Support Shared Decision Making Research Articles

Artificial-Intelligence Cloud-Based Platform to Support Shared Decision-Making in the Locoregional Treatment of Breast Cancer: Protocol for a Multidimensional Evaluation Embedded in the CINDERELLA Clinical Trial.

Shared decision-making (SDM) plays a crucial role in breast cancer care by empowering patients and reducing decision regret. Patient decision aids (PtDAs) are valuable tools for facilitating SDM, now available in digital and artificial intelligence (AI)-powered formats to offer increasingly personalized contents. The ongoing CINDERELLA clinical trial (ClinicalTrials.gov: NCT05196269) evaluates an innovative AI cloud-based approach using a web platform and a mobile application (CINDERELLA APProach) versus the conventional approach to support SDM in breast cancer patients undergoing locoregional treatment. This protocol outlines a trial-based multidimensional evaluation, encompassing economic, financial, implementability, and environmental considerations associated with the CINDERELLA APProach. A within-trial cost-consequence and cost-utility analysis from a societal perspective will be performed using patient-level data on outcomes and resource use. The latter will be valued in monetary terms using country-specific unit costs or patient valuations. A budget impact analysis will be performed over 1 and 5 years from the budget holder perspectives. The CINDERELLA APProach implementability will be assessed through an evaluation of its usability, acceptability, organizational impact, and overall feasibility. The environmental impact will be quantitatively assessed across several dimensions, such as quantity, appropriateness, and emissions, supplemented by qualitative insights. Overall, data for the evaluation will be gathered from patient questionnaires, interviews with patients and managers, focus groups with healthcare professionals, and app electronic data. A thorough understanding of the broad consequences of the CINDERELLA APProach may foster its successful translation into real-world settings, hopefully benefiting breast cancer patients and clinical practice.

Exploring practice and perspectives on shared decision-making about osteoporosis medicines in Fracture Liaison Services: the iFraP development qualitative study

SummaryInterviews and focus groups with patients, FLS clinicians, and GPs identified challenges relating to clinical and shared decision-making about bone health and osteoporosis medicines. Findings will inform the development of the multicomponent iFraP intervention to address identified training needs and barriers to implementation to facilitate SDM about osteoporosis medicines.PurposeThe iFraP (improving uptake of Fracture Prevention treatments) study aimed to develop a multicomponent intervention, including an osteoporosis decision support tool (DST), to support shared decision-making (SDM) about osteoporosis medicines. To inform iFraP intervention development, this qualitative study explored current practice in relation to communication about bone health and osteoporosis medicines, anticipated barriers to, and facilitators of, an osteoporosis DST, and perceived training needs.MethodsPatients attending an FLS consultation (n = 8), FLS clinicians (n = 9), and general practitioners (GPs; n = 7) were purposively sampled to participate in a focus group and/or telephone interview. Data were transcribed, inductively coded, and then mapped to the Theoretical Domains Framework (TDF) as a deductive framework to systematically identify possible barriers to, and facilitators of, implementing a DST.ResultsInductive codes were deductively mapped to 12 TDF domains. FLS clinicians were perceived to have specialist expertise (knowledge). However, clinicians described aspects of clinical decision-making and risk communication as difficult (cognitive skills). Patients reflected on decisional uncertainty about medicines (decision processes). Discussions about current practice and the proposed DST indicated opportunities to facilitate SDM, if identified training needs are met. Potential individual and system-level barriers to implementation were identified, such as differences in FLS configuration and a move to remote consulting (environmental context and resources).ConclusionsUnderstanding of current practice revealed unmet training needs, indicating that using a DST in isolation would be unlikely to produce a sustained shift to SDM. Findings will shape iFraP intervention development to address unmet needs.

Weight-Reduction Preferences Among OBSERVE Study Participants With Obesity or Overweight: Opportunities for Shared Decision-Making

ObjectiveLimited recent evidence exists regarding weight-reduction preferences among people with obesity in the United States (US). We assessed preferred magnitudes of weight reduction among adults with obesity and how these preferences differ by participant characteristics. MethodsThe Perceptions, Barriers, and Opportunities for Anti-obesity Medications in Obesity Care: A Survey of Patients, Providers and Employers was a cross-sectional study assessing perceptions of obesity and anti-obesity medications among people with obesity, healthcare providers, and employers in the US. Adults with obesity and overweight with obesity-related complications self-reported current weight and weight they associated with 5 preferences (“dream,” “goal,” “happy,” “acceptable,” and “disappointed.”) Preferred percent weight reductions for each preference were calculated. Multivariable regression analyses were performed identifying associations between weight-reduction preferences and participant characteristics. ResultsThe study included 1007 participants (women: 63.6%; White: 41.0%; Black or African American: 28.9%; Asian: 6.5%; Hispanic: 15.3%; and median body mass index (BMI): 34.2 kg/m2). Median preferred percent weight reductions were dream = 23.5%; goal = 16.7%; happy = 14.6%; acceptable = 10.3%; and disappointed = 4.8%. Women reported higher preferred weight reductions than men. Preferred weight reductions among Black/African American participants were lower than White participants. Regression analyses indicated significant associations, with higher preferred magnitudes of weight reduction within females, higher weight self-stigma, and BMI class in Hispanic participants compared to White. ConclusionIn this large, real-world study, preferred magnitudes of weight reduction exceeded outcomes typically achieved with established nonsurgical obesity treatments but may be attained with bariatric procedures and newer and emerging anti-obesity medications. Respecting patients’ preferences for treatment goals with obesity management could help support shared decision-making. Evaluating for an individual’s contributors to weight preferences, such as weight self-stigma, can further benefit holistic obesity care.

Iterative Development of an Interactive Website to Support Shared Decision-Making in Metastatic Breast Cancer.

Recent treatment advances have resulted in significantly increased survival times following metastatic breast cancer (MBC) diagnosis. Novel treatment approaches-and their related side effects-have changed the landscape of MBC treatment decision-making. We developed a prototype of an online educational tool to prepare patients with MBC for shared decision-making with their oncologists. We describe the five phases of tool development: (1) in-depth, semi-structured qualitative interviews and (2) feedback on storyboards of initial content with patients with MBC and oncology providers. This was followed by three phases of iterative feedback with patients in which they responded to (3) initial, non-navigable website content and (4) a beta version of the full website. In the final phase (5), patients newly diagnosed with MBC (N = 6) used the website prototype for 1week and completed surveys assessing acceptability, feasibility, treatment knowledge, preparation for decision-making, and self-efficacy for decision-making. Participants in Phase 1 characterized a cyclical process of MBC treatment decision-making and identified key information needs. Website content and structure was iteratively developed in Phases 2-4. Most participants in Phase 5 (n = 4) accessed the website 2-5 times. All participants who accessed the website at least once (n = 5) felt they learned new information from the website prototype and would recommend it to others newly-diagnosed with MBC. After using the website prototype, participants reported high preparation and self-efficacy for decision-making. This multiphase, iterative process resulted in a prototype intervention designed to support decision-making for MBC patients.

Could a Risk-adapted Approach Support Shared Decision-making Regarding Eligibility for Adjuvant Pembrolizumab for Patients with Clear Cell Renal Cell Carcinoma at High Risk of Recurrence? A Multicentre Cohort Study

The KEYNOTE-564 randomised controlled trial showed a disease-free survival benefit of adjuvant pembrolizumab (aPZB) in comparison to placebo for patients with clear cell renal cell carcinoma (ccRCC) at high risk of recurrence. Despite its recommendation by the European Association of Urology guidelines, the ultimate value of aPZB has recently been questioned. Arguably, patients who might benefit the most from aPZB are those whose probability of RCC recurrence outweighs their probability of dying from other causes over a reasonable timeframe after surgery. To assess the potential impact of this hypothesis on “eligibility” for aPZB, we queried our prospectively collected multi-institutional database for consecutive patients undergoing surgery for nonmetastatic renal masses (cT1–4 N0–1 M0) between 2015 and 2021 to identify ccRCC cases meeting the KEYNOTE-564 criteria. We stratified the patients using the risk-adapted model proposed by Stewart-Merrill et al (whereby stopping follow-up is warranted when the estimated risk of other-cause mortality [OCM] outweighs the estimated risk of RCC recurrence). Then we explored the proportion of patients whose follow-up could theoretically be stopped at 2, 5, 10, or 20 yr, for whom “eligibility” for aPZB might be more controversial. Overall, 1745 patients with ccRCC were included, of whom 419 (24%) met the KEYNOTE-564 criteria. The proportion of patients “not eligible” for aPZB because of higher probability of OCM than of RCC recurrence would have been 81%, 66%, 43%, and 29% at “recommended” follow-up of ≤2.0, ≤5, ≤10, and ≤20 yr, respectively. To the best of our knowledge, this is the first study providing insights to support shared decision-making regarding eligibility for aPZB for patients with nonmetastatic ccRCC with a focus on patient-related factors beyond tumour-driven prognostic scores. Patient summaryAn immunotherapy drug call pembrolizumab given after surgery for nonmetastatic kidney cancer may benefit some patients who have a high risk of disease recurrence, but it can have immune-related side effects. We found that comparing the risk of death from other causes and the risk of cancer recurrence could help in reducing overtreatment of patients who might not benefit from this drug.

Implementing Shared Decision-Making for Multiple Sclerosis: The MS-SUPPORT Tool

BackgroundDisease modifying therapies (DMTs) offer opportunities to improve the course of multiple sclerosis (MS), but decisions about treatment are difficult. People with multiple sclerosis (pwMS) want more involvement in decisions about DMTs, but new approaches are needed to support shared decision-making (SDM) because of the number of treatment options and the range of outcomes affected by treatment. We designed a patient-centered tool, MS-SUPPORT, to facilitate SDM for pwMS. We sought to evaluate the feasibility and impact of MS-SUPPORT on decisions about disease modifying treatments (DMTs), SDM processes, and quality-of-life. MethodsThis multisite randomized controlled trial compared the SDM intervention (MS-SUPPORT) to control (usual care) over a 12-month period. English-speaking adults with relapsing MS were eligible if they had an upcoming MS appointment and an email address. To evaluate clinician perspectives, participants’ MS clinicians were invited to participate. Patients were referred between November 11, 2019 and October 23, 2020 by their MS clinician or a patient advocacy organization (the Multiple Sclerosis Association of America). MS-SUPPORT is an online, interactive, evidence-based decision aid that was co-created with pwMS. It clarifies patient treatment goals and values and provides tailored information about MS, DMTs, and adherence. Viewed by patients before their clinic appointment, MS-SUPPORT generates a personalized summary of the patient's treatment goals and preferences, adherence, DMT use, and clinical situation to share with their MS clinician. Outcomes (DMT utilization, adherence, quality-of-life, and SDM) were assessed at enrollment, post-MS-SUPPORT, post-appointment, and quarterly for 1 year. ResultsParticipants included 501 adults with MS from across the USA (84.6% female, 83% white) and 34 of their MS clinicians (47% neurologists, 41% Nurse Practitioners, 12% Physician Assistants). Among the 203 patients who completed MS-SUPPORT, most (88.2%) reported they would recommend it to others and that it helped them talk to their doctor (85.2%), understand their options (82.3%) and the importance of taking DMTs as prescribed (82.3%). Among non-users of DMTs at baseline, the probability ratio of current DMT use consistently trended higher over one-year follow-up in the MS-SUPPORT group (1.30 [0.86-1.96]), as did the cumulative probability of starting a DMT within 6-months, with shorter time-to-start (46 vs 90 days, p=0.24). Among the 222 responses from 34 participating clinicians, more clinicians in the MS-SUPPORT group (vs control) trended towards recommending their patient start a DMT (9 of 108 (8%) vs 5 of 109 (5%), respectively, p=0.26). Adherence (no missed doses) to daily-dosed DMTs was higher in the MS-SUPPORT group (81.25% vs 56.41%, p=.026). Fewer patients forgot their doses (p=.046). The MS-SUPPORT group (vs control) reported 1.7 fewer days/month of poor mental health (p=0.02). ConclusionsMS-SUPPORT was strongly endorsed by patients and is feasible to use in clinical settings. MS-SUPPORT increased the short-term probability of taking and adhering to a DMT, and improved long-term mental health. Study limitations include selection bias, response bias, social desirability bias, and recall bias. Exploring approaches to reinforcement and monitoring its implementation in real-world settings should provide further insights into the value and utility of this new SDM tool.

Racial Disparities in Shared Decision-Making and the Use of mHealth Technology Among Adults With Hypertension in the 2017-2020 Health Information National Trends Survey: Cross-Sectional Study in the United States.

Mobile health (mHealth) technology has the potential to support shared decision-making (SDM) and improve hypertension control. However, our understanding of the variations in individuals' involvement in SDM and mHealth usage across different racial and ethnic groups in the United States is still limited. This study aimed to investigate the extent of involvement in SDM and the usage of mHealth technology in health-related activities among US adults with hypertension from diverse racial and ethnic backgrounds and to examine whether the mHealth usage differed by individuals' level of engagement in SDM. This study used cross-sectional data from the 2017 to 2020 Health Information National Trends Survey, which was conducted on US adults with self-reported hypertension, and race and ethnicity data were included. The exposure of interest was race and ethnicity. The outcomes were SDM and mHealth usage. SDM was assessed using an item: "In the past 12 months, how often did your health professional: involve you in decisions about your healthcare as much as you wanted?" mHealth usage was defined as using a smartphone or tablet to engage in (1) making health decisions, (2) discussing health decisions with health providers, (3) tracking health progress, and (4) sharing health information. Weighted multivariable logistic regression models were used to examine the association between race and ethnicity and SDM or mHealth usage adjusted for covariates and stratified by the level of engagement in SDM. This study included 4893 adults with hypertension, and the mean age was 61 (SD 13) years. The sample was 53% female, 61% (n=3006) non-Hispanic White, 19% (n=907) non-Hispanic Black or African American, 12% (n=605) Hispanic, 4% (n=193) non-Hispanic Asian, and 4% (n=182) non-Hispanic other. Compared to the non-Hispanic White adults, non-Hispanic Black adults were more likely to use mHealth to make health decisions (adjusted odds ratio [aOR] 1.70, 95% CI 1.23-2.34), share health information (aOR 1.46, 95% CI 1.02-2.08), and discuss health decisions with health providers (aOR 1.38, 95% CI 1.02-1.87). Significant associations were observed specifically among those who were always involved in SDM. Asian adults were less likely to be involved in SDM (aOR 0.51, 95% CI 0.26-0.99) and were more likely to use mHealth to track progress on a health-related goal (aOR 2.07, 95% CI 1.28-3.34) than non-Hispanic White adults. Hispanic adults were less likely to use mHealth to share health information (aOR 0.47, 95% CI 0.33-0.67) and discuss health decisions with health providers (aOR 0.65, 95% CI 0.46-0.94) compared to non-Hispanic White adults. This study observed racial and ethnic disparities in SDM and mHealth usage among US adults with hypertension. These findings emphasize the significance of comprehending the involvement of SDM and the usage of mHealth technology within racially and ethnically diverse populations.

Methodologies for Evaluating the Usability of Rehabilitation Technologies Aimed at Supporting Shared Decision-Making: Scoping Review.

The field of rehabilitation has seen a recent rise in technologies to support shared decision-making (SDM). Usability testing during the design process of SDM technologies is needed to optimize adoption and realize potential benefits. There is variability in how usability is defined and measured. Given the complexity of usability, a thorough examination of the methodologies used to measure usability to develop the SDM technologies used in rehabilitation care is needed. This scoping review aims to answer the following research questions: which methods and measures have been used to produce knowledge about the usability of rehabilitation technologies aimed at supporting SDM at the different phases of development and implementation? Which parameters of usability have been measured and reported? This review followed the Arksey and O'Malley framework. An electronic search was performed in the Ovid MEDLINE, Embase, CINAHL, and PsycINFO databases from January 2005 up to November 2020. In total, 2 independent reviewers screened all retrieved titles, abstracts, and full texts according to the inclusion criteria and extracted the data. The International Organization for Standardization framework was used to define the scope of usability (effectiveness, efficiency, and satisfaction). The characteristics of the studies were outlined in a descriptive summary. Findings were categorized based on usability parameters, technology interventions, and measures of usability. A total of 38 articles were included. The most common SDM technologies were web-based aids (15/33, 46%). The usability of SDM technologies was assessed during development, preimplementation, or implementation, using 14 different methods. The most frequent methods were questionnaires (24/38, 63%) and semistructured interviews (16/38, 42%). Satisfaction (27/38, 71%) was the most common usability parameter mapped to types of SDM technologies and usability evaluation methods. User-centered design (9/15, 60%) was the most frequently used technology design framework. The results from this scoping review highlight the importance and the complexity of usability evaluation. Although various methods and measures were shown to be used to evaluate the usability of technologies to support SDM in rehabilitation, very few evaluations used in the included studies were found to adequately span the selected usability domains. This review identified gaps in usability evaluation, as most studies (24/38, 63%) relied solely on questionnaires rather than multiple methods, and most questionnaires simply focused on the usability parameter of satisfaction. The consideration of end users (such as patients and clinicians) is of particular importance for the development of technologies to support SDM, as the process of SDM itself aims to improve patient-centered care and integrate both patient and clinician voices into their rehabilitation care.

Digital encounter decision aids linked to clinical practice guidelines: results from user testing SHARE-IT decision aids in primary care

BackgroundEncounter decision aids (EDAs) are tools that can support shared decision making (SDM), up to the clinical encounter. However, adoption of these tools has been limited, as they are hard to produce, to keep up-to-date, and are not available for many decisions. The MAGIC Evidence Ecosystem Foundation has created a new generation of decision aids that are generically produced along digitally structured guidelines and evidence summaries, in an electronic authoring and publication platform (MAGICapp). We explored general practitioners’ (GPs) and patients' experiences with five selected decision aids linked to BMJ Rapid Recommendations in primary care.MethodsWe applied a qualitative user testing design to evaluate user experiences for both GPs and patients. We translated five EDAs relevant to primary care, and observed the clinical encounters of 11 GPs when they used the EDA with their patients. We conducted a semi-structured interview with each patient after the consultation and a think-aloud interview with each GPs after multiple consultations. We used the Qualitative Analysis Guide (QUAGOL) for data analysis.ResultsDirect observations and user testing analysis of 31 clinical encounters showed an overall positive experience. The EDAs created better involvement in decision making and resulted in meaningful insights for patients and clinicians. The design and its interactive, multilayered structure made the tool enjoyable and well-organized. Difficult terminology, scales and numbers hindered understanding of certain information, which was sometimes perceived as too specialized or even intimidating. GPs thought the EDA was not suitable for every patient. They perceived a learning curve was required and the need for time investment was a concern. The EDAs were considered trustworthy as they were provided by a credible source.ConclusionsThis study showed that EDAs can be useful tools in primary care by supporting actual shared decision making and enhancing patient involvement. The graphical approach and clear representation help patients better understand their options. To overcome barriers such as health literacy and GPs attitudes, effort is still needed to make the EDAs as accessible, intuitive and inclusive as possible through use of plain language, uniform design, rapid access and training.Trial registrationThe study protocol was approved by the The Research Ethics Committee UZ/KU Leuven (Belgium) on 31–10-2019 with reference number MP011977.

Exploring the Acceptability of Text Messages to Inform and Support Shared Decision-making for Colorectal Cancer Screening: Online Panel Survey.

While online portals may be helpful to engage patients in shared decision-making at the time of cancer screening, because of known disparities in patient portal use, sole reliance on portals to support cancer screening decision-making could exacerbate well-known disparities in this health care area. Innovative approaches are needed to engage patients in health care decision-making and to support equitable shared decision-making. We assessed the acceptability of text messages to engage sociodemographically diverse individuals in colorectal cancer (CRC) screening decisions and support shared decision-making in practice. We developed a brief text message program offering educational information consisting of components of shared decision-making regarding CRC screening (eg, for whom screening is recommended, screening test options, and pros/cons of options). The program and postprogram survey were offered to members of an online panel. The outcome of interest was program acceptability measured by observed program engagement, participant-reported acceptability, and willingness to use similar programs (behavioral intent). We evaluated acceptability among historically marginalized categories of people defined by income, literacy, and race. Of the 289 participants, 115 reported having a low income, 146 were Black/African American, and 102 had less than extreme confidence in their health literacy. With one exception, we found equal or greater acceptability, regardless of measure, within each of the marginalized categories of people compared to their counterparts. The exception was that participants reporting an income below US $50,000 were less likely to engage with sufficient content of the program to learn that there was a choice among different CRC screening tests (difference -10.4%, 95% CI -20.1 to -0.8). Of note, Black/African American participants reported being more likely to sign up to receive text messages from their doctor's office compared to white participants (difference 18.7%, 95% CI 7.0-30.3). Study findings demonstrate general acceptance of text messages to inform and support CRC screening shared decision-making.

A blended learning for general practitioners and nurses on skills to support shared decision-making with patients about palliative cancer treatment: A one-group pre-posttest study

ObjectiveTo evaluate a newly developed blended learning programme for general practitioners (GPs) and nurses in supporting shared decision making (SDM) about palliative cancer treatment in a simulated setting. MethodsIn a pre-posttest study, healthcare professionals (HCPs) participated in the blended learning (i.e. e-learning and (online) training session). HCPs filled out surveys (T0 (baseline), T1 (after e-learning) and T2 (after full blended learning)) and engaged in simulated consultations at T0 and T2. The primary outcome was observed SDM support (Triple-S; DSAT-10 for validation). Secondary outcomes included satisfaction, knowledge about and attitude towards SDM support. Repeated measures General Linear Models were conducted. Results33 HCPs (17 GPs and 16 nurses) participated. SDM support significantly improved after training (Triple-S; medium effect). Observers’ overall rating of SDM support (medium effect) as well as HCPs’ knowledge (large effect) and beliefs about their capabilities (medium effect) improved after training. There was no difference in decision support skills (DSAT-10), HCPs’ other clinical behavioural intentions and satisfaction. HCPs evaluated the training positively. ConclusionBlended learning for HCPs on supporting SDM in palliative cancer care improved their skills, knowledge and confidence in simulated consultations. Practice implicationsThese first findings are promising for evaluating interprofessional SDM in clinical practice.

Development of Complementary Encounter and Patient Decision Aids for Shared Decision Making about Stroke Prevention in Atrial Fibrillation.

Decision aids (DAs) are helpful instruments used to support shared decision making (SDM). Patients with atrial fibrillation (AF) face complex decisions regarding stroke prevention strategies. While a few DAs have been made for AF stroke prevention, an encounter DA (EDA) and patient DA (PDA) have not been created to be used in conjunction with each other before. Using iterative user-centered design, we developed 2 DAs for anticoagulation choice and stroke prevention in AF. Prototypes were created, and we elicited feedback from patients and experts via observations of encounters, usability testing, and semistructured interviews. User testing was done with 33 experts (in AF and SDM) and 51 patients from 6 institutions. The EDA and PDA underwent 1 and 4 major iterations, respectively. Major differences between the DAs included AF pathophysiology and a preparation to meet with the clinician in the PDA as well as different language throughout. Content areas included personalized stroke risk, differences between anticoagulants, and risks of bleeding. Based on user feedback, developers 1) addressed feelings of isolation with AF, 2) improved navigation options, 3) modified content and flow for users new to AF and those experienced with AF, 4) updated stroke risk pictographs, and 5) added structure to the preparation for decision making in the PDA. These DAs focus only on anticoagulation for stroke prevention and are online, which may limit participation for those less comfortable with technology. Designing complementary DAs for use in tandem or separately is a new method to support SDM between patients and clinicians. Extensive user testing is essential to creating high-quality tools that best meet the needs of those using them. First-time complementary encounter and patient decision aids have been designed to work together or separately.User feedback led to greater structure and different experiences for patients naïve or experienced with anticoagulants in patient decision aids.Online tools allow for easier dissemination, use in telehealth visits, and updating as new evidence comes out.

Supporting Shared Decision-making About Surveillance After Breast Cancer With Personalized Recurrence Risk Calculations: Development of a Patient Decision Aid Using the International Patient Decision AIDS Standards Development Process in Combination With a Mixed Methods Design.

Although the treatment for breast cancer is highly personalized, posttreatment surveillance remains one-size-fits-all: annual imaging and physical examination for at least five years after treatment. The INFLUENCE nomogram is a prognostic model for estimating the 5-year risk for locoregional recurrences and second primary tumors after breast cancer. The use of personalized outcome data (such as risks for recurrences) can enrich the process of shared decision-making (SDM) for personalized surveillance after breast cancer. This study aimed to develop a patient decision aid (PtDA), integrating personalized risk calculations on risks for recurrences, to support SDM for personalized surveillance after curative treatment for invasive breast cancer. For the development of the PtDA, the International Patient Decision Aids Standards development process was combined with a mixed methods design inspired by the development process of previously developed PtDAs. In the development, 8 steps were distinguished: establishing a multidisciplinary steering group; definition of the end users, scope, and purpose of the PtDA; assessment of the decisional needs of end users; defining requirements for the PtDA; determining the format and implementation strategy for the PtDA; prototyping; alpha testing; and beta testing. The composed steering group convened during regular working-group sessions throughout the development process. The "Breast Cancer Surveillance Decision Aid" consists of 3 components that support the SDM process: a handout sheet on which personalized risks for recurrences, calculated using the INFLUENCE-nomogram, can be visualized and which contains an explanation about the decision for surveillance and a login code for a web-based deliberation tool; a web-based deliberation tool, including a patient-reported outcome measure on fear of cancer recurrence; and a summary sheet summarizing patient preferences and considerations. The PtDA was assessed as usable and acceptable during alpha testing. Beta testing is currently ongoing. We developed an acceptable and usable PtDA that integrates personalized risk calculations for the risk for recurrences to support SDM for surveillance after breast cancer. The implementation and effects of the use of the "Breast Cancer Surveillance Decision Aid" are being investigated in a clinical trial.

Shared Decision-Making for Drug-Drug Interactions: Formative Evaluation of an Anticoagulant Drug Interaction.

Warnings about drug-drug interactions (DDIs) between warfarin and nonsteroidal anti-inflammatory drugs (NSAIDs) within electronic health records indicate potential harm but fail to account for contextual factors and preferences. We developed a tool called DDInteract to enhance and support shared decision-making (SDM) between patients and physicians when both warfarin and NSAIDs are used concurrently. DDInteract was designed to be integrated into electronic health records using interoperability standards. The purpose of this study was to conduct a formative evaluation of a DDInteract that incorporates patient and product contextual factors to estimate the risk of bleeding. A randomized formative evaluation was conducted to compare DDInteract to usual care (UC) using physician-patient dyads. Using case vignettes, physicians and patients on warfarin participated in simulated virtual clinical encounters where they discussed the use of taking ibuprofen and warfarin concurrently and determined an appropriate therapeutic plan based on the patient's individualized risk. Dyads were randomized to either DDInteract or UC. Participants completed a postsession interview and survey of the SDM process. This included the 9-item Shared Decision-Making Questionnaire (SDM-Q-9), tool usability and workload National Aeronautics and Space Administration (NASA) Task Load Index, Unified Theory of Acceptance and Use of Technology (UTAUT), Perceived Behavioral Control (PBC) scale, System Usability Scale (SUS), and Decision Conflict Scale (DCS). They also were interviewed after the session to obtain perceptions on DDInteract and UC resources for DDIs. Twelve dyad encounters were performed using virtual software. Most (n=11, 91.7%) patients were over 50 years of age, and 9 (75%) had been taking warfarin for more than 2 years (75%). Regarding scores on the SDM-Q-9, participants rated DDInteract higher than UC for questions pertaining to helping patients clarify the decision (P=.03), involving patients in the decision (P=.01), displaying treatment options (P<.001), identifying advantages and disadvantages (P=.01), and facilitating patient understanding (P=.01) and discussion of preferences (P=.01). Five of the 8 UTAUT constructs showed differences between the 2 groups, favoring DDInteract (P<.05). Usability ratings from the SUS were significantly higher (P<.05) for physicians using DDInteract compared to those in the UC group but showed no differences from the patient's perspective. No differences in patient responses were observed between groups using the DCS. During the session debrief, physicians indicated little concern for the additional time or workload entailed by DDInteract use. Both clinicians and patients indicated that the tool was beneficial in simulated encounters to understand and mitigate the risk of harm from this DDI. Overall, DDInteract may improve encounters where there is a risk of bleeding due to a potential drug-drug interaction involving anticoagulants. Participants rated DDInteract as logical and useful for enhancing SDM. They reported that they would be willing to use the tool for an interaction involving warfarin and NSAIDs.

Patient-Reported Outcome Dashboards Within the Electronic Health Record to Support Shared Decision-making: Protocol for Co-design and Clinical Evaluation With Patients With Advanced Cancer and Chronic Kidney Disease.

BackgroundPatient-reported outcomes—symptoms, treatment side effects, and health-related quality of life—are important to consider in chronic illness care. The increasing availability of health IT to collect patient-reported outcomes and integrate results within the electronic health record provides an unprecedented opportunity to support patients’ symptom monitoring, shared decision-making, and effective use of the health care system.ObjectiveThe objectives of this study are to co-design a dashboard that displays patient-reported outcomes along with other clinical data (eg, laboratory tests, medications, and appointments) within an electronic health record and conduct a longitudinal demonstration trial to evaluate whether the dashboard is associated with improved shared decision-making and disease management outcomes.MethodsCo-design teams comprising study investigators, patients with advanced cancer or chronic kidney disease, their care partners, and their clinicians will collaborate to develop the dashboard. Investigators will work with clinic staff to implement the co-designed dashboard for clinical testing during a demonstration trial. The primary outcome of the demonstration trial is whether the quality of shared decision-making increases from baseline to the 3-month follow-up. Secondary outcomes include longitudinal changes in satisfaction with care, self-efficacy in managing treatments and symptoms, health-related quality of life, and use of costly and potentially avoidable health care services. Implementation outcomes (ie, fidelity, appropriateness, acceptability, feasibility, reach, adoption, and sustainability) during the co-design process and demonstration trial will also be collected and summarized.ResultsThe dashboard co-design process was completed in May 2020, and data collection for the demonstration trial is anticipated to be completed by the end of July 2022. The results will be disseminated in at least one manuscript per study objective.ConclusionsThis protocol combines stakeholder engagement, health care coproduction frameworks, and health IT to develop a clinically feasible model of person-centered care delivery. The results will inform our current understanding of how best to integrate patient-reported outcome measures into clinical workflows to improve outcomes and reduce the burden of chronic disease on patients and health care systems.International Registered Report Identifier (IRRID)DERR1-10.2196/38461

"You can't touch, you can't bond": Exploring COVID-19 pandemic impacts on rheumatoid arthritis patient goals and communication with clinicians.

"You can't touch, you can't bond": Exploring COVID-19 pandemic impacts on rheumatoid arthritis patient goals and communication with clinicians.

Shared decision-making in advanced kidney disease: a scoping review

ObjectivesTo provide a comprehensive overview of interventions that support shared decision-making (SDM) for treatment modality decisions in advanced kidney disease (AKD). To provide summarised information on their content, use and...

'Replace uncertainty with information': shared decision-making and decision quality surrounding catheter ablation for atrial fibrillation.

As a first step in developing a decision aid to support shared decision-making (SDM) for patients with atrial fibrillation (AF) to evaluate treatment options for rhythm and symptom control, we aimed to measure decision quality and describe decision-making processes among patients and clinicians involved in decision-making around catheter ablation for AF. We conducted a cross-sectional, mixed-methods study guided by an SDM model outlining decision antecedents, processes, and outcomes. Patients and clinicians completed semi-structured interviews about decision-making around ablation, feelings of decision conflict and regret, and preferences for the content, delivery, and format of a hypothetical decision aid for ablation. Patients also completed surveys about AF symptoms and aspects of decision quality. Fifteen patients (mean age 71.1 ± 8.6 years; 27% female) and five clinicians were recruited. For most patients, decisional conflict and regret were low, but they also reported low levels of information and agency in the decision-making process. Most clinicians report routinely providing patients with information and encouraging engagement during consultations. Patients reported preferences for an interactive, web-based decision aid that clearly presents evidence regarding outcomes using data, visualizations, videos, and personalized risk assessments, and is available in multiple languages. Disconnects between clinician efforts to provide information and bolster agency and patient experiences of decision-making suggest decision aids may be needed to improve decision quality in practice. Reported experiences with current decision-making practices and preferences for decision aid content, format, and delivery can support the user-centred design and development of a decision aid.

Decision aids for home and community care: a systematic review

ObjectivesDecision aids (DAs) for clients in home and community care can support shared decision-making (SDM) with patients, healthcare teams and informal caregivers. We aimed to identify DAs developed for home...

Interactive Inflammatory Bowel Disease Biologics Decision Aid Does Not Improve Patient Outcomes Over Static Education: Results From a Randomized Trial.

To support shared decision-making (SDM) between patients and providers surrounding biologic treatments, we created IBD&amp;me ( ibdandme.org )-a freely available, unbranded, interactive decision aid. We performed a multicenter comparative effectiveness trial comparing the impact of IBD&amp;me on SDM vs a biologics fact sheet developed by the Crohn's &amp; Colitis Foundation. We enrolled patients with inflammatory bowel disease (IBD) being seen at a clinic within IBD Qorus-a multicenter adult IBD learning health system-between March 5, 2019, and May 14, 2021. Eligible patients included those with recent IBD-related symptoms who reported that they wanted to discuss biologics with their provider during their upcoming visit. Patients were randomized 1:1 using stratified block randomization and received an e-mail 1 week before their visit inviting them to review either IBD&amp;me or a fact sheet. The primary outcome was patient perception of SDM as measured by the 9-Item SDM Questionnaire (0-100 scale; higher = better); the Student t test was used to compare outcomes between arms. Overall, 152 patients were randomized (biologics fact sheet 75, IBD&amp;me 77); most patients had Crohn's disease (66.4%) and were biologic-experienced (82.9%). No differences were seen between groups regarding SDM (fact sheet 72.6 ± 25.6, IBD&amp;me 75.0 ± 20.8; P = .57). Most patients stated they would be likely to recommend the fact sheet (79.6%) or IBD&amp;me (84.9%; P = .48) to another patient with IBD. No differences in outcomes were seen between IBD&amp;me and the biologics fact sheet in this comparative effectiveness study; patients reported high satisfaction with both resources. Further study, particularly among biologic naïve patients, is needed to determine the utility of interactive components to IBD decision aids.