title: [The truth about the clinical reality is in the registries. A register-based randomized clinical trial could provide representative picture].
abstract: A randomized, controlled clinical trial (RCT) is the best way to compare two treatment options since it eliminates the problem with confounding. However, todays' RCTs are often limited by including selected patients by the use of narrow inclusion criteria and multiple exclusion criteria. In a recent study of myocardial infarction survivors, the median age was 10 years older and the long term risk was 2-3 times higher in »real-world« data from a national registry compared with results from recently performed RCTs. These results raise questions about the generalizability of many RCTs. Our registries should therefore be used more often to evaluate new treatments. Registry-based randomized, controlled clinical trial (R-RCT) is a new concept that may not only lower the costs of randomized studies but also increase the generalizability of the trials.
authors.affiliation: - Hjärtkliniken Stockholm, Sweden - Hjärtkliniken Stockholm, Sweden.
authors.forename: Tomas
authors.initials: T
authors.lastname: Jernberg
authors.affiliation: Universitetssjukhuset i Linköping - Kardiologiska kliniken Linköping, Sweden Universitetssjukhuset i Linköping - Kardiologiska kliniken Linköping, Sweden.
authors.forename: Magnus
authors.initials: M
authors.lastname: Janzon
mesh_terms: D000367:Age Factors; D006801:Humans; D009203:Myocardial Infarction / Q000150:complications / Q000401:mortality; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012042:Registries / Q000592:standards*; D013548:Sweden / Q000453:epidemiology