Evidence map›Paper›PMID 31376090›Full record

ArticleCardiology and therapy2019

Patient-Reported Satisfaction and Study Drug Discontinuation: Post-Hoc Analysis of Findings from ROCKET AF.

Leo Ungar, Fatima Rodriguez, Anne S Hellkamp, Richard C Becker, Scott D Berkowitz, Guenter Breithardt, Keith A A Fox, Werner Hacke, Jonathan L Halperin, Graeme J Hankey and 5 more

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Cardiology and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00403767 (A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00403767 phase3completednot on this map

A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

TypeinterventionalSponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Ran2006 to 2010Enrolled14,269ConditionsAtrial Fibrillation, Stroke, EmbolismArmsRivaroxaban, Warfarin, Matching placebo for Rivaroxaban arm (Warfarin placebo), Matching placebo for Warfarin arm (Rivaroxaban placebo)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Leo UngarUniversity of California Irvine Medical Center, Orange, CA, USA. lungar@uci.edu.
Fatima RodriguezStanford Center for Clinical Research, Stanford University School of Medicine, Stanford, CA, USA.
Anne S HellkampDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Richard C BeckerUniversity of Cincinnati College of Medicine, Cincinnati, OH, USA.
Scott D BerkowitzBayer U.S. LLC, Parsippany, NJ, USA.
Guenter BreithardtHospital of the University of Münster, Münster, Germany.
Keith A A FoxUniversity of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, UK.
Werner HackeRuprecht-Karls-University, Heidelberg, Germany.
Jonathan L HalperinMount Sinai School of Medicine, New York, NY, USA.
Graeme J HankeySchool of Medicine and Pharmacology, The University of Western Australia, Crawley, Australia.
Christopher C NesselJanssen Research and Development, Raritan, NJ, USA.
Daniel E SingerMassachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Manesh R PatelDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Jonathan P PicciniDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA.
Kenneth W MahaffeyStanford Center for Clinical Research, Stanford University School of Medicine, Stanford, CA, USA.

Funding

SURPASS: (Statin Use and Risk Prediction of Atherosclerotic Cardiovascular Disease in minority Subgroups)K01HL144607 · NHLBI · STANFORD UNIVERSITY · PI RODRIGUEZ, FATIMA · 2019 to 2023
$856k
NHLBI NIH HHS K01 HL144607
6 · The paper itself

Abstract

introductionPatient-reported outcomes (PROs) and satisfaction endpoints are increasingly important in clinical trials and may be associated with treatment adherence. In this post hoc substudy from ROCKET AF, we examined whether patient-reported satisfaction was associated with study drug discontinuation.

methodsROCKET AF (n = 14,264) compared rivaroxaban with warfarin for prevention of stroke and systemic embolism in patients with atrial fibrillation. We analyzed treatment satisfaction scores: the Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM II). We compared satisfaction with study drug between the two treatment arms, and examined the association between satisfaction and patient-driven study drug discontinuation (stopping study drug due to withdrawal of consent, noncompliance, or loss to follow-up).

resultsA total of 1577 (11%) patients participated in the Patient Satisfaction substudy; 1181 (8.3%) completed both the ACTS and TSQM II 4 weeks after starting study drug. Patients receiving rivaroxaban did not experience significant differences in satisfaction compared with those receiving warfarin. During a median follow-up of 1.6 years, 448 premature study drug discontinuations occurred (213 rivaroxaban group; 235 warfarin group), of which 116 (26%) were patient-driven (52 [24%] rivaroxaban group; 64 [27%] warfarin group). No significant differences were observed between satisfaction level and rates of patient-driven study drug discontinuation.

conclusionsStudy drug satisfaction did not predict rate of study drug discontinuation. No significant difference was observed between satisfaction with warfarin and rivaroxaban, as expected given the double-blind trial design. Although these results are negative, the importance of PRO data will only increase, and these analyses may inform future studies that explore the relationship between drug-satisfaction PROs, adherence, and clinical outcomes. CLINICALTRIALS.GOV: NCT00403767.

fundingThe ROCKET AF trial was funded by Johnson & Johnson and Bayer.

Indexed as

AnticoagulantAtrial fibrillationDrug discontinuationPatient-reported outcomesPatient satisfaction endpointsRivaroxabanWarfarin

Identifiers

PMID31376090
PMCPMC6828909

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.