The Effectiveness of an Online Decision Aid on Reproductive Options for Couples at Risk of Transmitting a Genetic Disease to their Offspring: Protocol for a Randomized Controlled Trial

Shared decision making (SDM) is grounded in a compelling theoretical framework that ideally helps patients make decisions that are informed and concordant with their goals and values.1,2 Yet operationalizing SDM within routine clinical care remains an important challenge. Several approaches have been studied to improve SDM; such strategies include educating clinicians on communication techniques, using a multidisciplinary medical team, incorporating trained decision coaches, and using tools to support patients in their decision making. These tools, commonly referred to as patient decision aids (PtDAs), have garnered the most interest in operationalizing SDM.3 Accordingly, this article will focus specifically on the development and testing of PtDAs highlighting some important key points (see Box). ### Key Points of the Article on Decision Tool Development 1. PtDAs should be used in conjunction with a conversation with a clinician. 2. Helping patients consider and clarify their values around a decision is what makes a PtDA different from an information pamphlet. 3. Development is iterative, and the key tasks are to make sure the information is understandable, accurate, and unbiased and that the tool fits the needs and workflow of the end-users. 4. Trials designed to test the effectiveness of a decision aid need to consider both the patient’s and the clinician’s experience with the tool. 5. Decision aids should be living documents that will require updating when new information arises. Extensive work has been undertaken by the International Patient Decision Aid Standards (IPDAS) collaboration to provide guidance in this arena. Founded in 2003, IPDAS aims to “enhance the quality and effectiveness of PtDAs by establishing an evidence-informed framework for improving their content, development, implementation, and evaluation.”4,5 This article will draw on the extensive work of the IPDAS collaboration to describe a 4-step development process for those interested in developing PtDAs, which includes, step 1: understanding the decision; step 2: drafting the first …

Decision aids prepare people to participate in 'close call' decisions that involve weighing benefits, harms, and scientific uncertainty. To conduct a systematic review of randomised controlled trials (RCTs) evaluating the efficacy of decision aids for people facing difficult treatment or screening decisions. We searched MEDLINE (Ovid) (1966 to July 2006); Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library; 2006, Issue 2); CINAHL (Ovid) (1982 to July 2006); EMBASE (Ovid) (1980 to July 2006); and PsycINFO (Ovid) (1806 to July 2006). We contacted researchers active in the field up to December 2006. There were no language restrictions. We included published RCTs of interventions designed to aid patients' decision making by providing information about treatment or screening options and their associated outcomes, compared to no intervention, usual care, and alternate interventions. We excluded studies in which participants were not making an active treatment or screening decision, or if the study's intervention was not available to determine that it met the minimum criteria to qualify as a patient decision aid. Two review authors independently screened abstracts for inclusion, and extracted data from included studies using standardized forms. The primary outcomes focused on the effectiveness criteria of the International Patient Decision Aid Standards (IPDAS) Collaboration: attributes of the decision and attributes of the decision process. We considered other behavioural, health, and health system effects as secondary outcomes. We pooled results of RCTs using mean differences (MD) and relative risks (RR) using a random effects model. This update added 25 new RCTs, bringing the total to 55. Thirty-eight (69%) used at least one measure that mapped onto an IPDAS effectiveness criterion: decision attributes: knowledge scores (27 trials); accurate risk perceptions (11 trials); and value congruence with chosen option (4 trials); and decision process attributes: feeling informed (15 trials) and feeling clear about values (13 trials).This review confirmed the following findings from the previous (2003) review. Decision aids performed better than usual care interventions in terms of: a) greater knowledge (MD 15.2 out of 100; 95% CI 11.7 to 18.7); b) lower decisional conflict related to feeling uninformed (MD -8.3 of 100; 95% CI -11.9 to -4.8); c) lower decisional conflict related to feeling unclear about personal values (MD -6.4; 95% CI -10.0 to -2.7); d) reduced the proportion of people who were passive in decision making (RR 0.6; 95% CI 0.5 to 0.8); and e) reduced proportion of people who remained undecided post-intervention (RR 0.5; 95% CI 0.3 to 0.8). When simpler decision aids were compared to more detailed decision aids, the relative improvement was significant in knowledge (MD 4.6 out of 100; 95% CI 3.0 to 6.2) and there was some evidence of greater agreement between values and choice.In this review, we were able to explore the use of probabilities in decision aids. Exposure to a decision aid with probabilities resulted in a higher proportion of people with accurate risk perceptions (RR 1.6; 95% CI 1.4 to 1.9). The effect was stronger when probabilities were measured quantitatively (RR 1.8; 95% CI 1.4 to 2.3) versus qualitatively (RR 1.3; 95% CI 1.1 to 1.5).As in the previous review, exposure to decision aids continued to demonstrate reduced rates of: elective invasive surgery in favour of conservative options, decision aid versus usual care (RR 0.8; 95% CI 0.6 to 0.9); and use of menopausal hormones, detailed versus simple aid (RR 0.7; 95% CI 0.6 to 1.0). There is now evidence that exposure to decision aids results in reduced PSA screening, decision aid versus usual care (RR 0.8; 95% CI 0.7 to 1.0) . For other decisions, the effect on decisions remains variable.As in the previous review, decision aids are no better than comparisons in affecting satisfaction with decision making, anxiety, and health outcomes. The effects of decision aids on other outcomes (patient-practitioner communication, consultation length, continuance, resource use) were inconclusive.There were no trials evaluating the IPDAS decision process criteria relating to helping patients to recognize a decision needs to be made, understand that values affect the decision, or discuss values with the practitioner. Patient decision aids increase people's involvement and are more likely to lead to informed values-based decisions; however, the size of the effect varies across studies. Decision aids have a variable effect on decisions. They reduce the use of discretionary surgery without apparent adverse effects on health outcomes or satisfaction. The degree of detail patient decision aids require for positive effects on decision quality should be explored. The effects on continuance with chosen option, patient-practitioner communication, consultation length, and cost-effectiveness need further evaluation.

BackgroundDecision aids have been overall successful in improving the quality of health decision making. However, it is unclear whether the impact of the results of using decision aids also apply to older people (aged 65+). We sought to systematically review randomized controlled trials (RCTs) and clinical controlled trials (CCTs) evaluating the efficacy of decision aids as compared to usual care or alternative intervention(s) for older adults facing treatment, screening or care decisions.MethodsA systematic search of (1) a Cochrane review of decision aids and (2) MEDLINE, Embase, PsycINFO, Cochrane library central registry of studies and Cinahl. We included published RCTs/CCTs of interventions designed to improve shared decision making (SDM) by older adults (aged 65+) and RCTs/CCTs that analysed the effect of the intervention in a subgroup with a mean age of 65+. Based on the International Patient Decision aid Standards (IPDAS), the primary outcomes were attributes of the decision and the decision process. Other behavioral, health, and health system effects were considered as secondary outcomes. If data could be pooled, a meta-analysis was conducted. Data for which meta-analysis was not possible were synthesized qualitatively.ResultsThe search strategy yielded 11,034 references. After abstract and full text screening, 22 papers were included. Decision aids performed better than control resp. usual care interventions by increasing knowledge and accurate risk perception in older people (decision attributes). With regard to decision process attributes, decision aids resulted in lower decisional conflict and more patient participation.ConclusionsThis review shows promising results on the effectiveness of decision aids for older adults. Decision aids improve older adults’ knowledge, increase their risk perception, decrease decisional conflict and seem to enhance participation in SDM. It must however be noted that the body of literature on the effectiveness of decision aids for older adults is still in its infancy. Only one decision aid was specifically developed for older adults, and the mean age in most studies was between 65 and 70, indicating that the oldest-old were not included. Future research should expand on the design, application and evaluation of decision aids for older, more vulnerable adults.Electronic supplementary materialThe online version of this article (doi:10.1186/s12911-016-0281-8) contains supplementary material, which is available to authorized users.

Recent atrial fibrillation guidelines recommend shared decision-making between clinicians and patients when choosing stroke-prevention therapies. Although decision aids improve patients' knowledge and decisional conflicts, there is no decision aid for stroke-prevention strategies in people with atrial fibrillation receiving hemodialysis. The objective was to develop and field test the first decision aid for Atrial Fibrillation in HemoDialysis (AFHD-DA) for stroke prevention in atrial fibrillation and hemodialysis. This is a sequential 3-phase mixed-methods study following the International Patient Decision Aid Standards and the Ottawa Decision Support Framework. This study was conducted in 2 ambulatory hemodialysis centers in Montreal and Laval (Canada). Adults with atrial fibrillation receiving hemodialysis and clinicians (physicians, pharmacists, or nurse practitioners) involved in their care. In phase 1, we conducted systematic and 2 rapid reviews and formed the steering committee to pilot the first version of AFHD-DA. In phase 2, we refined the AFHD-DA through 4 rounds of focus groups and interviews, using a qualitative analysis of transcripts and a descriptive analysis of acceptability and usability scores. In phase 3, we field-tested the decision aid during 16 simulated clinical consultations. We assessed decisional conflict and patient knowledge using before-and-after paired t-tests and compared the proportion of patients with high decisional conflict using McNemar's test. We used the Ottawa Hospital preparation for decision-making scale and participants' feedback to evaluate how AFHD-DA facilitated shared decision-making. We enrolled 8 patients and 10 clinicians in phase 2. The predefined usability and acceptability thresholds (68 and 66, respectively) were reached. Theme saturation was achieved in the fourth round of focus groups and interviews. Four major themes emerged: acceptability, usability, decision-making process, and scientific value of the decision aid. Sixteen patients and 10 clinicians field-tested the decision aid in phase 3. In clinical settings, AFHD-DA significantly decreased the mean decisional conflict score from 41.0 to 13.6 (P < .001) and the proportion of patients with decisional conflicts from 81.3 to 18.8% (P = .002). It improved the patients' mean knowledge score from 62.7 to 76.6 (P = .001), and 81% of patients and 90% of clinicians felt highly prepared for decision-making. Clinical consultations lasted, on average, 21 minutes (standard deviation = 8). The main limitations were the low quality of existing literature, the small number of participants, and the absence of a control group. The decision aid facilitated time-efficient shared decision-making between clinicians and patients, improved patients' knowledge, and reduced decisional conflict around selecting a stroke-prevention strategy for patients with atrial fibrillation receiving hemodialysis.

BackgroundDecision 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.ObjectiveTo determine whether a decision aid increases informed choice about mammography screening programme participation.MethodsA 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.Results1,206 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.ConclusionThis 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.Trial registrationGerman Clinical Trials Register DRKS00005176.

A systematic review and meta-analysis of effectiveness of decision aids for vaccination decision-making

Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values. To assess the effects of decision aids in people facing treatment or screening decisions. Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008. We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids. Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision-making process.Secondary outcomes were behavioural, health, and health system effects.We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random-effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence. We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high-quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate-quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low-quality evidence) compared to usual care.Regarding attributes related to the decision-making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD -9.28/100; 95% CI -12.20 to -6.36; 27 studies; N = 5707; high-quality evidence), indecision about personal values (MD -8.81/100; 95% CI -11.99 to -5.63; 23 studies; N = 5068; high-quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate-quality evidence).Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and/or the preparation for decision making compared to usual care.Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate-specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition-specific health outcomes. Studies did not report adverse events associated with the use of decision aids.In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup. Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost-effectiveness, and use with lower literacy populations.

This prospective cohort study aimed to (i) evaluate patients' treatment decisions, decisional conflict and knowledge levels before and after use of a video-based decision aid (DA) on asymptomatic persistent endodontic lesions (APEL) and to (ii) elicit important decision factors for patients in the decision-making process. A video DA modelled after the International Patient Decision Aids Standards (IPDAS) was designed. The video was pilot-tested, revised and used on 50 patients referred to the graduate endodontic clinic and presenting with an incidental finding of APEL detected on radiographs, with informed consent (DSRB 2020/00133). Recruitment was conducted from June 2020 to November 2021. Patients' treatment decisions and decision-making process were studied. Patients also completed a questionnaire on knowledge gain, decisional conflict and confidence levels. Forty-three patients (48 teeth) out of 50 patients chose long-term monitoring of APEL while 7 patients (7 teeth) decided on endodontic intervention. Median knowledge scores increased from 58.3 (IQR: 41.7, 75.0) to 87.5 (IQR: 75.0, 100.0) (p < .001); median decisional conflict scale (DCS) scores decreased from 25.0 (IQR: 12.5, 34.4) to 3.1 (IQR: 0, 23.8) (p < .001), and 44 (88%) patients were confident or very confident with their treatment decisions. Statistical analyses showed that asymptomatic condition of tooth was the sole decision factor with statistical significance while socioeconomic factors (age, gender, race, education and income levels) showed no significant trend. The majority of patients presenting with APEL in this study chose long-term monitoring over immediate intervention. Using the video-based DA in the decision-making process significantly improved patients' knowledge and decreased their decisional conflict levels.

At the interface of medicine and dentistry: shared decision-making using decision aids and clinical decision support tools

BackgroundResearch has indicated a lack of disease-specific reproductive knowledge among patients with Inflammatory Bowel Disease (IBD) and this has been associated with increased “voluntary childlessness”. Furthermore, a lack of knowledge may contribute to inappropriate medication changes during or after pregnancy. Decision aids have been shown to support decision making in pregnancy as well as in multiple other chronic diseases. A published decision aid for pregnancy in IBD has not been identified, despite the benefit of pre-conception counselling and patient desire for a decision support tool. This study aimed to develop and test the feasibility of a decision aid encompassing reproductive decisions in the setting of IBD.MethodsThe International Patient Decision Aid Standards were implemented in the development of the Pregnancy in IBD Decision Aid (PIDA). A multi-disciplinary steering committee was formed. Patient and clinician focus groups were conducted to explore themes of importance in the reproductive decision-making processes in IBD. A PIDA prototype was designed; patient interviews were conducted to obtain further insight into patient perspectives and to test the prototype for feasibility.ResultsIssues considered of importance to patients and clinicians encountering decisions regarding pregnancy in the setting of IBD included fertility, conception timing, inheritance, medications, infant health, impact of surgery, contraception, nutrition and breastfeeding. Emphasis was placed on the provision of preconception counselling early in the disease course. Decisions relating to conception and medications were chosen as the current focus of PIDA, however content inclusion was broad to support use across preconception, pregnancy and post-partum phases. Favourable and constructive user feedback was received.ConclusionsThe novel development of a decision aid for use in pregnancy and IBD was supported by initial user testing.

<h3>Background</h3> Subacromial decompression surgery and rotator cuff repair surgery are often used to treat shoulder pain but evidence suggests these surgeries provide limited clinical benefit and may cause harm. We developed a patient decision aid – guided by the International Patient Decision Aids Standards (IPDAS) – that presents evidence-based information on the benefits and harms of these surgeries for shoulder pain compared to non-surgical options. <h3>Objective</h3> To evaluate whether our patient decision aid for people considering shoulder surgery influences treatment intentions, knowledge of options, attitudes towards shoulder surgery, percentage likely to make an informed choice, and decisional conflict, and whether the display of options in the decision aid influences these outcomes. <h3>Design</h3> Online randomised controlled trial. <h3>Methods</h3> Participants (n=425) with non-traumatic shoulder pain considering shoulder surgery were recruited online and randomised to i) a co-designed patient decision aid outlining the benefits and harms of shoulder surgery and non-surgical options (participants were further randomised to two versions of the decision aid: options side-by-side vs. top-and-bottom); and ii) information about shoulder pain from the National Health Service (NHS). Treatment intentions (as a continuous and dichotomous variable) was the primary outcome. Secondary outcomes included knowledge of options, attitudes towards shoulder surgery, percentage likely to make an informed choice, and decisional conflict. Multivariate linear and logistic regression models were used to evaluate between-group differences in outcomes. All outcomes were transformed to a 0–100 scale. <h3>Results</h3> 409 participants (96%) had post-intervention data. Mean age was 41.3 years, 44.2% were female, and mean shoulder pain over the last week was 6.3 out of 10. At baseline, mean treatment intentions was 73.3 (where 100 indicates definitely intending to have surgery) and 90.1% intended to have shoulder surgery (score of &gt;50/100 for treatment intentions). Post-intervention there was no between-group difference in mean treatment intentions (decision aid: 72.4 vs. control: 75.7, adjusted mean difference [MD] -0.2 on a 0–100 scale, 95% CI: -3.3 to 2.8) and percentage intending to have shoulder surgery (decision aid: 85.8% vs. control: 91.7%, adjusted Odds Ratio [OR] 0.7, 95% CI: 0.3 to 1.5). The decision aid slightly improved knowledge of options compared to the control (decision aid: 37.7 vs. control: 35.1, adjusted MD 4.4, 95% CI: 0.2 to 8.6), but there was no between-group difference in mean attitude towards shoulder surgery (decision aid: 73.0 vs. control: 75.3, adjusted MD -1.7 on a 0–100 scale, 95% CI: -4.4 to 1.0), percentage likely to make an informed choice (decision aid: 27.5% vs. control: 24.4%, adjusted OR 1.4, 95% CI: 0.9 to 2.3), and decisional conflict (decision aid: 22.6 vs. control: 22.7, adjusted MD -0.1, 95% CI: -1.9 to 1.7). The display of options did not influence any outcome. <h3>Conclusions</h3> In this online trial, a co-designed patient decision aid had no effect on treatment intention, attitudes, informed choice, and decisional conflict, but a small effect on improving knowledge. Future research is needed to evaluate whether decision aids for people considering shoulder surgery are beneficial when used in discussions with health professionals and earlier in the decision-making journey.

Way to evidence-based decision aids in orthodontics.

The increasing proportion of telemedicine and virtual care in orthopaedic surgery presents an opportunity for upstream delivery of patient facing tools, such as decision aids. Displaced diaphyseal clavicle fractures (DDCFs) are ideal for a targeted intervention because there is no superior treatment, and decisions are often dependent on patient's preference. A decision aid provided before consultation may educate a patient and minimize decisional conflict similarly to inperson consultation with an orthopaedic traumatologist. Patients with DDCF were enrolled into 2 groups. The usual care group participated in a discussion with a trauma fellowship-trained orthopaedic surgeon. Patients in the intervention group were administered a DDCF decision aid designed with the International Patient Decision Aid Standards. Primary comparisons were made based on a decisional conflict score. Secondary outcomes included treatment choice, pain score, QuickDASH, and opinion toward cosmetic appearance. A total of 41 patients were enrolled. Decisional conflict scores were similar and low between the 2 groups: 11.8 (usual care) and 11.4 (decision aid). There were no differences in secondary outcomes between usual care and the decision aid. Our decision aid for the management of DDCF produces a similarly low decisional conflict score to consultation with an orthopaedic trauma surgeon. This decision aid could be a useful resource for surgeons who infrequently treat this injury or whose practices are shifting toward telemedicine visits. Providing a decision aid before consultation may help incorporate patient's values and preferences into the decision-making process between surgery and nonoperative management. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

BackgroundWhen 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/DesignWe 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).DiscussionThis 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 registrationGerman Clinical Trials Register DRKS00005176.Electronic supplementary materialThe online version of this article (doi:10.1186/s12905-015-0210-5) contains supplementary material, which is available to authorized users.

Decision aids (DAs) have been developed in several health disciplines to support decision making informed by evidence, such as the benefits and risks of different treatment options. Decision aids can improve the decision-making process by reducing decisional conflict and helping patients to participate in decision making. The aim of this study was to design and develop a DA for treatment decision making in localized prostate cancer in Spain with regard to surgery, radiotherapy, or watchful waiting. We developed a DA based on the principles of the International Patient Decision Aid Standards Collaboration and according to the Ottawa Decision Support Framework. The structural development process involved DA developers, expert feedback, use of the Delphi method, and patient feedback. We conducted a pilot test on 34 men with localized prostate cancer. The DA is a structured booklet. According to the International Patient Decision Aid Standards checklist, the DA scored 22 of 27 points (81.48%). The development process section scored 22 of 24 points (91.6%), and the effectiveness of the decision-making process section scored 6 of 6 (100%). The clinical pilot test yielded positive feedback regarding the design, images, understandability, usability, explanations, and amount of information in the DA. We developed a Spanish DA with a strong quality score to help patients make an informed choice regarding their prostate cancer treatment. Future research will assess the impact of the DA and its association with improved decision making. This tool provides information about the risks and benefits of different treatment options and helps patients to understand the importance of their own values for informing treatment choices.