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Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
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Book Description
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.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385
Get Book Here
Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309475201
Category : Medical
Languages : en
Pages : 399
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Book Description
When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Author: Department Justice
Publisher: Createspace Independent Publishing Platform
ISBN: 9781500783945
Category :
Languages : en
Pages : 0
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Book Description
(a) Design and construction. (1) Each facility or part of a facility constructed by, on behalf of, or for the use of a public entity shall be designed and constructed in such manner that the facility or part of the facility is readily accessible to and usable by individuals with disabilities, if the construction was commenced after January 26, 1992. (2) Exception for structural impracticability. (i) Full compliance with the requirements of this section is not required where a public entity can demonstrate that it is structurally impracticable to meet the requirements. Full compliance will be considered structurally impracticable only in those rare circumstances when the unique characteristics of terrain prevent the incorporation of accessibility features. (ii) If full compliance with this section would be structurally impracticable, compliance with this section is required to the extent that it is not structurally impracticable. In that case, any portion of the facility that can be made accessible shall be made accessible to the extent that it is not structurally impracticable. (iii) If providing accessibility in conformance with this section to individuals with certain disabilities (e.g., those who use wheelchairs) would be structurally impracticable, accessibility shall nonetheless be ensured to persons with other types of disabilities, (e.g., those who use crutches or who have sight, hearing, or mental impairments) in accordance with this section.
Author: Erika McCallister
Publisher: DIANE Publishing
ISBN: 1437934889
Category : Computers
Languages : en
Pages : 59
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Book Description
The escalation of security breaches involving personally identifiable information (PII) has contributed to the loss of millions of records over the past few years. Breaches involving PII are hazardous to both individuals and org. Individual harms may include identity theft, embarrassment, or blackmail. Organ. harms may include a loss of public trust, legal liability, or remediation costs. To protect the confidentiality of PII, org. should use a risk-based approach. This report provides guidelines for a risk-based approach to protecting the confidentiality of PII. The recommend. here are intended primarily for U.S. Fed. gov¿t. agencies and those who conduct business on behalf of the agencies, but other org. may find portions of the publication useful.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264311734
Category :
Languages : en
Pages : 199
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Book Description
Laws and regulations affect the daily lives of businesses and citizens. High-quality laws promote national welfare and growth, while badly designed laws hinder growth, harm the environment and put the health of citizens at risk. This report analyses practices to improve the quality of laws ...
Author: United States
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 1192
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Book Description
Author: Nicholas Hans Steneck
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 184
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Book Description
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 122
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Book Description
Author: Donna K. Hammaker
Publisher: Jones & Bartlett Learning
ISBN: 1284128997
Category : Business & Economics
Languages : en
Pages : 436
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Book Description
This fifth edition of Health Records and the Law addresses the substantial changes brought about by the Health Insurance Portability and Accountability Act (HIPAA) and the growth of network information systems, with discussion of state laws affecting the use and disclosure of patient data. The text also discusses the highly complex interplay of federal and state privacy laws. In addition to the considerable new material concerning HIPAA and its regulations, this edition addresses the challenging area of how patient information may be used in connection with medical research and the impact that the Health Information Technology for Economic and Clinical Health (HITECH) Act is having on public health monitoring and surveillance.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030910291X
Category : Medical
Languages : en
Pages : 102
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Book Description
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 was enacted to improve the portability and continuity of health insurance; promote medical savings accounts; improve access to long-term care services and coverage; and simplify the administration of health insurance. HIPAA's Administrative Simplification provisions focus on facilitating the electronic exchange of information for financial and administrative functions related to patient care. However, the very advances that make it easier to transmit information also present challenges to preserving the confidentiality of potentially sensitive personal information contained in medical records. In 2003, the President's Cancer Panel discovered HIPAA Privacy Rule slowed research on cancer survivors, as well as causing increased bureaucracy, informed consent problems, and complications for clinical trials. Effect of the HIPAA Privacy Rule on Health Research evaluates the impact of HIPAA provisions and provides guidance to legislators on amendments needed to make this law better serve the interests of cancer survivors and others.
