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Does a decision aid improve informed choice in mammography screening? Results from a randomised controlled trial.

ABSTRACT: Decision aids can support informed choice in mammography screening, but for the German mammography screening programme no systematically evaluated decision aid exists to date. We developed a decision aid for women invited to this programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration.To determine whether a decision aid increases informed choice about mammography screening programme participation.A representative sample of 7,400 women aged 50 was drawn from registration offices in Westphalia-Lippe, Germany. Women were randomised to receive usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. Data were collected online at baseline, post-intervention, and 3 months follow-up. The primary outcome was informed choice. Secondary outcomes were the constituents of informed choice (knowledge, attitude, intention/uptake), decisional conflict, decision regret, and decision stage. Outcomes were analysed using latent structural equation models and ?2-tests.1,206 women participated (response rate of 16.3%). The decision aid increased informed choice. Women in the control group had lower odds to make an informed choice at post-intervention (OR 0.26, 95% CI 0.18-0.37) and at follow-up (OR 0.66, 95% CI 0.46-0.94); informed choices remained constant at 30%. This was also reflected in lower knowledge and more decisional conflict. Post-intervention, the uptake intention was higher in the control group, whereas the uptake rate at follow-up was similar. Women in the control group had a more positive attitude at follow-up than women receiving the decision aid. Decision regret and decision stage were not influenced by the intervention.This paper describes the first systematic evaluation of a newly developed decision aid for the German mammography screening programme in a randomised controlled trial. Our decision aid proved to be an effective tool to enhance the rate of informed choice and was made accessible to the public.German Clinical Trials Register DRKS00005176.

SUBMITTER: Reder M

PROVIDER: S-EPMC5728514 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Does a decision aid improve informed choice in mammography screening? Results from a randomised controlled trial.

Reder Maren M Kolip Petra P

PloS one 20171213 12

<h4>Background</h4>Decision aids can support informed choice in mammography screening, but for the German mammography screening programme no systematically evaluated decision aid exists to date. We developed a decision aid for women invited to this programme for the first time based on the criteria of the International Patient Decision Aids Standards Collaboration.<h4>Objective</h4>To determine whether a decision aid increases informed choice about mammography screening programme participation.< ...[more]

PMID: 29236722

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Project description:Tamoxifen and raloxifene are chemopreventive drugs that can reduce women’s relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women’s knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer.We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women’s intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable ‘informed choice’ (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman’s decision and relevant attitudes.Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067.The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision makers must retain over time. Examining informed decisions increases understanding of the impact of DAs. A standard for defining and measuring sufficient knowledge for informed decisions is needed.ClinicalTrials.gov: NCT00967824

Project description:ObjectiveTo determine whether a decision aid designed for adults with low education and literacy can support informed choice and involvement in decisions about screening for bowel cancer.DesignRandomised controlled trial.SettingAreas in New South Wales, Australia identified as socioeconomically disadvantaged (low education attainment, high unemployment, and unskilled occupations).Participants572 adults aged between 55 and 64 with low educational attainment, eligible for bowel cancer screening.InterventionPatient decision aid comprising a paper based interactive booklet (with and without a question prompt list) and a DVD, presenting quantitative risk information on the possible outcomes of screening using faecal occult blood testing compared with no testing. The control group received standard information developed for the Australian national bowel screening programme. All materials and a faecal occult blood test kit were posted directly to people's homes.Main outcome measuresInformed choice (adequate knowledge and consistency between attitudes and screening behaviour) and preferences for involvement in screening decisions.ResultsParticipants who received the decision aid showed higher levels of knowledge than the controls; the mean score (maximum score 12) for the decision aid group was 6.50 (95% confidence interval 6.15 to 6.84) and for the control group was 4.10 (3.85 to 4.36; P<0.001). Attitudes towards screening were less positive in the decision aid group, with 51% of the participants expressing favourable attitudes compared with 65% of participants in the control group (14% difference, 95% confidence interval 5% to 23%; P=0.002). The participation rate for screening was reduced in the decision aid group: completion of faecal occult blood testing was 59% v 75% in the control group (16% difference, 8% to 24%; P=0.001). The decision aid increased the proportion of participants who made an informed choice, from 12% in the control group to 34% in the decision aid group (22% difference, 15% to 29%; P<0.001). More participants in the decision aid group had no decisional conflict about the screening decision compared with the controls (51% v 38%; P=0.02). The groups did not differ for general anxiety or worry about bowel cancer.ConclusionsTailored decision support information can be effective in supporting informed choices and greater involvement in decisions about faecal occult blood testing among adults with low levels of education, without increasing anxiety or worry about developing bowel cancer. Using a decision aid to make an informed choice may, however, lead to lower uptake of screening. Trial registration ClinicalTrials.gov NCT00765869 and Australian New Zealand Clinical Trials Registry 12608000011381.

Project description:BackgroundInformed choice is of ethical and practical importance in mammography screening. To assess the level to which decisions regarding such screening are informed is thus imperative, but no specific instrument has been available to measure informed choice in the German mammography screening programme. The aims of this study were to develop the Informed Choice in Mammography Screening Questionnaire (IMQ) and to find first evidence for the factor structure, reliability and validity of its different components.MethodsThe IMQ was sent to 17.349 women aged 50 in Westphalia-Lippe, Germany. The instrument has been developed after consideration of (1) the results of qualitative interviews on decision making in the mammography screening programme, (2) relevant literature on other informed choice instruments and (3) a qualitative study on influencing factors. The IMQ comprises 3 scales (attitude, norms, and barriers), 1 index (knowledge) and singular items covering intention to participate and sociodemographic variables. To assess the psychometric properties of the components of the IMQ, confirmatory factor and item response theory analyses were conducted. Additionally, reliability, validity and item statistics were assessed.Results5.847 questionnaires were returned (response rate 33.7%). For attitude, the confirmatory factor analysis supported a one-factor structure. For norms, the model fit was not acceptable. Reliability levels were good with a Cronbach's α of.793 for attitude (4 items) and.795 for norms (5 items). For barriers, 9 items were deleted because of low discrimination indices; 6 items remained. The hypothesised assumption-subscale and the importance-subscale were confirmed, but these subscales showed poor reliabilities with Cronbach's α=.525 (4 items) and.583 (2 items). For the knowledge index, item response theory analysis showed that 6 out of 7 items were suitable. Hypotheses concerning the correlations between the different components were confirmed, which supported their convergent and divergent validity.ConclusionThe results of this study demonstrated that the IMQ is a multidimensional instrument. Further development of the barriers and norms scales is necessary. The IMQ can be utilised to assess the level of informed choices as well as influencing factors.

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Does a decision aid improve informed choice in mammography screening? Results from a randomised controlled trial.

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Does a decision aid improve informed choice in mammography screening? Results from a randomised controlled trial.

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