Patient-reported outcomes in atrial fibrillation research: results of a clinicaltrials.gov analysis

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dc.contributor.authorSteinberg, B.A.
dc.contributor.authorDorian, P.
dc.contributor.authorAnstrom, K.J.
dc.contributor.authorHess, R.
dc.contributor.authorMark, D.B.
dc.contributor.authorNoseworthy, P.A.
dc.contributor.authorSpertus, J.A.
dc.contributor.authorPiccini, J.P.
dc.date.issued2019
dc.description.abstractOBJECTIVES:This study sought to determine how frequently patient-reported outcomes (PROs) are collected in registered clinical studies of atrial fibrillation (AF). BACKGROUND:Improving symptom burden and quality of life are important goals in the treatment of AF and are best measured with PROs. METHODS:Data from Clincaltrials.gov were studied to identify PROs in AF studies. All studies reporting AF as the disease condition were included, and PROs were identified by search terms within the outcome measures field. Generic and AF-specific PROs were identified and assessed by study type and year. Clinicaltrials.gov reporting was compared with published reports of linked studies in PubMed. RESULTS:From 1999 to 2018, 1,709 studies including AF patients were posted; 238 studies (14%) included PROs. Collection of PROs was reported in 22% of trials (n = 83 of 386) studying procedural interventions and 11% of all Phase 3 studies (n = 18 of 168). Among the 238 studies with PROs, most described "quality of life" (n = 194 [82%]), and most (n = 198 [83%]) included only generic (not AF-specific) PROs. Only 17% of studies (n = 40) reporting PROs specified a previously published AF-specific tool, most commonly the AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) form (n = 20 [8.4%]). Among the available PubMed citations of 391 studies, 74 studies (19%) described collecting a specific PRO tool (n = 29 [7.4%]) for an AF-specific PRO. CONCLUSIONS:Despite increased emphasis on the importance of PROs in AF, a minority of registered clinical trials reported collecting PROs, with very few using validated, AF-specific PROs. Improving outcomes that are most important to patients will necessitate increased emphasis on these PROs in pivotal clinical studies.
dc.description.statementofresponsibilityBenjamin A.Steinberg, Paul Dorian, Kevin J.Anstrom, Rachel Hess, Daniel B.Mark, Peter A.Noseworthy ... et al.
dc.identifier.citationJACC: Clinical Electrophysiology, 2019; 5(5):599-605
dc.identifier.doi10.1016/j.jacep.2019.03.008
dc.identifier.issn2405-500X
dc.identifier.issn2405-5018
dc.identifier.orcidSpertus, J.A. [0000-0001-9485-0652] [0000-0002-2839-2611]
dc.identifier.urihttps://hdl.handle.net/2440/132200
dc.language.isoen
dc.publisherAmerican College of Cardiology Foundation
dc.rights© 2019 by the American College of Cardiology Foundation. Published by Elsevier.
dc.source.urihttps://doi.org/10.1016/j.jacep.2019.03.008
dc.subjectatrial fibrillation
dc.subjectoutcomes
dc.subjectpatient-reported outcomes
dc.subjectquality of life
dc.subject.meshHumans
dc.subject.meshAtrial Fibrillation
dc.subject.meshData Collection
dc.subject.meshQuality of Life
dc.subject.meshClinical Trials as Topic
dc.subject.meshPatient Reported Outcome Measures
dc.titlePatient-reported outcomes in atrial fibrillation research: results of a clinicaltrials.gov analysis
dc.typeJournal article
pubs.publication-statusPublished

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