Evidence map›Paper›PMID 39806624›Full record

ArticleBMJ open2024

Impact of alternative diagnostic labels for melanoma in situ on management choices and psychological outcomes: protocol for an online randomised study.

Zhuohan Wu, Brooke Nickel, Farzaneh Boroumand, David Elder, Peter M Ferguson, Richard A Scolyer, Blake O'Brien, Raymond Barnhill, Adewole S Adamson, Alexander C J van Akkooi and 9 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. A Clinical Perspective on Melanoma Overdiagnosis.The Australasian journal of dermatology · 2025
    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

19 authors.

Zhuohan WuWiser Healthcare collabration, Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.ORCID http://orcid.org/0009-0006-1281-3449
Brooke NickelSydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-8100-4278
Farzaneh BoroumandThe University of Sydney, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0003-2972-3969
David ElderDepartment of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Peter M FergusonMelanoma Institute Australia, North Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-8335-0406
Richard A ScolyerThe University of Sydney, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-8991-0013
Blake O'BrienSurgical Pathology, Sullivan Nicolaides Pathology, Brisbane, Queensland, Australia.
Raymond BarnhillDepartment of Translational Research, Paris Sciences and Lettres Research University, Paris, France.
Adewole S AdamsonDepartment of Internal Medicine, Austin, Austin, Texas, USA.ORCID http://orcid.org/0000-0002-1493-1776
Alexander C J van AkkooiMelanoma Institute Australia, North Sydney, New South Wales, Australia.
Jon EmeryGeneral Practice and Primary Care Academic Centre, University of Melbourne, Carlton, Victoria, Australia.ORCID http://orcid.org/0000-0002-5274-6336
Lisa ParkerEvidence, Policy and Influence Collaborative (EPIC), Charles Perkins Centre, University of Sydney, Sydney, New South Wales, Australia.
Donald LowCancer Voices New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0001-8962-946X
Cynthia LowCancer Voices New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0003-4297-1967
Elspeth DaviesPatient Researcher, Cambridge, Cambridge, UK.ORCID http://orcid.org/0009-0000-3499-681X
Sherrie LiuHealth Consumers New South Wales, Sydney, New South Wales, Australia.
Stacey LewisHealth Consumers New South Wales, Sydney, New South Wales, Australia.
Bella Spongberg-RossHealth Consumers New South Wales, Sydney, New South Wales, Australia.
Katy Jl BellWiser Healthcare Research Collaboration, Sydney, New South Wales, Australia katy.bell@sydney.edu.au.ORCID http://orcid.org/0000-0002-0137-3218

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA diagnosis of melanoma in situ presents negligible risk to a person's lifespan or physical well-being, but existing terminology makes it difficult for patients to distinguish these from higher risk invasive melanomas. This study aims to explore whether using an alternative label for melanoma in situ may influence patients' management choices and anxiety levels. METHODS AND ANALYSIS: This study is a between-subjects randomised online experiment, using hypothetical scenarios. Following consent, eligible participants will be randomised 1:1:1 to three labels: 'melanoma in situ' (control), 'low-risk melanocytic neoplasm' (intervention 1) and 'low-risk melanocytic neoplasm, in situ' (intervention 2). The required sample size is 1668 people. The co-primary outcomes are (1) choice between no further surgery or further surgery to ensure clear histological margins greater than 5 mm and (2) choice between patient-initiated clinical follow-up when needed (patient-led surveillance) and regular routinely scheduled clinical follow-up (clinician-led surveillance). Secondary outcomes include diagnosis anxiety, perceived risk of invasive melanoma and of dying from melanoma and management choice anxiety (after surgery choice and follow-up choice). We will make pairwise comparisons across the three diagnostic label groups using regression models (univariable and multivariable). ETHICS AND DISSEMINATION: The study has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12624000740594). Ethics approval has been received from The University of Sydney Human Research Ethics Committee (2024/HE000019). The results of the study will be published in a peer-reviewed medical journal, and a plain language summary of the findings will be shared on the Wiser Healthcare publication page (https://www.wiserhealthcare.org.au/category/publications/). TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ID 386943).

Indexed as

Choice BehaviorMelanomaSkin NeoplasmsAnxietyFemaleHumansRandomized Controlled Trials as TopicAdverse eventsClinical Decision-MakingDermatological tumoursPatient-Centered CareSurgical dermatologySurgical pathology

Identifiers

PMID39806624
PMCPMC11667480

What OpenQuestion holds

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LicenceCC BY
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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.