Understanding and addressing health care disparities relies on collecting and reporting accurate data in clinical care and research. Data regarding a child\'s race, ethnicity, and language; sexual orientation and gender identity; and socioeconomic and geographic characteristics are important to ensure equity in research practices and reported outcomes. Disparities are known to exist across these sociodemographic categories. More consistent, accurate data collection could improve understanding of study results and inform approaches to resolve disparities in child health. However, published guidance on standardized collection of these data in children is limited, and given the evolving nature of sociocultural identities, requires frequent updates. The Pediatric Emergency Care Applied Research Network, a multi-institutional network dedicated to pediatric emergency research, developed a Health Disparities Working Group in 2021 to support and advance equitable pediatric emergency research. The working group, which includes clinicians involved in pediatric emergency medical care and researchers with expertise in pediatric disparities and the conduct of pediatric research, prioritized creating a guide for approaches to collecting race, ethnicity, and language; sexual orientation and gender identity; and socioeconomic and geographic data during the conduct of research in pediatric emergency care settings. Our aims with this guide are to summarize existing barriers to sociodemographic data collection in pediatric emergency research, highlight approaches to support the consistent and reproducible collection of these data, and provide rationale for suggested approaches. These approaches may help investigators collect data through a process that is inclusive, consistent across studies, and better informs efforts to reduce disparities in child health.

BACKGROUND: Despite contributions provided by the recent clinical trials, several issues and challenges still remain unsolved in adjuvant colon cancer (CC). Hence, further studies should be planned to better refine risk assessment as well as to establish the optimal treatment strategy in the adjuvant setting. However, it is necessary to request adequate, contemporary and relevant variables and report them homogeneously in order to bring maximal information when analyzing their prognostic value.
METHODS: The project was devised to gain a consensus from experts engaged in the planning, accrual and analyses of stage II and III CC clinical trials, to identify mandatory and recommended baseline variables in order to i) harmonize future data collection worldwide in clinical trials dedicated to adjuvant treatment of CC; ii) propose guidance for Case Report Forms to be used for clinical trials in this setting. A total of 72 questions related to variables that should be reported and how to report them in adjuvant clinical trials were approved and then voted to reach a final consensus from panelists.
RESULTS: Data items on patient-related factors, histopathological features, molecular profile, circulating biomarkers and blood analyses were analyzed and discussed by the whole expert panel. For each item, we report data supporting the acquired consensus and the relevant issues that were discussed. Nineteen items were deemed to be mandatory for resected stage III patients and 24 for resected stage II disease. In addition, 9 and 4 items were judged as recommended for stage III and II, respectively.
CONCLUSIONS: In our opinion, these 28 variables should be used and uniformly reported in more comprehensive CRFs as research groups design future clinical trials in the field of adjuvant colon cancer.

This report introduces a Brighton Collaboration (BC) case definition for autoimmune hepatitis (AIH), which has been classified as a priority adverse event of special interest (AESI), as there were possible cases seen following COVID-19 vaccination. The case definition was developed by a group of subject matter and BC process experts to facilitate safety data comparability across pre- and post-licensure clinical trials, as well as pharmacovigilance activities in multiple settings with diverse resources and healthcare access. The usual BC case definition development process was followed in an expedited manner, and took two months to complete, including finalising the manuscript for publication, instead of the usual 1 year development time. It includes a systematic review of the literature and an expert consensus to define levels of diagnostic certainty for AIH, and provides specific guidelines for data collection and analysis. Histology, serological and biochemical tests and exclusion of alternate diagnosis were considered necessary to define the levels of certainty (definitive, probable and possible). AEFI reports of suspected AIH were independently classified by the WG members to test its useability and these classifications were used to finalise the case definition. The document underwent peer review by external AIH experts and a Reference Group of vaccine safety stakeholders in high-, low- and middle-income countries to ensure case definition useability, applicability, and scientific integrity. The expedited process can be replicated for development of other standardised case definitions for priority AESIs for endemics and epidemics. While applicable to cases reported following immunisation, the case definition is independent of lapsed time following vaccination and, as such, can also be used to determine background incidence for vaccinated and unvaccinated control groups in studies of causal association. While use of this case definition is also appropriate for the study of safety of other products including drugs, it is not meant to guide clinical case management.

This is a revision of the online November 2021 Brighton thrombosis with thrombocytopenia syndrome (TTS) case definition and a new Brighton Collaboration case definition for vaccine-induced immune thrombocytopenia and thrombosis (VITT). These case definitions are intended for use in clinical trials and post-licensure pharmacovigilance activities to facilitate safety data comparability across multiple settings. They are not intended to guide clinical management. The case definitions were developed by a group of subject matter and Brighton Collaboration process experts as part of the Coalition for Epidemic Preparedness Innovations (CEPI)-funded Safety Platform for Evaluation of vACcines (SPEAC). The case definitions, each with defined levels of diagnostic certainty, are based on relevant published evidence and expert consensus and are accompanied by specific guidelines for TTS and VITT data collection and analysis. The document underwent peer review by a reference group of vaccine safety stakeholders and haematology experts to ensure case definition useability, applicability and scientific integrity.

The true global burden of paediatric critical illness remains unknown. Studies on children with life-threatening conditions are hindered by the absence of a common definition for acute paediatric critical illness (DEFCRIT) that outlines components and attributes of critical illness and does not depend on local capacity to provide critical care. We present an evidence-informed consensus definition and framework for acute paediatric critical illness. DEFCRIT was developed following a scoping review of 29 studies and key concepts identified by an interdisciplinary, international core expert panel (n=24). A modified Delphi process was then done with a panel of multidisciplinary health-care global experts (n=109) until consensus was reached on eight essential attributes and 28 statements as the basis of DEFCRIT. Consensus was reached in two Delphi rounds with an expert retention rate of 89%. The final consensus definition for acute paediatric critical illness is: an infant, child, or adolescent with an illness, injury, or post-operative state that increases the risk for or results in acute physiological instability (abnormal physiological parameters or vital organ dysfunction or failure) or a clinical support requirement (such as frequent or continuous monitoring or time-sensitive interventions) to prevent further deterioration or death. The proposed definition and framework provide the conceptual clarity needed for a unified approach for global research across resource-variable settings. Future work will centre on validating DEFCRIT and determining high priority measures and guidelines for data collection and analysis that will promote its use in research.

Introduction: Ensuring high-quality scholarly output by graduate medical trainees can be a challenge. Within many specialties, including emergency medicine (EM), it is unclear what constitutes appropriate resident scholarly activity. We hypothesized that the quantity and quality of scholarly activity would improve with a clearer guideline, including a point system for eligible scholarly activities. Methods: A resident Scholarly Activity Guideline was implemented for EM residents in a university setting. The guideline consists of a point system in which point values, ranging from 1-10, are assigned to various types of scholarly activities. Residents must earn at least 10 points and present their work to meet their scholarly graduation requirement. We tracked scholarly activities for graduates from the classes of 2014-2020, with the guideline being implemented for the class of 2016. In a blind analysis, we compared median total points per resident, mean counts of the Boyer model of scholarship components per resident, and mean counts of significant scholarly output per resident before vs after the guideline was implemented. Significant scholarly output was defined as an implemented protocol, a research project with data collection and analysis, a research abstract presentation, or an oral abstract presentation. Results: Among 64 residents analyzed, 48 residents used the guideline. We found that median points per resident increased after the guideline was implemented (median, interquartile range: before 7 [7], after 11 [10, 13], P = 0.002). Post-guideline scholarly activities were found to represent more of Boyer\'s components of scholarship [mean before 0.81 [SD 0.40], mean after 1.52 [SD 0.71], mean difference 0.71, 95% confidence interval [CI] 0.332 ± 1.09, P < 0.001. There was no difference in the mean significant scholarly output per resident (mean before 1.38 [SD 1.02], mean after 1.02 [SD 1.00], mean difference 0.35, 95% CI 0.93 ± 0.23, P = 0.23). Conclusion: Implementation of a Scholarly Activity Guideline point system significantly increased the quantity and, by one of two measures, increased the quality of scholarly output in our program. Our point-based guideline successfully incorporated traditional and modern forms of scholarship that can be tailored to resident interests.

Persistent postural-perceptual dizziness (PPPD) is a functional disorder of the nervous system and currently one of the most common types of chronic dizziness. Currently existing questionnaires do not fully assess patients\' specific symptoms of PPPD. The Japanese Niigata PPPD Questionnaire (NPQ) was recently developed following consensus-based diagnosis criteria. The aim of this study was to translate it into German, evaluate its content with the help of experts and patients and, if necessary, revise the original version to allow for a comprehensive assessment of patients\' PPPD-related symptoms.
A 3-round expert Delphi survey and semi-structured patient interviews were conducted. 28 experts from Switzerland, Germany and Austria working in hospitals or outpatient centres were asked to complete a first questionnaire on various aspects of PPPD, on the translated, original NPQ and their own related experiences (Round one), a second questionnaire with statements regarding PPPD they could agree or disagree with using a 6-point Likert-scale (Round two), and a third survey to finally reach a consensus on statements to be integrated into the NPQ. In addition, eleven patients (mean age of 64.6±12.6 years; 6 females) were selected according to the criteria for the diagnosis of PPPD proposed by the Bárány Society and participated in a semi-structured interview asking for their opinion on the content of the original NPQ. All collected data were analysed using a descriptive evaluation and a qualitative content analysis based on verbatim transcripts.
Seven new items were added to the NPQ based on expert and patient comments and ratings. Its revised version (NPQ-R) comprises 19 items divided into five subscales using a 7-point Likert-scale with two additional subscales relating to associated symptoms and symptom behaviour in PPPD. The new maximal score is 114 points compared to 72 for the NPQ.
The NPQ-R is the first patient-reported outcome measurement for patients with PPPD in German. It should help to provide a comprehensive assessment of the intensity of PPPD in affected patients.

Low-Risk Alcohol Drinking Guidelines (LRDGs) aim to reduce the harms caused by alcohol. However, considerable discrepancies exist in the \'low-risk\' thresholds employed by different countries.
Drawing upon Canada\'s LRDGs update process, the current paper offers the following propositions for debate regarding the establishment of \'low-risk\' thresholds in national guidelines: (1) as an indicator of health loss, years of life lost (YLL) has several advantages that could make it more suitable for setting guidelines than deaths, premature deaths or disability adjusted years of life (DALYs) lost. (2) Presenting age-specific guidelines may not be the most appropriate way of providing LRDGs. (3) Given past overemphasis on the so-called protective effects of alcohol on health, presenting cause-specific guidelines may not be appropriate compared with a \'whole health\' effect derived from a weighted composite risk function comprising conditions that are causally related to alcohol consumption. (4) To help people reduce their alcohol use, presenting different risk zones associated with alcohol consumption instead of a single low risk threshold may be advantageous.
National LRDGs should be based on years of life lost and should be neither age-specific nor cause-specific. We recommend using risk zones rather than a single drinking threshold to help people assess their own risk and encourage the adoption of behaviours with positive health impacts across the alcohol use spectrum.

Surgery generates a vast amount of data from each procedure. Particularly video data provides significant value for surgical research, clinical outcome assessment, quality control, and education. The data lifecycle is influenced by various factors, including data structure, acquisition, storage, and sharing; data use and exploration, and finally data governance, which encompasses all ethical and legal regulations associated with the data. There is a universal need among stakeholders in surgical data science to establish standardized frameworks that address all aspects of this lifecycle to ensure data quality and purpose.
Working groups were formed, among 48 representatives from academia and industry, including clinicians, computer scientists and industry representatives. These working groups focused on: Data Use, Data Structure, Data Exploration, and Data Governance. After working group and panel discussions, a modified Delphi process was conducted.
The resulting Delphi consensus provides conceptualized and structured recommendations for each domain related to surgical video data. We identified the key stakeholders within the data lifecycle and formulated comprehensive, easily understandable, and widely applicable guidelines for data utilization. Standardization of data structure should encompass format and quality, data sources, documentation, metadata, and account for biases within the data. To foster scientific data exploration, datasets should reflect diversity and remain adaptable to future applications. Data governance must be transparent to all stakeholders, addressing legal and ethical considerations surrounding the data.
This consensus presents essential recommendations around the generation of standardized and diverse surgical video databanks, accounting for multiple stakeholders involved in data generation and use throughout its lifecycle. Following the SAGES annotation framework, we lay the foundation for standardization of data use, structure, and exploration. A detailed exploration of requirements for adequate data governance will follow.

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