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dc.contributor.authorPorzsolt, Franz
dc.contributor.authorWyers, Peter
dc.contributor.authorEisemann, Martin
dc.contributor.authorHabs, Michael
dc.date.accessioned2013-03-12T13:36:37Z
dc.date.available2013-03-12T13:36:37Z
dc.date.issued2012
dc.description.abstractRising concern for demonstrated real world comparative effectiveness has heightened interest in “pragmatic trials” design. Pragmatic trials investigate whether the efficacy, presumed or found in explanatory trials under ideal conditions, can also be detected under real world conditions, i.e. effectiveness. It is also recognized that ‘real world’ effects which are usually addressed in public health research gain growing interest in confirming the ‘road capability’ of results obtained under ideal study conditions. This paper demonstrates that studies under ideal or real world conditions use different methods, generate different information and cannot replace each other. The PCT design meets four requirements of public health and of effectiveness research. It includes all individuals who presented with the selected condition. It classifies the included individuals according to baseline risks. It enables plausibility controls. Finally, it compares the outcomes resulting from specified and not-specified interventions or treatments. We propose a pragmatic controlled trial (PCT) design in which patient preference and other co-factors crucial in determining the actual effectiveness of interventional options will not be neutralized by concealed randomization and blinding. This design is applicable to record the selected interventions and generated outcomes in day-to-day health care and is capable of incorporating preference and other participative factors into assessment of effectiveness. The PCT design is useful for public health research, e.g. the effectiveness of interventions to change smoking habits or to prevent death from breast cancer, as well as for comparative effectiveness research where it will supplement the traditional randomized controlled trial (RCT).en
dc.identifier.citationJournal of Public Health (2012), November.en
dc.identifier.cristinIDFRIDAID 969575
dc.identifier.doihttp://dx.doi.org/10.1007/s10389-012-0544-5
dc.identifier.issn0943-1853
dc.identifier.urihttps://hdl.handle.net/10037/4960
dc.identifier.urnURN:NBN:no-uit_munin_4674
dc.language.isoengen
dc.publisherSpringerlinken
dc.rights.accessRightsopenAccess
dc.subjectVDP::Medical disciplines: 700::Basic medical, dental and veterinary science disciplines: 710en
dc.subjectVDP::Medisinske Fag: 700::Basale medisinske, odontologiske og veterinærmedisinske fag: 710en
dc.subjectVDP::Medical disciplines: 700::Clinical medical disciplines: 750en
dc.subjectVDP::Medisinske Fag: 700::Klinisk medisinske fag: 750en
dc.titleForm follows function: pragmatic controlled trials (PCTs) have to answer different questions and require different designs than randomized controlled trials (RCTs)en
dc.typeJournal articleen
dc.typeTidsskriftartikkelen
dc.typePeer revieweden


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