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Randomized Controlled Trial
. 2020 Sep;123(5):714-721.
doi: 10.1038/s41416-020-0935-2. Epub 2020 Jun 17.

A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy

Affiliations
Randomized Controlled Trial

A dynamic web-based decision aid to improve informed choice in organised breast cancer screening. A pragmatic randomised trial in Italy

Anna Roberto et al. Br J Cancer. 2020 Sep.

Erratum in

Abstract

Background: Improving the quality of information and communication is a priority in organised breast cancer screening and an ethical duty. Programmes must offer the information each woman is looking for, promoting informed decision-making. This study aimed to develop and evaluate a web-based dynamic decision aid (DA).

Methods: A pragmatic randomised trial carried out in six regional organised screening programmes recruited women at the first invitation receiving DA or a web-based standard brochure (SB). The primary outcome was informed choice measured on knowledge, attitudes, and intentions. Follow-up period: 7-10 days. Secondary outcomes included participation rate, satisfaction, decisional conflict, and acceptability of DA.

Results: Two thousand one hundred and nineteen women were randomised and 1001 completed the study. Respectively, 43.9% and 36.9% in the DA and SB reached the informed choice. The DA gave a 13-point higher proportion of women aware about overdiagnosis compared to SB (38.3% versus 25.2%, p < 0.0001). The percentage of women attending screening was the same: 84% versus 83%. Decisional conflict was significantly lower in the DA group (14.4%) than in the SB group (19.3%).

Conclusion: DA increases informed choice. Complete information including the pros, cons, controversies, and overdiagnosis-overtreatment issues boost a woman's knowledge without reducing the rate of actual screening participation.

Clinical trial registration: ClinicalTrials.gov number NCT03097653.

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Conflict of interest statement

A.R., C. Colombo and P. Mosconi report grants from Italian Association for Cancer Research, competitive grant no. IG2015–17274, during the conduct of the study; G.C., R.S. and E.P. report grants from Mario Negri IRCCS Institute, during the conduct of the study; L.G. reports grants from Mario Negri IRCCS Institute and Gisma (Italian group that organised mammography screening) during the conduct of the study; P. Mantellini and M.V. report grants from Gisma (Italian group that organised mammography screening) during the conduct of the study. Authors not named here have disclosed no conflict of interest.

Figures

Fig. 1
Fig. 1
Consort flow diagram: overview of trial participation.
Fig. 2
Fig. 2
Informed choice: main outcome of the study.

References

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