This paper discusses the application of a class of Rasch models to situations where test items are grouped into subsets and the common attributes of items within these subsets brings into question the usual assumption of conditional independence. The models are all expressed as particular cases of the random coefficients multinomial logit model developed by Adams and Wilson. This formulation allows a very flexible approach to the specification of alternative models, and makes model testing particularly straightforward. The use of the models is illustrated using item bundles constructed in the framework of the SOLO taxonomy of Biggs and Collis.

This study estimated the treatment cost of pediatric abdominal tuberculosis that potentially needs surgical treatment in India. Data were collected from 38 in-patient children at Christian Medical Hospital, Ludhiana as part of a clinical study conducted to establish the patterns of presentation and outcomes of abdominal tuberculosis in an Indian setting. A bottom-up approach was used to estimate the costs from a healthcare provider perspective, and a generalized linear model (GLM) was run to find variables that had an impact on the costs. Costs were reported in international dollars ($) and India Rupees (INR). The results show that the average direct cost was $3095.00 (standard deviation [SD]: 3480.82) or 68,065.13 INR (SD: 76,539.69). The GLM results established that duration of treatment and surgical treatment were significantly associated with higher costs. Efforts of eliminating the condition should be strengthened.

Background: Burkholderia multivorans are gram-negative bacteria typically found in water and soil. B. multivorans outbreaks among patients without cystic fibrosis have been associated with exposure to contaminated medical devices or nonsterile aqueous products. Acquisition can also occur from exposure to environmental reservoirs like sinks or other hospital water sources. We describe an outbreak of B. multivorans among hospitalized patients without cystic fibrosis at 2 hospitals within the same healthcare system in California (hospitals A and B) between August 2021 and July 2022. Methods: We defined confirmed case patients as patients without cystic fibrosis hospitalized at hospital A or hospital B between January 2020 to July 2022 with B. multivorans isolated from any body site matching the outbreak strain. We reviewed medical records to describe case patients and to identify common exposures. We evaluated infection control practices and interviewed staff to detect exposures to nonsterile water. Select samples from water, ice, drains, and sink splash zone surfaces were collected and cultured for B. multivorans in March 2022 and July 2022 from both hospitals. Common aqueous products used among case patients were tested for B. multivorans. Genetic relatedness between clinical and environmental samples was determined using random amplified polymorphic DNA (RAPD) and repetitive extragenic palindromic polymerase chain reaction (Rep-PCR). Results: We identified 23 confirmed case patients; 20 (87%) of these were identified at an intensive care unit (ICU) in hospital A. B. multivorans was isolated from respiratory sources in 18 cases (78%). We observed medication preparation items, gloves, and patient care items stored within sink splash zones in ICU medication preparation rooms and patient rooms. Nonsterile water and ice were used for bed baths, swallow evaluations, and ice packs. B. multivorans was cultured from ice and water dispensed from an 11-year-old ice machine in the ICU at hospital A in March 2022 but no other water sources. Additional testing in July 2022 yielded B. multivorans from ice and a drain pan from a new ice machine in the same ICU location at hospital A. All products were negative. Clinical and environmental isolates were the same strain by RAPD and Rep-PCR. Conclusions: The use of nonsterile water and ice from a contaminated ice machine contributed to this outbreak. Water-related fixtures can serve as reservoirs for Burkholderia, posing infection risk to hospitalized and immunocompromised patients. During outbreaks of water-related organisms, such as B. multivorans , nonsterile water and ice use should be investigated as potential sources of transmission and other options should be considered, especially for critically ill patients.

Disclosures: None

Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and industry. A broad spectrum of studies use real-world data (RWD) to produce RWE, ranging from randomized trials with outcomes assessed using RWD to fully observational studies. Yet, many proposals for generating RWE lack sufficient detail, and many analyses of RWD suffer from implausible assumptions, other methodological flaws, or inappropriate interpretations. The Causal Roadmap is an explicit, itemized, iterative process that guides investigators to prespecify study design and analysis plans; it addresses a wide range of guidance within a single framework. By supporting the transparent evaluation of causal assumptions and facilitating objective comparisons of design and analysis choices based on prespecified criteria, the Roadmap can help investigators to evaluate the quality of evidence that a given study is likely to produce, specify a study to generate high-quality RWE, and communicate effectively with regulatory agencies and other stakeholders. This paper aims to disseminate and extend the Causal Roadmap framework for use by clinical and translational researchers; three companion papers demonstrate applications of the Causal Roadmap for specific use cases.

All levels of government are authorized to apply coronavirus disease 2019 (COVID-19) protection measures; however, they must consider how and when to ease lockdown restrictions to limit long-term societal harm and societal instability. Leaders that use a well-considered framework with an incremental approach will be able to gradually restart society while simultaneously maintaining the public health benefits achieved through lockdown measures. Economically vulnerable populations cannot endure long-term lockdown, and most countries lack the ability to maintain a full nationwide relief operation. Decision-makers need to understand this risk and how the Maslow hierarchy of needs and the social determinants of health can guide whole of society policies. Aligning decisions with societal needs will help ensure all segments of society are catered to and met while managing the crisis. This must inform the process of incremental easing of lockdowns to facilitate the resumption of community foundations, such as commerce, education, and employment in a manner that protects those most vulnerable to COVID-19. This study proposes a framework for identifying a path forward. It reflects on baseline requirements, regulations and recommendations, triggers, and implementation. Those desiring a successful recovery from the COVID-19 pandemic need to adopt an evidence-based framework now to ensure community stabilization and sustainability.

Seven half-day regional listening sessions were held between December 2016 and April 2017 with groups of diverse stakeholders on the issues and potential solutions for herbicide-resistance management. The objective of the listening sessions was to connect with stakeholders and hear their challenges and recommendations for addressing herbicide resistance. The coordinating team hired Strategic Conservation Solutions, LLC, to facilitate all the sessions. They and the coordinating team used in-person meetings, teleconferences, and email to communicate and coordinate the activities leading up to each regional listening session. The agenda was the same across all sessions and included small-group discussions followed by reporting to the full group for discussion. The planning process was the same across all the sessions, although the selection of venue, time of day, and stakeholder participants differed to accommodate the differences among regions. The listening-session format required a great deal of work and flexibility on the part of the coordinating team and regional coordinators. Overall, the participant evaluations from the sessions were positive, with participants expressing appreciation that they were asked for their thoughts on the subject of herbicide resistance. This paper details the methods and processes used to conduct these regional listening sessions and provides an assessment of the strengths and limitations of those processes.

Herbicide resistance is ‘wicked’ in nature; therefore, results of the many educational efforts to encourage diversification of weed control practices in the United States have been mixed. It is clear that we do not sufficiently understand the totality of the grassroots obstacles, concerns, challenges, and specific solutions needed for varied crop production systems. Weed management issues and solutions vary with such variables as management styles, regions, cropping systems, and available or affordable technologies. Therefore, to help the weed science community better understand the needs and ideas of those directly dealing with herbicide resistance, seven half-day regional listening sessions were held across the United States between December 2016 and April 2017 with groups of diverse stakeholders on the issues and potential solutions for herbicide resistance management. The major goals of the sessions were to gain an understanding of stakeholders and their goals and concerns related to herbicide resistance management, to become familiar with regional differences, and to identify decision maker needs to address herbicide resistance. The messages shared by listening-session participants could be summarized by six themes: we need new herbicides; there is no need for more regulation; there is a need for more education, especially for others who were not present; diversity is hard; the agricultural economy makes it difficult to make changes; and we are aware of herbicide resistance but are managing it. The authors concluded that more work is needed to bring a community-wide, interdisciplinary approach to understanding the complexity of managing weeds within the context of the whole farm operation and for communicating the need to address herbicide resistance.

The appeal of ketamine – in promptly ameliorating depressive symptoms even in those with non-response – has led to a dramatic increase in its off-label use. Initial promising results await robust corroboration and key questions remain, particularly concerning its long-term administration. It is, therefore, timely to review the opinions of mood disorder experts worldwide pertaining to ketamine's potential as an option for treating depression and provide a synthesis of perspectives – derived from evidence and clinical experience – and to consider strategies for future investigations.

Economists and others need estimates of future cash price volatility to use in risk management evaluation and education programs. This paper evaluates the performance of alternative volatility forecasts for fed cattle, feeder cattle, and corn cash price returns. Forecasts include time series (e.g. GARCH), implied volatility from options on futures contracts, and composite specifications. The overriding finding from this research, consistent with the existing volatility forecasting literature, is that no single method of volatility forecasting provides superior accuracy across alternative data sets and horizons. However, evidence is provided suggesting that risk managers and extension educators use composite methods when both time series and implied volatilities are available.

Computer based simulation models are increasingly being used to predict the environmental fate of crop protection chemicals. Some considerations that need to be given in selecting appropriate models for regulatory purposes include model applicability, validation, capability, ease of use, and documentation. Problems commonly encountered in modeling include limited accuracy, lack of defined objectives and standard modeling practices, and misuse of models and results. Models will continue to play an important role in the regulation of crop protection chemicals. It is important that regulators and industry agree on appropriate models and practices, and that regulatory decisions are not based solely on model results but take into account all available data.

Immunochemical techniques offer many advantages over chromatographic methods used for pesticide trace analysis of substrates such as soil, water, plants, urine, and blood. These advantages include speed of processing samples, high specificity for detecting a pesticide, reduced amount of preparation and cleanup of the sample before analysis, and a dramatic increase in the number of samples that can be analyzed. Immunoassays are based on the principle that antibodies to pesticides can be prepared, in animals, that can recognize and attach with exquisite specificity to certain chemical configurations displayed on the surface of a molecule. Small molecules such as herbicides usually are not immunogenic but can be made so by chemically bonding them to a large immunogenic protein such as bovine serum albumin before injection into an animal. Development of herbicide-specific antibodies and their use in direct and indirect enzyme-linked immunosorbent assays (EIA or ELISA) as well as radioimmunoassays (RIA) are discussed. The principles behind monoclonal antibody production are outlined, and immunoassays using polyclonal and monoclonal antibodies are compared. Specific reference is made to the development and use of indirect ELISA and RIA procedures for trace analysis of 2,4-D and picloram.