Young adults with early psychosis often disengage from essential early intervention services (i.e., Coordinated Specialty Care or CSC in the United States). While decision support interventions improve service engagement, their use in this population is underexplored. This study evaluated the feasibility, acceptability, fidelity, and potential impact of a decision coaching intervention for young adults with early psychosis in CSC services. Using a mixed-method, longitudinal, collective case study design, we assessed the intervention's impact on decision-making needs through the Decisional Conflict Scale and qualitative interviews. We also evaluated feasibility, fidelity, and acceptability through observations and feedback from interventionists and participants. Eight young adults from three CSC programs participated, showing variable engagement, with generally favorable fidelity and acceptability ratings. The Decisional Conflict Scale revealed mixed findings, while four themes from qualitative interviews emerged: Perspective and Information Seeking, Motivation and Prioritization, Empowerment and Confidence, and Critical Thinking and Evaluation. The findings suggest that training CSC providers-including peer specialists and clinicians-to deliver decision coaching with fidelity is feasible, well-received by young adults, and potentially impactful on decision-making. Replication in a larger controlled trial, addressing observed study limitations, is warranted. This trial was registered with ClinicalTrials.gov (Identifier: NCT04532034) on August 28, 2020, as Temple University Protocol Record 261047, Facilitating Engagement in Evidence-Based Treatment for Early Psychosis (https://clinicaltrials.gov/ct2/show/NCT04532034?term=NCT04532034&draw=2&rank=1).

HIV remission (or cure) clinical trials require potential participants to understand trial-related risks, approaches to minimize risks, potential benefits, procedures, and participation alternatives to make an informed decision. Decision aids (DAs) support preference-sensitive decisions. We report on the development and evaluation of a DA called Decision Partner, designed to support informed consent. We used an iterative, mixed-methods approach to develop and test Decision Partner. We conducted research and engagement activities among people living with HIV (PLWHIV), advocates, researchers, trialists, and clinicians which resulted in a product reflective of information required for informed choice. Among 20 PLWHIV, 90% rated that Decision Partner would be useful for decision-making. Decision conflict significantly decreased after using Decision Partner (37.3 to 16.8, p =.007) and knowledge significantly increased from pre to-post(z = -3.11, p <.01). Our findings indicated that Decision Partner holds promise to augment the informed consent process, in HIV remission trials.

This study investigates the barriers to and facilitators of sustaining a decision aid (DA) tool for patients with SLE in routine rheumatology outpatient care across the USA. The DA was initially developed for assisting patients with SLE in making informed medication choices by providing personalized information on their treatment process.

We conducted semi-structured interviews with clinicians, administrators, and information technology (IT) professionals from 15 geographically diverse rheumatology clinics that participated in a large-scale DA implementation trial. Interviews were transcribed and analysed using NVivo, with thematic coding to identify key factors influencing DA sustainability.

The analysis identified several facilitators, including the DA's user-friendly design and its effectiveness in simplifying complex medical information, aiding informed decision-making for patients with SLE. Challenges affecting DA sustainability included inconsistent staff knowledge about the DA, difficulties integrating the DA into clinical workflows, a lack of executive and physician champions, and a lack of structured training and communication strategies. Additionally, concerns were raised about the availability of staff support and the technological capabilities required to maintain use of the DA.

To sustain the DA in clinical practice, there is a need for enhanced training programs, better workflow integration, in-clinic physician champions, and effective use of electronic medical records for DA dissemination. Addressing these challenges would improve the impact of the DA on patient education and decision-making, ensuring its continued use in routine care.

ClinicalTrials.gov, NCT03735238.

Cytoreductive treatments for patients diagnosed with de novo synchronous metastatic hormone-sensitive prostate cancer (mHSPC) confer incremental survival benefits over systemic therapy, but these may lead to added toxicity and morbidity. Our objective was to determine patients' preferences for, and trade-offs between, additional cytoreductive prostate and metastasis-directed interventions.

A prospective multicentre discrete choice experiment trial was conducted at 30 hospitals in the UK between December 3, 2020 and January 25, 2023 (NCT04590976). The individuals were eligible for inclusion if they were diagnosed with de novo synchronous mHSPC within 4 mo of commencing androgen deprivation therapy and had performance status 0-2. A discrete choice experiment instrument was developed to elicit patients' preferences for cytoreductive prostate radiotherapy, prostatectomy, prostate ablation, and stereotactic ablative body radiotherapy to metastasis. Patients chose their preferred treatment based on seven attributes. An error-component conditional logit model was used to estimate the preferences for and trade-offs between treatment attributes.

A total of 352 patients were enrolled, of whom 303 completed the study. The median age was 70 yr (interquartile range [IQR] 64-76) and prostate-specific antigen was 94 ng/ml (IQR 28-370). Metastatic stages were M1a 10.9% (33/303), M1b 79.9% (242/303), and M1c 7.6% (23/303). Patients preferred treatments with longer survival and progression-free periods. Patients were less likely to favour cytoreductive prostatectomy with systemic therapy (Coef. -0.448; [95% confidence interval {CI} -0.60 to -0.29]; p < 0.001), unless combined with metastasis-directed therapy. Cytoreductive prostate radiotherapy or ablation with systemic therapy, number of hospital visits, use of a "day-case" procedure, or addition of stereotactic ablative body radiotherapy did not impact treatment choice. Patients were willing to accept an additional cytoreductive treatment with 10 percentage point increases in the risk of urinary incontinence and fatigue to gain 3.4 mo (95% CI 2.8-4.3) and 2.7 mo (95% CI 2.3-3.1) of overall survival, respectively.

Patients are accepting of additional cytoreductive treatments for survival benefit in mHSPC, prioritising preservation of urinary function and avoidance of fatigue.

We performed a large study to ascertain how patients diagnosed with advanced (metastatic) prostate cancer at their first diagnosis made decisions regarding additional available treatments for their prostate and cancer deposits (metastases). Treatments would not provide cure but may reduce cancer burden (cytoreduction), prolong life, and extend time without cancer progression. We reported that most patients were willing to accept additional treatments for survival benefits, in particular treatments that preserved urinary function and reduced fatigue.

Evaluate usability and utility of National Institute for Clinical Excellence (NICE) Patient Decision Aid's (PtDA's) for pelvic floor surgery. PtDA's reviewed were uterine prolapse, vault prolapse and stress urinary incontinence (SUI).

Ten women given the PtDA's during routine clinical care were recruited from each cohort and underwent a semi-structured interview with a clinical researcher.

Urogynaecology outpatients in an NHS tertiary teaching hospital.

Women considering surgical management of uterine/vault prolapse or SUI. Exclusion criteria included those under 18, unable to communicate in English or not eligible for all surgical options discussed in the PtDA's.

A qualitative, semi-structured interview evaluating women's opinions of the decision aid and the way in which they utilised the PtDA was conducted. The interviews were recorded and transcribed prior to undertaking thematic analysis utilising NVivo software.

The outcomes of interest were feedback for content, language, format and usage of the PtDA's and women's usage of PtDA's in decision-making.

Amendments suggested included removal of mesh from the SUI PtDA as this is not routinely available on the NHS and addition of a statement regarding the use of mesh in prolapse surgery. Additional anatomical diagrams were suggested. The need for a robust and regular update system was highlighted as was the provision of foreign language, audio and electronic versions.

PtDA's need updating to ensure relevant content. Clear, detailed and relevant information is required alongside active clinician engagement to reach a mutually agreeable treatment plan.

To (i) identify characteristics of digital technologies (DTs) used to facilitate shared decision-making (SDM) within the field of cardiovascular care, (ii) examine conceptualizations of SDM underpinning these DTs, and (iii) summarize designs and outcomes of evaluation studies concerning these DTs.

We conducted a scoping review following methodological guidelines by the Joanna Briggs Institute. Ten scientific databases were searched. We selected peer-reviewed articles in cardiovascular care, with SDM and DT in the title and/or abstract published between January 2000 and March 2023. We extracted data on the type of DT, intended user(s), time point and mode of use, purpose, decision topic, underlying SDM model, and designs and outcomes of evaluation studies. Data were analysed descriptively in a narrative synthesis. From 4432 search results, 48 articles reporting on 31 DTs were included. Half of the articles were published after 2018, with most published in 2022. Most DTs are web-based applications for interactive use before and during the encounter between patient and healthcare professional, to convey information on cardiovascular care, calculate personal risk, and/or recommend treatment options. Shared decision-making conceptualizations refer to the International Patient Decision Aid Standards and authors in the field. Thirty-seven evaluation studies report on 31 DTs, with heterogeneous results related to variation in intervention designs, measurement time points, and outcome measures.

A recent increase in the reporting of DTs to facilitate SDM in cardiovascular care indicates their potential. This scoping review offers researchers, developers, and clinicians a comprehensive overview of this literature.

Open Science Framework: https://doi.org/10.17605/OSF.IO/TRGQ5.

Young adult female (YA-F) cancer survivors report fertility-related uncertainty and distress. Roadmap to Parenthood ("Roadmap") is a web-based decision aid and planning tool for family building after cancer. This study examined the perceived impact of Roadmap, encompassing aspects of website utility and its effects on confidence and motivation, identified factors related to the perceived impact of Roadmap, and evaluated whether the perceived impact related to changes in psychosocial outcomes.

Secondary analyses of a single-arm pilot study were conducted. Participants completed a baseline survey (T1), accessed Roadmap, and completed a survey 1 month post-baseline (T2). The eHealth Impact Questionnaire (eHIQ) measured the perceived impact of Roadmap. A linear regression model evaluated associations between baseline factors and the eHIQ. Linear regression models evaluated relationships between the eHIQ and decisional conflict, unmet information needs, fertility self-efficacy, and self-efficacy for managing fertility-related negative emotions at T2, controlling for baseline (T1) levels of each outcome.

Among participants (N = 98), 93% reported accessing Roadmap. A more positive perceived impact of Roadmap was related to younger age (β =  - .348 p = .002), lower household income (β =  - .321. p = .021), greater health literacy (β = .326 p = .004), and dissatisfaction with post-treatment fertility discussions (β =  - .279 p = .029). Those who reported a more positive perceived impact of Roadmap reported lower decisional conflict (β =  - .368, p < .001) and unmet information needs (β =  - .515, p < .001); self-efficacy outcomes were not related.

A web-based decision aid for family building after cancer effectively supports important survivor subgroups. Future directions include assessing the needs of those with low health literacy and improving patient-provider communication.

While guidelines encourage individualized discussions of the risks and benefits of antiseizure medication (ASM) withdrawal after a period of seizure-freedom, no formal methods exist for assessing patient preferences. We report the initial development of a rapid patient preferences screener.

We conducted a mixed-methods study of adults who were ≥1 year seizure-free and seen for epilepsy across three institutions. We reviewed existing questionnaires and adapted three questions measuring core constructs influencing ASM decisions - views about ASMs, driving restrictions, and seizures. We added one additional "global" question, for 4 total questions. Participants rated question clarity and utility from 1 (low) to 7 (high).

Of 32 participants, the median patient age was 46 (interquartile range [IQR] 33-56), with a median 3 years since their last seizure (IQR 2-11). Median responses were: 2 (IQR 1-5) for being bothered by ASMs, 2 (IQR 1-6) for feeling that a driving restriction would be disruptive, and 5 (IQR 4-7) for feeling that another seizure would be serious. Respondents tended to disagree that ASMs are doing more harm than good (median 1, IQR 1-2). Participants rated question clarity (median 6, IQR 6-7) and utility (median 7, IQR 6-7) highly.

We report the initial development of a pre-visit rapid screener of patient preferences pertinent to ASM withdrawal in well-controlled epilepsy. Patients endorsed the utility of such a screener and provided guidance to improve items. We hope that this work will ultimately improve shared decision-making.

In public health, risk experts often define acceptable risk targets without community input. We developed a novel method for applying behavioral microeconomics to integrate individuals' risk preferences into risk assessment. To demonstrate this methodology, we explored a risk-risk tradeoff case scenario: increased asthma risk from increased cleaning and disinfection (C&D) and increased infection risk from decreased C&D for healthcare staff. Utilizing a risk-risk tradeoff (RRTO) framework, two datasets were informed with RRTO survey data describing the risks individuals would accept for one outcome to offset risk in another (i.e., "risk target"). A quantitative microbial risk assessment (QMRA) was deployed to output "critical concentrations," viral concentrations on surfaces that yield risk targets for a single contaminated surface touch and a work shift. Critical concentrations were over four orders of magnitude larger for single-touch scenarios. Critical concentrations across risk target datasets were similar. Using the RRTO framework to inform QMRA advances the incorporation of individuals' risk preferences in risk analyses outside economics.

To systematically review research analyzing the effectiveness of decision aids for end-of-life care, including how researchers specifically measure decision aid success.

We conducted a systematic review synthesizing quantitative, qualitative, and mixed-methods study results using Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Four databases were searched through February 18, 2023. Inclusion criteria required articles to evaluate end-of-life care decision aids. The review is registered under PROSPERO (#CRD42023408449).

A total of 715 articles were initially identified, with 43 meeting the inclusion criteria. Outcome measures identified included decisional conflict, less aggressive care desired, knowledge improvements, communication improvements, tool satisfaction, patient anxiety and well-being, and less aggressive care action completed. The majority of studies reported positive outcomes especially when the decision aid development included International Patient Decision Aid Standards.

Research examining end of life care decision aid use consistently reports positive outcomes.

This review presents data that can guide the next generation of decision aids for end-of-life care, namely using the International Patient Decision Aid Standards in developing tools and showing which tools are effective for helping to prevent the unnecessary suffering that can result when patients' dying preferences are unknown.

Shared decision-making is recommended for patients considering treatment options for severe aortic stenosis (AS) and chronic coronary artery disease (CAD). This review aims to systematically identify and assess patient decision aids (PtDAs) for chronic CAD and AS and evaluate the international evidence on their effectiveness for improving the quality of decision-making.

Five databases (Cochrane, CINAHL, Embase, MEDLINE, and PsycInfo), clinical trial registers, and 30 PtDA repositories/websites were searched from 2006 to March 2023. Screening, data extraction, and quality assessments were completed independently by multiple reviewers. Meta-analyses were conducted using Stata statistical software. Eleven AS and 10 CAD PtDAs were identified; seven were less than 5 years old. Over half of the PtDAs were web based and the remainder paper based. One AS and two CAD PtDAs fully/partially achieved international PtDA quality criteria. Ten studies were included in the review; four reported on the development/evaluation of AS PtDAs and six on CAD PtDAs. Most studies were conducted in the USA with White, well-educated, English-speaking participants. No studies fulfilled all quality criteria for reporting PtDA development and evaluation. Meta-analyses found that PtDAs significantly increased patient knowledge compared with 'usual care' (mean difference: 0.620; 95% confidence interval 0.396-0.845, P < 0.001) but did not change decisional conflict.

Patients who use PtDAs when considering treatments for AS or chronic CAD are likely to be better informed than those who do not. Existing PtDAs may not meet the needs of people with low health literacy levels as they are rarely involved in their development.

PROSPERO: CRD42021264700.

Pulmonary Rehabilitation (PR) services typically offer programmes to support individuals living with COPD make rehabilitation choices that best meet their needs, however, uptake remains low. Shared Decision-Making (SDM; e.g., Patient Decision Aids (PtDA)) interventions increase informed and values-based decision-making between individuals and healthcare professionals (HCPs). We aimed to develop an intervention to facilitate PR SDM which was acceptable to individuals living with COPD and PR HCPs.

An iterative development process involving qualitative methods was adopted. Broad overarching frameworks included: complex intervention development framework, the multiple stakeholder decision making support model, and the Ottawa Decision Support Framework. Development included: assembling a steering group, outlining the scope for the PtDA, collating data to inform the PtDA design, prototype development, alpha testing with individuals with COPD (n = 4) and PR HCPs (n = 8), PtDA finalisation, and design and development of supporting components. This took nine months.

The PtDA was revised six times before providing an acceptable, comprehensible, and usable format for all stakeholders. Supporting components (decision coaching training and a consultation prompt) were necessary to upskill PR HCPs in SDM and implement the intervention into the PR pathway.

We have developed a three-component SDM intervention (a PtDA, decision coaching training for PR healthcare professionals, and a consultation prompt) to support individuals living with COPD make informed and values-based decision about PR together with their PR healthcare professional. Clear implementation strategies are outlined which should support its integration into the PR pathway.

Decision-making about treatment when planning a pregnancy (family planning) is complex for women living with multiple sclerosis (MS). Decision tools can help this process, in 2016 MS Trust launched their online digital treatment decision tool to support people with MS.

To evaluate user-experience of this tool by exploring women's opinions about its content, interface, and usefulness in the context of family planning; and to synthesize recommendations to improve the tool.

Thirty participants qualitatively evaluated the tool using Think Aloud methodology. Sessions were conducted online using Microsoft Teams and were video recorded. Transcription was automated and data were thematically analyzed.

Women's first impression was that the tool presented a lot of information at once, which was difficult to take in, and they found it difficult to navigate. Although the tool was helpful in allowing them to compare treatment options, the filters were confusing, and the information related to pregnancy sometimes contradicted advice from their healthcare practitioners. They suggested rewording the pregnancy recommendations and filters, updating some content, and making some changes to the interface to meet users' cognitive needs.

The MS Trust treatment decision tool is excellent in helping women with treatment choices at initial diagnosis. However, it is not currently as useful when considering family plans. Recommendations were conveyed to MS Trust where some are now applied to the new live version and the rest are to be considered for future updating projects.

Management of an endoscopically resected malignant colorectal polyps can be challenging due to the risk of residual tumour and lymphatic spread. International studies have shown, that of those choosing surgical management instead of surveillance strategy, there are between 54% and 82% of bowel resections without evidence of residual tumour or lymphatic spread. As surgical management entails risks of complications and surveillance strategy entails risks of residual tumour or recurrence, a clinical dilemma arises when choosing a management strategy. Shared decision-making is a concept that can be used in preference-sensitive decision-making to facilitate patient involvement and empowerment to facilitate active patient participation in the decision-making process.

This study protocol describes our clinical multi-institutional, non-randomised, interventional phase II study at Danish surgical departments planned to commence in the second quarter of 2024. The aim of this study is to examine whether shared decision-making and using a patient decision aid in consultations affect patients' choice of management, comparing with retrospective data. The secondary aim is to investigate patients' experiences, perceived involvement, satisfaction, decision conflict and other outcomes using questionnaire feedback directly from the patients.

There are no conflicts of interest for principal or local investigators in any of the study sites. All results will be published at Danish and international meetings, and in English language scientific peer-reviewed journals. Our study underwent evaluation by the Regional Committees on Health Research Ethics for Southern Denmark (file number 20232000-47), concluding that formal approval was not required for this kind of research.

NCT05776381.

To determine the feasibility and acceptability of using a patient decision aid (DA) for women with elevated breast cancer risk who are considering MRI screening.

This pilot study employed a mixed methods design to develop, modify, and test an interactive DA. The DA was administered among a consecutive patient sample with an estimated Tyrer-Cuzick v.8 lifetime breast cancer risk of 20% or greater and without a pathologic genetic mutation. The decisional conflict scale was used to measure decisional conflict. Post-intervention provider and patient feedback evaluated shared decision-making, feasibility, and acceptability.

Twenty-four patients participated, with a median age of 44 years. Prior to DA use, sixteen patients (67%) were unsure whether to add MRI to their screening, six patients elected MRI (25%), and two patients declined MRI (8%). Following DA use, thirteen of sixteen of the initially undecided participants (81%) established a preference, with eleven electing to add MRI screening. Of participants with an initial preference, all maintained the same decision following use of the DA. Prior to the DA, the median decisional conflict score among participants was 25% (range 0-60%) compared with 0% (range 0-25%) after the DA. Healthcare providers reported that the DA was useful and easily incorporated into clinical workflow.

This pilot study shows that there may be a benefit to DA utilization in the high-risk breast cancer clinic to guide shared decision-making in establishing a screening preference. The findings warrant further research to test the use of the DA in a larger, multi-site trial.

This study evaluates whether using a patient decision aid (PDA) for patients with superficial basal-cell carcinoma (sBCC) results in a decreased decisional conflict level and increased knowledge.

In a prospective multicentre study, patient groups were included before and after implementation of a PDA. Decisional conflict levels were compared directly after making the treatment decision, measured once as the mean score on the decisional conflict scale (DCS). Higher scores correspond with higher conflict levels (0-100). Secondary outcomes were knowledge on treatment options, recognizing a BCC, and risk factors for developing a BCC measured on an adapted version of a validated knowledge questionnaire for melanoma patients, and patient satisfaction with the PDA.

Data was available for 103 patients in the control-group and 109 in the PDA-group. The mean DCS score in the control-group was 22.78 (SD 14.76) compared to 22.34 (SD 14.54) in the PDA-group; the decrease was non-significant (p = 0.828). The average percentage correct answers on the knowledge questionnaire increased from 76.5% in the control-group to 80.5% in the PDA-group (p = 0.044). According to the majority of patients in the PDA-group (73.7%) the PDA had added value.

Using the PDA had no significant effect on decisional conflict levels, but increased overall knowledge on relevant issues concerning sBCC.

The PDA can be used as an informational tool by patients with sBCC.

Testing healthcare delivery interventions in rigorous clinical trials is a critical step in improving patient care, but conducting multisite randomized clinical trials to test the effect of care delivery interventions has unique challenges and requires foresight and planning.

We conducted the first care delivery trial (A191402CD) in the Alliance for Clinical Trials in Oncology, a National Cancer Institute Community Oncology Research Program research base, which tested the effectiveness of two different decision aids for supporting shared decision-making about prostate cancer treatment. Our experience illustrates the kind of challenges that confront care delivery researchers as they seek to test interventions to improve the experiences of patients.

Lessons learned include the following: cluster-randomized designs introduce complexity; workflow disruption can discourage site participation; evidence-based methods may not always be sufficient.

We conclude with the following recommendations: assessing feasibility requires special rigor; relationships and interpersonal dynamics must be leveraged. Our experiences may inform future care delivery research.

Shared decision-making is increasingly embraced in health care and recommended in cardiovascular guidelines. Patient involvement in health care decisions, patient-clinician communication, and models of patient-centered care are critical to improve health outcomes and to promote equity, but formal models and evaluation in cardiovascular care are nascent. Shared decision-making promotes equity by involving clinicians and patients, sharing the best available evidence, and recognizing the needs, values, and experiences of individuals and their families when faced with the task of making decisions. Broad endorsement of shared decision-making as a critical component of high-quality, value-based care has raised our awareness, although uptake in clinical practice remains suboptimal for a range of patient, clinician, and system issues. Strategies effective in promoting shared decision-making include educating clinicians on communication techniques, engaging multidisciplinary medical teams, incorporating trained decision coaches, and using tools (ie, patient decision aids) at appropriate literacy and numeracy levels to support patients in their cardiovascular decisions. This scientific statement shines a light on the limited but growing body of evidence of the impact of shared decision-making on cardiovascular outcomes and the potential of shared decision-making as a driver of health equity so that everyone has just opportunities. Multilevel solutions must align to address challenges in policies and reimbursement, system-level leadership and infrastructure, clinician training, access to decision aids, and patient engagement to fully support patients and clinicians to engage in the shared decision-making process and to drive equity and improvement in cardiovascular outcomes.

Medical assistance in dying (MAiD) was legalized in Canada in 2016, with legislation updated in 2021. It is unclear whether resources are available to help patients make this difficult decision; therefore, we sought to identify and quality appraise Canadian MAiD resources for supporting patients making this decision.

We conducted an environmental scan by searching Canadian websites for online MAiD resources that were published after the 2016 MAiD legislation, patient targeted, publicly accessible and able to inform decisions about MAiD in Canada. We excluded resources that targeted health care professionals or policy-makers, service protocols and personal narratives. Two authors appraised resources using the International Patient Decision Aids Standards (IPDAS) criteria and the Patient Education Materials Assessment Tool (PEMAT) for health literacy. Descriptive analysis was conducted. We defined resources as patient decision aids if 7 IPDAS defining criteria were met, and we rated resources as adequate for understandability or actionability if the PEMAT score was 70% or greater.

We identified 80 MAiD resources. As of March 2023, 62 resources (90%) provided eligibility according to the 2021 legislation and 11 did not discuss any eligibility criteria. The median IPDAS score was 3 out of 7; 52% discussed alternative options and none provided benefits or harms. Of 80 resources, 59% were adequate for understandability and 29% were adequate for actionability.

Although many resources on MAiD were updated with 2021 legislation, few were adequate to support patients with lower health literacy. There is a need to determine whether a patient decision aid would be appropriate for people in Canada considering MAiD.

Shared decision-making (SDM) supports patients to make informed and value-based decisions about their care. We are developing an intervention to enable healthcare professionals to support patients' pulmonary rehabilitation (PR) decision-making. To identify intervention components we needed to evaluate others carried out in chronic respiratory diseases (CRDs). We aimed to evaluate the impact of SDM interventions on patient decision-making (primary outcome) and downstream health-related outcomes (secondary outcome).

We conducted a systematic review using the risk of bias (Cochrane ROB2, ROBINS-I) and certainty of evidence (Grading of Recommendations Assessment, Development and Evaluation) tools.

MEDLINE, EMBASE, PSYCHINFO, CINAHL, PEDRO, Cochrane Central Register of Controlled Trials, the International Clinical Trials Registry Platform Search Portal, ClinicalTrials.gov, PROSPERO, ISRCTN were search through to 11th April 2023.

Trials evaluating SDM interventions in patients living with CRD using quantitative or mixed methods were included.

Two independent reviewers extracted data, assessed risk of bias and certainty of evidence. A narrative synthesis, with reference to The Making Informed Decisions Individually and Together (MIND-IT) model, was undertaken.

Eight studies (n=1596 (of 17 466 citations identified)) fulfilled the inclusion criteria.Five studies included components targeting the patient, healthcare professionals and consultation process (demonstrating adherence to the MIND-IT model). All studies reported their interventions improved patient decision-making and health-related outcomes. No outcome was reported consistently across studies. Four studies had high risk of bias, three had low quality of evidence. Intervention fidelity was reported in two studies.

These findings suggest developing an SDM intervention including a patient decision aid, healthcare professional training, and a consultation prompt could support patient PR decisions, and health-related outcomes. Using a complex intervention development and evaluation research framework will likely lead to more robust research, and a greater understanding of service needs when integrating the intervention within practice.

CRD42020169897.

Firearm safety among individuals with Alzheimer disease and related dementias (ADRD) is an underdiscussed and underresearched concern in the United States, especially given the growing population of community-dwelling adults with ADRD. The "Safety in Dementia" (SiD) web-based decision aid was developed to support caregivers in addressing firearm access; the efficacy of SiD is unknown.

Through the SiD decision aid, the Safe at Home (S@H) study aims to support caregivers in making decisions about home safety that align with their goals and values, and behaviors regarding firearm access for persons with ADRD and firearm access.

The S@H study is a 2-armed randomized controlled trial to test the effect of the SiD decision aid on caregivers of community-dwelling adults with ADRD who have firearm access. S@H aims to recruit 500 ADRD caregivers (age ≥18 years, fluent in English or Spanish, and in the United States) through online or social media advertisements and through relevant organizations. Participants are randomized to view SiD or a control website at their own pace; all participants complete web-based questionnaires at baseline, 2 weeks, 2 months, and 6 months. The primary outcome is immediate preparation for decision-making; secondary outcomes include longitudinal decision outcomes and self-reported modifications to firearm access. The relative reach and effectiveness of each recruitment method (online/social media and through relevant organizations) will be assessed by examining differences in caregiver participation, retention rates, and relative cost.

The study enrollment began in May 2022. As of December 2022, a total of 117 participants had enrolled.

The S@H study is the first randomized trial of a firearm safety decision aid for ADRD caregivers. The results from this study will inform how best to support caregivers in decision-making regarding firearm safety. Further, results may guide approaches for recruiting caregivers and for dissemination of resources.

ClinicalTrials.gov NCT05173922; https://clinicaltrials.gov/ct2/show/NCT05173922.

DERR1-10.2196/43702.

This study aimed to investigate the associations between eHealth literacy, preferences for financial decision-making, and financial toxicity (FT) in a sample of Chinese cancer patients.

Eligible cancer patients were invited to participate in a cross-sectional survey from January to April 2021. Three measures (eHealth literacy scale, control preference scale, and COST) were used to analyze patients' eHealth literacy, decisional preferences, and FT, respectively. Wilcoxon signed-rank test and Kruskal-Wallis H test assessed the differences between population subgroups. Binary logistic and multivariate linear regression models were used to assess the relationships between eHealth literacy, decisional preferences, and FT.

A total of 590 cancer patients completed the questionnaire. We found that high FT was associated with poor ECOG performance, severe cancer stage, and longer cancer duration. Patients who preferred to adopt collaborative attitude toward decision-making showed a significantly higher eHealth literacy. However, there was an inverse relationship between eHealth literacy and a patient-driven attitude toward decision-making in female cancer patients. Regression analysis indicated that patients who were highly educated and actively employed might report a higher eHealth literacy. A significant relationship was found between high eHealth literacy and low FT. However, this relationship became insignificant when the background characteristics of cancer patients were taken into account.

A relationship between enhanced eHealth literacy, preference for collaborative decision-making, and low risk of FT is identified.

Interventions to improve patients' ability to use quality and reliable web-based information on cancer care should be encouraged.

Shared decision making (SDM) is gaining importance in cardiology, including Centers for Medicare & Medicaid Services (CMS) reimbursement policies requiring documented SDM for patients considering primary prevention implantable cardioverter defibrillators. The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at 7 sites. The purpose of this subanalysis was to qualitatively describe electrophysiology clinicians' experience implementing and using the DAs.

This included semi-structured individual interviews with electrophysiology clinicians at participating sites across the US, at least 6 months following conversion into the implementation phase of the trial (from June 2020 through February 2022). The interview guide was structured according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance [implementation evaluation model]) framework, assessing clinician experiences, which can impact implementation domains, and was qualitatively assessed using a mixed inductive/deductive method.

We completed 22 interviews post-implementation across all 7 sites. Participants included both physicians (n=16) and other clinicians who counsel patients regarding treatment options (n=6). While perception of SDM and the DA were positive, participants highlighted reasons for uneven delivery of DAs to appropriate patients. The CMS mandate for SDM was not universally viewed as associating with patients receiving DA's, but rather (1) logistics of DA delivery, (2) perceived effectiveness in improving patient decision-making, and (3) match of DA content to current patient populations. Remaining tensions include the specific trial data used in DAs and reconciling timing of delivery with when patients are actively making decisions.

Clinicians charged with delivering DAs to patients considering primary prevention implantable cardioverter defibrillators were generally supportive of the tenets of SDM, and of the DA tools themselves, but noted several opportunities to improve the reach and continued use of them in routine care.

URL: https://www.

gov; Unique Identifier: NCT03374891.

Recruitment of adults lacking the capacity to consent to trials requires the involvement of an alternative 'proxy' decision-maker, usually a family member. This can be challenging for family members, with some experiencing emotional and decisional burdens. Interventions to support proxy consent decisions in non-emergency settings are being developed. However, the ability to evaluate interventions is limited due to a lack of measures that capture outcomes of known importance, as identified through a core outcome set (COS).

Using established measure development principles, a four-stage process was used to develop and refine items for a new measure of proxy decision quality: (1) findings from a recent scoping review and consensus study were reviewed to identify items for inclusion in the scale and any existing outcome measures, (2) assessment of content coverage by existing measures and identification of insufficiency, (3) construction of a novel scale, and (4) cognitive testing to explore comprehension of the scale and test its content adequacy through interviews with family members of people with impaired capacity.

A range of outcome measures associated with healthcare decision-making and informed consent decisions, such as the Decisional Conflict Scale, were identified in the scoping review. These measures were mapped against the key constructs identified in the COS to assess content coverage. Insufficient coverage of areas such as proxy-specific satisfaction and knowledge sufficiency by existing instruments indicated that a novel measure was needed. An initial version of a combined measure (the CONCORD scale) was drafted and tested during cognitive interviews with eleven family members. The interviews established comprehension, acceptability, feasibility, and content adequacy of the scale. Participants suggested re-phrasing and re-ordering some questions, leading to the creation of a revised version.

The CONCORD scale provides a brief measure to evaluate the quality of decisions made on behalf of an adult who lacks the capacity to consent in non-emergency settings, enabling the evaluation of interventions to improve proxy decision quality. Initial evaluation indicates it has content adequacy and is feasible to use. Further statistical validation work is being undertaken.

It is not known whether older adults' willingness to deprescribe is associated with their health outcome priorities related to medications.

A cross-sectional survey was conducted from March-April 2020 using a nationally representative online panel. The survey presented two vignettes: (1) a preventive medicine; and (2) a symptom-relief medicine. Participants were asked whether they would be willing to stop each medicine if their doctor recommended it, and to rate their level of agreement with two health outcome priorities statements: "I am willing to accept the risk of future side effects … to feel better now," and "I would prefer to take fewer medicines, even if … I may not live as long or may have bothersome symptoms sometimes." Ordinal logistic regression was used to examine associations between willingness to stop each medicine, baseline characteristics and health outcome priorities.

Of 1193 panel members ≥65 years invited to participate, 835 (70%) completed the survey. Mean (SD) age was 73 years; 496 (59%) had taken a statin and 124 (15%) a prescription sedative-hypnotic. 507 (61%) were willing to stop preventive medicines; 276 (33%) were maybe willing. 419 (50%) were willing to stop symptom-relief medicines; 380 (46%) were maybe willing. Prioritizing fewer medicines was associated with higher odds of being willing to stop symptom-relief medicines (aOR 1.43 [95% CI 1.02-2.00]) and preventive medicines (aOR 1.52 [95% CI 1.05-2.18]). Prioritizing now over future was associated with lower odds of being willing to stop symptom-relief medicines (aOR 0.62 [95% CI 0.39-1.00]). Current/prior use of statins was associated with lower willingness to stop preventive medicines (aOR 0.66 [95% CI 0.48-0.91]).

Older adults' health outcome priorities related to medication use are associated with their willingness to consider deprescribing. Future research should determine how best to elicit patients' health outcome priorities to facilitate goal-concordant decisions about medication use.

In an era of personalised healthcare, it has become increasingly important to elicit individual-level preferences. While discrete choice experiments (DCEs) are widely used to measure patient preferences in the delivery of healthcare, the focus has been sample-level analysis. Using the DCE methodology, this project has designed a digital decision aid tool (DAT) with the potential to estimate individual preferences in real time to inform clinical consultation decisions in persistent pain management.

Using a feasibility randomised control trial, this study aims to assess the feasibility of using this Understanding Persistent Pain (UPP) DAT in a pharmacy-based clinical setting and to test processes for a future definite randomised trial. Community and practice-based pharmacists (up to 10) will be recruited in The National Health Service (NHS) Grampian and trained in the use of the digital UPP DAT. Pharmacists will recruit up to 60 patients who are living with persistent pain. Patients will be randomised to one of two groups: using the UPP DAT or usual care. Pharmacists will follow-up patients as needed according to clinical need and following standard practice. DCE response data collected by the UPP DAT will be analysed using the penalised logit model, allowing estimation of individual preferences in real time. We will follow-up pharmacists and patients who use the UPP DAT to gather feedback on their experiences.

This study received ethical approval from the North of Scotland Research Ethics Committee (21/NS/0059) and received Research & Development Management Permission to proceed from NHS Grampian (2021UA003E). The study has been registered in the ClinicalTrials.gov database. Findings will be disseminated in peer-reviewed publications, presentations and newsletters and made available in the University of Aberdeen and Pharmacy Research UK websites. Participants gave informed consent to participate in the study before taking part.

NCT05102578; clinicaltrials.gov.

People who are unable to make decisions about participating in research rely on proxies to make a decision based on their wishes and preferences. However, patients rarely discuss their preferences about research and proxies find it challenging to determine what their wishes would be. While the process of informed consent has traditionally been the focus of research to improve consent decisions, the more conceptually complex area of what constitutes 'good' proxy decision-making for research has remained unexplored. Interventions are needed to improve and support proxy decision-making for research but are hampered by a lack of understanding about what constitutes decision quality in this context. A global increase in conditions associated with cognitive impairment such as dementia has led to an urgent need for more research into these conditions. The COVID-19 pandemic and subsequent necessity to conduct research with large numbers of critically ill patients has made this need even more pressing. Much of the empirical research centres on the desire to improve decision accuracy, despite growing evidence that authenticity is more reflective of the aim of proxy decisions and concerns about the methodological flaws in authenticity-focused studies. Such studies also fail to take account of the impact of decision-making on proxies, or the considerable body of research on improving the quality of healthcare decisions. This paper reports a concept synthesis of the literature that was conducted to develop the first conceptualisation of 'good' proxy decisions about research participation. Elements of decision quality were identified across three stages of decision-making: proxy preparedness for decision-making which includes knowledge and understanding, and values clarification and preference elicitation; the role of uncertainty, decisional conflict, satisfaction and regret in the decision-making process; and preference linked outcomes and their effect. This conceptualisation provides an essential first step towards the future development of interventions to enhance the quality of proxy decision-making and ensure proxy decisions represent patients' values and preferences.

Pulmonary rehabilitation (PR) is highly evidenced but underutilised in patients living with chronic obstructive pulmonary disease (COPD). A menu of centre and home-based programmes is available to facilitate uptake but is not routinely offered. An appraisal of the current PR referral approach compared to a menu-based approach was warranted to explore the decision-making needs of patients living with COPD when considering a referral to PR. Face-to-face or telephone, semi-structured interviews were conducted with patients diagnosed with COPD and referred to PR and referring HCPs. Interviews were audio-recorded, transcribed verbatim and analysed using the enhanced critical incident technique. 14 HCPs and 11 patients were interviewed (n = 25). Interview data generated 276 critical incidents which informed 28 categories (30 sub-categories). Five high-level themes captured patients' decision-making needs for PR: Understanding COPD, understanding PR, perceived ability to access PR, a desire to accept PR, and supporting the offer. A menu-based approach would further support patients' PR decision-making, however, insufficient knowledge of the programmes would limit its perceived feasibility and acceptability. The development of shared decision making interventions (e.g., a patient decision aid) to elicit patient-centred, meaningful discussions about the menu is suggested.

Education for pretransplant, solid-organ recipient candidates aims to improve knowledge and understanding about the transplant process, outcomes, and potential complications to support informed, shared decision-making to reduce fears and anxieties about transplant, inform expectations, and facilitate adjustment to posttransplant life. In this review, we summarize novel pretransplant initiatives and approaches to educate solid-organ transplant recipient candidates. First, we review approaches that may be common to all solid-organ transplants, then we summarize interventions specific to kidney, liver, lung, and heart transplant. We describe evidence that emphasizes the need for multidisciplinary approaches to transplant education. We also summarize initiatives that consider online (eHealth) and mobile (mHealth) solutions. Finally, we highlight education initiatives that support racialized or otherwise marginalized communities to improve equitable access to solid-organ transplant. A considerable amount of work has been done in solid-organ transplant since the early 2000s with promising results. However, many studies on education for pretransplant recipient candidates involve relatively small samples and nonrandomized designs and focus on short-term surrogate outcomes. Overall, many of these studies have a high risk of bias. Frequently, interventions assessed are not well characterized or they are combined with administrative and data-driven initiatives into multifaceted interventions, which makes it difficult to assess the impact of the education component on outcomes. In the future, well-designed studies rigorously assessing well-defined surrogate and clinical outcomes will be needed to evaluate the impact of many promising initiatives.

Low-value medical testing is a major component of health care overuse, both directly and through the potential for borderline and/or incidental results to trigger cascades (downstream services of uncertain value). The costs and harms from marginal test results and their cascades can add up. It is thus important to both prevent low-value tests at the outset and mitigate cascades when they arise.

Informed by a framework for understanding and reducing overuse of care, this study employed user-centered design methods (focus groups and 1:1 design meetings) with patients and primary care physicians (PCPs) to understand the problem and iteratively develop an intervention.

Design meetings with 15 PCPs, 12 patients, and 3 patient focus groups revealed myriad drivers for medical test overuse and cascades. Patients commonly believed that all medical tests yield definitive results and lack downsides. PCPs cited expert recommendations, limited time during visits, fear of lawsuits, and desire to be responsive to patients as reasons for ordering potentially low-value medical tests. To address these issues, an intervention was designed using patient pre-visit educational materials, clinician reference materials on test interpretation and incidental findings, and clinician peer comparison on test overuse.

Overuse of medical testing is driven by a range of factors related to PCPs, patients, and their interactions. Multipronged interventions may have the potential to address these drivers after they are rigorously tested.

Despite the variety of pulmonary rehabilitation programmes for patients living with COPD, uptake remains low. To improve this, it is recommended that health professionals engage patients in informed decisions about pulmonary rehabilitation. Shared decision-making (SDM) facilitates informed and value-based decision-making between patients and health professionals. This protocol describes the development and evaluation of a complex SDM intervention for patients living with COPD, who are referred for pulmonary rehabilitation, and their pulmonary rehabilitation health professional.

We are developing a complex SDM intervention involving a patient decision aid (PtDA) and a decision coaching workshop. Prior to patient recruitment, pulmonary rehabilitation health professionals will attend the workshop. Upon referral to pulmonary rehabilitation, patients will receive the PtDA to support their decision-making prior to and during their pulmonary rehabilitation assessment with a health professional. The intervention will be evaluated in a one-arm exploratory study to investigate its feasibility and acceptability for patients and health professionals, with an integrated fidelity assessment. The primary outcome is recruitment feasibility, data collection feasibility and intervention fidelity. Secondary outcomes include routine pulmonary rehabilitation data, decisional conflict, patient activation, intervention attendance/attrition and patient and pulmonary rehabilitation health professional experience of the intervention. Quantitative outcomes will be evaluated using the most appropriate statistical test, dependent on the sample distribution. Qualitative outcomes will be evaluated using reflexive thematic analysis. Fidelity will be assessed using the Observer OPTION 5 scale.

This intervention will provide structure for an informed and values-based decision-making consultation between a patient with COPD and a pulmonary rehabilitation health professional with the potential for optimising pulmonary rehabilitation decision-making.

When standard treatment options are not available anymore, patients with advanced cancer may participate in early phase clinical trials. Improving this complex decision-making process may improve their quality of life. Therefore, this prospective multicenter study with questionnaires untangles several contributing factors to decisional conflict (which reflects the quality of decision-making) in patients with advanced cancer who recently decided upon early phase clinical trial participation (phase I or I/II). We hypothesized that health-related quality of life, health literacy, sense of hope, satisfaction with the consultation, timing of the decision, and the decision explain decisional conflict. Mean decisional conflict in 116 patients was 30.0 (SD = 16.9). Multivariate regression analysis showed that less decisional conflict was reported by patients with better global health status (β = −0.185, p = 0.018), higher satisfaction (β = −0.246, p = 0.002), and who made the decision before (β = −0.543, p < 0.001) or within a week after the consultation (β = −0.427, p < 0.001). These variables explained 37% of the variance in decisional conflict. Healthcare professionals should realize that patients with lower global health status and who need more time to decide may require additional support. Although altering such patient intrinsic characteristics is difficult, oncologists can impact the satisfaction with the consultation. Future research should verify whether effective patient-centered communication could prevent decisional conflict.

Building capacity to improve sex/gender knowledge and strengthen patient engagement in clinical trials requires training and support. The overall goal of this 2-year project is to refine, translate and evaluate two web-based open-access patient and investigator decision aids aimed to improve patient engagement partnerships in clinical trials.

Two decision aids were designed in Phase 1 of this programme of research and this protocol describes a subsequent sequential phased approach to refine/translate (Phase 2A) and conduct alpha/usability (Phase 2B) and beta/field (Phase 3) testing. Decision aid development is guided by the International Patient Decision Aid Standards, User-Centred Design, Ottawa Decision-Support Framework and the Ottawa Model of Research Use. We have integrated patient-oriented research methods by engaging patient partners across all phases of our programme of research. Decision aids will first be refined and then translated to French (Phase 2A). Eight iterative cycles of semistructured interviews with 40 participants (20 patient partners and 20 investigators) will be conducted to determine usability (Phase 2B). A pragmatic pre/post pilot study design will then be implemented for field/beta testing using another purposive sample of 80 English-speaking and French-speaking participants (40 patients and 40 investigators). The samples are purposive to ensure an equal representation of English-speaking and French-speaking participants and an equal representation of men and women. Since sex and/or gender differences in utilisation and effectiveness of decision aids have not been previously reported, Phase 3 outcomes will be reported for the total sample and separately for men and women.

Ethics approval has been granted from the University of Toronto (41109, 28 September 2021). Informed consent will be obtained from participants. Dissemination will include co-authored publications, conference presentations, educational national public forums, fact sheets/newsletters, social media sharing and videos/webinars.

Decisions aids (DA) can support patients to make informed decisions about screening tests. This study describes the development and initial evaluation of a lung cancer screening (LCS) DA targeted towards survivors of Hodgkin lymphoma (HL).

A prototype decision aid booklet was developed and subsequently reviewed by a steering group who provided feedback. Revisions were made to produce the DA tested in this study. HL survivors were recruited to an online survey and/or focus groups. Lymphoma practitioners were invited to an interview study. In the online survey, decisional conflict scales and knowledge scales were completed before and after accessing the DA. The focus groups and interviews explored acceptability and comprehensibility and the decisional needs of stakeholders. Focus groups and interviews were audio recorded. The framework method was used to analyse qualitative data.

38 HL survivors completed the online survey. Following exposure to the DA, knowledge of LCS and risk factors and decisional conflict scores (total score and subscale scores) improved significantly. 11 HL survivors took part in two focus groups (n = 5 and n = 6) and 11 practitioners were interviewed. Focus group and interview results: The language, format and length were considered acceptable. Both groups felt the DA was balanced and presented a choice. Icon arrays were felt to aid comprehension of absolute risk values and for some survivors, they reduced affective risk perceptions. Among survivors, the impact of radiation risk on decision making varied according to gender and screening interval, whilst practitioners did not anticipate it to be a major concern for patients. Both groups expressed that a screening offer could mitigate anxiety about lung cancer risk. As anticipated by practitioners, survivors expressed a desire to seek advice from their clinical team. Practitioners thought the DA would meet their informational needs regarding LCS  when supporting survivors.

The DA is considered acceptable by HL survivors and practitioners. The DA reduces decisional conflict and improves knowledge in HL survivors, suggesting that it would support HL survivors to make informed decisions when considering LCS in a future clinical trial.

Women with inflammatory bowel disease (IBD) with poor IBD-specific reproductive knowledge experience more childlessness and fear of IBD medications in pregnancy. The Pregnancy in IBD Decision Aid (PIDA), developed by an international multidisciplinary team, offers personalized online decision support regarding pregnancy in IBD.

Assess the impact of PIDA on quality of reproductive decision-making and pregnancy-related knowledge among preconception (PC) and pregnant patients with IBD, and evaluate acceptability to patients and clinicians.

PC and pregnant patients with IBD aged 18-45 completed questionnaires pre- and post-PIDA to assess quality of decision-making (Decisional Conflict Scale (DCS); Decision Self-Efficacy Scale (DSES) and IBD-in-pregnancy knowledge (Crohn's and Colitis Pregnancy Knowledge Score (CCPKnow)). Paired t test assessed for differences pre- and post-PIDA. Patients and clinicians completed acceptability surveys.

DCS and DSES were completed by 74 patients (42 Crohn's disease, 32 ulcerative colitis); 41 PC and 33 pregnant. DCS improved significantly post-PIDA in PC patients regarding pregnancy planning (t(40) = 4.83, p < 0.0001, Cohen's d_z = 0.75) and in pregnant patients regarding medication management (t(32) = 2.37, p = 0.0242, d_z = 0.41). DSES for PC patients improved significantly post-PIDA (t(40) = -3.56, p = 0.001, d_z = -0.56). CCPKnow improved significantly post-PIDA in PC (t(42) = 4.93, p < 0.0001, d_z = -0.75) and pregnant patients (t(32) = 5.1, p < 0.0001, d_z = -0.89). PIDA was deemed optimal for length, readability, and content amount and considered highly useful by patients (n = 73) and clinicians (n = 14).

Patients using PIDA developed an improved quality of reproductive decision-making and IBD-in-pregnancy knowledge. PIDA is an accessible tool that can empower women with IBD to make values-congruent, evidence-based decisions regarding pregnancy and may reduce voluntary childlessness.

Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measures limits evaluation of these interventions. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation.

We used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020.

A total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items from the scoping review (n = 36) and additional items proposed by participants (n = 1). Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group (n = 2). We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting.

The study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. These relate to the process of decision-making, proxies' experience of decision-making, and factors that influence decision-making such as understanding. Further work with people with impairing conditions and their families is needed to explore their views about the COS and to identify appropriate outcome measures and timing of measurement.

The study is registered on the COMET database ( https://www.comet-initiative.org/Studies/Details/1409 ).

To examine the efficacy and acceptability of decision aids (DAs) in counseling urogynecology patients with prolapse, stress urinary incontinence, or refractory overactive bladder.

This pilot study enrolled 33 patients into a control group that underwent usual care without a DA, followed by 33 patients into an intervention group where providers utilized a DA for counseling. Postvisit patient surveys assessed differences in treatment preference, knowledge, and in patient-physician collaboration using SURE, CollaboRATE, and Shared Decision Making (SDM) Process scales. Postvisit provider surveys assessed their perception of the usefulness and the difficulty of using a DA and visit length. Independent t tests were used for continuous variables (Knowledge and SDM Process scores) and Chi-Square for categorical variables (treatment preference, SURE, and CollaboRATE).

The majority of eligible patients 66/71 (93%) completed the survey. The intervention group trended toward higher knowledge scores (72% vs 60%, P  = 0.06), clearer treatment preferences (85% vs 67%, P  = 0.08), higher rates of top SURE scale scores (91% vs 73%, P  = 0.11), and top CollaboRATE scores (75% vs 52%, P  = 0.07). SDM process scores were similar across groups (3.2 vs 3.2, P  = 0.96). Providers used the DA in 73% of intervention group visits and rated the visit length as "normal" in both groups (70% vs 76%, P  = 0.78).

There were no statistically significant differences between the control group and the intervention group. The use of DAs was acceptable to providers and indicated a trend toward increased patient knowledge, treatment preference, and satisfaction. A larger study is warranted to examine the impact of DAs on decision making and patient experience.

Alignment between patients' treatment choices and treatments received is acknowledged as an important outcome of shared decision-making (SDM), yet recent research suggests that patients' choices do not always align with their actual treatment trajectories. This paper explores the alignment of patient-expressed treatment choices (for surgery or medical management) after exposure to decision aids and treatments received among patients with hip or knee osteoarthritis within High Value Healthcare Collaborative (HVHC) systems as the collaborative integrated decision aids intended to support SDM into routine clinical practice.

This retrospective cohort study examines data from adult (≥18 years) patients with hip or knee osteoarthritis who received decision aids as part of orthopaedic consultations within HVHC systems between 2012 and 2015. Multivariable logistic regression explored the association between patient-level characteristics with the odds of treatment choice-receipt alignment.

The majority of patients with knee osteoarthritis (68.3%) and hip osteoarthritis (71.9%) received treatments aligned with their choices following exposure to decision aids, but analyses reveal important differences in the odds of such alignment across patient characteristics. In adjusted models, African American patients with knee osteoarthritis had 50% lower odds of receiving treatment aligned with their choices compared with Caucasian patients (OR = 0.52, P < .05). Medicare- or Medicaid-insured knee patients had 49% and 59% lower odds (respectively) of receiving choice-aligned treatments relative to privately insured patients. Patients with knee (OR = 0.40, P < .01) or hip (OR = 0.75, P < .05) osteoarthritis at earlier decision-making stages had lower odds of receiving treatments congruent with their choices.

This work elucidates the odds of treatment choice-aligned care for patients within health care systems attempting to routinely integrate decision aids to support SDM into clinical practice and underscores the gaps in achieving this alignment among African American patients, those with public insurance and those at early decision-making stages.

In selected breast cancer patients, radiation treatment (RT) lowers the recurrence risk, with minor or no improvement of survival. In these patients, the choice to undergo RT is considered a preference-sensitive decision. To facilitate shared decision-making (SDM) for this choice, a patient decision aid was made. We aimed to evaluate the effect of the PtDA on decisional conflict.

We performed a multi-center pre- and post-intervention study (BRASA-trial). The first 214 patients made a choice without support of the PtDA; the subsequent 189 patients received a link to the PtDA. The primary endpoint was decisional conflict; secondary endpoints were perceived SDM and knowledge on treatment options. Patients filled out questionnaires immediately after, and three months after their decision. Data were analyzed with multi-level regression analysis.

After correcting for the difference in age and educational level, the mean (±SD) decisional conflict for the intervention group (27.3 ± 11.4) was similar to the control group (26.8 ± 11.4; difference = 0.86, 95 %CI 1.67,3.36) three months after their decision. This also applied to perceived SDM. Patients exposed to the PtDA pursued additional treatment less often (45% vs 56%, odds ratio 0.59, 95 %CI 0.37,0.95) and scored significantly higher on the knowledge test (7.4 ± 2.5 vs 6.1 ± 2.7, corrected difference = 1.0, 95 %CI 0.50,1.49). There was no significant increase in consultation time.

Handing out the PtDA was not associated with improved scores in decisional conflict or perceived SDM, but it was associated with a choice for less additional treatment and better knowledge about the treatment options.

In this study an interactive decision aid (DA) for men diagnosed with localized prostate cancer was adapted, extended and pre-tested. The DA's prototype was based on a literature review and other empirically tested DAs. Semi-structured interviews with 12 men (age 65-80) diagnosed with localized prostate cancer were conducted to get feedback on content, usability, and the DA's layout. The interviews were analyzed using thematic analysis and themes were identified using deductive and inductive coding. Participants found the accessibility of the information and the explicit values clarification tool helpful. Four themes were identified: (1) usability and design, (2) content and knowledge, (3) deciding factors of decision-making, and (4) social support. Participants valued receiving extensive and realistic information on surgery/radiation therapy side effects and getting unbiased presentations of treatment options. Following the thematic analysis, the DA was revised and tested in a survey among 11 newly diagnosed prostate cancer patients (age 60-74). The participants valued the DA and found it helpful when making a treatment decision, and all reported that they would recommend it to others making a prostate cancer treatment decision. The DA is currently being tested in a randomized clinical trial (RCT). This is the first DA developed for prostate cancer patients in Iceland and if the results of the RCT show that it is more effective than standard care in assisting newly diagnosed patients with their treatment decision, the DA can be easily translated and adapted to cultures similar to Iceland such as the Nordic countries.