Type your tag names separated by a space and hit enter

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

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.

Links

  • PMC Free PDF
  • PMC Free Full Text
  • FREE Publisher Full Text
  • Authors+Show Affiliations

    ,

    Bielefeld University, School of Public Health, Department of Prevention and Health Promotion, Universitätsstraβe 25, Bielefeld, 33615, Germany. maren.reder@uni-bielefeld.de.

    Bielefeld University, School of Public Health, Department of Prevention and Health Promotion, Universitätsstraβe 25, Bielefeld, 33615, Germany. petra.kolip@uni-bielefeld.de.

    Source

    BMC women's health 15: 2015 Jul 22 pg 53

    MeSH

    Breast Neoplasms
    Choice Behavior
    Clinical Protocols
    Decision Support Techniques
    Early Detection of Cancer
    Female
    Germany
    Humans
    Mammography
    Middle Aged
    Patient Acceptance of Health Care
    Patient Participation
    Randomized Controlled Trials as Topic
    Research Design

    Pub Type(s)

    Journal Article
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    26198675

    Citation

    Reder, Maren, and Petra Kolip. "Does a Decision Aid Improve Informed Choice in Mammography Screening? Study Protocol for a Randomized Controlled Trial." BMC Women's Health, vol. 15, 2015, p. 53.
    Reder M, Kolip P. Does a decision aid improve informed choice in mammography screening? Study protocol for a randomized controlled trial. BMC Womens Health. 2015;15:53.
    Reder, M., & Kolip, P. (2015). Does a decision aid improve informed choice in mammography screening? Study protocol for a randomized controlled trial. BMC Women's Health, 15, p. 53. doi:10.1186/s12905-015-0210-5.
    Reder M, Kolip P. Does a Decision Aid Improve Informed Choice in Mammography Screening? Study Protocol for a Randomized Controlled Trial. BMC Womens Health. 2015 Jul 22;15:53. PubMed PMID: 26198675.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Does a decision aid improve informed choice in mammography screening? Study protocol for a randomized controlled trial. AU - Reder,Maren, AU - Kolip,Petra, Y1 - 2015/07/22/ PY - 2014/08/04/received PY - 2015/07/01/accepted PY - 2015/7/23/entrez PY - 2015/7/23/pubmed PY - 2016/3/22/medline SP - 53 EP - 53 JF - BMC women's health JO - BMC Womens Health VL - 15 N2 - 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. SN - 1472-6874 UR - https://wwww.unboundmedicine.com/medline/citation/26198675/Does_a_decision_aid_improve_informed_choice_in_mammography_screening_Study_protocol_for_a_randomized_controlled_trial_ L2 - https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-015-0210-5 DB - PRIME DP - Unbound Medicine ER -