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Author: David Cella
Publisher: RTI Press
ISBN: 193483114X
Category : Medical
Languages : en
Pages : 97
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Book Description
Patient-reported outcomes (PROs) are measures of how patients feel or what they are able to do in the context of their health status; PROs are reports, usually on questionnaires, about a patient's health conditions, health behaviors, or experiences with health care that individuals report directly, without modification of responses by clinicians or others; thus, they directly reflect the voice of the patient. PROs cover domains such as physical health, mental and emotional health, functioning, symptoms and symptom burden, and health behaviors. They are relevant for many activities: helping patients and their clinicians make informed decisions about health care, monitoring the progress of care, setting policies for coverage and reimbursement of health services, improving the quality of health care services, and tracking or reporting on the performance of health care delivery organizations. We address the major methodological issues related to choosing, administering, and using PROs for these purposes, particularly in clinical practice settings. We include a framework for best practices in selecting PROs, focusing on choosing appropriate methods and modes for administering PRO measures to accommodate patients with diverse linguistic, cultural, educational, and functional skills, understanding measures developed through both classic and modern test theory, and addressing complex issues relating to scoring and analyzing PRO data.
Author: David Cella
Publisher: RTI Press
ISBN: 193483114X
Category : Medical
Languages : en
Pages : 97
Get Book Here
Book Description
Patient-reported outcomes (PROs) are measures of how patients feel or what they are able to do in the context of their health status; PROs are reports, usually on questionnaires, about a patient's health conditions, health behaviors, or experiences with health care that individuals report directly, without modification of responses by clinicians or others; thus, they directly reflect the voice of the patient. PROs cover domains such as physical health, mental and emotional health, functioning, symptoms and symptom burden, and health behaviors. They are relevant for many activities: helping patients and their clinicians make informed decisions about health care, monitoring the progress of care, setting policies for coverage and reimbursement of health services, improving the quality of health care services, and tracking or reporting on the performance of health care delivery organizations. We address the major methodological issues related to choosing, administering, and using PROs for these purposes, particularly in clinical practice settings. We include a framework for best practices in selecting PROs, focusing on choosing appropriate methods and modes for administering PRO measures to accommodate patients with diverse linguistic, cultural, educational, and functional skills, understanding measures developed through both classic and modern test theory, and addressing complex issues relating to scoring and analyzing PRO data.
Author: Bill Byrom
Publisher:
ISBN: 9781720281108
Category :
Languages : en
Pages : 96
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Book Description
The book concisely covers the entire landscape of ePROs and helps to dispel some of the myths and doubts on the topic. After making the case for ePRO assessment, the authors take the readers on a tour of issues related to design, validation, and implementation of ePRO solutions. The authors have provided recommendations ("Should skipping of items allowed?"), mitigation strategies ("How can we minimize issues that may arise during user acceptance testing?") and common pitfalls, such as issues that may arise when administering these assessments to patients from a variety of cultures. The bibliography of industry standards and best practices and the key references related to ePRO assessment make this book a valuable resource for anyone who wants to take a deep dive into the topic. Although the title of the book refers to patient-reported outcomes, the volume is a must-have for those who want to collect accurate and high-quality data relating to clinical outcomes in clinical trials. The authors are donating all royalties from the sale of this book. All royalties from book sales prior to October 2019 will be shared between the following registered charities. 50% of the royalties from the sale of this book will be donated to StoneBridge City Farm, Nottingham, UK. Stonebridge City Farm is a city farm in St. Ann's, Nottingham, looking after a range of animals, large and small and growing seasonal vegetables and herbs. They are a registered charity supporting people from Nottingham with learning disabilities. http: //www.stonebridgecityfarm.com/. Registered Charity Number: 1125245. 50% of the royalties will go to Make-A-Wish Ireland. Make-A-Wish Ireland has one simple aim - to grant the wishes of children with life-threatening medical conditions, to bring hope, strength and happiness. Since 1992, Make-A-Wish has granted wishes for more than 2,300 brave children across Ireland. A wish granted is true magic for the child, providing respite from their normal routines of hospitals, doctors and treatment. Make-A-Wish does not receive any government funding, and relies overwhelmingly on the kindness of the Irish public to continue granting wishes. https: //www.makeawish.ie/ Charity Registration Number: CRA20052256 / CHY15267
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: Yasser El Miedany
Publisher: Springer
ISBN: 3319328514
Category : Medical
Languages : en
Pages : 450
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Book Description
This book discusses the role of patient reported outcome measures (PROMs) in the diagnosis and management of rheumatic diseases and their implementation in patient-centered care. It aims to improve the quality and efficiency of patient care in standard practice by outlining the appropriate information-gathering and decision-making processes. The book highlights the evidence and advanced knowledge base of PROMs in rheumatic diseases such as rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, osteoarthritis, and systemic sclerosis. Featuring reviews of Patient Reported Outcome tools and Physician RheuMetric Measures as well as examples of patient reported outcome questionnaires, Patient Reported Outcome Measures in Rheumatic Diseases serves as an excellent introduction and resource for implementation of PROMs in clinical rheumatology practice.
Author: Dr Brian Tiplady
Publisher: Gower Publishing, Ltd.
ISBN: 1409458911
Category : Psychology
Languages : en
Pages : 304
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Book Description
Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. Bill Byrom and Brian Tiplady's ePro addresses these questions, reviews the new FDA guidance, and provides a very contemporary view on this important subject.
Author: Secretary of State for Health
Publisher: The Stationery Office
ISBN: 9780101743228
Category : Business & Economics
Languages : en
Pages : 92
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Book Description
This review incorporates the views and visions of 2,000 clinicians and other health and social care professionals from every NHS region in England, and has been developed in discussion with patients, carers and the general public. The changes proposed are locally-led, patient-centred and clinically driven. Chapter 2 identifies the challenges facing the NHS in the 21st century: ever higher expectations; demand driven by demographics as people live longer; health in an age of information and connectivity; the changing nature of disease; advances in treatment; a changing health workplace. Chapter 3 outlines the proposals to deliver high quality care for patients and the public, with an emphasis on helping people to stay healthy, empowering patients, providing the most effective treatments, and keeping patients as safe as possible in healthcare environments. The importance of quality in all aspects of the NHS is reinforced in chapter 4, and must be understood from the perspective of the patient's safety, experience in care received and the effectiveness of that care. Best practice will be widely promoted, with a central role for the National Institute for Health and Clinical Excellence (NICE) in expanding national standards. This will bring clarity to the high standards expected and quality performance will be measured and published. The review outlines the need to put frontline staff in control of this drive for quality (chapter 5), with greater freedom to use their expertise and skill and decision-making to find innovative ways to improve care for patients. Clinical and managerial leadership skills at the local level need further development, and all levels of staff will receive support through education and training (chapter 6). The review recommends the introduction of an NHS Constitution (chapter 7). The final chapter sets out the means of implementation.
Author: Joanne Birk Parsons
Publisher:
ISBN:
Category : Cancer
Languages : en
Pages : 108
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Book Description
Author: Brian Tiplady
Publisher: CRC Press
ISBN: 1317141903
Category : Business & Economics
Languages : en
Pages : 236
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Book Description
Patient self-reported data has become increasingly important in today's clinical trials. Trials in some disease indications rely upon patient recorded diary data as the primary endpoint to demonstrate drug efficacy - including, for example, indications such as insomnia, migraine and pain. In addition, improvements in quality of life measured using patient questionnaires can now be included as claims on drug labelling. Traditionally these data have been collected using paper questionnaires and diaries issued to subjects. Regulators and the industry have become increasingly aware of the limitations of recording patient reported outcomes data on paper including data quality and integrity issues. As a result there is a growing interest in collection of patient reported outcomes data using electronic means (ePRO). Solutions include handheld PDAs, Interactive Voice Response (IVR) systems, and other site-based hardware such as touchscreen PCs. Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. These include: ¢ How should instruments developed on paper be adapted for electronic use, and what degree of validation should be done between paper and electronic forms? ¢ How can researchers ensure they are complying with regulatory requirements including the PRO guidance published by FDA in 2009 when using ePRO solutions? ¢ Can fewer patients be exposed in a clinical trial as a result of improved data quality obtained using electronic diaries? ¢ What type of solution should be used for certain patient populations and protocols, and how can ePRO solutions be designed optimally to increase patient acceptability and compliance? Bill Byrom and Brian Tiplady's ePro addresses all these issues, reviews the new FDA guidance, and provides a very contemporary view on this important subject.
Author: David L. Streiner
Publisher: Oxford University Press, USA
ISBN: 0199685215
Category : Language Arts & Disciplines
Languages : en
Pages : 415
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Book Description
A new edition of this practical guide for clinicians who are developing tools to measure subjective states, attitudes, or non-tangible outcomes in their patients, suitable for those who have no knowledge of statistics.
Author: Debbie Wyatt
Publisher: SAGE
ISBN: 1473927366
Category : Health & Fitness
Languages : en
Pages : 1030
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Book Description
‘This book creates new ground for all health professionals working in cancer care to read, enjoy, look at and question their practice.’ Caroline Adcock, Clinical Practice Educator – Haematology and Oncology, Royal Shrewsbury Hospital Cancer and Cancer Care is a complete study of cancer, the care of people with the disease and its impact on everyday life. Addressing the physical and psychosocial aspects of the illness in detail, it covers all fundamental aspects of cancer diagnosis, treatment, survival and aspects of psychosocial support for all those affected by cancer: patients, their families, and their healthcare providers. Chapters include: - A review of the latest theory and evidence on over 30 separate topic areas - Reflective questions which challenge readers to reappraise what they have learned - Chapter overviews and chapter summaries which highlight the key points The book is essential reading for all those on cancer care courses at undergraduate and postgraduate level. It will be valuable reading for nurses, oncologists, psychologists, social workers and all healthcare practitioners and researchers working with people affected by cancer.
