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Introduction: Tele-pulmonary rehabilitation is increasingly advocated but cannot completely substitute for in-person services for chronic conditions. Adherence to Pulmonary rehabilitation (PR) remains low in chronic obstructive pulmonary disease (COPD) patients. Shared decision-making (SDM) promotes patients' participation in PR decisions and helps patients and healthcare providers to jointly make decisions that patients are informed and aligned with patient preferences and values, which are critical for patient adherence to PR. Objective: This study aimed to develop a hybrid in-person and virtual model of home-based PR services for older COPD patients and study the effectiveness of the patient decision aid (PDA)-supported recurring SDM intervention on patient adherence to PR, rehabilitation outcomes, and decision-related outcomes, as well as to explore the mechanisms of the intervention on PR adherence. Methods: A total of 78 older COPD patients were randomly assigned to the PR group (n = 39) or PDA-PR group (n = 39). Both groups were conducted hybrid in-person and virtual PR intervention for 3 months. The primary outcomes were patients' quality of life and PR adherence. The secondary outcomes were dyspnea symptoms, exercise self-efficacy, knowledge, and decision-related outcomes. Results: A total of 72 participants completed the 3-month PR program. There were statistically significant differences in PR adherence (p = 0.033), COPD assessment test (CAT) scores (p = 0.016), PR knowledge (p < 0.001), decision self-efficacy (p < 0.001), decision conflict (p < 0.001), and decision regret scores (p = 0.027) between the two groups. The modified Medical Research Council Dyspnoea scale (mMRC) score was significantly decreased only in PDA-PR group (p = 0.011). No statistically significant differences were observed in St George's Respiratory Questionnaire (SGRQ) score (p = 0.078), Exercise Self-Regulatory Efficacy Scale (Ex-SRES) score (p = 0.29) and COPD knowledge (p = 0.086) between the two groups. PR value score had a significant effect on adherence to PR (p = 0.007) and CAT score (p = 0.028). Conclusions: PDA supported recurring SDM intervention was helpful in maintaining older COPD patients' PR adherence and had advantages in improving quality of life, enhancing PR knowledge, decision self-efficacy, and reducing decision conflict and decision regret, but did not improve SGRQ and Ex-SRES. PR value score influenced patients' rehabilitation adherence and quality of life. Trial Registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR1900028563; http://apps.who.int/trialsearch/default.aspx. [ABSTRACT FROM AUTHOR]

Objective: To evaluate implementation of a patient decision aid for symptomatic uterine fibroid management to improve shared decision-making at five clinical settings across the United States. Methods: We used a type 3 hybrid effectiveness-implementation stepped-wedge design and the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) planning and evaluation framework. We conducted clinician training, monthly reach tracking with feedback to site clinical leads, patient and clinician surveys, and visit audio-recordings. Implementation strategies included assessment of organizational readiness for shared decision-making, synchronous clinician training, audit and feedback of decision aid reach, and access to multiple decision aid formats. Outcomes and analyses included patient-level reach, clinician-level adoption, and associations of patient-reported decision aid exposure (as treated) and setting-level implementation (intention-to-treat) with patient-reported (collaboRATE measure) and observed (OPTION-5 measure) shared decision-making. We also designed and assessed setting-level plans for sustainability and other factors impacting sustained decision aid use. Results: The decision aid was adopted by 72 of the 74 eligible gynecologists (97%) and reached 2553 patients across five settings. CollaboRATE scores improved among patients who reported receiving the decision aid (as-treated analysis, 69% vs. 59%; OR 1.6, 95% CI 1.16–2.27). CollaboRATE scores remained consistent before and after setting-level decision aid implementation (intention-to-treat analysis, 64% vs. 63%; OR 0.86, 95% CI 0.61–1.22). Participants would prefer to receive a decision aid at multiple time points (91.9% before the visit, 90.7% during the visit, 86.5% after the visit). Shared decision-making experiences did not improve when comparing pre vs. post-implementation collaboRATE scores across included settings (intention-to-treat, 64% vs. 63%; OR 0.86, 95% CI 0.61–1.22). Conclusion: When patients with symptomatic uterine fibroids are given decision aids, they report higher shared decision-making scores. However, the differences we observed between the as-treated and intention-to-treat results suggest that unaddressed implementation challenges continue to limit the extent to which patients receive decision aids and likely hinder their overall impact. Future efforts to implement decision aids should explore enhancing their integration into clinical workflows and standard operating procedures, supported by organizational incentives that prioritize shared decision-making. Trial registration: ClinicalTrials.gov NCT03985449; registered 6 June 2019. [ABSTRACT FROM AUTHOR]

Shared decision-making (SDM) aims to improve patients' experiences with care, treatment adherence, and health outcomes. However, the effectiveness of SDM in patients with a recent fracture who require anti-osteoporosis medication (AOM) is unclear. The objective of this study was to assess the effectiveness of a multicomponent adherence intervention (MCAI) including a patient decision aid (PDA) and motivational interviewing at Fracture Liaison Services (FLS) on multiple outcomes compared with usual care (UC). This pre-post superiority study included patients with a recent fracture attending FLS and with AOM treatment indication. The primary outcome was 1-year AOM persistence measured by pharmacy records. Secondary outcomes included treatment initiation, AOM adherence (measured by medication possession ratio [MPR]), decision quality (SDM process; 0–100, best), and decisional conflict (0–100, highest conflict), subsequent fractures, and mortality. Outcomes were tested in MCAI and UC groups at the first FLS visit and 4 and 12 months afterwards. Multiple imputation and uni- and multivariable analyses were performed. Post hoc analyses assessed the role of health literacy level. In total, 245 patients (MCAI: n  = 136, UC: n  = 109) were included. AOM persistence was 80.4% in the MCAI and 76.7% in the UC group (p =.626). SDM process scores were significantly better in MCAI (60.4 vs 55.1; p =.003). AOM initiation (97.8% vs 97.5%), MPR (90.9% vs 88.3%, p =.582), and decisional conflict (21.7 vs 23.0; p =.314) did not differ between groups. Results did not change importantly after adjustment. Stratified analyses by health literacy showed a better effect on MPR and SDM in those with adequate health literacy. This study showed no significant effect on AOM persistence; however, it demonstrated a significant positive effect of MCAI on SDM process in FLS attendees. (Netherlands Trial Registry, Trial NL7236 [NTR7435]; version 1.0; 26-11-2020 https://onderzoekmetmensen.nl/nl/trial/22858). [ABSTRACT FROM AUTHOR]

Abstract Objective To evaluate implementation of a patient decision aid for symptomatic uterine fibroid management to improve shared decision-making at five clinical settings across the United States. Methods We used a type 3 hybrid effectiveness-implementation stepped-wedge design and the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) planning and evaluation framework. We conducted clinician training, monthly reach tracking with feedback to site clinical leads, patient and clinician surveys, and visit audio-recordings. Implementation strategies included assessment of organizational readiness for shared decision-making, synchronous clinician training, audit and feedback of decision aid reach, and access to multiple decision aid formats. Outcomes and analyses included patient-level reach, clinician-level adoption, and associations of patient-reported decision aid exposure (as treated) and setting-level implementation (intention-to-treat) with patient-reported (collaboRATE measure) and observed (OPTION-5 measure) shared decision-making. We also designed and assessed setting-level plans for sustainability and other factors impacting sustained decision aid use. Results The decision aid was adopted by 72 of the 74 eligible gynecologists (97%) and reached 2553 patients across five settings. CollaboRATE scores improved among patients who reported receiving the decision aid (as-treated analysis, 69% vs. 59%; OR 1.6, 95% CI 1.16–2.27). CollaboRATE scores remained consistent before and after setting-level decision aid implementation (intention-to-treat analysis, 64% vs. 63%; OR 0.86, 95% CI 0.61–1.22). Participants would prefer to receive a decision aid at multiple time points (91.9% before the visit, 90.7% during the visit, 86.5% after the visit). Shared decision-making experiences did not improve when comparing pre vs. post-implementation collaboRATE scores across included settings (intention-to-treat, 64% vs. 63%; OR 0.86, 95% CI 0.61–1.22). Conclusion When patients with symptomatic uterine fibroids are given decision aids, they report higher shared decision-making scores. However, the differences we observed between the as-treated and intention-to-treat results suggest that unaddressed implementation challenges continue to limit the extent to which patients receive decision aids and likely hinder their overall impact. Future efforts to implement decision aids should explore enhancing their integration into clinical workflows and standard operating procedures, supported by organizational incentives that prioritize shared decision-making. Trial registration ClinicalTrials.gov NCT03985449; registered 6 June 2019.

Aim: To describe the development of a shared decision making intervention for planning end‐of‐life care for patients with kidney failure, their relatives and health professionals in kidney services. Background: End‐of‐life care conversations within standard disease management consultations are challenging for patients with kidney failure, their relatives and health professionals. End‐of‐life care planning is about making difficult decisions in advance, which is why health professionals need shared decision making skills to be able to initiate end‐of‐life conversations. Health professionals report needing more skills to raise the issue of end‐of‐life care options within consultations and patients want to be able to discuss issues important to them about future care plans. Methods: The development design was guided by the UK Medical Research Council's framework and a user‐centred approach was applied. Four workshops were conducted with end users. The Template for Intervention Description and Replication for Population Health and Policy interventions was used to shape which questions needed to be answered through the workshops and to present the intervention. The International Patient Decision Aid Standards (IPDAS) criteria set the standards to be achieved. Results: Areas considered significant to a shared decision making intervention were training of health professionals, conversations about end‐of‐life care, planning and evaluation of the decisions, reporting decisions in health records and repetition of consultation. The development process went through 14 iterations. Conclusion: An intervention named DESIRE was developed that comprises: (1) a training programme for health professionals; (2) shared decision making conversations; and (3) a patient decision aid. The intervention met 30 out of 33 IPDAS criteria. Implications for practice: DESIRE is intended to support shared decision making about planning end‐of‐life care among patients with kidney failure, their relatives and health professionals. The study provides important tools for the stakeholders engaged that can be used within different models of care. Impact: What problem did the study address?: International guidelines recommend health professionals involve patients with kidney failure in making decisions about end‐of‐life care, but there is variation in how this is implemented within and across kidney services. Furthermore, patients, relatives and health professionals find it challenging to initiate conversations about end‐of‐life care. What were the main findings?: The study resulted in the development of a complex intervention, called DESIRE, about shared decision making and planning end‐of‐life care for patients with kidney failure, their relatives and health professionals in kidney services, including a training programme for health professionals, shared decision making conversations and a patient decision aid. Where and on whom will the research have an impact?: The research contributes a shared decision making intervention to patients in the later stage of kidney failure, their relatives and health professionals. We believe that the DESIRE intervention could be introduced during consultations with health professionals at an earlier stage of the patient's illness trajectory, as well as being applied to other chronic diseases. Reporting Method: This intervention development research is reported according to the GUIDance for the rEporting of intervention Development (GUIDED) checklist and the DEVELOPTOOLS Reporting Checklist. Patient or Public Contribution: Patients, relatives and health professionals have been involved throughout the research process as part of the research team and advisory board. For this study, the advisory board has particularly contributed to the development process of the DESIRE intervention by actively participating in the four workshops, in the iterations between the workshops and in the preparation of the manuscript. [ABSTRACT FROM AUTHOR]

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

Objective: This study aimed to develop and pilot test a new framework for the adaptation of patient decision aids (PtDAs) using a specific case example of contraceptive method PtDAs for Chinese-speaking migrant women. Methods: We developed a novel approach for adaptation – the PACE (Population And ContExt adaption of decision aids) framework – that incorporated both existing models and frameworks and innovative elements. It involves six stages: selection and appraisal; review by content experts; content validity and usability pre-testing; translation; decisional needs assessment; and perceived acceptability, usability and feasibility testing. We then followed the framework to pilot and adapt a suite of PtDAs on contraceptive methods for Chinese-speaking migrant women in Australia. Twenty healthcare providers and 22 Chinese migrant women participated during the stages five and six. Results: The pilot resulted in adapted PtDAs that were acceptable to end users. For future research, we proposed further recommendations and considerations based on lessons learnt, which include flexibility in applying the framework and considering an additional real-world evaluation step. Conclusion: Adaptation of PtDAs required a multi-stage and multidisciplinary team-based and pragmatic approach as exemplified in the application of the PACE framework. Innovation: The PACE framework developed and piloted in this study fills a crucial gap in knowledge about how to adapt PtDAs for new populations and contexts and provides an innovative and systemic approach to guide the adaptation process.

Objective: To develop a patient decision aid facilitating shared decision making for patients with potential pancreatic cancer deciding about no treatment, surgical or medical treatment. Methods: Based on a user-centred design by Wittemann et al., we developed a shared decision making intervention in three phases: 1) Understanding decision needs 2) Development of a patient decision aid (PtDA) based on a generic template 3) Assessment of the intervention from interviews with patients (n = 11), relatives (n = 11), nurses (n = 4) and surgeons (n = 2) analysed with thematic analysis, and measuring patients' perceptions of choice of options with the Decisional Conflict Scale. Results: Results showed varying experiences with the use of the PtDA, with surgeons not finding PtDA useful as it was impractical and constraining with patients' conversations. There was no difference in patients' perceptions in choosing options for those being presented vs those patients not being presented for the PtDA. Conclusion: The format and structure of the PtDA was not feasible for the surgeons as fundamental users in the present clinic. Innovation: This study highlights the urgent need to consider clinical context before introducing a predefined tool and shows the importance of a multistakeholder approach. Research should focus on finding means to successful implement shared decision making.

Abstract Background In the context of healthcare centered on the patient, Patient Decision Aids (PtDAs) acts as an essential instrument, promoting shared decision-making (SDM). Considering the prevalent occurrence of myopia, the objective of this study is to furnish exhaustive and easily comprehensible information to assist patients in making well-informed decisions about their options for myopia laser correction. Method The research team developed a decision guide for myopia patients considering laser correction, aiming to facilitate informed decisions. The study followed the first four stages of the IPDAS process model: “scope/scoping,” “design,” “prototype development,” and “alpha testing.” Ten semi-structured interviews with patients (n = 6) and corneal specialist ophthalmologists (n = 4) were conducted to understand the challenges in selecting a laser correction method. Online meetings with 4 corneal specialists were held to discuss challenging cases. A comparison table of harms and benefits was created. The initial prototype was developed and uploaded on the internet portal. User feedback on software and text aspects was incorporated into the final web software, which was reviewed by a health education expert for user-friendliness and effectiveness. Result Educational needs assessment revealed concerns such as pain, daily life activities, return to work, the potential need for glasses (‘number return’), eye prescription stability, and possible complications. These shaped the decision aid tool’s content. Expert consensus was achieved in several areas, with some items added or extended. In areas lacking consensus, comments were added for clarity. Five clients assessed the web app (PDAIN), rating it 46/50 in user-centricity, 47/50 in usability, and 45/50 in accuracy and reliability, totaling 138/150. Post-piloting, software errors were documented and rectified. During the trial phase, five myopic users interacted with the software, leading to modifications. User feedback indicated the tool effectively enhanced understanding and influenced decision-making. Conclusion PDAIN, serves as a facilitative tool in the process of selecting a corneal laser correction method for myopic patients. It enabling Nearsighted patients to make informed decisions.

Abstract Background Dyspepsia is a commonly encountered clinical condition in Dutch general practice, which is often treated through the prescription of acid-reducing medication (ARM). However, recent studies indicate that the majority of chronic ARM users lack an indication for their use and that their long-term use is associated with adverse outcomes. We developed a patient-focussed educational intervention aiming to reduce low-value (chronic) use of ARM. Methods We conducted a randomized controlled study, and evaluated its effect on the low-value chronic prescription of ARM using data from a subset (n = 26) of practices from the Nivel Primary Care Database. The intervention involved distributing an educational waiting room posters and flyers informing both patients and general practitioners (GPs) regarding the appropriate indications for prescription of an ARM for dyspepsia, which also referred to an online decision aid. The interventions’ effect was evaluated through calculation of the odds ratio of a patient receiving a low-value chronic ARM prescription over the second half of 2021 and 2022 (i.e. pre-intervention vs. post-intervention). Results In both the control and intervention groups, the proportion of patients receiving chronic low-value ARM prescriptions slightly increased. In the control group, it decreased from 50.3% in 2021 to 49.7% in 2022, and in the intervention group it increased from 51.3% in 2021 to 53.1% in 2022. Subsequent statistical analysis revealed no significant difference in low-value chronic prescriptions between the control and intervention groups (Odds ratio: 1.11 [0.84–1.47], p > 0.05). Conclusion Our educational intervention did not result in a change in the low-value chronic prescription of ARM; approximately half of the patients of the intervention and control still received low-value chronic ARM prescriptions. The absence of effect might be explained by selection bias of participating practices, awareness on the topic of chronic AMR prescriptions and the relative low proportion of low-value chronic ARM prescribing in the intervention as well as the control group compared to an assessment conducted two years prior. Trial registration 10/31/2023 NCT06108817.

Background: In the context of healthcare centered on the patient, Patient Decision Aids (PtDAs) acts as an essential instrument, promoting shared decision-making (SDM). Considering the prevalent occurrence of myopia, the objective of this study is to furnish exhaustive and easily comprehensible information to assist patients in making well-informed decisions about their options for myopia laser correction. Method: The research team developed a decision guide for myopia patients considering laser correction, aiming to facilitate informed decisions. The study followed the first four stages of the IPDAS process model: "scope/scoping," "design," "prototype development," and "alpha testing." Ten semi-structured interviews with patients (n = 6) and corneal specialist ophthalmologists (n = 4) were conducted to understand the challenges in selecting a laser correction method. Online meetings with 4 corneal specialists were held to discuss challenging cases. A comparison table of harms and benefits was created. The initial prototype was developed and uploaded on the internet portal. User feedback on software and text aspects was incorporated into the final web software, which was reviewed by a health education expert for user-friendliness and effectiveness. Result: Educational needs assessment revealed concerns such as pain, daily life activities, return to work, the potential need for glasses ('number return'), eye prescription stability, and possible complications. These shaped the decision aid tool's content. Expert consensus was achieved in several areas, with some items added or extended. In areas lacking consensus, comments were added for clarity. Five clients assessed the web app (PDAIN), rating it 46/50 in user-centricity, 47/50 in usability, and 45/50 in accuracy and reliability, totaling 138/150. Post-piloting, software errors were documented and rectified. During the trial phase, five myopic users interacted with the software, leading to modifications. User feedback indicated the tool effectively enhanced understanding and influenced decision-making. Conclusion: PDAIN, serves as a facilitative tool in the process of selecting a corneal laser correction method for myopic patients. It enabling Nearsighted patients to make informed decisions. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To assess which information about microtia and the possible reconstructive options health care providers (HCPs), patients and parents believe should be included in a patient decision aid (PtDA). Design: A mixed-methods study comprised of an online survey of HCPs and focus group discussions with patients and parents. Participants: Survey respondents were members of the International Society for Auricular Reconstruction (ISAR). Focus group participants were patients with microtia and their parents, recruited through the microtia outpatient clinic at Amsterdam UMC, and through a Dutch patient organization for cleft and craniofacial conditions. Methods: An online, investigator-made survey was sent to ISAR members in December 2021. Semi-structured focus group discussions were held in February 2022. Quantitative results were summarized, and qualitative results were thematically grouped. Results: Thirty-two HCPs responded to the survey (response rate 41%). Most respondents (n = 24) were plastic surgeons, who had a median of 15 years of experience (IQR: 7-23 years). Two focus groups were held with a total of five patients and two parents. HCPs, patients and parents generally agreed on the information needed in a PtDA, emphasizing the importance of realistic expectation management. Patients and parents also considered psychosocial and functional outcomes, patient experiences, as well as patients' involvement in decision-making important. Conclusions: A PtDA for microtia reconstruction should target all patients with microtia, and include information on at least technique-related information, expected esthetic results, possible adverse effects, psychosocial and functional outcomes and patient experiences. Preference eliciting questions should be developed for both pediatric patients and their parents. [ABSTRACT FROM AUTHOR]

To examine whether patient involvement using a Patient Decision Aid has a positive effect on pain levels, by giving them an active role in choosing a pain schedule for postoperative pain assessment and pain management. A nonmatched case-control study. 101 adults 18 years or older were included to choose between 1 of 3 possible schedules for postoperative pain management. Perioperative variables, for example, patients' assessments of pain were registered at the hospital and further variables after discharge at postoperative day 1 (POD1), POD3, and POD7, for example, patients' ability to sleep and assessment of nausea. Less pain after discharge was seen among patients choosing pain schedule II at POD1 (P =.0439). A significantly higher consumption of opioids (P = 0010) on POD1 in patients who have chosen pain schedule II. Improved patient involvement by choosing a user-controlled pain schedule (pain schedule II) in postoperative pain management increased patient empowerment. [ABSTRACT FROM AUTHOR]

The aim of this study was to develop and evaluate a proof-of-concept opensource individualized Patient Decision Aid (iPDA) with a group of patients, physicians, and computer scientists. The iPDA was developed based on the International Patient Decision Aid Standards (IPDAS). A previously published questionnaire was adapted and used to test the user-friendliness and content of the iPDA. The questionnaire contained 40 multiple-choice questions, and answers were given on a 5-point Likert Scale (1-5) ranging from "strongly disagree" to "strongly agree." In addition to the questionnaire, semi-structured interviews were conducted with patients. We performed a descriptive analysis of the responses. The iPDA was evaluated by 28 computer scientists, 21 physicians, and 13 patients. The results demonstrate that the iPDA was found valuable by 92% (patients), 96% (computer scientists), and 86% (physicians), while the treatment information was judged useful by 92%, 96%, and 95%, respectively. Additionally, the tool was thought to be motivating for patients to actively engage in their treatment by 92%, 93%, and 91% of the above respondents groups. More multimedia components and less text were suggested by the respondents as ways to improve the tool and user interface. In conclusion, we successfully developed and tested an iPDA for patients with stage I-II Non-Small Cell Lung Cancer (NSCLC). [ABSTRACT FROM AUTHOR]

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

Abstract Background Decision aids can help patients set realistic expectations. In this study, we explored alternative presentations to visualise patient-reported outcomes (EQ-5D-5L) data within an online, individualized patient decision aid for total knee arthroplasty (TKA) that, in part, generates individualized comparisons based on age, sex and body mass index, to enhance usability prior to implementation into routine clinical practice. Methods We used data visualization techniques to modify the presentation of EQ-5D-5L outcomes data within the decision aid. The EQ-5D-5L data was divided into two parts allowing patients to compare themselves to similar individuals (1) pre-surgery and (2) 1-year post-surgery. We created 2 versions for each part and sought patient feedback on comprehension, usefulness, and visual appeal. Patients from an urban orthopedic clinic were recruited and their ratings and comments were recorded using a researcher-administered checklist. Data were managed using Microsoft Excel, R version 3.6.1 and ATLAS.ti V8 and analyzed using descriptive statistics and directed content analysis. Results A total of 24 and 25 patients participated in Parts 1 and 2, respectively. Overall, there was a slight preference for Version 1 in Part 1 (58.3%) and Version 2 in Part 2 (64%). Most participants demonstrated adequate comprehension for all versions (range 50–72%) and commented that the instructions were clear. While 50–60% of participants rated the content as useful, including knowing the possible outcomes of surgery, some participants found the information interesting only, were unsure how to use the information, or did not find it useful because they had already decided on a treatment. Participants rated visual appeal for all versions favorably but suggested improvements for readability, mainly larger font and image sizes and enhanced contrast between elements. Conclusions Based on the results, we will produce an enhanced presentation of EQ-5D-5L data within the decision aid. These improvements, along with further usability testing of the entire decision aid, will be made before implementation of the decision aid in routine clinical practice. Our results on patients’ perspectives on the presentation of EQ-5D-5L data to support decision making for TKA treatments contributes to the knowledge on EQ-5D-5L applications within healthcare systems for clinical care.

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

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

Introduction: Patient decision aids (PtDA) complement shared decision‐making with healthcare professionals and improve decision quality. However, PtDA often lack theoretical underpinning. We are codesigning a PtDA to help people with increased genetic cancer risks manage choices. The aim of an innovative workshop described here was to engage with the people who will use the PtDA regarding the theoretical underpinning and logic model outlining our hypothesis of how the PtDA would lead to more informed decision‐making. Methods: Short presentations about psychological and behavioural theories by an expert were interspersed with facilitated, small‐group discussions led by patients. Patients were asked what is important to them when they make health decisions, what theoretical constructs are most meaningful and how this should be applied to codesign of a PtDA. An artist created a visual summary. Notes from patient discussions and the artwork were analysed using reflexive thematic analysis. Results: The overarching theme was: It's personal. Contextual factors important for decision‐making were varied and changed over time. There was no one 'best fit' theory to target support needs in a PtDA, suggesting an inductive, flexible framework approach to programme theory would be most effective. The PtDA logic model was revised based on patient feedback. Conclusion: Meaningful codesign of PtDA including discussions about the theoretical mechanisms through which they support decision‐making has the potential to lead to improved patient care through understanding the intricately personal nature of health decisions, and tailoring content and format for holistic care. Patient Contribution: Patients with lived experience were involved in codesign and coproduction of this workshop and analysis as partners and coauthors. Patient discussions were the primary data source. Facilitators provided a semi‐structured guide, but they did not influence the patient discussions or provide clinical advice. The premise of this workshop was to prioritise the importance of patient lived experience: to listen, learn, then reflect together to understand and propose ideas to improve patient care through codesign of a PtDA. [ABSTRACT FROM AUTHOR]

Yuyu Jiang,1 Jianlan Guo,2 Mengjie Chen,1 Xueqiong Zou,1 Pingping Sun,1 Jing Gao,1 Baiyila Nuerdawulieti,1 Shanshan Wang1 1Research Office of Chronic Disease Management and Rehabilitation, Wuxi School of Medicine, Jiangnan University, Wuxi, People’s Republic of China; 2Department of Nursing, Wuxi Higher Health Vocational Technology School, Wuxi, People’s Republic of ChinaCorrespondence: Yuyu Jiang, Research office of chronic disease management and rehabilitation, Wuxi School of Medicine, Jiangnan University, No. 1800 Lihu Avenue, Wuxi, Jiangsu Province, People’s Republic of China, Tel +86-0510-85328363, Email doctoryuyu@jiangnan.edu.cnBackground: Pulmonary rehabilitation is an important part of the management of chronic obstructive pulmonary disease (COPD), but the participation rate of pulmonary rehabilitation in COPD patients is low. Patient decision aids can facilitate patient participation in pulmonary rehabilitation decisions by providing information and incorporating patient values. The aim of this study was to develop a pulmonary rehabilitation decision aid for patients with COPD.Objective: The aim of this study was to develop a WeChat-based pulmonary rehabilitation patient decision aid to help older patients with COPD participate in pulmonary rehabilitation decision-making.Methods: We developed the decision aid in 3 stages: (1) a literature review was performed to determine the evidence for pulmonary rehabilitation options and outcomes for patients with COPD. (2) a semi-structured interview study was conducted to develop and iterate patient decision aids. (3) usability, acceptability and language expression testing in patients and healthcare professionals.Results: A total of 16 randomized controlled studies were included in the literature review. Thirty-six participants received semi-structured interviews. The results of interview include four themes: key points of age-friendly design, content of the tool, presentation requirements of contents and study evidence of the tool and other views and suggestions. The resultant goals-of-care decision aid achieved good usability and acceptability. The frequency of language expression increased in both patients and healthcare professionals.Conclusion: This study uses a systematic development process to develop the first pulmonary rehabilitation decision aid for patients with COPD. It has good usability, acceptability and increased communication between patients and healthcare professionals in the pulmonary rehabilitation decision-making process.Trial Registration: Chinese Clinical Trial Registry (ChiCTR): ChiCTR1900028563; http://apps.who.int/trialsearch/default.aspx.Keywords: chronic obstructive pulmonary disease, shared decision making, pulmonary rehabilitation, patient decision aid

The aim of this study was to develop and evaluate a proof-of-concept open-source individualized Patient Decision Aid (iPDA) with a group of patients, physicians, and computer scientists. The iPDA was developed based on the International Patient Decision Aid Standards (IPDAS). A previously published questionnaire was adapted and used to test the user-friendliness and content of the iPDA. The questionnaire contained 40 multiple-choice questions, and answers were given on a 5-point Likert Scale (1–5) ranging from “strongly disagree” to “strongly agree.” In addition to the questionnaire, semi-structured interviews were conducted with patients. We performed a descriptive analysis of the responses. The iPDA was evaluated by 28 computer scientists, 21 physicians, and 13 patients. The results demonstrate that the iPDA was found valuable by 92% (patients), 96% (computer scientists), and 86% (physicians), while the treatment information was judged useful by 92%, 96%, and 95%, respectively. Additionally, the tool was thought to be motivating for patients to actively engage in their treatment by 92%, 93%, and 91% of the above respondents groups. More multimedia components and less text were suggested by the respondents as ways to improve the tool and user interface. In conclusion, we successfully developed and tested an iPDA for patients with stage I–II Non-Small Cell Lung Cancer (NSCLC).

Abstract Introduction Patient decision aids (PtDA) complement shared decision‐making with healthcare professionals and improve decision quality. However, PtDA often lack theoretical underpinning. We are codesigning a PtDA to help people with increased genetic cancer risks manage choices. The aim of an innovative workshop described here was to engage with the people who will use the PtDA regarding the theoretical underpinning and logic model outlining our hypothesis of how the PtDA would lead to more informed decision‐making. Methods Short presentations about psychological and behavioural theories by an expert were interspersed with facilitated, small‐group discussions led by patients. Patients were asked what is important to them when they make health decisions, what theoretical constructs are most meaningful and how this should be applied to codesign of a PtDA. An artist created a visual summary. Notes from patient discussions and the artwork were analysed using reflexive thematic analysis. Results The overarching theme was: It's personal. Contextual factors important for decision‐making were varied and changed over time. There was no one ‘best fit’ theory to target support needs in a PtDA, suggesting an inductive, flexible framework approach to programme theory would be most effective. The PtDA logic model was revised based on patient feedback. Conclusion Meaningful codesign of PtDA including discussions about the theoretical mechanisms through which they support decision‐making has the potential to lead to improved patient care through understanding the intricately personal nature of health decisions, and tailoring content and format for holistic care. Patient Contribution Patients with lived experience were involved in codesign and coproduction of this workshop and analysis as partners and coauthors. Patient discussions were the primary data source. Facilitators provided a semi‐structured guide, but they did not influence the patient discussions or provide clinical advice. The premise of this workshop was to prioritise the importance of patient lived experience: to listen, learn, then reflect together to understand and propose ideas to improve patient care through codesign of a PtDA.

Objectives: Different approaches to prosthodontic consultation, all involving a strong focus on shared decision-making, were analyzed from the perspective of patients by inter-group comparisons. No patient decision aid (PDA) was used in the control group, a paper-based PDA in test group 1, and a software-based PDA in test group 2. Materials and methods: Seventy-five patients were prospectively randomized to the control group or a test group. All patients then rated the consultation on a questionnaire, six key items of which were analyzed, along with the time spent on each consultation. Results: Overall satisfaction was highest in test group 2, with a significant difference from the control group (p = 0.015). Test group 2 showed the most favorable ratings for all six questionnaire items, which invariably was significant compared to the control group (p = 0.032). Test group 1 significantly differed from test group 2 based on two items (consultation was adequately intelligible: p = 0.011; consultation was adequately comprehensive: p = 0.034) but not from the control group based on any item (p = 0.070). Conclusions: Within the limitations of this study, the use of a software-based PDA, in particular, can be recommended based on patient satisfaction and was associated with the shortest sessions for consultation. Clinical relevance: Patients are routinely faced with a wealth of information in dental offices and may be overwhelmed especially by prosthetic treatment options and decision requirements. Our findings shed some light on the nature of aids that may truly be helpful in the process of shared decision-making. Trial registration: ClinicalTrials.gov.Identifier: ISRCTN11472465. [ABSTRACT FROM AUTHOR]

To develop and pilot a web-based patient decision aid (PDA) to support people living with motor neurone disease (plwMND) considering having a gastrostomy tube placed. In Phase 1, content and design were informed by semi-structured interviews, literature reviews and a prioritization survey. In Phase 2, the prototype PDA was tested with users and developed iteratively with feedback from surveys and 'think-aloud' interviews. Phase 1 and 2 participants were plwMND, carers and healthcare professionals (HCPs). In Phase 3, the PDA was evaluated by plwMND using validated questionnaires and HCPs provided feedback in focus groups. Sixteen plwMND, 16 carers and 25 HCPs took part in Phases 1 and 2. Interviews and the literature review informed a prioritization survey with 82 content items. Seventy-seven per cent (63/82) of the content of the PDA was retained. A prototype PDA, which conforms to international standards, was produced and improved during Phase 2. In Phase 3, 17 plwMND completed questionnaires after using the PDA. Most plwMND (94%) found the PDA completely acceptable and would recommend it to others in their position, 88% had no decisional conflict, 82% were well prepared and 100% were satisfied with their decision-making. Seventeen HCPs provided positive feedback and suggestions for use in clinical practice. Gastrostomy Tube: Is it for me? was co-produced with stakeholders and found to be acceptable, practical and useful. Freely available from the MND Association website, the PDA is a valuable tool to support the shared decision-making process for gastrostomy tube placement. [ABSTRACT FROM AUTHOR]

Objective: Shared decision making (SDM) and use of patient decision aids (PtDAs) are key components in patient-centered care in relapsed ovarian cancer. This paper describes the development and implementation process of PtDAs into a clinical routine in three departments. Methods: Two PtDAs were developed in collaboration between patients and clinicians. Acceptability and usability of the PtDAs were tested on clinicians and patients using items from the internationally validated questionnaire “Preparation for Decision Making Scale”. Results: Ten patients and 15 clinicians participated in the study. Most patients indicated that PtDAs would be helpful as preparation for the decision-making process with the clinicians. Ten (75%) of the clinicians responded that the PtDAs helped the patients to understand the benefits and disadvantages of each treatment option. Generally, the clinicians indicated that they would use SDM if they had a PtDA tailored to the clinical situation. Conclusions: Two PtDAs were systematically developed, tested, and implemented thereby supporting an SDM intervention. The PtDAs are still in use at the participating departments. Innovation: This study was successful in reusing a generic template for a patient decision aid (PtDA) developed at one institution and implemented in two other institutions. This was guided by a well-described systematic development process for PtDAs.

Purpose: The present study aimed to investigate whether exposure to a patient decision aid (PDA) had an impact on the proportion of patients selecting non-surgical or surgical treatments after anterior cruciate ligament (ACL) injuries and whether exposure to a PDA affected the proportion of patients switching from non-surgical to surgical treatment within the first year. Methods: In a consecutive case series, proportions of surgery and non-surgery were compared before and after patients' exposure to a PDA. Data were collected from the health records of patients with ACL injuries who presented to the Clinic of Sports Traumatology. To identify proportional differences between the two groups, t-tests and proportion tests were used. Results: In total, 1,053 patients with ACL injuries were included: 563 patients with no exposure to the PDA (January 2015 to January 2017) and 490 patients with exposure to the PDA (January 2017 to January 2019). Before implementing the PDA, 27% of the patients selected non-surgical treatment. After implementing the PDA, 30% choose non-surgical treatment (p > 0.05). Before implementing the PDA, 21% of patients who initially chose non-surgical treatment had surgery within the first year. After implementation of the PDA, this number fell to 16%, but the difference was not statistically significant (p > 0,05). Conclusion: Exposure to the PDA did not significantly alter the proportion of ACL injury patients selecting non-surgical or surgical treatments or the proportion of patients switching to surgery within the first year. [ABSTRACT FROM AUTHOR]

Objectives: International guidelines for managing pressure injury (PI) and ulcers recommend that family members and caregivers should be involved in making decisions for appropriate wound care. However, the effect of shared decision‑making (SDM) in the context of PI remains unknown. This study investigated the efficacy of nurse‑led medical SDM for PI treatment. Materials and Methods: We constructed a patient decision aid (PDA) for PI treatment on the basis of nursing evidence. Subsequently, we conducted a pilot randomized controlled trial to evaluate the efficacy of SDM compared with that of usual care (control group, [CG]) for PI treatment. Participants with stage 3, stage 4, or unstageable PI were included and randomized into two groups. In the SDM group (SDMG), 10 participants received the SDM intervention for PI before treatment. All participants were followed up for 4 weeks. Primary outcomes were measured using the nine‑item SDM Questionnaire (SDM‑Q‑9) and Decisional Conflict Scale (DCS). Secondary outcomes included wound size and cost of wound management. Results: The expert validity (medical professors and general population) of the PDA designed for PI was measured, and the content validity index was 0.96–0.97. A total of 20 participants were enrolled (10 received SDM and 10 received usual care). The mean age of the participants was 55.7 ± 8.8 years. No significant difference in baseline characteristics (sex, age, staging, or wound area) was observed between the two groups. The SDMG had higher SDM‑Q‑9 (P < 0.001) and DCS (P < 0.01) scores than did the CG. For the secondary outcomes, the SDMG had a decreased change of wound size and lower wound management costs than did the CG; nevertheless, the differences were not statistically significant. Conclusion: We constructed a PDA for PI treatment, which can be applied in clinical care. The pilot test results revealed that the participants had a lower cost related wound treatment and decreasing wound size in SDMG than CG after the intervention of SDM‑PI for 4 weeks. In the future, clinical studies should conduct large‑scale randomized trials based on the results of this pilot study. [ABSTRACT FROM AUTHOR]

Background: Patient decision aids (PDAs) are tools that facilitate informed shared decision-making between patients and health care providers. To address a previously identified need in treatment decision-making in hidradenitis suppurativa (HS), we developed an HS-PDA.Methods: Development of the HS-PDA was based on International Patient Decision Aids Standards. Evidence was derived from the North American Clinical Management Guidelines for HS.Results: Content from guidelines was transformed into patient-friendly language and reviewed by three physicians and two patient representatives. Feedback on HS-PDA content, presentation and practicality was obtained from 7 HS patients and 5 physicians. Revisions were made following thematic analysis. All patients felt the content on treatment options contained the right amount of information and 5 found it helpful to see these options contextualized to their values. Each stated they would use the HS-PDA during treatment decision-making. Three and four physicians respectively indicated the content was accurate and language was patient-friendly.Limitations: Small sample sizes may limit generalizability.Conclusion: This HS-PDA was developed in accordance with international standards based on current HS guidelines with input from patients and physicians. It is available online without cost.

Introduction and hypothesis: A treatment choice for female stress urinary incontinence (SUI) is preference sensitive for both patients and physicians. Multiple treatment options are available, with none being superior to any other. The decision-making process can be supported by a patient decision aid (PDA). We aimed to assess physicians' perceptions concerning the use of a PDA. Methods: In a mixed methods study, urologists, gynecologists and general practitioners in the Netherlands were asked to fill out a web-based questionnaire. Questions were based on the Tailored Implementation for Chronic Diseases checklist using the following domains: guideline factors, individual health professional factors, professional interactions, incentives and resources, and capacity for organizational change. Participants were asked to grade statements using a five-point Likert scale and to answer open questions on facilitators of and barriers to implementation of a PDA. Outcomes of statement rating were quantitatively analyzed and thematic analysis was performed on the outcomes regarding facilitators and barriers. Results: The response rate was 11%, with a total of 120 participants completing the questionnaire. Ninety-two of the physicians (77%) would use a PDA in female SUI. Evidence-based and unbiased content, the ability to support shared decision making, and patient empowerment are identified as main facilitators. Barriers are the expected prolonged time investment and the possible difficulty using the PDA in less health-literate patient populations. Conclusions: The majority of physicians would use a PDA for female SUI. We identified facilitators and barriers that can be used when developing and implementing such a PDA. [ABSTRACT FROM AUTHOR]

Background: Decisions about solid organ transplantation are complex. Patient decision aids (PDAs) enhance traditional education, by improving knowledge and supporting patients to align their values with treatments. There are increasing numbers of transplantation PDAs, however, it is unclear whether these are effective. We conducted a systematic review of studies assessing the impact of PDA use in transplantation. Methods: We searched the Cochrane Register of Controlled Trials, CINAHL, EMBASE, MEDLINE, and PsycINFO databases from database inception to October 26, 2020. We included primary studies of solid organ transplantation PDAs defined by the International Patient Decision Aids Standards. All comparators and reported outcomes were included. Mean difference in knowledge (before vs. after) was standardized on a 100‐point scale. Pooled‐effect for PDAs was calculated and compared to the standard of care for randomized controlled trials (RCTs) and meta‐analyzed using random effects. Analysis of all other outcomes was limited due to heterogeneity (PROSPERO registration, CRD42020215940). Results: Seven thousand four hundred and sixty‐three studies were screened, 163 underwent full‐text review, and 15 studies with 4278 participants were included. Nine studies were RCTs. Seven RCTs assessed knowledge; all demonstrated increased knowledge with PDA use (mean difference, 8.01;95%CI 4.69–11.34, p <.00001). There were many other outcomes, including behavior and acceptability, but these were too heterogenous and infrequently assessed for meaningful synthesis. Conclusions: This review found that PDAs increase knowledge compared to standard education, though the effect size is small. PDAs are mostly considered acceptable; however, it is difficult to determine whether they improve other decision‐making components due to the limited evidence about non‐knowledge‐based outcomes. [ABSTRACT FROM AUTHOR]

Abstract Background Patient involvement in discharge planning of patients with stroke can be accomplished by providing personalized outcome information and promoting shared decision-making. The aim of this study was to develop a patient decision aid (PtDA) for discharge planning of hospitalized patients with stroke. Methods A convergent mixed methods design was used, starting with needs assessments among patients with stroke and health care professionals (HCPs). Results of these assessments were used to develop the PtDA with integrated outcome information in several co-creation sessions. Subsequently, acceptability and usability were tested to optimize the PtDA. Development was guided by the International Patient Decision Aids Standards (IPDAS) criteria. Results In total, 74 patients and 111 HCPs participated in this study. A three-component PtDA was developed, consisting of: 1) a printed consultation sheet to introduce the options for discharge destinations, containing information that can be specified for each individual patient; 2) an online information and deliberation tool to support patient education and clarification of patient values, containing an integrated “patients-like-me” model with outcome information about discharge destinations; 3) a summary sheet to support actual decision-making during consultation, containing the patient’s values and preferences concerning discharge planning. In the acceptability test, all qualifying and certifying IPDAS criteria were fulfilled. The usability test showed that patients and HCPs highly appreciated the PtDA with integrated outcome information. Conclusions The developed PtDA was found acceptable and usable by patients and HCPs and is currently under investigation in a clinical trial to determine its effectiveness.

Abstract Background Patient decision aids (PtDAs) support patients and clinicians in shared decision-making (SDM). Real-world outcome information may improve patients’ risk perception, and help patients make decisions congruent with their expectations and values. Our aim was to develop an online PtDA to support kidney failure treatment modality decision-making, that: 1) provides patients with real-world outcome information, and 2) facilitates SDM in clinical practice. Methods The International Patient Decision Aids Standards (IPDAS) development process model was complemented with a user-centred and convergent mixed-methods approach. Rapid prototyping was used to develop the PtDA with a multidisciplinary steering group in an iterative process of co-creation. The results of an exploratory evidence review and a needs-assessment among patients, caregivers, and clinicians were used to develop the PtDA. Seven Dutch teaching hospitals and two national Dutch outcome registries provided real-world data on selected outcomes for all kidney failure treatment modalities. Alpha and beta testing were performed to assess the prototype and finalise development. An implementation strategy was developed to guide implementation of the PtDA in clinical practice. Results The ‘Kidney Failure Decision Aid’ consists of three components designed to help patients and clinicians engage in SDM: 1) a paper hand-out sheet, 2) an interactive website, and 3) a personal summary sheet. A ‘patients-like-me’ infographic was developed to visualise survival probabilities for each treatment modality on the website. Other treatment outcomes were incorporated as event rates (e.g. hospitalisation rates) or explained in text (e.g. the flexibility of each treatment modality). No major revisions were needed after alpha and beta testing. During beta testing, some patients ignored the survival probabilities because they considered these too confronting. Nonetheless, patients agreed that every patient has the right to choose whether they want to view this information. Patients and clinicians believed that the PtDA would help patients make informed decisions, and that it would support values- and preferences-based decision-making. Implementation of the PtDA has started in October 2020. Conclusions The ‘Kidney Failure Decision Aid’ was designed to facilitate SDM in clinical practice and contains real-world outcome information on all kidney failure treatment modalities. It is currently being investigated for its effects on SDM in a clinical trial.

Introduction: Patient decision aid (PDA) is a tool to prompt shared decision-making. The aim of this study was to evaluate the impact of a PDA on Chinese primary open-angle glaucoma patients. Methods: All subjects were randomized into control and PDA group. The questionnaires, including 1) glaucoma knowledge; 2) 8-item Morisky medication adherence scale (MMAS-8); 3) 10-item glaucoma medication adherence self-efficacy scale (GMASES-10); and 4) 16-item decision conflict scale (DCS), were evaluated at baseline, 3- and 6-month follow-up. Results: Totally, 156 subjects participated in this study, including 77 in the control group and 79 in the PDA group. Compared to the control group, PDA group showed around 1 point more improvement in disease knowledge at both 3 and 6 months (both p < 0.05), 2.5 (95% CI: [1.0, 4.1]) and 1.9 (95% CI: [0.2, 3.7]) points more improvement in GMASES-10 at 3 and 6 months, respectively, and reduction in DCS by 8.8 (95% CI: [4.6, 12.9]) points more at 3 months and 13.5 (95% CI: [8.9, 18.0]) points more at 6 months. No difference was detected in MMAS-8. Conclusion: PDA led to improvement in disease knowledge and self-confidence in medication adherence and reduced decision conflict compared to control group for at least 6 months. [ABSTRACT FROM AUTHOR]

Background: The timeliness of raising vaccine acceptance and uptake among the public is essential to overcoming COVID-19; however, the decision-making process among patients with underlying medical conditions is complex, leading individuals to vaccine hesitancy because of their health status. Although vaccine implementation is more effective when deployed as soon as possible, vaccine hesitancy is a significant threat to the success of vaccination programs. Objective: This study aims to evaluate the effectiveness of a communication tool for patients with underlying medical conditions who should decide whether to receive a COVID-19 vaccine. Methods: This 3-arm prospective randomized controlled trial will test the effect of the developed communication intervention, which is fully automated, patient decision aid (SMART-DA), and user-centered information (SMART-DA-α). The web-based intervention was developed to help decision-making regarding COVID-19 vaccination among patients with underlying medical conditions. Over 450 patients will be enrolled on the web from a closed panel access website and randomly assigned to 1 of 3 equal groups stratified by their underlying disease, sex, age, and willingness to receive a COVID-19 vaccine. SMART-DA-α provides additional information targeted at helping patients' decision-making regarding COVID-19 vaccination. Implementation outcomes are COVID-19 vaccination intention, vaccine knowledge, decisional conflict, stress related to decision-making, and attitudes toward vaccination, and was self-assessed through questionnaires. Results: This study was funded in 2020 and approved by the Clinical Research Information Service, Republic of Korea. Data were collected from December 2021 to January 2022. This paper was initially submitted before data analysis. The results are expected to be published in the winter of 2023. Conclusions: We believe that the outcomes of this study will provide valuable new insights into the potential of decision aids for supporting informed decision-making regarding COVID-19 vaccination and discovering the barriers to making informed decisions regarding COVID-19 vaccination, especially among patients with underlying medical conditions. This study will provide knowledge about the common needs, fears, and perceptions concerning vaccines among patients, which can help tailor information for individuals and develop policies to support them. [ABSTRACT FROM AUTHOR]

Abstract Background Generalized anxiety disorder (GAD) is one of the most prevalent mental health problems. Patients with GAD have unmet needs related to the information received about their disorder, its treatments and their participation in the decision-making process. The aim of this study is to develop and assess the acceptability of a patient decision aid (PtDA) for patients with GAD. Method The PtDA was developed following the International Patient Decision Aid Standards. The recommendations of the Spanish clinical practice guideline (CPG) for patients with GAD were used as the basis. The first prototype was developed by an expert committee, further improvements were made with patients (n = 2), clinical experts (n = 13) and the project management group (n = 7). The acceptability of this second draft was assessed by patients non-involved in the previous phases (n = 11). Results The final PtDA version included a brief description of GAD and its treatments. Most participants agreed that the PtDA was easy to use, visually appealing and useful. At least half of the participants learned new things about treatments and adverse effects. Conclusions A PtDA was developed for patients with GAD based on recommendations from the Spanish CPG. It was improved and accepted by patients and clinical experts involved. An evaluation of its effectiveness on the shared decision-making process during the clinical encounter is planned.

Abstract Background Around 10% of adults suffer from clinically significant breathlessness. High quality and actionable patient education materials (PEMs) and patient decision aids (PDAs) have an important role for shared decision making and patient self-management. Objective To systematically assess the effectiveness of patient education materials (PEMs) and patient decision aids (PDAs) on clinical outcomes. Secondly, to assess the quality of PEMs and PDAs for breathlessness that are accessible online. Methods A systematic review of PEM or PDA intervention for breathlessness published between 1 January 2010 and November 2020 was conducted. An environmental scan and quality assessment of publicly available PEMs and PDAs was also conducted. Results Out of 2985 records, five studies were eligible for inclusion in this systematic review. Results of two randomised controlled trials suggest potential effectiveness of PEMs to improve patient reported outcomes and reduce healthcare utilization. In the environmental scan, 88 materials were included. Minimum reading age for most was high (Grade 10) and PEMs scored an average of 87% for understandability and 67% for actionability. Based on the DISCERN tool only 10 were classified as high quality. Conclusion There is a paucity of evidence on the effectiveness of PEMs and PDAs for improvement in breathlessness. There is a need to develop higher quality PEMs for breathlessness.

Abstract Background People with moderate to severe depression in pregnancy must weigh potential risks of untreated or incompletely treated depression against the small, but uncertain risks of fetal antidepressant drug exposure. Clinical support alone appears insufficient for helping individuals with this complex decision. A patient decision aid (PDA) has the potential to be a useful tool for this population. The objective of our work was to use internationally recognized guidelines from the International Patient Decision Aids Standards Collaboration to develop an evidence-based PDA for antidepressant use in pregnancy. Methods A three-phased development process was used whereby, informed by patient and physician perspectives and evidence synthesis, a steering committee commissioned a web-based PDA for those deciding whether or not to start or continue antidepressant treatment for depression in pregnancy (Phase 1). A prototype was developed (Phase 2) and iteratively revised based on feedback during field testing based on a user-centred process (Phase 3). Results We developed a web-based PDA for people deciding whether to start or continue antidepressant use for depression in pregnancy. It has five interactive sections: (1) information on depression and treatment; (2) reasons to start/continue an antidepressant and to start/stop antidepressant medication; (3) user assessment of values regarding each issue; (4) opportunity to reflect on factors that contribute to decision making; and (5) a printable PDF that summarizes the user’s journey through the PDA. Conclusions This tool, which exclusively focuses on depression treatment with Selective Serotonin Reuptake Inhibitors and Serotonin–Norepinephrine Reuptake Inhibitors, can be used by individuals making decisions about antidepressant use to treat depression during pregnancy. Limitations of the PDA are that it is not for other conditions, nor other medications that can be used for depression, and in its pilot form cannot be used by women who do not speak English or who have a visual impairment. Pending further study, it has the potential to enhance quality of care and patient experience.

Abstract Purpose The aim of this study was to develop a patient decision aid (pDA) that could support patients with breast cancer (BC) in making an informed decision about breast reconstruction (BR) after mastectomy. Methods The development included four stages: (i) Establishment of a multidisciplinary team; (ii) Needs assessment consisting of semi‐structured interviews in patients and a survey among healthcare professionals (HCPs); (iii) Creation of content, design and technical system; and (iv) Acceptability and usability testing using a think‐aloud approach in patients and interviews among HCPs and representatives of the Dutch Breast Cancer Patient Organization. Results From the needs assessment, three themes were identified: Challenging period to make a decision, Diverse motivations for a personal decision and Information needed to make a decision about BR. HCPs valued the development of a pDA, especially to prepare patients for consultation. The pDA that was developed contained three parts: first, a consultation sheet for oncological breast surgeons to introduce the choice; second, an online tool including an overview of reconstructive options, the pros and cons of each option, information on the consequences of each option for daily life, exercises to clarify personal values and patient stories; and third, a summary sheet with patients’ values, preferences and questions to help inform and guide the discussion between the patient and her plastic surgeon. The pDA was perceived to be informative, helpful and easy to use by patients and HCPs. Conclusion Consistent with information needs, a pDA was developed to support patients with BC who consider immediate BR in making an informed decision together with their plastic surgeon. Patient or Public Contribution Patients participated in the needs assessment and in acceptability and usability testing.

Abstract Background In case of extreme premature delivery at 24 weeks of gestation, both early intensive care and palliative comfort care for the neonate are considered treatment options. Prenatal counseling, preferably using shared decision making, is needed to agree on the treatment option in case labor progresses. This article described the development of a digital decision aid (DA) to support pregnant women, partners and clinicians in prenatal counseling for imminent extreme premature labor. Methods This DA is developed following the International Patient Decision Aid Standards. The Dutch treatment guideline and the Dutch recommendations for prenatal counseling in extreme prematurity were used as basis. Development of the first prototype was done by expert clinicians and patients, further improvements were done after alpha testing with involved clinicians, patients and other experts (n = 12), and beta testing with non-involved clinicians and patients (n = 15). Results The final version includes information, probabilities and figures depending on users’ preferences. Furthermore, it elicits patient values and provides guidance to aid parents and professionals in making a decision for either early intensive care or palliative comfort care in threatening extreme premature delivery. Conclusion A decision aid was developed to support prenatal counseling regarding the decision on early intensive care versus palliative comfort care in case of extreme premature delivery at 24 weeks gestation. It was well accepted by parents and healthcare professionals. Our multimedia, digital DA is openly available online to support prenatal counseling and personalized, shared decision-making in imminent extreme premature labor.

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

ObjectivesThis study applied the theory of planned behavior (TPB) in shared decision making (SDM) to understand behavioral intention in patients with type 2 diabetes with regard to injection therapy for blood sugar control.MethodsA cross sectional study was conducted. Two hundred and fifty-four patients with type 2 diabetes participated this study and were interviewed by pharmacists in different clinics. A patient decision aid (PDA) entitled “Should I receive injection therapy regarding my type 2 diabetes condition?” was developed for this study and served as interview agenda which comprised 18 items to inquire their willingness to use injection therapy and related considerations during the SDM process.ResultsThe questionnaires were revised using item analysis, exploratory factor analysis, and a criteria of Cronbach's α > 0.7. This resulted in three constructs for all questionnaires that fit the TPB model. Attitude (β = 0.432; P < 0.001) and PBC (β = 0.258; P < 0.001) were directly correlated with intention. TPB explained 35.2% of the variance in intention toward the use of injection therapy.ConclusionsAttitude and PBC toward injection therapy positively and significantly influence the patients' intention to use injection therapy.Practical implicationsThese findings identify a key association for understanding behavioral intention in patients with type 2 diabetes with regard to blood sugar control during SDM.

Abstract Purpose The present study aimed to investigate whether exposure to a patient decision aid (PDA) had an impact on the proportion of patients selecting non‐surgical or surgical treatments after anterior cruciate ligament (ACL) injuries and whether exposure to a PDA affected the proportion of patients switching from non‐surgical to surgical treatment within the first year. Methods In a consecutive case series, proportions of surgery and non‐surgery were compared before and after patients’ exposure to a PDA. Data were collected from the health records of patients with ACL injuries who presented to the Clinic of Sports Traumatology. To identify proportional differences between the two groups, t‐tests and proportion tests were used. Results In total, 1,053 patients with ACL injuries were included: 563 patients with no exposure to the PDA (January 2015 to January 2017) and 490 patients with exposure to the PDA (January 2017 to January 2019). Before implementing the PDA, 27% of the patients selected non‐surgical treatment. After implementing the PDA, 30% choose non‐surgical treatment (p > 0.05). Before implementing the PDA, 21% of patients who initially chose non‐surgical treatment had surgery within the first year. After implementation of the PDA, this number fell to 16%, but the difference was not statistically significant (p > 0,05). Conclusion Exposure to the PDA did not significantly alter the proportion of ACL injury patients selecting non‐surgical or surgical treatments or the proportion of patients switching to surgery within the first year.

Background: To review whether online decision aids are available for patients contemplating pelvic exenteration (PE) for locally advanced and recurrent rectal cancer (LARC and LRRC).Methods: A grey literature review was carried out using the Google Search™ engine undertaken using a predefined search strategy (PROSPERO database CRD42019122933). Written health information was assessed using the DISCERN criteria and International Patient Decision Aids Standards (IPDAS) with readability content assessed using the Flesch-Kincaid reading ease test and Flesch-Kincaid grade level score.Results: Google search yielded 27, 782, 200 results for the predefined search criteria. 131 sources were screened resulting in the analysis of 6 sources. No sources were identified as a decision aid according to the IPDAS criteria. All sources provided an acceptable quality of written health information, scoring a global score of 3 for the DISCERN written assessment. The median Flesch-Kincaid reading ease was 50.85 (32.5-80.8) equating to a reading age of 15-18 years and the median Flesch-Kincaid grade level score was 7.65 (range 3-9.7), which equates to a reading age of 13-14.Conclusions: This study has found that there is a paucity of online information for patients contemplating PE. Sources that are available are aimed at a high health literate patient. Given the considerable morbidity associated with PE surgery there is a need for high quality relevant information in this area. A PDA should be developed to improve decision making and ultimately improve patient experience. [ABSTRACT FROM AUTHOR]

Background: Many women with chronic hypertension are conflicted about antihypertensive medication during pregnancy and some are non-adherent to prescribed medication.Objectives: Codesign, implement and evaluate a novel shared decision-making (SDM) intervention for use with pregnant women with chronic hypertension.Setting and Participants: Pregnant women with chronic hypertension and their principal healthcare professionals (obstetricians, midwives, and physicians), at three National Health Service hospital trusts with different models of care.Main Outcome Measures: The RE-AIM framework guided the evaluation. Primary: Decisional conflict scale, medication intention survey and women's acceptability. Secondary: Healthcare professionals' acceptability and the barriers and facilitators to SDM implementation with pregnant women with chronic hypertension.Results: Fifty women participated. Nearly half (46 %; n = 23) of women were from Black and Asian backgrounds. The SDM intervention was effective at reducing decisional conflict (mean reduction from baseline 42 %, 95 % CI 35-49, p ≤ 0.05). In 36 women (72 %), the reduction was of clinical importance. 24 women (48 %) were uncertain about or planned not to take antihypertensives prior to the SDM intervention, compared to two women (4 %) after the intervention. The intervention was acceptable to women and healthcare professionals. 10 of 14 healthcare professionals felt that the in-consultation aid facilitated SDM in current antenatal contexts, a similar proportion (10/14) felt the length of consultations hindered SDM.Conclusion: A novel codesigned SDM intervention reduced decisional conflict and increased women's intention to take antihypertensive agents during pregnancy. This intervention could be adopted into practice for women making pregnancy decisions where there is uncertainty around the medication management option. [ABSTRACT FROM AUTHOR]