The 5D Framework: A Clinical Primer for Fecal Microbiota Transplantation to Treat Clostridium difficile infection

Clostridium difficile infection is the most common health care–associated infection in the United States. Recently, fecal microbiota transplantation (FMT) has emerged as an effective and safe therapy for recurrent C difficile infection; however, despite rapid adoption there is no standardized clinical approach. Given the rapid adoption of FMT, in part because of stool banks, there is a need for a practical primer for clinicians to safely perform FMT. Accordingly, we aim to provide a simple approach entitled the 5D FMT framework to guide physicians. The 5D FMT framework includes: decision (selecting appropriate patient for FMT), donor (selection and screening), discussion (risk, benefits, alternatives), delivery (selecting appropriate modality for FMT administration), and discharge (counseling at discharge and follow-up). We aim to help clinicians take a simple but evidence-based approach to FMT to optimize efficacy and safety. This primer navigates how to decide whether a patient with C difficile infection is appropriate for FMT and how to select and screen stool donors, identify the ideal delivery modality, and provide follow-up care after FMT

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent

Introduction: The updated common rule, for human subjects research, requires that consents begin with a \u27concise and focused\u27 presentation of the key information that will most likely help someone make a decision about whether to participate in a study (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613-615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377-381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant\u27s race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, and Neonatal Nursing. 2018; 47(4): 529-534.). Methods: We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information. Results: The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. Conclusions: Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process

The TRENDS High-contrast Imaging Survey. I. Three Benchmark M Dwarfs Orbiting Solar-type Stars

We present initial results from a new high-contrast imaging program dedicated to stars that exhibit long-term Doppler radial velocity accelerations (or "trends"). The goal of the TRENDS (TaRgetting bENchmark-objects with Doppler Spectroscopy) imaging survey is to directly detect and study the companions responsible for accelerating their host star. In this first paper of the series, we report the discovery of low-mass stellar companions orbiting HD 53665, HD 68017, and HD 71881 using NIRC2 adaptive optics (AO) observations at Keck. Follow-up imaging demonstrates association through common proper motion. These comoving companions have red colors with estimated spectral types of K7-M0, M5, and M3-M4, respectively. We determine a firm lower limit to their mass from Doppler and astrometric measurements. In the near future, it will be possible to construct three-dimensional orbits and calculate the dynamical mass of HD 68017 B and possibly HD 71881 B. We already detect astrometric orbital motion of HD 68017 B, which has a projected separation of 13.0 AU. Each companion is amenable to AO-assisted direct spectroscopy. Further, each companion orbits a solar-type star, making it possible to infer metallicity and age from the primary. Such benchmark objects are essential for testing theoretical models of cool dwarf atmospheres

Simulation-based power and sample size calculation for designing interrupted time series analyses of count outcomes in evaluation of health policy interventions

Objective: The purpose of this study was to present the design, model, and data analysis of an interrupted time series (ITS) model applied to evaluate the impact of health policy, systems, or environmental interventions using count outcomes. Simulation methods were used to conduct power and sample size calculations for these studies. Methods: We proposed the models and analyses of ITS designs for count outcomes using the Strengthening Translational Research in Diverse Enrollment (STRIDE) study as an example. The models we used were observation-driven models, which bundle a lagged term on the conditional mean of the outcome for a time series of count outcomes. Results: A simulation-based approach with ready-to-use computer programs was developed to calculate the sample size and power of two types of ITS models, Poisson and negative binomial, for count outcomes. Simulations were conducted to estimate the power of segmented autoregressive (AR) error models when autocorrelation ranged from -0.9 to 0.9, with various effect sizes. The power to detect the same magnitude of parameters varied largely, depending on the testing level change, the trend change, or both. The relationships between power and sample size and the values of the parameters were different between the two models. Conclusion: This article provides a convenient tool to allow investigators to generate sample sizes that will ensure sufficient statistical power when the ITS study design of count outcomes is implemented

Predicting functional responses in agro-ecosystems from animal movement data to improve management of invasive pests

Functional responses describe how changing resource availability affects con- sumer resource use, thus providing a mechanistic approach to prediction of the invasibility and potential damage of invasive alien species (IAS). However, functional responses can be context dependent, varying with resource characteristics and availability, consumer attributes, and environmental variables. Identifying context dependencies can allow invasion and damage risk to be predicted across different ecoregions. Understanding how ecological factors shape the functional response in agro-ecosystems can improve predictions of hotspots of highest impact and inform strategies to mitigate damage across locations with varying crop types and avail- ability. We linked heterogeneous movement data across different agro-ecosystems to predict ecologically driven variability in the functional responses. We applied our approach to wild pigs (Sus scrofa), one of the most successful and detrimental IAS worldwide where agricultural resource depredation is an important driver of spread and establishment. We used continental- scale movement data within agro-ecosystems to quantify the functional response of agricul- tural resources relative to availability of crops and natural forage. We hypothesized that wild pigs would selectively use crops more often when natural forage resources were low. We also examined how individual attributes such as sex, crop type, and resource stimulus such as dis- tance to crops altered the magnitude of the functional response. There was a strong agricul- tural functional response where crop use was an accelerating function of crop availability at low density (Type III) and was highly context dependent. As hypothesized, there was a reduced response of crop use with increasing crop availability when non-agricultural resources were more available, emphasizing that crop damage levels are likely to be highly heterogeneous depending on surrounding natural resources and temporal availability of crops. We found sig- nificant effects of crop type and sex, with males spending 20% more time and visiting crops 58% more often than females, and both sexes showing different functional responses depend- ing on crop type. Our application demonstrates how commonly collected animal movement data can be used to understand context dependencies in resource use to improve our under- standing of pest foraging behavior, with implications for prioritizing spatiotemporal hotspots of potential economic loss in agro-ecosystems

SARS-CoV-2 vaccines and donor recruitment for FMT

Non peer reviewe

Long-term ecological research on Colorado Shortgrass Steppe

The SGS-LTER research site was established in 1980 by researchers at Colorado State University as part of a network of long-term research sites within the US LTER Network, supported by the National Science Foundation. Scientists within the Natural Resource Ecology Lab, Department of Forest and Rangeland Stewardship, Department of Soil and Crop Sciences, and Biology Department at CSU, California State Fullerton, USDA Agricultural Research Service, University of Northern Colorado, and the University of Wyoming, among others, have contributed to our understanding of the structure and functions of the shortgrass steppe and other diverse ecosystems across the network while maintaining a common mission and sharing expertise, data and infrastructure.Poster presented at the LTER All Scientists Meeting held in Estes Park, CO on September 10-13, 2012

International consensus conference on stool banking for faecal microbiota transplantation in clinical practice

Although faecal microbiota transplantation (FMT) has a well-established role in the treatment of recurrent Clostridioides difficile infection (CDI), its widespread dissemination is limited by several obstacles, including lack of dedicated centres, difficulties with donor recruitment and complexities related to regulation and safety monitoring. Given the considerable burden of CDI on global healthcare systems, FMT should be widely available to most centres. Stool banks may guarantee reliable, timely and equitable access to FMT for patients and a traceable workflow that ensures safety and quality of procedures. In this consensus project, FMT experts from Europe, North America and Australia gathered and released statements on the following issues related to the stool banking: general principles, objectives and organisation of the stool bank; selection and screening of donors; collection, preparation and storage of faeces; services and clients; registries, monitoring of outcomes and ethical issues; and the evolving role of FMT in clinical practice, Consensus on each statement was achieved through a Delphi process and then in a plenary face-to-face meeting. For each key issue, the best available evidence was assessed, with the aim of providing guidance for the development of stool banks in order to promote accessibility to FMT in clinical practice.Peer reviewe

Physicians' experiences with end-of-life decision-making: Survey in 6 European countries and Australia

Background: In this study we investigated (a) to what extent physicians have experience with performing a range of end-of-life decisions (ELDs), (b) if they have no experience with performing an ELD, would they be willing to do so under certain conditions and (c) which background characteristics are associated with having experience with/or being willing to make such ELDs. Methods: An anonymous questionnaire was sent to 16,486 physicians from specialities in which death is common: Australia, Belgium, Denmark, Italy, the Netherlands, Sweden and Switzerland. Results: The response rate differed between countries (39–68%). The experience of foregoing life-sustaining treatment ranged between 37% and 86%: intensifying the alleviation of pain or other symptoms while taking into account possible hastening of death between 57% and 95%, and experience with deep sedation until death between 12% and 46%. Receiving a request for hastening death differed between 34% and 71%, and intentionally hastening death on the explicit request of a patient between 1% and 56%. Conclusion: There are differences between countries in experiences with ELDs, in willingness to perform ELDs and in receiving requests for euthanasia or physician-assisted suicide. Foregoing treatment and intensifying alleviation of pain and symptoms are practiced and accepted by most physicians in all countries. Physicians with training in palliative care are more inclined to perform ELDs, as are those who attend to higher numbers of terminal patients. Thus, this seems not to be only a matter of opportunity, but also a matter of attitude

Reorganisation of faecal microbiota transplant services during the COVID-19 pandemic

The COVID-19 pandemic has led to an exponential increase in SARS-CoV- 2 infections and associated deaths, and represents a significant challenge to healthcare professionals and facilities. Individual countries have taken several prevention and containment actions to control the spread of infection, including measures to guarantee safety of both healthcare professionals and patients who are at increased risk of infection from COVID-19. Faecal microbiota transplantation (FMT) has a well-established role in the treatment of Clostridioides difficile infection. In the time of the pandemic, FMT centres and stool banks are required to adopt a workflow that continues to ensure reliable patient access to FMT while maintaining safety and quality of procedures. In this position paper, based on the best available evidence, worldwide FMT experts provide guidance on issues relating to the impact of COVID-19 on FMT, including patient selection, donor recruitment and selection, stool manufacturing, FMT procedures, patient follow-up and research activities