Evidence map›Paper›PMID 24892447›Full record

Trial reportBritish journal of cancer2014

Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial.

I Juraskova, P Butow, C Bonner, M L Bell, A B Smith, M Seccombe, F Boyle, L Reaby, J Cuzick, J F Forbes

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in British journal of cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04407676 (A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials), which is not on this map. Cited by 32 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 6 pooled it
10.0field-weighted citation impact, top 2% 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.

NCT04407676 naunknown statusnot on this mapstarted 2020, after this paper: background citation

A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials

TypeinterventionalSponsorRoyal Marsden NHS Foundation TrustRan2020 to 2023Enrolled34ConditionsSolid NeoplasmsArmsSummary PIS and Online Video Modules
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 6 syntheses or guidelines pooled it, 88 citations in OpenAlex.

  1. Decision aids for people facing health treatment or screening decisions.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Strategies to improve retention in randomised trials.The Cochrane database of systematic reviews · 2021
    Pooled it
  3. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018
    Pooled it
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  5. Factors affecting uptake and adherence to breast cancer chemoprevention: a systematic review and meta-analysis.Annals of oncology : official journal of the European Society for Medical Oncology · 2016
    Pooled it
  6. Decision aids for people considering taking part in clinical trials.The Cochrane database of systematic reviews · 2015
    Pooled it
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  8. Regenerative medicine: Stroke survivor and carer views and motivations towards a proposed stem cell clinical trial using placebo neurosurgery.Health expectations : an international journal of public participation in health care and health policy · 2018
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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 at 3 institutions in 2 countries.

I JuraskovaCentre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
P ButowCentre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
C BonnerCentre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
M L BellCentre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
A B SmithCentre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia.
M SeccombeAustralia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia.
F Boyle1] Centre for Medical Psychology and Evidence-based Decision-making (CeMPED), The University of Sydney, Sydney 2006, Australia [2] Australia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia [3] Pam McLean Centre, The University of Sydney, Sydney 2006, Australia.
L ReabyAustralia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia.
J CuzickCancer Research UK, Department of Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, Queen Mary College, University of London, London E1 4NS, UK.
J F ForbesAustralia and New Zealand Breast Cancer Trials Group, Australia University of Newcastle, Newcastle 2306, Australia.
University of Sydney · AUBreast Cancer Trials · AUUniversity of London · GB

Funding

Cancer Research UK 16891
6 · The paper itself

Abstract

backgroundDecision aids may improve informed consent in clinical trial recruitment, but have not been evaluated in this context. This study investigated whether decision aids (DAs) can reduce decisional difficulties among women considering participation in the International Breast Cancer Intervention Study-II (IBIS-II) trial.

methodsThe IBIS-II trial investigated breast cancer prevention with anastrazole in two cohorts: women with increased risk (Prevention), and women treated for ductal carcinoma in situ (DCIS). Australia, New Zealand and United Kingdom participants were randomised to receive a DA (DA group) or standard trial consent materials (control group). Questionnaires were completed after deciding about participation in IBIS-II (post decision) and 3 months later (follow-up).

resultsData from 112 Prevention and 34 DCIS participants were analysed post decision (73 DA; 73 control); 95 Prevention and 24 DCIS participants were analysed at follow-up (58 DA; 61 control). There was no effect on the primary outcome of decisional conflict. The DCIS-DA group had higher knowledge post decision, and the Prevention-DA group had lower decisional regret at follow-up.

conclusionsThis was the first study to evaluate a DA in the clinical trial setting. The results suggest DAs can potentially increase knowledge and reduce decisional regret about clinical trial participation.

Indexed as

Decision MakingDecision Support TechniquesBreast NeoplasmsFemaleHumansMiddle AgedPatient ParticipationPatient SatisfactionRandomized Controlled Trials as TopicSurveys and QuestionnairesTreatment Outcome

Identifiers

PMID24892447
PMCPMC4090720
OpenAlexW1990138272

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

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.