An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared decision-making: Early feasibility pilot study.

BACKGROUND: Guidelines recommend shared decision making when choosing treatment for severe aortic stenosis but implementation has lagged. We assessed the feasibility and impact of a novel decision aid for severe aortic stenosis at point-of-care. METHODS: This prospective multi-site pilot cohort study included adults with severe aortic stenosis and their clinicians. Patients were referred by their heart team when scheduled to discuss treatment options. Outcomes included shared decision-making processes, communication quality, decision-making confidence, decisional conflict, knowledge, stage of decision making, decision quality, and perceptions of the tool. Patients were assessed at baseline (T0), after using the intervention (T1), and after the clinical encounter (T2); clinicians were assessed at T2. Before the encounter, patients reviewed the intervention, Aortic Valve Improved Treatment Approaches (AVITA), an interactive, online decision aid. AVITA presents options, frames decisions, clarifies patient goals and values, and generates a summary to use with clinicians during the encounter. RESULTS: 30 patients (9 women [30.0%]; mean [SD] age 70.4 years [11.0]) and 14 clinicians (4 women [28.6%], 7 cardiothoracic surgeons [50%]) comprised 28 clinical encounters Most patients [85.7%] and clinicians [84.6%] endorsed AVITA. Patients reported AVITA easy to use [89.3%] and helped them choose treatment [95.5%]. Clinicians reported the AVITA summary helped them understand their patients' values [80.8%] and make values-aligned recommendations [61.5%]. Patient knowledge significantly improved at T1 and T2 (p = 0.004). Decisional conflict, decision-making stage, and decision quality improved at T2 (p = 0.0001, 0.0005, and 0.083, respectively). Most patients [60%] changed treatment preference between T0 and T2. Initial treatment preferences were associated with low knowledge, high decisional conflict, and poor decision quality; final preferences were associated with high knowledge, low conflict, and high quality. CONCLUSIONS: AVITA was endorsed by patients and clinicians, easy to use, improved shared decision-making quality and helped patients and clinicians arrive at a treatment that reflected patients' values. TRIAL REGISTRATION: Trial ID: NCT04755426, Clinicaltrials.gov/ct2/show/NCT04755426.

Implementing Shared Decision-Making for Multiple Sclerosis: The MS-SUPPORT Tool.

BACKGROUND: Disease modifying therapies (DMTs) offer opportunities to improve the course of multiple sclerosis (MS), but decisions about treatment are difficult. People with multiple sclerosis (pwMS) want more involvement in decisions about DMTs, but new approaches are needed to support shared decision-making (SDM) because of the number of treatment options and the range of outcomes affected by treatment. We designed a patient-centered tool, MS-SUPPORT, to facilitate SDM for pwMS. We sought to evaluate the feasibility and impact of MS-SUPPORT on decisions about disease modifying treatments (DMTs), SDM processes, and quality-of-life. METHODS: This multisite randomized controlled trial compared the SDM intervention (MS-SUPPORT) to control (usual care) over a 12-month period. English-speaking adults with relapsing MS were eligible if they had an upcoming MS appointment and an email address. To evaluate clinician perspectives, participants' MS clinicians were invited to participate. Patients were referred between November 11, 2019 and October 23, 2020 by their MS clinician or a patient advocacy organization (the Multiple Sclerosis Association of America). MS-SUPPORT is an online, interactive, evidence-based decision aid that was co-created with pwMS. It clarifies patient treatment goals and values and provides tailored information about MS, DMTs, and adherence. Viewed by patients before their clinic appointment, MS-SUPPORT generates a personalized summary of the patient's treatment goals and preferences, adherence, DMT use, and clinical situation to share with their MS clinician. Outcomes (DMT utilization, adherence, quality-of-life, and SDM) were assessed at enrollment, post-MS-SUPPORT, post-appointment, and quarterly for 1 year. RESULTS: Participants included 501 adults with MS from across the USA (84.6% female, 83% white) and 34 of their MS clinicians (47% neurologists, 41% Nurse Practitioners, 12% Physician Assistants). Among the 203 patients who completed MS-SUPPORT, most (88.2%) reported they would recommend it to others and that it helped them talk to their doctor (85.2%), understand their options (82.3%) and the importance of taking DMTs as prescribed (82.3%). Among non-users of DMTs at baseline, the probability ratio of current DMT use consistently trended higher over one-year follow-up in the MS-SUPPORT group (1.30 [0.86-1.96]), as did the cumulative probability of starting a DMT within 6-months, with shorter time-to-start (46 vs 90 days, p=0.24). Among the 222 responses from 34 participating clinicians, more clinicians in the MS-SUPPORT group (vs control) trended towards recommending their patient start a DMT (9 of 108 (8%) vs 5 of 109 (5%), respectively, p=0.26). Adherence (no missed doses) to daily-dosed DMTs was higher in the MS-SUPPORT group (81.25% vs 56.41%, p=.026). Fewer patients forgot their doses (p=.046). The MS-SUPPORT group (vs control) reported 1.7 fewer days/month of poor mental health (p=0.02). CONCLUSIONS: MS-SUPPORT was strongly endorsed by patients and is feasible to use in clinical settings. MS-SUPPORT increased the short-term probability of taking and adhering to a DMT, and improved long-term mental health. Study limitations include selection bias, response bias, social desirability bias, and recall bias. Exploring approaches to reinforcement and monitoring its implementation in real-world settings should provide further insights into the value and utility of this new SDM tool.

What matters most to patients with severe aortic stenosis when choosing treatment? Framing the conversation for shared decision making.

BACKGROUND: Guidelines recommend including the patient's values and preferences when choosing treatment for severe aortic stenosis (sAS). However, little is known about what matters most to patients as they develop treatment preferences. Our objective was to identify, prioritize, and organize patient-reported goals and features of treatment for sAS. METHODS: This multi-center mixed-methods study conducted structured focus groups using the nominal group technique to identify patients' most important treatment goals and features. Patients separately rated and grouped those items using card sorting techniques. Multidimensional scaling and hierarchical cluster analyses generated a cognitive map and clusters. RESULTS: 51 adults with sAS and 3 caregivers with experience choosing treatment (age 36-92 years) were included. Participants were referred from multiple health centers across the U.S. and online. Eight nominal group meetings generated 32 unique treatment goals and 46 treatment features, which were grouped into 10 clusters of goals and 11 clusters of features. The most important clusters were: 1) trust in the healthcare team, 2) having good information about options, and 3) long-term outlook. Other clusters addressed the need for and urgency of treatment, being independent and active, overall health, quality of life, family and friends, recovery, homecare, and the process of decision-making. CONCLUSIONS: These patient-reported items addressed the impact of the treatment decision on the lives of patients and their families from the time of decision-making through recovery, homecare, and beyond. Many attributes had not been previously reported for sAS. The goals and features that patients' value, and the relative importance that they attach to them, differ from those reported in clinical trials and vary substantially from one individual to another. These findings are being used to design a shared decision-making tool to help patients and their clinicians choose a treatment that aligns with the patients' priorities. TRIAL REGISTRATION: ClinicalTrials.gov, Trial ID: NCT04755426, Trial URL https://clinicaltrials.gov/ct2/show/NCT04755426.

Shared Decision-Making and Short-Course Radiotherapy for Operable Rectal Adenocarcinoma: A Patient's Right to Choose.

BACKGROUND: As new treatment options for colorectal cancer (CRC) emerge, physicians and WOC nurses must be prepared to assist patients to choose care that meets their needs and preferences. A patient with T2N0M0 rectal adenocarcinoma was offered the US current standard of practice; he was not offered alternative treatment options. This case study emphasizes the need to ensure patients are offered all reasonable options for treatment. Shared decision-making is a process that helps patients actively participate in their heath choices rather than exclusively relying on the judgment of a health care provider. CASE: Mr J was a 70-year-old man with operable CRC who sought care at a health care facility in his community. He was offered a single option, based on standard of care for this tumor stage: long-course neoadjuvant chemoradiotherapy followed by surgery and additional chemotherapy. After seeking a second opinion at a cancer care center in another state, Mr J chose to undergo a viable alternative treatment option (short-course radiotherapy, followed by surgery, with chemotherapy contingent on his nodal status post-surgery). No nodal involvement was found post- surgery (T2N0M0) enabling him to avoid postoperative chemotherapy. CONCLUSIONS: This case illustrates the need for all health care providers and carers to regularly engage in shared decision-making when choosing among treatment options. In this case, short-course radiotherapy offered Mr J a shorter duration of treatment and avoided the risk for adverse side effects associated with chemotherapy, resulting in improved health-related quality of life. Initial omission to disclose all treatment options to Mr J may have reflected the preferences of the surgeon, institutional financial pressures, or discomfort with shared decision-making, but it failed to provide him with full range of options, given his diagnosis and tumor stage. All members of the patient's care team, including the WOC nurse, play a pivotal role in ensuring transparency in medical care, including advocating for shared decision-making where patients are made aware of all viable treatments, followed by supporting the patient as they reach a decision.

Efficacy of a patient decision aid for improving person-centered decision-making by older adults with obstructive sleep apnea.

STUDY OBJECTIVES: Person-centered obstructive sleep apnea (OSA) care is a collaborative approach that is respectful of an individual's health priorities. Informed decision-making is essential to person-centered care, especially as patients age. In a feasibility study, we evaluated the effects of a new decision aid (Decide2Rest) on OSA treatment decision-making in older adults. METHODS: Patients (aged ≥ 60 years) with newly diagnosed OSA were recruited from two health care systems and randomized either to Decide2Rest or to a control program. Postintervention outcomes included 1) Decisional Conflict Scale (0-100, where 0 = low and 100 = high conflict), which measures perceptions of uncertainty, whether decisions reflect what matters most to patients, and whether patients feel supported in decision-making; 2) Preparation for Decision-Making scale (0-100, where 0 = least and 100 most prepared); and 3) OSA knowledge (0-100, where 0 = poor and 100 = outstanding). Multivariable linear regression models examined relationships between Decide2Rest and outcomes (Decisional Conflict Scale, Preparation for Decision-Making, OSA knowledge). RESULTS: Seventy-three patients were randomized to Decide2Rest (n = 36; mean age, 69 years; 72% male) vs control (n = 37; mean age, 69 years; 70% male). Results from the regressions, controlling for study site, indicate that the Decide2Rest program resulted in less decisional conflict (20.5 vs 32.7 on the Decisional Conflict Scale; P = .014), more preparedness for decision-making (87.8 vs 66.2 on the Preparation for Decision-Making scale; P < .001), and greater OSA knowledge (75.1 vs 65.3 OSA knowledge score; P = .04) scores than in the control group. CONCLUSIONS: The Decide2Rest program promotes person-centered OSA decision-making for older patients with newly diagnosed OSA. Future studies are needed to optimize implementation of the program. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov, Name: Improving Older Adults' Decision-Making for OSAT (eDecide2Rest); URL: https://clinicaltrials.gov/ct2/show/NCT03138993; Identifier: NCT03138993.

Improving patient-provider communication about chronic pain: development and feasibility testing of a shared decision-making tool.

BACKGROUND: Chronic pain has emerged as a disease in itself, affecting a growing number of people. Effective patient-provider communication is central to good pain management because pain can only be understood from the patient's perspective. We aimed to develop a user-centered tool to improve patient-provider communication about chronic pain and assess its feasibility in real-world settings in preparation for further evaluation and distribution. METHODS: To identify and prioritize patient treatment goals for chronic pain, strategies to improve patient-provider communication about chronic pain, and facilitate implementation of the tool, we conducted nominal group technique meetings and card sorting with patients with chronic pain and experienced providers (n = 12). These findings informed the design of the PainAPP tool. Usability and beta-testing with patients (n = 38) and their providers refined the tool and assessed its feasibility, acceptability, and preliminary impact. RESULTS: Formative work revealed that patients felt neither respected nor trusted by their providers and focused on transforming providers' negative attitudes towards them, whereas providers focused on gathering patient information. PainAPP incorporated areas prioritized by patients and providers: assessing patient treatment goals and preferences, functional abilities and pain, and providing patients tailored education and an overall summary that patients can share with providers. Beta-testing involved 38 patients and their providers. Half of PainAPP users shared their summaries with their providers. Patients rated PainAPP highly in all areas. All users would recommend it to others with chronic pain; nearly all trusted the information and said it helped them think about my treatment goals (94%), understand my chronic pain (82%), make the most of my next doctor's visit (82%), and not want to use opioids (73%). Beta-testing revealed challenges delivering the tool and summary report to patients and providers in a timely manner and obtaining provider feedback. CONCLUSIONS: PainAPP appears feasible for use, but further adaptation and testing is needed to assess its impact on patients and providers. TRIAL REGISTRATION: This study was approved by the University of New England Independent Review Board for the Protection of Human Subjects in Research (012616-019) and was registered with ClinicalTrials.gov (protocol ID: NCT03425266) prior to enrollment. The trial was prospectively registered and was approved on February 7, 2018.

A Novel Tool to Improve Shared Decision Making and Adherence in Multiple Sclerosis: Development and Preliminary Testing.

Background. Most people with multiple sclerosis (MS) want to be involved in medical decision making about disease-modifying therapies (DMTs), but new approaches are needed to overcome barriers to participation. Objectives. We sought to develop a shared decision-making (SDM) tool for MS DMTs, evaluate patient and provider responses to the tool, and address challenges encountered during development to guide a future trial. Methods. We created a patient-centered design process informed by image theory to develop the MS-SUPPORT SDM tool. Development included semistructured interviews and alpha and beta testing with MS patients and providers. Beta testing assessed dissemination and clinical integration strategies, decision-making processes, communication, and adherence. Patients evaluated the tool before and after a clinic visit. Results. MS-SUPPORT combines self-assessment with tailored feedback to help patients identify their treatment goals and preferences, correct misperceptions, frame decisions, and promote adherence. MS-SUPPORT generates a personal summary of their responses that patients can share with their provider to facilitate communication. Alpha testing (14 patients) identified areas needing improvement, resulting in reorganization and shortening of the tool. MS-SUPPORT was highly rated in beta testing (15 patients, 4 providers) on patient-provider communication, patient preparation, adherence, and other endpoints. Dissemination through both patient and provider networks appeared feasible. All patient testers wanted to share the summary report with their provider, but only 60% did. Limitations. Small sample size, no comparison group. Conclusions. The development process resulted in a patient-centered SDM tool for MS that may facilitate patient involvement in decision making, help providers understand their patients' preferences, and improve adherence, though further testing is needed. Beta testing in real-world conditions was critical to prepare the tool for future testing and inform the design of future studies.

Evaluation of a Novel Preference Assessment Tool for Patients with Multiple Sclerosis.

BACKGROUND: We developed a preference assessment tool to help assess patient goals, values, and preferences for multiple sclerosis (MS) management. All preference items in the tool were generated by people with MS. The aim of this study was to evaluate this tool in a national sample of people with MS. METHODS: English-speaking patients with MS aged 21 to 75 years with access to the internet were recruited. Participants completed the preference tool online, which included separate modules assessing three core preference areas: treatment goals, preferences for attributes of disease-modifying therapies, and factors influencing a change in treatment. The tool generated a summary of participants' treatment goals and preferences. Immediately after viewing the summary, participants were asked to evaluate the tool. Rankings of preference domains were compared with rankings obtained in another study. RESULTS: In 135 people with MS who completed the tool and evaluation, the highest ranked goal was brain health (memory, thinking, brain), followed by disability concerns (walking, strength, vision). Rankings were highly similar to those in the referent study. Nearly all participants reported that the tool helped them understand their goals and priorities regarding MS and that the summary appropriately reflected what is important to them. Most participants (87%) wanted to discuss their treatment goals and priorities with their clinician. CONCLUSIONS: This preference assessment tool successfully captured patients' goals, values, and preferences for MS treatment and could potentially be used to help patients communicate their preferences to their clinician.

Should We Use the IMPACT-Model for the Outcome Prognostication of TBI Patients? A Qualitative Study Assessing Physicians' Perceptions.

Introduction. Shared Decision-Making may facilitate information exchange, deliberation, and effective decision-making, but no decision aids currently exist for difficult decisions in neurocritical care patients. The International Patient Decision Aid Standards, a framework for the creation of high-quality decision aids (DA), recommends the presentation of numeric outcome and risk estimates. Efforts are underway to create a goals-of-care DA in critically-ill traumatic brain injury (ciTBI) patients. To inform its content, we examined physicians' perceptions, and use of the IMPACT-model, the most widely validated ciTBI outcome model, and explored physicians' preferences for communicating prognostic information towards families. Methods. We conducted a qualitative study using semi-structured interviews in 20 attending physicians (neurosurgery,neurocritical care,trauma,palliative care) at 7 U.S. academic medical centers. We used performed qualitative content analysis of transcribed interviews to identify major themes. Results. Only 12 physicians (60%) expressed awareness of the IMPACT-model; two stated that they "barely" knew the model. Seven physicians indicated using the model at least some of the time in clinical practice, although none used it exclusively to derive a patient's prognosis. Four major themes emerged: the IMPACT-model is intended for research but should not be applied to individual patients; mistrust in the IMPACT-model derivation data; the IMPACT-model is helpful in reducing prognostic variability among physicians; concern that statistical models may mislead families about a patient's prognosis. Discussion: Our study identified significant variability of the awareness, perception, and use of the IMPACT-model among physicians. While many physicians prefer to avoid conveying numeric prognostic estimates with families using the IMPACT-model, several physicians thought that they "ground" them and reduce prognostic variability among physicians. These findings may factor into the creation and implementation of future ciTBI-related DAs.

Changing Patients' Treatment Preferences and Values with a Decision Aid for Type 2 Diabetes Mellitus: Results from the Treatment Arm of a Randomized Controlled Trial.

INTRODUCTION: Failure to intensify treatment for type 2 diabetes mellitus (T2DM) when indicated, or clinical inertia, is a major obstacle to achieving optimal glucose control. This study investigates the impact of a values-focused patient decision aid (PDA) for T2DM antihyperglycemic agent intensification on patient values related to domains important in decision-making and preferred treatments. METHODS: Patients with poorly controlled T2DM who were taking a metformin-containing regimen were recruited through physicians to access a PDA presenting evidence-based information on T2DM and antihyperglycemic agent class options. Participants' preferences for treatment, decision-making, and the relative importance they placed on various values related to treatment options (e.g., dosing, weight gain, side effects) were assessed before and after interacting with the PDA. Changes from baseline were calculated (post-PDA minus pre-PDA difference) and assessed in univariate generalized linear models exploring associations with patients' personal values. RESULTS: Analyses included 114 diverse patients from 27 clinics across the US. The importance of avoiding injections, concern about hypoglycemia, and taking medications only once a day significantly decreased after interacting with the PDA [- 1.1 (p = 0.002), - 1.3 (p < 0.001), - 1.1 (p = 0.004), respectively], while the importance of taking medications that avoided weight gain increased [0.8 (p = 0.004)]. Prior to viewing the PDA, most patients (58.8%) had not begun thinking about the decision of adding a medication, and few (12.3%) indicated that they had already made a decision. Post-PDA, 46.5% could state a medication preference. CONCLUSION: The values-focused PDA for T2DM medication intensification prepared patients to make a shared decision with their clinician and changed patients' values regarding what was important in making that decision. Helping patients understand their options and underlying values can promote shared decision-making and may reduce clinical inertia delaying treatment intensification. FUNDING: Janssen Scientific Affairs, LLC.

Whose Preferences Matter? A Patient-Centered Approach for Eliciting Treatment Goals.

BACKGROUND: Patients facing a high-stakes clinical decision are often confronted with an overwhelming array of options. High-quality decisions about treatment should reflect patients' preferences as well as their clinical characteristics. Preference-assessment instruments typically focus on pre-selected clinical outcomes and attributes chosen by the investigator. OBJECTIVE: We sought to develop a patient-centered approach to elicit and compare the treatment goals of patients with multiple sclerosis (MS) and healthcare providers (HCPs). METHODS: We conducted five nominal group technique (NGT) meetings to elicit and prioritize treatment goals from patients and HCPs. Five to nine participants in each group responded silently to one question about their treatment goals. Responses were shared, consolidated, and ranked to develop a prioritized list for each group. The ranked lists were combined. Goals were rated and sorted into categories. Multidimensional scaling and hierarchical cluster analysis were used to derive a visual representation, or cognitive map, of the data and to identify conceptual clusters, reflecting how frequently items were sorted into the same category. RESULTS: Five NGT groups yielded 34 unique patient-generated treatment goals and 31 unique HCP-generated goals. There were differences between patients and HCPs in the goals generated and how they were clustered. Patients' goals tended to focus on the impact of specific symptoms on their day-to-day lives, whereas providers' goals focused on slowing down the course of disease progression. CONCLUSIONS: Differences between the treatment goals of patients and HCPs underscore the limitations of using HCP- or investigator-identified goals. This new adaptation of cognitive mapping is a patient-centered approach that can be used to generate and organize the outcomes and attributes for values clarification exercises while minimizing investigator bias and maximizing relevance to patients.

What Families Need and Physicians Deliver: Contrasting Communication Preferences Between Surrogate Decision-Makers and Physicians During Outcome Prognostication in Critically Ill TBI Patients.

BACKGROUND: Surrogate decision-makers ("surrogates") and physicians of incapacitated patients have different views of prognosis and how it should be communicated, but this has not been investigated in neurocritically ill patients. We examined surrogates' communication preferences and physicians' practices during the outcome prognostication for critically ill traumatic brain injury (ciTBI) patients in two level-1 trauma centers and seven academic medical centers in the USA. METHODS: We used qualitative content analysis and descriptive statistics of transcribed interviews to identify themes in surrogates (n = 16) and physicians (n = 20). RESULTS: The majority of surrogates (82%) preferred numeric estimates describing the patient's prognosis, as they felt it would increase prognostic certainty, and limit the uncertainty perceived as frustrating. Conversely, 75% of the physicians reported intentionally omitting numeric estimates during prognostication meetings due to low confidence in family members' abilities to appropriately interpret probabilities, worry about creating false hope, and distrust in the accuracy and data quality of existing TBI outcome models. Physicians felt that these models are for research only and should not be applied to individual patients. Surrogates valued compassion during prognostication discussions, and acceptance of their goals-of-care decision by clinicians. Physicians and surrogates agreed on avoiding false hope. CONCLUSION: We identified fundamental differences in the communication preferences of prognostic information between ciTBI patient surrogates and physicians. These findings inform the content of a future decision aid for goals-of-care discussions in ciTBI patients. If validated, these findings may have important implications for improving communication practices in the neurointensive care unit independent of whether a formal decision aid is used.

Patient-Reported Usability of Positive Airway Pressure Equipment Is Associated With Adherence in Older Adults.

Study objectives: To examine the usability of positive airway pressure (PAP) devices and its association with PAP adherence among older adults with sleep-disordered breathing. Methods: We mailed questionnaires to patients aged ≥65 years prescribed PAP therapy during the prior 36 months from two large healthcare systems. Survey participants completed the Usability of Sleep Apnea Equipment-Positive Airway Pressure (USE-PAP) questionnaire, which assessed the usability of their PAP device. Other questionnaire items included demographics and self-rated health. We also abstracted adherence data (mean nightly hours of PAP use available from one site) and interface type from the electronic health record. Results: Five hundred sixty-four patients completed the survey (response rate = 33%). The mean USE-PAP score (0 = best to 100 = worst) was 20 (SD ± 20). Mean duration of PAP use (available in 189 respondents) was 5.2 hours per night (SD ± 2.0). In a nested regression model predicting nightly hours of PAP use, a 10-point (0.5 SD) increase in USE-PAP score corresponded to a 0.37 hour/night reduction in PAP use. The model including the USE-PAP score explained a significant proportion (R2 = 15%) of the variation in nightly hours of PAP use above and beyond demographics, self-reported health, and interface type (∆R2 = 12%). Conclusions: Our results demonstrate that PAP usability varies among older patients and is associated with PAP adherence, above and beyond other predictors of adherence. These results support measuring and improving PAP usability to further improve PAP adherence for older patients.

Impact and Feasibility of Personalized Decision Support for Older Patients with Diabetes: A Pilot Randomized Trial.

BACKGROUND: Diabetes guidelines recommend individualizing glycemic goals (A1C) for older patients. The aim of this study was to assess a personalized Web-based decision support tool. METHODS: We randomized physicians and their patients with type 2 diabetes (≥65 years of age) to a support tool or educational pamphlet (75:25 patients). Prior to a visit, intervention patients interacted with the tool, which provided personalized risk predictions and elicited treatment preferences. Main outcomes included 1) patient-doctor communication, 2) decisional conflict, 3) changes in goals, and 4) intervention acceptability. RESULTS: We did not find significant differences in proportions of patients who had an A1C discussion (91% intervention v. 76% control; P = 0.19). Intervention patients had larger declines in the informed subscale of decisional conflict (-20 v. 0, respectively; P = 0.04). There were no significant differences in proportions of patients with changes in goals (49% v. 28%, respectively; P = 0.08). Most intervention patients reported that the tool was easy to use (91%) and helped them to communicate (84%). A limitation was that this was a pilot trial at one academic institution. CONCLUSIONS: Web-based decision support tools may be a practical approach to facilitating the personalization of goals for chronic conditions. TRIAL REGISTRATION: NCT02169999 ( https://clinicaltrials.gov/show/NCT02169999 ).

Patient-Provider Communication With Older Adults About Sleep Apnea Diagnosis and Treatment.

Patient-provider communication impacts adherence to therapy. We explored older adults' communication with their providers, preferences for communication, and views on communication attributes and decision aid characteristics, by conducting four focus groups. Several participants reported they had received insufficient information about their sleep apnea diagnosis and treatment options. Most participants felt that it would be helpful to have treatment information tailored to their needs, including information on the negative impact of treatment on comfort and convenience and disclosure about common barriers to adherence. Participants provided desired characteristics for a decision aid, including their preferred delivery method, content, and format. These findings have implications for how to design useful decision aids for older adults with newly diagnosed sleep apnea.

Ovarian suppression in combination endocrine adjuvant therapy in premenopausal women with early breast cancer.

PURPOSE: The benefits of adding ovarian suppression to either tamoxifen or aromatase inhibitors as adjuvant breast cancer therapy in premenopausal women are controversial. Therefore, we performed a systematic literature review and meta-analysis of relevant randomized trials. METHODS: We identified and combined four qualifying trials reporting disease-free survival (DFS) and overall survival (OS) using meta-analysis. RESULTS: Combining ABCSG-12, SOFT, and TEXT studies, there were 65 fewer DFS events (HR 0.89, 95% CI 0.57-1.39) but 30 more deaths for ovarian suppression plus aromatase inhibitor compared to ovarian suppression plus tamoxifen (HR 1.31, 95% CI 0.93-1.84, P = 0.12, τ = 0.03, heterogeneity, P = 0.18). DFS and OS were more concordant for combined SOFT and E-3193 findings; for ovarian suppression plus tamoxifen compared to tamoxifen alone, there were 24 fewer DFS events (HR 0.83, 95% CI 0.67-1.07, P = 0.09, τ 2 = 0) and 14 fewer deaths (HR 0.76, 95% CI 0.53-1.07). The SOFT Estrogen Substudy demonstrated inconsistent estrogen suppression with combined ovarian suppression and aromatase inhibitor. CONCLUSION: Given the discordance between DFS and OS and inconsistent estrogen suppression with ovarian suppression plus aromatase inhibitor, adding aromatase inhibitor to ovarian suppression as adjuvant therapy in premenopausal women is premature.

Perceived Effectiveness, Self-efficacy, and Social Support for Oral Appliance Therapy Among Older Veterans With Obstructive Sleep Apnea.

PURPOSE: Obstructive sleep apnea is a prevalent sleep disorder among older adults. Oral appliances are increasingly prescribed as therapy for obstructive sleep apnea. Adherence to oral appliance therapy is highly variable. Based on value-expectancy theory and other social-psychological theories, adherence to oral appliance therapy may be influenced by patients' perceived effectiveness of the therapy, self-efficacy, and availability of social support. We examined these perceptions among older adults with obstructive sleep apnea who were prescribed oral appliance therapy. METHODS: We mailed surveys to all patients aged ≥65 years who had been prescribed oral appliance therapy for obstructive sleep apnea over the prior 36 months at a Veterans Affairs medical center. We examined frequencies of responses to items that assessed perceived effectiveness, self-efficacy, and social support for nightly use of oral appliances from friends, family, or health care staff. FINDINGS: Thirty-nine individuals responded (response rate, 30%; mean [SD] age 71.4 [SD 6.3] years; 97% male). Thirty-six percent of the respondents perceived regular use of oral appliance therapy to be effective in managing obstructive sleep apnea; 39% agreed that they felt confident about using oral appliances regularly; 41% felt supported by people in their life in using oral appliance therapy; and 38% agreed that health care staff would help them to use their oral appliance regularly. These rates represented less than half of respondents despite the finding that 65% of patients believed that they would use their oral appliance regularly. IMPLICATIONS: Although oral appliance therapy is increasingly prescribed for obstructive sleep apnea, only about one third of older adults prescribed it perceived it to be an effective treatment, were confident about oral appliance use, and/or believed that they would receive needed support. Future research is needed to better understand older adults' perceptions so that interventions can be designed to improve the effectiveness of oral appliances, their self-efficacy for using oral appliances, and their social support for this therapy, which may, in turn, improve oral appliance therapy adherence.

Effects of Design Features of Explicit Values Clarification Methods: A Systematic Review.

BACKGROUND: Diverse values clarification methods exist. It is important to understand which, if any, of their design features help people clarify values relevant to a health decision. PURPOSE: To explore the effects of design features of explicit values clarification methods on outcomes including decisional conflict, values congruence, and decisional regret. DATA SOURCES: MEDLINE, all EBM Reviews, CINAHL, EMBASE, Google Scholar, manual search of reference lists, and expert contacts. STUDY SELECTION: Articles were included if they described the evaluation of 1 or more explicit values clarification methods. DATA EXTRACTION: We extracted details about the evaluation, whether it was conducted in the context of actual or hypothetical decisions, and the results of the evaluation. We combined these data with data from a previous review about each values clarification method's design features. DATA SYNTHESIS: We identified 20 evaluations of values clarification methods within 19 articles. Reported outcomes were heterogeneous. Few studies reported values congruence or postdecision outcomes. The most promising design feature identified was explicitly showing people the implications of their values, for example, by displaying the extent to which each of their decision options aligns with what matters to them. LIMITATIONS: Because of the heterogeneity of outcomes, we were unable to perform a meta-analysis. Results should be interpreted with caution. CONCLUSIONS: Few values clarification methods have been evaluated experimentally. More research is needed to determine effects of different design features of values clarification methods and to establish best practices in values clarification. When feasible, evaluations should assess values congruence and postdecision measures of longer-term outcomes.

Design Features of Explicit Values Clarification Methods: A Systematic Review.

BACKGROUND: Values clarification is a recommended element of patient decision aids. Many different values clarification methods exist, but there is little evidence synthesis available to guide design decisions. PURPOSE: To describe practices in the field of explicit values clarification methods according to a taxonomy of design features. DATA SOURCES: MEDLINE, all EBM Reviews, CINAHL, EMBASE, Google Scholar, manual search of reference lists, and expert contacts. STUDY SELECTION: Articles were included if they described 1 or more explicit values clarification methods. DATA EXTRACTION: We extracted data about decisions addressed; use of theories, frameworks, and guidelines; and 12 design features. DATA SYNTHESIS: We identified 110 articles describing 98 explicit values clarification methods. Most of these addressed decisions in cancer or reproductive health, and half addressed a decision between just 2 options. Most used neither theory nor guidelines to structure their design. "Pros and cons" was the most common type of values clarification method. Most methods did not allow users to add their own concerns. Few methods explicitly presented tradeoffs inherent in the decision, supported an iterative process of values exploration, or showed how different options aligned with users' values. LIMITATIONS: Study selection criteria and choice of elements for the taxonomy may have excluded values clarification methods or design features. CONCLUSIONS: Explicit values clarification methods have diverse designs but can be systematically cataloged within the structure of a taxonomy. Developers of values clarification methods should carefully consider each of the design features in this taxonomy and publish adequate descriptions of their designs. More research is needed to study the effects of different design features.