This systematic review to support a 2025 US Preventive Services Task Force Recommendation Statement summarizes published evidence on the benefits and harms of screening and harms of treatment of syphilis during pregnancy.
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Protocol for the development of a transdiagnostic core outcome set for mental health disorders in adults: the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative
Introduction
Mental health problems are important causes of disability and economic costs worldwide. Randomised clinical trials examining the treatment of mental health disorders measure heterogeneous outcomes, causing difficulties in data synthesis, interpretation and translation into clinical practice. The aim of the Patient Important Outcomes in Psychiatry (PIO-Psych) Initiative is to develop an overarching, transdiagnostic research-based and consensus-based core outcome set for adult mental health disorders.
Methods and analysis
The development of the PIO-Psych transdiagnostic core outcome set will include three phases: (1) a systematic scoping review of the literature to develop the initial list of outcomes for the Delphi study; (2) a Delphi study in three rounds including people with lived experience of mental health disorders and their relatives, clinicians, researchers and others (administrators, mental healthcare policymakers, philosophers); (3) a hybrid consensus meeting to agree on the final overarching, transdiagnostic core outcome set and corresponding time points of assessment of each outcome.
Ethics and dissemination
Ethical approval is not applicable to this study according to the Research Ethics Committee of the Capital Region of Denmark, as it is not an interventional study. All data will be reported anonymously, and it will not be possible to identify study participants. Results will be disseminated via stakeholder and research networks and peer-reviewed publications.
Trial registration details
The PIO-Psych Initiative was pre-registered with COMET (Core Outcome Measures for Effectiveness Trials) on 17 May 2024 (https://www.comet-initiative.org/Studies/Details/3125).
Prevalence and types of errors in the electronic health record: protocol for a mixed systematic review
Introduction
In countries with access to the electronic health record (EHR), both patients and healthcare professionals have reported finding errors in the EHR, so-called EHRrors. These can range from simple typos to more serious cases of missing or incorrect health information. Despite their potential detrimental effect, the evidence on EHRrors has not been systematically analysed. It is unknown how common EHRrors are or how they impact patients and healthcare professionals.
Methods and analysis
A mixed systematic review will be carried out to address the research gap. We will search PubMed, Web of Science and CINAHL for studies published since 2000, which report original research data on patient-identified and healthcare professional-identified EHRrors. We will analyse (1) the prevalence of EHRrors, (2) the types of EHRrors and (3) their impact on care. Quantitative and qualitative findings will be synthesised following the Joanna Briggs Institute Framework for Mixed Systematic Reviews. Identified studies will be critically appraised for meta-biases and risk of bias in individual studies. The confidence in the emerging evidence will be further assessed through the Grading of Recommendations Assessment, Development and Evaluation approach. Findings will be contextualised and interpreted involving an international team of patient representatives and practising healthcare professionals.
Ethics and dissemination
The study will not involve collection or analysis of individual patient data; thus, ethical approval is not required. Results will be published in a peer-reviewed publication and further disseminated through scientific events and educational materials.
PROSPERO registration number
CRD42024622849.
Perinatal outcomes for infants exposed to systemic cancer treatment during gestation: a systematic review and meta-analysis
Objectives
The incidence of cancer diagnosed during pregnancy is increasing, but data relating to perinatal outcomes for infants exposed to systemic cancer treatment in utero remain limited. This systematic review and meta-analysis aimed to synthesise evidence from the available literature to investigate whether perinatal outcomes for babies born to women with gestational cancer differ based on whether they are exposed to systemic cancer treatment in utero.
Design
A systematic review was conducted according to PRISMA-P guidelines. We extracted raw data from the eligible studies to calculate ORs and 95% CIs for perinatal outcomes reported in the included studies.
Data sources
A comprehensive search of Medline, Embase, Cochrane Library and CINAHL databases identified studies published between January 2001 and May 2025.
Eligibility criteria
Studies were eligible for inclusion in the review that reported on both a study group (women with gestational cancer who received systemic therapy during pregnancy) and a comparison group (women with gestational cancer who did not receive systemic therapy during pregnancy).
Data extraction and synthesis
Two independent reviewers extracted data. Perinatal outcomes included spontaneous abortion, pregnancy termination, intrauterine growth restrictions (IUGR), stillbirth, intrauterine foetal death, neonatal mortality, preterm birth (
[Articles] Helicobacter pylori infection, anti-Helicobacter pylori treatment and risk of colorectal cancer and adenoma: an observational study and a meta-analysis
H. pylori infection may represent a significant risk factor for the development of colorectal cancer. The effect of anti-H. pylori treatment on colorectal cancer incidence and mortality necessitates further investigation through large-scale, randomized controlled trials with prolonged follow-up durations.
[Articles] Music therapy for the treatment of anxiety: a systematic review with multilevel meta-analyses
The findings suggest that music therapy, particularly receptive methods or combinations of receptive and active approaches, offer effective, flexible, and scalable interventions for reducing anxiety symptoms, offering psychological benefits that enhance patient autonomy and quality of life, though its impact on physiological outcomes and long-term effects requires further research.
Automated Vessel Occlusion Software in Acute Ischemic Stroke: Pearls and Pitfalls
Stroke, Ahead of Print. Software programs leveraging artificial intelligence to detect vessel occlusions are now widely available to aid in stroke triage. Given their proprietary use, there is a surprising lack of information regarding how the software works, who is using the software, and their performance in an unbiased real-world setting. In this educational review of automated vessel occlusion software, we discuss emerging evidence of their utility, underlying algorithms, real-world diagnostic performance, and limitations. The intended audience includes specialists in stroke care in neurology, emergency medicine, radiology, and neurosurgery. Practical tips for onboarding and utilization of this technology are provided based on the multidisciplinary experience of the authorship team.
Glucagon-like peptide-1 Receptor Agonists and Gastrointestinal Adverse Events: a Systematic Review and Meta-analysis
Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are widely used for glycemic control or weight management in patients with type 2 diabetes mellitus (T2DM) or overweight/obesity. However, there are concerns regarding their association with serious gastrointestinal adverse events though findings have been inconsistent.
Continuous heart rate variability monitoring–understanding patterns of stress and recovery and their relationship with self-reported burnout, resilience and well-being in doctors: a protocol for a sequential explanatory mixed-methods study
Introduction
The medical profession is facing an unprecedented crisis. Reasons for this are complex and multifactorial; however, rising rates of burnout will undoubtedly contribute to problems with recruitment and retention. Chronic workplace stress, whereby there are insufficient resources available to meet the demands doctors face, is a contributor to burnout. There are a wide variety of available self-report measures for stress, with heart rate variability (HRV) shown to be a biomarker of stress and recovery in doctors. We aim to triangulate continuous HRV measurements with validated self-report measures and qualitative data to better understand the patterns of stress and recovery.
Methods and analysis
This study has a sequential explanatory mixed-methods design. Participants will be recruited from multiple sites within National Health Service (NHS) Grampian. Initially, participants will complete a suite of validated scales, including the Maslach Burnout Inventory for Medical Personnel, the Resilience Scale for Adults and the Interpersonal, Community, Occupational, Physical, Psychological (ICOPPE) well-being scale. Following this, participants will undertake seven consecutive days of ecological momentary assessment of real-time demands, resources and fatigue, alongside 7 days of continuous ambulatory assessment of HRV via Firstbeat Bodyguard 3 chest-worn monitors. Participants will be provided with a summary report following their study period. If 40 participants are recruited within the recruitment timeframe, multilevel modelling will be used to analyse data; otherwise, N-of-1 statistical techniques will be used. Following initial analysis of the quantitative data, participants of interest will be invited to take part in semistructured interviews, which will be thematically analysed and presented alongside the quantitative data.
Ethics and dissemination
This study was approved by the University of Aberdeen, School of Medicine, Medical Sciences and Nutrition ethics review board (ref. 3389193) and the NHS Grampian research and development team. Results will be disseminated in international peer-reviewed journals.
Trial registration number
NCT06721312.
Population pharmacokinetics and pharmacodynamics of two dosing regimens of antenatal corticosteroids: protocol for a prospective nested study in a randomised controlled trial
Introduction
Antenatal corticosteroid (ACS) regimens have remained unchanged since the initial trials in 1972, with the optimal regimen still undetermined. The WHO ACTION (Antenatal CorticosTeroids for Improving Outcomes in preterm Newborns)-III trial is a three-arm individually randomised double-blind trial evaluating the efficacy and safety of two different ACS dosing regimens (currently used and lower-dose ACS regimens vs placebo) in women with a high probability of having a late preterm birth. This study protocol nested within this trial aims to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) effects of two different ACS dosing regimens in pregnant women in the late preterm period (34–36 weeks) to help inform an optimal dosing regimen.
Methods and analysis
The study will be conducted in two of the five countries participating in the WHO ACTION-III trial—India (Delhi, Belagavi) and Nigeria (Ibadan and Ile-Ife). We will use a population PK approach using sparse sampling to study the PK effects of the two ACS regimens, that is, 6 mg dexamethasone phosphate (DEXp) or 2 mg betamethasone phosphate (BETp), administered intramuscularly every 12 hours for a maximum of four doses or till birth, whichever is earlier, compared with placebo. We will also ascertain the fetal–maternal ratio of DEXp and BETp at birth.
Maternal venous blood samples will be collected at 0, 1–4 hours, 8–12 hours after the first dose, and at 24–36 hours, 48–60 hours, 72–96 hours after the last dose, and immediately after birth, along with cord blood. Concentrations of DEXp and BETp will be measured at set time points using a validated liquid chromatography mass spectroscopy assay. PD parameters measured will include total and differential white blood cell count (by automated analysers using electrical impedance), plasma glucose (hexokinase method) and serum cortisol (using a validated electrochemiluminescence immunoassay), at predefined time points. PK models will be developed for each drug using non-linear mixed effects methods. Optimal dosing will be investigated using Monte Carlo simulations.
Ethics and dissemination
The study has been approved by the WHO Ethics Review Committee and the site-specific ethics committees of the participating leading institutions. Written informed consent will be obtained from all participants. The study results will be published in a peer-reviewed journal and presented at scientific conferences.
Trial registration number
ISRCTN11434567.
Impact of Venous CONgestion on Organ Function and Outcomes in Sepsis (ICON-Sepsis): a prospective observational cohort study protocol
Introduction
Sepsis is a common condition with significant morbidity, mortality and annual costs of care in the billions of dollars. Despite innumerable studies on the causes of, and therapies for, sepsis, the mortality rate has not changed substantially in the last 20 years. Treatments remain generic, with current guidelines recommending the same approach for all patients, regardless of the litany of differences that exist at baseline. Moreover, the blanket administration of 30 cc/kg of intravenous fluid (IVF) to all patients is recognised as being directly harmful to some. Patient-level heterogeneity in prior sepsis trials is recognised as a substantial contributor to all these problems, yet no prior investigation has attempted to identify volume-informed septic phenotypes, a necessary first step towards precision care.
Methods and analysis
Predicated on prior studies demonstrating detectability of organ-level congestion, we hypothesise that central venous hypertension (1) is deleterious to the function of the lungs, liver, kidneys and vascular endothelium; (2) is worsened by cardiac dysfunction and IVF administration; and (3) contributes to adverse organ-specific and overall outcomes. Beginning in the emergency department, cardiac function will be assessed with echocardiography while congestion in the lungs and kidneys will be assessed using previously validated sonographic markers of congestion. Biomarkers for each organ will be collected concurrently, thereby increasing the fidelity of our phenotypic profiles by pairing indicators of macroscopic and microscopic stress and dysfunction. Data will also be collected at 24 hours and 7 days (or discharge, whichever comes first) after presentation. Classical and machine learning approaches will be used to analyse our large data stream and develop a rule-based system to identify distinct subpopulations of patients with sepsis who have greater risk/likelihood of both organ-specific and overall adverse outcomes.
Ethics and dissemination
This project has been approved by the Wayne State University Institutional Review Board, with patient enrolment beginning in April 2024. Findings will be reported and disseminated via conference presentations and open-access publications.
Access to mental healthcare for refugees, asylum seekers and migrants: an umbrella review of barriers
Objective
To identify the factors that prevent or hinder access to mental healthcare services for refugees, asylum seekers and migrants.
Design
An umbrella review was conducted on scoping reviews, systematic reviews, meta-analyses and meta-syntheses published between January 2013 and December 2023.
Data sources
The databases searched (on 11 December 2023) included PubMed (via NCBI, including MEDLINE), Embase (via Embase.com), Web of Science Core Collection, Scopus and the Cochrane Database of Systematic Reviews (via Cochrane Library). Search strings were categorised as concepts, wherein concept one was population (refugees, asylum seekers and migrants), concept two was mental health services and concept three was the type of review (systematic review, meta-analysis, scoping review or literature review).
Eligibility criteria for selecting studies
Reviews were included if study participants were refugees, asylum seekers and migrants. Additionally, mental health-providing services or organisations and mental health providers were included. Excluded study participants were people with a migration background and second- or third-generation migrants.
Data extraction and synthesis
Two independent reviewers screened the identified articles on title and abstract. The 48 full-text articles were assessed in detail against inclusion and exclusion criteria by the two researchers and one person from the Belgian Superior Health Council.
Results
18 reviews were included. The extensive literature review identified various factors that prevent and restrict access to mental healthcare services for individuals with a recent migration background. Among the eight concepts of barriers, the most frequently mentioned were stigma and stigmatisation, language and communication challenges, financial obstacles, cultural barriers (including religious beliefs and faith) and issues with service delivery. Additionally, differences in culture, education and gender were recognised as factors limiting access to mental health services. Recommendations for policy and practice included implementing a multidisciplinary and multi-agency approach to facilitate access for newly arriving migrants and refugees, increasing financial allocations for translation and interpretation services, enabling policies to promote mental health utilisation and introducing educational programmes at the grassroot level among migrants and refugees.
Conclusion
Policy implementation should address the identified barriers and be routinely assessed for efficacy in service delivery and uptake. Future research should focus on enabling the utilisation of mental healthcare services among migrants, asylum seekers, and refugees.
Protocol for the development of a core outcome set for type 1 diabetes risk screening
Introduction
Type 1 diabetes is a chronic autoimmune disease that often presents with diabetic ketoacidosis at diagnosis. Since detection of type 1 diabetes risk is possible using genetic risk scores and autoantibody assays, prevention of diabetic ketoacidosis or delayed onset of type 1 diabetes may be possible and may improve outcomes. Several pilot screening programmes for type 1 diabetes risk have emerged worldwide but outcomes measured in these screening programmes are heterogeneous, making it difficult to compare and synthesise findings across studies. To improve the standardisation of outcome reporting and measurement, we aim to develop a patient-oriented core outcome set for studies of type 1 diabetes risk screening.
Methods and analysis
This five-step protocol was developed in alignment with the COS-STAndardised Protocol Statement and the Core Outcome Measures in Effectiveness Trials framework. The five steps will include: (1a) conducting a rapid literature review, (1b) gathering input on candidate outcomes from members of the public, (2) combining literature and public input to prepare a preliminary list of outcomes, (3) conducting Delphi surveys with a range of stakeholders to begin to establish consensus on outcomes, (4) holding a final consensus meeting to establish consensus on outcomes and (5) establishing the outcome measurement instruments for the core outcome set.
Ethics and dissemination
Ethics approval has been provided by The Hospital for Sick Children Research Ethics Board. The core outcome set will be distributed to researchers and clinicians involved in diabetes screening and clinical care, patient and family networks, research funders, journal editors, public health experts, and policymakers. Disseminated materials will be tailored to the various end users in the form of publication through academic journals, policy briefs, conferences, educational webinars, websites and social media.
[Articles] Efficacy and tolerability of pharmacological interventions for schizophrenia non-responsive to prior treatment: a systematic review and network meta-analysis
Clozapine remains the gold standard, outperforming several antipsychotics, while specific combinations may offer added benefits but require careful risk-benefit evaluation. Networks sparsity increases the likelihood of chance findings for estimates based on single studies. These results emphasise the need for personalised treatment, further research comparing non-clozapine antipsychotic combinations to high-dose clozapine monotherapy, and studies on long-term outcomes.
Faecalibacterium prausnitzii: one species with multiple potential implications in cancer research
The gut microbiota is pivotal for maintaining health through beneficial symbiotic interaction with the host supporting the homeostasis of the gastrointestinal tract but also of the majority of extraintestinal organs. Alterations in the gut microbiome have been linked to the pathogenesis of various diseases, including cancer, which remains a leading cause of mortality worldwide. The colonisation or overgrowth of certain bacterial species at the expense of others has been implicated in tumorigenesis. For instance, Helicobacter pylori infection is known to cause chronic inflammation and significantly increases the risk of developing gastric cancer, while Bacteroides fragilis and Fusobacterium nucleatum overgrowth have been associated with colorectal cancer (CRC). Consequently, several microbiota-based strategies have been developed to regulate cancer progression, enhance immune responses towards tumorous cells and improve the effectiveness of current anticancer therapies.1 Among the most abundant bacteria in the healthy human gut microbiota, Faecalibacterium prausnitzii, an anaerobic member…
Global prevalence of ultra-short coeliac disease (USCD): the first systematic review and meta-analysis
We reviewed the recent cohort study by Raju et al1 on ultra-short coeliac disease (USCD), the first multicentre international study assessing the characteristics of this new entity and comparing them to classic coeliac disease. The study revealed findings that may necessitate a re-evaluation of the current diagnostic guidelines and screening protocols. However, the results showed disparities in USCD prevalence rates among biopsy-confirmed cases across centres, ranging from 0.2% to 8.8%. Moreover, the study did not report the number of bulb biopsies conducted at each centre. Hence, we aimed to systematically assess the global prevalence of USCD and determine factors that might influence its rates. See the for subgroup analyses and methodology. Literature was searched from inception to June 2024 (PubMed, Web of Science, Cochrane, Scopus) for studies reporting the prevalence of USCD, using the term or reporting seropositive cases with villous atrophy (VA) confined to the bulb