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UPDATE trial: investigating the effects of ultra-processed versus minimally processed diets following UK dietary guidance on health outcomes: a protocol for an 8-week community-based cross-over randomised controlled trial in people with overweight or obes

Por: Dicken · S. · Makaronidis · J. · van Tulleken · C. · Jassil · F. C. · Hall · K. · Brown · A. C. · Gandini Wheeler-Kingshott · C. A. M. · Fisher · A. · Batterham · R.
Introduction

Obesity increases the risk of morbidity and mortality. A major driver has been the increased availability of ultra-processed food (UPF), now the main UK dietary energy source. The UK Eatwell Guide (EWG) provides public guidance for a healthy balanced diet but offers no UPF guidance. Whether a healthy diet can largely consist of UPFs is unclear. No study has assessed whether the health impact of adhering to dietary guidelines depends on food processing. Furthermore, our study will assess the impact of a 6-month behavioural support programme aimed at reducing UPF intake in people with overweight/obesity and high UPF intakes.

Methods and analysis

UPDATE is a 2x2 cross-over randomised controlled trial with a 6-month behavioural intervention. Fifty-five adults aged ≥18, with overweight/obesity (≥25 to 2), and ≥50% of habitual energy intake from UPFs will receive an 8-week UPF diet and an 8-week minimally processed food (MPF) diet delivered to their home, both following EWG recommendations, in a random order, with a 4-week washout period. All food/drink will be provided. Participants will then receive 6 months of behavioural support to reduce UPF intake. The primary outcome is the difference in weight change between UPF and MPF diets from baseline to week 8. Secondary outcomes include changes in diet, waist circumference, body composition, heart rate, blood pressure, cardiometabolic risk factors, appetite regulation, sleep quality, physical activity levels, physical function/strength, well-being and aspects of behaviour change/eating behaviour at 8 weeks between UPF/MPF diets, and at 6-month follow-up. Quantitative assessment of changes in brain MRI functional resting-state connectivity between UPF/MPF diets, and qualitative analysis of the behavioural intervention for feasibility and acceptability will be undertaken.

Ethics and dissemination

Sheffield Research Ethics Committee approved the trial (22/YH/0281). Peer-reviewed journals, conferences, PhD thesis and lay media will report results.

Trial registration number

NCT05627570

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

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

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

Design

Diagnostic Test Accuracy study.

Setting

Six UK hospitals.

Methods

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

Results

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

Conclusions

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

Trial registration number

ISRCTN79058224.

Impacts of armed conflicts on tuberculosis burden and treatment outcomes: a systematic review

Por: Gebreyohannes · E. A. · Wolde · H. F. · Akalu · T. Y. · Clements · A. C. A. · Alene · K. A.
Objectives

This systematic review aimed to summarise existing literature on the impacts of armed conflicts on tuberculosis burden and treatment outcomes.

Design

A systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature Plus, Scopus, ScienceDirect, Embase and medRxiv.

Data extraction and synthesis

Three reviewers independently screened, selected eligible studies and extracted data. A narrative review was undertaken to summarise the findings qualitatively.

Results

Eleven studies were included in this review, reporting on tuberculosis incidence rates, prevalence and treatment outcomes, including mortality. Overall, the impact of armed conflicts on case notifications was variable. Six studies reported overall increases in tuberculosis case notifications following the onset of conflicts, while three studies reported overall decreases in tuberculosis case notifications. Factors, including limited access to healthcare services, challenges in surveillance and laboratory confirmation, the destruction of health systems and incapacitating the healthcare workforce, contributed to a decrease in the number of notified cases. The higher tuberculosis notification in some of the studies could be attributed to the disruption of tuberculosis prevention and control programmes as well as increased socioeconomic deprivation, including malnutrition, mass migration, poor living conditions and overcrowding that are worsened during conflicts. Armed conflicts without effective interventions were associated with worse tuberculosis treatment outcomes, including lower proportions of people with treatment success and higher proportions of people with loss to follow-up, mortality and treatment failure. However, implementing various interventions in conflict settings (such as establishing a National Tuberculosis Control Programme) led to higher tuberculosis notification rates and treatment success.

Conclusion

The impact of armed conflicts on tuberculosis notification is complex and is influenced by multiple factors. The findings of this review underscore the importance of concerted efforts to control tuberculosis in conflict settings using available resources.

Physician and nurse well-being, patient safety and recommendations for interventions: cross-sectional survey in hospitals in six European countries

Por: Aiken · L. H. · Sermeus · W. · McKee · M. · Lasater · K. B. · Sloane · D. · Pogue · C. A. · Kohnen · D. · Dello · S. · Maier · C. B. B. · Drennan · J. · McHugh · M. D. · For the Magnet4Europe Consortium · Sermeus · Bruyneel · Witte · Schaufeli · Dello · Kohnen · Aiken · McHugh · Smith
Objectives

To determine the well-being of physicians and nurses in hospital practice in Europe, and to identify interventions that hold promise for reducing adverse clinician outcomes and improving patient safety.

Design

Baseline cross-sectional survey of 2187 physicians and 6643 nurses practicing in 64 hospitals in six European countries participating in the EU-funded Magnet4Europe intervention to improve clinicians’ well-being.

Setting

Acute general hospitals with 150 or more beds in six European countries: Belgium, England, Germany, Ireland, Sweden and Norway.

Participants

Physicians and nurses with direct patient contact working in adult medical and surgical inpatient units, including intensive care and emergency departments.

Main outcome measures

Burnout, job dissatisfaction, physical and mental health, intent to leave job, quality of care and patient safety and interventions clinicians believe would improve their well-being.

Results

Poor work/life balance (57% physicians, 40% nurses), intent to leave (29% physicians, 33% nurses) and high burnout (25% physicians, 26% nurses) were prevalent. Rates varied by hospitals within countries and between countries. Better work environments and staffing were associated with lower percentages of clinicians reporting unfavourable health indicators, quality of care and patient safety. The effect of a 1 IQR improvement in work environments was associated with 7.2% fewer physicians and 5.3% fewer nurses reporting high burnout, and 14.2% fewer physicians and 8.6% fewer nurses giving their hospital an unfavourable rating of quality of care. Improving nurse staffing levels (79% nurses) and reducing bureaucracy and red tape (44% physicians) were interventions clinicians reported would be most effective in improving their own well-being, whereas individual mental health interventions were less frequently prioritised.

Conclusions

Burnout, mental health morbidities, job dissatisfaction and concerns about patient safety and care quality are prevalent among European hospital physicians and nurses. Interventions to improve hospital work environments and staffing are more important to clinicians than mental health interventions to improve personal resilience.

Implementation of rapid genomic sequencing in safety-net neonatal intensive care units: protocol for the VIrtual GenOme CenteR (VIGOR) proof-of-concept study

Por: D'Gama · A. M. · Hills · S. · Douglas · J. · Young · V. · Genetti · C. A. · Wojcik · M. H. · Feldman · H. A. · Yu · T. W. · G Parker · M. · Agrawal · P. B. · VIGOR Network · Agrawal · Allcroft · Bhandari · Cantu · DGama · Douglas · Feldman · Genetti · Hills · Honrubia · Kritzer · Parke
Introduction

Rapid genomic sequencing (rGS) in critically ill infants with suspected genetic disorders has high diagnostic and clinical utility. However, rGS has primarily been available at large referral centres with the resources and expertise to offer state-of-the-art genomic care. Critically ill infants from racial and ethnic minority and/or low-income populations disproportionately receive care in safety-net and/or community settings lacking access to state-of-the-art genomic care, contributing to unacceptable health equity gaps. VIrtual GenOme CenteR is a ‘proof-of-concept’ implementation science study of an innovative delivery model for genomic care in safety-net neonatal intensive care units (NICUs).

Methods and analysis

We developed a virtual genome centre at a referral centre to remotely support safety-net NICU sites predominantly serving racial and ethnic minority and/or low-income populations and have limited to no access to rGS. Neonatal providers at each site receive basic education about genomic medicine from the study team and identify eligible infants. The study team enrols eligible infants (goal n of 250) and their parents and follows families for 12 months. Enrolled infants receive rGS, the study team creates clinical interpretive reports to guide neonatal providers on interpreting results, and neonatal providers return results to families. Data is collected via (1) medical record abstraction, (2) surveys, interviews and focus groups with neonatal providers and (3) surveys and interviews with families. We aim to examine comprehensive implementation outcomes based on the Proctor Implementation Framework using a mixed methods approach.

Ethics and dissemination

This study is approved by the institutional review board of Boston Children’s Hospital (IRB-P00040496) and participating sites. Participating families are required to provide electronic written informed consent and neonatal provider consent is implied through the completion of surveys. The results will be disseminated via peer-reviewed publications and data will be made accessible per National Institutes of Health (NIH) policies.

Trial registration number

NCT05205356/clinicaltrials.gov.

Microbial interactions among Gardnerella, Prevotella and Fannyhessea prior to incident bacterial vaginosis: protocol for a prospective, observational study

Por: Muzny · C. A. · Elnaggar · J. H. · Sousa · L. G. V. · Lima · A. · Aaron · K. J. · Eastlund · I. C. · Graves · K. J. · Dong · C. · Van Gerwen · O. T. · Luo · M. · Tamhane · A. · Long · D. · Cerca · N. · Taylor · C. M.
Introduction

The aetiology of bacterial vaginosis (BV), a biofilm-associated vaginal infection, remains unknown. Epidemiologic data suggest that it is sexually transmitted. BV is characterised by loss of lactic acid-producing lactobacilli and an increase in facultative and strict anaerobic bacteria. Gardnerella spp are present in 95%–100% of cases; Gardnerella vaginalis has been found to be more virulent than other BV-associated bacteria (BVAB) in vitro. However, G. vaginalis is found in women with normal vaginal microbiota and colonisation is not sufficient for BV development. We hypothesise that Gardnerella spp initiate BV biofilm formation, but incident BV (iBV) requires incorporation of other key BVAB (ie, Prevotella bivia, Fannyhessea vaginae) into the biofilm that alter the transcriptome of the polymicrobial consortium. This study will investigate the sequence of microbiologic events preceding iBV.

Methods and analysis

This study will enrol 150 women aged 18–45 years with normal vaginal microbiota and no sexually transmitted infections at a sexual health research clinic in Birmingham, Alabama. Women will self-collect twice daily vaginal specimens up to 60 days. A combination of 16S rRNA gene sequencing, qPCR for Gardnerella spp, P. bivia and F. vaginae, and broad range 16S rRNA gene qPCR will be performed on twice daily vaginal specimens from women with iBV (Nugent score 7–10 on at least 2 consecutive days) and controls (with comparable age, race, contraceptive method and menstrual cycle days) maintaining normal vaginal microbiota to investigate changes in the vaginal microbiota over time for women with iBV. Participants will complete daily diaries on multiple factors including sexual activity.

Ethics and dissemination

This protocol is approved by the University of Alabama at Birmingham Institutional Review Board (IRB-300004547) and written informed consent will be obtained from all participants. Findings will be presented at scientific conferences and published in peer-reviewed journals as well as disseminated to providers and patients in communities of interest.

Early sepsis care with the National Early Warning Score 2-guided Sepsis Hour-1 Bundle in the emergency department: hybrid type 1 effectiveness-implementation pilot stepped wedge randomised controlled trial (NEWS-1 TRIPS) protocol

Por: Lam · R. P. K. · Hung · K. K. C. · Lui · C. T. · Kwok · W. S. · Lam · W. W. T. · Lau · E. H. Y. · Sridhar · S. · Ng · P. Y. T. · Cheng · C. H. · Tsang · T. C. · Tsui · M. S. H. · Graham · C. A. · Rainer · T. H.
Introduction

Early sepsis treatment in the emergency department (ED) is crucial to improve patient survival. Despite international promulgation, the uptake of the Surviving Sepsis Campaign (SSC) Hour-1 Bundle (lactate measurement, blood culture, broad-spectrum antibiotics, 30 mL/kg crystalloid for hypotension/lactate ≥4 mmol/L and vasopressors for hypotension during/after fluid resuscitation within 1 hour of sepsis recognition) is low across healthcare settings. Delays in sepsis recognition and a lack of high-quality evidence hinder its implementation. We propose a novel sepsis care model (National Early Warning Score, NEWS-1 care), in which the SSC Hour-1 Bundle is triggered objectively by a high NEWS-2 (≥5). This study aims to determine the feasibility of a full-scale type 1 hybrid effectiveness-implementation trial on the NEWS-1 care in multiple EDs.

Methods and analysis

We will conduct a pilot type 1 hybrid trial and prospectively recruit 200 patients from 4 public EDs in Hong Kong cluster randomised in a stepped wedge design over 10 months. All study sites will start with an initial period of standard care and switch in random order at 2-month intervals to the NEWS-1 care unidirectionally. The implementation evaluation will employ mixed methods guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, which includes qualitative and quantitative data from focus group interviews, staff survey and clinical record reviews. We will analyse the 14 feasibility outcomes as progression criteria to a full-scale trial, including trial acceptability to patients and staff, patient and staff recruitment rates, accuracy of sepsis screening, protocol adherence, accessibility to follow-up data, safety and preliminary clinical impacts of the NEWS1 care, using descriptive statistics.

Ethics and dissemination

The institutional review boards of all study sites approved this study. This study will establish the feasibility of a full-scale hybrid trial. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities.

Trial registration number

NCT05731349.

Burden of drug-resistant tuberculosis among contacts of index cases: a protocol for a systematic review

Por: Akalu · T. Y. · Clements · A. C. A. · Gebreyohannes · E. A. · Wolde · H. F. · Shiferaw · F. W. · Alene · K. A.
Introduction

People having close contact with drug-resistant tuberculosis (DR-TB) patients are at increased risk of contracting and developing the disease. However, no comprehensive review has been undertaken to estimate the burden of DR-TB among contacts of DR-TB patients. Therefore, the current systematic review will quantify the prevalence and incidence of DR-TB among contacts of DR-TB patients.

Method and analysis

Systematic searches will be conducted in Medline, Embase, Web of Science, Scopus, Cochrane Central Register of Controlled trials (CENTRAL) and Cumulative Index to Nursing and Allied Health Literature (CINHAL) databases. The search will be conducted without restrictions on time, language and geography. A random-effects meta-analysis will be conducted for effect estimates. The pooled prevalence and incidence of DR-TB will be compared between people with and without contact with DR-TB patients. The presence of heterogeneity between studies will be assessed by Higgins I2 statistics. Subgroup analysis will be conducted to determine the source of heterogeneity. The risk of bias will be assessed using a visual inspection of the funnel plot and Egger’s regression test statistics. Trim and fill analysis will be done in the presence of publication bias. A sensitivity analysis will be conducted by trimming low-quality studies. The systematic review will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol guidelines.

Ethics and dissemination

Ethical approval will not be required for this study as it will be a systematic review and meta-analysis based on previously published evidence. The findings of the systematic review will be presented at scientific conferences and published in scientific journals.

Protocol registration

The protocol is published in PROSPERO with registration number CRD42023390339.

RELEASE-HF study: a protocol for an observational, registry-based study on the effectiveness of telemedicine in heart failure in the Netherlands

Por: van Eijk · J. · Luijken · K. · Jaarsma · T. · Reitsma · J. B. · Schuit · E. · Frederix · G. W. J. · Derks · L. · Schaap · J. · Rutten · F. H. · Brugts · J. · de Boer · R. A. · Asselbergs · F. W. · Trappenburg · J. C. A. · RELEASE-HF Investigators · Jan Borleffs · Dalen · Erol-Yilmaz
Introduction

Meta-analyses show postive effects of telemedicine in heart failure (HF) management on hospitalisation, mortality and costs. However, these effects are heterogeneous due to variation in the included HF population, the telemedicine components and the quality of the comparator usual care. Still, telemedicine is gaining acceptance in HF management. The current nationwide study aims to identify (1) in which subgroup(s) of patients with HF telemedicine is (cost-)effective and (2) which components of telemedicine are most (cost-)effective.

Methods and analysis

The RELEASE-HF (‘REsponsible roLl-out of E-heAlth through Systematic Evaluation – Heart Failure’) study is a multicentre, observational, registry-based cohort study that plans to enrol 6480 patients with HF using data from the HF registry facilitated by the Netherlands Heart Registration. Collected data include patient characteristics, treatment information and clinical outcomes, and are measured at HF diagnosis and at 6 and 12 months afterwards. The components of telemedicine are described at the hospital level based on closed-ended interviews with clinicians and at the patient level based on additional data extracted from electronic health records and telemedicine-generated data. The costs of telemedicine are calculated using registration data and interviews with clinicians and finance department staff. To overcome missing data, additional national databases will be linked to the HF registry if feasible. Heterogeneity of the effects of offering telemedicine compared with not offering on days alive without unplanned hospitalisations in 1 year is assessed across predefined patient characteristics using exploratory stratified analyses. The effects of telemedicine components are assessed by fitting separate models for component contrasts.

Ethics and dissemination

The study has been approved by the Medical Ethics Committee 2021 of the University Medical Center Utrecht (the Netherlands). Results will be published in peer-reviewed journals and presented at (inter)national conferences. Effective telemedicine scenarios will be proposed among hospitals throughout the country and abroad, if applicable and feasible.

Trial registration number

NCT05654961.

Optimisation of Organ Preservation treatment strategies in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy: Additional contact X-ray brachytherapy versus eXtending the observation period and local excision (

Por: Geubels · B. M. · van Triest · B. · Peters · F. P. · Maas · M. · Beets · G. L. · Marijnen · C. A. M. · Custers · P. A. · Rutten · H. J. T. · Theuws · J. C. M. · Verrijssen · A.-S. E. · Cnossen · J. S. · Burger · J. W. A. · Grotenhuis · B. A.
Introduction

Standard treatment for patients with intermediate or locally advanced rectal cancer is (chemo)radiotherapy followed by total mesorectal excision (TME) surgery. In recent years, organ preservation aiming at improving quality of life has been explored. Patients with a complete clinical response to (chemo)radiotherapy can be managed safely with a watch-and-wait approach. However, the optimal organ-preserving treatment strategy for patients with a good, but not complete clinical response remains unclear. The aim of the OPAXX study is to determine the rate of organ preservation that can be achieved in patients with rectal cancer with a good clinical response after neoadjuvant (chemo)radiotherapy by additional local treatment options.

Methods and analysis

The OPAXX study is a Dutch multicentre study that investigates the efficacy of two additional local treatments aiming at organ preservation in patients with a good, but not complete response to neoadjuvant treatment (ie near-complete response or a small residual tumour mass

Ethics and dissemination

The trial protocol has been approved by the medical ethics committee of the Netherlands Cancer Institute (METC20.1276/M20PAX). Informed consent will be obtained from all participants. The trial results will be published in an international peer-reviewed journal.

Trial registration number

NCT05772923.

Avoidance of healthcare service use and correlates among HIV-positive patients in Vietnam: a cross-sectional study

Por: Nguyen · H. L. T. · Bui · T. M. · Dam · V. A. T. · Nguyen · T. T. · Nguyen · H. T. · Zeng · G. M. · Bradley · D. · Nguyen · Q. N. · Ngo · T. V. · Latkin · C. A. · Ho · R. C. · Ho · C. S.
Objective

The prevention of HIV/AIDS is not making sufficient progress. The slow reduction of HIV/AIDS infections needs to prioritise hesitancy towards service utilisation, including treatment duration, social support and social stigma. This study investigates HIV-positive patients’ avoidance of healthcare services and its correlates.

Design

A cross-sectional study.

Setting

The secondary data analysis used cross-sectional data from a randomised controlled intervention, examining the effectiveness of HIV-assisted smartphone applications in the treatment of HIV/AIDS patients in the Bach Mai and Ha Dong clinics in Hanoi.

Methods

Simple random sampling was used to identify 495 eligible patients. Two-tailed 2, Mann-Whitney, multivariate logistic and ordered logistic regression models were performed.

Primary and secondary outcome measures

The main study outcome was the patients’ healthcare avoidance and frequency of healthcare avoidance. The association of individual characteristics, social and behavioural determinants of HIV patients’ usage of health services was also determined based on the collected data using structured questionnaires.

Results

Nearly half of the participants avoid health service use (47.3%), while 30.7% rarely avoid health service use. Duration of antiretroviral therapy and initial CD4 cell count were negatively associated with avoidance of health services and frequency of health service avoidance. Similarly, those with the middle and highest income were more likely to avoid health services compared with those with the lowest income. People having health problems avoided health service use more frequently (OR 1.47, 95% CI 1.35 to 1.61).

Conclusions

Our study’s findings identify characteristics of significance in relation to health service avoidance and utilisation among HIV-positive patients. The results highlighted the need to improve satisfaction, adherence and utilisation of treatment. Moreover, identifying ways to address or incorporate those social determinants in new policy may also help the treatment of HIV/AIDS and strategically allocate funding in the changing financial and political climate of Vietnam.

Trial registration number

Thai Clinical Trials Registry TCTR20220928003.

Genital tract infections, the vaginal microbiome and gestational age at birth among pregnant women in South Africa: a cohort study protocol

Por: Gigi · R. M. S. · Mdingi · M. M. · Jung · H. · Claassen-Weitz · S. · Bütikofer · L. · Klausner · J. D. · Muzny · C. A. · Taylor · C. M. · van de Wijgert · J. H. H. M. · Peters · R. P. H. · Low · N.
Introduction

Preterm birth complications are the most common cause of death in children under 5 years. The presence of multiple microorganisms and genital tract inflammation could be the common mechanism driving early onset of labour. South Africa has high levels of preterm birth, genital tract infections and HIV infection among pregnant women. We plan to investigate associations between the presence of multiple lower genital tract microorganisms in pregnancy and gestational age at birth.

Methods and analysis

This cohort study enrols around 600 pregnant women at one public healthcare facility in East London, South Africa. Eligible women are ≥18 years and at Chlamydia trachomatis and Neisseria gonorrhoeae, with treatment if test results are positive. At these visits, additional vaginal specimens are taken for: PCR detection and quantification of Trichomonas vaginalis, Candida spp., Mycoplasma genitalium, M. hominis, Ureaplasma urealyticum and U. parvum; microscopy and Nugent scoring; and for 16S ribosomal RNA gene sequencing and quantification. Pregnancy outcomes are collected from a postnatal visit and birth registers. The primary outcome is gestational age at birth. Statistical analyses will explore associations between specific microorganisms and gestational age at birth. To explore the association with the quantity of microorganisms, we will construct an index of microorganism load and use mixed-effects regression models and classification and regression tree analysis to examine which combinations of microorganisms contribute to earlier gestational age at birth.

Ethics and dissemination

This protocol has approvals from the University of Cape Town Research Ethics Committee and the Canton of Bern Ethics Committee. Results from this study will be uploaded to preprint servers, submitted to open access peer-reviewed journals and presented at regional and international conferences.

Trial registration number

NCT06131749; Pre-results.

Evaluation of functional vision and eye-related quality of life in children with congenital ectopia lentis: a prospective cross-sectional study

Por: Liang · X. · Zheng · D. · Young · C. A. · Ma · Y. · Ling · L. · Zou · M. · Liu · S. · Zhang · X. · Jin · G.
Objectives

This study aims to evaluate the effect of congenital ectopia lentis (CEL) on functional vision and eye-related quality of life (ER-QOL) in children and their families using the Paediatric Eye Questionnaire (PedEyeQ).

Design

A questionnaire survey administered via in-person interviews of patients with CEL and their parents.

Participants

51 children with CEL and 53 visually normal controls accompanied by 1 parent completed the survey questionnaires for the study from March 2022 to September 2022.

Outcome measures

PedEyeQ domain scores. Functional vision and ER-QOL of children and their families were evaluated by calculating and comparing the Rasch domain scores of the PedEyeQ.

Results

PedEyeQ domain scores were significantly worse with CEL compared with controls (p

Conclusions

In this study, children with CEL had reduced functional vision and ER-QOL compared with controls. Parents of children with CEL also experience reduced quality of life.

Development and validation of a risk prediction model for pulmonary tuberculosis among presumptive tuberculosis cases in Ethiopia

Por: Wolde · H. F. · Clements · A. C. A. · Alene · K. A.
Background

Early diagnosis and treatment of tuberculosis (TB) is one of the key strategies to achieve the WHO End TB targets. This study aimed to develop and validate a simple, convenient risk score to diagnose pulmonary TB among presumptive TB cases.

Methods

This prediction model used Ethiopian national TB prevalence survey data and included 5459 presumptive TB cases from all regions of Ethiopia. Logistic regression was used to determine which variables are predictive of pulmonary TB. A risk prediction model was developed, incorporating significant variables (p

Results

Of total participants, 94 (1.7%) were confirmed to have TB. The final prediction model included three factors with different scores: (1) TB contact history, (2) chest X-ray (CXR) abnormality and (3) two or more symptoms of TB. The optimal cut-off point for the risk score was 6 and was found to have a good discrimination accuracy (c-statistic=0.70, 95% CI: 0.65 to 0.75). The risk score has sensitivity of 51.1%, specificity of 79.9%, positive predictive value of 4.3% and negative predictive value of 98.9%. After internal validation, the optimism coefficient was 0.003, which indicates the model is internally valid.

Conclusion

We developed a risk score that combines TB contact, number of TB symptoms and CXR abnormality to estimate individual risk of pulmonary TB among presumptive TB cases. Though the score is easy to calculate and internally validated, it needs external validation before widespread implementation in a new setting.

Experiences of using artificial intelligence in healthcare: a qualitative study of UK clinician and key stakeholder perspectives

Por: Fazakarley · C. A. · Breen · M. · Leeson · P. · Thompson · B. · Williamson · V.
Objectives

Artificial intelligence (AI) is a rapidly developing field in healthcare, with tools being developed across various specialties to support healthcare professionals and reduce workloads. It is important to understand the experiences of professionals working in healthcare to ensure that future AI tools are acceptable and effectively implemented. The aim of this study was to gain an in-depth understanding of the experiences and perceptions of UK healthcare workers and other key stakeholders about the use of AI in the National Health Service (NHS).

Design

A qualitative study using semistructured interviews conducted remotely via MS Teams. Thematic analysis was carried out.

Setting

NHS and UK higher education institutes.

Participants

Thirteen participants were recruited, including clinical and non-clinical participants working for the NHS and researchers working to develop AI tools for healthcare settings.

Results

Four core themes were identified: positive perceptions of AI; potential barriers to using AI in healthcare; concerns regarding AI use and steps needed to ensure the acceptability of future AI tools. Overall, we found that those working in healthcare were generally open to the use of AI and expected it to have many benefits for patients and facilitate access to care. However, concerns were raised regarding the security of patient data, the potential for misdiagnosis and that AI could increase the burden on already strained healthcare staff.

Conclusion

This study found that healthcare staff are willing to engage with AI research and incorporate AI tools into care pathways. Going forward, the NHS and AI developers will need to collaborate closely to ensure that future tools are suitable for their intended use and do not negatively impact workloads or patient trust. Future AI studies should continue to incorporate the views of key stakeholders to improve tool acceptability.

Trial registration number

NCT05028179; ISRCTN15113915; IRAS ref: 293515.

Multimodality local consolidative treatment versus conventional care of advanced lung cancer after first-line systemic anti-cancer treatment: study protocol for the RAMON multicentre randomised controlled trial with an internal pilot

Por: Beard · C. · Rogers · C. A. · Fleming · L. · Conibear · J. · Evison · M. · Newsom-Davis · T. · Barwick · T. · Mills · N. · Stokes · E. A. · De Sousa · P. · Batchelor · T. · Rawlinson · J. · Baos · S. · Harris · R. · Lim · E.
Introduction

Lung cancer is the most common cause of cancer death worldwide and most patients present with extensive disease. One-year survival is improving but remains low (37%) despite novel systemic anti-cancer treatments forming the current standard of care. Although new therapies improve survival, most patients have residual disease after treatment, and little is known on how best to manage it. Therefore, residual disease management varies across the UK, with some patients receiving only maintenance systemic anti-cancer treatment while others receive local consolidative treatment (LCT), alongside maintenance systemic anti-cancer treatment. LCT can be a combination of surgery, radiotherapy and/or ablation to remove all remaining cancer within the lung and throughout the body. This is intensive, expensive and impacts quality of life, but we do not know if it results in better survival, nor the extent of impact on quality of life and what the cost might be for healthcare providers. The RAMON study (RAdical Management Of Advanced Non-small cell lung cancer) will evaluate the acceptability, effectiveness and cost-effectiveness of LCT versus no LCT after first-line systemic treatment for advanced lung cancer.

Methods and analysis

RAMON is a pragmatic open multicentre, parallel group, superiority randomised controlled trial. We aim to recruit 244 patients aged 18 years and over with advanced non-small-cell lung cancer from 40 UK NHS hospitals. Participants will be randomised in a 1:1 ratio to receive LCT alongside maintenance treatment, or maintenance treatment alone. LCT will be tailored to each patient’s specific disease sites. Participants will be followed up for a minimum of 2 years. The primary outcome is overall survival from randomisation.

Ethics and dissemination

The West of Scotland Research Ethics Committee (22/WS/0121) gave ethical approval in August 2022 and the Health Research Authority in September 2022. Participants will provide written informed consent before participating in the study. Findings will be presented at international meetings, in peer-reviewed publications, through patient organisations and notifications to patients.

Trial registration number

ISRCTN11613852.

Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK

Por: Walsh · T. S. · Aitken · L. M. · McKenzie · C. A. · Boyd · J. · Macdonald · A. · Giddings · A. · Hope · D. · Norrie · J. · Weir · C. · Parker · R. A. · Lone · N. I. · Emerson · L. · Kydonaki · K. · Creagh-Brown · B. · Morris · S. · McAuley · D. F. · Dark · P. · Wise · M. P. · Gordon · A. C.
Introduction

Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care.

Methods and analysis

Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of –2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.

The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40–50 UK ICUs.

Ethics and dissemination

The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines.

Trial registration number

ClinicalTrials.gov NCT03653832.

Latin American Cerebral Palsy Register (LATAM-CPR): study protocol to develop a collaborative register with surveillance of children with cerebral palsy in Latin American countries

Por: Ruiz Brunner · M. d. l. M. · Jahan · I. · Cuestas · E. · Cieri · M. E. · Escobar Zuluaga · J. · Condinanzi · A. L. · Sanchez · F. · McIntyre · S. · Smithers-Sheedy · H. · Muhit · M. · Badawi · N. · Diaz · R. · Diaz · A. · Carranza · J. · Duran · C. · Quintero Valencia · C. A. · Melarag
Introduction

Cerebral palsy (CP) is one of the leading causes of childhood disability globally with a high burden in low-income and middle-income countries (LMICs). Preliminary findings from the global LMIC CP Register (GLM CPR) suggest that the majority of CP in LMICs are due to potentially preventable causes. Such data are lacking in the Latin American region. Generating comparable epidemiological data on CP from this region could enable translational research and services towards early diagnosis and early intervention. We aim to establish a Latin American multicountry network and online data repository of CP called Latin American Cerebral Palsy Register (LATAM-CPR).

Methods and analysis

The LATAM-CPR will be modelled after the GLM CPR and will support new and emerging Latin American CP registers following a harmonised protocol adapted from the GLM CPR and piloted in Argentina (ie, Argentine Register of Cerebral Palsy). Both population-based and institution-based surveillance mechanisms will be adopted for registration of children with CP aged less than 18 years to the participating CP registers. The data collection form of the LATAM-CPR will include risk factors, clinical profile, rehabilitation, socioeconomical status of children with CP. Descriptive data on the epidemiology of CP from each participating country will be reported, country-specific and regional data will be compared.

Ethics and dissemination

Individual CP registers have applied ethics approval from respective national human research ethics committees (HREC) and/or institutional review boards prior to the establishment and inclusion into the LATAM-CPR. Ethical approval for LATAM-CPR has already been obtained from the HREC in the two countries that started (Argentina and Mexico). Findings will be disseminated and will be made publicly available through peer-reviewed publications, conference presentations and social media communications.

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.

Barriers and facilitators for developing a prehospital emergency care system evaluation tool (PEC-SET) for low-resource settings: a qualitative analysis

Por: Joiner · A. · Blewer · A. L. · Pek · P. P. · Ostbye · T. · Staton · C. A. · Silvalila · M. · Ong · M. · Nadarajan · G. D.
Objectives

Strengthening of emergency care systems, including prehospital systems, can reduce death and disability. We aimed to identify perspectives on barriers and facilitators relating to the development and implementation of a prehospital emergency care system assessment tool (PEC-SET) from prehospital providers representing several South and Southeast (SE) Asian countries.

Design

We conducted a qualitative study using focus group discussions (FGD) informed by the Consolidated Framework for Implementation Research (CFIR). FGDs were conducted in English, audioconferencing/videoconferencing was recorded, transcribed verbatim and coded using an inductive and deductive approach. Participants suggested specific elements to be measured within three main ‘pillars’ of disease conditions proposed by the research team of the tool being developed (cardiovascular, trauma and perinatal emergencies).

Setting

We explored the perspectives of medical directors in six low-income and middle-income countries (LMICs) in South and SE Asia.

Participants

A total of 16 participants were interviewed (1 Vietnam, 4 Philippines, 4 Thailand, 5 Malaysia, 1 Indonesia and 1 Pakistan) as a part of 4 focus groups.

Results

Themes identified within the four CFIR constructs included: (1) Intervention characteristics: importance of developing an contextually specific tool, need for generalisability, trialling in one geographical area or with one pillar before expanding; (2) Inner setting: data transfer barriers, workforce shortages; (3) Outer setting: underdevelopment of EMS nationally; need for further EMS system development prior to implementing a tool and (4) Individual characteristics: lack of buy-in by prehospital personnel. Elements proposed by participants included both process and outcome measures.

Conclusions

Through the CFIR framework, we identified several themes which can provide a basis for codeveloping a PEC-SET for LMICs with local stakeholders. This work may inform development of quality improvement tools in LMIC PEC systems.

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