Development Of Decision Aid Research Articles

P3 - Development of a patient decision aid for kidney failure treatment modality decisions: Presenter(s): Nelly van Uden, Santeon, Netherlands

P3 - Development of a patient decision aid for kidney failure treatment modality decisions: Presenter(s): Nelly van Uden, Santeon, Netherlands

Abstract P1-08-10: A web-based Patient Decision Aid Toolkit for unaffected BRCA mutation carriers

Abstract Women with a pathogenic mutation in the BRCA1 or BRCA2 genes have an elevated lifetime risk of developing breast and ovarian cancer. To address this risk, women are managed with a combination of surveillance and/or risk-reduction strategies. Decisions about risk management strategies can be complex, personal and multifactorial. Women often struggle with the decision-making process. In addition, within the clinical environment, there may be variations in recommendations between clinicians that can leave women uncertain and less able to choose a risk management pathway. The overall aim of this project is the development of a web-based patient decision aid toolkit for BRCA mutation carriers that will improve the decision-making process by providing the user with information about their cancer risk, options for risk management and potential benefits and side effects. Development of the patient decision aid was guided by the International Patient Decision Aid Standards (IPDAS). With appropriate ethical approval, a mixed methods approach was used to identify suitable content for the decision aid. A decision-making needs assessment was conducted to identify the information needs of women with a BRCA mutation. Semi-structured interviews were held with cancer unaffected BRCA mutation carriers (n = 16) and key stakeholders including healthcare professionals, policy makers and patient group representatives (n= 10). Data were analysed by thematic analysis. Systematic scoping reviews were conducted to synthesise relevant evidence on risk-management options, benefits, harms and the development and testing of patient decision aids in general. Content for the decision aid was refined using a Delphi process to build consensus on items for inclusion in the decision aid amongst a diverse panel of experts (n=13). A prototype patient decision aid was developed which included written information as well as visual depictions of risk, videos and photographs to enhance the patient’s information experience. A ‘values clarification’ activity was included to enable women to work through their own values and preferences relating to risk management interventions and their associated benefits and side-effects. Initial ‘sandpit’ testing of the decision aid prototype was performed by the research team and advisory group. Usability testing was conducted with BRCA mutation carries (n = 8) and healthcare professionals (n = 8) using both qualitative interviews and quantitative surveys. The research team made final revisions to the decision aid based on participant feedback and committee consensus. This evidence-based patient decision aid can be used by BRCA mutation carriers unaccompanied or during a clinical consultation. We envisage that this decision aid will improve the decision-making process by assisting women and clinicians during shared decision-making regarding cancer risk management. Citation Format: Sarah A. McGarrigle, Carol Spillane, Niamh Byrne, Manria Polus, Geraldine Prizeman, Amanda Drury, Elizabeth Connolly, Anne-Marie Brady, Yvonne Hanhauser. A web-based Patient Decision Aid Toolkit for unaffected BRCA mutation carriers [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-08-10.

Ethical Need for a Fertility Decision-Aid for Transgender Adults of Reproductive Age

Ethical Need for a Fertility Decision-Aid for Transgender Adults of Reproductive Age

The Perspectives of Surrogates and Healthcare Providers Regarding SDM (Shared Decision-Making).

The purpose of this paper is to explore the attitudes of surrogacy and medical service providers toward SDM and to identify the barriers and promoters of SDM in this population. To this end, we conducted a qualitative study of surrogacy and medical service providers in the First Affiliated Hospital of Soochow University using semistructured interviews. Thirty participants (11 agents, 12 ICU physicians, and 7 ICU nurses) were interviewed. The three stakeholders showed different attitudes toward SDM. They reported barriers to SDM, including insufficient cognition of decision-makers, high expectations, negative psychological experiences, previous decision-making experiences, excessive workload, heavy financial burden, and lack of decision AIDS. They reported facilitators of SDM, including trust, effective communication, decision support, value clarification, outcome commitment, and continuous service. This study explored the different attitudes of the three stakeholders and identified various barriers and facilitators of SDM. It highlights the need to develop localised decision AIDS and to involve agents and nurses more in the decision-making process. Therefore, this paper identifies barriers and facilitators of SDM in this population. In addition, the study identified various barriers and facilitators to SDM and highlighted the need to develop localised decision AIDS and involve agents and nurses more in the decision-making process. Finally, the barriers and facilitators of SDM are established. The paper also shows that the development of localized decision AIDS and greater involvement of agents and nurses in the decision-making process are integral to good treatment outcomes.

Taking shared decision making for prostate cancer to the next level: Requirements for a Dutch treatment decision aid with personalized risks on side effects

BackgroundDifferent curative treatment modalities need to be considered in case of localized prostate cancer, all comparable in terms of survival and recurrence though different in side effects. To better inform patients and support shared decision making, the development of a web-based patient decision aid including personalized risk information was proposed. This paper reports on requirements in terms of content of information, visualization of risk profiles, and use in practice. MethodsBased on a Dutch 10-step guide about the setup of a decision aid next to a practice guideline, an iterative and co-creative design process was followed. In collaboration with various groups of experts (health professionals, usability and linguistic experts, patients and the general public), research and development activities were continuously alternated. ResultsContent requirements focused on presenting information only about conventional treatments and main side effects; based on risk group; and including clear explanations about personalized risks. Visual requirements involved presenting general and personalized risks separately; through bar charts or icon arrays; and along with numbers or words, and legends. Organizational requirements included integration into local clinical pathways; agreement about information input and output; and focus on patients' numeracy and graph literacy skills. ConclusionsThe iterative and co-creative development process was challenging, though extremely valuable. The translation of requirements resulted in a decision aid about four conventional treatment options, including general or personalized risks for erection, urinary and intestinal problems that are communicated with icon arrays and numbers. Future implementation and validation studies need to inform about use and value in practice.

Development of a Patient Decision Aid for Rectal Cancer Patients with Clinical Complete Response after Neo-Adjuvant Treatment.

Surgery is the primary component of curative treatment for patients with rectal cancer. However, patients with a clinical complete response (cCR) after neo-adjuvant treatment may avoid the morbidity and mortality of radical surgery. An organ-sparing strategy could be an oncological equivalent alternative. Therefore, shared decision making between the patient and the healthcare professional (HCP) should take place. This can be facilitated by a patient decision aid (PtDA). In this study, we developed a PtDA based on a literature review and the key elements of the Ottawa Decision Support Framework. Additionally, a qualitative study was performed to review and evaluate the PtDA by both HCPs and former rectal cancer patients by a Delphi procedure and semi-structured interviews, respectively. A strong consensus was reached after the first round (I-CVI 0.85-1). Eleven patients were interviewed and most of them indicated that using a PtDA in clinical practice would be of added value in the decision making. Patients indicated that their decisional needs are centered on the impact of side effects on their quality of life and the outcome of the different options. The PtDA was modified taking into account the remarks of patients and HCPs and a second Delphi round was held. The second round again showed a strong consensus (I-CVI 0.87-1).

"SDM:HOSP"- a generic model for hospital-based implementation of shared decision making.

Shared decision making (SDM) is a core element in the meeting between patient and healthcare professionals, but has proved difficult to implement and sustain in routine clinical practice. One of five Danish regions set out to succeed and to develop a model that ensures lasting SDM based on learnings from large-scale real-world implementation initiatives that go beyond the 'barriers' and 'facilitators' research approach. This paper describes this process and development of a generic implementation model, SDM:HOSP. This project was carried out in the Region of Southern Denmark with five major hospital units. Based on existing theory of SDM, SDM implementation, implementation science and improvement methodology, a process of four phases were described; development of conceptual elements, field-testing, evaluation, and development of the final implementation model. The conceptual elements developed aimed to prepare leaders, train SDM teachers, teach clinicians to perform SDM, support development of patient decision aids, and support systematic planning, execution and follow-up. Field testing was done including continuous participant evaluations and an overall evaluation after one year. Data from field testing and learnings from the implementation process, illustrated the need for a dynamic and easy adjustable model. The final SDM:HOSP model included four themes; i)Training of Leaders, ii) Training of Teachers and Clinicians, iii) Decision Helper, and iv) 'Process', each with details in three levels, 1) shared elements, 2) recommendations, and 3) local adaption. A feasible and acceptable model for implementation of SDM across hospitals and departments that accounts for different organizations and cultures was developed. The overall design can easily be adapted to other organizations and can be adjusted to fit the specific organization and culture. The results from the ongoing and overall evaluation suggest promising avenues for future work in further testing and research of the usability of the model.

User-relevant factors influencing the prosthesis use of persons with a transfemoral amputation or knee-disarticulation: A meta-synthesis of qualitative literature and focus group results.

Persons with a transfemoral amputation or knee-disarticulation are heavily reliant on an adequate set of components for their prosthesis. To improve the process of adjusting the specific prosthetic properties to the expectations of the prosthesis users, it is of importance to first identify which factors have an influence on prosthesis use. Therefore, we aimed to identify factors that influence prosthesis use in adults with a transfemoral amputation or knee-disarticulation. A qualitative meta-synthesis was conducted by searching five databases (last update January 20th 2022). Studies were considered eligible if they contained qualitative data about adult persons with a transfemoral amputation or knee-disarticulation with experience in using a prosthesis and focused on the users' opinions. All eligible studies were independently screened by two reviewers. The results sections of the included studies were entered in Atlas.ti software (v8) and coded using the framework approach. The quality of the included studies was assessed using the Critical Appraisal Skills Program (CASP) qualitative research checklist. Results of the meta-synthesis were validated with prosthesis users (n = 8) in a focus group. Out of 5757 articles, 14 studies were included. An overview of seven themes ('prosthesis related'; 'rehabilitation, costs and prosthetist'; 'mental'; 'physical'; 'social'; 'activities and participation' and 'walking') containing 84 factors was created. Ten factors were added during the focus group, resulting in an overview of 94 factors that may influence the prosthesis use of lower-limb prosthesis users. Participants would like more user-involvement from the rehabilitation team. The development of a patient decision aid could help this process in the future. The large number of factors demonstrates that there is a great variety between prosthesis users and the factors that influence their prosthesis use. Therefore, it is important to take individual preferences into account for the selection of a new prosthesis.

Development of a Surgical Decision Aid for Patients with Nephrolithiasis: Shockwave Lithotripsy vs Ureteroscopy.

Introduction and Objective: Shared decision making is recommended to guide medical/surgical treatment strategies. We aimed at developing a surgical decision aid (SDA) facilitating decision making between ureteroscopy (URS) or shockwave lithotripsy (SWL) in patients with symptomatic nephrolithiasis. Methods: The SDA scope was identified through discussions with patients and urologists in the Michigan Urological Surgery Improvement Collaborative (MUSIC). A steering committee of patient advocates, MUSIC coordinating center, content experts, biostatisticians, and urologists was formed. Content domains were assessed through best available evidence and content experts. For content validation we anonymously surveyed 35 MUSIC urologists. Content validity ratios (CVR), numeric value indicating degree of expert validity, were calculated. Face validation interviews were conducted with patient advocates. Results: The SDA prototype using descriptive plain language and pictorial information was designed for nephrolithiasis patients, candidates for SWL or URS. It first provides patients procedural education whereas the second section informs urologists of patient goals. Six content domains were chosen: anesthesia type, effectiveness, number of procedures, risk, pain, and recovery. Overall, 91.4% and 85.7% of MUSIC urologists indicated that each section accomplished their goals, respectively. Anesthesia received an unacceptable CVR. High levels of face validation overall were reported with unacceptable scoring for anesthesia and recovery. Conclusions: We developed an SDA facilitating treatment choice between SWL and URS with promising content and face validity. Agreement and contradiction between anesthesia type and recovery validation results indicate the importance of shared decision making and the need for a validated SDA. Future work should focus on the SDAs value and opportunities for refinement in practice.

Development of the Tool to Empower Parental Telling and Talking (TELL Tool): A digital decision aid intervention about children's origins from donated gametes or embryos.

This study aimed to create and develop a well-designed, theoretically driven, evidence-based, digital, decision Tool to Empower Parental Telling and Talking (TELL Tool) prototype. This developmental study used an inclusive, systematic, and iterative process to formulate a prototype TELL Tool: the first digital decision aid for parents who have children 1 to 16 years of age and used donated gametes or embryos to establish their families. Recommendations from the International Patient Decision Aids Standards Collaboration and from experts in decision aid development, digital health interventions, design thinking, and instructional design guided the process. The extensive developmental process incorporated researchers, clinicians, parents, children, and other stakeholders, including donor-conceived adults. We determined the scope and target audience of the decision aid and formed a steering group. During design work, we used the decision-making process model as the guiding framework for selecting content. Parents' views and decisional needs were incorporated into the prototype through empirical research and review, appraisal, and synthesis of the literature. Clinicians' perspectives and insights were also incorporated. We used the experiential learning theory to guide the delivery of the content through a digital distribution plan. Following creation of initial content, including storyboards and scripts, an early prototype was redrafted and redesigned based on feedback from the steering group. A final TELL Tool prototype was then developed for alpha testing. Detailing our early developmental processes provides transparency that can benefit the donor-conceived community as well as clinicians and researchers, especially those designing digital decision aids. Future research to evaluate the efficacy of the TELL Tool is planned.

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.

Decision Aid Interventions for Family Caregivers of Persons With Advanced Dementia in Decision-Making About Feeding Options: A Scoping Review.

We provided an overview of the literature on decision aid interventions for family caregivers of older adults with advanced dementia regarding decision making about tube feeding. We synthesized (1) the use of theory during the development, implementation, and evaluation of decision aids; (2) the development, content, and delivery of decision aid interventions; (3) caregivers' experience with decision aid interventions; and (4) the effect of decision aid interventions on caregivers' quality of decision-making about feeding options. Scoping review. We conducted a scoping review of peer-reviewed studies published January 1, 2000-June 30, 2022, in MEDLINE, EMBASE, The Cochrane Library, CINAHL, and Web of Science databases. The process was guided by Arksey and O'Malley's methodological framework, which includes identifying the research question, choosing related studies, charting the data, and summarizing results. Empirical articles concerning the decision aid interventions about feeding options were selected. Six publications reporting 4 unique decision aid interventions were included. All the interventions targeted caregivers of older adults with advanced dementia. Three decision aids were culturally adapted from existing decision aids. The Ottawa Decision Support Framework and the International Patient Decision Aid Standards Framework were used in these 6 publications. Interventions aimed to improve decision making regarding tube feeding for caregivers through static delivery methods. Caregivers rated these decision aids as helpful and acceptable. Decisional conflict and knowledge of feeding options were the most common outcomes evaluated. Reduction in decisional conflict and increase in knowledge were consistently found among dementia caregivers, but no intervention effects were found on preferences for the use of tube feeding. Decision aid interventions effectively improve decision-making regarding tube feeding among the target population. Cultural adaptation of an existing decision aid intervention is the main strategy. However, the lack of guidance of a cultural adaptation framework in this process may lead to difficulties explaining caregivers' behavioral changes. Moreover, merely providing information is not enough to change caregivers' preferences or behavior of use of tube feeding. A systematic approach to cultural adaptation and interactive intervention is needed in future studies.

Delays to Surgery in Emergency Department Cases of Ectopic Pregnancy: A Quality Improvement Study

ObjectiveCreate a process map for emergency department (ED) presentations of surgical ectopic pregnancy, and identify areas of management amenable to quality improvement. MethodsA retrospective chart review of all patients undergoing surgical management of ectopic pregnancy at a large, urban, academic tertiary care centre from 2015 to 2017 was performed. ResultsSeventy-three patients were included. There were 6 (8.2%) unstable A cases (recommended time to operating room [OR] 0–2 hours), 23 (31.5%) stable A cases, and 44 (60%) B cases (recommended time to OR 2–8 hours). The percent of patients who were in the OR within the recommended time window were 6 (100%) for unstable A cases, 13 (56%) stable A cases, and 29 (65.9%) stable B cases, respectively (P = 0.139). Notable time delays include the time from gynaecology referral to the time seen by gynaecology (29.7% of total wait time for stable A cases from ED to OR) and the time the OR was booked to the time the patient was brought to the OR (53.2% of total wait time for stable B cases). Of the patients seen by physician at the emergency department first, the time from triage to the OR was significantly shorter for patients that received bedside ultrasound only (0.67 ± 0.5 hours vs. 2.1 ± 1.8 hours [P = 0.007]). ConclusionThis is the first study to map the ED presentation of surgical ectopic pregnancy. The management of ectopic pregnancy would benefit from the development of surgical triage decision aids, a surgical care pathway, and increased use of screening bedside ultrasound.

Person-based co-design of a decision aid template for people with a genetic predisposition to cancer.

People with genetic predispositions to cancer are faced with complex health decisions about managing their risk. Decision aids can support informed, values-based decisions, alongside shared decision-making with a clinician. Whilst diagnoses of genetic predispositions to cancer are increasing, there is no scalable decision aid to support these people. This paper presents an accessible, relevant decision aid template which can be adapted for different predispositions to cancer. The decision aid template was co-developed with 12 patients affected by cancer and informed by empirical and theoretical literature. In addition, consultations were conducted with a further 19 people with Lynch syndrome; a specific genetic predisposition to cancer. Clinical stakeholders were consulted regularly. Coulter's framework for decision aid development guided the process, and these activities were complemented by the International Patient Decision Aid Standards, and the latest evidence on communicating risk in decision aids. Programme theory was developed to hypothesise how the decision aid would support decision-making and contextual factors which could influence the process. Guiding principles co-developed with the patient panel described how the decision aid could effectively engage people. The in-depth co-design process led to the identification of five core components of an accessible decision aid template for people with a genetic predisposition to cancer: defining the decision; option grid showing implications of each option; optional further details such as icon arrays to show tailored risk and personal narratives; values clarification activity; and a summary to facilitate discussion with a clinician. Specific guidance was produced describing how to develop each component. The guiding principles identified that the decision aid template needed to promote trust, reduce distress, and be comprehensive, personally relevant and accessible in order to engage people. Adopting a co-design process helped ensure that the decision aid components were relevant and accessible to the target population. The template could have widespread application through being adapted for different genetic predispositions. The exact content should be co-designed with people from diverse backgrounds with lived experience of the specific predisposition to ensure it is as useful, engaging and relevant as possible.

The efficacy and safety of several interventions of corticosteroids for CRSwNP patients after endoscope sinus surgery: A protocol for systematic review and network meta-analysis.

Corticosteroid has been a mainstay of chronic rhinosinusitis with nasal polyps (CRSwNP) medical therapy. While endoscopic sinus surgery (ESS) will be performed when patients had failed to respond to maximal medical therapy. Many studies shown that several corticosteroids of interventions (e.g., nasal spray, oral, atomization/nebulization, nasal irrigation, direct infiltration, and steroid-eluting stent, etc) have each demonstrated significant efficacy compared with placebo or no corticosteroids intervention except intranasal corticosteroids for the treatment of CRSwNP after ESS. The aim of this systematic review and network meta-analysis is to answer the following question: which 1 is the best corticosteroid of intervention for CRSwNP patients after ESS? A systematic review will be conducted to identify studies involving randomized controlled trials which compared several different interventions of corticosteroids (e.g., nasal spray, oral, atomization/nebulization, nasal irrigation, direct infiltration, steroid-eluting stent, etc) for CRSwNP patients after ESS. The primary outcomes are efficacy (e.g., effective rate or cure rate), visual analogic scale of symptom severity, Lund-Kennedy endoscopic score, adverse events, and so on. We will comprehensively search PubMed, Embase, Cochrane Library, ClinicalTrials.gov, Web of Science, Chinese National Knowledge Infrastructure, Wangfang and VIP journal database from inception to July, 2022. For studies which meet our inclusion criteria, 2 reviewers will extract data independently and assess the quality of literature using a revision of version 2 of the Cochrane risk of bias tool (RoB 2.0). A random effects model will be used for all pairwise meta-analyses (with a 95% confidence interval). Network meta-analyses will be conducted to generate estimates of comparative effectiveness of each intervention class and rankings of their effectiveness. The results of this study expect to provide a high-quality, evidence-based recommendation on which 1 is the best corticosteroid of intervention for CRSwNP patients after ESS? This study will provide evidence regarding the comparability of several interventions of corticosteroids for CRSwNP patients after ESS. Also, the data generated from this review will provide health-care providers with a clear evidence synthesis of CRSwNP patients after ESS management strategies. These data will be incorporated into the development of a patient decision aid to assist patients and clinicians in making a preference-based decision when faced with a CRSwNP patients after ESS as well.

Decision aid development and its acceptability among adults with attention-deficit/hyperactivity disorders regarding treatment discontinuation after remission.

Current clinical guidelines for attention-deficit/hyperactivity disorder (ADHD) put shared decision making (SDM) at the center of care. However, there remain challenges in SDM in ADHD management, particularly regarding the decision to continue or discontinue medication after ADHD remission in adult patients. We aimed to develop a decision aid (DA) for adult patients with ADHD regarding the continuation or discontinuation of their ongoing ADHD medications after they have attained remission. We systematically developed a DA according to the International Patient Decision Aid Standard (IPDAS). First, we created a DA prototype using the results of our previous systematic review and meta-analysis that identified the consequences of continuing and discontinuing ADHD medications. Second, we administered a mixed-method questionnaire (alpha acceptability testing) to adult patients with ADHD and healthcare providers to improve the DA prototype and develop it into a final version that is acceptable for clinical settings. Our DA consisted of ADHD description, the option to continue or discontinue ADHD medications, the advantages and disadvantages of the consequences, as well as value clarification exercises for each option. Patients (n = 20) reported that the DA had acceptable language (85%), adequate information (75%), and a well-balanced presentation (53%). Healthcare providers (n = 19) provided favorable feedback. The final DA met all six IPDAS requisite criteria. Our results could facilitate the SDM process between patients and healthcare providers on the continuation or discontinuation of ADHD medication following remission. Further studies should verify the effects of using the DA during the SDM process among patients across the age spectrum with ADHD and healthcare providers.

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.

Development and evaluation of a patient decision aid for pediatric interval appendectomy

ObjectiveOne option for the treatment of perforated appendicitis in pediatric patients is interval appendectomy (IA). A patient decision aid (PDA) can be useful in the decision-making process regarding IA. The...

AML-512 Characteristics of the First 100 Subjects in Development of an AML Patient Decision Aid

Limited evidence exists related to quality of life (QOL) and survival between treatment intensities of patients with acute myelogenous leukemia (AML). The American Society of Hematology recommends shared decision-making when treating older adults with newly diagnosed AML according to individual goals of care. The objective of this study is to provide patient characteristics and goals of treatment from the initial one hundred enrolled patients in the development of a patient decision-making aid comparing intensive with non-intensive treatment. This is a prospective exploratory observational study. The study team recruited older (≥60 years) AML patients from inpatient and outpatient areas of Moffitt Cancer Center from 7/8/20 - 12/17/21. Survival of the first 100 participants ≥ 60 years of age with newly diagnosed AML presented. Each patient defined their goals of care with treatment at baseline. The primary outcome is the development of a decision aid for older newly diagnosed AML patients based on QOL and survival data in efforts to improve goal concordant care. Patient survival and treatment goals are presented. Of the one hundred patients forty-two are living (24 had intensive chemotherapy, eighteen had non-intensive regimens); most men, 59% (38/64) received intensive treatment, and 61% of women (22/36) received non-intensive treatment. Nine non-Caucasians were enrolled. Ages ranged from 61-77 for intensive compared to 62-86 for non-intensive. The most used intensive treatment was CPX-351 compared to azacitidine and venetoclax for non-intensive treatments. Seventy-three patients chose improved quality of life over survival as their treatment goal. Five patients died prior to starting non-intensive treatment. Treatment decisions are primarily based on survival data. For patients to participate in the decision-making process, quality of life data is needed to provide goal-concordant care. The current model in development will provide robust quality of life data from over two hundred patients based on survival and quality of life with two treatment intensities. Funding provided by NIN/NINR 5K23NR018488.

Development and Validation of a Patient Decision Aid for the Treatment of Ankle Arthritis

Category: Ankle Arthritis; Ankle Introduction/Purpose: Choosing a treatment course can be challenging for patients with ankle osteoarthritis given the multiple operative and nonoperative options. We developed and validated the Ankle Arthritis Patient Decision Aid as a tool to improve shared decision-making for such patients. Methods: Eighty patients of 2 surgeons at a US academic foot and ankle practice were recruited from October 2020 to June 2021 using an electronic medical record messaging system. Participants reviewed the tool and answered survey questions evaluating its quality and factors affecting treatment choice in a hypothetical patient scenario. We evaluated the tool using decisional conflict scores (maximum, 40 points, with higher scores indicating greater uncertainty), pre- and post-knowledge test scores (maximum, 8 points), and helpfulness scores (maximum, 7 points). We compared pre- and post-test knowledge scores using paired Student t- tests. Alpha=.05. Results: Mean (+- standard deviation) knowledge scores improved from 4.8 +- 1.2 (pre-test) to 6.7 +- 1.3 (post-test), for a mean improvement of 1.9 +- 1.4 (p<.001). The mean decisional conflict score was 4.1 +- 5.7, reflecting minimal uncertainty. Factors greatly affecting participants' treatment choices were desire to maintain a high level of physical activity (n=58), risk of complications (n=35), recovery time (n=33), and risk of increased rate of arthritis in adjacent joints (n=32). The mean reported helpfulness score was 5.9 +- 1.2, reflecting substantial benefit. Conclusion: The Ankle Arthritis Patient Decision Aid is a comprehensible tool that significantly improves patient knowledge regarding treatment options for ankle arthritis.