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01.12.2015 | STUDY PROTOCOL | Ausgabe 1/2015 Open Access

BMC Women's Health 1/2015

Does a decision aid improve informed choice in mammography screening? Study protocol for a randomized controlled trial

Zeitschrift:
BMC Women's Health > Ausgabe 1/2015
Autoren:
Maren Reder, Petra Kolip
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​s12905-015-0210-5) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

MR and PK conceived of the study and participated in its design. MR drafted the manuscript, which was revised by both authors. Both authors read and approved the final manuscript.

Authors’ information

PK is professor for prevention and health promotion at the Bielefeld School of Public Health. MR is research assistant at the Bielefeld School of Public Health.

Abstract

Background

When invited for the first time at age 50, most women in Germany have to decide whether they wish to participate in the German mammography screening programme. For ethical reasons, screening decisions should be informed choices, but this is rarely the case with mammography screening. Decision aids are interventions with the potential to support informed choice by improving the following factors: knowledge, clarity of personal attitude, and implementation of an intention. Currently, no systematically evaluated decision aid exists for the German mammography screening programme. Therefore, the objective of this randomized controlled trial is to assess the effectiveness of a decision aid for first-time mammography screening programme invitees.

Methods/Design

We have developed a decision aid for women invited to the mammography screening programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration. The effectiveness of the decision aid will be evaluated in a randomized controlled trial with a 3-month follow-up. We will invite 7400 women aged 50 years from the district of Westfalen-Lippe, Germany, to participate. This sample will be drawn from registration office data. The primary outcome will be informed choice. The secondary outcomes will be the components of informed choice (knowledge, attitude, decision/implementation). Decisional conflict, decision regret, eHealth literacy, health behaviours, perceived behavioural control, subjective norms, invitation status, and demographic variables will be assessed. Data will be collected online at baseline, post-intervention, and at the 3-month follow-up. Participants will be randomized to receive either the decision aid or usual care (invitation and standard leaflet of the mammography screening programme).

Discussion

This paper describes the evaluation of a decision aid for the German mammography screening programme in a randomized controlled trial. If the decision aid proves to be an effective tool to enhance the rate of informed choice, it will be made accessible to the public and the use of this decision aid for first-time invitees will be recommended. The long-term effect could be an improvement in informed choices in women invited to the mammography screening programme.

Trial registration

German Clinical Trials Register DRKS00005176.
Zusatzmaterial
Additional file 1 Sample personal decision aid PDF. This PDF can be downloaded at the end of the online DA. It includes the static information part as well as the responses that were previously given by the user.
12905_2015_210_MOESM1_ESM.pdf
Literatur
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