Evidence map›Paper›PMID 34937393›Full record

ArticleCirculation. Heart failure2022

Quantifying Benefit-Risk Preferences for Heart Failure Devices: A Stated-Preference Study.

Shelby D Reed, Jui-Chen Yang, Timothy Rickert, F Reed Johnson, Juan Marcos Gonzalez, Robert J Mentz, Mitchell W Krucoff, Sreekanth Vemulapalli, Philip B Adamson, David J Gebben and 6 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Circulation. Heart failure, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
3.5field-weighted citation impact, top 6% of its field
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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
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

16 authors at 7 institutions in 2 countries.

Shelby D ReedDepartment of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC.ORCID 0000-0002-7654-4464
Jui-Chen YangDuke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC.ORCID 0000-0001-8229-6578
Timothy RickertDuke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC.
F Reed JohnsonDepartment of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC.
Juan Marcos GonzalezDepartment of Population Health Sciences (S.D.R., F.R.J., J.M.G.), Duke University School of Medicine, Durham, NC.
Robert J MentzDuke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC.ORCID 0000-0002-3222-1719
Mitchell W KrucoffDuke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC.
Sreekanth VemulapalliDuke Clinical Research Institute (S.D.R., J.-C.Y., T.R., F.R.J., J.M.G., R.J.M., M.W.K., S.V.), Duke University School of Medicine, Durham, NC.ORCID 0000-0003-1599-2957
Philip B AdamsonAbbott Laboratories, Austin, TX (P.B.A.).ORCID 0000-0002-8974-9004
David J GebbenFood and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD (D.J.G., A.S., M.E.T.).
Liliana Rincon-GonzalezMedical Device Innovation Consortium, Arlington, VA (L.R.-G.).
Anindita SahaFood and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD (D.J.G., A.S., M.E.T.).ORCID 0000-0003-0306-4264
Daniel SchaberMedtronic plc, Minneapolis, MN (D.S.).
Kenneth M SteinBoston Scientific Corporation, Marlborough, MA (K.M.S.).
Michelle E TarverFood and Drug Administration, Center for Devices and Radiological Health, Silver Spring, MD (D.J.G., A.S., M.E.T.).
Dean Bruhn-DingCVRx Inc, Minneapolis, MN (D.B.-D.).
Duke University · USCenter for Devices and Radiological Health · USAbbott (United Kingdom) · GBBoston Scientific (United States) · USCVRx (United States) · USMedtronic (United States) · USThe Medical Device (United Kingdom) · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRegulatory and clinical decisions involving health technologies require judgements about relative importance of their expected benefits and risks. We sought to quantify heart-failure patients' acceptance of therapeutic risks in exchange for improved effectiveness with implantable devices.

methodsIndividuals with heart failure recruited from a national web panel or academic medical center completed a web-based discrete-choice experiment survey in which they were randomized to one of 40 blocks of 8 experimentally controlled choice questions comprised of 2 device scenarios and a no-device scenario. Device scenarios offered an additional year of physical functioning equivalent to New York Heart Association class III or a year with improved (ie, class II) symptoms, or both, with 30-day mortality risks ranging from 0% to 15%, in-hospital complication risks ranging from 0% to 40%, and a remote adjustment device feature. Logit-based regression models fit participants' choices as a function of health outcomes, risks and remote adjustment.

resultsLatent-class analysis of 613 participants (mean age, 65; 49% female) revealed that two-thirds were best represented by a pro-device, more risk-tolerant class, accepting up to 9% (95% CI, 7%-11%) absolute risk of device-associated mortality for a one-year gain in improved functioning (New York Heart Association class II). Approximately 20% were best represented by a less risk-tolerant class, accepting a maximum device-associated mortality risk of 3% (95% CI, 1%-4%) for the same benefit. The remaining class had strong antidevice preferences, thus maximum-acceptable risk was not calculated.

conclusionsQuantitative evidence on benefit-risk tradeoffs for implantable heart-failure device profiles may facilitate incorporating patients' views during product development, regulatory decision-making, and clinical practice.

Indexed as

AdultAgedChoice BehaviorFemaleHeart FailureHumansLogistic ModelsMaleMiddle AgedPatient PreferenceRiskRisk AssessmentSurveys and Questionnairesdecision makingheart failurepatient preferencerisk assessmentsurveys and questionnaires

Identifiers

PMID34937393
PMCPMC8763248
OpenAlexW4200393579

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.