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Background Methods Results Conclusions Limited decision‐support tools are available to help shared decision‐making (SDM) regarding food oral immunotherapy (OIT) initiation. No current tool covers all foods, forms, and pediatric ages for which OIT is offered.In compliance with International Patient Decision Aid Standards criteria, this pediatric decision‐aid comparing OIT versus avoidance was developed in three stages. Nested qualitative data assessing OIT decisional needs were supplemented with evidence‐synthesis from the OIT literature to create the prototype decision‐aid content. This underwent iterative development with food allergy experts and patient advocacy stakeholders until unanimous consensus was reached regarding content, bias, readability, and utility in making a choice. Lastly, the tool underwent validated assessment of decisional acceptability, decisional conflict, and decisional self‐efficacy.The decision‐aid underwent 5 iterations, resulting in a 4‐page written aid (Flesch–Kincaid reading level 6.1) explaining therapy choices, risks and benefits, providing self‐rating for attribute importance for the options and self‐assessment regarding how adequate the information was in decision‐making. A total of n = 135 caregivers of food‐allergic children assessed the decision‐aid, noting good acceptability, high decisional self‐efficacy (mean score 85.9/100) and low decisional conflict (mean score 20.9/100). Information content was rated adequate and sufficient, the therapy choices wording balanced, and presented without bias for a “best choice.” Lower decisional conflict was associated with caregiver‐reported anaphylaxis.This first pediatric OIT decision‐aid, agnostic to product, allergen, and age has good acceptability, limited bias, and is associated with low decisional conflict and high decisional self‐efficacy. It supports SDM in navigating the decision to start OIT or continue allergen avoidance. [ABSTRACT FROM AUTHOR]

Summary: Restless legs syndrome (RLS) is a common neurological disorder characterised by an urge to move arms and legs, usually associated with discomfort, pain, motor restlessness, and sleep disturbance. An individually adapted treatment is needed but difficult to optimise, which makes shared decision‐making (SDM) important. However, brief validated instruments on how patients with RLS perceive their involvement in treatment decisions are lacking. Therefore, the aim was to validate two instruments, SURE (Sure of myself, Understand information, Risk–benefit ratio, Encouragement, i.e., to assess decisional conflict) and CollaboRATE (brief patient survey focused on SDM, i.e., to assess SDM), in patients with RLS. A cross‐sectional design, including 788 participants with RLS (65% females, mean [SD] age 70.8 [11.4] years) from a national patient organisation for RLS, was used. A postal survey was sent out to collect data regarding weight, height, comorbidities, demographics, and RLS‐related treatment data. The following instruments were included: the SURE, CollaboRATE, Restless Legs Syndrome‐6 Scale, and eHealth Literacy Scale. Confirmatory factor analysis and Rasch models were used to assess the validity and reliability of the SURE and CollaboRATE. Measurement invariance, unidimensionality, and differential item functioning (DIF) across age, gender, and medication groups were assessed. The SURE and CollaboRATE were both identified as unidimensional instruments with satisfactory internal consistency. No DIF across age and gender was identified, while significant DIF was observed for both the SURE and CollaboRATE regarding medication use categories. However, both the SURE and CollaboRATE are potential instruments to be used in research, but also as reflection tools by healthcare professionals, patients, and students to explore and assess SDM, and support its development in clinical care. [ABSTRACT FROM AUTHOR]

Objectives: Decision‐making for patients with a locally advanced laryngeal carcinoma (T3 and T4) is challenging due to the treatment choice between organ preservation and laryngectomy, both with different and high impact on function and quality of life (QoL). The complexity of these treatment decisions and their possible consequences might lead to decisional conflict (DC). This study aimed to explore the level of DC in locally advanced laryngeal carcinoma patients facing curative decision‐making, and to identify possible associated factors. Methods: In this multicenter prospective cohort study, participants completed questionnaires on DC, level of shared decision‐making (SDM), and a knowledge test directly after counseling and 6 months after treatment. Descriptive statistics and Spearman correlation tests were used to analyze the data. Results: Directly after counseling, almost all participants (44/45; 98%) experienced Clinically Significant DC score (CSDC >25, scale 0–100). On average, patients scored 47% (SD 20%) correct on the knowledge test. Questions related to radiotherapy were answered best (69%, SD 29%), whilst only 35% (SD 29%) of the questions related to laryngectomy were answered correctly. Patients' perceived level of SDM (scale 0–100) was 70 (mean, SD 16.2), and for physicians this was 70 (SD 1.7). Conclusion: Most patients with advanced larynx cancer experience high levels of DC. Low knowledge levels regarding treatment aspects indicate a need for better patient counseling. Level of Evidence: 4 Laryngoscope, 134:3604–3610, 2024 [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: Decisional conflict is used increasingly as an outcome measure in advance care planning (ACP) studies. When the Decisional Conflict Scale (DCS) is used in anticipatory decision‐making contexts, the scale is typically tethered to hypothetical scenarios. This study reports preliminary validation data for hypothetical scenarios relating to life‐sustaining treatments and care utilisation to inform their broader use in ACP studies. Methods: Three hypothetical scenarios were developed by a panel of multidisciplinary researchers, clinicians and community representatives. A convenience sample of 262 older adults were surveyed. Analyses investigated comprehensibility, missing data properties, sample norms, structural, convergent and discriminant validity. Results: Response characteristics suggested that two of the scenarios had adequate comprehensibility and response spread. Missing response rates were unrelated to demographic characteristics. Predicted associations between DCS scores and anxiety (r's =.31–.37, p <.001), and ACP engagement (r's = −.41 to −.37, p <.001) indicated convergent validity. Conclusion: A substantial proportion of older adults reported clinically significant levels of decisional conflict when responding to a range of hypothetical scenarios about care or treatment. Two scenarios showed acceptable comprehensibility and response characteristics. A third scenario may be suitable following further refinement. Patient or Public Contribution: The scenarios tested here were designed in collaboration with a community representative and were further piloted with two groups of community members with relevant lived experiences; four people with life‐limiting conditions and five current or former care partners. [ABSTRACT FROM AUTHOR]

Aim: Patient understanding of disease can guide decision‐making in the management of anal fistula. This prospective feasibility study aimed to assess the acceptability and methods of assessing the impact of viewing realistic models on patients with anal fistula. Methods: New referrals to a tertiary clinic participated in this single‐centre, parallel‐group randomized controlled study. Baseline characteristics, Decisional Conflict Scale and understanding of disease were assessed pre‐consultation. Participants were randomized to a standard consultation, where disease and treatment options were explained using magnetic resonance images and drawn diagrams, or a similar consultation supplemented with an appropriate generic three‐dimensional (3D) printed model. Understanding of disease and proposed surgery, Decisional Conflict Scale and ratings of visual aids were assessed post‐consultation, along with 3D model feedback. Results: All 52 patients who were approached agreed to be randomized (25 standard, 27 3D consultation). Understanding of disease increased post‐consultation in both groups. Post‐consultation decisional conflict (0, no; 100, high decisional conflict) was low (median 27 post‐standard vs. 24 post‐3D consultation). Patients scored highly on measures assessing understanding of proposed surgery. 3D models were rated highly, with 96% of patients wanting to see them again in future consultations. Conclusions: Three‐dimensional printed fistula models are a welcome addition to outpatient consultations with results suggesting that understanding of surgery is improved. A future trial should be powered to detect whether 3D models result in a significant improvement in understanding beyond traditional methods of explanation and explore the conditions in which models have their maximal utility. ClinicalTrials.gov Registration ID This study was registered on ClinicalTrials.gov (ID: NCT04069728). Registered on 23 August 2019. [ABSTRACT FROM AUTHOR]

Background: Informed consent is an ethical prerequisite for psychotherapy. There are no routinely used standardized strategies for obtaining informed consent. A new optimized informed consent consultation (OIC) strengthened treatment‐relevant aspects. It remains unclear which factors influence the OIC efficacy regarding clinical and decision‐related outcomes. Methods: N = 122 adults were included in a randomized controlled online trial. Participants received an information brochure on psychotherapy (TAU; n = 61) or OIC + TAU (n = 61). The main and interaction effects of group allocation, therapeutic alliance, prior knowledge about psychotherapy and treatment motivation on treatment expectations, decisional conflict and capacity to consent were tested. Floodlight analyses were conducted for significant interactions. Results: Large interaction effects were shown between treatment motivation and group allocation on treatment expectations (β = −0.53) and between prior knowledge and group assignment on capacity to consent (β = 0.68). The interaction between treatment motivation and group allocation was significant up to a motivation score of 5.54 (range: 1–7). The interaction between prior knowledge and group assignment was significant up to a knowledge score of 14.38 (range: 5–20). Conclusion: Moderator analyses indicated varying efficacy degrees for the OIC regarding decisional outcomes and expectation. Especially patients with little treatment motivation or low prior knowledge benefited from optimized information about the efficacy and possible side effects of psychotherapy. Trial Registration: PsychArchives (https://doi.org/10.23668/psycharchives.4929): 17.06.2021 [ABSTRACT FROM AUTHOR]

Couples at risk of transmitting a genetic disease to their offspring may experience doubts about their reproductive options. This study examines the effects of an online decision aid (DA) on the (joint) reproductive decision‐making process of couples (not pregnant at time of inclusion) at risk of transmitting a genetic disease to their offspring. The primary outcome is decisional conflict, and secondary outcomes are knowledge, realistic expectations, deliberation, joint informed decision‐making, and decisional self‐efficacy. These outcomes were measured with a pretest–posttest design: before use (T0), after use (T1), and 2 weeks after use (T2) of the decision aid (DA). Usability of the DA was assessed at T1. Paired sample t‐tests were used to compute differences between baseline and subsequent measurements. The comparisons of T0‐T1 and T0‐T2 indicate a significant reduction in mean decisional conflict scores with stronger effects for participants with high baseline decisional conflict scores. Furthermore, use of the DA led to increased knowledge, improved realistic expectations, and increased levels of deliberation, with higher increase in participants with low baseline scores. Decision self‐efficacy only improved for participants with lower baseline scores. Participants indicated that the information in the DA was comprehensible and clearly organized. These first results indicate that this online DA is an appropriate tool to support couples at risk of transmitting a genetic disease and a desire to have (a) child(ren) in their reproductive decision‐making process. [ABSTRACT FROM AUTHOR]

As uptake of rapid genome sequencing (GS) in the neonatal period steadily increases, a clinical genetics service that is optimized to the needs of parents becomes increasingly important. We aimed to investigate factors that influence decision making about rapid GS by parents of infants admitted to neonatal intensive care units (NICU) and explore their experiences of decisional conflict and anxiety during this time. Parents of neonates suspected of having a genetic disorder and offered rapid GS in the NICU completed a questionnaire measuring experience with GS counseling, decisional conflict, and anxiety level. Our results demonstrate that despite a largely positive GS experience (70%; 21/30) among the survey respondents, 50.0% (14/28) experienced moderate to severe anxiety measured using the GAD‐7 scale, and 34.6% (9/26) experienced decisional conflict measured using the SURE scale. We also showed that prematurity may be a modifier of anxiety in this group of parents and although not statistically significant, distance lived away from the hospital site could have practical significance. Open‐ended responses to survey questions highlighted that feeling overwhelmed, the types of engagements parents had with healthcare providers, and the timing of information provision also influenced parental decision making in this setting. We suggest that the GAD‐7 scale for generalized anxiety and SURE scale for decisional conflict could be incorporated by genetic counselors into routine care of parents of neonates who have been offered rapid GS to identify those who may need additional support (resources, information, or psychological). These tools may inform ways that communication between patients and providers can be improved and enhanced and clinical genetics services in the NICU can be optimized. We suggest that integrating genetic counselors into the NICU care team could increase access for this population and ensure delivery of optimized patient education and counseling. [ABSTRACT FROM AUTHOR]

Objective: Preparing family surrogates for patient death and end-of-life (EOL) decision making may reduce surrogate decisional conflict and regret. Preparedness for patient death involves cognitive and emotional preparedness. We assessed the associations of surrogates' death-preparedness states (that integrate both cognitive and emotional preparedness for patient death) with surrogates' decisional conflict and regret.Methods: Associations of 173 surrogates' death-preparedness states (no, cognitive-only, emotional-only, and sufficient preparedness states) with decisional conflict (measured by the Decision Conflict Scale) and heightened decisional regret (Decision Regret Scale scores >25) were evaluated using hierarchical linear modeling and hierarchical generalized linear modeling, respectively, during a longitudinal observational study at a medical center over cancer patients' last 6 months.Results: Surrogates reported high decisional conflict (mean [standard deviation] = 41.48 [6.05]), and 52.7% of assessments exceeded the threshold for heightened decisional regret. Surrogates in the cognitive-only preparedness state reported a significantly higher level of decisional conflict (β = 3.010 [95% CI = 1.124, 4.896]) than those in the sufficient preparedness state. Surrogates in the no (adjusted odds ratio [AOR] [95% CI] = 0.293 [0.113, 0.733]) and emotional-only (AOR [95% CI] = 0.359 [0.149, 0.866]) preparedness states were less likely to suffer heightened decisional regret than those in the sufficient preparedness state.Conclusions: Surrogates' decisional conflict and heightened decisional regret are associated with their death-preparedness states. Improving emotional preparedness for the patient's death among surrogates in the cognitive-only preparedness state and meeting the specific needs of those in the no, emotional-only, and sufficient preparedness states are actionable high-quality EOL-care interventions that may lessen decisional conflict and decisional regret. [ABSTRACT FROM AUTHOR]

Purpose: To examine the trajectory of decisional conflict and anxiety experienced by adolescents after the cancer diagnosis, and explore their perceptions on participation in shared decision‐making (SDM). Design: This longitudinal study used incorporated data from questionnaires and interviews. Methods: Participants recruited from an academic hospital in southern Taiwan ranged in age from 13 to 20 years with a cancer diagnosis within 1 month and received cancer treatment. Each participant completed questionnaires on decisional conflict and anxiety at diagnosis, 1, 3, and 6 months later. Individual interviews were to gain an in‐depth understanding of SDM. Findings: Total scores on decisional conflict changed significantly over time (F = 2.98, p = 0.039); the scores at 1 month were higher than 3 months (t = 2.18, p = 0.04) and 6 months (t = 2.97, p = 0.008). Participants perceived significantly different levels of values clarify (F = 9.49, p < 0.01) and support (F = 8.46, p < 0.01) over time. Only 27.3% of participants were anxiety‐free. No significant differences were found in anxiety over time. The perception of SDM was a situational involvement. Conclusions: Decisional conflict changed over time. Participants experienced greater decisional conflict at 4–8 weeks after diagnosis and their anxiety did not decrease over time. The different levels of participation in SDM during their treatment trajectory were found. Clinical Relevance: Participants experienced the highest decisional conflict during diagnosis, and highlighted how their roles in healthcare discussions varied from direct participation to indirect involvement. Further research is needed to develop an SDM model which accommodates different levels of needs and implements timely support. [ABSTRACT FROM AUTHOR]

Many parents are motivated to pursue genome‐wide (exome or genome) sequencing to find a diagnosis for their child with a suspected but undiagnosed genetic condition. However, the impact of the genomic test extends beyond the provision of results and the so‐called 'diagnostic odyssey'. Our goal was to quantify post‐test decisional regret and characterize long‐term, post‐test experiences and unmet needs of the parents of children with suspected genetic diseases after they had received the results of genome‐wide sequencing. Study participants were parents of children who underwent trio genome‐wide sequencing as part of the CAUSES research study at Children's & Women's Health Centre of British Columbia. About half of the participants received a definite or likely genetic diagnosis after clinical interpretation of the genome‐wide sequencing results. Parents who participated in the current study (n = 121) completed the Decisional Regret Scale four weeks after receiving results. A subset of these parents (n = 32) had semi‐structured interviews a median of 7 months (range 3–20 months) after results disclosure and post‐test genetic counseling. Most parents expressed either no regret or mild regret about having undergone genome‐wide sequencing on both the Decisional Regret Scale and in the interviews. Parents whose children did not receive a genetic diagnosis were slightly more likely to have decisional regret on this quantitative scale. Analysis of transcribed interviews revealed the following major themes: (a) a lack of decisional conflict around having the testing; (b) a lack of decisional regret post‐testing; (c) expressions of both relief and continued uncertainty around the meaning of a genetic diagnosis; (d) expression of initial disappointment and evolving interpretation surrounding a result yielding no genetic diagnosis; and (e) needing time to absorb the test results. Our results suggest that parents need time to absorb the testing results and that long‐term post‐test counseling, including acknowledging feelings of relief, loss, and disappointment, may help parents adapt to the genomic test results and assist families to anticipate and plan for the next steps in their child's medical trajectory, whether or not a diagnosis is found. [ABSTRACT FROM AUTHOR]

Objectives: Numerous therapies exist for adult obstructive sleep apnea (OSA), creating potential for patient decisional conflict (DC) that impacts treatment adherence and post‐treatment regret. We evaluated the prevalence of elevated DC in OSA patients presenting for positive airway pressure (PAP) alternative therapies and identified gaps in available resources about OSA therapies. Study Design: Cross‐sectional study. Methods: A cross‐sectional study was performed based on questionnaires completed by adult OSA patients presenting to an academic sleep surgery clinic from March to October 2020. Surveys examined sleep symptoms, sleep apnea treatment history, goals of therapy, and the SURE checklist, a validated 4‐item DC screening scale. Additional qualitative data about OSA decision tool needs were queried with structured interviews in a smaller subset of patients. Results: Among 100 respondents, 60 were open to multiple treatment options, whereas 22 were not interested in surgical treatment. Eighty‐one respondents (81%) had elevated DC (SURE score < 4). High DC was not associated with CPAP history, OSA severity, or daytime sleepiness (Epworth Sleepiness Scale score ≥ 10). Elevated DC was related to uncertainty regarding optimal treatment choice in 54% of respondents (n = 54), and lack of knowledge regarding risks and benefits of each treatment option in 71% (n = 71). Common themes identified in 9 interviewed patients suggested helpful resources should ideally compare treatment modalities and educate on surgery details, efficacy, and recovery. Conclusions: The majority of OSA patients presenting to sleep surgery clinics have elevated decisional conflict influenced by limited knowledge about options and the risks and benefits of each therapy. There is a need for decision tools that can reduce decisional conflict and promote equitable knowledge about PAP alternative OSA treatments. Level of Evidence: 4 Laryngoscope, 131:2384–2390, 2021 [ABSTRACT FROM AUTHOR]

Objective: To assess the relationship between depression, anxiety, stress, worry, intolerance of uncertainty (IU), and shared decision making (SDM) in parents of pediatric otolaryngology surgical patients with their perceptions of decisional conflict (DC). Study Design: Cross-sectional. Setting: Academic pediatric otolaryngology outpatient clinic. Methods: Participants were legal guardians of pediatric patients who met criteria for otolaryngologic surgery. Participants completed a demographic survey as well as validated Decisional Conflict Scale (DCS); Shared Decision-Making Scale (SDMS); Depression, Anxiety and Stress Scale–21 (DASS-21); Penn State Worry Questionnaire (PSWQ); and short form of the Intolerance of Uncertainty Scale (IUS-12). Results: A total of 114 participants were enrolled. Respondents were predominantly female (93.0%) and married (60.5%). Most guardians had not consented previously for otolaryngologic surgery for their child (69.3%). Participants reported low levels of DC and depression as well as moderate levels of anxiety and stress. DC scores were not significantly correlated to DASS-21, PSWQ, or SDM. IUS-12 Total and subscale IUS-12 prospective negatively correlated with Total DC. DC was not related to age, sex, education level, previous otolaryngologic surgery, or type of surgery recommended. Conclusion: In this group, an association was found between IU and DC. Clinicians should be aware that DC is not modified by previous surgical experience. Interventions aimed at addressing parental IU related to surgery may reduce DC. Further research efforts could help us understand how mental health relates to surgical decision making. [ABSTRACT FROM AUTHOR]

Objectives: Shared decision‐making describes a collaborative process in which healthcare providers and patients/families make treatment decisions using the best available evidence, while taking into account the patient's values and preferences. The objectives of this study were to assess the level of decisional conflict and shared decision‐making experienced by older children and their parents when considering elective adentonsillectomies. Design: A prospective cohort study. Setting: Paediatric otolaryngology clinic in a teaching hospital. Participants: Participants included 53 children older than 9 years and their parents who underwent consultation for tonsillectomy with or without adenoidectomy. Main outcomes measures: Children and parents completed the Decisional Conflict Scale (DCS) and Shared Decision‐Making Questionnaire‐Patient Version (SDM‐Q‐9). Surgeons completed the Shared Decision‐Making Questionnaire‐Physician Version (SDM‐Q‐Doc). Results: Overall, 10 (19%) parents and 18 (34%) children reported clinically significant decisional conflict. Parents who opted not to proceed with surgery had significantly higher DCS scores than those who decided to proceed with surgery. Both parents and children SDM‐Q‐9 and total DCS scores were significantly negatively correlated. Physician SDM‐Q‐Doc and parent total DCS scores were negatively correlated, while parent and physician SDM scores were positively correlated. Conclusions: Many older children and parents reported significant decisional conflict when considering elective paediatric otolaryngology surgery. Decisional conflict levels for both children and parents decreased with greater perceived levels of shared decision‐making. Older children did not appear to discern the same levels of shared decision‐making as parents and surgeons. Future research should assess methods to implement shared decision‐making into clinical practice for clinicians, parents and children when appropriate. [ABSTRACT FROM AUTHOR]

Objectives: To determine if shared decision-making tools (SDMTs) improve clinical outcomes for these children. Shared decision making (SDM) is a collaborative process in which patients and clinicians jointly establish treatment plans that integrate clinical evidence and patient values/preferences. We previously reported less decisional conflict using a SDMT for families of children with obstructive sleep apnea (OSA) without tonsillar hypertrophyl; however, the clinical impact of this finding is unknown.Methods: Prospective single-blind randomized controlled trial for consecutive patients referred to a multidisciplinary upper airway center. The study group used a SDMT, whereas the control group did not; all were followed until their next appointment and polysomnogram.Results: We assessed 50 families (24 study, 26 controls); mean age of patients was 8.8 (95% confidence interval 6.9-10.6) years, and 44% were female. After their initial visit, there was agreement between families and providers on the best treatment option for 22 of 24 (91.7%) study patients and 12 of 26 (46.2%) controls (P < 0.001). Before the first follow-up, four control families (15.4%) modified their treatment plan, whereas none of the study families did so (P =  0.04). Continuous positive airway pressure (CPAP) compliance was 27% (3 of 11) for controls and 57% (5 of 8) for study patients (P =  0.11). The median obstructive apnea-hypopnea index significantly improved in study patients from 13.4 (range, 20.0-57.2) to 3.5 (range 0.4-45.5, P =  0.01] events per hour, but not in controls, with 9.4 (range, 0.9-76.2) to 4.9 (range, 0-116, P =  0.10) events per hour.Conclusion: Families of children with OSA without tonsillar hypertrophy who were counseled regarding treatment options using SMDTs were more likely to undergo agreed upon treatment and had higher CPAP compliance.Level Of Evidence: 1b. Laryngoscope, 129:2646-2651, 2019. [ABSTRACT FROM AUTHOR]

Shared decision‐making (SDM) is a collaborative approach in which clinicians educate, support, and guide patients as they make informed, value‐congruent decisions. SDM improves patients' health‐related outcomes through increasing knowledge, reducing decisional conflict, and enhancing experience of care. We measured SDM in genetic counselling appointments with 27 pregnant women who were at increased risk to have a baby with a genetic abnormality. The eight experienced genetic counsellors who participated had no specific SDM training and were unaware that SDM was being assessed. Audio transcripts of appointments were scored using 'Observing Patient Involvement in Decision Making' (OPTION12). Patients' anxiety and decisional conflict were also assessed. The genetic counsellors' mean OPTION12score was 42.4% (SD 9.0%; possible range 0–100%). Specific SDM behaviours that scored highest included introducing the concept of equipoise and listing all options with their pros and cons. Behaviours that scored lowest included eliciting patients' preferred approach to receiving information and desired degree of involvement in decision‐making. Patients' levels of anxiety and decisional conflict were unassociated with genetic counsellors' OPTION12scores. Some SDM behaviours were better demonstrated in this prenatal genetic counselling study than others. Formal training of genetic counsellors in SDM may enhance use of this approach in their professional practice. [ABSTRACT FROM AUTHOR]

In our previous installment, we introduced shared decision making (SDM) as a collaborative process in which patients, families, and clinicians develop a mutually optimized treatment plan when more than 1 reasonable treatment option exists. In this subsequent installment of our Evidence-Based Medicine in Otolaryngology Series, we expand on the topic of SDM, including the related current state of clinical decision making, the impact of SDM on health care utilization and patient satisfaction, the potential role of system and society changes, the experience with SDM as it relates to race and ethnicity, existing financial incentives, and the validated instruments that assess the extent to which SDM occurs. [ABSTRACT FROM AUTHOR]

Objectives/hypothesis: Shared decision-making is a process whereby patients and clinicians jointly establish a treatment plan integrating clinical evidence and patient values and preferences. Although this approach has been successfully employed in numerous medical disciplines, often using shared decision-making tools, otolaryngologic research assessing its use is scant. Our primary objective was therefore to determine if the tools we developed reduced decisional conflict for children with obstructive sleep apnea without tonsillar hypertrophy.Study Design: Prospective, single-blind, randomized controlled trial.Methods: We enrolled consecutive patients meeting inclusion criteria who were referred to our multidisciplinary upper airway center. Study patients used a shared decision-making tool whereas controls did not. Measures of decisional conflict (SURE [Sure of myself, Understanding information, Risk benefit ratio, Encouragement], CollaboRATE, and the Decisional Conflict Scale [DCS]) were obtained pre- and postvisit.Results: We assessed 50 families (study group = 24, controls = 26). The mean age was 8.8 ± 6.6 years, 44% were female, 86% were white, and the mean obstructive apnea-hypopnea index was 12.7 ± 15.6 events/hour. The previsit mean DCS score was similar for controls (42.7) and study patients (40.8) (P = .38). The postvisit mean DCS score for controls was 13.3 and for study patients 6.1 (P = .034). Improvement in this score was greater in the study group (P = .03). At previsit evaluation, 63% of controls and 58% of study patients were unsure about their options. Postvisit, this improved to 4.1% and 0%, respectively.Conclusions: Families counseled regarding treatment options using shared decision-making tools had significantly less decisional conflict than those who did not use these tools. These positive outcomes suggest that clinicians should consider integrating this approach into clinical practice.Level Of Evidence: 1b. Laryngoscope, 128:1007-1015, 2018. [ABSTRACT FROM AUTHOR]

Shared decision making (SDM) is a collaborative process in which patients, families, and clinicians develop a mutually agreed upon treatment plan when more than one reasonable treatment option exists. This cooperative engagement fosters improvements in patient satisfaction, disease management, and outcomes and also has the capacity to promote evidence-based care. Thus, this seventh installment of our Evidence-Based Medicine in Otolaryngology series focuses on SDM. We introduce SDM, including its potential to reduce decisional conflict and decisional regret, when it should be used, its potential benefits, barriers to implementation, and its role in the management of chronic disease and otolaryngological conditions. [ABSTRACT FROM AUTHOR]

Background: Patients with prostate cancer and their providers face uncertainty as they consider adjuvant radiotherapy (ART) or salvage radiotherapy (SRT) after undergoing radical prostatectomy. The authors prospectively evaluated the impact of the Decipher test, which predicts metastasis risk after radical prostatectomy, on decision making for ART and SRT.Methods: A total of 150 patients who were considering ART and 115 who were considering SRT were enrolled. Providers submitted a management recommendation before processing the Decipher test and again at the time of receipt of the test results. Patients completed validated surveys on prostate cancer (PCa)-specific decisional effectiveness and PCa-related anxiety.Results: Before the Decipher test, observation was recommended for 89% of patients considering ART and 58% of patients considering SRT. After Decipher testing, 18% (95% confidence interval [95% CI], 12%-25%) of treatment recommendations changed in the ART arm, including 31% among high-risk patients; and 32% (95% CI, 24%-42%) of management recommendations changed in the salvage arm, including 56% among high-risk patients. Decisional Conflict Scale (DCS) scores were better after viewing Decipher test results (ART arm: median DCS before Decipher, 25 and after Decipher, 19 [P<.001]; SRT arm: median DCS before Decipher, 27 and after Decipher, 23 [P<.001]). PCa-specific anxiety changed after Decipher testing; fear of PCa disease recurrence in the ART arm (P = .02) and PCa-specific anxiety in the SRT arm (P = .05) decreased significantly among low-risk patients. Decipher results reported per 5% increase in 5-year metastasis probability were associated with the decision to pursue ART (odds ratio, 1.48; 95% CI, 1.19-1.85) and SRT (odds ratio, 1.41; 95% CI, 1.09-1.81) in multivariable logistic regression analysis.Conclusions: Knowledge of Decipher test results was associated with treatment decision making and improved decisional effectiveness among men with PCa who were considering ART and SRT. Cancer 2017;123:2850-59. © 2017 American Cancer Society. [ABSTRACT FROM AUTHOR]

Objectives/hypothesis: To date, there has been little research on shared decision making and decisional outcomes in pediatric surgery. The objectives of this study were to describe the level of decisional conflict and decisional regret experienced by parents considering otoplasty for their children, and to determine if they are related to perceptions of shared decision making.Study Design: Prospective cohort clinical study.Methods: Sixty-five consecutive parents of children who underwent surgical consultation for otoplasty were prospectively enrolled. Participants completed the Demographic Form, the Decisional Conflict Scale, and the Shared Decision-Making Questionnaire after the consultation visit. The consulting surgeons completed the physician version of the Shared Decision-Making Questionnaire. Six months after surgery, parents completed the Decisional Regret Scale.Results: The median decisional conflict was 15.63; 21 (32.8%) parents scored 25 or above, a previously defined cutoff indicating clinically significant decisional conflict. Parent ratings of shared decision making and decisional conflict were significantly negatively correlated (P < 0.001); however, there was no significant correlation between physician ratings of shared decision making and parental decisional conflict. Significant decisional regret was reported in two (3.2%) participants. Decisional regret and parent and physician ratings of shared decision making were both significantly negatively correlated (P = 0.044 and P = 0.001, respectively). Decisional regret and decisional conflict scores were significantly positively correlated (P = 0.001). Parent and physician ratings of shared decision making were correlated (intraclass correlation = 0.625, P < 0.001).Conclusion: Many parents experienced significant decisional conflict when making decisions about their child's elective surgical treatment. Fewer parents experienced significant decisional regret after the procedure. Parents who perceived themselves as being more involved in the decision making process reported less decisional conflict and decisional regret. Parents and physicians had varied perceptions of the degree of shared decision making. Future research should develop interventions to increase parents' involvement in decision making and explore the influence of significant decisional conflict and decisional regret on health outcomes.Level Of Evidence: 2b. Laryngoscope, 126:S5-S13, 2016. [ABSTRACT FROM AUTHOR]

Background: The technologies currently available to detect the presence of foetal genetic abnormalities are complex, and undergoing prenatal diagnostic testing can have wide‐ranging repercussions. Before individuals can decide with certainty whether or not to take these tests, they first need to grasp the many psychosocial and clinical dimensions of prenatal genetic testing. Objective: To test a model integrating key psychosocial and clinical factors as predictors of decisional conflict in decisions about whether or not to undergo prenatal genetic testing. Method: Adults (n = 457) read one of four hypothetical scenarios asking them to imagine expecting a child and considering the option of a prenatal test able to detect a genetic condition; age of condition onset (birth vs. adulthood) and its curability (no cure vs. curable) were manipulated. Participants completed measures of decisional conflict, perceived benefits from normal results, test response efficacy, condition coherence, child‐related worry, perceived disagreement with the other parent's preference, motivation to comply with doctors' perceived preferences, and parity. Results: Prenatal testing decisional conflict was positively predicted by perceiving normal results as beneficial, doubting the test's reliability, lacking understanding of the genetic condition, worrying about the health of the foetus, perceiving differences of opinion from partner/spouse, wanting to follow doctors' preferences, and being childless. Discussion: These results, of growing relevance given the increasing availability of new technologies in pregnancy care, can inform communication strategies that facilitate coupless' decision making. Conclusion: This study provides insights into factors that might complicate prenatal testing decision making. [ABSTRACT FROM AUTHOR]

Background Oral anticoagulation reduces stroke and disability in atrial fibrillation (AF) but is underused. We evaluated the effects of a novel patient-clinician shared decision-making (SDM) tool in reducing oral anticoagulation patient's decisional conflict as compared with usual care. Methods and Results We designed and evaluated a new digital decision aid in a multicenter, randomized, comparative effectiveness trial, ENHANCE-AF (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention). The digital AF shared decision-making toolkit was developed using patient-centered design with clear health communication principles (eg, meaningful images, limited text). Available in English and Spanish, the toolkit included the following: (1) a brief animated video; (2) interactive questions with answers; (3) a quiz to check on understanding; (4) a worksheet to be used by the patient during the encounter; and (5) an online guide for clinicians. The study population included English or Spanish speakers with nonvalvular AF and a CHA 2 DS 2 -VASc stroke score ≥1 for men or ≥2 for women. Participants were randomized in a 1:1 ratio to either usual care or the shared decision-making toolkit. The primary end point was the validated 16-item Decision Conflict Scale at 1 month. Secondary outcomes included Decision Conflict Scale at 6 months and the 10-item Decision Regret Scale at 1 and 6 months as well as a weighted average of Mann-Whitney U -statistics for both the Decision Conflict Scale and the Decision Regret Scale. A total of 1001 participants were enrolled and followed at 5 different sites in the United States between December 18, 2019, and August 17, 2022. The mean patient age was 69±10 years (40% women, 16.9% Black, 4.5% Hispanic, 3.6% Asian), and 50% of participants had CHA 2 DS 2 -VASc scores ≥3 (men) or ≥4 (women). The primary end point at 1 month showed a clinically meaningful reduction in decisional conflict: a 7-point difference in median scores between the 2 arms (16.4 versus 9.4; Mann-Whitney U -statistics=0.550; P =0.007). For the secondary end point of 1-month Decision Regret Scale, the difference in median scores between arms was 5 points in the direction of less decisional regret ( P =0.078). The treatment effects lessened over time: at 6 months the difference in medians was 4.7 points for Decision Conflict Scale ( P =0.060) and 0 points for Decision Regret Scale ( P =0.35). Conclusions Implementation of a novel shared decision-making toolkit (afibguide.com; afibguide.com/clinician) achieved significantly lower decisional conflict compared with usual care in patients with AF. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04096781.

Objective The decisional conflict scale ( DCS) measures the perception of uncertainty in choosing options, factors contributing to decision conflict and effective decision making. This study examined the validity and reliability of the Chinese version of the DCS in Hong Kong Chinese women deciding breast cancer ( BC) surgery. Method A Chinese version of the 16-item DCS was administered to 471 women awaiting initial consultation for BC diagnosis. Confirmatory factor analysis ( CFA) assessed the factor structure. Internal consistency, and convergent and discriminant validities of the factor structure were assessed. Results CFA revealed the original factor structure of the DCS showed poor fit to this sample. Exploratory factor analysis revealed an alternative three-factor structure, Informed and Values Clarity, Uncertainty and Effective Decision and Support, was optimal. Cronbach's alpha ranged from 0.51 to 0.87. Correlations between decision-making difficulties and satisfaction with medical consultation demonstrated acceptable convergent validity. Construct validity was supported by correlations between decision regret and psychological distress. Discriminant validity was supported by differentiation between delaying and non-delaying decision-makers. Conclusions The three-factor DCS-14 is a valid and practical measure for assessing decisional conflict in deciding BC surgery. It shows good potential for use in assessing decision satisfaction for women diagnosed with BC. [ABSTRACT FROM AUTHOR]

Background Childbirth fear is associated with increased obstetric interventions and poor emotional and psychological health for women. The purpose of this study is to test an antenatal psycho-education intervention by midwives in reducing women's childbirth fear. Methods Women ( n = 1,410) attending three hospitals in South East Queensland, Australia, were recruited into the BELIEF trial. Participants reporting high fear were randomly allocated to intervention ( n = 170) or control ( n = 169) groups. All women received a decision-aid booklet on childbirth choices. The telephone counseling intervention was offered at 24 and 34 weeks of pregnancy. The control group received usual care offered by public maternity services. Primary outcome was reduction in childbirth fear ( WDEQ-A) from second trimester to 36 weeks' gestation. Secondary outcomes were improved childbirth self-efficacy, and reduced decisional conflict and depressive symptoms. Demographic, obstetric & psychometric measures were administered at recruitment, and 36 weeks of pregnancy. Results There were significant differences between groups on postintervention scores for fear of birth ( p < 0.001) and childbirth self-efficacy ( p = 0.002). Decisional conflict and depressive symptoms reduced but were not significant. Conclusion Psycho-education by trained midwives was effective in reducing high childbirth fear levels and increasing childbirth confidence in pregnant women. Improving antenatal emotional well-being may have wider positive social and maternity care implications for optimal childbirth experiences. [ABSTRACT FROM AUTHOR]

BACKGROUND Decisional conflict is a source of anxiety and stress for men diagnosed with prostate cancer given uncertainty surrounding myriad treatment options. Few data exist to help clinicians identify which patients are at risk for decisional conflict. The purpose of this study was to examine factors associated with decisional conflict in economically disadvantaged men diagnosed with prostate cancer before any treatment choices were made. METHODS A total of 70 men were surveyed at a Veterans Administration clinic with newly diagnosed localized prostate cancer enrolled in a randomized trial testing a novel shared decision-making tool. Baseline demographic, clinical, and functional data were collected. Independent variables included age, race, education, comorbidity, relationship status, urinary/sexual dysfunction, and prostate cancer knowledge. Tested outcomes were Decisional Conflict Scale, Uncertainty Subscale, and Perceived Effectiveness Subscale. Multiple linear regression modeling was used to identify factors associated with decisional conflict. RESULTS Mean age was 63 years, 49% were African American, and 70% reported an income less than $30,000. Poor prostate cancer knowledge was associated with increased decisional conflict and higher uncertainty ( P < .001 and P = 0.001, respectively). Poor knowledge was also associated with lower perceived effectiveness ( P = 0.003) whereas being in a relationship was associated with higher decisional conflict ( P = 0.03). CONCLUSIONS Decreased patient knowledge about prostate cancer is associated with increased decisional conflict and lower perceived effective decision-making. Interventions to increase comprehension of prostate cancer and its treatments may reduce decisional conflict. Further work is needed to better characterize this relationship and identify effective targeted interventions. Cancer 2014;120:2721-2727. © 2014 American Cancer Society. [ABSTRACT FROM AUTHOR]

Background: The decision to pursue fertility preservation (FP) after a cancer diagnosis is complex. We examined the prevalence of high decisional conflict and specific factors that influence this decision using the Decisional Conflict Scale (DCS).Methods: The FIRST project is a web-based survey of female cancer survivors (ages 18-44 years) who have undergone gonadotoxic treatment. We evaluated the association between recalled decisional conflict and referral to FP counseling and demographic, socioeconomic, and cancer variables.Results: Of 208 participants, 115 subjects (55%) had scores consistent with high decisional conflict (DCS score >37.5 of 100), and 43 (21%) were in the moderate range (25-37.5). In unadjusted analysis, high decisional conflict was associated with lack of referral to FP consultation, not undergoing FP treatment, concerns regarding FP cost, length of survivorship, lower income, education, partner status, and cancer type. In multivariable analysis, significantly higher prevalence of high decisional conflict was observed in participants who were not referred for FP consultation (prevalence ratio [PR], 1.25; 95% confidence interval [CI], 1.06-1.47), as well as in participants who reported cost of FP services to be prohibitive (PR, 1.16 [95% CI, 1.03-1.31]). Prevalence of high DCS was lower for women who underwent FP treatment (PR, 0.67 [95% CI, 0.52-0.86]).Conclusions: In this study of female young adult cancer survivors, the majority recalled significant decisional conflict about FP at cancer diagnosis. Increasing access to FP via referral for counseling and cost reduction may decrease decisional conflict about FP for young patients struggling with cancer and fertility decisions. [ABSTRACT FROM AUTHOR]

Objectives To study associations between pregnant women's knowledge of prenatal screening and decisional conflict in deciding whether to participate in first-trimester screening for Down syndrome in a setting of required informed consent, and to study associations between knowledge and personal wellbeing, and worries in pregnancy. Methods A population-based cross-sectional study with 6427 pregnant women consecutively included before the time of a nuchal translucency scan. Participants were recruited from three Danish obstetric departments offering prenatal screening free of charge. The results presented are based on 4111 pregnant women (64%). Knowledge was measured using 15 questions. The primary outcomes were measured using pre-existing validated scales, i.e. The Decisional Conflict Scale, the WHO Well-Being Index and the Cambridge Worry Scale. Associations were analyzed by multivariate logistic and linear regression analyses. Results A higher level of knowledge was associated with less decisional conflict when deciding whether to participate in first-trimester Down syndrome screening (adjusted odds ratio 1.31 (95% CI, 1.26-1.37)). An increased level of knowledge was also associated with higher levels of wellbeing (adjusted linear coefficient 0.51 (95% CI, 0.26-0.75), P < 0.001). Knowledge was not associated with worries, either in general or specifically about something being wrong with the baby. Conclusion The results of this study indicate the importance of ensuring a high level of knowledge for pregnant women making choices about participation in prenatal screening for Down syndrome in order to improve the psychological management of test decisions. Copyright © 2011 ISUOG. Published by John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

This study investigated differences in the emergence of decisional conflict in healthy and depressed participants. The two groups of interest were questioned about their experience of decisional conflict and ongoing thoughts and impressions during decision making. As predicted, depressed participants experienced more decisional conflict than healthy participants. Furthermore, the diverse processes hypothesis was supported: In healthy participants, preoccupation with the task was the only predictor of decisional conflict. In depressed participants, decisional conflict was predicted by a combination of depression-related processes (e.g. low self-efficacy, lack of concentration, rumination, etc.). This research reduces the gap between the relevance of the symptom of indecisiveness (e.g. for diagnostic purposes) and the lack of knowledge in this realm of psychopathology. Copyright © 2009 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To examine the effect of enhanced information regarding the risks, benefits, and life-sustaining treatment alternatives on hypothetical medical decisions and decisional conflict in older, community-dwelling Caucasian and African-American adults. DESIGN: Two-group (enhanced information; no information) between-subjects design. SETTING: Community-based dwellings, two assisted living facilities, and one senior citizen center. PARTICIPANTS: Seventy-eight adults (aged 74.5±7.18) with a mean Telephone Interview for Cognitive Status—Modified (TICS-m) score of 31.5±4.7 were recruited through personal contacts and informational talks held at the recruitment sites. MEASUREMENTS: Measures included the Life Support Preferences/Predictions Questionnaire—modified (LSPQ-m); the Decisional Conflict Scale; and enhanced information, including detailed descriptions of life-sustaining treatment options for each LSPQ-m illness scenario, risks of the treatment, benefits of the treatment, and alternatives for each treatment (called medical information stimuli). RESULTS: Enhanced information (e.g., medical information stimuli) reduced decisional conflict ( P=.049, d=0.47) for hypothetical life-sustaining treatment decisions. A mixed analysis of variance with group and race as between-subjects variables and illness and treatment as within-subjects variables revealed significant main effects of race, illness, and treatment, as well as a significant race-by-illness-by-group interaction (Wilk's lambda=0.923, F(2, 73)=3.05, P=.05, partial η2=0.08). Enhanced information produced different patterns of desire for life-sustaining treatments in African Americans and Caucasians. CONCLUSION: Physicians and other healthcare professionals can reduce decisional conflict in patients by providing enhanced information regarding treatment risks, benefits, and alternatives. Such decision aids may provide new information or knowledge and thus reduce desire for treatment in African Americans. [ABSTRACT FROM AUTHOR]

Objective To evaluate the effectiveness of a decision aid for prenatal testing of fetal abnormalities compared with a pamphlet in supporting women’s decision making. Design A cluster randomised controlled trial. Setting Primary health care. Population Women in early pregnancy consulting a GP. Methods GPs were randomised to provide women with either a decision aid or a pamphlet. The decision aid was a 24-page booklet designed using the Ottowa Decision Framework. The pamphlet was an existing resource available in the trial setting. Main outcome measures Validated scales were used to measure the primary outcomes, informed choice and decisional conflict, and the secondary outcomes, anxiety, depression, attitudes to the pregnancy/fetus and acceptability of the resource. Outcomes were measured at 14 weeks of gestation from questionnaires that women completed and returned by post. Findings Women in the intervention group were more likely to make an informed decision 76% (126/165) than those in the control group 65% (107/165) (adjusted OR 2.08; 95% CI 1.14–3.81). A greater proportion of women in the intervention group 88% (147/167) had a ‘good’ level of knowledge than those in the control group 72% (123/171) (adjusted OR 3.43; 95% CI 1.79–6.58). Mean (SD) decisional conflict scores were low in both groups, decision aid 1.71 (0.49), pamphlet 1.65 (0.55) (adjusted mean difference 0.10; 95% CI −0.02 to 0.22). There was no strong evidence of differences between the trial arms in the measures of psychological or acceptability outcomes. Conclusion A tailored prenatal testing decision aid plays an important role in improving women’s knowledge of first and second trimester screening tests and assisting them to make decisions about screening and diagnostic tests that are consistent with their values. [ABSTRACT FROM AUTHOR]

A large body of research suggests that preferences are constructed rather than merely accessed in the course of making decisions. The current research examines the stability of constructed preferences over time. Preferences for various factors relevant to a job choice were measured prior to presentation of the job-choice task, at the point of decision, and again following a delay. It was found that relative to baseline pre-decision levels, preferences shifted to provide stronger support for the emerging decision. Preference changes proved to be transient, receding to baseline after 1 week (Experiment 1), and even within 15 minutes (Experiment 2). These findings, which can be interpreted in terms of decision-making by constraint satisfaction, suggest that preferences are constructed to serve the decision at hand, without constraining the decision maker in future decisions. Copyright © 2007 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Objective To identify the determinants of the intention of physicians to screen for decisional conflict in clinical practice. Background Screening for decisional conflict is one of the key competencies when educating health professionals about shared decision making. Theory-based knowledge about variables predicting their intention to screen for decisional conflict in clinical practice would help design effective implementation interventions in this area. Design Data of two cross-sectional surveys embedded within a large implementation study of the Ottawa Decision Support Framework (ODSF) in primary care. Setting and participants In total, 122 health professionals from five family practice teaching units. Methods Intention to screen for decisional conflict in clinical practice was defined as the intention to use the clinical version of the Decisional Conflict Scale (DCS) with patients at the end of the clinical encounter. It was assessed at the entry and the exit from this study. Both intentions were entered as a dependent variable in multivariate analyses. Main results At entry, the intention was influenced by: attitude ( P < 0.001), subjective norm ( P < 0.001), perceived behavioural control ( P < 0.001) and clinical site ( P < 0.05). On exit, it was influenced by: subjective norm ( P < 0.001), perceived behavioural control ( P < 0.001), clinical site ( P < 0.05), international Continuing Medical Education (CME) ( P < 0.05), other diplomas ( P < 0.05) and intervention ( P < 0.05). In post hoc analyses, there was a statistically significant difference between entry and exit in the impact of the level of exposure to the multifaceted implementation intervention on the intention ( P = 0.003). Conclusions Variables predicting the intention of health professionals to screen for decisional conflict in clinical practice using the DCS change over time suggesting that effective implementation interventions in this area will need to be modified longitudinally. [ABSTRACT FROM AUTHOR]

Aim: The aim of this research study was to clarify the effect that counseling using the Ottawa Personal Decision Guide had on pregnant women in helping them to decide whether or not to undergo prenatal testing. It compared the “decisional conflict” of a group of women interviewed by a nurse using the guide with that of a second group who were only given standard genetic counseling. Methods: A group of pregnant women attending the hospital for genetic counseling was randomly divided into an intervention group and a control group. The women in the intervention group were given standard genetic counseling, followed by an interview based on the decision aid guide. The women in the control group were given only standard genetic counseling. Both groups were followed up. The primary outcome of the study was to determine the level of decisional conflict, as measured by the Japanese version of the Decisional Conflict Scale. The secondary outcome was self-esteem, based on the Rosenburg Self-Esteem Scale. The outcome indicators were obtained from responses given in patient questionnaires conducted after standard genetic counseling (pre-intervention) and after the conclusion of the decision-making process (postintervention). Results: The pre-intervention and postintervention changes in decisional conflict scores (primary outcome) indicated no significant difference between the two groups. However, with regard to postintervention decisional conflict, the rate of the response “mild to high decisional conflict” was lower for the intervention group than the control group. No significant difference between the two groups was detected for the secondary outcome of self-esteem. Conclusions: The reasons for the lack of a clear effect on the level of decisional conflict are that the pre-intervention responses for both groups were obtained after completion of the standard genetic counseling program and because follow-up conducted by the nurses took the form of care given in response to patients’ needs. The use of decision aids to assist in the decision-making process had no effect on the level of self-esteem in the two groups. As a result, there was a similar level of intervention for both groups. However, as there was no clear indication that the use of the Ottawa Personal Decision Guide was harmful, it will be a useful tool in the medical care setting. [ABSTRACT FROM AUTHOR]