Evidence map›Paper›PMID 41571417›Full record

Trial reportBMJ open2026

Factors influencing the decision to accept or decline aortic valve replacement for asymptomatic aortic stenosis: a nested longitudinal qualitative substudy of the EASY-AS randomised trial.

Peter Allmark, Bethany Taylor, Angela Mary Tod, Tony Ryan, Marc Dweck, Gerry P McCann, Anvesha Singh

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in BMJ open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04204915 (A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis), which is not on this map. Not yet cited in PubMed.

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

NCT04204915 narecruitingnot on this map

A Randomised Controlled Trial of Early Valve Replacement in Severe ASYmptomatic Aortic Stenosis

TypeinterventionalSponsorUniversity of LeicesterRan2020 to 2031Enrolled2,104ConditionsAortic StenosisArmsAortic valve replacement
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Peter AllmarkSchool of Allied Health Professions, Pharmacy, Nursing and Midwifery, University of Sheffield, Sheffield, UK.
Bethany TaylorSchool of Allied Health Professions, Pharmacy, Nursing and Midwifery, University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0003-4090-3047
Angela Mary TodSchool of Allied Health Professions, Pharmacy, Nursing and Midwifery, University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0001-6336-3747
Tony RyanSchool of Allied Health Professions, Pharmacy, Nursing and Midwifery, University of Sheffield, Sheffield, UK.ORCID http://orcid.org/0000-0002-8549-3101
Marc DweckBritish Heart Foundation Centre of Research Excellence and Edinburgh Heart Centre, Royal Infirmary of Edinburgh, University of Edinburgh, Edinburgh, UK.
Gerry P McCannDepartment of Cardiovascular Sciences, University of Leicester, Leicester National Institute for Health and Care Research Biomedical Research Centre, and Leicester British Heart Foundation Centre of Research Excellence, Leicester, UK.ORCID http://orcid.org/0000-0002-5542-8448
Anvesha SinghDepartment of Cardiovascular Sciences, University of Leicester, Leicester National Institute for Health and Care Research Biomedical Research Centre, and Leicester British Heart Foundation Centre of Research Excellence, Leicester, UK as707@le.ac.uk.ORCID http://orcid.org/0000-0003-1112-3973

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo examine how patients and family members decide whether to accept a highly invasive intervention (aortic valve replacement (AVR)) when their condition (aortic stenosis (AS)) is asymptomatic and its course uncertain.

designNested, longitudinal, qualitative substudy of an ongoing randomised controlled trial (RCT) (NCT04204915) testing early intervention (EI) versus watchful waiting (WW) in patients with asymptomatic severe AS.

settingSix select UK sites of the RCT.

participantsSelect participants of the RCT, their next-of-kin and some who declined RCT participation.

results73 interviews were conducted, with 41 participants.Few knew much about AS before diagnosis. Uncertainty and the need for reliable information regarding symptoms and progress was a significant problem.While some expressed unease at a major intervention for an asymptomatic condition, there were no outright objections to the idea.Those who declined participation in the RCT did so for personal reasons, for example, their home circumstances did not permit the required period of recovery or they felt too old to risk intervention.Reasons for accepting early intervention included the belief that the condition was serious and likely to deteriorate, and so better to have the intervention before such deterioration, as well as avoiding long waiting lists. Trusting clinicians' judgement played a part in some decisions. Patients also wanted choice in the type of intervention received.The longitudinal interviews (n=32) showed satisfaction in the early intervention group despite some problems in the the early recovery phase, especially for those undergoing surgical AVR.

conclusionsWhere evidence supports major intervention for an asymptomatic condition, patients are likely to accept the offer, although personal circumstances play an important role in decision-making. Where a condition is not well known to the public, such as AS, patients rely on clinicians and other resources to help decide. Liaison with patient groups in developing shared decision-making resources may help with complex decisions. TRIAL REGISTRATION NUMBER: NCT04204915.

Indexed as

Aortic Valve StenosisDecision MakingHeart Valve Prosthesis ImplantationPatient Acceptance of Health CareAgedAged, 80 and overAsymptomatic DiseasesFemaleHumansLongitudinal StudiesMaleMiddle AgedQualitative ResearchUnited KingdomWatchful WaitingCardiac surgeryCardiovascular DiseaseQUALITATIVE RESEARCHValvular heart disease

Identifiers

PMID41571417
PMCPMC12829354

What OpenQuestion holds

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LicenceCC BY
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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.