Do Women With High eHealth Literacy Profit More From a Decision Aid on Mammography Screening? Testing the Moderation Effect of the eHEALS in a Randomized Controlled Trial

Background: Our decision aid on mammography screening developed according to the criteria of the International Patient Decision Aids Standards Collaboration increases knowledge compared to usual care. However, it remains unclear whether this decision aid is more effective in women with higher eHealth literacy. Our objective was to test whether the positive effect of the decision aid on knowledge is moderated by eHealth literacy.Methods: A total of 1,206 women aged 50 from Westphalia-Lippe, Germany, participated (response rate of 16.3%) in our study and were randomized to usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. eHealth literacy was assessed at baseline with the Electronic Health Literacy Scale (eHEALS); knowledge was assessed at baseline and post-intervention. First, we compared the 2-factor model of the German eHEALS (information-seeking and information-appraisal) found in previous research and the 3-factor model we hypothesized for decision aid use to the originally proposed 1-factor model. Second, we modeled the measurement model according to the superior factor model found in step one and tested whether the eHEALS moderated the effect of the decision aid on knowledge.Results: The 3-factor model of the eHEALS had a better model fit than the 1-factor or 2-factor model. Both information-seeking, information-appraisal, and information-use had no effect on knowledge post-intervention. All three interactions of the decision aid with information-seeking, information-appraisal, and information-use were not significant. Equally, neither education nor its interaction with the decision aid had an effect on knowledge post-intervention.Conclusion: The decision aid developed in this project increases knowledge irrespective of level of eHealth literacy. This means that not only women with high eHealth literacy profit from the decision aid but that the decision aid has been successfully conceptualized as a comprehensible information tool that can be used by women of varying eHealth literacy levels.Trial registration: German Clinical Trials Register DRKS00005176 (https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00005176)

How Can Informed Choice in Mammography Screening Be Improved? Development and Evaluation of a Decision Aid

Reder M. How Can Informed Choice in Mammography Screening Be Improved? Development and Evaluation of a Decision Aid. Bielefeld: Universität Bielefeld; 2019.Background. Most women in Germany have to decide whether they want to attend the Mammography Screening Programme to which they are invited once they turn 50. Informedness is an ethical requirement for decisions on screening but research shows that informed choice is not sufficiently realised. Decision aids are a promising class of interventions to realise informed choice as they improve knowledge, clarify values, and improve behavioural implementation of and satisfaction with a decision. However, there is a knowledge gap regarding which components of decision aids are effective. Manuscript 1 provides evidence for knowledge increase through use of crowd-figure-pictograms. Prior to this research project, no decision aid existed that aimed at average risk women in the target age group of mammography screening and was evaluated in a randomised controlled trial. Most previous studies on decision aids only looked at their immediate effect and did not follow-up on whether the decision was implemented and which medium-term effects the decision aid had on knowledge and post-decisional satisfaction. Therefore, a twofold gap remains: We lack (1) a decision aid appropriate for women invited to the German Mammography Screening Programme and (2) evidence on medium-term effects of decision aids. Methods. The main research project of this dissertation developed a decision aid for women invited to the German Mammography Screening Programme for the first time and evaluated it in a randomised controlled trial with a 3-month follow-up. Acceptability and effectiveness of the decision aid including possible moderators (eHealth literacy and education) were evaluated. Details of the study protocol are presented in Manuscript 2. To be able to assess all relevant outcomes, two other research projects were employed for instrument development and validation. Development and validation of a questionnaire assessing informed choice are described in Manuscript 3; translation and validation of a measure for eHealth literacy are described in Manuscript 4. Results. Women rated the decision aid as acceptable. Manuscript 5 provides evidence of the effectiveness of the decision aid: Women who had received the decision aid were more likely to make an informed choice, to have higher knowledge, and to have lower decisional conflict. Uptake was not affected. Manuscript 6 shows that the effect of the decision aid on knowledge was moderated by neither eHealth literacy nor education level. Conclusions. This dissertation was the first to develop and systematically evaluate a decision aid for the German Mammography Screening Programme. To achieve this, it integrated the results of three related research projects for instrument development and testing of crowd-figure-pictograms. The developed decision aid was acceptable to its users and effective in increasing the proportion of informed choices. Knowledge was also increased through the decision aid irrespective of eHealth literacy or education level. Thus, the decision aid developed in this project is an important support tool for women deciding whether to participate in the Mammography Screening Programme

Communities That Care. Schülerbefragung in Niedersachsen 2017

«Communities That Care» (CTC) hat die Prävention von jugendlichem Problemverhalten zum Ziel. Durch CTC sollen positive Rahmenbedingungen in Gemeinden etabliert und gefördert werden, um so Kindern und Jugendlichen sichere und gesundheitsförderliche Entwicklungsbedingungen zu ermöglichen. Durch die Niedersachsenweite Schülerbefragung, die 2017 bereits zum dritten Mal stattfand, wurden Referenzwerte zur Häufigkeit von Risiko- und Schutzfaktoren problematischen Verhaltens ermittelt. Gemeinden können die Daten ihrer lokalen Schülerbefragungen mit diesen Referenzwerten vergleichen und so die Problembereiche ihrer Gemeinde ermitteln. Hierzu können dann passende Präventionsangebote ausgewählt werden. Die niedersachsenweite Schülerbefragung 2017 wurde im Rahmen einer Kooperation der Universität Hildesheim und des Landespräventionsrats Niedersachsen im Justizministerium realisiert

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

Reder M, Kolip P. Does a decision aid improve informed choice in mammography screening? Results from a randomised controlled trial. PLOS ONE. 2017;12(12): e0189148.Background 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. Objective To determine whether a decision aid increases informed choice about mammography screening programme participation. Methods 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 χ2-tests. Results 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. Conclusion 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

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

Reder M, Kolip P. Does a decision aid improve informed choice in mammography screening? Study protocol for a randomized controlled trial. BMC Women's Health. 2015;15(1): 53.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

Crowd-figure-pictograms improve women’s knowledge about mammography screening. Results from a randomised controlled trial

Reder M, Thygesen LC. Crowd-figure-pictograms improve women’s knowledge about mammography screening. Results from a randomised controlled trial. BMC Research Notes. 2018;11(1): 332.**Objective** To evaluate the effect of crowd-figure-pictograms on women’s numeric knowledge about mammography screening in a three-armed parallel randomised controlled trial. **Results** 552 women were randomised to receive (1) non-numeric information (n = 192), (2) non-numeric and numeric information (n = 186), or (3) non-numeric and numeric information complemented by crowd-figure-pictograms (n = 174). Baseline numeric knowledge was low (control 0.61, numeric 0.66, and pictogram 0.51 on a scale ranging from 0 to 5). Women in the crowd-figure-pictogram group had a larger knowledge increase than women in the numeric group (2.42 vs 2.06, p = .03). Both groups had significant increases in knowledge compared to the control (0.20, p Trial registration German Clinical Trials Register DRKS00014736, retrospectively registered 11 May 201

The TeleTAnDem intervention - Study protocol for a psychotherapeutic intervention for family caregivers of people with dementia

Soellner R, Reder M, Machmer A, Holle R, Wilz G. The TeleTAnDem intervention - Study protocol for a psychotherapeutic intervention for family caregivers of people with dementia. BMC Nursing. 2015;14(11): 11

Do Women With High eHealth Literacy Profit More From a Decision Aid on Mammography Screening? Testing the Moderation Effect of the eHEALS in a Randomized Controlled Trial

Reder M, Soellner R, Kolip P. Do Women With High eHealth Literacy Profit More From a Decision Aid on Mammography Screening? Testing the Moderation Effect of the eHEALS in a Randomized Controlled Trial. Frontiers in Public Health. 2019;7: 46.Background: Our decision aid on mammography screening developed according to the criteria of the International Patient Decision Aids Standards Collaboration increases knowledge compared to usual care. However, it remains unclear whether this decision aid is more effective in women with higher eHealth literacy. Our objective was to test whether the positive effect of the decision aid on knowledge is moderated by eHealth literacy. Methods: A total of 1,206 women aged 50 from Westphalia-Lippe, Germany, participated (response rate of 16.3%) in our study and were randomized to usual care (i.e., the standard information brochure sent with the programme's invitation letter) or the decision aid. eHealth literacy was assessed at baseline with the Electronic Health Literacy Scale (eHEALS); knowledge was assessed at baseline and post-intervention. First, we compared the 2-factor model of the German eHEALS (information-seeking and information-appraisal) found in previous research and the 3-factor model we hypothesized for decision aid use to the originally proposed 1-factor model. Second, we modeled the measurement model according to the superior factor model found in step one and tested whether the eHEALS moderated the effect of the decision aid on knowledge. Results: The 3-factor model of the eHEALS had a better model fit than the 1-factor or 2-factor model. Both information-seeking, information-appraisal, and information-use had no effect on knowledge post-intervention. All three interactions of the decision aid with information-seeking, information-appraisal, and information-use were not significant. Equally, neither education nor its interaction with the decision aid had an effect on knowledge post-intervention. Conclusion: The decision aid developed in this project increases knowledge irrespective of level of eHealth literacy. This means that not only women with high eHealth literacy profit from the decision aid but that the decision aid has been successfully conceptualized as a comprehensible information tool that can be used by women of varying eHealth literacy levels

Development of the Informed Choice in Mammography Screening Questionnaire (IMQ): factor structure, reliability, and validity

Reder M, Berens E-M, Spallek J, Kolip P. Development of the Informed Choice in Mammography Screening Questionnaire (IMQ): factor structure, reliability, and validity. BMC Psychology. 2019;7(1): 17.Background Informed 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. Methods The 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. Results 5.847 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. Conclusion The 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

A cross-sectional study on informed choice in the mammography screening programme in Germany (InEMa): a study protocol

Berens E-M, Reder M, Kolip P, Spallek J. A cross-sectional study on informed choice in the mammography screening programme in Germany (InEMa): a study protocol. BMJ Open. 2014;4(9):e006145.Introduction: Breast cancer is the most prevalent cancer among women. In Germany, women are invited to a population-based mammography screening programme for the first time at the age of 50. Since it is still discussed whether the benefits of mammography screening outweigh its harms, the concept of informed choice has gained importance. The objective of this cross-sectional study is to assess the proportion of informed choices in the mammography screening programme. A special focus is on the examination of the impact of Turkish migration background and educational level on informed choices. Methods and analysis: The proportion of informed choices is evaluated in a cross-sectional study with 3-month follow-up for behavioural implementation of the screening intention. A randomly selected sample of 17 000 women aged 50 years living in Westphalia-Lippe, a region in the Federal State of North-Rhine Westphalia, is invited to participate in this study. To reach adequate numbers of Turkish women, all possibly Turkish women in the sample are identified through a name algorithm and contacted. The sample is drawn from women registered in the study area for which the registration offices consented to supply data for the study (88% of all towns/cities in the study region). Women identified through the Turkish name algorithm received all materials in German and Turkish. The primary outcome is informed choice. Data are collected on informed choice components (knowledge, attitude, decision/implementation) as well as on its possible determinants (eg, health behaviour, perceived behavioural control, subjective norms, invitation status, migration background and other demographic variables). Data are collected before the screening appointment and at 3 months follow-up. Ethics and dissemination: The study was approved by the ethical committee of the Medical Faculty of Muenster University. Results will be published in a relevant scientific journal and communicated to respondents and relevant institutions