Evidence map›Paper›PMID 28899412›Full record

Trial reportTrials2017

The effect of information about the benefits and harms of mammography on women's decision-making: study protocol for a randomized controlled trial.

Misericòrdia Carles, Montserrat Martínez-Alonso, Anna Pons, Maria José Pérez-Lacasta, Lilisbeth Perestelo-Pérez, Maria Sala, Carmen Vidal, Montse Garcia, Ana Toledo-Chávarri, Núria Codern and 7 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03046004 (The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 25% 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.

NCT03046004 nacompletednot on this map

The Effect of Receiving Information About the Benefits and Harms of Mammography Screening on Women's Decision Making

TypeinterventionalSponsorInstitut de Recerca Biomèdica de LleidaRan2016 to 2018Enrolled400ConditionsBreast Cancer ScreeningArmsDecision aid for breast cancer screening, Standard leaflet
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Improved breast lesion detection in mammogram images using a deep neural network.Diagnostic and interventional radiology (Ankara, Turkey) · 2023
    Article
  5. Article
  6. 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

17 authors at 8 institutions in 3 countries.

Misericòrdia CarlesDepartment of Economics, University Rovira i Virgili, Reus, Spain.
Montserrat Martínez-AlonsoDepartment of Basic Medical Sciences, University of Lleida-IRBLLEIDA, Lleida, Spain.
Anna PonsLleida Biomedical Research Institute (IRBLLEIDA), Lleida, Spain.
Maria José Pérez-LacastaDepartment of Economics, University Rovira i Virgili, Reus, Spain.
Lilisbeth Perestelo-PérezEvaluation Unit of the Canary Islands Health Service (SESCS), Tenerife, Spain.
Maria SalaHealth Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain.
Carmen VidalCancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Spain.
Montse GarciaCancer Prevention and Control Program, Catalan Institute of Oncology-IDIBELL, L'Hospitalet de Llobregat, Spain.
Ana Toledo-ChávarriHealth Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain.
Núria CodernÀreaQ, Evaluation and Qualitative Research, Barcelona, Spain.
Maria Feijoo-CidDepartment of Nursing, Faculty of Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain.
Anabel RomeroHealth Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain.
Roger PlaResearch Group on Economic Evaluation and Health (GRAES), Reus, Spain.
Jorge Soler-GonzálezLleida Biomedical Research Institute (IRBLLEIDA), Lleida, Spain.
Xavier CastellsHealth Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain.
Montserrat RuéResearch Group on Economic Evaluation and Health (GRAES), Reus, Spain. montse.rue@cmb.udl.cat.
InforMa Group
Spanish Clinical Research Network · ESInstitut d'Investigació Biomédica de Bellvitge · ESUniversitat de Lleida · ESInstituto de Investigación Biomédica de Lleida · ESUniversitat Autònoma de Barcelona · ESHealth Economics and Outcomes Research (United Kingdom) · GBServicio Canario de la Salud · ESUniversitat Rovira i Virgili · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening.

methodsA two-stage, randomized controlled trial (RCT). In the first stage, 40 Basic Health Areas (BHAs) will be selected and randomized to intervention or control. In the second stage, women within each BHA will be randomly selected (n = 400). Four breast cancer screening programs (BCSPs) of the Spanish public health system, three in Catalonia and one in the Canary Islands will participate in the study. Women in the intervention arm will receive a leaflet with detailed information on the benefits and harms of screening using mammography. Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial examinations of the BCSP. The primary outcome is informed choice, a dichotomous variable that combines knowledge, attitudes, and intentions. Secondary outcomes include decisional conflict; confidence in the decision made; anxiety about screening participation; worry about breast cancer; anticipated regret; time perspective; perceived importance of benefits/harms of screening; perceived risk of breast cancer; and leaflet acceptability. Primary and secondary outcomes are assessed 2-3 weeks after the intervention. DISCUSSION: This is the first RCT that assesses the effect of informing about the benefits and harms of breast cancer screening in Spain in women facing the decision to be screened using mammography. It aims to assess the impact of information on several decisional outcomes and to contribute to paving the road towards shared decision-making in breast cancer screening in our country.

trial registrationClinicalTrials.gov registry, ID: NCT03046004 . Retrospectively registered on 4 February 2017. Trial name: InforMa study.

Indexed as

Access to InformationChoice BehaviorMammographyPamphletsRadiation DosageRadiation ExposureBreast NeoplasmsDecision MakingFemaleHealth Knowledge, Attitudes, PracticeHumansMass ScreeningMiddle AgedPatient Education as TopicPatient ParticipationPredictive Value of TestsBreast cancerDecision aidsEarly detectionInformed choiceScreening

Identifiers

PMID28899412
PMCPMC5596499
OpenAlexW2755398987

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.