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84:
to the patient; not including safety for fetus). Since data quality can be evaluated outside a particular purpose (on a general level), fitness for purpose is evaluated separate from data quality and is not included in the concept of data quality.* Real-World
Evidence ā What Is It and What Can It Tell Us?
50:
in question as expected. RWE provides answers to these problems and also to analyze effects of drugs over a longer period of time. Pharmaceutical companies and health insurance payers study RWE to understand patient pathways to deliver appropriate care for appropriate individuals and to minimize their own
49:
Real-world evidence comes into play when clinical trials cannot really account for the entire patient population of a particular disease. Patients with comorbidities or belonging to a distant geographic region or age limit who did not participate in any clinical trial may not respond to the treatment
83:
must be fit for purpose. An RWD resource can be fit for addressing some questions, but not others. For example, a dataset that lacks mother-to-baby links may not be appropriate to address drug risk for fetus but can be used for questions for drug safety in patients taking epilepsy treatment (limited
70:
to generate evidence, data must be of sufficient quality. Kahn et al. define data quality as consisting of three components: (1) conformance (do data values adhere to do specified standard and formats?; subtypes: value, relational and computational conformance); (2) completeness (are data values
62:
Data quality (DQ) is the degree to which a given dataset meets a user's requirements. In the primary healthcare setting, poor quality data can lead to poor patient care, negatively affect the validity and reproducibility of research results and limit the value that such data may have for public
308:
Berger, Marc L. et al. āGood
Practices for Realāworld Data Studies of Treatment And/or Comparative Effectiveness: Recommendations from the Joint ISPORāISPE Special Task Force on Realāworld Evidence in Health Care Decision Making.ā
244:
Kahn MG, Callahan TJ, Barnard J, Bauck AE, Brown J, Davidson BN, Estiri H, Goerg C, Holve E, Johnson SG, Liaw ST, Hamilton-Lopez M, Meeker D, Ong TC, Ryan P, Shang N, Weiskopf NG, Weng C, Zozus MN, Schilling L (2016).
34:(RWD). RWE can be generated by different study designs or analyses, including but not limited to, randomized trials, including large simple trials, pragmatic trials, and retrospective or prospective
361:
201:
Ehsani-Moghaddam B, Martin K, Queenan JA (2021). "Data quality in healthcare: A report of practical experience with the
Canadian Primary Care Sentinel Surveillance Network data".
71:
present?); and (3) plausibility (are data values believable?; subtypes uniqueness, atemporal; temporal). Sometimes, data reliability and data quality are used interchangeably.
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is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of
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247:"A Harmonized Data Quality Assessment Terminology and Framework for the Secondary Use of Electronic Health Record Data"
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169:"Text - H.R.34 - 114th Congress (2015-2016): 21st Century Cures Act | Congress.gov | Library of Congress"
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Clinical evidence of medical product's benefits or risks derived from analysis of real-world data
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Mahajan, Rajiv. āReal World Data: Additional Source for Making
Clinical Decisions.ā
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362:"Real-world evidence: From activity to impact in healthcare decision making"
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International
Journal of Applied and Basic Medical Research
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243:
352:"Observational Health Data Sciences and Informatics"
343:"Use of Real World Data in Development Programmes"
79:Similarly to having sufficient data quality, the
1728:
182:Commissioner, Office of the (April 25, 2023).
54:by investing on drugs that work for patients.
1211:
382:
315:26.9 (2017): 1033ā1039. PMC. Web. 5 May 2018.
181:
46:to expand the role of real world evidence.
1218:
1204:
671:Reproductive endocrinology and infertility
389:
375:
1012:Bachelor of Medicine, Bachelor of Surgery
270:
1510:Preventable fraction among the unexposed
1506:Attributable fraction for the population
1514:Preventable fraction for the population
1502:Attributable fraction among the exposed
1729:
137:
74:
1199:
370:
203:Health Information Management Journal
1677:Correlation does not imply causation
1593:Animal testing on non-human primates
1150:
911:Physical medicine and rehabilitation
312:Pharmacoepidemiology and Drug Safety
299:5.2 (2015): 82. PMC. Web. 5 May 2018
125:Correlation does not imply causation
1160:
87:The New England Journal of Medicine
13:
1047:Medical Scientist Training Program
237:
14:
1758:
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161:
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1560:Pre- and post-test probability
1282:Patient and public involvement
1037:Doctor of Osteopathic Medicine
471:Oral and maxillofacial surgery
357:"Need for Real World Evidence"
302:
287:
194:
175:
1:
130:
1687:Sex as a biological variable
1017:Bachelor of Medical Sciences
784:Neurosurgical anesthesiology
396:
7:
1651:Intention-to-treat analysis
1623:Analysis of clinical trials
1552:Specificity and sensitivity
1306:Randomized controlled trial
93:
10:
1763:
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1660:Interpretation of results
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1621:
1570:
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1393:Nested caseācontrol study
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995:
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684:
639:
548:
419:
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1262:Academic clinical trials
971:Transplantation medicine
862:Clinical neurophysiology
779:Obstetric anesthesiology
699:Interventional radiology
459:Digestive system surgery
338:"21st Century Cures Act"
215:10.1177/1833358319887743
110:Pragmatic clinical trial
1480:Relative risk reduction
1328:Adaptive clinical trial
1272:Evidence-based medicine
1255:Adaptive clinical trial
842:Intensive care medicine
816:Mass gathering medicine
661:Maternalāfetal medicine
263:10.13063/2327-9214.1244
100:Evidence-based medicine
1468:Number needed to treat
434:Cardiothoracic surgery
40:21st Century Cures Act
1472:Number needed to harm
1359:Cross-sectional study
1311:Scientific experiment
1267:Clinical study design
1085:Personalized medicine
944:Reproductive medicine
869:Occupational medicine
823:Evolutionary medicine
329:"Real World Evidence"
184:"Real-World Evidence"
145:"Real-World Evidence"
120:Quantitative research
63:health surveillance.
36:observational studies
1438:Cumulative incidence
1105:Traditional medicine
1065:Alternative medicine
932:Addiction psychiatry
746:Transfusion medicine
741:Medical microbiology
656:Gynecologic oncology
508:Reproductive surgery
115:Qualitative research
90:, December 6, 2016.
1345:Observational study
1277:Real world evidence
1231:experimental design
1127:History of medicine
1110:Veterinary medicine
917:Preventive medicine
769:Adolescent medicine
611:Infectious diseases
75:Fitness for purpose
20:Real-world evidence
1742:Health informatics
1631:Riskābenefit ratio
1598:First-in-man study
1548:Case fatality rate
1389:Caseācontrol study
1363:Longitudinal study
1075:Molecular oncology
1032:Doctor of Medicine
1022:Master of Medicine
939:Radiation oncology
811:Emergency medicine
764:Addiction medicine
731:Clinical chemistry
726:Clinical pathology
518:Transplant surgery
476:Orthopedic surgery
454:Colorectal surgery
105:Levels of evidence
1747:Clinical research
1724:
1723:
1672:Survivorship bias
1636:Systematic review
1603:Multicenter trial
1566:
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1556:Likelihood-ratios
1528:Clinical endpoint
1496:Population impact
1450:Period prevalence
1227:Clinical research
1193:
1192:
1027:Master of Surgery
991:
990:
976:Tropical medicine
922:Prison healthcare
837:Hospital medicine
801:Disaster medicine
791:Aviation medicine
606:Hospital medicine
513:Surgical oncology
498:Pediatric surgery
492:
439:Endocrine surgery
38:. In the USA the
1754:
1571:Trial/test types
1446:Point prevalence
1424:
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1367:Ecological study
1350:EBM II-2 to II-3
1321:Open-label trial
1316:Blind experiment
1292:Controlled study
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847:Medical genetics
832:General practice
709:Nuclear medicine
584:Gastroenterology
540:Vascular surgery
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66:In order to use
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1120:Chief physician
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981:Travel medicine
966:Sports medicine
949:Sexual medicine
889:Palliative care
884:Pain management
828:Family medicine
806:Diving medicine
752:
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635:
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503:Plastic surgery
449:General surgery
429:Cardiac surgery
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81:real-world data
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1715:List of topics
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961:Sleep medicine
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1488:Hazard ratio
1372:Cohort study
1276:
1095:Rural health
1080:Nanomedicine
631:Rheumatology
562: /
481:Hand surgery
466:Neurosurgery
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152:. Retrieved
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58:Data quality
48:
23:
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1682:Null result
1641:Replication
1536:Infectivity
1458:Association
1409:Case report
1399:Case series
1382:Prospective
1165:Wikiproject
954:Venereology
899:Neonatology
796:Dermatology
651:Gynaecology
643:gynaecology
626:Pulmonology
444:Eye surgery
406:Specialties
257:(1): 1244.
149:www.fda.gov
1731:Categories
1484:Odds ratio
1476:Risk ratio
1442:Prevalence
1428:Occurrence
1404:Case study
927:Psychiatry
913:(PM&R)
906:Phlebology
894:Pediatrics
721:Anatomical
686:Diagnostic
666:Obstetrics
616:Nephrology
601:Hematology
596:Geriatrics
589:Hepatology
574:Cardiology
564:Immunology
154:2022-09-19
131:References
1544:Morbidity
1532:Virulence
1434:Incidence
1115:Physician
999:education
857:Neurology
852:Narcology
716:Pathology
694:Radiology
569:Angiology
533:Andrology
231:208743562
1737:Evidence
1708:Glossary
1701:Category
1578:In vitro
1419:Measures
1238:Overview
1145:Category
621:Oncology
552:medicine
550:Internal
398:Medicine
281:27713905
223:31805788
94:See also
28:medicine
1583:In vivo
1185:Outline
1155:Commons
1100:Therapy
997:Medical
560:Allergy
528:Urology
421:Surgery
272:5051581
1175:Portal
1042:MDāPhD
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1522:Other
757:Other
251:eGEMs
227:S2CID
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277:PMID
219:PMID
491:ENT
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345:at
333:FDA
331:at
267:PMC
259:doi
211:doi
188:FDA
44:FDA
24:RWE
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