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.

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.

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.

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.

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.

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.

Data Harmonization Guidelines to Combine Multi-platform Genomic Data from Admixed Populations and Boost Power in Genome-Wide Association Studies.

Data harmonization involves combining data from multiple independent sources and processing the data to produce one uniform dataset. Merging separate genotypes or whole-genome sequencing datasets has been proposed as a strategy to increase the statistical power of association tests by increasing the effective sample size. However, data harmonization is not a widely adopted strategy due to the difficulties with merging data (including confounding produced by batch effects and population stratification). Detailed data harmonization protocols are scarce and are often conflicting. Moreover, data harmonization protocols that accommodate samples of admixed ancestry are practically non-existent. Existing data harmonization procedures must be modified to ensure the heterogeneous ancestry of admixed individuals is incorporated into additional downstream analyses without confounding results. Here, we propose a set of guidelines for merging multi-platform genetic data from admixed samples that can be adopted by any investigator with elementary bioinformatics experience. We have applied these guidelines to aggregate 1544 tuberculosis (TB) case-control samples from six separate in-house datasets and conducted a genome-wide association study (GWAS) of TB susceptibility. The GWAS performed on the merged dataset had improved power over analyzing the datasets individually and produced summary statistics free from bias introduced by batch effects and population stratification. © 2024 Wiley Periodicals LLC. Basic Protocol 1: Processing separate datasets comprising array genotype data Alternate Protocol 1: Processing separate datasets comprising array genotype and whole-genome sequencing data Alternate Protocol 2: Performing imputation using a local reference panel Basic Protocol 2: Merging separate datasets Basic Protocol 3: Ancestry inference using ADMIXTURE and RFMix Basic Protocol 4: Batch effect correction using pseudo-case-control comparisons.

A practical guide for writing a PhD thesis.

There is an increasing number of PhD students in health sciences, but no formal reporting guideline for writing a thesis exists. This review provides a practical guide with an overview of the article-based/synopsis PhD thesis that consists of eight parts: 1) initial formalities, 2) introduction, 3) methodological considerations, 4) study presentations, 5) discussion, 6) conclusion, 7) perspectives, and 8) concluding formalities. It is elaborated with detailed information, practical advice, and a template, so the thesis complies with the demands of the Danish Graduate Schools of Health Sciences.

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.

Protocol for the development of a reporting guideline for umbrella reviews on epidemiological associations using cross-sectional, case-control and cohort studies: the Preferred Reporting Items for Umbrella Reviews of Cross-sectional, Case-control and Cohort studies (PRIUR-CCC).

INTRODUCTION: Observational studies are fraught with several biases including reverse causation and residual confounding. Overview of reviews of observational studies (ie, umbrella reviews) synthesise systematic reviews with or without meta-analyses of cross-sectional, case-control and cohort studies, and may also aid in the grading of the credibility of reported associations. The number of published umbrella reviews has been increasing. Recently, a reporting guideline for overviews of reviews of healthcare interventions (Preferred Reporting Items for Overviews of Reviews (PRIOR)) was published, but the field lacks reporting guidelines for umbrella reviews of observational studies. Our aim is to develop a reporting guideline for umbrella reviews on cross-sectional, case-control and cohort studies assessing epidemiological associations. METHODS AND ANALYSIS: We will adhere to established guidance and prepare a PRIOR extension for systematic reviews of cross-sectional, case-control and cohort studies testing epidemiological associations between an exposure and an outcome, namely Preferred Reporting Items for Umbrella Reviews of Cross-sectional, Case-control and Cohort studies (PRIUR-CCC). Step 1 will be the project launch to identify stakeholders. Step 2 will be a literature review of available guidance to conduct umbrella reviews. Step 3 will be an online Delphi study sampling 100 participants among authors and editors of umbrella reviews. Step 4 will encompass the finalisation of PRIUR-CCC statement, including a checklist, a flow diagram, explanation and elaboration document. Deliverables will be (i) identifying stakeholders to involve according to relevant expertise and end-user groups, with an equity, diversity and inclusion lens; (ii) completing a narrative review of methodological guidance on how to conduct umbrella reviews, a narrative review of methodology and reporting in published umbrella reviews and preparing an initial PRIUR-CCC checklist for Delphi study round 1; (iii) preparing a PRIUR-CCC checklist with guidance after Delphi study; (iv) publishing and disseminating PRIUR-CCC statement. ETHICS AND DISSEMINATION: PRIUR-CCC has been approved by The Ottawa Health Science Network Research Ethics Board and has obtained consent (20220639-01H). Participants to step 3 will give informed consent. PRIUR-CCC steps will be published in a peer-reviewed journal and will guide reporting of umbrella reviews on epidemiological associations.

[Scientific, transparent and applicable rankings of Chinese pathological guidelines and consensus published in the medical journals in 2022].

The STAR tool was used to evaluate and analyze the science, transparency, and applicability of Chinese pathology guidelines and consensus published in medical journals in 2022. There were a total of 18 pathology guidelines and consensuses published in 2022, including 1 guideline and 17 consensuses. The results showed that the guideline score was 21.83 points, lower than the overall guideline average (43.4 points). Consensus ratings scored an average of 27.87 points, on par with the overall consensus level (28.3 points). Areas that scored above the overall level were "conflict of interest" and "working groups", while areas that scored below the overall level were "proposals", "funding", "evidence", "consensus approaches" and "accessibility". To sum up, the formulation of pathology guidelines and consensuses in 2022 is not standardized, and the evidence retrieval process, evidence evaluation methods and grading criteria for recommendations on clinical issues are not provided in the formulation process; the process and method for reaching consensus are not provided, the plan is lacking, and registration is not carried out. It is therefore suggested that guidelines/consensus makers in the field of pathology should attach importance to evidence-based medical evidence, strictly follow guideline formulation methods and processes, further improve the scientific, applicable and transparent guidelines/consensuses in the field, and better provide support for clinicians and patients.

What guidance exists to support patient partner compensation practices? A scoping review of available policies and guidelines.

BACKGROUND: An integral aspect of patient engagement in research, also known as patient and public involvement, is appropriately recognising patient partners for their contributions through compensation (e.g., coauthorship, honoraria). Despite known benefits to compensating patient partners, our previous work suggested compensation is rarely reported and researchers perceive a lack of guidance on this issue. To address this gap, we identified and summarised available guidance and policy documents for patient partner compensation. METHODS: We conducted this scoping review in accordance with methods suggested by the JBI. We searched the grey literature (Google, Google Scholar) in March 2022 and Overton (an international database of policy documents) in April 2022. We included articles, guidance or policy documents regarding the compensation of patient partners for their research contributions. Two reviewers independently extracted and synthesised document characteristics and recommendations. RESULTS: We identified 65 guidance or policy documents. Most documents were published in Canada (57%, n = 37) or the United Kingdom (26%, n = 17). The most common recommended methods of nonfinancial compensation were offering training opportunities to patient partners (40%, n = 26) and facilitating patient partner attendance at conferences (38%, n = 25). The majority of guidance documents (95%) suggested financially compensating (i.e., offering something of monetary value) patient partners for their research contributions. Across guidance documents, the recommended monetary value of financial compensation was relatively consistent and associated with the role played by patient partners and/or specific engagement activities. For instance, the median monetary value for obtaining patient partner feedback (i.e., consultation) was $19/h (USD) (range of $12-$50/h). We identified several documents that guide the compensation of specific populations, including youth and Indigenous peoples. CONCLUSION: Multiple publicly available resources exist to guide researchers, patient partners and institutions in developing tailored patient partner compensation strategies. Our findings challenge the perception that a lack of guidance hinders patient partner financial compensation. Future efforts should prioritise the effective implementation of these compensation strategies to ensure that patient partners are appropriately recognised. PATIENT OR PUBLIC CONTRIBUTIONS: The patient partner coauthor informed protocol development, identified data items, and interpreted findings.