Evidence map›Paper›PMID 33435731›Full record

ArticleCirculation. Cardiovascular quality and outcomes2021

Comparability of Event Adjudication Versus Administrative Billing Claims for Outcome Ascertainment in the DAPT Study: Findings From the EXTEND-DAPT Study.

Kamil F Faridi, Hector Tamez, Neel M Butala, Yang Song, Changyu Shen, Eric A Secemsky, Laura Mauri, Jeptha P Curtis, Jordan B Strom, Robert W Yeh

Abstract readComparative Study
In one paragraph

Article in Circulation. Cardiovascular quality and outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed.

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  11. Endovascular Therapies for Pulmonary Embolism: A Landscape of Uncertainties and Opportunities.Journal of the Society for Cardiovascular Angiography & Interventions · 2024
    Article
  12. Optimal P2YAmerican heart journal plus : cardiology research and practice · 2023
    Article
  13. Outcomes of stroke events during transcatheter aortic valve implantation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022
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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

10 authors.

Kamil F FaridiSection of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT (K.F.F., J.P.C.).
Hector TamezRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA (K.F.F., H.T., C.S., E.A.S., J.B.S., R.W.Y.).
Neel M ButalaCardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA (N.M.B., R.W.Y.).
Yang SongBaim Institute for Clinical Research, Boston, MA (Y.S., L.M.).
Changyu ShenRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA (K.F.F., H.T., C.S., E.A.S., J.B.S., R.W.Y.).
Eric A SecemskyRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA (K.F.F., H.T., C.S., E.A.S., J.B.S., R.W.Y.).
Laura MauriBaim Institute for Clinical Research, Boston, MA (Y.S., L.M.).
Jeptha P CurtisSection of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT (K.F.F., J.P.C.).
Jordan B StromRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA (K.F.F., H.T., C.S., E.A.S., J.B.S., R.W.Y.).
Robert W YehRichard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Boston MA (K.F.F., H.T., C.S., E.A.S., J.B.S., R.W.Y.).

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Institutional Career Development CoreKL2TR001862 · NCATS · YALE UNIVERSITY · PI CANTLEY, LLOYD G, EDELMAN, E. JENNIFER · 2016 to 2025
$12.2M
Use of Registries, Claims and Health System Data to Enhance the Evaluation of Cardiovascular Therapies in Clinical TrialsR01HL136708 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Issa J. Dahabreh, Robert Yeh · 2017 to 2026
$6.9M
Identification of the Components of Frailty Using Administrative Data and Metabolite ProfilingK23HL144907 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI STROM, JORDAN BLAIR · 2019 to 2023
$1.0M
Using Claims-Based Signatures of Frailty to Support Individualized Treatment of Aortic Valve Stenosis and Coronary Artery DiseaseK24HL150321 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI Robert Yeh · 2020 to 2026
$862k
Shared Decision-Making to Improve the Health Status of Patients with Claudication: Developing and Implementing Strategies to Individualize Treatment DecisionsK23HL150290 · NHLBI · BETH ISRAEL DEACONESS MEDICAL CENTER · PI SECEMSKY, ERIC ALEXANDER · 2020 to 2024
$851k
NCATS NIH HHS KL2 TR001862NCATS NIH HHS UL1 TR001863NHLBI NIH HHS K23 HL144907NHLBI NIH HHS K23 HL150290NHLBI NIH HHS K24 HL150321NHLBI NIH HHS R01 HL136708
6 · The paper itself

Abstract

backgroundData from administrative claims may provide an efficient alternative for end point ascertainment in clinical trials. However, it is uncertain how well claims data compare to adjudication by a clinical events committee in trials of patients with cardiovascular disease.

methodsWe matched 1336 patients ≥65 years old who received percutaneous coronary intervention in the DAPT (Dual Antiplatelet Therapy) Study with the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims as part of the EXTEND (Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data) Study. Adjudicated trial end points were compared with Medicare claims data with

resultsAt 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction, and stroke) was similar between trial-adjudicated events and claims data (7.9% versus 7.2%, respectively;

conclusionsClaims data had moderate agreement with adjudication for myocardial infarction and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, although additional monitoring is likely needed to ensure accurate assessment of events.

Indexed as

AgedDrug Therapy, CombinationFemaleHumansMaleMedicareMyocardial InfarctionPercutaneous Coronary InterventionPlatelet Aggregation InhibitorsStrokeTreatment OutcomeUnited StatesPlatelet Aggregation Inhibitorsadministrative claims, healthcarebleedingclinical trialmedicaremyocardial infarction

Identifiers

PMID33435731
PMCPMC7855905

What OpenQuestion holds

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Registered trials

None linked

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.