Patient autonomy and shared decision-making in the context of clinical trial participation.

AIMS: This study aimed to explore how incorporating shared decision-making (SDM) can address recruitment challenges in clinical trials. Specifically, it examines how SDM can align the trial process with patient preferences, enhance patient autonomy and increase active patient participation. Additionally, it identifies potential conflicts between SDM and certain clinical trial aspects, such as randomization or blinding, and proposes solutions to mitigate these issues. MATERIALS AND METHODS: We conducted a comprehensive review of existing literature on patient recruitment challenges in clinical trials and the role of SDM in addressing these challenges. We analysed case studies and trial reports to identify common obstacles and assess the effectiveness of SDM in improving patient accrual. Additionally, we evaluated three proposed solutions: adequate trial design, communication skill training and patient decision aids. RESULTS: Our review indicates that incorporating SDM can significantly enhance patient recruitment by promoting patient autonomy and engagement. SDM encourages physicians to adopt a more open and informative approach, which aligns the trial process with patient preferences and reduces psychological barriers such as fear and mental stress. However, implementing SDM can conflict with elements such as randomization and blinding, potentially complicating trial design and execution. DISCUSSION: The desire for patient autonomy and active engagement through SDM may clash with traditional clinical trial methodologies. To address these conflicts, we propose three solutions: redesigning trials to better accommodate SDM principles, providing communication skill training for physicians and developing patient decision aids. By focussing on patient wishes and emotions, these solutions can integrate SDM into clinical trials effectively. CONCLUSION: Shared decision-making provides a framework that can promote patient recruitment and trial participation by enhancing patient autonomy and engagement. With proper implementation of trial design modifications, communication skill training and patient decision aids, SDM can support rather than hinder clinical trial execution, ultimately contributing to the advancement of evidence-based medicine.

Decisional needs and interventions for young women considering contraceptive options: an umbrella review.

BACKGROUND: Although women face a wide range of contraceptive options, globally, young women are at risk of unintended pregnancies. Our umbrella review aimed to determine the decisional needs of nulligravida women aged 11 to 30 considering contraceptive options and identify effective interventions to support their involvement in making decisions about contraceptive use. METHODS: We followed Joanna Briggs Institute methods for umbrella reviews, theoretically guided by the Ottawa Decision Support Framework. We searched six electronic databases. Two reviewers independently screened citations, extracted data, and appraised quality using AMSTAR2. We analysed findings descriptively. RESULTS: Of 124 citations, we identified 11 reviews of variable quality (critically low to moderate quality): Six reported decisional needs and 5 reported on interventions. Decisional needs of young women were: (a) information needs about contraceptive options (e.g., mechanism of actions, eligibility, administration, side effects); (b) unclear values (concerns about hormone use) and features of different options (based on their religious values); and (c) need for support and resources (support from society and need for privacy). Compared to controls, decision support interventions including patient decision aids and patient education material increased knowledge and improved discussion of options with their clinicians. CONCLUSION: Young women making contraceptive decisions experience unmet decisional needs. Effective interventions such as patient decision aids and general patient education materials may address their decisional needs and enhance their level of participation in making contraception decisions. Implications and contribution to the field: Young women's decisional needs when considering contraceptive use are informational needs, unclear values (including religious influences), need for support and resources when facing this decision. Interventions, such as patient decision aid and patient education material can, address decisional needs by improving young women's knowledge about contraceptive options.

Dissemination of colorectal cancer information among Hispanic patients and their social network.

BACKGROUND: Colorectal cancer (CRC) screening decision aids can inform patients about CRC screening benefits, costs, and procedures. Patients who receive the decision aid report wanting to share the information with their families and friends. We evaluated a CRC screening decision aid on Hispanic patients' communication to their alters and whether patient-alter communication leads to alters' CRC screening intention. METHODS: We conducted a one-arm pre/post study of Hispanic patients and their alters; patients (n = 42) and their alters (n = 19) were recruited from a clinic site in Yakima County, Washington State. Patients viewed a CRC screening decision aid at the clinic site. Survey data from patients and alters were collected via telephone including patients' communication with their alters about CRC screening after viewing the decision aid and alters' intention to be screened for CRC after talking to the patient. RESULTS: Most participants reported sharing CRC information with their alters after viewing the decision aid, and most alters confirmed they had received CRC information from participants (68%). The decision aid was associated with participants' own intention to undergo CRC screening and with alters' intention to be screened for CRC using a fecal occult blood test (p = 0.014) and sigmoidoscopy (p = 0.011). CONCLUSIONS: Patient decision aids have the potential to increase CRC screening behavior beyond the decision aid recipients to their social network. TRIAL REGISTRATION: Trials Registration Number: NCT04444232 "Retrospectively registered."

On subjective measures of decision quality.

In times of person-centered care, it is all the more important to support patients in making good decisions about their care. One way to offer such support to patients is by way of Patient Decision Aids (PDAs). Ranging from patient brochures to web-based tools, PDAs explicitly state the decisions patients face, inform them about their medical options, help them to clarify and discuss their values, and ultimately make a decision. However, lingering discussions surround effectiveness research on PDAs. In this article, I focus on two subjective measures of decision quality that are widely used as outcome measures in effectiveness research on PDAs (i.e., the Decisional Conflict Scale (DCS) and measures of regret). Although these measurement instruments have attracted critical attention in the scientific literature, bioethicists have hardly engaged with them. Therefore, I set myself to analyze the relationship between (the different subscales of) the DCS and measures of regret, on the one hand, and ethical principles such as beneficence and autonomy, on the other hand. In light of that analysis, I will clarify some discussions regarding the use of these measures of decision quality in effectiveness research on PDAs. This should help us to align the way we evaluate PDAs with ethical principles and avoid that our attempts to support patients in making good decisions about their care that is so central to person-centered care point in unethical directions.

Empowering Patients Through Shared Decision Making in Breast Cancer Consultations.

Receiving a breast cancer diagnosis renders breast cancer consultations pivotal moments in a patient's journey, where decisions about treatment options, including breast reconstruction, can profoundly impact their physical and emotional well-being. Shared decision making (SDM) is a collaborative approach that involves healthcare professionals and patients working together to make decisions that align with the patient's values, preferences, and goals. SDM can hence lead to: 1. informed choices and patient empowerment; 2. enhanced patient satisfaction. One of the key decisions that patients face is whether or not to undergo breast reconstruction and the varying options available. However, while SDM has proven benefits, there still appears to be a lack of knowledge among some healthcare professionals. Hence, suggestions for mitigation include the employment of patient decision aids and clear communication strategies.Level of Evidence V This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Interventions to Facilitate Shared Decision-Making Using Decision Aids with Coronary Heart Disease Patients: Systematic Review and Meta-Analysis.

Background: Coronary heart disease (CHD) is the leading cause of death in the world. There are some decision-making conflicts in the management of chest pain, treatment methods, stent selection, and other aspects due to the unstable condition of CHD in the treatment stage. Although using decision aids to facilitate shared decision-making (SDM) contributes to high-quality decision-making, it has not been evaluated in the field of CHD. This review systematically assessed the effects of SDM in patients with CHD. Methods: We conducted a systematic review and meta-analysis of randomized controlled trials of SDM interventions in patients with CHD from database inception to 1 June 2022 (PROSPERO [Unique identifier: CRD42022338938]). We searched for relevant studies in the PubMed, Embase, Cochrane Library, Web of Science, CNKI, and Wan Fang databases. The primary outcomes were knowledge and decision conflict. The secondary outcomes were satisfaction, patient participation, trust, acceptance, quality of life, and psychological condition. Results: A total of 8244 studies were retrieved. After screening, ten studies were included in the analysis. Compared with the control group, SDM intervention with patient decision aids obviously improved patients' knowledge, decision satisfaction, participation, and medical outcomes and reduced decision-making conflict. There was no significant effect of SDM on trust. Conclusions: This study showed that SDM intervention in the form of decision aids was beneficial to decision-making quality and treatment outcomes among patients with CHD. The results of SDM interventions need to be evaluated in different environments.

The Impact of Shared Decision-Making on the Quality of Decision Making in Aortic Dissection: A before-and-after Comparison Study.

Background: Complex surgical plans and consideration of risks and benefits often cause decisional conflicts for decision-makers in aortic dissection (AD) surgery, resulting in decision delay. Shared decision-making (SDM) improves decision readiness and reduces decisional conflicts. The purpose of this study was to investigate the impact of SDM on decision quality in AD. Methods: One hundred and sixty AD decision-makers were divided into two groups: control (n = 80) and intervention (n = 80). The surgical plan for the intervention group was determined using patient decision aids. The primary outcome was decisional conflict. Secondary outcomes included decision preparation, decision satisfaction, surgical method, postoperative complications, actual participation role, and duration of consultation. The data were analyzed with SPSS 26.0 (IBM Corp., Chicago, IL, USA). p < 0.05 was considered statistically significant. Results: The decisional conflict score was significantly lower in the intervention group than in the control group (p < 0.001). The decision preparation and decision satisfaction scores in the intervention group were significantly higher than those in the control group (p < 0.001). There were more SDM decision-makers in the intervention group (16 [20%] vs. 42 [52.50%]). There was no statistical significance in the choice of surgical, postoperative complications, duration of consultation, and hospital and post-operative intensive care unit stay time (p = 0.267, p = 0.130, p = 0.070, p = 0.397, p = 0.421, respectively). Income, education level, and residence were the influencing factors of decision-making conflict. Conclusions: SDM can reduce decisional conflict, improve decision preparation and satisfaction, and help decision-makers actively participate in the medical management of patients with AD without affecting the medical outcome.

Patient Decision Aids Before Informed Consent Conversations for Image-Guided Procedures: Controlled Trials at Two Institutions.

BACKGROUND. Patient decision aids (PDAs) improve informed consent practices. Available PDAs for image-guided procedures are of limited quality. OBJECTIVE. The purpose of this article was to evaluate the impact of PDAs on understanding and satisfaction among patients undergoing informed consent conversations before outpatient image-guided procedures. METHODS. This prospective study included patients awaiting an interventional radiology clinic visit to discuss and obtain informed consent for an image-guided procedure. The study was conducted at two academic medical centers (site A, visits from August 2020 to July 2021; site B, visits from January 2021 to October 2021). Patients were assigned systematically at site A and randomly at site B to electronically receive or not receive a two-page PDA before the visit. PDAs described procedures and their benefits, risks, and alternatives at a sixth- to eighth-grade health literacy level and were vetted by diverse patient focus groups. Patients completed a postvisit survey (site A, by telephone; site B, online) assessing understanding of the procedure and satisfaction with the consent conversation using 5-point scales. Data were pooled between sites. RESULTS. The study included 105 patients (59 men, 46 women; median age, 67 years; 51 from site A, 54 from site B; 53 who received PDA, 52 who did not). Survey response rate was 100% (51/51) at site A and 67% (62/92) at site B. Patients who received, versus did not receive, a PDA reported greater understanding of benefits (4.5 vs 4.0, p < .001), risks (4.4 vs 3.6, p < .001), and alternatives (4.0 vs 3.3, p < .001), and of what procedures involved (4.4 vs 4.1, p = .02) and were more likely to feel that they were provided with enough time with the clinician (4.7 vs 4.5, p = .03), listened to carefully (4.8 vs 4.4, p < .001), free to choose any option including not to have the procedure (4.7 vs 4.3, p < .001), given enough time to make a decision (4.8 vs 4.3, p < .001), encouraged to ask questions (4.8 vs 4.5, p < .001), and had questions answered (4.8 vs 4.4, p = .001). CONCLUSION. Well-vetted plain-language PDAs provided before image-guided procedure consent conversations improve patients' self-perceived understanding of the procedure and satisfaction with the conversation. CLINICAL IMPACT. PDAs can be implemented effectively without requiring additional clinician time or effort.

Using Patient Decision Aids for Cardiology Care in Diverse Populations.

PURPOSE OF REVIEW: Patient decision aids (PDAs) are tools that help guide treatment decisions and support shared decision-making when there is equipoise between treatment options. This review focuses on decision aids that are available to support cardiac treatment options for underrepresented groups. RECENT FINDINGS: PDAs have been developed to support multiple treatment decisions in cardiology related to coronary artery disease, valvular heart disease, cardiac arrhythmias, heart failure, and cholesterol management. By considering the unique needs and preferences of diverse populations, PDAs can enhance patient engagement and promote equitable healthcare delivery in cardiology. In this review, we examine the benefits, challenges, and current trends in implementing PDAs, with a focus on improving decision-making processes and outcomes for patients from underrepresented racial and ethnic groups. In addition, the article highlights key considerations when implementing PDAs and potential future directions in the field.

Implementing shared decision-making interventions in breast cancer clinical practice: a scoping review.

BACKGROUND: Shared decision-making (SDM) is a collaborative process whereby patients and clinicians jointly deliberate on the best treatment option that takes into account patients' preferences and values. In breast cancer care, different treatment options have become available to patients in the last decade. Various interventions, including patient decision aids (PtDAs), have been designed to promote SDM in this disease area. This study aimed at investigating the factors that influence the successful adoption and implementation of SDM interventions in real-world healthcare delivery settings. METHODS: A scoping review of scientific and grey literature was conducted for the period 2006-2021 to analyse the support for SDM interventions and their adoption in breast cancer clinical practice. The interpretation of findings was based on the Practical, Robust Implementation and Sustainability Model (PRISM) for integrating research findings into practice. RESULTS: Overall, 19 studies were included for data synthesis, with more than 70% published since 2017. The availability of SDM tools does not automatically translate into their actual use in clinical settings. Factors related to users' co-creation, the clinical team's attitude and knowledge, organisational support and regulatory provisions facilitate the adoption of SDM interventions. However, overlooking aspects such as the re-organisation of care pathways, patient characteristics, and assigning of resources (human, financial, and facilities) can hinder implementation efforts. CONCLUSIONS: Compared to the mounting evidence on the efficacy of SDM interventions, knowledge to support their sustained implementation in daily care is still limited, albeit results show an increasing interest in strategies that facilitate their uptake in breast cancer care over time. These findings highlight different strategies that can be used to embed SDM interventions in clinical practice. Future work should investigate which approaches are more effective in light of organisational conditions and external factors, including an evaluation of costs and healthcare system settings.

The quality of German - language patient decision aids for oncological patients on the internet.

BACKGROUND: Previous studies have already shown that decision aids are a suitable tool for patient decision-making. The aim of this work is to conduct an online search for freely available, German-language patient decision aids (PDAs) for cancer patients, followed by an assessment of their quality. For this purpose, a rating tool that is as manageable as possible was developed on the basis of already existing quality criteria. METHODS: A simulated patient online search was conducted via the four most frequently used search engines in Germany. A quality assessment tool was created utilizing international and national guidelines, with a focus on practicality and manageability. Subsequently, the identified PDAs were rated by 4 raters based on the rating tool. RESULTS: The number of German-language oncology PDAs is low (n = 22 of 200 URLs) with limited variability regarding rare cancers. Most originate from non-profit organizations. The overall quality is low, as indicated by an average of 57.52% of the maximum evaluation points of the developed quality assessment tool. Reference values used to assess quality were related to e.g. support/effectiveness, adaptation, layout, etc. No qualitative differences were found regarding different publishers. Quality differed between PDAs of different length, with longer PDAs achieving better results. CONCLUSION: Overall, the supply and quality of German-language PDAs is not satisfactory. The assessment tool created in this study provides a solid, but more manageable basis, for developing and identifying high-quality PDAs. PRACTICE IMPLICATIONS: PDAs should be increasingly used by physicians in practice. For this, a quick qualitative assessment of PDAs in everyday life must be possible. Future research has to investigate especially the aspect of the length of a PDA in more detail.

Digital encounter decision aids linked to clinical practice guidelines: results from user testing SHARE-IT decision aids in primary care.

BACKGROUND: Encounter decision aids (EDAs) are tools that can support shared decision making (SDM), up to the clinical encounter. However, adoption of these tools has been limited, as they are hard to produce, to keep up-to-date, and are not available for many decisions. The MAGIC Evidence Ecosystem Foundation has created a new generation of decision aids that are generically produced along digitally structured guidelines and evidence summaries, in an electronic authoring and publication platform (MAGICapp). We explored general practitioners' (GPs) and patients' experiences with five selected decision aids linked to BMJ Rapid Recommendations in primary care. METHODS: We applied a qualitative user testing design to evaluate user experiences for both GPs and patients. We translated five EDAs relevant to primary care, and observed the clinical encounters of 11 GPs when they used the EDA with their patients. We conducted a semi-structured interview with each patient after the consultation and a think-aloud interview with each GPs after multiple consultations. We used the Qualitative Analysis Guide (QUAGOL) for data analysis. RESULTS: Direct observations and user testing analysis of 31 clinical encounters showed an overall positive experience. The EDAs created better involvement in decision making and resulted in meaningful insights for patients and clinicians. The design and its interactive, multilayered structure made the tool enjoyable and well-organized. Difficult terminology, scales and numbers hindered understanding of certain information, which was sometimes perceived as too specialized or even intimidating. GPs thought the EDA was not suitable for every patient. They perceived a learning curve was required and the need for time investment was a concern. The EDAs were considered trustworthy as they were provided by a credible source. CONCLUSIONS: This study showed that EDAs can be useful tools in primary care by supporting actual shared decision making and enhancing patient involvement. The graphical approach and clear representation help patients better understand their options. To overcome barriers such as health literacy and GPs attitudes, effort is still needed to make the EDAs as accessible, intuitive and inclusive as possible through use of plain language, uniform design, rapid access and training. TRIAL REGISTRATION: The study protocol was approved by the The Research Ethics Committee UZ/KU Leuven (Belgium) on 31-10-2019 with reference number MP011977.

Consent in Interventional Radiology-How Can We Make It Better?

Informed consent is an important part of the clinician-patient relationship. However, studies suggest consent practices tend to be limited in consistency and completeness. This may be particularly challenging for interventional radiology given more limited public awareness and the often fast-paced, dynamic nature of our practices. This article reviews these challenges as well as ideal consent practices and potential approaches to improve consent in interventional radiology.

Systematic Review of Patient Decision Aids for Stroke Prevention Therapy in Atrial Fibrillation Management.

Background: Atrial Fibrillation (AF) is a major cause of stroke. Oral anticoagulation can reduce the risk of AF-associated stroke by 65% but it remains underused. Stroke prevention therapy in patients with AF has been considered a good target for shared decision making with patient decision aids as it is a long-term, preference-sensitive decision with known risk-benefit trade-offs. The aim of this systematic review was to summarize published literature on the effectiveness of patient decision aids on the choice of and adherence to stroke prevention therapy in individuals with AF. Methods: We conducted a structured literature search for prospective studies evaluating decision aids for AF stroke prevention therapy in adult patients with nonvalvular AF. We included studies that compared those exposed to a decision aid with a control condition for outcomes including choice of therapy, adherence, decisional conflict and patient knowledge. Quantitative meta-analysis was not feasible due to excessive between-study heterogeneity. Results: Eight studies met inclusion and exclusion criteria. Six studies were randomized clinical trials and two were pre-post comparisons. Of the 8 studies, each evaluated a different decision aid, with only three including all contemporary oral anticoagulant drugs. All decision aids improved AF knowledge compared to baseline or control and decision aids reduced decisional conflict in four of six studies. However, there were inconsistent effects of the studied decision aids on initiation of oral anticoagulation. Adherence to initial stroke prevention therapy choice appeared to benefit from decision aid use in 2 studies that addressed this issue. Conclusions: Decision aids for stroke prevention increased AF patients' knowledge and decisional confidence but had variable impacts on choice of and adherence to stroke prevention therapy. The results highlight the need for well-designed decision aids that present patients with all contemporary therapeutic options.

Effectiveness of Decision Aid in Men with Localized Prostate Cancer: a Multicenter Randomized Controlled Trial at Tertiary Referral Hospitals in an Asia Pacific Country.

There are several treatment options for localized prostate cancer with very similar outcome but vary in terms of technique and side effect profiles and risks. Considering the potential difficulty in choosing the best treatment, a patient decision aid (PDA) is used to help patients in their decision-making process. However, the use and applicability of PDA in a country in Asia Pacific region like Malaysia is still unknown. This study aims to evaluate the effectiveness of a PDA modified to the local context in improving patients' knowledge, decisional conflict, and preparation for decision making among men with localized prostate cancer. Sixty patients with localized prostate cancer were randomly assigned to control and intervention groups. A self-administered questionnaire, which evaluate the knowledge on prostate cancer (23 items), decisional conflict (10 items) and preparation for decision-making (10 items), was given to all participants at pre- and post-intervention. Data were analyzed using independent T test and paired T test. The intervention group showed significant improvement in knowledge (p = 0.02) and decisional conflict (p = 0.01) from baseline. However, when compared between the control and intervention groups, there were no significant differences at baseline and post-intervention on knowledge, decisional conflict and preparation for decision-making. A PDA on treatment options of localized prostate cancer modified to the local context in an Asia Pacific country improved patients' knowledge and decisional conflict but did not have significant impact on the preparation for decision-making. The study was also registered under the Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12614000668606 registered on 25/06/2014.

Effectiveness of a decision aid for patients with knee osteoarthritis: a randomized controlled trial.

OBJECTIVE: To assess the effectiveness of a Patient Decision Aid (PtDA) for knee osteoarthritis. METHOD: Randomized controlled trial, in which 193 patients were allocated to the PtDA or usual care. Outcome measures were the Decisional Conflict Scale (DCS), knowledge of osteoarthritis and arthroplasty, satisfaction with the decision-making process (SDMP) and treatment preference, assessed immediately after the intervention. At 6 months, the same measures were applied in non-operated patients, whereas those who underwent arthroplasty completed the SDMP and the Decisional Regret Scale (DRS). RESULTS: The PtDA produced a significant immediate improvement of decisional conflict (MD = -11.65, 95%CI: -14.93, -8.37), objective knowledge (MD = 10.37, 99%IC: 3.15, 17.70) and satisfaction (MD = 6.77, 99%CI: 1.19, 12.34), and a different distribution of preferences (χ2 = 8.74, p = 0.033). Patients with less than secondary education obtained a stronger effect on decisional conflict (p = 0.015 for the interaction) but weaker for knowledge (p = 0.051). At 6 months, there were no significant differences in any variable, including the rate of total knee replacement. Operated patients showed a low level of regret, which was not affected by the intervention. CONCLUSION: The PtDA is effective immediately after its application, but it shows no effects in the medium-term. Future research should investigate which subgroups of patients could benefit more from this intervention, as well as the longitudinal evolution of decision-related psychological variables.

Effectiveness of patient decision aids for total hip and knee arthroplasty decision-making: a systematic review.

OBJECTIVES: To determine the effectiveness of patient decision aids (PtDAs) compared to alternative interventions (including usual care) on decision quality and quality of the decision-making process for adults with hip and knee osteoarthritis considering primary elective total joint arthroplasty. METHODS: A systematic review guided by Cochrane methods and PRISMA reporting guidelines. Studies were searched in five databases. Included studies were RCTs evaluating the effect of PtDAs on total joint arthroplasty decision-making. Study quality was appraised with Cochrane's risk of bias tool. Quality and strength of recommendations were appraised with GRADE. RESULTS: Ten included studies were conducted in North American using the same PtDA. Compared to usual care, PtDA groups demonstrated increased decision quality (e.g., higher knowledge, more informed values-based choices) and quality of the decision making process (e.g., decreased decisional conflict) (6 trials). Secondary outcomes showed increased surgeon satisfaction within the consultation and no difference in patient satisfaction or uptake of the chosen option (surgery: RR 1.03, 95% CI = 0.84 to 1.25; I2 = 66%; 4 trials). When PtDAs formtats were compared, there were similar effects but no difference between PtDAs (4 trials). CONCLUSIONS: There was low to very low GRADE certainty of evidence for the effect of PtDAs on decision quality and quality of the decision-making process compared to usual care. No differences were found when different formats of PtDAs were compared (moderate to very low GRADE certainty of evidence).

Influence of Shared Decision Making on Decisional Conflict and Regret in Postpartum Mother-Infant Care: A Randomized Controlled Trial.

OBJECTIVES: Although postpartum rooming-in is encouraged by the World Health Organization, independent separated nursery care is still widely adopted in Eastern countries. Our aim is to evaluate the effect of shared decision making (SDM) assisted by patient decision aids on subjective decisional conflict and regret among women who are required to make choices regarding postpartum infant care. METHODS: A total of 196 pregnant women who came for routine checkups 1 month before delivery were randomly assigned to the SDM group or the classic group. Before the mothers were discharged after delivery, their decision-making difficulties were evaluated. The primary outcome was the decisional conflict, which was assessed using the SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) scale. The secondary outcome was the decisional regret, which was measured using the Decision Regret scale. RESULTS: Compared with the classic group, SDM group had surer feelings about the choice (P＜.001), felt more confident about knowing the benefits and risks of each option (P＜.001), had a clearer understanding of the benefits and risks (P＜.001), and felt sufficiently supported with enough advice to make a suitable choice (P＜.001). No significant difference was noted in the Decision Regret scores between groups. The choice of 24-hour rooming-in, 12-hour rooming-in, and separated nursery care was not significantly different between groups. CONCLUSIONS: SDM reduced the decisional conflict and uncertainty of the mothers. Available choices of postpartum mother-infant care should be provided to mothers through SDM that includes individual values, health goals, and clear knowledge and transparency.

Processes for evidence summarization for patient decision aids: A Delphi consensus study.

BACKGROUND: Patient decision aids (PDAs) should provide evidence-based information so patients can make informed decisions. Yet, PDA developers do not have an agreed-upon process to select, synthesize and present evidence in PDAs. OBJECTIVE: To reach the consensus on an evidence summarization process for PDAs. DESIGN: A two-round modified Delphi survey. SETTING AND PARTICIPANTS: A group of international experts in PDA development invited developers, scientific networks, patient groups and listservs to complete Delphi surveys. DATA COLLECTION: We emailed participants the study description and a link to the online survey. Participants were asked to rate each potential criterion (omit, possible, desirable, essential) and provide qualitative feedback. ANALYSIS: Criteria in each round were retained if rated by >80% of participants as desirable or essential. If two or more participants suggested rewording, reordering or merging, the steering group considered the suggestion. RESULTS: Following two Delphi survey rounds, the evidence summarization process included defining the decision, reporting the processes and policies of the evidence summarization process, assembling the editorial team and managing (collect, manage, report) their conflicts of interest, conducting a systematic search, selecting and appraising the evidence, presenting the harms and benefits in plain language, and describing the method of seeking external review and the plan for updating the evidence (search, selection and appraisal of new evidence). CONCLUSION: A multidisciplinary stakeholder group reached consensus on an evidence summarization process to guide the creation of high-quality PDAs. PATIENT CONTRIBUTION: A patient partner was part of the steering group and involved in the development of the Delphi survey.

Integrating Option Grid Patient Decision Aids in the Epic Electronic Health Record: Case Study at 5 Health Systems.

BACKGROUND: Some researchers argue that the successful implementation of patient decision aids (PDAs) into clinical workflows depends on their integration into electronic health records (EHRs). Anecdotally, we know that EHR integration is a complex and time-consuming task; yet, the process has not been examined in detail. As part of an implementation project, we examined the work involved in integrating an encounter PDA for symptomatic uterine fibroids into Epic EHR systems. OBJECTIVE: This study aims to identify the steps and time required to integrate a PDA into the Epic EHR system and examine facilitators and barriers to the integration effort. METHODS: We conducted a case study at 5 academic medical centers in the United States. A clinical champion at each institution liaised with their Epic EHR team to initiate the integration of the uterine fibroid Option Grid PDAs into clinician-facing menus. We scheduled regular meetings with the Epic software analysts and an expert Epic technologist to discuss how best to integrate the tools into Epic for use by clinicians with patients. The meetings were then recorded and transcribed. Two researchers independently coded the transcripts and field notes before categorizing the codes and conducting a thematic analysis to identify the facilitators and barriers to EHR integration. The steps were reviewed and edited by an Epic technologist to ensure their accuracy. RESULTS: Integrating the uterine fibroid Option Grid PDA into clinician-facing menus required an 18-month timeline and a 6-step process, as follows: task priority negotiation with Epic software teams, security risk assessment, technical review, Epic configuration; troubleshooting, and launch. The key facilitators of the process were the clinical champions who advocated for integration at the institutional level and the presence of an experienced technologist who guided Epic software analysts during the build. Another facilitator was the use of an emerging industry standard app platform (Health Level 7 Substitutable Medical Applications and Reusable Technologies on Fast Healthcare Interoperability Resources) as a means of integrating the Option Grid into existing systems. This standard platform enabled clinicians to access the tools by using single sign-on credentials and prevented protected health information from leaving the EHR. Key barriers were the lack of control over the Option Grid product developed by EBSCO (Elton B Stephens Company) Health; the periodic Epic upgrades that can result in a pause on new software configurations; and the unforeseen software problems with Option Grid (ie, inability to print the PDA), which delayed the launch of the PDA. CONCLUSIONS: The integration of PDAs into the Epic EHR system requires a 6-step process and an 18-month timeline. The process required support and prioritization from a clinical champion, guidance from an experienced technologist, and a willing EHR software developer team.