Towards a Reporting Guideline for Studies on Information Extraction from Clinical Texts.

BACKGROUND: The rapid technical progress in the domain of clinical Natural Language Processing and information extraction (IE) has resulted in challenges concerning the comparability and replicability of studies. AIM: This paper proposes a reporting guideline to standardize the description of methodologies and outcomes for studies involving IE from clinical texts. METHODS: The guideline is developed based on the experiences gained from data extraction for a previously conducted scoping review on IE from free-text radiology reports including 34 studies. RESULTS: The guideline comprises the five top-level categories information model, architecture, data, annotation, and outcomes. In total, we define 28 aspects to be reported on in IE studies related to these categories. CONCLUSIONS: The proposed guideline is expected to set a standard for reporting in studies describing IE from clinical text and promote uniformity across the research field. Expected future technological advancements may make regular updates of the guideline necessary. In future research, we plan to develop a taxonomy that clearly defines corresponding value sets as well as integrating both this guideline and the taxonomy by following a consensus-based methodology.

Guidelines to support the design, and selection and appraisal of multimedia teaching aids for microbiology education.

Microbiology education has a serious handicap - the lack of visibility of the players of the subject and their interactions - which engenders a disproportionate reliance upon multimedia teaching aids (MTAs). The International Microbiology Literacy Initiative (IMiLI) is creating educational resources in societally-relevant microbiology complemented by appropriate MTAs. However, proper guidance supporting microbiology educators in locating and selecting, or commissioning the creation of, adequate MTAs for different target audiences and learning objectives is lacking. The aims of this study were to (i) identify important considerations regarding educational/didactical standards and the design of educational multimedia and (ii) create an evidence-based guideline for selecting and appraising existing, and informing the creation of new, microbiology MTAs. This investigation is based on an exploratory, mixed-methods approach. The results of two literature reviews (covering educational and good practice multimedia design) informed the collation of a preliminary appraisal guideline for videos, animations, comics, and video games. A web-scraping approach was utilised to locate and retrieve existing exemplars of the four multimedia types and create four pertinent multimedia databases (including metadata). The preliminary guideline was piloted (and revised accordingly) by appraising quasi-random (or purposive) samples of each multimedia type. Educational multimedia experts were interviewed to discuss the findings. Finally, the guideline was updated to reflect the expert comments together with the results of the pilot appraisals. The final guideline has four components: (i) central considerations for selecting and appraising multimedia for specific audiences and educational purposes, (ii) multimedia selection tool, (iii) multimedia appraisal tools, and (iv) extensive background information as appendices linking all sections for further comprehension. Broad utilisation of the guideline has significant potential for simplifying and systematising multimedia selection/creation, leading to superior multimedia-based learning outcomes, establishing a rapid selection database (pre-appraised multimedia), reducing disparities in microbiology education and incentivising educational content creators.

Practical guide to writing cover letters and response letters for scientific journals.

Communicating with scientific journals is a central part of the publication process, yet sparsely covered in the medical literature. A cover letter to the editor(s) should always accompany new submissions, whereas response (or rebuttal) letters relate to revisions and replying to referees' comments following peer review. This review describes the two types of letters, focusing on content, style, and structure, and provides helpful tips for handling challenging reviewer scenarios.

Guidelines for minimal information on cellular senescence experimentation in vivo.

Cellular senescence is a cell fate triggered in response to stress and is characterized by stable cell-cycle arrest and a hypersecretory state. It has diverse biological roles, ranging from tissue repair to chronic disease. The development of new tools to study senescence in vivo has paved the way for uncovering its physiological and pathological roles and testing senescent cells as a therapeutic target. However, the lack of specific and broadly applicable markers makes it difficult to identify and characterize senescent cells in tissues and living organisms. To address this, we provide practical guidelines called "minimum information for cellular senescence experimentation in vivo" (MICSE). It presents an overview of senescence markers in rodent tissues, transgenic models, non-mammalian systems, human tissues, and tumors and their use in the identification and specification of senescent cells. These guidelines provide a uniform, state-of-the-art, and accessible toolset to improve our understanding of cellular senescence in vivo.

Validation of a new protocol for a zebrafish MEFL (malformation or embryo-fetal lethality) test method that conforms to the ICH S5 (R3) guideline.

Detecting the toxic effects of chemicals on reproduction and development without using mammalian animal models is crucial in the exploitation of pharmaceuticals for human use. Zebrafish are a promising animal model for investigating pharmacological effects and toxicity during vertebrate development. Several studies have suggested the use of zebrafish embryos for the assessment of malformations or embryo-fetal lethality (MEFL). However, a reproducible protocol as a standard for the zebrafish MEFL test method that fulfills global requests has not been established based on the International Council of Harmonisation (ICH) S5 (R3) guidelines. To establish such a toxicity test method, we developed a new and easy protocol to detect MEFL caused by chemicals, especially those with teratogenic potential, using fertilized zebrafish eggs (embryos) within 5 days of development. Our toxicity test trials using the same protocol in two to four different laboratories corroborated the high inter-laboratory reproducibility. Our test method enabled the detection of 18 out of 22 test compounds that induced rat MEFL. Thus, the prediction rate of our zebrafish test method for MEFL was almost 82% compared with that of rat MEFL. Collectively, our study proposes the establishment of an easy and reproducible protocol for the zebrafish MEFL test method for reproductive and developmental toxicity that meets ICH guideline S5 (R3), which can be further considered in combination with information from other sources for regulatory use.

JBI Scoping Review Network - Recursos

A JBI Scoping Review Network é apoiada pelo JBI Scoping Review Methodology Group, formado por metodologistas apaixonados por desenvolver recursos e educar indivíduos, organizações e instituições sobre a melhor abordagem para revisões de escopo.

Applying the WHO-INTEGRATE evidence-to-decision framework in the development of WHO guidelines on parenting interventions: step-by-step process and lessons learnt.

BACKGROUND: Development of guidelines for public health, health system, and health policy interventions demands complex systems thinking to understand direct and indirect effects of interventions within dynamic systems. The WHO-INTEGRATE framework, an evidence-to-decision framework rooted in the norms and values of the World Health Organization (WHO), provides a structured method to assess complexities in guidelines systematically, such as the balance of an intervention's health benefits and harms and their human rights and socio-cultural acceptability. This paper provides a worked example of the application of the WHO-INTEGRATE framework in developing the WHO guidelines on parenting interventions to prevent child maltreatment, and shares reflective insights regarding the value added, challenges encountered, and lessons learnt. METHODS: The methodological approach comprised describing the intended step-by-step application of the WHO-INTEGRATE framework and gaining reflective insights from introspective sessions within the core team guiding the development of the WHO guidelines on parenting interventions and a methodological workshop. RESULTS: The WHO-INTEGRATE framework was used throughout the guideline development process. It facilitated reflective deliberation across a broad range of decision criteria and system-level aspects in the following steps: (1) scoping the guideline and defining stakeholder engagement, (2) prioritising WHO-INTEGRATE sub-criteria and guideline outcomes, (3) using research evidence to inform WHO-INTEGRATE criteria, and (4) developing and presenting recommendations informed by WHO-INTEGRATE criteria. Despite the value added, challenges, such as substantial time investment required, broad scope of prioritised sub-criteria, integration across diverse criteria, and sources of evidence and translation of insights into concise formats, were encountered. CONCLUSIONS: Application of the WHO-INTEGRATE framework was crucial in the integration of effectiveness evidence with insights into implementation and broader implications of parenting interventions, extending beyond health benefits and harms considerations and fostering a whole-of-society-perspective. The evidence reviews for prioritised WHO-INTEGRATE sub-criteria were instrumental in guiding guideline development group discussions, informing recommendations and clarifying uncertainties. This experience offers important lessons for future guideline panels and guideline methodologists using the WHO-INTEGRATE framework.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Guideline for reporting systematic reviews of outcome measurement instruments (OMIs): PRISMA-COSMIN for OMIs 2024.

PURPOSE: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024. METHODS: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement. RESULTS: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥ 67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts. CONCLUSION: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: In order to encourage its wide dissemination this article is freely accessible on the web sites of the journals: Health and Quality of Life Outcomes; Journal of Clinical Epidemiology; Journal of Patient-Reported Outcomes; Quality of Life Research.

Learning from an experience, challenges and approaches in the workplace during COVID-19 pandemic: a content analysis of international documents.

BACKGROUND: This study aims to investigate international measures for pandemic control in the workplace based on guidelines from international organizations to learn from their experiences. METHODS: We conducted a qualitative study using content analysis. The search method involved reviewing published guidelines on preventing and responding to the COVID-19 pandemic in workplaces. After the screening process, ten guidelines were included in the content analysis. During the analysis, 200 meaning codes, 49 subcategories, and eleven categories were identified. Trustworthiness criteria were utilized to ensure the accuracy and strength of the findings. RESULTS: Eleven categories of international content during the COVID-19 pandemic were legal requirements and duties of employees and employers, structural and program changes, risk assessment, risk communication, information and training, internal and external consultation and cooperation, provision of facilities and tools for workplace hygiene, special conditions, special groups, closing and reopening workplaces, reducing contact and exposure and mental health. CONCLUSIONS: Protecting employees during a pandemic requires a multifaceted approach and strong advocacy. The operational plan for pandemic control should be developed based on the level of risk, with support tailored to employees' conditions and needs. Cooperation among international organizations is essential to develop a standardized plan and issue comprehensive guidelines in response to health emergencies with a global perspective and local implementation, drawing from the lessons learned during the COVID-19 pandemic.

Still to ARRIVE at adequate reporting of orthodontic studies involving animal models.

BACKGROUND: The ARRIVE 2.0 guidelines were introduced to improve the reporting of animal studies. The aim of this study was to assess the reporting adherence of orthodontic speciality animal studies in relation to ARRIVE 2.0 guidelines. Associations between the reporting and study characteristics were explored. MATERIALS AND METHOD: An electronic database search was undertaken using Medline via PubMed (www.pubmed.ncbi.nlm.nih.gov) to identify studies meeting the eligibility criteria published between 1 January 2018 and 31 December 2023. Data extraction was performed in duplicate and independently. Descriptive statistics and frequency distributions for the responses to each checklist item were calculated. Mean values for adequate reporting per ARRIVE item were calculated. A sum score was calculated by adding the responses (0 = not reported, 1 = inadequate reporting, 2 = adequate reporting) per item and sub-questions. On an exploratory basis, univariable linear regression between summary score and study characteristics (year of publication, continent of authorship, type of centre, and number of authors) was performed. RESULTS: Three hundred and eighty-four studies were analysed. Variability in the adequate reporting of the ARRIVE 2.0 guideline items was evident. In particular, in 32% of studies, there was a lack of reporting of the priori sample size calculation. Overall, the mean reporting score for the sample was 57.9 (SD 6.7 and range 34-74). There were no associations between score and study characteristics except for a weak association for year of publication with a small improvement over time (each additional year). CONCLUSIONS: The reporting of animal studies relevant to the speciality of orthodontics is sub-optimal in relation to the ARRIVE 2.0 guidelines. There was a tendency for the non-reporting of items pertaining to study sample size, eligibility, methods to reduce bias and interpretation/scientific implications. Greater awareness and reporting adherence to the ARRIVE 2.0 guidelines are required to reduce research waste involving animal models.

Systematic reviews and meta-analyses in neurosurgery Part II: a guide to designing the protocol.

Despite clearly established guidelines, recent audits have found the conduct and reporting of systematic reviews and meta-analyses (SRMAs) within neurosurgery to be relatively lackluster in methodological rigor and compliance. Protocols of SRMAs allow for planning and documentation of review methods, guard against arbitrary decision-making during the review process, and enable readers to assess for the presence of selective reporting. To aid transparency, authors should provide sufficient detail in their protocol so that the readers could reproduce the study themselves. Development of our guideline drew heavily from the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P) initiative. The objective of this article is not to enumerate every detail of this checklist, but to provide guidance to authors preparing their protocol, with examples, for a systematic review in neurosurgery. Particularly, we emphasize on the PICO framework - population (P), interventions (I), comparators (C), outcomes (O) - which is central to constructing a clinical question, defining the scope of the systematic review, defining and prioritizing the primary outcome, to specifying the eligibility criteria, designing the search strategy, and identifying potential sources of heterogeneity. We encourage our readers to make use of this guideline alongside the PRISMA-P 2015 statement, when drafting and appraising systematic review protocols.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: explanation and elaboration.

Adequate and transparent reporting is necessary for critically appraising research. Yet, evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-empaneled a group of authors to develop methodological and statistical reporting guidelines identifying the minimum information needed to document and evaluate observational studies and clinical trials in oral health: the OHstat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The final version was subsequently approved by the Task Force in September 2021, submitted for journal review in 2022, and revised in 2023. The checklist consists of 48 guidelines: 5 for introductory information, 17 for methods, 13 for statistical analysis, 6 for results, and 7 for interpretation; 7 are specific to clinical trials. Each of these guidelines identifies relevant information, explains its importance, and often describes best practices. The checklist was published in multiple journals. The article was published simultaneously in JDR Clinical and Translational Research, the Journal of the American Dental Association, and the Journal of Oral and Maxillofacial Surgery. Completed checklists should accompany manuscripts submitted for publication to these and other oral health journals to help authors, journal editors, and reviewers verify that the manuscript provides the information necessary to adequately document and evaluate the research.

The OHStat Guidelines for Reporting Observational Studies and Clinical Trials in Oral Health Research: manuscript checklist.

Adequate and transparent reporting is necessary for critically appraising published research. Yet, ample evidence suggests that the design, conduct, analysis, interpretation, and reporting of oral health research could be greatly improved. Accordingly, the Task Force on Design and Analysis in Oral Health Research-statisticians and trialists from academia and industry-identified the minimum information needed to report and evaluate observational studies and clinical trials in oral health: the OHStat Guidelines. Drafts were circulated to the editors of 85 oral health journals and to Task Force members and sponsors and discussed at a December 2020 workshop attended by 49 researchers. The guidelines were subsequently revised by the Task Force's writing group. The guidelines draw heavily from the Consolidated Standards for Reporting Trials (CONSORT), Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and CONSORT harms guidelines and incorporate the SAMPL guidelines for reporting statistics, the CLIP principles for documenting images, and the GRADE indicating the quality of evidence. The guidelines also recommend reporting estimates in clinically meaningful units using confidence intervals, rather than relying on P values. In addition, OHStat introduces 7 new guidelines that concern the text itself, such as checking the congruence between abstract and text, structuring the discussion, and listing conclusions to make them more specific. OHStat does not replace other reporting guidelines; it incorporates those most relevant to dental research into a single document. Manuscripts using the OHStat guidelines will provide more information specific to oral health research.