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| electronic clinical outcome assessment: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 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. |
| electronic clinical outcome assessment: Electronic Patient-Reported Outcome Measures Bill Byrom, Willie Muehlhausen, 2018-09-19 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 |
| electronic clinical outcome assessment: The Prevention and Treatment of Missing Data in Clinical Trials National Research Council, Division of Behavioral and Social Sciences and Education, Committee on National Statistics, Panel on Handling Missing Data in Clinical Trials, 2010-12-21 Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data. |
| electronic clinical outcome assessment: Field Trials of Health Interventions Peter G. Smith, Richard H. Morrow, David A. Ross, 2015 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. |
| electronic clinical outcome assessment: Patient-Reported Outcomes in Performance Measurement David Cella, Elizabeth A. Hahn, Sally E. Jensen, Zeeshan Butt, Cindy J. Nowinski, Nan Rothrock, Kathleen N. Lohr, 2015-09-17 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. |
| electronic clinical outcome assessment: EPro Bill Byrom, Brian Tiplady, 2010 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. |
| electronic clinical outcome assessment: Sharing Clinical Trial Data Institute of Medicine, Board on Health Sciences Policy, Committee on Strategies for Responsible Sharing of Clinical Trial Data, 2015-04-20 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. |
| electronic clinical outcome assessment: Neuroscience Trials of the Future National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Neuroscience and Nervous System Disorders, 2016-11-07 On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future. |
| electronic clinical outcome assessment: Outcome Assessment in Advanced Practice Nursing Ruth M. Kleinpell, 2004-01-15 This book provides up-to-date resources and examples of outcome measures, tools and methods that can be used by APNs in their quest to keep pace with new developments in the rapidly expanding field of outcome measurement. The chapter authors, recognized expert practitioners, offer invaluable insight into the process of conducting outcomes assessments in all APN practice, including the clinical nurse, nurse practitioner, certified registered nurse anesthetist and certified nurse midwife practice specialties. Detailed figures, tables, and examples of outcome studies from actual research in APN practice make this an essential resource for evaluating the true impact the advanced practice nurse has on the delivery and fulfillment of care. |
| electronic clinical outcome assessment: Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide Agency for Health Care Research and Quality (U.S.), 2013-02-21 This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. 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. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov) |
| electronic clinical outcome assessment: Needs of the Cancer Patient Joanne Birk Parsons, 1977 |
| electronic clinical outcome assessment: Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies OECD, World Health Organization, 2019-10-17 This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies. |
| electronic clinical outcome assessment: Novel Designs of Early Phase Trials for Cancer Therapeutics Shivaani Kummar, Chris Takimoto, 2018-05-26 Novel Designs of Early Phase Trials for Cancer Therapeutics provides a comprehensive review by leaders in the field of the process of drug development, the integration of molecular profiling, the changes in early phase trial designs, and endpoints to optimally develop a new generation of cancer therapeutics. The book discusses topics such as statistical perspectives on cohort expansions, the role and application of molecular profiling and how to integrate biomarkers in early phase trials. Additionally, it discusses how to incorporate patient reported outcomes in phase one trials. This book is a valuable resource for medical oncologists, basic and translational biomedical scientists, and trainees in oncology and pharmacology who are interested in learning how to improve their research by using early phase trials. |
| electronic clinical outcome assessment: Outcome Measures and Metrics in Systemic Lupus Erythematosus Zahi Touma, 2021-07-22 Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that manifests with a myriad of clinical and laboratory features. The assessment of SLE is comprehensive and includes different core set domains; disease activity, damage, health-related quality of life, adverse events and economic impact. This comprehensive book is focused on the instruments and outcome measures utilized in the assessment of SLE. It targets different audiences including physicians, scientists/researchers and different health professionals interested in learning about the art of measurement in SLE. The book highlights the importance of measurement in the assessment of SLE in a clinical settings, research and clinical trials. Each of the chapters provide a systematic approach to the instruments utilized in the assessment of a specific construct in SLE (e.g., disease activity, fatigue, etc.) and incorporate a comprehensive coverage of disease specific and disease generic measures. It also discusses different patient-reported outcomes that are crucial to reflect patient perceptions of their health condition and cover constructs such as fatigue, pain, anxiety and depression, cognition, frailty, and many others. |
| electronic clinical outcome assessment: Essentials of Outcome Assessment Benjamin M. Ogles, Michael J. Lambert, Scott A. Fields, 2002-04-22 The authors are the leading experts in outcome assessment. * Call-out boxes, bullet points, icons, and other reader-friendly design elements are used extensively throughout the text. * Written in an engaging, easy-reference style. |
| electronic clinical outcome assessment: Health Measurement Scales David L. Streiner, Geoffrey R. Norman, John Cairney, 2015 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. |
| electronic clinical outcome assessment: Patient-Reported Outcomes Joseph C. Cappelleri, Kelly H. Zou, Andrew G. Bushmakin, Jose Ma. J. Alvir, Demissie Alemayehu, Tara Symonds, 2013-12-20 Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up-to-date volume on conceptual and analytical issues of PRO measures. The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO measures. It covers both introductory and advanced psychometric and biostatistical methods for constructing and analyzing PRO measures. The authors include many relevant real-life applications based on their extensive first-hand experiences in the pharmaceutical industry. They implement a wealth of simulated datasets to illustrate concepts and heighten understanding based on practical scenarios. For readers interested in conducting statistical analyses of PRO measures and delving more deeply into the analytic details, most chapters contain SAS code and output that illustrate the methodology. Along with providing numerous references, the book highlights current regulatory guidelines. |
| electronic clinical outcome assessment: Effective Psychotherapists William R. Miller, Theresa B. Moyers, 2021-02-08 What is it that makes some therapists so much more effective than others, even when they are delivering the same evidence-based treatment? This instructive book identifies specific interpersonal skills and attitudes--often overlooked in clinical training--that facilitate better client outcomes across a broad range of treatment methods and contexts. Reviewing 70 years of psychotherapy research, the preeminent authors show that empathy, acceptance, warmth, focus, and other characteristics of effective therapists are both measurable and teachable. Richly illustrated with annotated sample dialogues, the book gives practitioners and students a blueprint for learning, practicing, and self-monitoring these crucial clinical skills. |
| electronic clinical outcome assessment: Basic Methods Handbook for Clinical Orthopaedic Research Volker Musahl, Jón Karlsson, Michael T. Hirschmann, Olufemi R. Ayeni, Robert G. Marx, Jason L. Koh, Norimasa Nakamura, 2019-02-01 This book is designed to meet the needs of both novice and senior researchers in Orthopaedics by providing the essential, clinically relevant knowledge on research methodology that is sometimes overlooked during training. Readers will find a wealth of easy-to-understand information on all relevant aspects, from protocol design, the fundamentals of statistics, and the use of computer-based tools through to the performance of clinical studies with different levels of evidence, multicenter studies, systematic reviews, meta-analyses, and economic health care studies. A key feature is a series of typical case examples that will facilitate use of the volume as a handbook for most common research approaches and study types. Younger researchers will also appreciate the guidance on preparation of abstracts, poster and paper presentations, grant applications, and publications. The authors are internationally renowned orthopaedic surgeons with extensive research experience and the book is published in collaboration with ISAKOS. |
| electronic clinical outcome assessment: Cochrane Handbook for Systematic Reviews of Interventions Julian P. T. Higgins, Sally Green, 2008-11-24 Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves. |
| electronic clinical outcome assessment: Principles of Assessment and Outcome Measurement for Allied Health Professionals Alison J. Laver-Fawcett, Diane L. Cox, 2021-10-26 Principles of Assessment and Outcome Measurement for Allied Health Professionals The revised and updated second edition of Principles of Assessment and Outcome Measurement for Allied Health Professionals offers an authoritative guide for allied health professionals and students. The authors, noted experts on the topic, explore the assessment process that encompasses the data collection methods, the evaluation process that determines the effectiveness of an intervention, and standardised and systematic outcome measurement procedures. The book discusses in detail the various methods of data collection (observation, interview, standardised testing) and the types of sources (self-report, proxy, observational) for collecting information. The main purposes of assessment (descriptive, evaluative, predictive, discriminative) are also presented. The book addresses the topics of standardization, levels of measurement, reliability, validity, and clinical usefulness. The text provides the information needed to select and perform assessment and outcomes measurement to inform goal setting, evaluate outcomes, and ensure that interventions are effective, efficient, and economical in order to provide quality services to clients and their carers. This important book: Covers information on assessment and measurement in practice, research, and service evaluation and improvement Explores how to develop and evaluate assessments and outcome measures Offers an international perspective Discusses the criteria for choosing a particular assessment approach Informs the critical appraisal of the evidence underpinning standardised assessments and measures, and selecting the best tools for practice or research Includes updated and additional case studies Provides worksheets and additional illustrations to enhance understanding Written for allied health students and professionals, Principles of Assessment and Outcome Measurement for Allied Health Professionals is the essential guide to assessing, measuring, and evaluating the impact and outcome of clinical practice and interventions. |
| electronic clinical outcome assessment: Cancer and Cancer Care Debbie Wyatt, Nicholas Hulbert-Williams, 2014-11-30 ‘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. |
| electronic clinical outcome assessment: The SAGE Encyclopedia of Educational Research, Measurement, and Evaluation Bruce B. Frey, 2018-01-29 This encyclopedia is the first major reference guide for students new to the field, covering traditional areas while pointing the way to future developments. |
| electronic clinical outcome assessment: Outcome Measures for Health Education and Other Health Care Interventions Kate Lorig, Anita Stewart, Philip Ritter, Virginia Gonzalez, Diana Laurent, John Lynch, 1996-04-18 Although Outcome Measurement has become an important tool in the evaluation of health promotion patient education and other health services interventions, problems remain in locating reliable measurements and scales. This book provides a unique compilation of more than 50 self-administered scales for measuring health behaviors, health status, self-efficacy, and health-care utilization. |
| electronic clinical outcome assessment: Raynaud’s Phenomenon Fredrick M. Wigley, Ariane L. Herrick, Nicholas A. Flavahan, 2014-10-24 Raynaud’s Phenomenon: A Guide to Pathogenesis and Treatment comprehensively reviews the understanding of a disorder that continues to challenge primary care clinicians and specialists alike. In the last decade, there have been important advances not only in understanding the pathophysiology of Raynaud’s Phenomenon (RP), but also in developing diagnostic methods and effective drug and non-drug therapies. Thoroughly discussing the various manifestations of RP, including childhood RP, RP secondary to connective tissue disease, and a variety of other associated disorders that include vascular perturbation that mimics RP, this title provides a wealth of new information available on normal and abnormal thermoregulation and helps physicians identify the best therapeutic approaches to treating RP. The work offers differential diagnosis options, reviews potential causes such as autoimmune disease, industrial trauma, drugs, and metabolic causes and provides clear recommendations for therapy. Engaging readers with case vignettes and a plethora of visual aids, Raynaud’s Phenomenon: A Guide to Pathogenesis and Treatment is a state-of-the-art, authoritative reference and invaluable contribution to the literature that will be of interest to physicians, patients, and individuals dealing with these disease processes. |
| electronic clinical outcome assessment: Mental Health Outcome Measures Graham Thornicroft, Michele Tansella, 2012-12-06 Mental Health Outcome Measures provides an authoritative review of measurement scales currently available to assess the outcomes of mental health service intervention. The excerpt of summaries by leading writers in the field assess the contributions of scale in areas including mental state examination, quality of life, patient satisfaction, needs assessments, measurement of service cost, global functioning scales, and social disability. These chapters provide a critical appraisal of how far such scales have been shown to be reliable and valid, and provide valuable insights in to their ease of use. This book will provide an invaluable reference manual for those who want to take research on mental health services, and for those who need to interpret this research for policy, planning, and clinical practice. |
| electronic clinical outcome assessment: Cognitive Interviewing Gordon B. Willis, 2005 The work provides general guidance about questionnaire design, development, and pre-testing sequence, with an emphasis on the cognitive interview. |
| electronic clinical outcome assessment: Diagnostic and Statistical Manual of Mental Disorders (DSM-5) American Psychiatric Association, 2021-09-24 |
| electronic clinical outcome assessment: Clinical Pharmacist's Guide to Biostatistics and Literature Evaluation Robert DiCenzo, 2011 Whether you are interpreting the medical literature to optimize patient care, improve health outcomes, or generate hypothesis for research, an understanding of biostatistics is essential for success. Despite exposure to biostatistics in undergraduate and professional education, pharmacists tend to be less confident in their knowledge of biostatistics and their ability to interpret the medical literature than in their clinical skills. This book was developed to bolster the pharmacist's knowledge and confidence for using biostatistical tools for interpreting the literature. With material drawn from ACCP's renowned Pharmacotherapy Self-Assessment Program (PSAP) and the live pharmacotherapy preparatory course Updates in Therapeutics, editor Robert DiCenzo, Pharm.D., FCCP, BCPS, has designed this review to support pharmacists' preparation for the Pharmacotherapy and Ambulatory Care Board of Pharmacy Specialties (BPS) examinations. |
| electronic clinical outcome assessment: Physical Rehabilitation Outcome Measures Elspeth Finch, 2002 The revised and expanded second edition of this easy-to-use manual reflects current methods used by today's rehabilitation professionals to establish and measure outcomes. Chapters cover the development of an outcome measure plan, how to choose the appropriate outcome measure, measure properties and terms used in review of measures, the application of outcome measures to individual clients, and how outcome data can be used in client programme planning and evaluation. New to this edition are: a new template for reviewing outcome measures, updated terminology, case histories, and a new appendix including a critical appraisal form. A dual-platform CD-ROM accompanying the book contains a new template for reviewing outcome measures, revised terminology and reviews and references for over 70 measures. |
| electronic clinical outcome assessment: Principles and Practice of Clinical Research John I. Gallin, Frederick P Ognibene, 2011-04-28 The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government |
| electronic clinical outcome assessment: Guidelines for Computer-based Tests and Interpretations American Psychological Association. Committee on Professional Standards, 1986 |
| electronic clinical outcome assessment: User's Manual for the Medical Outcomes Study (MOS) Core Measures of Health-related Quality of Life Ron D. Hays, Cathy Donald Sherbourne, Rebecca M. Mazel, 1995 This manual describes self-administered patient questionnaires that were developed for patients participating in the Medical Outcomes Study. |
| electronic clinical outcome assessment: Motivational Enhancement Therapy Manual , 1992 |
| electronic clinical outcome assessment: Equity and excellence: Great Britain: Department of Health, 2010-07-12 Equity and Excellence : Liberating the NHS: Presented to Parliament by the Secretary of State for Health by Command of Her Majesty |
| electronic clinical outcome assessment: Quality of Life Peter M. Fayers, David Machin, 2013-05-23 Quality of life studies form an essential part of the evaluation of any treatment. Written by two authors who are well respected within this field, Quality of Life: The Assessment, Analysis and Interpretation of Patient-reported Outcomes, Second Edition lays down guidelines on assessing, analysing and interpreting quality of life data. The new edition of this standard book has been completely revised, updated and expanded to reflect many methodological developments emerged since the publication of the first edition. Covers the design of instruments, the practical aspects of implementing assessment, the analyses of the data, and the interpretation of the results Presents all essential information on Quality of Life Research in one comprehensive volume Explains the use of qualitative and quantitative methods, including the application of basic statistical methods Includes copious practical examples Fills a need in a rapidly growing area of interest New edition accommodates significant methodological developments, and includes chapters on computer adaptive testing and item banking, choosing an instrument, systematic reviews and meta analysis This book is of interest for everyone involved in quality of life research, and it is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and practitioners in the fields of cancer and other chronic diseases. Reviews of the First Edition – Winner of the first prize in the Basis of Medicine Category of the BMA Medical Book Competition 2001: “This book is highly recommended to clinicians who are actively involved in the planning, analysis and publication of QoL research.” CLINICAL ONCOLOGY “This book is highly recommended reading.” QUALITY OF LIFE RESEARCH |
| electronic clinical outcome assessment: Mindfulness-oriented Recovery Enhancement for Addiction, Stress, and Pain Eric L. Garland, 2013 Human existence can be beset by a variety of negative mental states such that life seems devoid of meaning, but it can also be liberated--a meaningful life reclaimed and savored through cultivation of a higher kind of mind. This quality, mindfulness, refers to both a set of contemplative practices and certain distinct psychological states and traits, and it can be cultivated through intentional effort and training. In Mindfulness-Oriented Recovery Enhancement for Addiction, Stress, and Pain, Eric L. Garland presents an innovative program of intervention that can be put into practice by therapists working with people struggling with addiction and the conditions that underlie it. Unlike other substance abuse treatment modalities, which focus largely on relapse prevention, Mindfulness-Oriented Recovery Enhancement (MORE) concentrates on helping people to recover a sense of meaning and fulfillment in everyday life, embracing its pleasures and pain without avoiding challenges by turning to substance use. Along with chapters on the bipsychosocial model underlying MORE and the current state of research on mindfulness, this book includes a complete treatment manual laying out for clinicians, step by step, how to run MORE groups--including adaptations to address chronic pain and prescription opioid misuse-- and enhance the holistic recovery process for people striving to overcome addiction. With addiction a widespread and growing problem in our society, Mindfulness-Oriented Recovery Enhancement could not be more timely or needed. It integrates the latest research on addiction, cognitive neuroscience, positive psychology, and mindfulness into a practice that has garnered empirical support and holds the promise of release and fulfillment for those who suffer from addiction.--Publisher's website. |
| electronic clinical outcome assessment: Fast Facts: Digital Medicine A. Coravos, J.C. Goldsack, D.R. Karlin, C. Nebeker, E. Perakslis, N. Zimmerman, M.K. Erb, 2020-04-03 Technology is changing how we practice medicine. Sensors and wearables are getting smaller and cheaper, and algorithms are becoming powerful enough to predict medical outcomes. Yet despite rapid advances, healthcare lags behind other industries in truly putting these technologies to use. A major barrier is the cross-disciplinary approach required to create digital tools, a process that requires knowledge from many people across a range of fields. 'Fast Facts: Digital Medicine – Measurement' aims to overcome that barrier, introducing the reader to core concepts and terms and facilitating dialogue. Contrasting 'clinical research' with routine 'clinical care', this short colorful book describes types of digital measurement and how to use and validate digital measures in different settings. And with the burgeoning development of digital medicine tools, the authors provide a timely overview of the security, ethical, regulatory and legal issues to be considered before a product can enter the market. Contents: • What is digital medicine? • Where does digital medicine fit? • Regulatory considerations • Ethical principles and our responsibilities • Ethics in practice • Security, data rights and governance • Digital biomarkers and clinical outcomes • Measurement in clinical trials • Verification and validation • The future of digital medicine |
| electronic clinical outcome assessment: Occupational Therapy Practice Framework: Domain and Process Aota, 2014 As occupational therapy celebrates its centennial in 2017, attention returns to the profession's founding belief in the value of therapeutic occupations as a way to remediate illness and maintain health. The founders emphasized the importance of establishing a therapeutic relationship with each client and designing an intervention plan based on the knowledge about a client's context and environment, values, goals, and needs. Using today's lexicon, the profession's founders proposed a vision for the profession that was occupation based, client centered, and evidence based--the vision articulated in the third edition of the Occupational Therapy Practice Framework: Domain and Process. The Framework is a must-have official document from the American Occupational Therapy Association. Intended for occupational therapy practitioners and students, other health care professionals, educators, researchers, payers, and consumers, the Framework summarizes the interrelated constructs that describe occupational therapy practice. In addition to the creation of a new preface to set the tone for the work, this new edition includes the following highlights: a redefinition of the overarching statement describing occupational therapy's domain; a new definition of clients that includes persons, groups, and populations; further delineation of the profession's relationship to organizations; inclusion of activity demands as part of the process; and even more up-to-date analysis and guidance for today's occupational therapy practitioners. Achieving health, well-being, and participation in life through engagement in occupation is the overarching statement that describes the domain and process of occupational therapy in the fullest sense. The Framework can provide the structure and guidance that practitioners can use to meet this important goal. |
| electronic clinical outcome assessment: Quality of Life Assessment in Clinical Trials Maurice J. Staquet, Ron D. Hays, Peter M. Fayers, 1998 Researchers in all clinical fields are becoming increasingly aware of the importance of quality of life measurements in judging the efficacy of a given treatment, and it is becoming more common for psychological criteria to play an important role in the evaluation of therapies. In the past ten years a number of methods have been developed for carrying out such assessments. Quality of life research does however use special statistical methods which might well be unfamiliar to the clinician. Quality of life assessment in clinical trials: methods and practice explores these methods in a non-mathematical manner, comparing and contrasting the tools available to the clinician, and highlighting any potential pitfalls. It describes the methods used to collect and analyse quality of life data. The book will have widespread appeal to clinical trialists and researchers from a wide range of specialties. |
Electronics - Wikipedia
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The data models used often vary by eCOA (electronic Clinical Outcome Assessment) provider and sponsor. Standardization of PRO data sets in clinical trials is crucial for ensuring …
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the data gap/Level of clinical evidence required: The level of clinical evidence needed to fill the clinical evidence gap must be considered when determining the methods for data collection. …
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The data models used often vary by eCOA (electronic Clinical Outcome Assessment) provider and sponsor. Standardization of PRO data sets in clinical trials is crucial for ensuring …
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Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
Electronic Clinical Outcome Assessment Solutions Market …
Electronic Clinical Outcome Assessment Solutions Market Growth & Trends The global electronic clinical outcome assessment solutions market size is anticipated to reach USD 4.12 billion by …
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Computerised systems, electronic data, validation, audit trail, user management, security, electronic clinical outcome assessment (eCOA), interactive response technology (IRT), case …
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Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
Accelerating Study Start Up Through An Electronic Clinical …
Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
Accelerating Study Start Up Through An Electronic Clinical …
Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
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Accelerating Study Start Up Through An Electronic Clinical …
Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
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Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
Accelerating Study Start Up Through An Electronic Clinical …
Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
Accelerating Study Start Up Through An Electronic Clinical …
Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
Accelerating Study Start Up Through An Electronic Clinical …
Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
Accelerating Study Start Up Through An Electronic Clinical …
Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
Accelerating Study Start Up Through An Electronic Clinical …
Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
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Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
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Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
Accelerating Study Start Up Through An Electronic Clinical …
Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
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Through An Electronic Clinical Outcome Assessment (eCOA) Library IQVIA’s global library of pre-built assessments gives sponsors instant access to validated tools that capture the patient’s …
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