Planning for Long-Term Use of Biomedical Data
Planning for Long-Term Use of Biomedical Data

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-07-09

Total Pages: 93

ISBN-13: 0309672759

DOWNLOAD EBOOK

Biomedical research data sets are becoming larger and more complex, and computing capabilities are expanding to enable transformative scientific results. The National Institutes of Health's (NIH's) National Library of Medicine (NLM) has the unique role of ensuring that biomedical research data are findable, accessible, interoperable, and reusable in an ethical manner. Tools that forecast the costs of long-term data preservation could be useful as the cost to curate and manage these data in meaningful ways continues to increase, as could stewardship to assess and maintain data that have future value. The National Academies of Sciences, Engineering, and Medicine convened a workshop on July 11-12, 2019 to gather insight and information in order to develop and demonstrate a framework for forecasting long-term costs for preserving, archiving, and accessing biomedical data. Presenters and attendees discussed tools and practices that NLM could use to help researchers and funders better integrate risk management practices and considerations into data preservation, archiving, and accessing decisions; methods to encourage NIH-funded researchers to consider, update, and track lifetime data; and burdens on the academic researchers and industry staff to implement these tools, methods, and practices. This publication summarizes the presentations and discussion of the workshop.

Life-Cycle Decisions for Biomedical Data
Life-Cycle Decisions for Biomedical Data

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-09-04

Total Pages: 185

ISBN-13: 0309670063

DOWNLOAD EBOOK

Biomedical research results in the collection and storage of increasingly large and complex data sets. Preserving those data so that they are discoverable, accessible, and interpretable accelerates scientific discovery and improves health outcomes, but requires that researchers, data curators, and data archivists consider the long-term disposition of data and the costs of preserving, archiving, and promoting access to them. Life Cycle Decisions for Biomedical Data examines and assesses approaches and considerations for forecasting costs for preserving, archiving, and promoting access to biomedical research data. This report provides a comprehensive conceptual framework for cost-effective decision making that encourages data accessibility and reuse for researchers, data managers, data archivists, data scientists, and institutions that support platforms that enable biomedical research data preservation, discoverability, and use.

Sharing Clinical Trial Data
Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

DOWNLOAD EBOOK

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.

Fundamentals of Clinical Data Science
Fundamentals of Clinical Data Science

Author: Pieter Kubben

Publisher: Springer

Published: 2018-12-21

Total Pages: 219

ISBN-13: 3319997130

DOWNLOAD EBOOK

This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.

Artificial Intelligence in Healthcare
Artificial Intelligence in Healthcare

Author: Adam Bohr

Publisher: Academic Press

Published: 2020-06-21

Total Pages: 385

ISBN-13: 0128184396

DOWNLOAD EBOOK

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

Evidence-Based Medicine and the Changing Nature of Health Care
Evidence-Based Medicine and the Changing Nature of Health Care

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2008-09-06

Total Pages: 202

ISBN-13: 0309113695

DOWNLOAD EBOOK

Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.

Beyond the HIPAA Privacy Rule
Beyond the HIPAA Privacy Rule

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-03-24

Total Pages: 334

ISBN-13: 0309124999

DOWNLOAD EBOOK

In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Race, Ethnicity, and Language Data
Race, Ethnicity, and Language Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2009-12-30

Total Pages: 286

ISBN-13: 0309140129

DOWNLOAD EBOOK

The goal of eliminating disparities in health care in the United States remains elusive. Even as quality improves on specific measures, disparities often persist. Addressing these disparities must begin with the fundamental step of bringing the nature of the disparities and the groups at risk for those disparities to light by collecting health care quality information stratified by race, ethnicity and language data. Then attention can be focused on where interventions might be best applied, and on planning and evaluating those efforts to inform the development of policy and the application of resources. A lack of standardization of categories for race, ethnicity, and language data has been suggested as one obstacle to achieving more widespread collection and utilization of these data. Race, Ethnicity, and Language Data identifies current models for collecting and coding race, ethnicity, and language data; reviews challenges involved in obtaining these data, and makes recommendations for a nationally standardized approach for use in health care quality improvement.

Registries for Evaluating Patient Outcomes
Registries for Evaluating Patient Outcomes

Author: Agency for Healthcare Research and Quality/AHRQ

Publisher: Government Printing Office

Published: 2014-04-01

Total Pages: 385

ISBN-13: 1587634333

DOWNLOAD EBOOK

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.

Field Trials of Health Interventions
Field Trials of Health Interventions

Author: Peter G. Smith

Publisher:

Published: 2015

Total Pages: 479

ISBN-13: 0198732864

DOWNLOAD EBOOK

This is an open access title available under the terms of a CC BY-NC 4.0 International licence. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. Before new interventions are released into disease control programmes, it is essential that they are carefully evaluated in field trials'. These may be complex and expensive undertakings, requiring the follow-up of hundreds, or thousands, of individuals, often for long periods. Descriptions of the detailed procedures and methods used in the trials that have been conducted have rarely been published. A consequence of this, individuals planning such trials have few guidelines available and little access to knowledge accumulated previously, other than their own. In this manual, practical issues in trial design and conduct are discussed fully and in sufficient detail, that Field Trials of Health Interventions may be used as a toolbox' by field investigators. It has been compiled by an international group of over 30 authors with direct experience in the design, conduct, and analysis of field trials in low and middle income countries and is based on their accumulated knowledge and experience. Available as an open access book via Oxford Medicine Online, this new edition is a comprehensive revision, incorporating the new developments that have taken place in recent years with respect to trials, including seven new chapters on subjects ranging from trial governance, and preliminary studies to pilot testing.