Longitudinal observational research study: establishing the Australasian Congenital Cytomegalovirus Register (ACMVR)

Purpose
Congenital cytomegalovirus (cCMV) is an important cause of long-term childhood disability. In Australia, the identification and treatment practices and the long-term clinical and neurodevelopmental outcomes of children with cCMV are unknown. The Australasian cCMV Register (ACMVR) is a longitudinal register and resource for research that aims to describe and explore, in Australian children with cCMV: (1) their clinical characteristics over time, (2) antiviral therapy use/prescribing up to 1 year of age and (3) risk factors and potential avenues for prevention of adverse sequelae of the virus.

Participants
Children

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Effect of transcranial magnetic stimulation on perioperative neurocognitive dysfunction: study protocol for a systematic review and meta-analysis of randomised controlled trials

Introduction
Perioperative neurocognitive disorders (PNDs), a common postoperative complication associated with anaesthesia and surgical procedures, are characterised by impairments in memory, attention, language comprehension and social functioning. Accumulating evidence from clinical studies indicates that transcranial magnetic stimulation (TMS)—a non-invasive neuromodulatory modality capable of targeted cortical stimulation—may offer therapeutic promise for PND management. To comprehensively assess the intervention efficacy and safety parameters of TMS in mitigating postoperative cognitive decline, we propose conducting a systematic review and meta-analysis of randomised controlled trials adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Our findings aim to provide evidence-based insights into the neuroprotective potential of TMS for mitigating cognitive decline in surgical populations.

Methods and analysis
The investigation will implement a multifaceted search protocol encompassing international and Chinese scholarly resources. The search will be conducted in major databases, including Web of Science, Embase, PubMed, Cochrane Library, China Biology Medicine, China National Knowledge Infrastructure, Wan Fang Database and Chinese Scientific Journal Database from inception to 31 March 2025. To capture the latest research trends, ongoing trials will be simultaneously searched in the WHO International Clinical Trial Registry Platform, ClinicalTrials.gov and the China Clinical Trial Registry. Grey literature will be supplemented through resources such as GreyNet International, OpenGrey and Google Scholar. The inclusion criteria for this review are restricted to randomised controlled trials investigating the application of TMS as an intervention for PND. Primary endpoints comprise clinically confirmed incidence rates of postoperative delirium and delayed neurocognitive recovery. Two researchers will independently perform literature screening, data extraction and risk of bias assessment. The risk of bias in included studies will be evaluated using the Cochrane Risk of Bias Tool 2.0. Evidence certainty will be appraised through the GRADE framework with explicit justification for downgrading decisions. Meta-analysis will be conducted using STATA V.15.1 statistical software. The data synthesis process will incorporate standardised methodologies, including heterogeneity testing, sensitivity analysis and assessment of publication bias.

Ethics and dissemination
This study will not involve the collection of biometric information or medical privacy data throughout the research process, thus complying with the exemption criteria outlined in the ‘Measures for Ethical Review of Biomedical Research Involving Human Subjects.’ The findings will adhere to academic standards and be submitted for publication in reputable international medical journals following a rigorous double-blind peer-review process.

Systematic review registration
The research protocol has been prospectively registered on the PROSPERO international prospective systematic review registration platform (registration number: CRD42025636978).

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The emerging economic evidence and methods used to evaluate clinical registries: a systematic scoping review protocol

Introduction
A clinical registry is a systematically collected database of health-specific information about a patient population. Clinical registries can be used for a variety of purposes including surveillance, monitoring of outcomes and patient care. The establishment and maintenance of clinical registries come with a significant cost. This scoping review aims to identify the methods used to economically evaluate clinical registries including their costs and benefits.

Methods
This systematic scoping review protocol has been developed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. The final review will be reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. The electronic databases Medline, Embase, Cochrane Library and The Cumulative Index to Allied Health Literature(CINAHL) database will be searched. Relevant national organisation websites will be searched to identify empirical studies within grey literature. The inclusion criteria include studies that economically evaluate clinical registries and are published in the English language from inception to February 2025. Two reviewers will independently screen 100% of titles and abstracts and full texts of studies for inclusion. Data will be extracted from eligible studies prior to being assessed for quality using a multi-tool approach.

Ethics and dissemination
The findings of this review will be published in an international peer-reviewed journal. They are likely to be of interest to custodians of existing clinical registries and to those wishing to establish or evaluate clinical registries.
Keywords
Clinical registries, economic evaluation, costs, cost-effectiveness, health economics, registry based studies

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Patient-Reported Incident Measure (PRIM) tools for reporting patient safety incidents: protocol for a scoping review

Introduction
Patient safety incidents during healthcare cause a high burden and mortality, but many go unreported. Involving patients and caregivers in the identification and reporting of safety incidents would add value to the current incident reporting systems used by health professionals. Identifying and analysing patient safety incidents is essential to prevent future events, allowing organisations to apply a learning-from-error approach and to implement improvement plans. Patient-Reported Incident Measures are tools for patients and caregivers to report safety issues related to their healthcare. In accordance with WHO’s patient safety taxonomy, the term patient safety incidents is used throughout this protocol to encompass events that do and do not reach the patient, including what are commonly referred to as near misses and adverse events. We aim to identify and describe the published literature about tools for patients or caregivers to report patient safety incidents in healthcare.

Methods and analysis
We will conduct a scoping review. We have developed inclusion criteria using the PCC (population, concept and context) format, where population includes adult patients or caregivers; concept refers to documents describing formal tools used to report patient safety incidents; and context includes any healthcare setting, such as hospitals or mental health centres, during or immediately after care. The scoping review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. Evidence sources include primary research, systematic reviews, meta-analyses, conference abstracts, letters, guidelines, as well as policy documents, reports, blogs and websites, without language restriction. An initial database search in Medline, Embase, CINAHL, and Cochrane Library from database inception up to June 2023 identified 4500 initial citations, of which 4103 were selected for evaluation after duplicates were removed. We will supplement the search by checking the reference lists of included studies for additional sources of evidence and an additional search in Google to identify non-peer-reviewed documents. This initial search will be updated before completing the review. We will use a self-created data collection form for data extraction and perform a narrative synthesis to integrate and summarise the review findings. We will describe the general characteristics of the tool: setting, scope, format, content, type of patient safety incident and severity, the moment of notification, relation to patient safety incident reporting and learning systems, development process, testing, validation, or piloting, among other characteristics. As a result of this scoping review, we intend to provide an index of patient/caregiver-reported safety notification tools and a list of descriptive or evaluation studies.

Ethics and dissemination
We will only use published data. Approval from the human research ethics committee is not required. The results of this scoping review will be submitted for publication in an international peer-reviewed journal and scientific meetings. Findings will also be disseminated through digital science platforms and academic social media.

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Understanding disparities in access to and quality of surgical care for African, Caribbean and Black communities in high-income countries with universal healthcare: a scoping review protocol

Introduction
African, Caribbean and Black (ACB) communities experience disparities in health outcomes, with higher rates of chronic diseases, such as heart disease and stroke, and lower self-reported health status compared to their White counterparts. Barriers to timely access to healthcare services further exacerbate these inequities. Some studies link racialisation to surgical disparities and subpar surgical outcomes. However, the findings are diverse, and there is no synthesis of the evidence on disparities in surgical care for ACB patients in high-income countries with universal healthcare systems. The objective of the scoping review is to systematically describe, characterise and map the existing literature on disparities in the access to and quality of surgical care among ACB patients in high-income countries with universal healthcare systems, and to identify gaps in the literature on surgical access and quality of surgical care in ACB patients.

Methods and analysis
The scoping review will follow the Joanna Briggs Institute methodology and report according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. The search strategy will be customised for each database (MEDLINE, Embase, CINAHL, APA PsycINFO and Cochrane Library) using terms for ACB and surgery. Grey literature and references from included studies will be searched for additional sources, with no limitations on publication date or language. All study designs will be eligible. Two independent reviewers will screen titles, abstracts and full texts in duplicate for eligibility. One reviewer will chart data, with a second reviewer validating the data charted. The findings will be synthesised, quantitatively summarised using descriptive statistics and qualitatively analysed through thematic analysis.

Ethics and dissemination
Ethics approval is not required as the study utilises published data. The dissemination of the findings will inform future research and improve understanding of the surgical care experiences of ACB patients. Dissemination will target academics and healthcare professionals through publications, presentations and workshops.

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Hyperangulated videolaryngoscope for difficult airway management: a protocol for a systematic review with meta-analysis and trial sequential analysis

Introduction
Videolaryngoscopes are recommended as the top preference for tracheal intubation in adults, children, infants and neonates, and even in patients with anticipated difficult airways, since they are generally easier to use and quicker to master than fibreoptic bronchoscopes. Compared with standard videolaryngoscopes, hyperangulated videolaryngoscopes possess a more sharply curved blade or blade tip, resulting in a higher first-attempt success rate among patients with anticipated difficult airways. However, hyperangulated videolaryngoscopes also pose challenges in advancing the tracheal tube, which decreases the first-attempt success rate while increasing the tracheal intubation time when the tracheal tube introducer is unsuitable. Hence, controversy still remains regarding the efficiency of hyperangulated videolaryngoscopes as first-line devices in patients with anticipated difficult airways, owing to the inconsistent clinical findings. Consequently, we will conduct a protocol for a systematic review and meta-analysis to determine the usefulness of hyperangulated videolaryngoscopes in patients with anticipated difficult airways.

Methods and analysis
English-language databases (Web of Science, Cochrane Library, PubMed, Embase and Ovid Medline), Chinese electronic databases (VIP database, China National Knowledge Infrastructure, and Wanfang database) and clinical trial registry platforms will be scoured from their inception to May 2025 to locate randomised controlled trials of hyperangulated videolaryngoscopes in patients with anticipated difficult airways. For continuous data, mean differences or standardised mean differences, accompanied by their 95% CIs, and for dichotomous data, the risk ratio, accompanied by its 95% CI, will be calculated using Review Manager V.5.4. Either a fixed-effects model or a random-effects model will be used depending on the magnitude of statistical heterogeneity as evaluated via the I2 test. The risk of bias will be assessed via the Cochrane risk-of-bias tool 2. Additionally, the quality of evidence regarding each outcome will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation. The reliability of all outcomes will be appraised via trial sequential analysis. Moreover, the publication bias of all outcomes will be examined using Funnel plots and Egger’s regression test.

Ethics and dissemination
Ethical approval was not required for this systematic review protocol. The results will be disseminated through peer-reviewed publications.

PROSPERO registration number
CRD42024627484

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Annual cases of colon cancer by age group after Medicaid expansion in the USA in 2014: a difference-in-differences study

Background
Studies examining the association between Medicaid expansion (ME) under the Affordable Care Act (ACA) and colon cancer incidence have produced mixed results.

Objective
To re-visit the association between the ACA-ME and annual cases of colon cancer.

Design
Difference-in-differences (DiD).

Setting
The primary analyses used data from the National Cancer Database from 2010 to 2018, a hospital-based cancer registry in the USA. We also conducted exploratory analyses using data from the Surveillance, Epidemiology and End Results (SEER) registry.

Patients
Patients aged 40 and older with newly diagnosed colon cancer.

Measurements
The primary outcome was the percent change in colon cancer of all stages. Secondary outcomes were percent changes in stage I and stage IV cases.

Results
Among those aged 40–49, we observed a statistically significant greater increase in stage I colon cancer in expansion states relative to non-expansion states (DiD (percent change) 9.7% (95% CI, 2.5% to 17.4%)). In those aged 50–64, we did not observe statistically significant differences between the two state groups in any of the outcomes. Among those aged 65+, we observed a statistically significant relative decrease for all stages in ACA-ME states (–1.0% (95% CI, –1.0% to –3.0%)) and for stage IV (–3.0% (95% CI, –2.0% to –5.0%)). We explored our findings among younger individuals (

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