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Patient-reported Outcome
A patient-reported outcome (PRO) is a health outcome directly reported by the patient who experienced it. It stands in contrast to an outcome reported by someone else, such as a physician-reported outcome, a nurse-reported outcome, and so on. PRO methods, such as questionnaires, are used in clinical trials or other clinical settings, to help better understand a treatment's efficacy or effectiveness. The use of digitized PROs, or electronic patient-reported outcomes (ePROs), is on the rise in today's health research setting. Terminology PROs should not be confused with PCOs, or '' patient-centered outcomes''. The latter implies the use of a questionnaire covering issues and concerns that are specific to a patient. Instead, ''patient-reported'' outcomes refers to reporting situations in which only the patient provides information related to a specific treatment or condition; this information may or may not be of concern to the patient. Further, PROs should not be confused with PREM ...
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Outcomes Research
Outcomes research is a branch of public health research which studies the end results ( outcomes) of the structure and processes of the health care system on the health and well-being of patients and populations. According to one medical outcomes and guidelines source book - 1996, ''Outcomes research'' includes health services research that focuses on identifying variations in medical procedures and associated health outcomes. Though listed as a synonym for the National Library of Medicine MeSH term "Outcome Assessment (Health Care)", outcomes research may refer to both health services research and healthcare outcomes assessment, which aims at Health technology assessment, decision making, and policy analysis through systematic evaluation of quality of care, access, and effectiveness. Description Outcomes research is applied to clinical and population based research that seeks to study and optimize the end results of healthcare in terms of benefits to the patient and society. T ...
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Quality Of Life
Quality of life (QOL) is defined by the World Health Organization as "an individual's perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns". Standard indicators of the quality of life include wealth, employment, the environment, physical and mental health, education, recreation and leisure time, social belonging, religious beliefs, safety, security and freedom. QOL has a wide range of contexts, including the fields of international development, healthcare, politics and employment. Health related QOL (HRQOL) is an evaluation of QOL and its relationship with health. Engaged theory One approach, called engaged theory, outlined in the journal of ''Applied Research in the Quality of Life'', posits four domains in assessing quality of life: ecology, economics, politics and culture. In the domain of culture, for example, it includes the following subdoma ...
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American Joint Replacement Registry
The American Joint Replacement Registry (AJRR) is a non-profit organization established to foster the creation of a national center for data collection, and is dedicated to the improvement in arthroplasty patient care. History In partnership with the American Academy of Orthopaedic Surgeons (AAOS), the AJRR was founded in 2009 with the goal to optimize patient outcomes through collection of data on all primary and revision total joint replacement procedures in the U.S., while enhancing patient safety, improving quality of care, and reducing the cost for patients. Since then, the AJRR has grown to over 620 participating hospitals with over 400,000 procedures in their database. Both figures are expected to increase by year's end, and will continue to do so as more participants join the registry. In February 2010, The AAOS ratified the AJRR Board of Directors. In November 2010, AJRR received 501(c)(3) status, and in December 2010, their Business Plan was finalized and approved by t ...
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Ankylosing Spondylitis Quality Of Life
The Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire is a patient-reported outcome (PRO) measure which assesses the quality of life of patients with ankylosing spondylitis. The ASQoL is based on the needs-based quality of life model. It is a self-administered questionnaire which contains 18 items and takes up to four minutes to complete. Developed by Galen Research and published in 2003, the ASQoL has been used in clinical studies worldwide. The content for the measure was drawn from qualitative interviews that were conducted with ankylosing spondylitis (AS) patients. The draft version of the ASQoL was created and then went through several stages of testing to ensure it had good face validity, content validity, reproducibility and construct validity. Content Language adaptations The ASQoL was initially developed in UK English and Dutch, but to date a total of 37 language versions have been adapted. The language adaptations can be broken down into waves: Pha ...
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Migraine Specific Quality Of Life (MSQOL)
The Migraine Specific Quality of Life (MSQoL) is a patient-reported outcome measure (PRO or PROM) which assesses the quality of life of migraineurs. It is a 25-item questionnaire which is filled out by the patient and is used to determine how the patient's life has been affected by their migraines. History and development The MSQoL was funded by the Wellcome Foundation and developed by Galen Research, as part of an international research study which was conducted in eight countries, with initial work conducted in the UK and US. In the UK, 30 patients who suffer from migraine were interviewed, while 25 patients were interviewed in the US. A focus group was also held with 5 participants. Transcripts of these interviews were used to determine the questionnaire items. The MSQoL was assessed for reliability and validity and was found to have good consistency and test-retest reliability. Scores on the MSQoL were also found to be consistent with another measure of well-being as well ...
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Consumer Assessment Of Healthcare Providers And Systems
Consumer Assessment of Healthcare Providers and Systems (CAHPS) refers to a set of surveys that ask patients to report on their health care experiences. The surveys are free to anyone who wants to use them. They focus on aspects of healthcare quality that patients find important and are well-equipped to assess, such as the communication skills of providers and ease of access to healthcare services. The development of CAHPS surveys is funded and overseen by the Agency for Healthcare Research and Quality The Agency for Healthcare Research and Quality (AHRQ; pronounced "ark" by initiates and often "A-H-R-Q" by the public) is one of twelve agencies within the United States Department of Health and Human Services (HHS). The agency is headquartered i ... (AHRQ), a US government organization. AHRQ does not administer the surveys. Surveys must be administered by a qualified vendor. Several types of CAHPS surveys are available for different kinds of healthcare settings and providers. E ...
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Nottingham Health Profile
The Nottingham Health Profile (NHP) is a general patient reported outcome measure which seeks to measure subjective health status. It is a questionnaire designed to measure a patient’s view of their own health status, in a number of areas. It can be completed in 5 minutes. The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays. The second part of the NHP is optional and can be omitted without ruining the test results. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100. __TOC__ Development Work on the NHP began in 1975 at the De ...
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SF-36
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it, the SF-6D, is commonly used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of a health treatment. The original SF-36 stemmed from the Medical Outcome Study, MOS, which was conducted by the RAND Corporation. Since then a group of researchers from the original study released a commercial version of SF-36 while the original SF-36 is available in public domain license free from RAND. A shorter version is the SF-12, which contains 12 items rather than 36. If having only adequate physical and mental health summary scores is of interest, "then the SF12 may be the instrument of choice". Difference between the SF-36 and the RAND-36 The SF-36 and RAND-36 include the same set of items that were developed in the Medical Outcomes Study. Scoring of the general h ...
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EQ-5D
EQ-5D is a standardised measure of health-related quality of life developed by thEuroQol Groupto provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys. EQ-5D assesses health status in terms of five dimensions of health and is considered a ‘generic’ questionnaire because these dimensions are not specific to any one patient group or health condition. EQ-5D can also be referred to as a patient-reported outcome (PRO) measure, because patients can complete the questionnaire themselves to provide information about their current health status and how this changes over time. ‘EQ-5D’ is not an abbreviation and is the correct term to use when referring to the instrument in general. EQ-5D is widely used around the world in clinical trials and real-world clinical settings, population studies, and health economic evaluations. By mid-2020, the number of EQ-5D studies registered with the EuroQol Group totalled over 39,000. These co ...
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Quality-adjusted Life Year
The quality-adjusted life year (QALY) is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead). QALYs can be used to inform health insurance coverage determinations, treatment decisions, to evaluate programs, and to set priorities for future programs. Critics argue that the QALY oversimplifies how actual patients would assess risks and outcomes, and that its use may restrict patients with disabilities from accessing treatment. Proponents of the measure acknowledge that the QALY has some shortcomings, but that its ability to quantify tradeoffs and opportunity costs from the patient and societal perspective make it a critical tool for equitably allocating resources. Calculation The QALY is a measure of the value of health outcomes to the people who experience ...
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Linguistic Validation
Linguistic validation is the process of investigating the reliability, conceptual equivalence, and content validityU.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH"Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims"December 2009 of translations of patient-reported outcome (PRO) measures. Methodology Most usually, linguistic validation refers to a process whereby translated text is actively tested with patients in the target population and target language group through cognitive debriefing interviews. For example, if the PRO instrument is intended to measure the symptoms of diabetes in a trial in Denmark, the linguistic validation interviews would be conducted with diabetic patients in Denmark, who speak Danish as their mother tongue. Th ...
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Journal Of Comparative Effectiveness Research
The ''Journal of Comparative Effectiveness Research'' is a peer-reviewed medical journal that was established in 2012 and is published by Future Medicine. The editors-in-chief are Sheldon Greenfield (University of California, Irvine) and Eugene Rich ( Mathematica Policy Research). The journal covers all aspects of comparative effectiveness research, including patient-centered outcomes research, pharmacoeconomics and health economics, relating to diagnostics, therapeutics, surgical procedures, or other healthcare services or options. Abstracting and indexing The journal is abstracted and indexed in EMBASE/ Excerpta Medica, EMCare, Index Medicus/MEDLINE/PubMed, Science Citation Index Expanded, and Scopus. According to the ''Journal Citation Reports'', the journal has a 2016 impact factor The impact factor (IF) or journal impact factor (JIF) of an academic journal is a scientometric index calculated by Clarivate that reflects the yearly mean number of citations of artic ...
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