Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams's Books

Patient Outcomes Research Teams (PORTS)

Managing Conflict of Interest

By: Institute of Medicine,Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams

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Patient Outcomes Research Teams (PORTS)

Managing Conflict of Interest

By: Institute of Medicine,Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams

The new Agency for Health Care Policy and Research in the U.S. Public Health Service is funding a set of multidisciplinary groups called Patient Outcomes Research Teams (PORTs). Their purpose is to assess alternative treatments for medical conditions using a variety of outcome measures. In guiding insurance coverage, these PORTs are expected to wield considerable influence on medical practice and health policy. This book addresses possible threats to their credibility that might be based on real or apparent conflicts of interest, including both financial and other conflicts. It raises points to consider for the new agency, for PORTs and their institutions, for industry, for the health services research community, and for the U.S. Congress in avoiding and managing conflicts of interest.

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183

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National Academies Press

Published Date

ISBN 10

0309044820

ISBN 13

9780309044820

Patient Outcomes Research Teams (PORTS)

Managing Conflict of Interest

By: Institute of Medicine,Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams

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Patient Outcomes Research Teams (PORTS)

Managing Conflict of Interest

By: Institute of Medicine,Committee on Potential Conflicts of Interest in Patient Outcomes Research Teams

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183

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National Academies Press

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ISBN 10

0309044820

ISBN 13

9780309044820

The Artificial Heart

Prototypes, Policies, and Patients

By: Institute of Medicine,Division of Health Care Services,Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute

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The Artificial Heart

Prototypes, Policies, and Patients

By: Institute of Medicine,Division of Health Care Services,Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute

A significant medical event is expected in 1992: the first human use of a fully implantable, long-term cardiac assist device. This timely volume reviews the artificial heart program-and in particular, the National Institutes of Health's major investment-raising important questions. The volume includes: Consideration of the artificial heart versus heart transplantation and other approaches to treating end-stage heart disease, keeping in mind the different outcomes and costs of these treatments. A look at human issues, including the number of people who may require the artificial heart, patient quality of life, and other ethical and societal questions. Examination of how this technology's use can be targeted most appropriately. Attention to achieving access to this technology for all those who can benefit from it. The committee also offers three mechanisms to aid in allocating research and development funds.

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313

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National Academies Press

Published Date

ISBN 10

0309045320

ISBN 13

9780309045322

Enhancing the Effectiveness of Team Science

By: National Research Council,Division of Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on the Science of Team Science

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Enhancing the Effectiveness of Team Science

By: National Research Council,Division of Behavioral and Social Sciences and Education,Board on Behavioral, Cognitive, and Sensory Sciences,Committee on the Science of Team Science

The past half-century has witnessed a dramatic increase in the scale and complexity of scientific research. The growing scale of science has been accompanied by a shift toward collaborative research, referred to as "team science." Scientific research is increasingly conducted by small teams and larger groups rather than individual investigators, but the challenges of collaboration can slow these teams' progress in achieving their scientific goals. How does a team-based approach work, and how can universities and research institutions support teams? Enhancing the Effectiveness of Team Science synthesizes and integrates the available research to provide guidance on assembling the science team; leadership, education and professional development for science teams and groups. It also examines institutional and organizational structures and policies to support science teams and identifies areas where further research is needed to help science teams and groups achieve their scientific and translational goals. This report offers major public policy recommendations for science research agencies and policymakers, as well as recommendations for individual scientists, disciplinary associations, and research universities. Enhancing the Effectiveness of Team Science will be of interest to university research administrators, team science leaders, science faculty, and graduate and postdoctoral students.

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255

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National Academies Press

Published Date

ISBN 10

0309316855

ISBN 13

9780309316859

Finding What Works in Health Care

Standards for Systematic Reviews

By: Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research

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Finding What Works in Health Care

Standards for Systematic Reviews

By: Institute of Medicine,Board on Health Care Services,Committee on Standards for Systematic Reviews of Comparative Effectiveness Research

Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

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267

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National Academies Press

Published Date

ISBN 10

0309216710

ISBN 13

9780309216715

Opportunities for Organ Donor Intervention Research

Saving Lives by Improving the Quality and Quantity of Organs for Transplantation

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Issues in Organ Donor Intervention Research

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Opportunities for Organ Donor Intervention Research

Saving Lives by Improving the Quality and Quantity of Organs for Transplantation

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Issues in Organ Donor Intervention Research

The organ donation and transplantation system strives to honor the gift of donated organs by fully using those organs to save and improve the quality of the lives of their recipients. However, there are not enough donated organs to meet the demand and some donated organs may not be recovered, some recovered organs may not be transplanted, and some transplanted organs may not function adequately. Organ donor intervention research can test and assess interventions (e.g., medications, devices, and donor management protocols) to maintain or improve organ quality prior to, during, and following transplantation. The intervention is administered either while the organ is still in the deceased donor or after it is recovered from the donor but before it is transplanted into a recipient. Organ donor intervention research presents new challenges to the organ donation and transplantation community because of ethical questions about who should be considered a human subject in a research study, whose permission and oversight are needed, and how to ensure that such research does not threaten the equitable distribution of a scarce and valuable resource. Opportunities for Organ Donor Intervention Research focuses on the ethical, legal, regulatory, policy, and organizational issues relevant to the conduct of research in the United States involving deceased organ donors. This report provides recommendations for how to conduct organ donor intervention research in a manner that maintains high ethical standards, that ensures dignity and respect for deceased organ donors and their families, that provides transparency and information for transplant candidates who might receive a research organ, and that supports and sustains the public's trust in the process of organ donation and transplantation.

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171

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National Academies Press

Published Date

ISBN 10

0309464870

ISBN 13

9780309464871

Clinical Practice Guidelines We Can Trust

By: Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines

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Clinical Practice Guidelines We Can Trust

By: Institute of Medicine,Board on Health Care Services,Committee on Standards for Developing Trustworthy Clinical Practice Guidelines

Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

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217

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National Academies Press

Published Date

ISBN 10

0309164222

ISBN 13

9780309164221

Evolution of Translational Omics

Lessons Learned and the Path Forward

By: Institute of Medicine,Board on Health Sciences Policy,Board on Health Care Services,Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials

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Evolution of Translational Omics

Lessons Learned and the Path Forward

By: Institute of Medicine,Board on Health Sciences Policy,Board on Health Care Services,Committee on the Review of Omics-Based Tests for Predicting Patient Outcomes in Clinical Trials

Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

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354

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National Academies Press

Published Date

ISBN 10

0309224187

ISBN 13

9780309224185

Framing Opioid Prescribing Guidelines for Acute Pain

Developing the Evidence

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Evidence-Based Clinical Practice Guidelines for Prescribing Opioids for Acute Pain

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Framing Opioid Prescribing Guidelines for Acute Pain

Developing the Evidence

The opioid overdose epidemic combined with the need to reduce the burden of acute pain poses a public health challenge. To address how evidence-based clinical practice guidelines for prescribing opioids for acute pain might help meet this challenge, Framing Opioid Prescribing Guidelines for Acute Pain: Developing the Evidence develops a framework to evaluate existing clinical practice guidelines for prescribing opioids for acute pain indications, recommends indications for which new evidence-based guidelines should be developed, and recommends a future research agenda to inform and enable specialty organizations to develop and disseminate evidence-based clinical practice guidelines for prescribing opioids to treat acute pain indications. The recommendations of this study will assist professional societies, health care organizations, and local, state, and national agencies to develop clinical practice guidelines for opioid prescribing for acute pain. Such a framework could inform the development of opioid prescribing guidelines and ensure systematic and standardized methods for evaluating evidence, translating knowledge, and formulating recommendations for practice.

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223

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National Academies Press

Published Date

ISBN 10

030949690X

ISBN 13

9780309496902

Conflict of Interest in Medical Research, Education, and Practice

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice

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Conflict of Interest in Medical Research, Education, and Practice

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Conflict of Interest in Medical Research, Education, and Practice

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

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436

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National Academies Press

Published Date

ISBN 10

030913188X

ISBN 13

9780309131889

Scientific Standards for Studies on Modified Risk Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

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Scientific Standards for Studies on Modified Risk Tobacco Products

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Scientific Standards for Studies on Modified Risk Tobacco Products

Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.

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370

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National Academies Press

Published Date

ISBN 10

0309223989

ISBN 13

9780309223980

Ethics Manual

By: American College of Physicians (2003- ). Ethics and Human Rights Committee,Lois Snyder

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Ethics Manual

By: American College of Physicians (2003- ). Ethics and Human Rights Committee,Lois Snyder

Examines the issues in medical ethics faced by doctors and their patients. This book also discusses the distinction and potential conflicts between legal and ethical obligations while making clinical decisions. It includes sections on: Genetic testing, Organ donation, Care of patients at the end of life, Health and human rights, and more.

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ACP Press

Published Date

ISBN 10

1930513658

ISBN 13

9781930513655

The Government's Public Health White Paper (Cm 6374)

Written Evidence

By: Great Britain: Parliament: House of Commons: Health Committee

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The Government's Public Health White Paper (Cm 6374)

Written Evidence

By: Great Britain: Parliament: House of Commons: Health Committee

White Paper Cm. 6374 (ISBN 010163742X) was published 16th November 2004.

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310

Publisher

The Stationery Office

Published Date

ISBN 10

0215025067

ISBN 13

9780215025067

An Evidence Framework for Genetic Testing

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on the Health of Select Populations,Committee on the Evidence Base for Genetic Testing

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An Evidence Framework for Genetic Testing

Advances in genetics and genomics are transforming medical practice, resulting in a dramatic growth of genetic testing in the health care system. The rapid development of new technologies, however, has also brought challenges, including the need for rigorous evaluation of the validity and utility of genetic tests, questions regarding the best ways to incorporate them into medical practice, and how to weigh their cost against potential short- and long-term benefits. As the availability of genetic tests increases so do concerns about the achievement of meaningful improvements in clinical outcomes, costs of testing, and the potential for accentuating medical care inequality. Given the rapid pace in the development of genetic tests and new testing technologies, An Evidence Framework for Genetic Testing seeks to advance the development of an adequate evidence base for genetic tests to improve patient care and treatment. Additionally, this report recommends a framework for decision-making regarding the use of genetic tests in clinical care.

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149

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National Academies Press

Published Date

ISBN 10

0309453291

ISBN 13

9780309453295

Knowing What Works in Health Care

A Roadmap for the Nation

By: Institute of Medicine,Board on Health Care Services,Committee on Reviewing Evidence to Identify Highly Effective Clinical Services

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Knowing What Works in Health Care

A Roadmap for the Nation

By: Institute of Medicine,Board on Health Care Services,Committee on Reviewing Evidence to Identify Highly Effective Clinical Services

There is currently heightened interest in optimizing health care through the generation of new knowledge on the effectiveness of health care services. The United States must substantially strengthen its capacity for assessing evidence on what is known and not known about "what works" in health care. Even the most sophisticated clinicians and consumers struggle to learn which care is appropriate and under what circumstances. Knowing What Works in Health Care looks at the three fundamental health care issues in the United States-setting priorities for evidence assessment, assessing evidence (systematic review), and developing evidence-based clinical practice guidelines-and how each of these contributes to the end goal of effective, practical health care systems. This book provides an overall vision and roadmap for improving how the nation uses scientific evidence to identify the most effective clinical services. Knowing What Works in Health Care gives private and public sector firms, consumers, health care professionals, benefit administrators, and others the authoritative, independent information required for making essential informed health care decisions.

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279

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National Academies Press

Published Date

ISBN 10

0309113563

ISBN 13

9780309113564

Treatment of Posttraumatic Stress Disorder

An Assessment of the Evidence

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Treatment of Posttraumatic Stress Disorder

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Treatment of Posttraumatic Stress Disorder

An Assessment of the Evidence

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Treatment of Posttraumatic Stress Disorder

Mental disorders, including posttraumatic stress disorder (PTSD), constitute an important health care need of veterans, especially those recently separated from service. Treatment of Posttraumatic Stress Disorder: An Assessment of the Evidence takes a systematic look the efficacy of pharmacologic and psychological treatment modalities for PTSD on behalf of the Department of Veterans Affairs. By reviewing existing studies in order to draw conclusions about the strength of evidence on several types of treatment, the Committee on the Treatment of Posttraumatic Stress Disorder found that many of these studies were faulty in design and performance, and that relatively few of these studies have been conducted in populations of veterans, despite suggestions that civilian and veteran populations respond differently to various types of treatment. The committee also notes that the evidence is scarce on the acceptability, efficacy, or generalizability of treatment in ethnic and cultural minorities, as few studies stratified results by ethnic background. Despite challenges in the consistency, quality, and depth of research, the committee found the evidence sufficient to conclude the efficacy of exposure therapies in treating PTSD. The committee found the evidence inadequate to determine efficacy of different types of pharmacotherapies, of three different psychotherapy modalities, and of psychotherapy delivered in group formats. The committee also made eight critical recommendations, some in response to the VA's questions related to recovery and the length and timing of PTSD treatment, and others addressing research methodology, gaps in evidence and funding issues.

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