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OBJECTIVES: Shared Decision Making (SDM) has potential to support Pulmonary Rehabilitation (PR) decision-making when patients are offered a menu of centre- and home-based options. This study sought to evaluate the feasibility and acceptability of a three-component PR SDM intervention for individuals with Chronic Obstructive Pulmonary Disease (COPD) and PR healthcare professionals. METHODS: Participants were recruited from Dec 2021-Sep 2022. Healthcare professionals attended decision coaching training and used the consultation prompt during consultations. Individuals received the Patient Decision Aid (PtDA) at PR referral. Outcomes included recruitment capability, data completeness, intervention fidelity, and acceptability. Questionnaires assessed patient activation and decisional conflict pre and post-PR. Consultations were assessed using Observer OPTION-5. Optional interviews/focus groups were conducted. RESULTS: 13% of individuals [n = 31, 32% female, mean (SD) age 71.19 (7.50), median (IQR) MRC dyspnoea 3.50 (1.75)] and 100 % of healthcare professionals (n = 9, 78% female) were recruited. 28 (90.32%) of individuals completed all questionnaires. SDM was present in all consultations [standardised scores were mean (SD) = 36.97 (21.40)]. Six healthcare professionals and five individuals were interviewed. All felt consultations using the PtDA minimised healthcare professionals' bias of centre-based PR, increased individuals' self-awareness of their health, prompted consideration of how to improve it, and increased involvement in decision-making. DISCUSSION: Results indicate the study processes and SDM intervention is feasible and acceptable and can be delivered with fidelity when integrated into the PR pathway.

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BACKGROUND: Diverticular disease is a common gastrointestinal diagnosis with over 2.7 million clinic visits yearly. National guidelines from the American Society of Colon and Rectal Surgeons state that "the decision to recommend elective sigmoid colectomy after recovery from uncomplicated acute diverticulitis should be individualized." However, tools to individualize this decision are lacking. OBJECTIVE: This study aimed to develop an online educational decision aid (DA) to facilitate effective surgeon and patient communication about treatment options for recurrent left-sided diverticulitis. METHODS: We used a modified design sprint methodology to create a prototype DA. We engaged a multidisciplinary team and adapted elements from the Ottawa Personal Decision Guide. We then iteratively refined the prototype by conducting a mixed methods assessment of content and usability testing, involving cognitive interviews with patients and surgeons. The findings informed the refinement of the DA. Further testing included an in-clinic feasibility review. RESULTS: Over a 4-day in-person rapid design sprint, including patients, surgeons, and health communication experts, we developed a prototype of a diverticulitis DA, comprising an interactive website and handout with 3 discrete sections. The first section contains education about diverticulitis and treatment options. The second section clarifies the potential risks and benefits of both clinical treatment options (medical management vs colectomy). The third section invites patients to participate in a value clarification exercise. After navigating the DA, the patient prints a synopsis that they bring to their clinic appointment, which serves as a guide for shared decision-making. CONCLUSIONS: Design sprint methodology, emphasizing stakeholder co-design and complemented by extensive user testing, is an effective and efficient strategy to create a DA for patients living with recurrent diverticulitis facing critical treatment decisions.

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Background: The spreading adoption of value-based models of healthcare delivery has incentivized the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice, with the potential to enrich the decision-making process with patient-reported data. Methods: This perspective article explores PROs and the shared decision-making (SDM) process as components of value-based healthcare. We describe the potential of PROMs and PREMs within the decision-making process and present a digital framework for informing the shared decision-making process using aggregated data from a healthcare system PROMs and PREMs program, including early results from implementation in hospital network in Madrid, Spain. Results: The proposed digital framework incorporates aggregated data from a hospital network PROMs and PREMs program as part of a digital patient decision aid (PDA) for patients with lymphoma. After the first hematologist appointment, participating patients access the PDA to review relevant information about clinical and patient-reported outcomes for each of the possible options, assign a personal order of priority to different outcomes, and then select their preferred course of action. Patients' answers are automatically uploaded to the EHR and discussed with hematologists at the next appointment. After beginning treatment, patients are invited to participate in the network PROMs program; participants' PROMs data are fed back into the PDA, thus "closing the circle" between the decision-making process and patient-reported data collection.During the first 14 months after launching the decision aid in October 2022, of 25 patients diagnosed with follicular lymphoma at the four participating hospitals, 13 patients decided to participate. No significant differences in age or sex were observed between groups. Average SDM Q-9 score for patients filling in the questionnaire (n = 6) was 36.15 of 45 points. Conclusion: Various obstacles toward widespread implementation of SDM exist such as time constraints, lack of motivation, and resistance to change. Support and active engagement from policy makers and healthcare managers is key to overcome hurdles for capturing patient-reported data and carrying out shared decision-making at healthcare system level. Early results of a digital framework for PRO-enriched SDM seem to be beneficial to the decision-making process.

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Objective: This study presents the development process of a heart failure (HF) medication decision aid (DA) specific to Singapore context, with the objective of promoting cost conversations. Methods: Phase 1 was to create a DA prototype, where two HF clinicians were consulted on their input and needs. Phase 2 was pilot testing where the prototype was tested on HF patients and revised based on their feedback. Results: The DA is a one-page poster that compares only two classes of HF medications. It encompasses seven attributes for comparison, including route of administration, treatment duration, frequency of use, hospitalization rate, survival rate, low blood pressure probability with personalized subsidized cost being the key attribute. A total of 48 patients participated in the pilot testing with only 2 patients (4.2 %) finding the DA difficult to understand. Almost all patients agreed that the DA provided greater clarity in the medication options. Conclusion: By integrating the needs of both clinicians and patients and conducting user testing, we developed a novel HF medication DA. Patients found the tool easy to understand and acceptable. Innovation: This innovative DA aims to improve cost conversations by providing tailored, concise, and locally relevant information for efficient use.

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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.

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BACKGROUND AND OBJECTIVE: Evidence on the cost effectiveness of decision aids to guide management decisions for men with prostate cancer is limited. We examined the cost utility of the Navigate online decision aid for men with prostate cancer in comparison to usual care (no decision aid). METHODS: A Markov model with a 10-yr time horizon was constructed from a government health care perspective. Data from the Navigate trial (n = 302) and relevant published studies were used for model inputs. Incremental costs and quality-adjusted life-years (QALYs) were calculated for the two strategies. One-way and probabilistic sensitivity analyses were undertaken to address model uncertainty. KEY FINDINGS AND LIMITATIONS: On average, the Navigate strategy was estimated to cost AU$8899 (95% uncertainty interval [UI] AU$7509-AU$10438) and produce 7.08 QALYs (95% UI 6.73-7.36) in comparison to AU$9559 (95% UI AU$8177-AU$11017) and 7.03 QALYs (95% UI 6.67-7.31) or usual care. The Navigate strategy dominated usual care as it produced cost-savings and higher QALYs, although differences for both outcomes were small over 10 yr. The likelihood of Navigate being cost effective at a conventionally acceptable threshold of AU$50000 per QALY gained was 99.7%. This study is limited by the availability, quality, and choice of the data used in the model. CONCLUSIONS AND CLINICAL IMPLICATIONS: Use of an online decision aid for men with prostate cancer appears to be cost effective relative to usual care in Australia, driven by the higher acceptance and uptake of active surveillance. Wider implementation of decision aids may better inform men diagnosed with prostate cancer about their management options. PATIENT SUMMARY: We looked at the cost effectiveness of an online decision aid for guiding Australian men with prostate cancer in choosing a management option. We found that this decision aid was cost effective, mainly because more men chose active surveillance. Decision aids that inform patients about their management options should be more widely used in health care.

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Objective: Hospital at Home (HaH) programs currently lack decision support tools to help efficiently navigate the complex decision-making process surrounding HaH as a care option. We assessed user needs and perspectives to guide early prototyping and co-creation of 4PACS (Partnering Patients and Providers for Personalized Acute Care Selection), a decision support app to help patients make an informed decision when presented with discrete hospitalization options. Methods: From December 2021 to January 2022, we conducted semi-structured interviews via telephone with patients and caregivers recruited from Atrium Health's HaH program and physicians and a nurse with experience referring patients to HaH. Interviews were evaluated using thematic analysis. The findings were synthesized to create illustrative user descriptions to aid 4PACS development. Results: In total, 12 stakeholders participated (3 patients, 2 caregivers, 7 providers [physicians/nurse]). We identified 4 primary themes: attitudes about HaH; 4PACS app content and information needs; barriers to 4PACS implementation; and facilitators to 4PACS implementation. We characterized 3 user descriptions (one per stakeholder group) to support 4PACS design decisions. User needs included patient selection criteria, clear program details, and descriptions of HaH components to inform care expectations. Implementation barriers included conflict between app recommendations and clinical judgement, inability to adequately represent patient-risk profile, and provider burden. Implementation facilitators included ease of use, auto-populating features, and appropriate health literacy. Conclusions: The findings indicate important information gaps and user needs to help inform 4PACS design and barriers and facilitators to implementing 4PACS in the decision-making process of choosing between hospital-level care options.

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Background: Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person's life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations.Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods: The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion: The iFraP trial will answer important questions about the effectiveness of the new 'iFraP' osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration ISRCTN: 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407.

Background: For people with osteoporosis, broken bones (called 'fragility fractures') can occur from low or no trauma and cause significant disability. Medicines can strengthen bone and lower the chance of fragility fractures. However, many people who experience a fragility fracture do not start or continue taking osteoporosis medicines. People commonly choose not to take osteoporosis medicines because they are unsure what medicines are for, confused about fracture 'risk' and/or worried about side-effects. To address this, we developed the 'iFraP intervention': 1. The iFraP 'decision-support tool': to support patients and healthcare professionals talk together to make decisions about medicines2. iFraP training for healthcare professionals to:a. use the tool in appointments with patientsb. give understandable, clear and consistent information c. listen to and address patient concerns This trial investigates whether the iFraP intervention makes decision-making about osteoporosis medicines easier, and whether it is cost-effective, acceptable and practical to deliver. Methods: 380 patients will take part who will be 50 years and older and referred to a fracture prevention service, because they have broken a bone. Patients taking part will be allocated to receive either a usual NHS appointment or an appointment using the iFraP intervention. Patients will complete a questionnaire before their appointment, and 2 weeks and 3 months afterwards. Some patients will be asked if they consent to have their appointment recorded and/or be interviewed, to understand how the decision-support tool is being used, and patient's views of the iFraP intervention. Outputs: If successful, the iFraP intervention will benefit patients and the NHS by helping patients make decisions about osteoporosis medicine. If the iFraP intervention increases the number of people with osteoporosis that start and continue taking osteoporosis medicines, iFraP will lower the number of future fractures, and reduce the negative outcomes that result from fractures (e.g. significant disability).

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INTRODUCTION: Parents who use donated gametes or embryos to form their families struggle with telling their children about their genetic origins. We developed the Tool to Empower Parental Telling and Talking (TELL Tool) to support parents in disclosure to their children and an eBook attention control. METHOD: A randomized parallel, two-group, attention-controlled clinical pilot trial was conducted online during COVID-19. Feasibility, acceptability, and preliminary effects among parents with children aged 1-16 years were examined. RESULTS: Over 10 months, our target of 75 parents were enrolled (85% of eligible [95% confidence interval (CI), 76% to 91%]), and 68% (95% CI: 57% to 78%) were retained at 12 weeks. At 4 and 12 weeks, positive trends were found for parental disclosure, telling confidence, and anxiety compared with attention controls. DISCUSSION: The study protocol is feasible, and the TELL Tool is acceptable to parents and demonstrates a positive effect on parents' ability to tell their children. The results support the implementation of a large efficacy trial.

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BACKGROUND: Despite the availability of school-based human papillomavirus (HPV) vaccination programs, disparities in vaccine coverage persist. Barriers to HPV vaccine acceptance and uptake include parental attitudes, knowledge, beliefs, and system-level barriers. A total of 3 interventions were developed to address these barriers: an in-person presentation by school nurses, an email reminder with a web-based information and decision aid tool, and a telephone reminder using motivational interviewing (MI) techniques. OBJECTIVE: Here we report on the development and formative evaluation of interventions to improve HPV vaccine acceptance and uptake among grade 4 students' parents in Quebec, Canada. METHODS: In the summer of 2019, we conducted a formative evaluation of the interventions to assess the interventions' relevance, content, and format and to identify any unmet needs. We conducted 3 focus group discussions with parents of grade 3 students and nurses. Interviews were recorded, transcribed, and analyzed for thematic content using NVivo software (Lumivero). Nurses received training on MI techniques and we evaluated the effect on nurses' knowledge and skills using a pre-post questionnaire. Descriptive quantitative analyses were carried out on data from questionnaires relating to the training. Comparisons were made using the proportions of the results. Finally, we developed a patient decision aid using an iterative, user-centered design process. The iterative refinement process involved feedback from parents, nurses, and experts to ensure the tool's relevance and effectiveness. The evaluation protocol and data collection tools were approved by the CHU (Centre Hospitalier Universitaire) de Québec Research Ethics Committee (MP-20-2019-4655, May 16, 2019). RESULTS: The data collection was conducted from April 2019 to March 2021. Following feedback (n=28) from the 3 focus group discussions in June 2019, several changes were made to the in-person presentation intervention. Experts (n=27) and school nurses (n=29) recruited for the project appreciated the visual and simplified information on vaccination in it. The results of the MI training for school nurses conducted in August 2019 demonstrated an increase in the skills and knowledge of nurses (n=29). School nurses who took the web-based course (n=24) filled out a pretest and posttest questionnaire to evaluate their learning. The rating increased by 19% between the pretest and posttest questionnaires. Several changes were made between the first draft of the web-based decision-aid tool and the final version during the summer of 2019 after an expert consultation of experts (n=3), focus group participants (n=28), and parents in the iterative process (n=5). More information about HPV and vaccines was added, and users could click if more detail is desired. CONCLUSIONS: We developed and pilot-tested 3 interventions using an iterative process. The interventions were perceived as potentially effective to increase parents' knowledge and positive attitudes toward HPV vaccination, and ultimately, vaccine acceptance. Future research will assess the effectiveness of these interventions on a larger scale.

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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.

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BACKGROUND: Concordance between a person's values and the test or treatment they ultimately receive is widely considered to be an essential outcome for good decision quality. There is little research, however, on why patients receive "discordant" care. A large, randomized trial of decision aids for colorectal cancer (CRC) screening provided an opportunity to assess why some patients received a different test than the one they preferred at an earlier time point. METHODS: Of 688 patients who participated in the trial, 43 received a different CRC screening test than the one they selected after viewing a decision aid 6 mo prior. These patients answered 2 brief, open-ended questions about the reasons for this discordance. The research team analyzed their answers using qualitative description. RESULTS: Patient responses reflected 6 major categories: barriers or risks of initially favored test, benefits of alternative test, costs or health insurance coverage, discussion with family or friends, provider factors or recommendation, and health issues. CONCLUSIONS: Some of the patients' explanations fit well with the informed concordance approach, which infers poor decision quality from the existence of discordant care, since in these cases it appears that the patient's values and preferences were not adequately respected. Other statements suggest that the patient had an informed rationale for changing their mind about which test to undergo. These cases may reflect high-quality decision making, despite the existence of discordance as measured in the trial. This analysis highlights a major challenge to a popular approach for assessing decision quality, the difficulty of normatively assessing the quality of decision making when apparent discordant care has been provided, and the need to assess patient values and preference over time. HIGHLIGHTS: Value-choice concordance is an accepted measure for assessing decision quality in decision aid trials, but greater exploration of apparently discordant care challenges key assumptions of this method; this study provides evidence that discordance as typically measured may not always reflect low-quality patient decision making.Researchers evaluating decision aids and assessing decision quality should consider the use of qualitative methods to supplement measures of decision quality and consider assessing patient preferences at multiple time points.

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Objective: To improve sustainability of a patient decision aid for systemic treatment of metastatic colorectal cancer, we evaluated real-world experiences and identified ways to optimize decision aid content and future implementation. Methods: Semi-structured interviews with patients and medical oncologists addressed two main subjects: user experience and decision aid content. Content analysis was applied. Fifteen experts discussed the results and devised improvements based on experience and literature review. Results: Thirteen users were interviewed. They confirmed the relevance of the decision aid for shared decision making. Areas for improvement of content concerned; 1) outdated and missing information, 2) an imbalance in presentation of treatment benefits and harms, and 3) medical oncologists' expressed preference for a more center-specific or patient individualized decision aid, presenting a selection of the guideline recommended treatment options. Key points for improvement of implementation were better alignment within the care pathway, and clear instruction to users. Conclusion: We identified relevant opportunities for improvement of an existing decision aid and developed an updated version and accompanying implementation strategy accordingly. Innovation: This paper outlines an approach for continued decision aid and implementation strategy development which will add to sustainability. Implementation success of the improved decision aid is currently being studied in a multi-center mixed-methods implementation study.

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Currently, there are no resources to support culturally and linguistically diverse (CALD) women with breast cancer to make decisions about undergoing breast reconstruction (BR). This study evaluated the usability and acceptability of decision aids (DAs) for Vietnamese- and Arabic-speaking women. This two-phase qualitative recruited Vietnamese- (Phase 1) and Arabic-speaking (Phase 2) adult (age ≥ 18 years) women who were diagnosed with breast cancer and could read Vietnamese/Arabic. Women participated in either think-aloud telephone interviews (Phase 1) or semi-structured telephone interviews (Phase 2) and provided feedback on the DA. Interviews were audio-recorded, translated, and transcribed from Vietnamese/Arabic to English, and inductive thematic analysis was undertaken. Additionally, Arabic-speaking women completed the Preparation for Decision Making (PrepDM) scale in Round 2. Twenty-five women were recruited in two phases (Phase 1: Vietnamese-speaking women, n = 14; Phase 2: Arabic-speaking, n = 11). Three themes were developed in Phase 1: (1) DA content and reception; (2) linguistic attributes and cultural appropriateness; and (3) factors that improve the DAs' impact. Three themes were developed in Phase 2: (1) varying perceptions of DA content; (2) linguistic and cultural suitability of information; and (3) impact of DA on decision making. Women from both phases identified areas for improvement: minimising the use of medical terminology, considering the cultural taboos associated with the word 'breast', and addressing remaining information gaps. Both language DAs were generally perceived as acceptable and useful in providing information about BR options and prompting women's reflections about the suitability of BR as part of their treatment. The mean PrepDM score for Arabic-speaking women in Round 2 was 4.8/5 (SD = 0.3). Further work is needed to ensure that culturally adapted DAs take into account the myriad of information needs and health literacy levels. The key role of healthcare professionals in shared decision making among CALD populations should also be considered.

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Objectives: To examine patient education, counselling practices, decision aids, and education resources related to fertility preservation for transgender and gender diverse (TGD) youth and young adults. Methods: A scoping review was conducted using a comprehensive literature search (Ovid MEDLINE, PubMed Medline, OVID Embase, Ovid PsychoINFO, and Cochrane Central Register of Controlled Trials) conducted from 1806 to October 21, 2022. Inclusion criteria involved abstracts and articles on patient education, counselling, decision aids or education resources regarding fertility preservation for TGD youth and adults. Results: Of 1,228 identified articles and abstracts, only six articles met inclusion criteria. Three key themes were identified: (1) patient education and counselling practices (n = 4), with majority of patients receiving fertility preservation counselling at their respective centres; (2) decision aids and strategies for clinicians on fertility preservation for TGD individuals (n = 2) and; (3) patient education resources (n = 1). There was a paucity of literature on decision aids and patient education resources. Conclusions: This study highlights the need to further develop and evaluate decision aids for healthcare providers and patient education resources, including eLearning modules, around fertility preservation for TGD individuals.

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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.

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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.

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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.

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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.

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PURPOSE: The ideal management of distal radius fractures (DRFs) in patients aged 65 years and older is debated. Acknowledging the evidence that both nonsurgical and surgical treatment yield similar outcomes one year after injury, a patient decision aid (PDA) could facilitate patient engagement in treatment decision-making. The purpose of this study was to develop a PDA to guide patients in the treatment of DRFs in patients ≥65 years of age. METHODS: The DRF PDA was developed using an established decision sciences framework. The PDA included an overview of DRFs, treatment options (casting vs surgery), risk/benefits, and a values clarification section. During the development phase, hand surgeons and patients reviewed the PDA; then, semistructured interviews were performed with participants to elicit feedback. RESULTS: Eleven patients and 11 hand surgeons participated in the study. All patients found the PDA useful and almost all stated it would make the treatment decision easier. Most patients believed that there was enough information in the PDA, but one desired more information about surgical risks. Almost all surgeons stated the PDA would be easy for patients to use and understand, and approximately half believed that it would help patients make a more informed decision. Most surgeons expressed that the PDA would complement their usual approach to counseling patients, but some noted it would involve changes to their workflow. Most participants believed the information presented was unbiased, but one patient thought it was biased toward surgery, whereas a few surgeons believed that it was biased toward nonsurgical treatment. CONCLUSIONS: All patients expressed that the PDA was informative, comprehensive, and easy to understand and would be helpful if they were deciding about DRF treatment. Surgeons believed that patients would find the PDA easy to use and understand, but some had concerns about incorporating it into their clinic workflow. CLINICAL RELEVANCE: A decision aid for the treatment of DRFs in patients aged ≥65 years can be used to engage patients in the shared decision-making process.

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