Download or read book Making clinical trials more patient centered using digital interactive e consent tools written by Barbara Bowles Biesecker and published by RTI Press. This book was released on 2019-10-20 with total page 10 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research participants are required to give their consent to participate in clinical trials and nonexempt government-funded studies. The goal is to facilitate participant understanding of the intent of the research, its voluntary nature, and the potential benefits and harms. Ideally, participants make an informed choice whether to participate; one that is based on having sufficient relevant knowledge and that is consistent with their values and preferences. Achieving this objective can be challenging, and as such, many scholars have declared the consent process flawed or “broken.” Moreover, clinical trials are complex studies, and compelling evidence suggests that current consent processes are inadequate in achieving informed choice. E-consent offers a dynamic, engaging consent delivery mode that can effectively support making informed decisions about whether to participate in a trial.
Download or read book Making Clinical Trials More Patient centered Using Digital Interactive E consent Tools written by Barbara Biesecker and published by . This book was released on 2019 with total page 5 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research participants are required to give their consent to participate in clinical trials and nonexempt government-funded studies. The goal is to facilitate participant understanding of the intent of the research, its voluntary nature, and the potential benefits and harms. Ideally, participants make an informed choice whether to participate; one that is based on having sufficient relevant knowledge and that is consistent with their values and preferences. Achieving this objective can be challenging, and as such, many scholars have declared the consent process flawed or "broken." Moreover, clinical trials are complex studies, and compelling evidence suggests that current consent processes are inadequate in achieving informed choice. E-consent offers a dynamic, engaging consent delivery mode that can effectively support making informed decisions about whether to participate in a trial.
Download or read book DNA based Population Screening for Precision Public Health written by Laura V. Milko and published by Frontiers Media SA. This book was released on 2022-11-28 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Download or read book Virtual Clinical Trials written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-11-16 with total page 127 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.
Download or read book Oxford Textbook of Pediatric Pain written by Bonnie J. Stevens and published by Oxford University Press. This book was released on 2021 with total page 713 pages. Available in PDF, EPUB and Kindle. Book excerpt: The oxford textbook of paediatric pain brings together clinicians, educators, trainees and researchers to provide an authoritative resource on all aspects of pain in infants, children and youth.
Download or read book Patient Engagement written by Guendalina Graffigna and published by Walter de Gruyter GmbH & Co KG. This book was released on 2016-01-01 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patient engagement should be envisaged as a key priority today to innovate healthcare services delivery and to make it more effective and sustainable. The experience of engagement is a key qualifier of the exchange between the demand (i.e. citizens/patients) and the supply process of healthcare services. To understand and detect the strategic levers that sustain a good quality of patients’ engagement may thus allow not only to improve clinical outcomes, but also to increase patients’ satisfaction and to reduce the organizational costs of the delivery of services. By assuming a relational marketing perspective, the book offers practical insights about the developmental process of patients’ engagement, by suggesting concrete tools for assessing the levels of patients’ engagement and strategies to sustain it. Crucial resources to implement these strategies are also the new technologies that should be (1) implemented according to precise guidelines and (2) designed according to a user-centered design process. Furthermore, the book describes possible fields of patients’ engagement application by describing the best practices and experiences matured in different fields
Download or read book Informed Consent and Health Literacy written by Institute of Medicine and published by National Academies Press. This book was released on 2015-03-04 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt: Informed consent - the process of communication between a patient or research subject and a physician or researcher that results in the explicit agreement to undergo a specific medical intervention - is an ethical concept based on the principle that all patients and research subjects should understand and agree to the potential consequences of the clinical care they receive. Regulations that govern the attainment of informed consent for treatment and research are crucial to ensuring that medical care and research are conducted in an ethical manner and with the utmost respect for individual preferences and dignity. These regulations, however, often require - or are perceived to require - that informed consent documents and related materials contain language that is beyond the comprehension level of most patients and study participants. To explore what actions can be taken to help close the gap between what is required in the informed consent process and communicating it in a health-literate and meaningful manner to individuals, the Institute of Medicine's Roundtable on Health Literacy convened a one-day public workshop featuring presentations and discussions that examine the implications of health literacy for informed consent for both research involving human subjects and treatment of patients. Topics covered in this workshop included an overview of the ethical imperative to gain informed consent from patients and research participants, a review of the current state and best practices for informed consent in research and treatment, the connection between poor informed consent processes and minority underrepresentation in research, new approaches to informed consent that reflect principles of health literacy, and the future of informed consent in the treatment and research settings. Informed Consent and Health Literacy is the summary of the presentations and discussion of the workshop.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book Clinical Trial Project Management written by Ashok Kumar Peepliwal and published by Elsevier. This book was released on 2023-11-15 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials, in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing etc. covering entire clinical trial process of conductance. In addition to that the author also incorporated the clinical trial approval process of USFDA, EMA, and JAPAN to conduct the clinical trials. Covers how to conduct clinical trials in detail Present useful, basic, and advanced statistical tools Provides real-time project management methods like Program Evaluation Review Technique (PERT) and Critical Path Method (CPM) to manage complex projects are described in the book
Download or read book Oncology Informatics written by Bradford W. Hesse and published by Academic Press. This book was released on 2016-03-17 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oncology Informatics: Using Health Information Technology to Improve Processes and Outcomes in Cancer Care encapsulates National Cancer Institute-collected evidence into a format that is optimally useful for hospital planners, physicians, researcher, and informaticians alike as they collectively strive to accelerate progress against cancer using informatics tools. This book is a formational guide for turning clinical systems into engines of discovery as well as a translational guide for moving evidence into practice. It meets recommendations from the National Academies of Science to "reorient the research portfolio" toward providing greater "cognitive support for physicians, patients, and their caregivers" to "improve patient outcomes." Data from systems studies have suggested that oncology and primary care systems are prone to errors of omission, which can lead to fatal consequences downstream. By infusing the best science across disciplines, this book creates new environments of "Smart and Connected Health." Oncology Informatics is also a policy guide in an era of extensive reform in healthcare settings, including new incentives for healthcare providers to demonstrate "meaningful use" of these technologies to improve system safety, engage patients, ensure continuity of care, enable population health, and protect privacy. Oncology Informatics acknowledges this extraordinary turn of events and offers practical guidance for meeting meaningful use requirements in the service of improved cancer care. Anyone who wishes to take full advantage of the health information revolution in oncology to accelerate successes against cancer will find the information in this book valuable. Presents a pragmatic perspective for practitioners and allied health care professionals on how to implement Health I.T. solutions in a way that will minimize disruption while optimizing practice goals Proposes evidence-based guidelines for designers on how to create system interfaces that are easy to use, efficacious, and timesaving Offers insight for researchers into the ways in which informatics tools in oncology can be utilized to shorten the distance between discovery and practice
Download or read book Behavioral Healthcare and Technology written by Lisa A. Marsch and published by Oxford University Press, USA. This book was released on 2015 with total page 369 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, there has been an explosion of research focused on using technology in healthcare, including web- and mobile- health assessment and intervention tools, as well as smartphone sensors and smart environments for monitoring and promoting health behavior. This work has shown that technology-based therapeutic tools offer considerable promise for monitoring and responding to individuals' health behavior in real-time. They may also function as important clinician-extenders or stand-alone tools, may be cost-effective and may offer countless opportunities for tailoring behavioral monitoring and intervention delivery in a manner that is optimally responsive to each individual's profile and health behavior trajectory over time. Additionally, informational and communication technologies may be used in the context of decision support tools to help individuals better understand and access treatment. Technology may enable entirely new models of healthcare both within and outside of formal systems of care and thus offers the opportunity to revolutionize healthcare delivery. This edited book defines the state of scientific research related to the development, experimental evaluation, and effective dissemination of technology-based therapeutic tools targeting behavioral health. Behavioral Healthcare and Technology provides an overview of current evidence-based approaches to leverage technology to promote behavioral health, including management of substance use, mental health, diet/exercise, medication adherence, as well as chronic disease self-management. Additionally, the book defines the state of implementation research examining models for deploying technology-based behavioral healthcare systems and integrating them into various care settings to increase the quality and reach of evidence-based behavioral healthcare while reducing costs.
Download or read book Pragmatic Randomized Clinical Trials written by Cynthia J. Girman and published by Academic Press. This book was released on 2021-04-08 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pragmatic Randomized Clinical Trials Using Primary Data Collection and Electronic Health Records addresses the practical aspects and challenges of the design, implementation, and dissemination of pragmatic randomized trials, also sometimes referred to as practical or hybrid randomized trials. While less restrictive and more generalizable than traditional randomized controlled trials, such trials have specific challenges which are addressed in this book. The book contains chapters encompassing common designs along with advantages and limitations of such designs, analytic aspects in planning trials and estimating sample size, and how to use patient partners to help design and operationalize pragmatic randomized trials. Pragmatic trials conducted using primary data collection and trials embedded in electronic health records - including electronic medical records and administrative insurance claims - are addressed. This comprehensive resource is valuable not only for pharmacoepidemiologists, biostatisticians and clinical researchers, but also across the biomedical field for those who are interested in applying pragmatic randomized clinical trials in their research. Addresses typical designs and challenges of pragmatic randomized clinical trials (pRCTs) Encompasses analytic aspects of such trials Discusses real cases on operational challenges in launching and conducting pRCTs in electronic health records
Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.
Download or read book Acceptable Risk written by Baruch Fischhoff and published by Cambridge University Press. This book was released on 1981 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: A framework for making decisions about risks, with recommendations for research, public policy, and practice.
Download or read book A History and Theory of Informed Consent written by Ruth R. Faden and published by Oxford University Press, USA. This book was released on 1986 with total page 409 pages. Available in PDF, EPUB and Kindle. Book excerpt: A timely, authoritative discussion of an important clincial topic, this useful book outlines the history, function, nature and requirements of informed consent, focusing on patient autonomy as central to the concept. Primarily a philosophical analysis, the book also covers legal aspects, with chapters on disclosure, comprehension, and competence.
Download or read book Real world Evidence in Onco Hematological Patients written by Claudia Vener and published by Frontiers Media SA. This book was released on 2022-12-02 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt:
