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Patient-Reported Outcomes in Atrial Fibrillation Research: Results of a Clinicaltrials.gov Analysis.

ABSTRACT: OBJECTIVES: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.

SUBMITTER: Steinberg BA

PROVIDER: S-EPMC6540810 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Patient-Reported Outcomes in Atrial Fibrillation Research: Results of a Clinicaltrials.gov Analysis.

Steinberg Benjamin A BA Dorian Paul P Anstrom Kevin J KJ Hess Rachel R Mark Daniel B DB Noseworthy Peter A PA Spertus John A JA Piccini Jonathan P JP

JACC. Clinical electrophysiology 20190501 5

<h4>Objectives</h4>This study sought to determine how frequently patient-reported outcomes (PROs) are collected in registered clinical studies of atrial fibrillation (AF).<h4>Background</h4>Improving symptom burden and quality of life are important goals in the treatment of AF and are best measured with PROs.<h4>Methods</h4>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 t ...[more]

PMID: 31122382

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Project description:BackgroundAtrial fibrillation is a large and growing burden across all types of healthcare. Both incidence and prevalence are expected to double in the next 20 years, with huge impact on hospital admissions, costs and patient quality of life. Patient wellbeing determines the management strategy for atrial fibrillation, including the use of rhythm control therapy and the clinical success of heart rate control. Hence, evaluation of quality of life is an emerging and important part of the assessment of patients with atrial fibrillation. Although a number of questionnaires to assess quality of life in atrial fibrillation are available, a comprehensive overview of their measurement properties is lacking.Methods and resultsWe performed a systematic review of the measurement properties of atrial fibrillation-specific health-related quality of life questionnaires. Methodological quality was assessed using the Consensus based Standards for selection of health Measurement Instruments (COSMIN) checklist, with measurement properties rated for quality against optimal criteria and levels of evidence. We screened 2,216 articles, of which eight articles describing five questionnaires were eligible for inclusion: Atrial Fibrillation 6 (AF6), Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT), Atrial Fibrillation Quality of Life Questionnaire (AFQLQ), Atrial Fibrillation Quality of Life (AFQoL), and Quality of Life in Atrial Fibrillation (QLAF). Good reliability (internal consistency and test-retest reliability) was demonstrated for AF6, AFEQT, AFQLQ and AFQoL. Content, construct and criterion validity were positively rated only in AFEQT. Responsiveness was positively rated only in AFEQT, but with limited evidence. Overall, AFEQT showed strong positive evidence for 2 of 9 measurement properties, compared to one for AFQoL and none for the remaining questionnaires.InterpretationGiven the low ratings for many measurement properties, no single questionnaire can be recommended, although AFEQT performed strongest. Further studies to robustly assess reliability, validity and responsiveness of AF-specific quality of life questionnaires are required. This review consolidates the current evidence for quality of life assessment in patients with atrial fibrillation and identifies priority areas for future research.

Dataset Information

Patient-Reported Outcomes in Atrial Fibrillation Research: Results of a Clinicaltrials.gov Analysis.

Publications

Patient-Reported Outcomes in Atrial Fibrillation Research: Results of a Clinicaltrials.gov Analysis.

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