Improving laboratory animal genetic reporting: LAG-R guidelines.

The biomedical research community addresses reproducibility challenges in animal studies through standardized nomenclature, improved experimental design, transparent reporting, data sharing, and centralized repositories. The ARRIVE guidelines outline documentation standards for laboratory animals in experiments, but genetic information is often incomplete. To remedy this, we propose the Laboratory Animal Genetic Reporting (LAG-R) framework. LAG-R aims to document animals' genetic makeup in scientific publications, providing essential details for replication and appropriate model use. While verifying complete genetic compositions may be impractical, better reporting and validation efforts enhance reliability of research. LAG-R standardization will bolster reproducibility, peer review, and overall scientific rigor.

Typical Guidelines for Well-Balanced Diet and Science Communication in Japan and Worldwide.

Numerous studies have investigated healthy diets and nutrients. Governments and scientists have communicated their findings to the public in an easy-to-understand manner, which has played a critical role in achieving citizens' well-being. Some countries have published dietary reference intakes (DRIs), whereas some academic organizations have provided scientific evidence on dietary methods, such as traditional diets. Recently, more user-friendly methods have been introduced; the Health Star Rating system and Optimized Nutri-Dense Meals are examples from Australia and Japan, respectively. Both organizations adopt a novel approach that incorporates nudges. This review summarizes the science communication regarding food policies, guidelines, and novel methods in Japan and other countries. In the food policies section, we discuss the advantages and disadvantages of the DRIs and food-based guidelines published by the government. Dietary methods widely known, such as The Mediterranean diet, Nordic diet, Japanese traditional diet, and the EAT-Lancet guidelines, were also reviewed. Finally, we discussed future methods of science communications, such as nudge.

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.

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.

Reporting guidelines for precision medicine research of clinical relevance: the BePRECISE checklist.

Precision medicine should aspire to reduce error and improve accuracy in medical and health recommendations by comparison with contemporary practice, while maintaining safety and cost-effectiveness. The etiology, clinical manifestation and prognosis of diseases such as obesity, diabetes, cardiovascular disease, kidney disease and fatty liver disease are heterogeneous. Without standardized reporting, this heterogeneity, combined with the diversity of research tools used in precision medicine studies, makes comparisons across studies and implementation of the findings challenging. Specific recommendations for reporting precision medicine research do not currently exist. The BePRECISE (Better Precision-data Reporting of Evidence from Clinical Intervention Studies & Epidemiology) consortium, comprising 23 experts in precision medicine, cardiometabolic diseases, statistics, editorial and lived experience, conducted a scoping review and participated in a modified Delphi and nominal group technique process to develop guidelines for reporting precision medicine research. The BePRECISE checklist comprises 23 items organized into 5 sections that align with typical sections of a scientific publication. A specific section about health equity serves to encourage precision medicine research to be inclusive of individuals and communities that are traditionally under-represented in clinical research and/or underserved by health systems. Adoption of BePRECISE by investigators, reviewers and editors will facilitate and accelerate equitable clinical implementation of precision medicine.

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.

The role of the International Society for Stem Cell Research (ISSCR) guidelines in disease modeling.

Human stem cell-based modeling systems are valuable tools that can greatly improve the clinical translation of basic research. Importantly, the successful application of human stem cell-based models to biomedical research depends on the widespread adoption of ethical principles and practical standards. To achieve this outcome, the International Society for Stem Cell Research (ISSCR) provides a comprehensive set of recommendations that aim to promote the ethical usage of human stem cells and to ensure rigor and reproducibility within the field. Understanding and implementing these recommendations should be a top priority for investigators around the world.

Guidelines and best practices for assessing young children remotely.

Given the recent rise in the use of remote assessments to collect data from young children, researchers and practitioners would benefit from guidance on best practices within the field. Based on our experiences with assessing over 600 preschoolers remotely, our research team provides a set of main principles to guide professionals to successfully create and operationalize systems for remote assessment. Guidelines include detailed information about how to choose a technology platform, select and use online assessments, and how to adapt traditional tasks for remote use. We also note the challenges inherent in using certain types of tasks, provide tips for scheduling remote sessions, and offer advice for how to promote children's engagement throughout the assessment process.

Towards tailored guidelines for microbial air quality in the food industry.

Airborne microorganisms in food processing environments pose a potential risk for food product contamination. Yet, the absence of established standards or guidelines setting quantitative limits on airborne microorganisms underscores a critical gap in current regulatory frameworks. This review seeks to explore the feasibility of establishing quantitative limits for airborne microorganisms in food processing facilities, aiming to provide evidence-based guidance to enhance food safety practices in the industry. The review begins by addressing the complexities of microbial air quality in the food industry through a general literature search covering sources of airborne microorganisms, factors affecting particle deposition, air sampling methods and preventive measures. Subsequently, it employs a structured approach to assess the significance of air quality and its impact on product quality. Utilizing the PRISMA method, relevant scientific literature from May 2002 to May 2022 was examined, resulting in 26 articles meeting inclusion criteria from a pool of 11,737 original research papers. Additionally, the review investigates existing probability models for assessing airborne contamination to enhance air quality risk assessment in food safety management systems. The literature reveals a lack of substantial evidence supporting a direct correlation between airborne microorganisms and food contamination. The absence of standardized air sampling methodologies in previous studies hinders the comparability and reliability of research findings. Additionally, the literature fails to establish a conclusive relationship between influencing factors such as total particle counts, temperature, relative humidity and airborne contamination. Contradictory probability models for quantifying airborne contamination, and the absence of tailored preventive measures, hinder effective control and undermine microbial contamination control in diverse food processing contexts. In conclusion, the development of numeric guidelines for airborne contamination necessitates a tailored approach, considering factors such as product characteristics and production context. By integrating risk assessment models into this process, a more thorough comprehension of contamination risks can be achieved, providing tailored guidance based on the identified risk levels for each product. Ongoing collaborative efforts are essential to develop evidence-based guidelines that effectively mitigate risks without incurring unnecessary costs.

When boundaries benefit science and society.

In the rapidly moving field of stem cell and embryo research, research questions often sit at the intersection of scientific inquiry and ethical considerations. The International Society for Stem Cell Research (ISSCR) produces guidelines to help navigate decisions in this area. For Cell's 50th Anniversary Focus on Developmental Biology, scientific editor Sarah Geisler discussed the importance of the ISSCR guidelines on stem cell and embryo research for both the stem cell community and the broader public with Amander Clark, Robin Lovell-Badge, and Janet Rossant, who have been involved in the ongoing evolution of the guidelines. A lightly edited transcript of their conversation is shared here.

Research with Refugee Populations in North America: Applying the NIH Guiding Principles for Ethical Research.

This article examines the ethics of research design and the initiation of a study (e.g., recruitment of participants) involving refugee participants. We aim to equip investigators and members of IRBs with a set of ethical considerations and pragmatic recommendations to address challenges in refugee-focused research as it is developed and prepared for IRB review. We discuss challenges including how refugees are being defined and identified; their vulnerabilities before, during, and following resettlement that impacts their research participation; recruitment; consent practices including assent and unaccompanied minors; and conflicts of interest. Ethical guidance and regulatory oversight provided by international bodies, federal governments, and IRBs are important for enforcing the protection of participants. We describe the need for additional ethical guidance and awareness, if not special protections for refugee populations as guided by the National Institutes of Health (NIH) Guiding Principles for Ethical Research.

[Verification of Response Uncertainty in Electrometers through Cross-Comparison with a Novel Current Source: A Comparative Study with Guidelines for Electrometers Used in Radiation Therapy Dosimeters].

BACKGROUND: A new quality assurance and control method for electrometers using a new current source, different from the method published in the guidelines for electrometers, has been reported. This current source uses dry batteries and exhibits excellent performance in terms of voltage, temperature, and time characteristics. The electrometer sensitivity coefficient can be calculated by comparing the sensitivity of one electrometer with that of another on the electrometer calibration coefficient that has been calibrated by a calibration laboratory in advance in both methods. The guideline method requires two or more sets of ionization chambers and electrometers in the facility. In contrast, our method does not use ionization chambers; therefore, the sensitivity ratio of the electrometer can be measured in any facility. This study compared the uncertainty of the electrometer sensitivity factor calculated using the new current source method (current method) with that calculated using a linear accelerator (LINAC) and ionization chambers (LINAC method) described in the electrometer guidelines. METHOD: In this study, we used a current source that we invented previously by Kawaguchi Electric Works in Japan. The sensitivity ratios of the electrometers were measured with three manufacture's electrometers. The electrometer sensitivity factor was calculated by multiplying the electrometer calibration coefficient. The ionization chamber was 30013 (PTW), and the current source was the current obtained from 10 MV TrueBeam X-rays under calibration conditions. The mean value, standard deviation, and coefficient of variation were calculated. The time required to set up the ionization chamber for calculating the sensitivity ratio of the electrometer was also measured. The accuracy was confirmed by calculating the expanded uncertainty of the electrometer sensitivity coefficients. RESULTS: The LINAC method had a maximum coefficient of variation of 0.072%. The gross time of the LINAC method was approximately 110 min. The current method had a maximum coefficient of variation of 0.0055% and took less than half the time taken by the LINAC method (35 min) because there was no waiting time for the ionization chamber to be set up and the applied voltage to stabilize under calibration conditions. The expanded uncertainties of the electrometer calibration coefficients were 0.36% and 0.36%, respectively. CONCLUSION: The new cross-comparison method for electrometer sensitivity factors using a current source is more efficient and useful than the linear accelerator method described in the guidelines; furthermore, this method ensured accuracy for quality assurance and control of electrometers.

AI Through Ethical Lenses: A Discourse Analysis of Guidelines for AI in Healthcare.

While the technologies that enable Artificial Intelligence (AI) continue to advance rapidly, there are increasing promises regarding AI's beneficial outputs and concerns about the challenges of human-computer interaction in healthcare. To address these concerns, institutions have increasingly resorted to publishing AI guidelines for healthcare, aiming to align AI with ethical practices. However, guidelines as a form of written language can be analyzed to recognize the reciprocal links between its textual communication and underlying societal ideas. From this perspective, we conducted a discourse analysis to understand how these guidelines construct, articulate, and frame ethics for AI in healthcare. We included eight guidelines and identified three prevalent and interwoven discourses: (1) AI is unavoidable and desirable; (2) AI needs to be guided with (some forms of) principles (3) trust in AI is instrumental and primary. These discourses signal an over-spillage of technical ideals to AI ethics, such as over-optimism and resulting hyper-criticism. This research provides insights into the underlying ideas present in AI guidelines and how guidelines influence the practice and alignment of AI with ethical, legal, and societal values expected to shape AI in healthcare.

The 2024 French guidelines for scenario design in simulation-based education: manikin-based immersive simulation, simulated participant-based immersive simulation and procedural simulation.

BACKGROUND: Simulation-based education in healthcare encompasses a wide array of modalities aimed at providing realistic clinical experiences supported by meticulously designed scenarios. The French-speaking Society for Simulation in Healthcare (SoFraSimS) has developed guidelines to assist educators in the design of scenarios for manikin- or simulated participant- based immersive simulation and procedural simulation, the three mainly used modalities. METHODS: After establishing a French-speaking group of experts within the SoFraSimS network, we performed an extensive literature review with theory-informed practices and personal experiences. We used this approach identify the essential criteria for practice-based scenario design within the three simulation modalities. RESULTS: We present three comprehensive templates for creating innovative scenarios and simulation sessions, each tailored to the specific characteristics of a simulation modality. The SoFraSimS templates include five sections distributed between the three modalities. The first section contextualizes the scenario by describing the practicalities of the setting, the instructors and learners, and its connection to the educational program. The second section outlines the learning objectives. The third lists all the elements necessary during the preparation phase, describing the educational method used for procedural simulation (such as demonstration, discovery, mastery learning, and deliberate practice). The fourth section addresses the simulation phase, detailing the behaviors the instructor aims to analyze, the embedded triggers, and the anticipated impact on simulation proceedings (natural feedback). This ensures maximum control over the learning experience. Finally, the fifth section compiles elements for post-simulation modifications to enhance future iterations. CONCLUSION: We trust that these guidelines will prove valuable to educators seeking to implement simulation-based education and contribute to the standardization of scenarios for healthcare students and professionals. This standardization aims to facilitate communication, comparison of practices and collaboration across different learning and healthcare institutions.

'What this article adds'1. The SoFraSimS provides guidelines to facilitate the development of simulation-based activities.2. These guidelines are theory-informed as well as evidence and experience-based.3. A detailed approach to writing a complete activity or scenario for procedural and immersive simulation including manikins or simulated participants is provided (the 'SoFraSimS templates').4. This work aims at standardizing practices and exchanging scenarios between simulation centers.

A rapid review of guidelines on the involvement of adolescents in health research.

BACKGROUND: Meaningful involvement of adolescents in health research is their fundamental human right and has many benefits. A lack of awareness among researchers on how to meaningfully involve adolescents in health research has been linked to adolescent under involvement in health research. To address this barrier, studies have reported the need for more guidance. To inform the development of better guidelines on adolescent involvement, there is a need to first consolidate the currently available guidance on adolescent involvement in health research and to identify the gaps in these guidelines. This review aims to systematically identify all the currently available guidelines on adolescent involvement in health research and evaluate their scope, content, context, and quality. METHODS: This rapid review was pre-registered with PROSPERO #CRD42021293586. It included documents that incorporated tangible recommendations on the involvement of adolescents in health research. We searched six databases for peer-reviewed literature: MEDLINE, CINAHL, Embase, Scopus, Web of Science, and ERIC. We conducted a grey literature search in Google Scholar, Google, websites of 472 relevant organisations and sought expert input. The quality of the guidelines was assessed using the Appraisal of Guidelines for REsearch & Evaluation (AGREE-II) Instrument. Data was analysed using descriptive analyses and narrative synthesis. RESULTS: We found that the current guidelines on adolescent involvement in health research are often narrow in scope, targeting specific users and populations while focusing on limited research areas. The guidelines individually fail to provide comprehensive coverage of recommendations across all topics related to adolescent research involvement, that are collectively addressed across all included guidelines. Furthermore, these guidelines tend to be context-specific and are generally of low quality, often due to inadequate stakeholder involvement and a lack of rigorous development methods. CONCLUSION: This review provides a consolidated list of guidelines on adolescent involvement in health research along with their quality scores as a resource for researchers to select the guidelines suitable for their research topic, context, and scope for adolescent involvement. There is a need to develop a set of guidelines on adolescent involvement in research, which are comprehensive in scope, cover all key aspects of adolescent involvement in health research, can be adapted for different contexts, and which are based on rigorous and systematic methods. PATIENT AND PUBLIC INVOLVEMENT: Adolescent co-researchers D. B. and C. W. were involved at different stages of the review process. D. B. screened 25% of the peer-reviewed articles at the title and abstract screening stage and 10% at full-text screening stage. C. W. extracted data from 10% of the included guidelines. Both co-researchers reviewed and shared their feedback on the article and are co-authors on this paper. They will also be invited to contribute to further dissemination of the findings from this review.