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 Report of the International Bioethics Committee of UNESCO IBC on Social Responsibility and Health written by UNESCO and published by UNESCO. This book was released on 2010 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 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 385 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 Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research written by Council of Europe and published by Council of Europe. This book was released on 2005-01-01 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: This protocol covers the full range of research activities in the health field that involve interventions on human beings. It aims to protect the dignity and identity of everyone involved, without discrimination.

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: This book defines the state of scientific research focused on the development, experimental evaluation, and effective implementation of technology-based (web, mobile) therapeutic tools targeting behavioral health. Written by an expert interdisciplinary group of authors, Behavioral Healthcare and Technology defines the opportunity for science-based technology to transform models of behavioral healthcare.

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 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 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 236 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 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 Innovation in Clinical Trial Methodologies written by Peter Schueler and published by Academic Press. This book was released on 2020-11-20 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovation in Clinical Trial Methodologies: Lessons Learned during the Corona Pandemic presents a selection of updated chapters from Re-Engineering Clinical Trials that feature innovative options and methods in clinical trials. The Coronavirus pandemic is an accelerator for digitalization in many industries, including clinical trials. This book considers best practices, alternative study concepts requiring fewer patients, studies with less patient interaction, the design of "virtualized" protocols, and moving from data to decisions. This book will be helpful to pharmacologists, physicians and clinical researchers involved in the process of clinical development and clinical trial design. Considers multiple digital and virtual strategies Explores best practices, including the use of reduced patient involvement Brings together expert, trusted information to increase the efficiency and effectiveness of clinical trials

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 228 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 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 The Practice of Patient Centered Care Empowering and Engaging Patients in the Digital Era written by R. Engelbrecht and published by IOS Press. This book was released on 2017-11-16 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical informatics is increasingly central to the effective and efficient delivery of healthcare today. This book presents the proceedings of the European Federation for Medical Informatics Special Topic Conference (EFMI STC 2017), held in Tel Aviv, Israel, in October 2017. The theme and title of the 2017 edition of this annual conference is ‘The practice of patient centered care: Empowering and engaging patients in the digital era’. The aim of the conference series is to increase interaction and collaboration between the stakeholder groups from both health and ICT across, but not limited to, Europe by providing a platform for researchers, data scientists, practitioners, decision makers and entrepreneurs to discuss sustainable and inclusive digital health innovations aimed at the engagement and empowerment of patients/consumers. The book is divided into 3 sections: full papers, short communications, and posters, and covers a wide range of topics from the field of medical informatics. It will be of interest to healthcare planners and providers everywhere.

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 Artificial Intelligence in Healthcare written by Adam Bohr and published by Academic Press. This book was released on 2020-06-21 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: Artificial Intelligence (AI) in Healthcare is more than a comprehensive introduction to artificial intelligence as a tool in the generation and analysis of healthcare data. The book is split into two sections where the first section describes the current healthcare challenges and the rise of AI in this arena. The ten following chapters are written by specialists in each area, covering the whole healthcare ecosystem. First, the AI applications in drug design and drug development are presented followed by its applications in the field of cancer diagnostics, treatment and medical imaging. Subsequently, the application of AI in medical devices and surgery are covered as well as remote patient monitoring. Finally, the book dives into the topics of security, privacy, information sharing, health insurances and legal aspects of AI in healthcare. - Highlights different data techniques in healthcare data analysis, including machine learning and data mining - Illustrates different applications and challenges across the design, implementation and management of intelligent systems and healthcare data networks - Includes applications and case studies across all areas of AI in healthcare data