OBJECTIVE: Pharmacopoeias regulate the manufacture of potentised pharmaceutical preparations used in different branches of complementary and integrative medicine. The physicochemical properties and biological activity of these preparations are often investigated in preclinical research, yet no guidelines for experimental research currently exist in this area. The present PrePoP guidelines aim to provide recommendations to promote high-quality, statistically sound, and reproducible preclinical research on potentised preparations.
METHODS: Input was gathered from researchers nominated by the relevant scientific societies using a simplified Delphi consensus approach covering the most relevant aspects of basic research methodology in the field including appropriate controls, sample preparation and handling, and statistics. After three rounds of feedback, a consensus was finally reached on the most important aspects and considerations for conducting high-quality research on potentised preparations.
RESULTS: We present a series of recommendations on a range of topics including experimental controls, system stability, blinding and randomisation, environmental influences, and procedures for the preparation of potentised samples and controls, and we address some specific challenges of this research field.
CONCLUSIONS: This expert consensus process resulted in a robust set of methodological guidelines for research on potentised preparations and provides a valuable framework that will inform and improve the quality of subsequent research in this emerging field.
UNASSIGNED: Tournier AL, Bonamin LV, Buchheim-Schmidt S, Cartwright S, Dombrowsky C, Doesburg P, Holandino C, Kokornaczyk MO, van de Kraats EB, López-Carvallo JA, Nandy P, Mazón-Suástegui JM, Mirzajani F, Poitevin B, Scherr C, Thieves K, Würtenberger S, Baumgartner S. Scientific guidelines for preclinical research on potentised preparations manufactured according to current pharmacopoeias-the PrePoP guidelines. J Integr Med. 2024; Epub ahead of print.

As the informatics community grows in its ability to address health disparities, there is an opportunity to expand our impact by focusing on the disability community as a health disparity population. Although informaticians have primarily catered design efforts to one disability at a time, digital health technologies can be enhanced by approaching disability from a more holistic framework, simultaneously accounting for multiple forms of disability and the ways disability intersects with other forms of identity. The urgency of moving toward this more holistic approach is grounded in ethical, legal, and design-related rationales. Shaped by our research and advocacy with the disability community, we offer a set of guidelines for effective engagement. We argue that such engagement is critical to creating digital health technologies which more fully meet the needs of all disabled individuals.

BACKGROUND: To the best of our knowledge, there are no reporting guidelines for design, conduct and reporting of Finite Element studies in health sciences. We intend to propose specific and detailed guidelines for reporting these studies.
METHODS: After recognizing the need to have uniform guidelines for reporting of finite element analysis in medicine and dentistry, a group of 5 researchers working on FEA as their research area met in the summer of 2020 and drafted the methodology for the development of such guidelines. Each researcher individually made a list of major headings required for reporting these studies and met again in September 2020 to finalize the domains. Subsequently, sub headings and details were charted. The draft list of items for reporting the guidelines were presented to a larger team of 15 experts and some changes were further made based on their inputs.
RESULTS: The guidelines entail seven major domains and their sub-domains, including parameters for model structure, segmentation, mesh structure, force application and model validation, etc. This checklist aims to improvise the reporting and consistency of FEA studies.
CONCLUSIONS: We hope that the usage and adoption of these guidelines by the scientific community would result in more thoughtful and uniform documentation. Also, the confidence in the results would be enhanced through model reproducibility, reusability and accountability. The proposed guidelines were named as \'Reporting of in-silico studies using finite element analysis in medicine\' and the term \'RIFEM\' was used as acronym.

Progress in gene-drive research has stimulated discussion and debate on ethical issues including community engagement and consent, policy and governance, and decision-making involved in development and deployment. Many organizations, academic institutions, foundations, and individual professionals have contributed to ensuring that these issues are considered prior to the application of gene-drive technology. Central topics include co-development of the technology with local stakeholders and communities and reducing asymmetry between developers and end-users. Important questions include with whom to conduct engagement and how to define community acceptance, develop capacity-building activities, and regulate this technology. Experts, academics, and funders have suggested that global frameworks, standards, and guidelines be developed to direct research in answering these important questions. Additionally, it has been suggested that ethical principles or commitments be established to further guide research practices. The challenging and interesting contradiction that we explore here is that the vast majority of these conversations transpire with little or no input from potential end-users or stakeholders who, we contend, should ultimately determine the fate of the technology in their communities. The question arises, whose concerns regarding marginalization, disempowerment, and inequity should be included in discussions and decisions concerning how inequities are perceived and how they may be addressed? At what stage will true co-development occur and how will opinions, perspectives and knowledge held by low-income country stakeholders be applied in determining answers to the questions regarding the ethics being debated on the academic stage? Our opinion is that the time is now.

A well-documented method and experimental design are essential to ensure the reproducibility and reliability in animal research. Experimental studies using exercise programs in animal models have experienced an exponential increase in the last decades. Complete reporting of forced wheel and treadmill exercise protocols would help to ensure the reproducibility of training programs. However, forced exercise programs are characterized by a poorly detailed methodology. Also, current guidelines do not cover the minimum data that must be included in published works to reproduce training programs. For this reason, we have carried out a systematic review to determine the reproducibility of training programs and experimental designs of published research in rodents using a forced wheel system. Having determined that most of the studies were not detailed enough to be reproducible, we have suggested guidelines for animal research using FORCED exercise wheels, which could also be applicable to any form of forced exercise.

In March 2019, SmartTots, a public-private partnership between the US Food and Drug Administration and the International Anesthesia Research Society, hosted a meeting attended by research experts, anaesthesia journal editors, and government agency representatives to discuss the continued need for rigorous preclinical research and the importance of establishing reporting standards for the field of anaesthetic perinatal neurotoxicity. This group affirmed the importance of preclinical research in the field, and welcomed novel and mechanistic approaches to answer some of the field\'s largest questions. The attendees concluded that summarising the benefits and disadvantages of specific model systems, and providing guidance for reporting results, would be helpful for designing new experiments and interpreting results across laboratories. This expert opinion report is a summary of these discussions, and includes a focused review of current animal models and reporting standards for the field of perinatal anaesthetic neurotoxicity. This will serve as a practical guide and road map for novel and rigorous experimental work.

This review article highlights the current state of perinatal depression (PND) research including established standards of care and innovative research in progress. PND can have a significant adverse impact on mother, child, and family; however, to date, wide-scale identification, prevention, and treatment have been limited. PND is heterogenous in presentation with likely multifactorial etiologies for each woman. Challenges in PND research are discussed including a need for universal tools, standardized measures, benchmarks, and best practices. Current examples are reviewed that highlight approaches to novel treatment paradigms and interventions. This includes reviewing epidemiologic studies in PND research, examining the biological underpinnings of PND, and discussing examples from this field and other fields currently developing translational research that spans from bench to bedside. Current and future challenges and opportunities in developing best practices for the treatment of PND are outlined. We also discuss the use of the NIMH Research Domain Criteria approach for PND research and provide recommendations for future directions in PND research collaboration. In conclusion, greater precision in perinatal psychiatry can be possible in the future with the development of guidelines and best practices that build on current work and apply innovative and collaborative approaches of scientists, providers, patients, community members, and government officials.

BACKGROUND: Translational neuroscience is largely concerned with establishing causal links between biological processes and functional outcomes. Exciting new methods have emerged and top-tier biomedical journals are placing increasingly high demand for experiments that link outcomes. One pitfall to making these connections is the \"ecological fallacy\"-establishing a relationship between outcomes based on aggregate (averaged) results (a distinct issue from correlation vs causation).
METHODS: To showcase the ecological fallacy, we first used simulated data to define and demonstrate the problem. Next, we performed a systematic review to determine the prevalence of the fallacy in top-tier biomedical journals (Science, Nature Medicine, Neuron, Nature, Nature Neuroscience, Cell). Based on our own research interests and specializations, we specifically focused on recent publications in the area of spinal cord injury and regenerative medicine.
RESULTS: Of the articles reviewed which examined a relationship between central nervous system regeneration and a behavioural outcome, 100% (21/21) were subject to possible ecological fallacy.
CONCLUSIONS: Ecological fallacy is highly prevalent in neuroscience research and could partially account for translation failures in this field. Reporting guidelines for in vivo experiments should include subject-level correlation analyses for the primary outcomes.

OBJECTIVE: To analyze the robustness of randomized controlled trials (RCTs) referenced in the American Diabetes Association\'s Standards of Medical Care in Diabetes-2017 using the Fragility Index (FI) and Fragility Quotient (FQ).
METHODS: We performed a systematic survey of all RCTs referenced in the Standards of Medical Care in Diabetes-2017. One investigator screened for trials and then recorded data from them, including sample size per group, event rate per group, and the dichotomous outcome analyzed by trialists. The FI and FQ for each outcome were calculated. Outcomes were then surveyed to determine whether the outcome used for analysis aligned with the guideline recommendation.
RESULTS: Thirty-five RCTs were included in this study. Thirty-three of 35 (94%) FIs were based on the trial outcomes referenced in the clinical practice guideline. The median sample size was 2548 participants ([IQR], 522-6946). The median total number of events for each outcome was 403 (IQR, 86-969). Nineteen (54%) P Values were below 0.05, 8 (22.4%) were below 0.01. The median FI for all trials was 16 (IQR, 4-29). The median FQ was 0.007 (IQR, 0.003-0.014). FI was not related to risk of bias or Science Citation Index but was significantly correlated with sample size (for significant trials; r=0.77, P < .001, for neutral trials; r=0.76, P < .001).
CONCLUSIONS: We found that the robustness of RCTs varied, but on the whole were not robust in nature. Most trials demonstrated a modest FI and FQ. As a result, conclusions drawn from these trials should take this information into account.

The ethical conduct of research includes, in part, patient agreement to participate in studies and the protection of health information. In the evolving world of data science and the accessibility of large quantities of web-based data created by millions of individuals, novel methodologic approaches to answering research questions are emerging. This article explores research ethics in the context of big data.