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Developing blood-brain barrier arterial spin labelling as a non-invasive early biomarker of Alzheimers disease (DEBBIE-AD): a prospective observational multicohort study protocol

Por: Padrela · B. · Mahroo · A. · Tee · M. · Sneve · M. H. · Moyaert · P. · Geier · O. · Kuijer · J. P. A. · Beun · S. · Nordhoy · W. · Zhu · Y. D. · Buck · M. A. · Hoinkiss · D. C. · Konstandin · S. · Huber · J. · Wiersinga · J. · Rikken · R. · de Leeuw · D. · Grydeland · H. · Tippett · L. · Caw
Introduction

Loss of blood-brain barrier (BBB) integrity is hypothesised to be one of the earliest microvascular signs of Alzheimer’s disease (AD). Existing BBB integrity imaging methods involve contrast agents or ionising radiation, and pose limitations in terms of cost and logistics. Arterial spin labelling (ASL) perfusion MRI has been recently adapted to map the BBB permeability non-invasively. The DEveloping BBB-ASL as a non-Invasive Early biomarker (DEBBIE) consortium aims to develop this modified ASL-MRI technique for patient-specific and robust BBB permeability assessments. This article outlines the study design of the DEBBIE cohorts focused on investigating the potential of BBB-ASL as an early biomarker for AD (DEBBIE-AD).

Methods and analysis

DEBBIE-AD consists of a multicohort study enrolling participants with subjective cognitive decline, mild cognitive impairment and AD, as well as age-matched healthy controls, from 13 cohorts. The precision and accuracy of BBB-ASL will be evaluated in healthy participants. The clinical value of BBB-ASL will be evaluated by comparing results with both established and novel AD biomarkers. The DEBBIE-AD study aims to provide evidence of the ability of BBB-ASL to measure BBB permeability and demonstrate its utility in AD and AD-related pathologies.

Ethics and dissemination

Ethics approval was obtained for 10 cohorts, and is pending for 3 cohorts. The results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Evaluation of the efficacy and safety of a precise thymalfasin-regulated PRaG regimen for advanced refractory solid tumours: protocol for the open-label, prospective, multicentre study (PRaG5.0 study)

Por: Kong · Y. · Chen · R. · Xu · M. · Zhang · J. · Chen · G. · Hong · Z. · Zhang · H. · Dai · X. · Ma · Y. · Zhao · X. · Peng · Y. · Zhang · C. · Xing · P. · Zhang · L.
Introduction

The PRaG regimen, which consists of hypofractionated radiotherapy combined with a programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitor and granulocyte-macrophage colony stimulating factor (GM-CSF), has been demonstrated to have a survival benefit in patients with advanced solid tumours who have failed at least two lines of treatment. Nonetheless, lymphopenia poses an impediment to the enduring efficacy of PD-1/PD-L1 inhibitor therapy. Adequate lymphocyte reserves are essential for the efficacy of immunotherapy. Coupling the PRaG regimen with immunomodulatory agents that augment the number and functionality of lymphocytes may yield further survival benefits in this cohort of patients.

Objective

The aim of this study is to investigate the effectiveness and safety of a meticulously thymalfasin-controlled PRaG regimen in patients with advanced and chemotherapy-resistant solid tumours.

Methods and analysis

The study has a prospective, single-arm, open-label, multicentre design and aims to recruit up to 60 patients with histologically confirmed advanced solid tumours that have relapsed or metastasised. All eligible patients will receive a minimum of two cycles of the PRaG regimen comprising thymalfasin followed by maintenance treatment with a PD-1/PD-L1 inhibitor and thymalfasin for 1 year or until disease progression. Patients will be monitored according to the predetermined protocol for a year or until disease progression after initiation of radiotherapy.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University, on 25 November 2022 (JD-LK-2022-151-01) and all other participating hospitals. Findings will be disseminated through national and international conferences. We also plan to publish our findings in high-impact peer-reviewed journal.

Trial registration number

NCT05790447.

A socially interdependent choice framework for social influences in healthcare decision-making: a study protocol

Por: Nouwens · S. P. H. · Veldwijk · J. · Pilli · L. · Swait · J. D. · Coast · J. · de Bekker-Grob · E. W.
Objectives

Current choice models in healthcare (and beyond) can provide suboptimal predictions of healthcare users’ decisions. One reason for such inaccuracy is that standard microeconomic theory assumes that decisions of healthcare users are made in a social vacuum. Healthcare choices, however, can in fact be (entirely) socially determined. To achieve more accurate choice predictions within healthcare and therefore better policy decisions, the social influences that affect healthcare user decision-making need to be identified and explicitly integrated into choice models. The purpose of this study is to develop a socially interdependent choice framework of healthcare user decision-making.

Design

A mixed-methods approach will be used. A systematic literature review will be conducted that identifies the social influences on healthcare user decision-making. Based on the outcomes of a systematic literature review, an interview guide will be developed that assesses which, and how, social influences affect healthcare user decision-making in four different medical fields. This guide will be used during two exploratory focus groups to assess the engagement of participants and clarity of questions and probes. The refined interview guide will be used to conduct the semistructured interviews with healthcare professionals and users. These interviews will explore in detail which, and how, social influences affect healthcare user decision-making. Focus group and interview transcripts will be analysed iteratively using a constant comparative approach based on a mix of inductive and deductive coding. Based on the outcomes, a social influence independent choice framework for healthcare user decision-making will be drafted. Finally, the Delphi technique will be employed to achieve consensus about the final version of this choice framework.

Ethics and dissemination

This study was approved by the Erasmus School of Health Policy and Management Research Ethics Review Committee (ESHPM, Rotterdam, The Netherlands; reference ETH2122-0666).

Laparoscopic continuous seromuscular circumsuture for myomectomy: a real-world, retrospective, East-Asian cohort study

Por: Shi · X. · Wu · H. · Liu · J. · Zhu · J. · Zhang · L.
Objective

This study aimed to introduce a novel laparoscopic haemostasis for myomectomy and investigate the independent risk factors for uterine fibroid recurrence.

Design

A retrospective cohort study.

Setting

Following strengthening the reporting of observational studies in epidemiology (STROBE) criteria, a retrospective study of prospectively collected available data of the consecutive patients who underwent the myomectomy in the department of obstetrics and gynaecology of the single centre between February 2018 and December 2020.

Participants

177 patients who underwent laparoscopic myomectomy resection were enrolled in the present cohort study.

Materials and methods

Patients were classified into two groups according to their different methods of haemostasis in laparoscopic surgery. Recurrence-free survival was compared between the groups during an average follow-up of nearly 2 years.

Results

Of the 177 patients from 672 consecutive patients in the retrospective cohort, laparoscopic circular suture and baseball suture were carried out in 102 (57.6%) and 75 (42.4%) patients, respectively. The total amount of blood lost during surgery varied significantly (37.6 vs 99.5 mL) (p3 (HR 2.222, 95% CI 1.376 to 3.977, p=0.039; HR 3.625, 95% CI 1.526 to 6.985, p=0.003; HR 3.139, 95% CI 1.651 to 5.968, p

Conclusion

The laparoscopic continuous seromuscular circumsuture for myomectomy can effectively reduce the amount of surgical bleeding and accelerate the perioperative recovery for surgical safety. The main factors affecting the recurrence of uterine fibroids were age, location, number and volume of uterine fibroids. The nomogram can more straightforwardly assist clinicians to determine the risk of recurrence after laparoscopic myomectomy.

Silhouette showcards confirm altered obesity-associated body image perception in international cohort study of African-origin populations

Por: Choo-Kang · C. · Reese · T. O. · Micklesfield · L. K. · Bovet · P. · Bedu-Addo · K. · Forrester · T. · Gilbert · J. A. · Goedecke · J. H. · Plange-Rhule · J. · Lambert · E. V. · Layden · B. T. · Rae · D. E. · Viswanathan · B. · Luke · A. · Dugas · L.
Objectives

Given the increasing prevalence of obesity and need for effective interventions, there is a growing interest in understanding how an individual’s body image can inform obesity prevention and management. This study’s objective was to examine the use of silhouette showcards to measure body size perception compared with measured body mass index, and assess body size dissatisfaction, in three different African-origin populations spanning the epidemiological transition. An ancillary objective was to investigate associations between body size perception and dissatisfaction with diabetes and hypertension.

Setting

Research visits were completed in local research clinics in respective countries.

Participants

Seven hundred and fifty-one African-origin participants from the USA and the Republic of Seychelles (both high-income countries), and Ghana (low/middle-income country).

Primary and secondary outcome measures

Silhouette showcards were used to measure perceived body size and body size dissatisfaction. Objectively measured body size was measured using a scale and stadiometer. Diabetes was defined as fasting blood glucose ≥126 mg/dL and hypertension was defined as ≥130 mm Hg/80 mm Hg.

Results

Most women and men from the USA and Seychelles had ‘Perceived minus Actual weight status Discrepancy’ scores less than 0, meaning they underestimated their actual body size. Similarly, most overweight or obese men and women also underestimated their body size, while normal weight men and women were accurately able to estimate their body size. Finally, participants with diabetes were able to accurately estimate their body size and similarly desired a smaller body size.

Conclusions

This study highlights that overweight and obese women and men from countries spanning the epidemiological transition were unable to accurately perceive their actual body size. Understanding people’s perception of their body size is critical to implementing successful obesity prevention programmes across the epidemiological transition.

Development of a prognostic model for long-term survival of young patients with bladder cancer: a retrospective analysis of the SEER Database

Por: Guo · L. · Liu · L. · Liu · Y. · Yang · T. · Wang · G. · Liu · J. · Li · S. · Cai · J.
Objectives

This study aims to present the clinical characteristics of young patients with bladder cancer (YBCa), evaluate related risk factors and construct a nomogram based on data acquired from the Surveillance, Epidemiology, and End Results (SEER) Database.

Design

Retrospective analysis of the SEER Database (2004–2015) for primary YBCa.

Setting and participants

Data for YBCa (defined as those aged 40 years or younger) were extracted from the SEER Database, which covers approximately 28% of the US population, using the SEER*Stat software (V.8.4.0.1). A total of 1233 YBCa were identified. Patients were randomly assigned to the training and validation sets. The database included clinicopathological features, demographic information and survival outcomes, such as age, gender, race, year of diagnosis, marital status at diagnosis, primary tumour site, histological type, tumour grade, tumour, node, metastases (TNM) staging, treatment regimen for the primary tumour, cause of death and survival time. A nomogram model was developed using univariate and multivariate analyses. The prediction model was validated using the consistency index (C-index), calibration curve and receiver operating characteristic curve.

Primary outcome measures

3-year, 5-year and 10-year overall survival (OS).

Results

1233 YBCa from 2004 to 2015 were randomly assigned to the training set (n=865) and validation set (n=368). Age, marital status, tumour grade, histological type and TNM staging were included in the nomogram. The C-index of the model was 0.876. The 3-year, 5-year and 10-year OS area under the curve values for the training and validation sets were 0.949, 0.923 and 0.856, and 0.919, 0.890 and 0.904, respectively. Calibration plots showed that the nomogram had a robust predictive accuracy.

Conclusions

To our knowledge, this is the first study to establish a precise nomogram predicting the 3-year, 5-year and 10-year OS in YBCa based on multivariate analyses. Our nomogram may serve as a valuable reference for future diagnostics and individualised treatments for YBCa. However, external validation is warranted to assess the accuracy and generalisability of our prognostic model.

Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol

Por: Vahid · F. · Dessenne · C. · Tur · J. A. · Bouzas · C. · Devaux · Y. · Malisoux · L. · Monserrat-Mesquida · M. · Sureda · A. · Desai · M. S. · Turner · J. D. · Lamy · E. · Perez-Jimenez · M. · Ravn-Haren · G. · Andersen · R. · Forberger · S. · Nagrani · R. · Ouzzahra · Y. · Fontefrancesc
Introduction

Despite international efforts, the number of individuals struggling with obesity is still increasing. An important aspect of obesity prevention relates to identifying individuals at risk at early stage, allowing for timely risk stratification and initiation of countermeasures. However, obesity is complex and multifactorial by nature, and one isolated (bio)marker is unlikely to enable an optimal risk stratification and prognosis for the individual; rather, a combined set is required. Such a multicomponent interpretation would integrate biomarkers from various domains, such as classical markers (eg, anthropometrics, blood lipids), multiomics (eg, genetics, proteomics, metabolomics), lifestyle and behavioural attributes (eg, diet, physical activity, sleep patterns), psychological traits (mental health status such as depression) and additional host factors (eg, gut microbiota diversity), also by means of advanced interpretation tools such as machine learning. In this paper, we will present a protocol that will be employed for a scoping review that attempts to summarise and map the state-of-the-art in the area of multicomponent (bio)markers related to obesity, focusing on the usability and effectiveness of such biomarkers.

Methods and analysis

PubMed, Scopus, CINAHL and Embase databases will be searched using predefined key terms to identify peer-reviewed articles published in English until January 2024. Once downloaded into EndNote for deduplication, CADIMA will be employed to review and select abstracts and full-text articles in a two-step procedure, by two independent reviewers. Data extraction will then be carried out by several independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Peer Review of Electronic Search Strategies guidelines will be followed. Combinations employing at least two biomarkers from different domains will be mapped and discussed.

Ethics and dissemination

Ethical approval is not required; data will rely on published articles. Findings will be published open access in an international peer-reviewed journal. This review will allow guiding future directions for research and public health strategies on obesity prevention, paving the way towards multicomponent interventions.

Artificial intelligence driven malnutrition diagnostic model for patients with acute abdomen based on GLIM criteria: a cross-sectional research protocol

Por: Ma · W. · Cai · B. · Wang · Y. · Wang · L. · Sun · M.-W. · Lu · C. D. · Jiang · H.
Background

Patients with acute abdomen often experience reduced voluntary intake and a hypermetabolic process, leading to a high occurrence of malnutrition. The Global Leadership Initiative on Malnutrition (GLIM) criteria have rapidly developed into a principal methodological tool for nutritional diagnosis. Additionally, machine learning is emerging to establish artificial intelligent-enabled diagnostic models, but the accuracy and robustness need to be verified. We aimed to establish an intelligence-enabled malnutrition diagnosis model based on GLIM for patients with acute abdomen.

Method

This study is a single-centre, cross-sectional observational investigation into the prevalence of malnutrition in patients with acute abdomen using the GLIM criteria. Data collection occurs on the day of admission, at 3 and 7 days post-admission, including biochemical analysis, body composition indicators, disease severity scoring, nutritional risk screening, malnutrition diagnosis and nutritional support information. The occurrence rate of malnutrition in patients with acute abdomen is analysed with the GLIM criteria based on the Nutritional Risk Screening 2002 and the Mini Nutritional Assessment Short-Form to investigate the sensitivity and accuracy of the GLIM criteria. After data cleansing and preprocessing, a machine learning approach is employed to establish a predictive model for malnutrition diagnosis in patients with acute abdomen based on the GLIM criteria.

Ethics and dissemination

This study has obtained ethical approval from the Ethics Committee of the Sichuan Academy of Medical Sciences and Sichuan Provincial People’s Hospital on 28 November 2022 (Yan-2022–442). The results of this study will be disseminated in peer-reviewed journals, at scientific conferences and directly to study participants.

Trial registration number

ChiCTR2200067044.

Diabetes care in the pandemic era in the Midwestern USA: a semi-structured interview study of the patient perspective

Por: Gonzalez Bravo · C. · Sabree · S. A. · Dukes · K. · Adeagbo · M. J. · Edwards · S. · Wainwright · K. · Schaeffer · S. E. · Villa · A. · Wilks · A. D. · Carvour · M. L.
Objectives

To understand patients’ experiences with diabetes care during the COVID-19 pandemic, with an emphasis on rural, medically underserved, and/or minoritised racial and ethnic groups in the Midwestern USA.

Design

Community-engaged, semi-structured interviews were conducted by medical student researchers trained in qualitative interviewing. Transcripts were prepared and coded in the language in which the interview was conducted (English or Spanish). Thematic analysis was conducted, and data saturation was achieved.

Setting

The study was conducted in communities in Eastern and Western Iowa.

Participants

Adults with diabetes (n=20) who were fluent in conversational English or Spanish were interviewed. One-third of participants were residents of areas designated as federal primary healthcare professional shortage areas and/or medically underserved areas, and more than half were recruited from medical clinics that offer care at no cost.

Results

Themes across both English and Spanish transcripts included: (1) perspectives of diabetes, care providers and care management; (2) challenges and barriers affecting diabetes care; and (3) participant feedback and recommendations. Participants reported major constraints related to provider availability, costs of care, access to nutrition counselling and mental health concerns associated with diabetes care during the pandemic. Participants also reported a lack of shared decision-making regarding some aspects of care, including amputation. Finally, participants recognised systems-level challenges that affected both patients and providers and expressed a preference for proactive collaboration with healthcare teams.

Conclusions

These findings support enhanced engagement of rural, medically underserved and minoritised groups as stakeholders in diabetes care, diabetes research and diabetes provider education.

Development of radiographic knee osteoarthritis and the associations to radiographic changes and baseline variables in individuals with knee pain: a 2-year longitudinal study

Por: Törnblom · M. · Bremander · A. · Aili · K. · Andersson · M. L. E. · Nilsdotter · A. · Haglund · E.
Objectives

The aim was to study the development of radiographic knee osteoarthritis (RKOA) in individuals with knee pain over 2 years, and the associations between radiographic changes and baseline variables.

Design

Longitudinal cohort study.

Participants and setting

This study is part of the Halland Osteoarthritis cohort. The included 178 individuals, aged 30–67, had knee pain, without cruciate ligament injury or radiographic findings and 67% were women. The presence of RKOA was defined as Ahlbäck score of ≥1 in ≥1 knee. (Ahlbäck grade 1: joint space narrowing in the tibiofemoral joint

Results

In all, 13.8% (n=24) developed RKOA in 2 years whereof all had clinical KOA at baseline, as defined by NICE. Deterioration to RKOA was significantly associated with higher BMI, OR 1.119 (95% CI 1.024 to 1.223; p=0.013), and VFA, 1.008 (95% CI 1.000 to 1.016; p=0.049), worse knee pain intensity, 1.238 (95% CI 1.028 to 1.490; p=0.024), worse scores for KOOS Pain, 0.964 (95% CI 0.937 to 0.992; p=0.013) and KOOS Symptoms, 0.967 (95% CI 0.939 to 0.996; p=0.027), KOOS Activities of daily living 0.965 (95% CI 0.935 to 0.996; p=0.026) and KOOS Quality of Life 0.973 (95% CI 0.947 to 0.999; p=0.044), at baseline.

Conclusions

One out of seven individuals with clinical KOA developed RKOA in only 2 years. Baseline variables associated with RKOA after 2 years may possibly be detected early by using the NICE guideline, assessment of obesity and self-reported data of symptoms to support first-line treatment: education, exercise and weight control.

Trial registration number

ClinicalTrials.gov (NCT04928170)

Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) - protocol for a multi-centre open-label randomised trial

Por: Hudson · E. M. · Noutch · S. · Webster · J. · Brown · S. R. · Boele · F. W. · Al-Salihi · O. · Baines · H. · Bulbeck · H. · Currie · S. · Fernandez · S. · Hughes · J. · Lilley · J. · Smith · A. · Parbutt · C. · Slevin · F. · Short · S. · Sebag-Montefiore · D. · Murray · L.
Introduction

Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.

Methods and analysis

BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.

Ethics and dissemination

BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.

Trial registration number

ISRCTN60524.

Randomised trials conducted using cohorts: a scoping review

Por: Nickolls · B. J. · Relton · C. · Hemkens · L. · Zwarenstein · M. · Eldridge · S. · McCall · S. J. · Griffin · X. L. · Sohanpal · R. · Verkooijen · H. M. · Maguire · J. L. · McCord · K. A.
Introduction

Cohort studies generate and collect longitudinal data for a variety of research purposes. Randomised controlled trials (RCTs) increasingly use cohort studies as data infrastructures to help identify and recruit trial participants and assess outcomes.

Objective

To examine the extent, range and nature of research using cohorts for RCTs and describe the varied definitions and conceptual boundaries for RCTs using cohorts.

Design

Scoping review.

Data sources

Searches were undertaken in January 2021 in MEDLINE (Ovid) and EBM Reviews—Cochrane Methodology Registry (Final issue, third Quarter 2012).

Eligibility criteria

Reports published between January 2007 and December 2021 of (a) cohorts used or planned to be used, to conduct RCTs, or (b) RCTs which use cohorts to recruit participants and/or collect trial outcomes, or (c) methodological studies discussing the use of cohorts for RCTs.

Data extraction and synthesis

Data were extracted on the condition being studied, age group, setting, country/continent, intervention(s) and comparators planned or received, unit of randomisation, timing of randomisation, approach to informed consent, study design and terminology.

Results

A total of 175 full-text articles were assessed for eligibility. We identified 61 protocols, 9 descriptions of stand-alone cohorts intended to be used for future RCTs, 39 RCTs using cohorts and 34 methodological papers.

The use and scope of this approach is growing. The thematics of study are far-ranging, including population health, oncology, mental and behavioural disorders, and musculoskeletal conditions.

Authors reported that this approach can lead to more efficient recruitment, more representative samples, and lessen disappointment bias and crossovers.

Conclusion

This review outlines the development of cohorts to conduct RCTs including the range of use and innovative changes and adaptations. Inconsistencies in the use of terminology and concepts are highlighted. Guidance now needs to be developed to support the design and reporting of RCTs conducted using cohorts.

National cross-sectional cluster survey of tuberculosis prevalence in Timor-Leste: a study protocol

Por: Lopes · C. · Joao · J. C. · Lowbridge · C. · Martins · N. · dos Santos · R. I. G. · da Silva · E. · Dias · J. · Ramalingam · S. · Amaral · S. · Oakley · T. · Ico · L. d. C. · Sarmento · N. · Yan · J. · Francis · J. R.
Introduction

Timor-Leste has one of the world’s highest estimated tuberculosis (TB) incidences, yet the data which informs this estimate is limited and the true burden of TB disease is not known. TB prevalence surveys offer the best means of determining robust estimates of disease burden. This study aims to provide an estimate of the prevalence of bacteriologically confirmed pulmonary TB in Timor-Leste and provide additional insights into diagnostic coverage and health-seeking behaviour of persons with symptoms suggestive of TB.

Methods and analysis

A national population-based cross-sectional cluster survey will be conducted in which participants aged 15 years and older will be screened for pulmonary TB using an algorithm consisting of symptom screening and digital X-ray of the chest with computer-aided detection software for X-ray interpretation. Xpert Ultra and liquid culture methods will be used to confirm survey TB cases. Additional data will be collected from persons reporting symptoms suggestive of TB to assess health-seeking behaviour and access to TB diagnosis and care. The survey aims to screen a target sample population of 20 068 people, living within 50 clusters, representing every municipality of Timor-Leste. Bacteriologically confirmed pulmonary TB prevalence will be estimated using WHO-recommended methods.

Ethics and dissemination

Research ethics approval has been granted by the human research ethics committee of the Northern Territory, Australia, and the Instituto Nacional da Saúde, Timor-Leste. The results will be published in a peer-reviewed scientific journal and disseminated with relevant stakeholders.

Trial registration number

ACTRN12623000718640.

Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study

Por: Llurba · E. · Crispi · F. · Crovetto · F. · Youssef · L. · Delgado · J. L. · Puig · I. · Mora · J. · Krofta · L. · Mackova · K. · Martinez-Varea · A. · Tubau · A. · Ruiz · A. · Paya · A. · Prat · M. · Chantraine · F. · Comas · C. · Kajdy · A. · Lopez-Tinajero · M. F. · Figueras · F. · Gratac
Introduction

Pre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal–fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35–37 weeks’ gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35–37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes.

Methods and analysis

We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35–37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect).

Ethics and dissemination

The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences.

Trial registration number

NCT04766866.

Meta-analysis on inflammation and autonomic nervous system of coronary heart disease combined with depression

Por: Li · G. · Zhang · L. · Liu · M.
Objectives

This meta-analysis aimed to explore the association between inflammatory factors, heart rate variability (HRV) and the coexistence of coronary heart disease (CHD) and depression.

Design

Systematic review and meta-analysis. Complying with the Meta-analysis Of Observational Studies in Epidemiology statement.

Data sources

We searched PubMed, Web of Science and EMBASE for the data from the inception date to 16 March 2023.

Eligibility criteria

We included cross-sectional and cohort studies with inclusion criteria: (1) patients with CHD; (2) depression measurement and (3) including inflammatory factors or cardiac biomarkers or HRV.

Data extraction and synthesis

Two authors searched the databases independently. The effect estimates and heterogeneity were synthesised by Review Manager V.5.3. Sensitivity analysis and publication bias were analysed by STATA software. The quantitative synthesis outcomes were presented by mean difference (MD) or standard MD (SMD) with 95% CI.

Results

By searching the databases, we identified a total of 6750 articles. There were 22 articles left after selection, including 6344 participants. This meta-analysis indicated that patients with CHD with depression had higher levels of C reaction protein (CRP) (SMD 0.50, 95% CI (0.19 to 0.81), p=0.001), high-sensitivity C reactive protein (hs-CRP) (SMD 0.28, 95% CI (0.07 to 0.48), p=0.008), IL-6 (SMD 0.49, 95% CI (0.05 to 0.92), p=0.03) and a lower level of the mean RR interval and the SD of all RR intervals (SMD –0.64, 95% CI (–1.11 to –0.17), p=0.008), SD of the 5 min averages of all normal RR intervals (MD –12.77 ms, 95% CI (–21.20 to –4.33), p=0.003), overage of the SD of all normal RR intervals for each 5 min segment (MD –13.83 ms, 95% CI (–15.94 to –11.72), p50 ms (pNN50) (SMD –0.86, 95% CI (–1.41 to –0.31), p=0.002), than those without depression.

Conclusions

This study underscores the association between elevated CRP, hs-CRP, IL-6 and lower HRV in patients with CHD with depression. It emphasises the importance of clinicians assessing CRP, hs-CRP, IL-6 and HRV in patients with CHD to potentially identify depressive conditions.

Prevalence of metabolic syndrome in patients with inflammatory bowel disease: a systematic review and meta-analysis

Por: Shen · Z. · Zhang · M. · Liu · Y. · Ge · C. · Lu · Y. · Shen · H. · Zhu · L.
Objectives

Patients with inflammatory bowel disease (IBD) may experience comorbidities involving metabolic syndrome (MetS). However, this association remains controversial. Our objective was to estimate the prevalence of MetS in patients with IBD and assess whether MetS is more strongly associated with ulcerative colitis (UC) or Crohn’s disease (CD).

Design

Systematic review and meta-analysis.

Data sources

PubMed, Cochrane Library, Web of Science, EMBASE and MEDLINE were searched from their inception to July 2022.

Eligibility criteria

Observational studies reporting data regarding the rate of comorbid MetS among patients with IBD and published in English.

Data extraction and synthesis

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses and the Meta-analysis of Observational Studies in Epidemiology reporting guidelines were followed. Pooled prevalence, ORs and 95% CIs were calculated using random-effects models. The Newcastle-Ottawa Scale and the Agency for Healthcare Research and Quality checklist were used. Heterogeneity, sensitivity and stratified analyses were performed using R (V.4.2.1).

Results

11 eligible studies involving 2501 patients were included. Of these studies, four reported MetS prevalence separately by IBD phenotype, and only one contained a non-IBD comparison group. Overall, the methodological quality of the included studies was moderate. The pooled prevalence of MetS in IBD was 19.4% (95% CI 15.1% to 23.8%), with a moderate heterogeneity (I2=51.8%, Cochrane Q statistic=12.4, p=0.053). Stratified analyses demonstrated that the aggregate estimate of comorbid MetS was significantly higher in UC than in CD (38.2% vs 13.6%, 2=4.88, p=0.03). We found a positive association between MetS and UC compared with CD (OR=2.11, 95% CI 1.19 to 3.74, p=0.01). Additionally, four studies identified that higher age was a risk factor associated with the development of MetS.

Conclusions

MetS is not rare in IBD, especially in UC. However, longitudinal studies are needed to further clarify the relationship between IBD and MetS.

PROSPERO registration number

CRD42022346340.

Coutilisation of oral rehydration solution and zinc for treating diarrhoea and its associated factors among under-five children in East Africa: a multilevel robust Poisson regression

Por: Legesse · B. T. · Wondie · W. T. · Gedefaw · G. D. · Workineh · Y. T. · Seifu · B. L.
Objective

This study aimed to assess the coutilisation of oral rehydration solution (ORS) and zinc for treating diarrhoea and its associated factors among under-5 children in East Africa.

Design

Cross-sectional study design. Multilevel Poisson regression analysis with robust variance was fitted to identify predictors of zinc and ORS coutilisation. An adjusted prevalence ratio (aPR) with a 95% CI was reported to declare the statistical significance.

Setting

Twelve East African countries.

Participants

16 850 under-5 children who had diarrhoea were included in the study.

Result

In East African nations, the coutilisation of ORS and zinc for the treatment of diarrhoea in children under 5 was 53.27% with a 95% CI (52.54% to 54.01%). Children of mothers with primary education (aPR 1.15, 95% CI 1.09 to 1.20), secondary education (aPR 1.08, 95% CI 1.02 to 1.14), higer education (aPR 1.19, 95% CI 1.10 to 1.29), those from maternal age category of 20–24 (aPR 1.14, 95% CI 1.07 to 1.21), age category of 25–29 (aPR 1.13, 95% CI 1.06 to 1.21), age category of 30–34 (aPR 1.09, 95% CI 1.02 to 1.16), those from wealthy households (aPR 1.04, 95% CI 1.01 to 1.09) and those who have a media exposure (aPR 1.04, 95% CI 1.01 to 1.08) were more likely to receive combination.

Conclusion

Only half of the under-5 children with diarrhoea in East Africa were treated with a combination of ORS and zinc. To increase the use of the suggested combination therapy of ORS with zinc, it is important to empower women through education and prevent teen pregnancy.

Prognostic and clinicopathological significance of the Controlling Nutritional Status (CONUT) score in patients with lymphoma: a meta-analysis

Por: Li · L. · Shou · L.
Objectives

The role of the Controlling Nutritional Status (CONUT) scores in predicting the prognosis of lymphoma cases has been extensively explored, with no consistent results. The present meta-analysis focused on accurately evaluating whether CONUT could be used to predict the prognosis of lymphoma cases and its clinicopathological value.

Design

The present meta-analysis was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The prognostic significance of CONUT to overall survival (OS) and progression-free survival (PFS) in lymphoma was estimated by calculating pooled HRs with 95% CIs. The relationship between CONUT and clinicopathological characteristics was measured based on pooled ORs with 95% CIs.

Data sources

PubMed, Web of Science, Embase and Cochrane Library databases were comprehensively searched from inception through 24 March 2023.

Statistical methods

Either a random-effects model or a fixed-effects model was selected depending on the level of heterogeneity among the included studies.

Results

This meta-analysis enrolled seven articles, containing 2060 patients with lymphoma. According to the pooled analysis, a higher CONUT score significantly predicted poor OS (HR=1.94, 95% CI 1.46 to 2.57, p

Conclusions

According to our results, higher CONUT scores were significantly associated with poor OS and PFS in lymphoma.

Feasibility of quality indicators on prehospital advanced airway management in a physician-staffed emergency medical service: survey-based assessment of the provider point of view

Por: Kottmann · A. · Pasquier · M. · Carron · P.-N. · Maudet · L. · Rouve · J.-D. · Suppan · L. · Caillet-Bois · D. · Riva · T. · Albrecht · R. · Krüger · A. · Sollid · S. J. M.
Objective

We aimed to determine the feasibility of quality indicators (QIs) for prehospital advanced airway management (PAAM) from a provider point of view.

Design

The study is a survey based feasibility assessment following field testing of QIs for PAAM.

Setting

The study was performed in two physician staffed emergency medical services in Switzerland.

Participants

42 of the 44 emergency physicians who completed at least one case report form (CRF) dedicated to the collection of the QIs on PAAM between 1 January 2019 and 31 December 2021 participated in the study.

Intervention

The data required to calculate the 17 QIs was systematically collected through a dedicated electronic CRF.

Primary and secondary outcome measures

Primary outcomes were provider-related feasibility criteria: relevance and acceptance of the QIs, as well as reliability of the data collection. Secondary outcomes were effort to collect specific data and to complete the CRF.

Results

Over the study period, 470 CRFs were completed, with a median of 11 per physician (IQR 4–17; range 1–48). The median time to complete the CRF was 7 min (IQR 3–16) and was considered reasonable by 95% of the physicians. Overall, 75% of the physicians assessed the set of QIs to be relevant, and 74% accepted that the set of QIs assessed the quality of PAAM. The reliability of data collection was rated as good or excellent for each of the 17 QIs, with the lowest rated for the following 3 QIs: duration of preoxygenation, duration of laryngoscopy and occurrence of desaturation during laryngoscopy.

Conclusions

Collection of QIs on PAAM appears feasible. Electronic medical records and technological solutions facilitating automatic collection of vital parameters and timing during the procedure could improve the reliability of data collection for some QIs. Studies in other services are needed to determine the external validity of our results.

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.

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