Medical imaging has seen substantial and rapid technical advances during the past decade, including advances in image acquisition devices, processing and analysis software, and agents to enhance specificity. Traditionally, medical imaging has defined anatomy, but increasingly newer, more advanced, imaging technologies provide biochemical and physiologic information based on both static and dynamic modalities. These advanced technologies are important not only for detecting disease but for characterizing and assessing change of disease with time or therapy. Because of the rapidity of these advances, research to determine the utility of quantitative imaging in either clinical research or clinical practice has not had time to mature. Methods to appropriately develop, assess, regulate, and reimburse must be established for these advanced technologies. Efficient and methodical processes that meet the needs of stakeholders in the biomedical research community, therapeutics developers, and health care delivery enterprises will ultimately benefit individual patients. To help address this, the authors formed a collaborative program-the Quantitative Imaging Biomarker Alliance. This program draws from the very successful precedent set by the Integrating the Healthcare Enterprise effort but is adapted to the needs of imaging science. Strategic guidance supporting the development, qualification, and deployment of quantitative imaging biomarkers will lead to improved standardization of imaging tests, proof of imaging test performance, and greater use of imaging to predict the biologic behavior of tissue and monitor therapy response. These, in turn, confer value to corporate stakeholders, providing incentives to bring new and innovative products to market.
Quantitative imaging biomarkers could speed the development of new treatments for unmet medical needs and improve routine clinical care. However, it is not clear how the various regulatory and nonregulatory (eg, reimbursement) processes (often referred to as pathways) relate, nor is it clear which data need to be collected to support these different pathways most effi ciently, given the timeand cost-intensive nature of doing so. The purpose of this article is to describe current thinking regarding these pathways emerging from diverse stakeholders interested and active in the defi nition, validation, and qualifi cation of quantitative imaging biomarkers and to propose processes to facilitate the development and use of quantitative imaging biomarkers. A fl exible framework is described that may be adapted for each imaging application, providing mechanisms that can be used to develop, assess, and evaluate relevant biomarkers. From this framework, processes can be mapped that would be applicable to both imaging product development and to quantitative imaging biomarker development aimed at increasing the effectiveness and availability of quantitative imaging.
The Millon Clinical Multiaxial Inventory (MCMI) was administered to 270 adult outpatients with major affective disorders at the same time that a semistructured, diagnostic interview was conducted by a clinician. The mood of the patient was then rated, and the clinician completed the Hamilton Depression Rating Scale and the Mania Rating Scale. A consensual diagnosis was arrived at by the team of investigators using DSM-III criteria. Significant correlations were found between four MCMI affective scales and the global mood state of the patient. Analysis of covariance indicated that the MCMI affective scales are significantly related to DSM-III affective disorders even after the effect of the current mood of the patient is partialled out. The clinical usefulness of each of the scales is discussed.
Opportunities for funded radiologic research are greater than ever, and the amount of federal funding coming to academic radiology departments is increasing. Even so, many medical school-based radiology departments have little or no research funding. Accordingly, a consensus panel was convened to discuss ways to enhance research productivity and broaden the base of research strength in as many academic radiology departments as possible. The consensus panel included radiologists who have leadership roles in some of the best-funded research departments, radiologists who direct other funded research programs, and radiologists with related expertise. The goals of the consensus panel were to identify the attributes associated with successful research programs and to develop an action plan for radiology research based on these characteristics.
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A national random-sample survey of 4011 primary care physicians was conducted to determine the extent to which they are providing HIV prevention and clinical services, and to learn what characteristics and attitudes might impede the provision of such services. Physicians were asked about their history-taking practices for new adult and adolescent patients, including asking about the use of illicit drugs (injection and noninjection), the number of sexual partners, use of condoms and contraceptives, past episodes of sexually transmitted diseases (STDs), sexual orientation, and sexual contact with partner(s) at high risk for HIV. A preliminary analysis was conducted and reported earlier by the Centers for Disease Control and Prevention (CDC), focusing on the HIV-prevention services being provided by primary care physicians. This report provides additional analyses from this study, focusing on characteristics and attitudes that may prevent physicians from providing these services. Male physicians and the physicians' belief that patients would be offended if asked questions about their sex behaviors were strongly predictive of not asking new patients about their sex and drug behaviors. The physician's specialty was also a strong predictor-OB/GYNs were predictive of asking these questions and GP/FPs were predictive of not asking the questions. Physicians who indicated that a majority of their patients were white were less likely to report asking patients about their sex and drug behaviors. The authors conclude that a substantial number of primary care physicians are missing important opportunities to prevent HIV transmission by not adequately assessing patients' risks and not providing necessary risk-reduction counseling during their physician-patient encounters. Physician's attitudes and beliefs about their patients, as well as their level of experience with HIV, may help to explain these observations.
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