Conditional assurance: the answer to the questions that should be asked within drug development.
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ABSTRACT:
SUBMITTER: Temple JR
PROVIDER: S-EPMC9291040 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Over the last 10-20 years, international guidelines and consensus statements for the management of common allergic diseases (e.g. allergic rhinitis and asthma) have been developed and disseminated worldwide. However, their impact on knowledge and standard of clinical practice among primary care physicians and specialists is unknown. OBJECTIVE:To investigate need for an improvement in the dissemination of international guidelines for the diagnosis and management of allergic rhinitis. METHODS:Seven medical students who attended 3-day 1st International Basic Allergy Course (2010) took down all questions raised during the entire course. A systemic analysis of these questions was performed to identify areas for improvement in diagnosis and management of allergic diseases mainly in the Association of Southeast Asian Nations (ASEAN) region. RESULTS:268 participants, 143 males and 125 females, comprising Ear, Nose and Throat (ENT) specialists (n = 106) and trainees (n = 34), general practitioners (n = 87), and other healthcare professionals (n = 41) attended the course. Of the 103 questions recorded, 59 were regarding treatment modalities in allergy practice such as immunotherapy (n = 38), pharmacologics (n = 15), nasal surgery (n = 2), and others (n = 4). 41 questions (39.8%) have answers based in the Allergic Rhinitis and its Impact on Asthma guidelines (2001 and 2008). Certain questions were selected for further analysis because they appeared to be (a) more commonly asked (e.g. immunotherapy) or (b) were deemed to be challenging or, even controversial (e.g. food allergy and differential diagnosis between vasovagal and anaphylaxis reaction), as the recommendations in current international guidelines were less well-defined. CONCLUSION:Our study identified several problems that, if tackled, could help minimize confusion and provide better care for patients suffering from allergic diseases especially in the ASEAN region.
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Project description:Severe acute respiratory syndrome coronavirus 2 infection and development of coronavirus disease 2019 presents a major health care challenge of global dimensions. Laboratory diagnostics of infected patients, and the assessment of immunity against severe acute respiratory syndrome coronavirus 2, presents a major cornerstone in handling the pandemic. Currently, there is an increase in demand for antibody testing and a large number of tests are already marketed or are in the late stage of development. However, the interpretation of test results depends on many variables and factors, including sensitivity, specificity, potential cross-reactivity and cross-protectivity, the diagnostic value of antibodies of different isotypes, and the use of antibody testing in identification of acutely ill patients or in epidemiological settings. In this article, the recently established COVID-19 Task Force of the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) addresses these issues on the basis of currently available data sets in this rapidly moving field.
| S-EPMC7256507 | biostudies-literature
Project description:OBJECTIVES:To characterise the information needs of family doctors by collecting the questions they asked about patient care during consultations and to classify these in ways that would be useful to developers of knowledge bases. DESIGN:Observational study in which investigators visited doctors for two half days and collected their questions. Taxonomies were developed to characterise the clinical topic and generic type of information sought for each question. SETTING:Eastern Iowa. PARTICIPANTS:Random sample of 103 family doctors. MAIN OUTCOME MEASURES:Number of questions posed, pursued, and answered; topic and generic type of information sought for each question; time spent pursuing answers; information resources used. RESULTS:Participants asked a total of 1101 questions. Questions about drug prescribing, obstetrics and gynaecology, and adult infectious disease were most common and comprised 36% of all questions. The taxonomy of generic questions included 69 categories; the three most common types, comprising 24% of all questions, were "What is the cause of symptom X?" "What is the dose of drug X?" and "How should I manage disease or finding X?" Answers to most questions (702, 64%) were not immediately pursued, but, of those pursued, most (318, 80%) were answered. Doctors spent an average of less than 2 minutes pursuing an answer, and they used readily available print and human resources. Only two questions led to a formal literature search. CONCLUSIONS:Family doctors in this study did not pursue answers to most of their questions. Questions about patient care can be organised into a limited number of generic types, which could help guide the efforts of knowledge base developers.
| S-EPMC28191 | biostudies-literature
Project description:Although mitochondrial DNA (mtDNA) has long been used for assessing genetic variation within and between populations, its workhorse role in phylogeography has been criticized owing to its single-locus nature. The only choice for testing mtDNA results is to survey nuclear loci, which brings into contrast the difference in locus effective size and coalescence times. Thus, it remains unclear how erroneous mtDNA-based estimates of species history might be, especially for evolutionary events in the recent past. To test the robustness of mtDNA and nuclear sequences in phylogeography, we provide one of the largest paired comparisons of summary statistics and demographic parameters estimated from mitochondrial, five Z-linked and 10 autosomal genes of 30 avian species co-distributed in the Caucasus and Europe. The results suggest that mtDNA is robust in estimating inter-population divergence but not in intra-population diversity, which is sensitive to population size change. Here, we provide empirical evidence showing that mtDNA was more likely to detect population divergence than any other single locus owing to its smaller Ne and thus faster coalescent time. Therefore, at least in birds, numerous studies that have based their inferences of phylogeographic patterns solely on mtDNA should not be readily dismissed.
| S-EPMC4810844 | biostudies-other
Project description:Using chlorophyll (Chl) a fluorescence many aspects of the photosynthetic apparatus can be studied, both in vitro and, noninvasively, in vivo. Complementary techniques can help to interpret changes in the Chl a fluorescence kinetics. Kalaji et al. (Photosynth Res 122:121-158, 2014a) addressed several questions about instruments, methods and applications based on Chl a fluorescence. Here, additional Chl a fluorescence-related topics are discussed again in a question and answer format. Examples are the effect of connectivity on photochemical quenching, the correction of F V /F M values for PSI fluorescence, the energy partitioning concept, the interpretation of the complementary area, probing the donor side of PSII, the assignment of bands of 77 K fluorescence emission spectra to fluorescence emitters, the relationship between prompt and delayed fluorescence, potential problems when sampling tree canopies, the use of fluorescence parameters in QTL studies, the use of Chl a fluorescence in biosensor applications and the application of neural network approaches for the analysis of fluorescence measurements. The answers draw on knowledge from different Chl a fluorescence analysis domains, yielding in several cases new insights.
| S-EPMC5357263 | biostudies-other
Project description:As telehealth gains momentum as a service delivery model in the United States within the rehabilitation professions, regulatory and legal questions arise. This article examines the following questions: Is there a need to secure licenses in two states (i.e., where the practitioner resides, and where the client is located), before engaging in telehealth?Do state laws differ concerning if and how telehealth can occur?Do any states expressly disallow telehealth?Can services delivered through telehealth be billed the same way as services provided in-person?If practitioners fulfill the requirements to maintain licensure (e.g., continuing education obligations) in their state of residence, do they also need to fulfill the requirements to maintain licensure for the state in which the client resides?Will professional malpractice insurance cover services delivered through telehealth?Does a sole practitioner need to abide by HIPAA regulations?Responses to these questions are offered to raise awareness of the regulatory and legal implications associated with the use of a telehealth service delivery model within the professions of occupational therapy, physical therapy, speech-language pathology and audiology.
| S-EPMC4296804 | biostudies-other
Project description:ObjectiveThe purpose of this study was to compare pharmacy students' ability to correctly answer drug information questions using Micromedex with Watson, Micromedex without Watson, or Google.MethodsThis multicenter randomized trial compared pharmacy student responses to drug information questions using Micromedex with Watson, Micromedex without Watson, or Google from January to March of 2020. First- to fourth-year pharmacy students at two institutions were included. The primary outcome was the number of correct answers. Secondary outcomes were the time taken to answer the questions and differences in number of correct answers by pharmacy student year and institution.ResultsThe analysis included 162 participants: 52 students in the Micromedex group, 51 students in the Watson group, and 59 students in the Google group. There was a significant difference among groups in the total number of questions answered correctly (p=0.02). Post-hoc analysis revealed that participants in the Micromedex group answered more questions correctly than those in the Google group (p=0.015). There were no significant differences between Micromedex and Watson groups (p=0.52) or between Watson and Google groups (p=0.22). There was also no difference in time to complete the questions among groups (p=0.72).ConclusionUtilizing Google did not save students time and led to more incorrect answers. These findings suggest that health care educators and health sciences librarians should further reinforce training on the appropriate use of drug information resources.
| S-EPMC8270367 | biostudies-literature
Project description:Citizen science provides quantitative results to support environmental health assessments (EHAs), but standardized approaches do not currently exist to translate findings into actionable solutions. The emergence of low-cost portable sensor technologies and proliferation of publicly available datasets provides unparalleled access to supporting evidence; yet data collection, analysis, interpretation, visualization, and communication are subjective approaches that must be tailored to a decision-making audience capable of improving environmental health. A decade of collaborative efforts and two citizen science projects contributed to three lessons learned and a set of frequently asked questions (FAQs) that address the complexities of environmental health and interpersonal relations often encountered in citizen science EHAs. Each project followed a structured step-by-step process in order to compare and contrast methods and approaches. These lessons and FAQs provide advice to translate citizen science research into actionable solutions in the context of a diverse range of environmental health issues and local stakeholders.
| S-EPMC5981999 | biostudies-literature
Project description:The rapidly evolving science about the Coronavirus Disease 2019 (COVID-19) pandemic created unprecedented health information needs and dramatic changes in policies globally. We describe a platform, Watson Assistant (WA), which has been used to develop conversational agents to deliver COVID-19 related information. We characterized the diverse use cases and implementations during the early pandemic and measured adoption through a number of users, messages sent, and conversational turns (ie, pairs of interactions between users and agents). Thirty-seven institutions in 9 countries deployed COVID-19 conversational agents with WA between March 30 and August 10, 2020, including 24 governmental agencies, 7 employers, 5 provider organizations, and 1 health plan. Over 6.8 million messages were delivered through the platform. The mean number of conversational turns per session ranged between 1.9 and 3.5. Our experience demonstrates that conversational technologies can be rapidly deployed for pandemic response and are adopted globally by a wide range of users.
| S-EPMC7798957 | biostudies-literature
Project description:IntroductioneConsult allows primary care providers (PCPs) to access timely specialist advice and informs patient care. To understand the use of eConsult in long-term care (LTC) settings, we examined the clinical content and types of questions asked by LTC PCPs.MethodsA descriptive, retrospective study of eConsults submitted through the Champlain BASE™ eConsult Service between January 1, 2017, and December 31, 2018, by LTC PCPs was conducted. Cases were classified using validated taxonomies. Descriptive statistics were generated for content and question type classifications, service utilization data, and close-out survey responses.Results22 LTC PCPs submitted 113 eConsults. They sought advice about drug treatment (58%), diagnosis (44%), and management (38%) in a breadth of clinical areas, often skin-related (39%). Long-term care PCPs frequently asked more than one question type (42%). They received advice within 1 week (91%) and rated eConsult as very helpful and educational. Three case examples are presented.ConclusionThis study demonstrates the type of advice LTC PCPs are seeking through eConsult and its usefulness in this setting. Long-term care stakeholders are encouraged to consider implementing eConsult in other regions, as a means to improve access to timely specialist advice, support clinical decision-making, and improve residents' quality of life.
| S-EPMC8404619 | biostudies-literature