Development of an Electronic Decision Aid Tool to Facilitate Mainstream Genetic Testing in Ovarian Cancer Patients.

BACKGROUND: Multigene panel testing is an important component of cancer treatment plans and risk assessment, but there are many different panel options and choosing the most appropriate panel can be challenging for health care providers and patients. Electronic tools have been proposed to help patients make informed decisions about which gene panel to choose by considering their preferences and priorities. MATERIALS AND METHODS: An electronic decision aid (DA) tool was developed in line with the International Patient Decision Aids Standards collaboration. The multidisciplinary project team collaborated with an external health care communications agency and the MGH Cancer Center Patient and Family Advisory Council (PFAC) to develop the DA. Surveys of genetic counselors and patients were used to scope the content, and alpha testing was used to refine the design and content. RESULTS: Surveys of genetic counselors (n = 12) and patients (n = 228) identified common themes in discussing panel size and strategies for helping patients decide between panels and in identifying confusing terms for patients and distribution of patients' choices. The DA, organized into 2 major sections, provides educational text, graphics, and videos to guide patients through the decision-making process. Alpha testing feedback from the PFAC (n = 4), genetic counselors (n = 3) and a group of lay people (n = 8) identified areas to improve navigation, simplify wording, and improve layout. CONCLUSION: The DA developed in this study has the potential to facilitate informed decision-making by patients regarding cancer genetic testing. The distinctive feature of this DA is that it addresses the specific question of which multigene panel may be most suitable for the patient. Its acceptability and effectiveness will be evaluated in future studies.

Where there is no genetic counselor: An online decision-aid supports the majority of parents' diagnostic genomic testing choices for their children.

PURPOSE: We evaluated DECIDE, an online pretest decision-support tool for diagnostic genomic testing, in nongenetics specialty clinics where there are no genetic counselors (GCs). METHODS: Families of children offered genomic testing were eligible to participate. Fifty-six parents/guardians completed DECIDE at home, at their convenience. DECIDE includes an integrated knowledge quiz and decisional conflict screen. Six months later, parents were offered follow-up questionnaires and interviews about their experiences. RESULTS: Forty parents (71%) had sufficient knowledge and no decisional conflict surrounding their testing decision, but 6 of this group had residual questions. These 6, plus 16 with decisional conflict or insufficient knowledge, saw a GC. At follow-up, little-to-no decisional regret and few negative emotions were identified in any parents. Most chose testing and described their decision as easy, yet stressful, and described many motivations for sequencing. Parents appreciated the simple comprehensive information DECIDE provided and the ability to view it in a low-stress environment. CONCLUSION: DECIDE provides adequate decision-support to enable most parents to make value-consistent choices about genetic testing for their child. Parents reported that DECIDE helped to clarify motivations for pursuing (or declining) testing. DECIDE is a timely, well-tested, and accessible tool in clinical settings without GCs.

Decision aids for patients with carotid stenosis.

BACKGROUND: Shared decision-making tools have been underused by clinicians in real-world practice. Changes to the National Coverage Determination by Medicare for carotid stenting greatly expand the coverage for patients, but simultaneously require a shared decision-making interaction that involves the use of a validated tool. Accordingly, our objective was to evaluate the currently available decision aids for carotid stenosis. METHODS: We conducted a review of the literature for published work on decision aids for the treatment of carotid disease. RESULTS: Four publications met inclusion criteria. We found the format of the decision aid impacted patient comprehension and decision making, although patient characteristics also played a role in the therapeutic decisions made. Notably, none of the available decision aids included the widely adopted transcarotid artery revascularization as an option. CONCLUSIONS: Further work is needed in the development of a widespread validated decision aid instrument for patients with carotid stenosis.

Eggsurance? A randomized controlled trial of a decision aid for elective egg freezing.

STUDY QUESTION: Does a purpose-designed Decision Aid for women considering elective egg freezing (EEF) impact decisional conflict and other decision-related outcomes? SUMMARY ANSWER: The Decision Aid reduces decisional conflict, prepares women for decision-making, and does not cause distress. WHAT IS ALREADY KNOWN: Elective egg-freezing decisions are complex, with 78% of women reporting high decisional conflict. Decision Aids are used to support complex health decisions. We developed an online Decision Aid for women considering EEF and demonstrated that it was acceptable and useful in Phase 1 testing. STUDY DESIGN, SIZE, DURATION: A single-blind, two-arm parallel group randomized controlled trial was carried out. Target sample size was 286 participants. Randomization was 1:1 to the control (existing website information) or intervention (Decision Aid plus existing website information) group and stratified by Australian state/territory and prior IVF specialist consultation. Participants were recruited between September 2020 and March 2021 with outcomes recorded over 12 months. Data were collected using online surveys and data collection was completed in March 2022. PARTICIPANTS/MATERIALS, SETTING, METHODS: Females aged ≥18 years, living in Australia, considering EEF, proficient in English, and with internet access were recruited using multiple methods including social media posts, Google advertising, newsletter/noticeboard posts, and fertility clinic promotion. After completing the baseline survey, participants were emailed their allocated website link(s). Follow-up surveys were sent at 6 and 12 months. Primary outcome was decisional conflict (Decisional Conflict Scale). Other outcomes included distress (Depression Anxiety and Stress Scale), knowledge about egg freezing and female age-related infertility (study-specific measure), whether a decision was made, preparedness to decide about egg freezing (Preparation for Decision-Making Scale), informed choice (Multi-Dimensional Measure of Informed Choice), and decision regret (Decision Regret Scale). MAIN RESULTS AND THE ROLE OF CHANCE: Overall, 306 participants (mean age 30 years; SD: 5.2) were randomized (intervention n = 150, control n = 156). Decisional Conflict Scale scores were significantly lower at 12 months (mean score difference: -6.99 [95% CI: -12.96, -1.02], P = 0.022) for the intervention versus control group after adjusting for baseline decisional conflict. At 6 months, the intervention group felt significantly more prepared to decide about EEF than the control (mean score difference: 9.22 [95% CI: 2.35, 16.08], P = 0.009). At 12 months, no group differences were observed in distress (mean score difference: 0.61 [95% CI: -3.72, 4.93], P = 0.783), knowledge (mean score difference: 0.23 [95% CI: -0.21, 0.66], P = 0.309), or whether a decision was made (relative risk: 1.21 [95% CI: 0.90, 1.64], P = 0.212). No group differences were found in informed choice (relative risk: 1.00 [95% CI: 0.81, 1.25], P = 0.983) or decision regret (median score difference: -5.00 [95% CI: -15.30, 5.30], P = 0.337) amongst participants who had decided about EEF by 12 months (intervention n = 48, control n = 45). LIMITATIONS, REASONS FOR CAUTION: Unknown participant uptake and potential sampling bias due to the recruitment methods used and restrictions caused by the coronavirus disease 2019 pandemic. Some outcomes had small sample sizes limiting the inferences made. The use of study-specific or adapted validated measures may impact the reliability of some results. WIDER IMPLICATIONS OF THE FINDINGS: This is the first randomized controlled trial to evaluate a Decision Aid for EEF. The Decision Aid reduced decisional conflict and improved women's preparation for decision making. The tool will be made publicly available and can be tailored for international use. STUDY FUNDING/COMPETING INTEREST(S): The Decision Aid was developed with funding from the Royal Women's Hospital Foundation and McBain Family Trust. The study was funded by a National Health and Medical Research Council (NHMRC) Project Grant APP1163202, awarded to M. Hickey, M. Peate, R.J. Norman, and R. Hart (2019-2021). S.S., M.P., D.K., and S.B. were supported by the NHMRC Project Grant APP1163202 to perform this work. R.H. is Medical Director of Fertility Specialists of Western Australia and National Medical Director of City Fertility. He has received grants from MSD, Merck-Serono, and Ferring Pharmaceuticals unrelated to this study and is a shareholder of CHA-SMG. R.L. is Director of Women's Health Melbourne (Medical Practice), ANZSREI Executive Secretary (Honorary), RANZCOG CREI Subspecialty Committee Member (Honorary), and a Fertility Specialist at Life Fertility Clinic Melbourne and Royal Women's Hospital Public Fertility Service. R.A.A. has received grants from Ferring Pharmaceuticals unrelated to this study. M.H., K.H., and R.J.N. have no conflicts to declare. TRIAL REGISTRATION NUMBER: ACTRN12620001032943. TRIAL REGISTRATION DATE: 11 August 2020. DATE OF FIRST PATIENT'S ENROLMENT: 29 September 2020.

Development and usability of a decision aid to initiate anti-osteoporosis medication treatment in patients visiting the fracture liaison service with a recent fracture.

This study describes the development of a decision aid (DA), aimed at supporting patients in their decision whether to start anti-osteoporosis medication. People with recent fractures or osteoporosis and health professionals were supportive of the DA initiative. An experimental study been started to assess (cost-)effectiveness of the DA. PURPOSE: At fracture liaison services (FLS), patients with a recent fracture ánd osteoporosis or a prevalent vertebral fracture are advised to start anti-osteoporosis medication (AOM). This study describes the development of a decision aid (DA) to support patients and healthcare providers (HCPs) in their decision about whether to start AOM. METHODS: The DA was developed according to International Patient Decision Aid Standards (IPDAS). A systematic procedure was chosen including scope, design, prototype development, and alpha testing. A previously developed DA for women with osteoporosis was used as a basis. Furthermore, input from literature searches, the Dutch guideline on management of osteoporosis, and from people with a fracture or osteoporosis was used. The updated DA was evaluated during alpha testing. RESULTS: The DA facilitates the decision of patients whether to initiate AOM treatment and provides information on fractures and osteoporosis, general risk factors that increase the likelihood of a subsequent fracture, the role of lifestyle, personalized risk considerations of a subsequent fracture with and without AOM treatment, and AOM options and their characteristics in an option grid. Alpha testing with 15 patients revealed that patient preferences and needs were adequately presented, and several suggestions for improvement (e.g. adding more specific information, simplifying terminology, improving icon use) were accounted for. Participants from the alpha testing recommended use of the DA during outpatient visits. CONCLUSION: Professionals and persons with osteoporosis were supportive of the proposed DA and its usability. The DA could help in a shared decision-making process between patients and HCPs.

Impact of timing and format of patient decision aids for breast cancer patients on their involvement in and preparedness for decision making - the IMPACTT randomised controlled trial protocol.

BACKGROUND: After curative surgery for early-stage breast cancer, patients face a decision on whether to undergo surgery alone or to receive one or more adjuvant treatments, which may lower the risk of recurrence. Variations in survival outcomes are often marginal but there are differences in the side effects and other features of the options that patients may value differently. Hence, the patient's values and preferences are critical in determining what option to choose. It is well-researched that the use of shared decision making and patient decision aids can support this choice in a discussion between patient and clinician. However, it is still to be investigated what impact the timing and format of the patient decision aid have on shared decision making outcomes. In this trial, we aim to investigate the impact of a digital pre-consult compared to a paper-based in-consult patient decision aid on patients' involvement in shared decision making, decisional conflict and preparedness to make a decision. METHODS: The study is a randomised controlled trial with 204 patients at two Danish oncology outpatient clinics. Eligible patients are newly diagnosed with early-stage breast cancer and offered adjuvant treatments after curative surgery to lower the risk of recurrence. Participants will be randomised to receive either an in-consult paper-based patient decision aid or a pre-consult digital patient decision aid. Data collection includes patient and clinician-reported outcomes as well as observer-reported shared decision making based on audio recordings of the consultation. The primary outcome is the extent to which patients are engaged in a shared decision making process reported by the patient. Secondary aims include the length of consultation, preparation for decision making, preferred role in shared decision making and decisional conflict. DISCUSSION: This study is the first known randomised, controlled trial comparing a digital, pre-consult patient decision aid to an identical paper-based, in-consult patient decision aid. It will contribute evidence on the impact of patient decision aids in terms of investigating if pre-consult digital patient decisions aids compared to in-consult paper-based decision aids support the cancer patients in being better prepared for decision making. TRIAL REGISTRATION: ClinicalTrials.gov (NCT05573022).

Radical cystectomy or trimodality therapy for muscle-invasive bladder cancer: a qualitative study exploring patient priorities and counselling needs when making a treatment choice.

BACKGROUND: This study aims to explore the priorities and counselling needs of patients with muscle-invasive bladder cancer faced with a decision between radical cystectomy and trimodality therapy. METHODS: We performed a qualitative study according to the phenomenological approach. Sixteen muscle-invasive bladder cancer survivors who underwent radical cystectomy or trimodality therapy completed a semi-structured interview between May 2022 and February 2023. Patients were recruited via Ghent University Hospital and a patient organisation. Data were analysed with inductive thematic analysis by a multi-disciplinary team using an iterative approach and investigators' triangulation. RESULTS: Four main priorities determining the treatment decision were identified. (1) curing the disease; (2) health-related quality of life (physical, mental and social); (3) confidence in the treatment, which was mainly based on trust in the clinician; and (4) personal attributes. Trust in the clinician can be achieved by fulfilling the patient's information needs (accurate, complete, clear, impartial, personalised, realistic, and transparent information), ensuring accessibility of the clinician, and creating a clear and personalised treatment plan, involving patients to the extend they desire. Many patients considered a patient decision aid as a valuable asset in this process. CONCLUSION: Priorities vary between patients with muscle-invasive bladder cancer. Identifying individual priorities and offering personalised information about them is crucial for ensuring trust in the clinician and confidence in the treatment. Use of a patient decision aid can be beneficial in this process.

Patient Perspectives on a Decision Aid for Systemic Lupus Erythematosus: Insights and Future Considerations.

OBJECTIVE: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with a wide spectrum of clinical manifestations. A decision aid (DA) for SLE was developed and implemented in 15 rheumatology clinics throughout the United States. This study explored the experiences of patients who viewed the DA to understand how patients engage with and respond to the SLE DA. METHODS: We conducted a qualitative descriptive study using semistructured interviews with a convenience sample of 24 patients during May to July 2022. RESULTS: Patients recognized the value of the SLE DA in providing general knowledge about SLE and different treatment options. However, patients expressed a desire for more comprehensive lifestyle information to better manage their condition. Another theme was the importance of having multiple formats available to cater to their different needs, as well as tailoring the DA to different stages of SLE. CONCLUSION: This study contributes to a broader understanding of how to provide patient-centered care for patients with SLE by offering practical insights that can inform the development of more effective, patient-centric health information technologies for managing chronic diseases, ultimately improving patient outcomes. Overall, this study underscores the significance of optimizing both the information content and determining the appropriate delivery of the tool for its future sustainability.

Online decision aid for patients with prostate cancer evaluated by 11 290 patients and 91 urologists in Germany.

OBJECTIVE: To evaluate the nationwide online decision aid 'Entscheidungshilfe Prostatakrebs' (established in 2016, >11.000 users and 60 new users/week) for patients with non-metastatic prostate cancer (PCa), from the perspective of patients and urologists. PATIENTS AND METHODS: To provide personalised information, the tool collects most of the International Consortium for Health Outcomes Measurement standard set, personal preferences, psychological features, and a validated rating of the tool. To evaluate urologists' opinions, we developed a structured two-page questionnaire. All data were collected anonymously. RESULTS: From June 2016 to December 2020, 11 290 patients used the PCa decision aid. Their median (interquartile range [IQR]) age was 67 (61-72) years. The median (IQR) time from initial diagnosis to using the tool was 4 (3-7) weeks. In all, 87.7% of users reported high satisfaction. In a multivariable model, predictors for considering observation were higher knowledge, using the decision aid alone, lower oncological risk, normal erectile function, and respective personal preferences. Of 194 urologists, 91 (47%) had implemented the decision aid in their clinical practice. The urologists' mean (SD) satisfaction score (1 'very good'; 6 'unsatisfactory') with it was 1.45 (0.55), and 92% recommended it. Half of the urologists reported time savings. CONCLUSION: Patients and urologists report a very high level of acceptance and satisfaction with this online tool. It offers advantages in shared decision-making and time efficiency. The usage of the decision aid might improve the adoption of active surveillance and watchful waiting when indicated.

Codesign of Lynch ChoicesTM : Using implementation science to create a clinically deliverable patient decision support website to transform cancer genetics care pathways.

BACKGROUND: Resources including Patient Decision Aids (PtDA) are useful and valued by patients and clinicians to provide information and complement shared decision-making. Despite their promise, few PtDA exist for patients with genetic cancer susceptibility facing difficult decisions about risk management. We aimed to fill this gap, partnering with patients to codesign Lynch ChoicesTM , a PtDA website for families with Lynch Syndrome. In addition to a Patient Reference Panel, we purposively invited an international stakeholder panel including charities, public bodies, clinical and academic experts. Implementation strategies and frameworks were employed to optimise translation of research findings to improve care. METHODS: Patient/stakeholder suggestions were incorporated in a transparent Table of Changes and prioritised using the Person-Based Approach throughout planning and codesign of Lynch ChoicesTM . An interactive stakeholder meeting was convened to identify barriers and facilitators to clinical implementation of the PtDA. RESULTS: Patient and stakeholder partnerships drove the direction of the research throughout codesign, resulting in several iterative refinements to the PtDA prior to roll out including the addition of illustrations/videos, clearer presentation of cancer risks and increased accessibility for lower literacy. Barriers and facilitators identified from stakeholders were used to create an implementation process map. CONCLUSIONS: Creating an effective, engaging PtDA is not enough. Systematic uptake in real world clinical practice, with its resource limitations, is needed to optimise benefit to patients and clinicians. Assessment of speed and breadth of dissemination and usage will be collected to further evidence the benefit of embedding implementation science methods from the outset to translate research findings into clinical practice.

The Impact of a Digital Contraceptive Decision Aid on User Outcomes: Results of an Experimental, Clinical Trial.

BACKGROUND: Nearly 40% of unplanned pregnancies in the USA are the result of inconsistent or incorrect contraceptive use. Finding ways to increase women's comfort and satisfaction with contraceptive use is therefore critical to public health. One promising pathway for improving patient outcomes is through the use of digital decision aids that assist women and their physicians in choosing a contraceptive option that women are comfortable with. Testing the ability of these aids to improve patient outcomes is therefore a necessary first step toward incorporating this technology into traditional physician appointments. PURPOSE: To evaluate the effectiveness of a novel contraceptive decision aid at minimizing decisional conflict and increasing comfort with contraception among adult women. METHODS: In total, 310 adult women were assigned to use either the Tuune contraceptive decision aid or a control aid modeled after a leading online contraceptive prescriber's patient intake form. Participants then completed self-report measures of decisional conflict, contraceptive expectations, satisfaction, and contraceptive use intentions. Individual between-subjects analysis of variance (ANOVA) models were used to examine these outcomes. RESULTS: Women using the Tuune decision aid (vs. those using the control aid) reported lower decisional conflict, more positive contraceptive expectations, greater satisfaction with the decision aid and recommendation, and more positive contraceptive use intentions. CONCLUSIONS: Use of Tuune improved each of the predicted patient outcomes relative to a control decision aid. Online decision aids, particularly when used alongside physician consultations, may be an effective tool for increasing comfort with contraceptive use. CLINICAL TRIALS REGISTRATION #: NCT05177783, ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT05177783.

Digital decision aids that help women and their physicians choose contraceptive options that women are most comfortable with present one promising way to improve contraceptive use outcomes, such as avoiding unplanned pregnancies. However, current decision aids have been found to struggle in helping improve women's satisfaction with and confidence in their contraceptive choices. The aim of this study was to test the effectiveness of a new digital decision aid, named Tuune, at helping improve women's confidence and comfort with contraception. Three hundred and ten adult women were randomly assigned to use and then receive a contraceptive recommendation from either the Tuune decision aid or a control aid designed after leading traditional health intake forms. Women's confidence and satisfaction with the aids, as well as their contraceptive recommendation, were then compared between groups. We found good evidence to suggest that women using the Tuune contraceptive decision aid were more satisfied and positive about their contraceptive choices and reported greater intentions to use contraception with increased confidence compared to women who used the control decision aid. New online decision aids, like Tuune, may be an effective tool for increasing women's comfort and experiences using contraception.

Development of the AMPDECIDE Decision Aid to Facilitate Shared Decision Making in Patients Facing Amputation Secondary to Chronic Limb Threatening Ischemia.

INTRODUCTION: We developed a patient decision aid to enhance patient participation in amputation level decision making when there is a choice between a transmetatarsal or transtibial amputation. METHODS: In accordance with International Patient Decision Aid Standards, we developed an amputation level patient decision aid for patients who are being considered for either a transmetatarsal or transtibial amputation, incorporating qualitative literature data, quantitative literature data, qualitative provider and patient interviews, expert panel input and iterative patient feedback. RESULTS: The rapid qualitative literature review and qualitative interviews identified five domains outcome priority domains important to patients facing amputation secondary to chronic limb threatening ischemia: 1) the ability to walk, 2) healing and risk for reamputation, 3) rehabilitation program intensity, 4) ease of prosthetic use, and 5) limb length after amputation. The rapid quantitative review identified only two domains with adequate evidence comparing differences in outcomes between the two amputation levels: mobility and reamputation. Patient, surgeon, rehabilitation and decision aid expert feedback allowed us to integrate critical facets of the decision including addressing the emotional context of loss of limb, fear and anxiety as an obstacle to decision making, shaping the decision in the context of remaining life years, and how to facilitate patient knowledge of value tradeoffs. CONCLUSIONS: Amputation level choice is associated with significant outcome trade-offs. The AMPDECIDE patient decision aid can facilitate acknowledgment of patient fears, enhance knowledge of amputation level outcomes, assist patients in determining their personal outcome priorities, and facilitate shared amputation level decision making.

Patient and physician decision-making dynamics in overactive bladder care: A mixed methods study.

AIMS: Overactive bladder management includes multiple therapeutic options with comparable efficacy but a range of administration modalities and side effects, creating an ideal setting for shared decision-making. This study investigates patient and physician health beliefs surrounding decision-making and expectations for overactive bladder with the aim of better understanding and ultimately improving decision-making in overactive bladder care. METHODS: Patient and physician participants completed a questionnaire followed by a semi-structured interview to assess health beliefs surrounding decision making and expectations for overactive bladder treatment. The semi-structured interview guide, developed in an iterative fashion by the authors, probed qualities of overactive bladder therapies patients and physicians valued, their process of treatment selection, and their experiences with therapies. RESULTS: Patients (n = 20) frequently cited treatment invasiveness, efficacy, and safety as the most important qualities that influenced their decision when selecting overactive bladder therapy. Physicians (n = 12) frequently cited safety/contraindications, convenience, cost/insurance, and patient preference as the most important qualities. In our integration analysis, we identified four key themes associated with decision making in overactive bladder care: frustration with inaccessibility of overactive bladder treatments, discordant perception of patient education, diverging acceptability of expected outcomes, and lack of insight into other parties' decisional priorities and control preferences. CONCLUSIONS: While both patients and physicians desire to engage in a shared decision-making process when selecting therapies for overactive bladder, this process is challenged by significant divergence between patient and physician viewpoint across key domains.

Supporting the Choice for Conservative and Surgical Treatment in Female Stress Urinary Incontinence: Development and Evaluation of a Patient Decision Aid.

INTRODUCTION: Making a treatment decision for female stress urinary incontinence (SUI) can be challenging for patients and healthcare providers. Dutch guidelines advise to counsel both pelvic floor muscle therapy and midurethral sling surgery as primary treatment options in uncomplicated moderate to severe cases. The use of a patient decision aid (PDA) can support decision-making, reduce decisional conflict and decisional regret, and increase knowledge. The aim of this study was to develop and evaluate an online PDA for females (SUI). METHODS: This mixed-methods study was performed in consecutive stages by a multidisciplinary working group. PDA design was based on the International Patient Decision Aids Standards (IPDAS) and on outcomes of needs assessments amongst patients and healthcare providers. Content was based on Dutch guidelines, targeted literature searches and patient information from the Dutch scientific society for gynecology. The concept version was evaluated by patients, patients' advocates, and healthcare providers. RESULTS: Using the nominal group technique, the working group established the design and format of the PDA. Fifty-six out of 58 applicable items of the IPDAS were met. The PDA contains information on the condition, advice on lifestyle adaptations, and describes surgical and nonsurgical treatment options. The option grid contains comparisons of the primary treatment options. Furthermore, value clarification exercises and narratives were included. Acceptability and usability evaluation of the concept version was performed by 15 healthcare providers, three patients, and two patients' advocates. Comments were processed in the working group, resulting in the final version of the PDA, which was supported by all assessors. CONCLUSION: Our multidisciplinary working group developed an online PDA for women with moderate to severe SUI including conservative and surgical treatment options, based on IPDAS criteria, guidelines, scientific evidence, and needs assessments from patients and healthcare providers. This PDA is supported by patients, healthcare providers, scientific societies, and the Dutch patients' association. The next step is to evaluate and implement this PDA in daily practice. TRIAL REGISTRATION: ID 2014-308.

Acceptability of Using a Decision Aid to Support Family Carers of People With Dementia Towards the End of Life: A Qualitative Study.

OBJECTIVES: To explore the experiences, acceptability and utility of a decision aid for family carers of people with dementia towards the end of life. METHODS: We conducted semi-structured interviews with a sample of family carers enroled into a 6-month feasibility study in England, sampling to gain a range of experiences and views, based on relationship to person they cared for (e.g., spouse, adult child), age, gender, and self-reported use of the decision aid during the feasibility study. Interviews were conducted in March 2021-July 2021 and analysed using reflexive thematic analysis. We used COREQ checklist to report our methods and results. RESULTS: Family carers found the decision aid acceptable, describing it as comprehensive, accessible with relevant information and its presentation enabled good engagement. Experiences of the decision aid covered four main themes which demonstrated the perceived acceptability and utility: 1. A source of support and reassurance; 2. Empowering conversations and confidence; 3. Including the person living with dementia; and 4. Breaking down complexity. CONCLUSIONS: An aid focussing on decisions about dementia end of life care supported family carers break down complex and emotive decisions, not only with making decisions in the moment but also in future planning. PATIENT OR PUBLIC CONTRIBUTION: Our three Patient and Public Involvement (PPI) members (all former family carers) were crucial throughout the wider study. PPI supported development of the topic guides, supported trialling the topic guide and interview procedures and finally supported the development of themes as part of the analysis.

A Decision Aid for Patients Considering Surgery for Sciatica: Codesign and User-Testing With Patients and Clinicians.

BACKGROUND: Surgery can help patients with leg pain caused by sciatica recover faster, but by 12 months outcomes are similar to nonsurgical management. For many the decision to have surgery may require reflection, and patient decision aids are an evidence-based clinical tool that can help guide patients through this decision. OBJECTIVE: The aim of this study was to develop and refine a decision aid for patients with sciatica who are deciding whether to have surgery or 'wait and see' (i.e., try nonsurgical management first). DESIGN: Semistructured interviews with think-aloud user-testing protocol. PARTICIPANTS: Twenty clinicians and 20 patients with lived experience of low back pain or sciatica. OUTCOME MEASURES: Items from Technology Acceptance Model, Preparation for Decision Making Scale and Decision Quality Instrument for Herniated Disc 2.0 (knowledge instrument). METHODS: The prototype integrated relevant research with working group perspectives, decision aid standards and health literacy guidelines. The research team refined the prototype through seven rounds of user-testing, which involved discussing user-testing feedback and implementing changes before progressing to the next round. RESULTS: As a result of working group feedback, the decision aid was divided into sections: before, during and after a visit to the surgeon. Across all rounds of user-testing, clinicians rated the resource 5.9/7 (SD = 1.0) for perceived usefulness, and 6.0/7 for perceived ease of use (SD = 0.8). Patients reported the decision aid was easy to understand, on average correctly answering 3.4/5 knowledge questions (SD = 1.2) about surgery for sciatica. The grade reading score for the website was 9.0. Patients scored highly on preparation for decision-making (4.4/5, SD = 0.7), suggesting strong potential to empower patients. Interview feedback showed that patients and clinicians felt the decision aid would encourage question-asking and help patients reflect on personal values. CONCLUSIONS: Clinicians found the decision aid acceptable, patients found it was easy to understand and both groups felt it would empower patients to actively engage in their care and come to an informed decision that aligned with personal values. Input from the working group and user-testing was crucial for ensuring that the decision aid met patient and clinician needs. PATIENT OR PUBLIC CONTRIBUTION: Patients and clinicians contributed to prototype development via the working group.

Patient Perspectives on a Patient-Facing Tool for Lung Cancer Screening.

BACKGROUND: Individuals with high risk for lung cancer may benefit from lung cancer screening, but there are associated risks as well as benefits. Shared decision-making (SDM) tools with personalized information may provide key support for patients. Understanding patient perspectives on educational tools to facilitate SDM for lung cancer screening may support tool development. AIM: This study aimed to explore patient perspectives related to a SDM tool for lung cancer screening using a qualitative approach. METHODS: We elicited patient perspectives by showing a provider-facing SDM tool. Focus group interviews that ranged in duration from 1.5 to 2 h were conducted with 23 individuals with high risk for lung cancer. Data were interpreted inductively using thematic analysis to identify patients' thoughts on and desires for a patient-facing SDM tool. RESULTS: The findings highlight that patients would like to have educational information related to lung cancer screening. We identified several key themes to be considered in the future development of patient-facing tools: barriers to acceptance, preference against screening and seeking empowerment. One further theme illustrated effects of patient-provider relationship as a limitation to meeting lung cancer screening information needs. Participants also noted several suggestions for the design of technology decision aids. CONCLUSION: These findings suggest that patients desire additional information on lung cancer screening in advance of clinical visits. However, there are several issues that must be considered in the design and development of technology to meet the information needs of patients for lung cancer screening decisions. PATIENT OR PUBLIC CONTRIBUTION: Patients, service users, caregivers or members of the public were not involved in the study design, conduct, analysis or interpretation of the data. However, clinical experts in health communication provided detailed feedback on the study protocol, including the focus group approach. The study findings contribute to a better understanding of patient expectations for lung cancer screening decisions and may inform future development of tools for SDM.

'It is empowering and gives people dignity in a very difficult process': A multistage, multimethod qualitative study to understand the views of end users in the cultural adaptation of a dementia and driving decision aid.

BACKGROUND: Decisions about driving for individuals living with dementia (ILWD) can be challenging. There are limited evidence-based person-centred interventions in the United Kingdom that support decisions about transitioning to not driving or guidelines for developing decision aids for ILWD. This study aimed to understand the important features of a decision aid through the cultural adaptation of Australian dementia and driving decision aid (DDDA) for ILWD residing in the United Kingdom. METHODS: This qualitative study was theoretically underpinned by a person-centred framework and conducted over three stages: (1) Development of a draft UK-specific DDDA; (2) semistructured interviews with ILWD and an online survey with stakeholders to obtain their views on a draft UK DDDA and (3) content analysis and synthesis of qualitative data to inform the final version of the decision aid. RESULTS: Eleven ILWD and six of their spouses participated in interviews, and 102 stakeholders responded to an online survey. The four broad features identified as important to include in a decision aid for drivers living with dementia were: a structured and interactive format; positive and supportive messaging and presentation; relevant and concise content and choice-centred. The perceived benefits of the decision aid were identified as supporting conversations, enhancing collaborative decision making and enabling agency with decisions about driving and future mobility options. CONCLUSIONS: Decision aids that are underpinned by interactive choice-driven questions enhance a person-centred approach to decisions about driving. Positively framing decision aids through the presentation and content can facilitate engagement with the decision-making process about driving. The findings have implications for the development of decision aids designed for ILWD on other important health and social topics. PATIENT AND PUBLIC INVOLVEMENT: Advocating for the development of a UK DDDA were ILWD. Healthcare professionals contributed to the development of a draft UK DDDA. Former and current drivers living with dementia, family members, healthcare professionals and other support networks of ILWD participated in interviews or an online survey which informed the final version of the UK DDDA.

Would shared decision-making be useful in breast cancer screening programmes? A qualitative study using focus group discussions to gather evidence from French women with different socioeconomic backgrounds.

BACKGROUND: To inform the development of an online tool to be potentially used in shared decision-making about breast cancer screening, French women were questioned about participation in breast cancer screening, the health professional's role, and their perceptions of the proposed tool. METHODS: We organised focus group discussions with 55 French women. Two different strategies were used to recruit women from high and low socioeconomic backgrounds. We applied both inductive and deductive approaches to conduct a thematic analysis of the discussions. We analysed the responses by using the main determinants from different health behaviour models and compared the two groups. RESULTS: Independently of socioeconomic status, the most important determinant for a woman's participation in breast cancer screening was the perceived severity of breast cancer and the perceived benefits of its early detection by screening. Cues to action reported by both groups were invitation letters; recommendations by health professionals, or group/community activities and public events were reported by women from high and low socioeconomic backgrounds, respectively. Among other positive determinants, women from high socioeconomic backgrounds reported making informed decisions and receiving peer support whereas women from low socioeconomic backgrounds reported community empowerment through group/community events. Fear of cancer was reported as a barrier in both groups. Among other barriers, language issues were reported only by women from low socioeconomic backgrounds; women from high socioeconomic backgrounds reported breast cancer screening-related risks other than overdiagnosis and/or overtreatment. Barriers to accessing the online tool to be developed were mainly reported by women from high socioeconomic backgrounds. CONCLUSION: Limitations in implementing shared decision-making for women from low socioeconomic backgrounds were highlighted. An online tool that is suitable for all women, regardless of socioeconomic status, would provide "on-demand" reliable and tailored information about breast cancer screening and improve access to health professionals and social exchanges.

Advance care planning in the treatment of implantable left ventricular assist device: a republication of the review published in Japanese Journal of Artificial Organs.

Advance care planning (ACP) is essential in managing serious and chronic illnesses to ensure that patients receive care aligned with their personal values, goals, and preferences. This review focuses on integrating ACP in the treatment of patients receiving implantable left ventricular assist devices (VADs). The heart failure palliative care team developed a unique advance directive form and pamphlet to facilitate ACP discussions, emphasizing not only medical treatment preferences but also patients' values and life goals.The study highlights the distinction between bridge to transplantation (BTT) and destination therapy (DT) in VAD patients, with different goals and considerations for ACP. The use of decision aids developed especially for DT candidates as a communication tool helps in sharing patients' wishes and facilitates shared decision-making, particularly in the complex decisions surrounding DT therapy.Challenges in implementing ACP, such as time constraints due to urgent medical conditions, difficulties in patient communication, and the recent COVID-19 pandemic, are addressed. The need for a comprehensive healthcare system capable of supporting patients' ACP wishes, especially in the community setting, is also pointed out.Future directions include not only developing materials to ease ACP discussions and ensuring that ACP content is shared among healthcare providers to foster collaborative and detailed planning, but also a call for widespread adoption of ACP in Japan.This is a translation of a paper written in Japanese Journal of Artificial Organs (Vol. 52, No. 1, pp. 89-92) with additions and corrections.