT.

Outcome measures

Overall survival (OS) and cancer-specific survival (CSS).

Results

Due to clinicopathological characteristic imbalances between patients with BC aged 65–79 years and those aged ≥80 years, PSM was used to categorise the population into two groups for analysis: the 65–79 years age group (n=38 128) and the ≥80 years age group (n=7634). Among patients aged 65–79 years, Kaplan-Meier analysis post-PSM indicated that ACT was effective in improving OS (p

Conclusions

Patients with HR+/HER2– BC ≥80 years of age may be considered exempt from ACT because no benefits were found in terms of OS and CSS.

Defining acceptable data collection and reuse standards for queer artificial intelligence research in mental health: protocol for the online PARQAIR-MH Delphi study

Por: Joyce · D. W. · Kormilitzin · A. · Hamer-Hunt · J. · McKee · K. R. · Tomasev · N.
Introduction

For artificial intelligence (AI) to help improve mental healthcare, the design of data-driven technologies needs to be fair, safe, and inclusive. Participatory design can play a critical role in empowering marginalised communities to take an active role in constructing research agendas and outputs. Given the unmet needs of the LGBTQI+ (Lesbian, Gay, Bisexual, Transgender, Queer and Intersex) community in mental healthcare, there is a pressing need for participatory research to include a range of diverse queer perspectives on issues of data collection and use (in routine clinical care as well as for research) as well as AI design. Here we propose a protocol for a Delphi consensus process for the development of PARticipatory Queer AI Research for Mental Health (PARQAIR-MH) practices, aimed at informing digital health practices and policy.

Methods and analysis

The development of PARQAIR-MH is comprised of four stages. In stage 1, a review of recent literature and fact-finding consultation with stakeholder organisations will be conducted to define a terms-of-reference for stage 2, the Delphi process. Our Delphi process consists of three rounds, where the first two rounds will iterate and identify items to be included in the final Delphi survey for consensus ratings. Stage 3 consists of consensus meetings to review and aggregate the Delphi survey responses, leading to stage 4 where we will produce a reusable toolkit to facilitate participatory development of future bespoke LGBTQI+–adapted data collection, harmonisation, and use for data-driven AI applications specifically in mental healthcare settings.

Ethics and dissemination

PARQAIR-MH aims to deliver a toolkit that will help to ensure that the specific needs of LGBTQI+ communities are accounted for in mental health applications of data-driven technologies. The study is expected to run from June 2024 through January 2025, with the final outputs delivered in mid-2025. Participants in the Delphi process will be recruited by snowball and opportunistic sampling via professional networks and social media (but not by direct approach to healthcare service users, patients, specific clinical services, or via clinicians’ caseloads). Participants will not be required to share personal narratives and experiences of healthcare or treatment for any condition. Before agreeing to participate, people will be given information about the issues considered to be in-scope for the Delphi (eg, developing best practices and methods for collecting and harmonising sensitive characteristics data; developing guidelines for data use/reuse) alongside specific risks of unintended harm from participating that can be reasonably anticipated. Outputs will be made available in open-access peer-reviewed publications, blogs, social media, and on a dedicated project website for future reuse.

Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19)

Por: Somayaji · R. · Luke · D. R. · Lau · A. · Guner · R. · Tabak · O. F. · Hepokoski · M. · Gardetto · N. · Conrad · S. A. · Kumar · S. D. · Ghosh · K. · Robbins · S. M. · Senger · D. L. · Sun · D. · Lim · R. K. S. · Liu · J. · Eser · F. · Karaali · R. · Tremblay · A. · Muruve · D.
Objective

Dipeptidase-1 (DPEP-1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19.

Design

Phase 2a randomised, placebo-controlled, double-blinded, trial.

Setting

Hospitals in Canada, Turkey and the USA.

Participants

A total of 61 subjects with moderate-to-severe COVID-19.

Interventions

Randomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days.

Primary and secondary outcome measures

The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers.

Results

At 28 days, 27 (90.3%) and 28 (93.3%) of subjects in the placebo and LSALT groups were free of respiratory failure and the need for RRT (p=0.86). On days 14 and 28, the number of patients still requiring more intensive respiratory support (O2 ≥6 L/minute, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation) was 6 (19.4%) and 3 (9.7%) in the placebo group versus 2 (6.7%) and 2 (6.7%) in the LSALT group, respectively (p=0.14; p=0.67). Unadjusted analysis of ventilation-free days demonstrated 22.8 days for the LSALT group compared with 20.9 in the placebo group (p=0.4). LSALT-treated subjects had a significant reduction in the fold expression from baseline to end of treatment of serum CXCL10 compared with placebo (p=0.02). Treatment-emergent adverse events were similar between groups.

Conclusion

In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19.

Trial registration number

NCT04402957.

Identifying the top 10 research priorities for the school food system in the UK: a priority setting exercise

Por: Schliemann · D. · Spence · S. · OKane · N. · Chiang · C. C. · Olgacher · D. · McKinley · M. C. · Woodside · J. V. · on behalf of the GENIUS network · Schliemann · Spence · OKane · Chiang · Olgacher · McKinley · Woodside
Introduction

The school food system varies widely between schools and across the UK. There is a need to understand evidence gaps in school food research to allow the development, implementation and evaluation of policies and interventions to support children’s healthy eating at school. This study aimed to conduct a priority setting exercise to co-produce research priorities in relation to the UK school food system.

Methods

The James Lind Alliance process informed this priority setting exercise; all key steps engaged a wide range of UK school food stakeholders (including teachers, parents, principals, school governors, policymakers, caterers). An initial online stakeholder survey identified perceived research priorities. In a second survey, stakeholders were asked to rank these priorities. Lastly, an online priority setting workshop with stakeholders elicited the most important research priorities.

Results

In 2021, school food stakeholders (n=1280) completed the first survey, from which 136 research priorities were identified. In the second survey, participants (n=107) ranked these research priorities regarding their importance. Lastly, 30 workshop participants discussed and reached consensus on the research priorities. After final refinement by the research team, 18 priorities resulted, with the top 10 being related to the provision of free school meals (effectiveness of cost-effectiveness of different levels of eligibility, including universal provision), implementation of policy (including improving uptake) and food standards, issues around procurement, leadership, inequalities, social norms, the eating environment, food culture throughout the school setting and healthy eating.

Conclusion

The top 10 research priorities were elicited through a rigorous approach, including a wide range of stakeholders across the UK. These should be considered by policymakers, researchers and others to inform research, evidence-based policy development and, ultimately, improve the UK school food system.

Tax revenue lost due to illicit cigarettes in South Africa: 2002-2022

Por: Vellios · N. · van Walbeek · C.
Objective

To estimate lost excise and value-added tax (VAT) revenue as a result of illicit cigarette trade from 2002 to 2022.

Design

Using gap analysis, we estimated the number of illicit cigarettes by calculating the difference between the number of self-reported cigarettes (derived from nationally representative surveys) and the number of legal (tax-paid) cigarettes (derived from government sources) from 2002 to 2022. We then calculated the excise and VAT revenue that the government lost through illicit trade, taking into account that some people would have quit or reduced their consumption if cigarette prices had been higher (ie, tax paid).

Setting

South Africa.

Outcome measures

Illicit trade estimates and lost revenue estimates.

Results

The illicit cigarette market comprised 5% of the market in 2009, peaked at 60% in 2021, and decreased to 58% in 2022. Accounting for the fact that some people would have reduced their consumption if cigarette prices had been higher (had the illicit marke not existed), the government lost R15 billion in excise revenue and R3 billion in VAT revenue in 2022. From 2002 to 2022, the government lost R119 billion (2022 prices) in excise and VAT revenue. The majority of the lost revenue occurred in the period 2010 to 2022, where R110 billion (2022 prices) in excise and VAT revenue was lost. A comprehensive sensitivity analysis indicates that the estimated lost revenue of R119 billion from 2002 to 2022 falls within the range of R65 billion to R130 billion (all 2022 prices).

Conclusions

The South African government has been losing a significant amount of revenue by not receiving excise and VAT from all cigarettes consumed in South Africa. This trend is likely to continue if the government does not secure the supply chain from the point of production to the point of sale.

Application of generative language models to orthopaedic practice

Por: Caterson · J. · Ambler · O. · Cereceda-Monteoliva · N. · Horner · M. · Jones · A. · Poacher · A. T.
Objective

To explore whether large language models (LLMs) Generated Pre-trained Transformer (GPT)-3 and ChatGPT can write clinical letters and predict management plans for common orthopaedic scenarios.

Design

Fifteen scenarios were generated and ChatGPT and GPT-3 prompted to write clinical letters and separately generate management plans for identical scenarios with plans removed.

Main outcome measures

Letters were assessed for readability using the Readable Tool. Accuracy of letters and management plans were assessed by three independent orthopaedic surgery clinicians.

Results

Both models generated complete letters for all scenarios after single prompting. Readability was compared using Flesch-Kincade Grade Level (ChatGPT: 8.77 (SD 0.918); GPT-3: 8.47 (SD 0.982)), Flesch Readability Ease (ChatGPT: 58.2 (SD 4.00); GPT-3: 59.3 (SD 6.98)), Simple Measure of Gobbledygook (SMOG) Index (ChatGPT: 11.6 (SD 0.755); GPT-3: 11.4 (SD 1.01)), and reach (ChatGPT: 81.2%; GPT-3: 80.3%). ChatGPT produced more accurate letters (8.7/10 (SD 0.60) vs 7.3/10 (SD 1.41), p=0.024) and management plans (7.9/10 (SD 0.63) vs 6.8/10 (SD 1.06), p

Conclusions

This study shows that LLMs are effective for generation of clinical letters. With little prompting, they are readable and mostly accurate. However, they are not consistent, and include inappropriate omissions or insertions. Furthermore, management plans produced by LLMs are generic but often accurate. In the future, a healthcare specific language model trained on accurate and secure data could provide an excellent tool for increasing the efficiency of clinicians through summarisation of large volumes of data into a single clinical letter.

Do smoking abstinence periods among pregnant smokers improve birth weight? A secondary analysis of a randomised, controlled trial

Por: Berlin · I. · Goldzahl · L. · Jusot · F. · Berlin · N.
Objectives

Maternal smoking during pregnancy is associated with low birth weight (LBW). Reduction of cigarette consumption does not seem to improve birth weight but it is not known whether implementation of periods of smoking abstinence improves it. We assessed whether the number of 7-day periods of smoking abstinence during pregnancy may help reduce the number of newborns with LBW.

Design and setting

Secondary analysis of a randomised, controlled, multicentre, smoking cessation trial among pregnant smokers.

Participants

Pregnant women were included at

Primary outcome measure

Newborns with low birth weight.

Results

40 and 367 newborns were born with and without LBW, respectively. Adjusted for all available confounders, 3 or more periods of at least 7 days’ smoking abstinence during pregnancy was associated with reduced likelihood of LBW compared with no abstinence periods (OR = 0.124, 95% CI 0.03 to 0.53, p = 0.005). Reduction of smoking intensity by at least 50% was not associated with birth weight.

Conclusion

Aiming for several periods of smoking abstinence among pregnant smokers unable to remain continuously abstinent from smoking may be a better strategy to improve birth weight than reducing cigarette consumption.

Trial registration number

ClinicalTrials.gov NCT02606227.

Effectiveness of a community-based multicomponent lifestyle intervention (the ADA programme) to improve the quality of life of French breast cancer survivors: protocol for a pragmatic cluster randomised trial and embedded qualitative study

Por: El-Khoury · F. · Mino · J.-C. · Deschamps · N. · Lopez · C. · Menvielle · G. · Dargent-Molina · P.
Introduction

Breast cancer survivors (BCSs) are often faced with multiple mental and physical sequelae and are at increased risk of emotional distress, degraded health-related quality of life (HRQoL), chronic pain and fatigue.

Physical activity is strongly associated with improved HRQoL and survival rates; however, adherence rates to recommendations for a healthy lifestyle are seldom satisfactory among BCSs. Also, few studies have examined the effectiveness of multicomponent and personalised interventions that integrate physical activity and motivational techniques to improve the HRQoL of BCS.

Method and analysis

"Activité physique adaptée Doublée d’un Accompagnement d’après cancer" (ADA) is an integrated programme of physical activity enriched with a dietary and supportive care approach targeting BCS in the early post-treatment phase. The effectiveness of the ADA intervention will be evaluated using a cluster randomised controlled trial design with two arms (ADA programme vs usual care; 1:1 ratio).

The ADA intervention aims to recruit 160 participants and will be implemented by Siel Bleu, a non-profit association specialised in health prevention via adapted physical activity. Measurements will be performed at baseline, 3, 6 and 12 months after the start of the intervention. The primary outcome will be participants’ HRQoL, at 12 months measured by the Functional Assessment of Chronic Illness Therapy-Fatigue global score. Secondary outcome will include participants’ physical, social, emotional and functional well-being. The effect of the intervention on physical activity level, motivation for physical activity, relation to food and self-efficacy will also be evaluated.

Ethics and dissemination

The study was approved by the ‘CPP Paris XI’ Institutional Review Board on 5 May 2022 (Ref no.: 21.04512.000048-22004). The study’s findings will be shared through various channels, including academic publications, simplified reports for wider audiences and active engagement with medical and institutional organisations as well as patients’ associations.

Trial registration number

NCT05658341.

High-flow nasal oxygenation versus face mask oxygenation for preoxygenation in patients undergoing double-lumen endobronchial intubation: protocol of a randomised controlled trial

Por: He · R. · Fang · Y. · Jiang · Y. · Yao · D. · Li · Z. · Zheng · W. · Liu · Z. · Luo · N.
Introduction

With the growing emphasis on swift recovery, minimally invasive thoracic surgery has advanced significantly. Video-assisted thoracoscopic surgery (VATS) has seen rapid development, and the double-lumen tube (DLT) remains the most dependable method for tracheal intubation in VATS. However, hypoxaemia during DLT intubation poses a threat to the perioperative safety of thoracic surgery patients. Recently, transnasal high-flow nasal oxygen (HFNO) has shown promise in anaesthesia, particularly in handling short-duration hypoxic airway emergencies. Yet, its application in the perioperative period for patients undergoing pulmonary surgery with compromised cardiopulmonary function lacks evidence, and there are limited reliable clinical data.

Methods and analysis

A prospective, randomised, controlled, single-blind design will be employed in this study. 112 patients aged 18–60 years undergoing elective VATS-assisted pulmonary surgery will be enrolled and randomly divided into two groups: the nasal high-flow oxygen group (H group) and the traditional mask transnasal oxygen group (M group) in a 1:1 ratio. HFNO will be used during DLT intubation for the prevention of asphyxia in group H, while conventional intubation procedures will be followed by group M. Comparison will be made between the two groups in terms of minimum oxygen saturation during intubation, hypoxaemia incidence during intubation, perioperative complications and postoperative hospital days.

Ethics and dissemination

Approval for this study has been granted by the local ethics committee at Shenzhen Second People’s Hospital. The trial results will be disseminated through peer-reviewed journals and scientific conferences.

Trial registration number

NCT05666908.

Epidemiology of COVID-19 outbreaks in aged care facilities during postvaccine period: a systematic review and meta-analysis

Por: Hashan · M. R. · Smoll · N. · Chapman · G. · King · C. · Walker · J. · Kirk · M. · Akbar · D. · Booy · R. · Khandaker · G.
Objective

We aimed to define the epidemiology of COVID-19 outbreaks in aged care facilities (ACFs) during the postvaccine period, including vaccine effectiveness (VE) for this high-risk group.

Design

Systematic review and meta-analysis.

Data sources

Ovid Medline, Ovid Embase, Scopus, Web of Science and Cochrane databases were searched through 1 September 2023.

Eligibility criteria

Any original observational studies and trials reporting data on COVID-19 outbreaks among the partially/fully vaccinated residents from ACFs during or after the worldwide implementation of vaccine roll-out.

Data extraction and synthesis

We estimated the attack rate, case fatality rate, mortality rate and VE during postvaccine period. Random effect model was adopted for meta-analysis. Quality assessment on all included studies was performed using the Meta Quality Appraisal Tool.

Results

38 articles were included from 12 countries reporting 79 outbreaks with 1708 confirmed cases of COVID-19 from 78 ACFs. The pooled attack rate was 28% (95% CI 20% to 37%) among the fully vaccinated residents. Two-thirds (62.5%) of the index cases were unvaccinated healthcare professionals (eg, physicians, nurses) and caregivers. Unvaccinated residents had a significantly higher rates (12%) (95% CI 7% to 19%) of mortality compared with the vaccinated residents (2%) (95% CI% 1 to 4%) and the post-COVID-19 vaccine estimates for case fatality rate (13% vs 23%) and hospitalisation rate (17% vs 37%) were substantially lower. VE in preventing disease among residents in ACFs was 73% (95% CI 49% to 86). Overall, the included studies were heterogeneous in nature, however, the risk of bias was low to moderate.

Conclusions

Our study reaffirmed the impact of vaccination as a key public health measure to minimise the burden of COVID-19 in ACFs. Facilities with higher crowding indexes should be prioritised for vaccination and should advocate for higher vaccination targets among staff and residents as a critical intervention strategy to minimise disease burden in this vulnerable population.

Early predictors of bacterial pneumonia infection in children with congenital heart disease after cardiopulmonary bypass: a single-centre retrospective study

Por: Wang · Q. · Liu · H. · Zou · L. · Cun · Y. · Shu · Y. · Patel · N. · Yu · D. · Mo · X.
Objectives

The objective of this study was to evaluate the early predictors of bacterial pneumonia infection in children with congenital heart disease (CHD) after cardiopulmonary bypass (CPB).

Design

Retrospective study.

Setting

A freestanding tertiary paediatric hospital in China.

Participants

Patients admitted to the hospital due to CHD who underwent open-heart surgery.

Outcome measures

We retrospectively reviewed and analysed data from 1622 patients with CHD after CPB from June 2018 to December 2020 at the Children’s Hospital of Nanjing Medical University. Enrolled patients were assigned to an infection group or a non-infection group according to the presence of postoperative bacterial pneumonia infection, and the differences in clinical indicators were compared. Potential predictors were analysed by multivariate logistic regression analysis and area under the curve (AUC) analysis.

Results

Among the 376 patients (23.2%) in the infection group, the three most common bacteria were Streptococcus pneumoniae in 67 patients (17.8%), Escherichia coli in 63 patients (16.8%) and Haemophilus influenzae in 53 patients (14.1%). The infection group exhibited a lower weight (8.0 (6.0–11.5) kg vs 11.0 (7.5–14.5) kg, p

Conclusions

In our study, weight, PCT and CRP were found to be independent predictors of pulmonary bacterial infection after CPB. Moreover, PCT was the most specific predictor, and CRP was the most sensitive independent predictor that might be beneficial for the early diagnosis of pulmonary bacterial infection after CPB in patients with CHD.

Cohort profile: BioMD-Y (biopsychosocial factors of major depression in youth) - a biobank study on the molecular genetics and environmental factors of depression in children and adolescents in Munich

Por: Scherff · A. D. · Feldmann · L. · Piechaczek · C. · Pehl · V. · Wagenbüchler · P. · Wermuth · I. · Ghotbi · N. · Allgaier · A.-K. · Freisleder · F. J. · Beins · E. C. · Forstner · A. J. · Nöthen · M. M. · Czamara · D. · Rex-Haffner · M. · Ising · M. · Binder · E. · Greimel · E. · Sch
Purpose

BioMD-Y is a comprehensive biobank study of children and adolescents with major depression (MD) and their healthy peers in Germany, collecting a host of both biological and psychosocial information from the participants and their parents with the aim of exploring genetic and environmental risk and protective factors for MD in children and adolescents.

Participants

Children and adolescents aged 8–18 years are recruited to either the clinical case group (MD, diagnosis of MD disorder) or the typically developing control group (absence of any psychiatric condition).

Findings to date

To date, four publications on both genetic and environmental risk and resilience factors (including FKBP5, glucocorticoid receptor activation, polygenic risk scores, psychosocial and sociodemographic risk and resilience factors) have been published based on the BioMD-Y sample.

Future plans

Data collection is currently scheduled to continue into 2026. Research questions will be further addressed using available measures.

Reinforcing informed medication prescription for low back pain in the emergency department (RIME): a controlled interrupted time series implementation study protocol

Por: O'Leary · S. · Heine · J. · Warren · J. · Smyth · T. · Ballard · E. · Mitchell · G. · See · W. · Barlas · P. · Machado · G. C. · Cottrell · M. · Comans · T. · Foster · N. E.
Introduction

Management guidelines for low back pain (LBP) recommend exclusion of serious pathology, followed by simple analgesics, superficial heat therapy, early mobilisation and patient education. An audit in a large metropolitan hospital emergency department (ED) revealed high rates of non-recommended medication prescription for LBP (65% of patients prescribed opioids, 17% prescribed benzodiazepines), high inpatient admission rates (20% of ED LBP patients), delayed patient mobilisation (on average 6 hours) and inadequate patient education (48% of patients). This study aims to improve medication prescription for LBP in this ED by implementing an intervention shown previously to improve guideline-based management of LBP in other Australian EDs.

Methods and analysis

A controlled interrupted time series study will evaluate the intervention in the ED before (24 weeks; 20 March 2023–3 September 2023) and after (24 weeks; 27 November 2024–12 May 2024) implementation (12 weeks; 4 September 2023–26 November 2023), additionally comparing findings with another ED in the same health service. The multicomponent implementation strategy uses a formalised clinical flow chart to support clinical decision-making and aims to change clinician behaviour, through clinician education, provision of alternative treatments, educational resources, audit and feedback, supported by implementation champions. The primary outcome is the percentage of LBP patients prescribed non-recommended medications (opioids, benzodiazepines and/or gabapentinoids), assessed via routinely collected ED data. Anticipated sample size is 2000 patients (n=1000 intervention, n=1000 control) based on average monthly admissions of LBP presentations in the EDs. Secondary outcomes include inpatient admission rate, time to mobilisation, provision of patient education, imaging requests, representation to the ED within 6 months and healthcare costs. In nested qualitative research, we will study ED clinicians’ perceptions of the implementation and identify how benefits can be sustained over time.

Ethics and dissemination

This study received ethical approval from the Metro North Human Research Ethics Committee (HREC/2022/MNHA/87995). Study findings will be published in peer-reviewed journals and presented at international conferences and educational workshops.

Trial registration number

ACTRN12622001536752.

Qualitative study of challenges with recruitment of hospitals into a cluster controlled trial of clinical decision support in Australia

Por: Baysari · M. T. · Van Dort · B. A. · Stanceski · K. · Hargreaves · A. · Zheng · W. Y. · Moran · M. · Day · R. O. · Li · L. · Westbrook · J. · Hilmer · S. N.
Objective

To identify barriers to hospital participation in controlled cluster trials of clinical decision support (CDS) and potential strategies for addressing barriers.

Design

Qualitative descriptive design comprising semistructured interviews.

Setting

Five hospitals in New South Wales and one hospital in Queensland, Australia.

Participants

Senior hospital staff, including department directors, chief information officers and those working in health informatics teams.

Results

20 senior hospital staff took part. Barriers to hospital-level recruitment primarily related to perceptions of risk associated with not implementing CDS as a control site. Perceived risks included reductions in patient safety, reputational risk and increased likelihood that benefits would not be achieved following electronic medical record (EMR) implementation without CDS alerts in place. Senior staff recommended clear communication of trial information to all relevant stakeholders as a key strategy for boosting hospital-level participation in trials.

Conclusion

Hospital participation in controlled cluster trials of CDS is hindered by perceptions that adopting an EMR without CDS is risky for both patients and organisations. The improvements in safety expected to follow CDS implementation makes it challenging and counterintuitive for hospitals to implement EMR without incorporating CDS alerts for the purposes of a research trial. To counteract these barriers, clear communication regarding the evidence base and rationale for a controlled trial is needed.

Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlle

Por: Friedland · B. A. · Mgodi · N. M. · Palanee-Phillips · T. · Mathur · S. · Plagianos · M. G. · Bruce · I. V. · Lansiaux · M. · Murombedzi · C. · Musara · P. · Dandadzi · A. · Reddy · K. · Ndlovu · N. · Zulu · S. K. · Shale · L. R. · Zieman · B. · Haddad · L. B.
Introduction

Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women’s sexual and reproductive health needs. We will gauge the DPP’s acceptability in two cross-over clinical trials.

Methods and analysis

PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16–40 years) and Harare, Zimbabwe (n=30, 16–24 years) will be randomised 1:1 to the order of regimens—DPP or two separate tablets—each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024.

Ethics and dissemination

PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand’s Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences.

Trial registration numbers

NCT04778514, NCT04778527.

Understanding and maximising the community impact of seasonal malaria chemoprevention in Burkina Faso (INDIE-SMC): study protocol for a cluster randomised evaluation trial

Por: Moreno · M. · Barry · A. · Gmeiner · M. · Yaro · J. B. · Serme · S. S. · Byrne · I. · Ramjith · J. · Ouedraogo · A. · Soulama · I. · Grignard · L. · Soremekun · S. · Koele · S. · ter Heine · R. · Ouedraogo · A. Z. · Sawadogo · J. · Sanogo · E. · Ouedraogo · I. N. · Hien · D. · Sirima · S. B
Introduction

Seasonal malaria chemoprevention (SMC) involves repeated administrations of sulfadoxine-pyrimethamine plus amodiaquine to children below the age of 5 years during the peak transmission season in areas of seasonal malaria transmission. While highly impactful in reducing Plasmodium falciparum malaria burden in controlled research settings, the impact of SMC on infection prevalence is moderate in real-life settings. It remains unclear what drives this efficacy decay. Recently, the WHO widened the scope for SMC to target all vulnerable populations. The Ministry of Health (MoH) in Burkina Faso is considering extending SMC to children below 10 years old. We aim to assess the impact of SMC on clinical incidence and parasite prevalence and quantify the human infectious reservoir for malaria in this population.

Methods and analysis

We will perform a cluster randomised trial in Saponé Health District, Burkina Faso, with three study arms comprising 62 clusters of three compounds: arm 1 (control): SMC in under 5-year-old children, implemented by the MoH without directly observed treatment (DOT) for the full course of SMC; arm 2 (intervention): SMC in under 5-year-old children, with DOT for the full course of SMC; arm 3 (intervention): SMC in under 10-year-old children, with DOT for the full course of SMC. The primary endpoint is parasite prevalence at the end of the malaria transmission season. Secondary endpoints include the impact of SMC on clinical incidence. Factors affecting SMC uptake, treatment adherence, drug concentrations, parasite resistance markers and transmission of parasites will be determined.

Ethics and dissemination

The London School of Hygiene & Tropical Medicine’s Ethics Committee (29193) and the Burkina Faso National Medical Ethics Committee (Deliberation No 2023-05-104) approved this study. The findings will be presented to the community; disease occurrence data and study outcomes will also be shared with the Burkina Faso MoH. Findings will be published irrespective of their results.

Trial registration number

NCT05878366.

Exploring community behaviours and stakeholder challenges in engaging communities with dengue prevention behaviour in Malaysia: implementation research for a qualitative study with a community-based participatory research design

Por: Samsudin · N. A. · Karim · N. · Othman · H. · Naserrudin · N. A. · Sahani · M. · Hod · R. · Siau · C. S. · Harif · M. N. · Abd. Samad · B. H. · Zaini · Z.-I. I.
Objectives

To use a community-based participatory research (CBPR) design to explore local community behaviours and stakeholders’ challenges in engaging communities in dengue prevention behaviours in Hulu Langat, Selangor, Malaysia.

Design

This CBPR design in implementation comprised in-depth interviews (IDIs) and focus group discussions (FGDs). Themes were identified from the data with inductive and deductive thematic analysis.

Setting

FGDs were conducted in local community areas and IDIs were conducted in the local authority (LA) office and the Hulu Langat district health office.

Participants

All FGD and IDI participants consented to the study, and included health authorities (n=4), LAs (n=7), community leader (n=1), faith leader (n=1), patients diagnosed with dengue (IDIs, n=2) and permanent residents of Hulu Langat who had been exposed to dengue infectious disease (FGDs, n=27).

Results

The main themes were categorised into community behaviour and stakeholder challenges. The community behaviour-related themes were awareness of dengue disease and Aedes mosquitoes, perception of risk and severity, and involvement of authorities. The themes related to stakeholder challenges were resource constraints and capacity issues, jurisdictional constraints and coordination, and educational dissemination and vandalism.

Conclusions

The actions of the authorities shape community and stakeholder behaviours. Effective communication, including clear and aesthetically pleasing messages, motivates individuals to take appropriate actions. It is crucial for the authorities to engage in inclusive communication and consider diverse perspectives, such as those of residents and individuals exposed to dengue infection. Authorities that provide accurate and unbiased information foster transparency and enable informed decision-making by all stakeholders.

Adverse birth outcomes and childhood overweight at age of 3-8 years in a prospective cohort study in Tianjin, China

Por: Zhang · R. · Gao · M. · Li · W. · Liu · H. · Wang · S. · Wang · H. · Li · N. · Li · J. · Yu · Z. · Hu · G. · Leng · J. · Yang · X.
Objectives

To explore associations between adverse birth outcomes and childhood overweight at 3–8 years of age.

Design

A prospective cohort study.

Setting

Six central urban districts of Tianjin, China.

Participants

1681 woman–child pairs.

Methods

1681 woman–child pairs were followed up for 8 years in Tianjin, China. Demographic and clinical information including birth outcomes was collected longitudinally, commencing from first antenatal care visit till postpartum period. Offspring height and weight were measured at 3–8 years of age. High and low weight/length ratios (WLR) at birth were, respectively, defined as ≥90th and ≤10th gestational week and sex-specific percentiles. Overweight for children at 3–5 and 6–8 years of age were, respectively, defined as body mass index (BMI)-for-age and -sex above the 2 z-score and 1 z-score curves of the WHO’s child growth standards. Binary logistic regression analysis was used to obtain ORs and 95% CI with a stepwise backward selection method to select independent predictors.

Primary outcomes measures

Childhood overweight.

Results

Of 1681 children, 10.7% (n=179) and 27.8% (n=468) developed overweight at 3–5 and 6–8 years of age, respectively. Large for gestational age (LGA) was associated with increased risk of overweight at 3–5 years of age (aOR: 1.86, 95% CI: 1.27 to 2.72) while high WLR at birth was associated with increased risk of overweight at 6–8 years of age (1.82, 1.41 to 2.34). Low WLR at birth was associated with decreased risk of overweight at 6–8 years of age (0.52, 0.30 to 0.90).

Conclusions

LGA and high WLR at birth predicted childhood overweight at 3–5 and 6–8 years of age, respectively. Low WLR at birth was associated with decreased risk of childhood overweight at 6–8 years of age.

Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions

Por: Wilkinson · J. · Heal · C. · Antoniou · G. A. · Flemyng · E. · Alfirevic · Z. · Avenell · A. · Barbour · G. · Brown · N. J. L. · Carlisle · J. · Clarke · M. · Dicker · P. · Dumville · J. C. · Grey · A. · Grohmann · S. · Gurrin · L. · Hayden · J. A. · Heathers · J. · Hunter · K. E. · Lasser
Introduction

Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.

Methods and analysis

The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.

Ethics and dissemination

The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

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