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Prospective accuracy study on an artificial intelligence-based ultrasound system for gestational age estimation among pregnant women in Ghana, Kenya and South Africa: protocol

Por: Swarray Deen · A. · McDougall · A. R. A. · Chemway · R. · Craik · R. · Jayaratnam · S. · Joseph · N. · Mahar · R. · Koye · D. · Nguyen · L. · Simpson · J. · Gwako · G. · Hadebe · R. L. · Nartey · E. T. · Minckas · N. · Gülmezoglu · A. M. · Vogel · J. P. · Osman · A. · PEARLS Collaborat
Background

Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the ‘Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening’ (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.

Methods and analysis

This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11+0 to 13+6 weeks’ gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14+0 and 27+6 weeks’ gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11+0 to 13+6 weeks’).

Ethics and dissemination

This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024–28489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.

Impact of PerioperAtive LidocAine Infusions on Enhanced Recovery After Noncardiac Surgery (IMPALA-ERAS) in an inpatient setting: rationale, design and protocol for a sequential, repeated crossover trial

Por: Rouleau · G. W. · Smith · A. W. · Parrish · C. G. · Allen · L. J. · Jayaram · J. E. · Ruble · S. R. · Adkins · C. M. · Eden · S. · Shotwell · M. S. · Yaghmour · E. T. · Statzer · N. J. · Wanderer · J. P. · Henson · C. P. · Shams · D. · Kertai · M. D. · Investigators · I. · IMPALA Inves
Introduction

Multimodal analgesic strategies designed to minimise perioperative opioid exposure are fundamental components of enhanced recovery after surgery (ERAS) pathways. Despite widespread implementation of ERAS protocols, the optimal analgesic regimen remains undefined, as the individual contributions of specific agents to overall analgesic efficacy and opioid-sparing effects are not fully elucidated. Intravenous lidocaine, a widely utilised local anaesthetic, possesses both analgesic and anti-inflammatory properties and has been associated with improved gastrointestinal recovery. This study seeks to pragmatically evaluate the impact of incorporating perioperative intravenous lidocaine infusion into established ERAS pathways on postoperative functional recovery.

Methods and analysis

The Impact of PerioperAtive LidocAine Infusions (IMPALA) on ERAS trial is a single-centre, pragmatic, cluster-randomised, double-blinded, placebo-controlled study. A total of 2290 patients undergoing elective colorectal surgery, emergency general surgery, urology, ventral hernia repair, surgical oncology or spine surgery will be randomly assigned to receive either intraoperative and postoperative intravenous lidocaine infusions (administered for up to 48 hours) or placebo as part of a standardised multimodal analgesic regimen integrated into established ERAS pathways. The primary outcome is case mix index–adjusted resource length of stay, defined as the time interval from surgical initiation to hospital discharge adjusted for case mix index. The primary outcome is total inpatient opioid consumption within the first 72 hours, reported in oral morphine milligram equivalents. Secondary outcomes include various in-hospital clinical endpoints derived from the electronic health record.

Ethics and dissemination

This protocol and accompanying statistical analysis plan outline the study design, primary and secondary endpoints and analytic methodology. The IMPALA-ERAS trial has received ethical approval from the Vanderbilt University Institutional Review Board (IRB: 250617). The findings will be disseminated via peer-reviewed publications and presentations at national conferences. Results from this trial are expected to inform evidence-based practices regarding perioperative lidocaine infusion and its potential contributions to enhanced postoperative recovery in surgical patients.

Trial registration number

NCT07224711.

Protocol for a multicentre, randomised controlled trial of computerised cognitive rehabilitation in survivors of critical illness: the RETURN-III study

Por: Rolfsen · M. L. · Murphy · T. J. · Birdrow · C. I. · Raman · R. · Mastalerz · N. A. · Wurtz · M. J. · Lee · J. · Thompson · J. · Mart · M. F. · Rivera · E. L. · Nordness · M. F. · Collar · E. M. · Kiehl · A. · Trindade · A. J. · Dragnich · A. · Qian · E. T. · Greevy · R. A. · Jackson · J.
Introduction

Cognitive impairment after critical illness is a common occurrence that has a profound impact on millions of people worldwide each year. Currently, no interventions after critical illness have been found to promote cognitive recovery. Cognitive training has shown promise in other populations (eg, community-dwelling adults), predominantly in improving the trained cognitive domain (eg, memory, reasoning or executive function). In pilot work, in-person cognitive training with intensive care unit (ICU) survivors was found to not only improve the trained domain but also may reduce disabilities in daily function. Computerised cognitive rehabilitation (CCR) is a more scalable option, which we have demonstrated the feasibility of use among ICU survivors. Whether CCR is efficacious in ICU survivors remains unknown.

Methods and analysis

The Returning to Everyday Tasks Utilising Rehabilitation Networks-III (RETURN-III) study is a multicentre, randomised, double-blinded, parallel group controlled trial testing the hypothesis that CCR versus active control will result in less cognitive impairment after critical illness. Adult patients who recently experienced acute respiratory failure or shock in medical and surgical ICUs at two hospitals in Nashville (TN, USA) will be enrolled. Participants will be randomised within 12 weeks of hospital discharge to a 12-week home-based programme of CCR (or control), with the goal of five 30 min sessions per week. In-person assessments will be performed at baseline, 3 months and 12 months after randomisation. The primary outcome is global cognitive function 3 months after randomisation using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score. Secondary outcomes will include 12-month RBANS global cognitive function, 3-month and 12-month subjective cognition by the Cognitive Self-Report Questionnaire, daily function related to cognition by the Functional Activities Questionnaire and processing speed/executive function by Trail Making Test part B. With an anticipated enrolment of 160 patients, the study will have at least 80% power to detect a 7-point or higher difference in RBANS cognition scores between the two groups (

Ethics and dissemination

The RETURN-III study was approved by the institutional review boards at each participating site. The results will be submitted for publication in a peer-reviewed journal and presented at one or more scientific conferences following completion of data collection.

Trial registration number

NCT04353804.

Randomised double-blind controlled study protocol of the cumulative live birth rate of in vitro fertilisation following sperm preparation by a microfluidic chip method versus a density gradient centrifugation method

Por: Lee · S. T. C. · Tong · P. Y. W. · Lam · K. K. W. · Lock · C. H. Y. · Lam · M. T. · Lai · S. F. · Leung · E. T. Y. · Chiu · P. C. N. · Li · R. H. W. · Yeung · W. S. B. · Ng · E. H. Y.
Introduction

Semen samples are commonly processed by a density gradient centrifugation method to isolate the most motile spermatozoa for fertilisation during in vitro fertilisation (IVF). Centrifugation can cause considerable damage to spermatozoa by the reactive oxygen species produced during the process, which has a negative effect on the IVF success. A microfluidic chip is an alternative sperm preparation technique using a miniaturised device containing channels and chambers in the microscale range for nanoparticle preparation. This technology enables the selection of mobile spermatozoa from semen samples without the need of centrifugation, leading to reduced DNA fragmentation. This study aims to compare the cumulative live birth rate of IVF following sperm preparation by a microfluidic chip method versus a density gradient centrifugation method.

Method/analysis

This is a randomised double-blind study. Infertile patients attending the Centre of Assisted Reproduction and Embryology, Queen Mary Hospital and Kwong Wah Hospital for IVF will be recruited. With an anticipated 10% increase in live birth rate following the use of a microfluidic chip method, the calculated sample size is 516 women in each group to give a power of 0.8 and type 1 error of 0.05. Assuming a 10% drop-out rate, the total sample size is set to be 1136 or 568 women in each group. They will be randomly assigned on the day of oocyte retrieval by a laboratory staff into one of the following two groups: (1) the microfluidic chip group and (2) the density gradient group for sperm preparation and subsequent use in fertilisation. Other IVF procedures will be the same as our standard practice. Both patients and clinicians were blinded from the group allocation. The primary outcome is the cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation. The cumulative live birth rates between the two groups will be analysed by 2 test.

Ethics/dissemination

Ethical approval was granted from the Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster (Approval Number: UW 23–293) and the Institutional Review Board of Kwong Wah Hospital (Approval Number: KC/KE-23-0108/FR-4). A written informed consent will be obtained from each woman before any study procedure according to good clinical practice. The results of this randomised trial will be disseminated in a peer-reviewed journal.

Trial registration number

NCT06005311.

Association of nurse staffing ratios with patient mortality and length of stay in Chilean public hospitals: a cross-sectional study

Por: Simonetti · M. · Galiano · A. · Agüero · A. · Lasater · K. B. · Lake · E. T. · Aiken · L. H.
Objectives

To evaluate variation in nurse staffing ratios in intensive care unit (ICU) and medical-surgical units in Chilean public hospitals and the extent to which nurse staffing is associated with patient mortality and length of stay.

Design

Cross-sectional.

Setting

Out of a population of 45 general high-complexity Chilean public hospitals, 43 participated in the study.

Participants

514 ICU and 1850 medical-surgical bedside nurses answered an online survey to provide data on their working conditions, including staffing. Patient outcomes were measured using the 2023 national discharge database from the Ministry of Health containing data from 344 567 adult patients admitted to an ICU or a medical-surgical unit.

Primary outcome measures

Primary patient outcomes were mortality within 30 days after admission and length of stay. The association between nurse staffing and the primary outcomes was tested using mixed logistic regression models for mortality and mixed zero-truncated negative binomial regression for length of stay.

Results

The analytical sample represented 95.6% of public Chilean hospitals. In the average hospital, ICU nurses cared for 3.0 patients at a time (range: 1.1–4.5); nurses on medical-surgical units cared for 10.1 patients (range: 6.9–13.6). Each additional patient in a nurse’s workload was associated with a statistically significant higher odds of death and longer length of stay in medical-surgical units (OR 1.043, 95% CI 1.042 to 1.043; incidence rate ratio 1.032, 95% CI 1.007 to 1.058, respectively) and higher odds of death in ICU (OR 1.12, 95% CI 1.112 to 1.128).

Conclusions

There is considerable variation in nurse staffing among Chilean public hospitals with negative consequences for patient outcomes. Regardless of the unit type, patients in hospitals where nurses care for more patients at a time are more likely to die; in medical or surgical units, they are more likely to have longer lengths of stay. Systematically reducing the numbers of patients in a nurses’ workload has the potential to decrease inequalities across the public healthcare system by decreasing preventable deaths and decreasing the length of patient stays to thereby improve access for patients on waitlists.

How does prior infection and vaccination relate to the risk of incident SARS-CoV-2 infection/reinfection? A prospective cohort study among nine clinical sites in the USA, February 2021 to January 2023

Por: Judge · A. · Beidelman · E. T. · Allison · D. B. · Dickinson · S. · Gadde · K. M. · Golzarri Arroyo · L. · Ioannidis · J. P. · Macagno · A. L. · Macy · J. T. · Maki · K. C. · Perlman · S. · Ricciardi · M. J. · Rosenberg · M. · Ludema · C.
Objective

To estimate the relative effectiveness of vaccination (0, 1, 2, ≥3 doses) and prior infection, in combination, on risk of SARS-CoV-2 infection/reinfection.

Design

Prospective cohort study.

Participants

We recruited participants for the Aegis Study from nine clinics across five US states. Participants must have been 18 years or older, had a history of a positive PCR for SARS-CoV-2, SARS-CoV-2 antigen or antibody test for SARS-CoV-2 with documentation or had no suspected or documented prior SARS-CoV-2 infection, intended to remain in study area for the next 12 months, and had elevated risk of future SARS-CoV-2 exposure. Exclusion criteria included acute illness, contraindication to phlebotomy, use of immunosuppressants or receipt of systemic immunoglobulins.

Methods

We used extended Cox regression with robust standard errors to estimate the association between time-varying number of vaccine doses and baseline prior infection on risk of infection/reinfection among a prospective cohort of US adults between February 2021 and January 2023, accounting for censoring using inverse probability of censoring weights. Additionally, to quantify possible exposure misclassification of prior infection by comparing prior infection operationalised as (1) documented/self-reported prior infection and (2) documented/self-reported prior infection plus nucleocapsid antibody indication of prior infection.

Results

Of n=2178 who completed enrolment, n=1887 adults (63% female; 65% non-Latino White) contributed 366 905 days of observation. Participants contributed an average of 7.2 months of follow-up between February 2021 and January 2023. 28% (n=533) of individuals were infected or reinfected during the study period. Similar relative effectiveness was observed between the two different operationalisations of prior infection. After correction for prior infection status in the nearly 16% of those without study documentation of prior infection who had nucleocapsid antibody levels comparable to documented cases, relative to the unvaccinated with no prior infection, estimated effectiveness generally increased with increasing vaccine doses and prior infection (without prior infection: one (17%, 95% CI –31% to 47%), two (49%, 95% CI 31% to 63%), ≥three (71%, 95% CI 58% to 80%) vaccine doses; with prior infection: none (56%, 95% CI 30% to 72%), one (71%, 95% CI 42% to 86%), two (65%, 95% CI 49% to 76%), ≥three (80%, 95% CI 68% to 88%) vaccine doses). Pairwise comparisons at each vaccine dose (ref: no prior infection) revealed that prior infection provided additional protection, with stronger relationships for no and one dose (none: 56% (95% CI 30% to 72%), one: 66% (95% CI 28% to 84%), two: 31% (95% CI 7% to 49%), ≥three 31% (95% CI 0% to 53%)). There was a marked decrease in the protection offered by vaccination, prior infection, or both in the Omicron period versus pre-Omicron period.

Conclusion

In our real-world observational sample, vaccination (with two and ≥three vaccine doses of any Food and Drug Administration Emergency Use Authorization approved vaccine) and prior infection conferred benefits for protection against infection/reinfection. Re-classification of prior infection status based on antibody levels had little effect on results.

Treatment adherence, survival outcomes and barriers to care of non-Hodgkin lymphoma in Northwest Ethiopia: a mixed-methods study

Por: Kassaw · A. T. · Teferi · E. T. · Zerihun · T. E. · Mussie · D. A. · Melese · T. B. · Admasu · M. T. · Wallie · B. Y. · Birarra · M. K.
Objective

To evaluate treatment adherence, survival and systemic patient and provider level factors associated with non-Hodgkin’s lymphoma (NHL) management as reported by healthcare providers.

Design

Explanatory sequential mixed-methods study comprising a retrospective hospital-based cohort and a qualitative descriptive study.

Setting

Felege Hiwot Comprehensive Specialized Hospital in Bahir Dar, Ethiopia, and the University of Gondar Comprehensive Specialized Hospital in Gondar, Ethiopia.

Participants

Adults (≥18 years) with histologically confirmed NHL who initiated systemic chemotherapy were eligible. We randomly selected 182 patients with NHL treated and diagnosed between 1 August 2019 and 31 July 2024, for retrospective chart review out of a total of 283 patients during the study period. 14 healthcare professionals with at least 1 year of oncology experience participated in in-depth interviews.

Primary and secondary outcome

The primary outcome was overall survival, defined as the time from histological diagnosis to death from any cause. The secondary outcome was treatment adherence, defined as interruption between cycles or abandonment of prescribed chemotherapy.

Results

At a median follow-up of 18 months, the estimated 3-year overall survival rate was 48.5% (95% CI 37.8% to 58.4%). Lower survival rate was independently associated with B-symptoms (adjusted HR (AHR) 2.7, 95% CI 1.6 to 4.4), high intermediate International Prognostic Index (IPI) (AHR 3.7, 95% CI 1.8 to 6.9) and high IPI (AHR 5.5, 95% CI 2.7 to 11.3). Treatment abandonment and interruption occurred in 22.5% and 20.5% of patients, respectively. Exposure to rituximab was more likely to abandon therapy (²=4.8, p=0.03). Patient residence in rural areas was associated with higher rates oftreatment interruption (² = 6.0, p = 0.01), whereas absence of healthinsurance was associated with treatment abandonment (² = 8.0, p =0.005).

In the qualitative analysis, healthcare providers identified multilevel barriers to NHL care, including low patient awareness and late presentation, frequent misdiagnosis at the primary care level, weak referral systems, financial constraints, inconsistent drug availability and limited diagnostic capacity. These systemic and patient-level challenges are often associated with delayed diagnosis, treatment interruption and suboptimal survival outcomes.

Conclusions

3-year survival among adults with NHL in Northwest Ethiopia was substantially lower than reported in high-income settings. Mortality was higher among patients with B-symptoms and elevated IPI scores. High rates of treatment interruption and abandonment were observed. Patient-level and system-level factors are associated with reduced survival and treatment continuity. Strengthening early diagnosis, risk stratification and financial protection may support improved treatment adherence and survival outcomes.

Applying intersectionality theory to health outcomes and healthcare utilisation of ethnic minority populations: a systematic review protocol

Por: Bilney · E. V. M. · Tse · E. T. Y. · Chan · M. M. L. · Shi · Q. · Ma · J. · Parry · J. E. · Wong · D. K. K. · Bernal Pulido · L. G. · Wong · W. C. W. · Chan · L. · Tanuseputro · P.
Introduction

Intersectionality, as applied to health, provides a framework for understanding how overlapping social identities, such as ethnicity, gender and socioeconomic status, shape differential health outcomes and healthcare experiences. Individuals who occupy multiple marginalised identities often experience compounded disadvantages. Ethnic minority (EM) populations, defined here as social groups who are numerically smaller and/or socially marginalised within a given national or regional context based on ethnicity, race, culture, language, ancestry, or related heritage (often overlapping with racialised identities), frequently experience systemic exclusion, racism and structural barriers that also contribute to persistent disparities in morbidity, mortality and healthcare access. However, much health research relies on single-axis analyses, which can obscure within-group variation and may inadvertently reinforce inequities. Despite growing recognition of intersectionality, its empirical application to EM health remains limited. This systematic review aims to synthesise evidence on how intersectionality theory has been conceptualised and applied to understand health outcomes and healthcare utilisation among EM populations globally.

Methods and analysis

This systematic review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and the PRISMA-Equity Extension. Comprehensive searches of peer-reviewed databases and grey literature, including MEDLINE, EMBASE, CINAHL Plus, Scopus, Web of Science and ProQuest will identify quantitative, qualitative and mixed-method empirical studies published from 2000 to 2026. Eligible studies must implement intersectionality theory to EM health or healthcare utilisation outcomes. Two independent reviewers will screen titles, abstracts and full-text articles. Data extraction will also be conducted independently and discrepancies will be discussed with input from a third reviewer. Guided by the PROGRESS-Plus equity framework, findings will be synthesised thematically, implementing a mixed-method convergent integrated synthesis design.

Ethics and dissemination

This review only analyses previously published data, thus it does not require ethical approval. Findings will be presented at relevant academic or professional conferences and submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD420251248887.

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