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BACKGROUND: The heterogeneous biology of ductal carcinoma in situ (DCIS), as well as the variable outcomes, in the setting of numerous treatment options have led to prognostic uncertainty. Consequently, making treatment decisions is challenging and necessitates involved communication between patient and provider about the risks and benefits. We developed and investigated an interactive decision support tool (DST) designed to improve communication of treatment options and related long-term risks for individuals diagnosed with DCIS. FINDINGS: The DST was developed for use by individuals aged > 40 years with DCIS and is based on a disease simulation model that integrates empirical data and clinical characteristics to predict patient-specific impacts of six DCIS treatment choices. Personalized risk predictions for each treatment option were communicated using icon arrays and percentages for each outcome. Users of the DST were asked before and after interacting with the DST about: (1) awareness of DCIS treatment options, (2) willingness to consider these options, (3) knowledge of risks associated with DCIS, and (4) helpfulness of the DST. Data were collected from January 2019 to April 2022. Users' median estimated risk of dying from DCIS in 10 years decreased from 9% pre-tool to 3% post-tool (p < 0.0001). 76% (n = 101/132) found the tool helpful. CONCLUSIONS: Information about DCIS treatment options and related risk predictions was effectively communicated, and a large majority participants found the DST to be helpful. Successfully informing patients about their treatment options and how their individual risks affect those options is a critical step in the decision-making process. CLINICALTRIALS: gov Identifier NCT02926911.

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Cascade testing is an imperative process to engage Lynch syndrome patients' at-risk relatives in early cancer risk reduction interventions. How genetic counselors communicate about cascade testing is crucial to patients' intentions of and actual involvement in family communication. Based on data from 20 interviews with genetic counselors, this qualitative study examined their perceptions of barriers and facilitators of offering cascade testing to at-risk relatives and the specific communication strategies they use to discuss cascade testing with patients. We identified patient-level, genetic counselor-level, and system-level barriers and facilitators of having discussions with Lynch syndrome patients about cascade testing. The qualitative data also revealed four prominent communication strategies that genetic counselors use for such discussions: build rapport, reframe the benefits of family communication, adapt communication, and provide various resources. These findings highlight genetic counselors' needs of practical and structural support to facilitate their communication about cascade testing, especially when patients are hesitant or lack resources or skills to notify at-risk relatives about cascade testing.

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BACKGROUND: The risk of recurrence is an important consideration when deciding to treat patients medically or with elective colectomy after recovery from diverticulitis. It is unclear whether age is associated with recurrence. This study aimed to examine the relationship between age and the risk of recurrent diverticulitis while considering important epidemiologic factors, such as birth decade. METHODS: The Utah Population Database was used to identify individuals with incident severe diverticulitis, defined as requiring an emergency department visit or hospitalization, between 1998 and 2018. This study measured the relationship between age and recurrent severe diverticulitis after adjusting for birth decade and other important variables, such as sex, urban/rural status, complicated diverticulitis, and body mass index using a Cox proportional hazards model. RESULTS: The cohort included 8606 individuals with a median age of 61 years at index diverticulitis diagnosis. After adjustment, among individuals born in the same birth decade, increasing age at diverticulitis onset was associated with an increased risk of recurrent diverticulitis (hazard ratio [HR] for 10 years, 1.8; 95% CI, 1.5-2.1). Among individuals with the same age of onset, those born in a more recent birth decade were also at greater risk of recurrent diverticulitis (HR, 1.9; 95% CI, 1.6-2.3). CONCLUSION: Among individuals with an index episode of severe diverticulitis, recurrence was associated with increasing age and more recent birth decade. Clinicians may wish to employ age-specific strategies when counseling patients regarding treatment options after a diverticulitis diagnosis.

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Background. Parents with a fetus diagnosed with a complex congenital heart defect (CHD) are at high risk of negative psychological outcomes. Purpose. To explore whether parents' psychological and decision-making outcomes differed based on their treatment decision and fetus/neonate survival status. Methods. We prospectively enrolled parents with a fetus diagnosed with a complex, life-threatening CHD from September 2018 to December 2020. We tested whether parents' psychological and decision-making outcomes 3 months posttreatment differed by treatment choice and survival status. Results. Our sample included 23 parents (average Age[years]: 27 ± 4, range = 21-37). Most were women (n = 18), non-Hispanic White (n = 20), and married (n = 21). Most parents chose surgery (n = 16), with 11 children surviving to the time of the survey; remaining parents (n = 7) chose comfort-directed care. Parents who chose comfort-directed care reported higher distress (x¯ = 1.51, s = 0.75 v. x¯ = 0.74, s = 0.55; Mdifference = 0.77, 95% confidence interval [CI], 0.05-1.48) and perinatal grief (x¯ = 91.86, s = 22.96 v. x¯ = 63.38, s = 20.15; Mdifference = 27.18, 95% CI, 6.20-48.16) than parents who chose surgery, regardless of survival status. Parents who chose comfort-directed care reported higher depression (x¯ = 1.64, s = 0.95 v. x¯ = 0.65, s = 0.49; Mdifference = 0.99, 95% CI, 0.10-1.88) than parents whose child survived following surgery. Parents choosing comfort-directed care reported higher regret (x¯ = 26.43, s = 8.02 v. x¯ = 5.00, s = 7.07; Mdifference = 21.43, 95% CI, 11.59-31.27) and decisional conflict (x¯ = 20.98, s = 10.00 v. x¯ = 3.44, s = 4.74; Mdifference = 17.54, 95% CI; 7.75-27.34) than parents whose child had not survived following surgery. Parents whose child survived following surgery reported lower grief (Mdifference = -19.71; 95% CI, -39.41 to -0.01) than parents whose child had not. Conclusions. The results highlight the potential for interventions and care tailored to parents' treatment decisions and outcomes to support parental coping and well-being. Highlights: Question: Do the psychological and decision-making outcomes of parents differ based on their treatment decision and survival outcome following prenatal diagnosis with complex CHD?Findings: In this exploratory study, parents who decided to pursue comfort-directed care after a prenatal diagnosis reported higher levels of psychological distress and grief as well as higher decisional conflict and regret than parents who decided to pursue surgery.Meaning: The findings from this exploratory study highlight potential differences in parents' psychological and decision-making outcomes following a diagnosis of complex CHD for their fetus, which appear to relate to the treatment approach and the treatment outcome and may require tailoring of psychological and decision support.

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PURPOSE: This exploratory study examines differences in parents' quality of life by treatment decision and the child's survival outcome in the context of life-threatening congenital heart disease (CHD). DESIGN AND METHODS: Parents of a fetus or neonate diagnosed with severe CHD enrolled in the observational control group of a clinical trial (NCT04437069) and completed quality of life (i.e., contact with clinicians, social support, partner relationship, state of mind), mental and physical health survey measures. Comparisons were made between parents who chose comfort-directed care or surgery and between those whose child did and did not survive. RESULTS: Parents who chose surgery and their child did not survive reported the most contact with their clinicians. Parents who chose comfort-directed care reported lower social support than parents who chose surgery and their child did not survive as well as poorer state of mind compared to parents who chose surgery. CONCLUSIONS: Some aspects of parents' quality of life differed based on their treatment decision. Parents who choose comfort-directed care are vulnerable to some negative outcomes. PRACTICE IMPLICATIONS: Decision support tools and bereavement resources to assist parents with making and coping with a complex treatment decision is important for clinical care.

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Introduction: Decision aids (DAs) are helpful instruments used to support shared decision making (SDM). Patients with atrial fibrillation (AF) face complex decisions regarding stroke prevention strategies. While a few DAs have been made for AF stroke prevention, an encounter DA (EDA) and patient DA (PDA) have not been created to be used in conjunction with each other before. Design: Using iterative user-centered design, we developed 2 DAs for anticoagulation choice and stroke prevention in AF. Prototypes were created, and we elicited feedback from patients and experts via observations of encounters, usability testing, and semistructured interviews. Results: User testing was done with 33 experts (in AF and SDM) and 51 patients from 6 institutions. The EDA and PDA underwent 1 and 4 major iterations, respectively. Major differences between the DAs included AF pathophysiology and a preparation to meet with the clinician in the PDA as well as different language throughout. Content areas included personalized stroke risk, differences between anticoagulants, and risks of bleeding. Based on user feedback, developers 1) addressed feelings of isolation with AF, 2) improved navigation options, 3) modified content and flow for users new to AF and those experienced with AF, 4) updated stroke risk pictographs, and 5) added structure to the preparation for decision making in the PDA. Limitations: These DAs focus only on anticoagulation for stroke prevention and are online, which may limit participation for those less comfortable with technology. Conclusions: Designing complementary DAs for use in tandem or separately is a new method to support SDM between patients and clinicians. Extensive user testing is essential to creating high-quality tools that best meet the needs of those using them. Highlights: First-time complementary encounter and patient decision aids have been designed to work together or separately.User feedback led to greater structure and different experiences for patients naïve or experienced with anticoagulants in patient decision aids.Online tools allow for easier dissemination, use in telehealth visits, and updating as new evidence comes out.

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BACKGROUND: Shared decision making (SDM) improves the likelihood that patients will receive care in a manner consistent with their priorities. To facilitate SDM, decision aids (DA) are commonly used, both to prepare a patient before their clinician visit, as well as to facilitate discussion during the visit. However, the relative efficacy of patient-focused or encounter-based DAs on SDM and patient outcomes remains largely unknown. We aim to directly estimate the comparative effectiveness of two DA's on SDM observed in encounters to discuss stroke prevention strategies in patients with atrial fibrillation (AF). METHODS: The study aims to recruit 1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention strategies, in a 2x2 cluster randomized multi-center trial at six sites. Two DA's were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter. Patients will be randomized to PDA or usual care; clinicians will be randomized to EDA or usual care. RESULTS: Primary outcomes are quality of SDM, patient decision making, and patient knowledge. Secondary outcomes include anticoagulation choice, adherence, and clinical events. CONCLUSION: This trial is the first randomized, head-to-head comparison of the effects of an EDA versus a PDA on SDM. Our results will help to inform future SDM interventions to improve patients' AF outcomes and experiences with stroke prevention strategies.

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BACKGROUND: Parents who receive a diagnosis of a severe, life-threatening CHD for their foetus or neonate face a complex and stressful decision between termination, palliative care, or surgery. Understanding how parents make this initial treatment decision is critical for developing interventions to improve counselling for these families. METHODS: We conducted focus groups in four academic medical centres across the United States of America with a purposive sample of parents who chose termination, palliative care, or surgery for their foetus or neonate diagnosed with severe CHD. RESULTS: Ten focus groups were conducted with 56 parents (Mage = 34 years; 80% female; 89% White). Results were constructed around three domains: decision-making approaches; values and beliefs; and decision-making challenges. Parents discussed varying approaches to making the decision, ranging from relying on their "gut feeling" to desiring statistics and probabilities. Religious and spiritual beliefs often guided the decision to not terminate the pregnancy. Quality of life was an important consideration, including how each option would impact the child (e.g., pain or discomfort, cognitive and physical abilities) and their family (e.g., care for other children, marriage, and career). Parents reported inconsistent communication of options by clinicians and challenges related to time constraints for making a decision and difficulty in processing information when distressed. CONCLUSION: This study offers important insights that can be used to design interventions to improve decision support and family-centred care in clinical practice.

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INTRODUCTION: Parents who receive the diagnosis of a life-threatening, complex heart defect in their fetus or neonate face a difficult choice between pursuing termination (for fetal diagnoses), palliative care or complex surgical interventions. Shared decision making (SDM) is recommended in clinical contexts where there is clinical equipoise. SDM can be facilitated by decision aids. The International Patient Decision Aids Standards collaboration recommends the inclusion of values clarification methods (VCMs), yet little evidence exists concerning the incremental impact of VCMs on patient or surrogate decision making. This protocol describes a randomised clinical trial to evaluate the effect of a decision aid (with and without a VCM) on parental mental health and decision making within a clinical encounter. METHODS AND ANALYSIS: Parents who have a fetus or neonate diagnosed with one of six complex congenital heart defects at a single tertiary centre will be recruited. Data collection for the prospective observational control group was conducted September 2018 to December 2020 (N=35) and data collection for two intervention groups is ongoing (began October 2020). At least 100 participants will be randomised 1:1 to two intervention groups (decision aid only vs decision aid with VCM). For the intervention groups, data will be collected at four time points: (1) at diagnosis, (2) postreceipt of decision aid, (3) postdecision and (4) 3 months postdecision. Data collection for the control group was the same, except they did not receive a survey at time 2. Linear mixed effects models will assess differences between study arms in distress (primary outcome), grief and decision quality (secondary outcomes) at 3-month post-treatment decision. ETHICS AND DISSEMINATION: This study was approved by the University of Utah Institutional Review Board. Study findings have and will continue to be presented at national conferences and within scientific research journals. TRIAL REGISTRATION NUMBER: NCT04437069 (Pre-results).

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BACKGROUND AND OBJECTIVES: Little data exist on provider perspectives about counselling and shared decision-making for complex CHD, ways to support and improve the process, and barriers to effective communication. The goal of this qualitative study was to determine providers' perspectives regarding factors that are integral to shared decision-making with parents faced with complex CHD in their fetus or newborn; and barriers and facilitators to engaging in effective shared decision-making. METHODS: We conducted semi-structured interviews with providers from different areas of practice who care for fetuses and/or children with CHD. Providers were recruited from four geographically diverse centres. Interviews were recorded, transcribed, and analysed for key themes using an open coding process with a grounded theory approach. RESULTS: Interviews were conducted with 31 providers; paediatric cardiologists (n = 7) were the largest group represented, followed by nurses (n = 6) and palliative care providers (n = 5). Key barriers to communication with parents that providers identified included variability among providers themselves, factors that influenced parental comprehension or understanding, discrepant expectations, circumstantial barriers, and trust/relationship with providers. When discussing informational needs of parents, providers focused on comprehensive short- and long-term outcomes, quality of life, and breadth and depth that aligned with parental goals and needs. In discussing resources to support shared decision-making, providers emphasised the need for comprehensive, up-to-date information that was accessible to parents of varying situations and backgrounds. CONCLUSIONS: Provider perspectives on decision-making with families with CHD highlighted key communication issues, informational priorities, and components of decision support that can enhance shared decision-making.

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BACKGROUND: Up to 30% of patients with ulcerative colitis will undergo surgery resulting in an ileal pouch-anal anastomosis (IPAA) or permanent end ileostomy (EI). We aimed to understand how patients decide between these two options. METHODS: We performed semi-structured interviews with ulcerative colitis patients who underwent surgery. Areas of questioning included the degree to which patients participated in decision-making, challenges experienced, and suggestions for improving the decision-making process. We analyzed the data using a directed content and thematic approach. RESULTS: We interviewed 16 patients ranging in age from 28 to 68 years. Nine were male, 10 underwent IPAA, and 6 underwent EI. When it came to participation in decision-making, 11 patients felt independently responsible for decision-making, 3 shared decision-making with the surgeon, and 2 experienced surgeon-led decision-making. Themes regarding challenges during decision-making included lack of support from family, lack of time to discuss options with the surgeon, and the overwhelming complexity of the decision. Themes for ways to improve decision-making included the need for additional information, the desire for peer education, and earlier consultation with a surgeon. Only 3 patients were content with the information used to decide about surgery. CONCLUSIONS: Patients with ulcerative colitis who need surgery largely experience independence when deciding between IPAA and EI, but struggle with inadequate educational information and social support. Patients may benefit from early access to surgeons and peer guidance to enhance independence in decision-making. Preoperative educational materials describing surgical complications and postoperative lifestyle could improve decision-making and facilitate discussions with loved ones.

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COVID-19 has affected the health and well-being of almost every American. The aim of this study was to examine the sustained impacts of COVID-19 prevention measures on the diet and exercise habits, risk for food insecurity, and quality of life among adults in the U.S. We conducted a longitudinal study using a convenience sample of participants recruited via Amazon's Mechanical Turk (MTurk) platform between March 30 and April 7, 2020, and 8 months into the outbreak, from November 2 to November 21, 2020. We compared self-reported diet and exercise habits and risk for food insecurity shortly after the pandemic began, in April, to those reported in November. We also measured changes in quality-of-life using the PROMIS-29 + 2 (PROPr) scale. A total of 636 respondents completed both surveys. Compared to reports in April, respondents ate lunch and dinner out more frequently in November and consumed more take-out and fast food. Weekly frequencies of consuming frozen food and the number of daily meals were slightly lower in November than they were in April. 54% of respondents screened positively for being at risk for food insecurity in April, reducing to 41% by November. In April, survey respondents were found to have lower quality-of-life relative to U.S. population norms, but by November levels of depression and cognitive function had improved. Our findings underscore how the initial effects of the pandemic on diet, exercise, risk for food insecurity, and quality of life have evolved. As U.S. states re-open, continued efforts to encourage healthy eating and support mental health, especially to reduce feelings of anxiety and social isolation, remain important to mitigate the potential long-term effects of the pandemic.

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Background: More than 10% of US adults are living with type 2 diabetes. The Centers for Disease Control and Prevention established the National Diabetes Prevention Program (National DPP) in 2010 in an effort to delay or prevent this disease among individuals at high risk. Unfortunately, enrollment and retention rates are low. This qualitative study aims to understand barriers and facilitators to enrolling and completing the National DPP among women, and to provide recommendations for improvement. Methods: Semistructured interviews were conducted with the following: (1) women who were eligible for the National DPP, but declined to enroll (n=11); (2) women who enrolled in the National DPP, but did not complete the program (n=12); and (3) clinicians who treat women eligible for the National DPP (n=12). Transcripts of the interviews were coded using content analysis. Results: The 35 interviews (23 patients and 12 clinicians) provided further insight into known barriers, such as the cost of the program, the time that it takes, and inconvenient locations. The study also identified previously undiscovered barriers, including the program not meeting participants' expectations and facilitating referrals. Furthermore, improved communication between clinicians, patients, and National DPP staff could ensure that both clinicians and National DPP staff are aware of patients' goals and their individual barriers to success. Conclusions: Enrollment and retention in the National DPP may be improved with additional communication, more training for National DPP staff to work more closely with participants, adding better incentives to participation, and making the program more accessible through flexibility in time and/or locations.

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INTRODUCTION: Regular endoscopic surveillance is the gold standard Barrett's esophagus (BE) surveillance, yet harms of surveillance for some patients may outweigh the benefits. We sought to characterize physicians' BE surveillance cessation recommendations. METHODS: We surveyed gastroenterologists about their BE surveillance recommendations varying patient age, comorbidity, and BE length. RESULTS: Clinicians varied in recommendations for repeat surveillance. Patient age showed the largest variation among decisions, whereas BE length varied the least. DISCUSSION: Age and comorbidities seem to influence BE surveillance cessation decisions, but with variation. Clear cessation guidelines balancing the risks and benefits for BE surveillance are warranted.

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OBJECTIVE: Shared decision making (SDM) tools can help implement guideline recommendations for patients with atrial fibrillation (AF) considering stroke prevention strategies. We sought to characterize all available SDM tools for this purpose and examine their quality and clinical impact. METHODS: We searched through multiple bibliographic databases, social media, and an SDM tool repository from inception to May 2020 and contacted authors of identified SDM tools. Eligible tools had to offer information about warfarin and ≥1 direct oral anticoagulant. We extracted tool characteristics, assessed their adherence to the International Patient Decision Aids Standards, and obtained information about their efficacy in promoting SDM. RESULTS: We found 14 SDM tools. Most tools provided up-to-date information about the options, but very few included practical considerations (e.g., out-of-pocket cost). Five of these SDM tools, all used by patients prior to the encounter, were tested in trials at high risk of bias and were found to produce small improvements in patient knowledge and reductions in decisional conflict. CONCLUSION: Several SDM tools for stroke prevention in AF are available, but whether they promote high-quality SDM is yet to be known. The implementation of guidelines for SDM in this context requires user-centered development and evaluation of SDM tools that can effectively promote high-quality SDM and improve stroke prevention in patients with AF.

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OBJECTIVE: To examine associations between sociodemographic and mental health characteristics with household risk for food insecurity during the COVID-19 outbreak. DESIGN: Cross-sectional online survey analysed using univariable tests and a multivariable logistic regression model. SETTING: The United States during the week of 30 March 2020. PARTICIPANTS: A convenience sample of 1965 American adults using Amazon's Mechanical Turk platform. Participants reporting household food insecurity prior to the pandemic were excluded from analyses. RESULTS: One thousand two hundred and fifty participants reported household food security before the COVID-19 outbreak. Among this subset, 41 % were identified as at risk for food insecurity after COVID-19, 55 % were women and 73 % were white. On a multivariable analysis, race, income, relationship status, living situation, anxiety and depression were significantly associated with an incident risk for food insecurity. Black, Asian and Hispanic/Latino respondents, respondents with an annual income <$100 000 and those living with children or others were significantly more likely to be newly at risk for food insecurity. Individuals at risk for food insecurity were 2·60 (95 % CI 1·91, 3·55) times more likely to screen positively for anxiety and 1·71 (95 % CI 1·21, 2·42) times more likely to screen positively for depression. CONCLUSIONS: An increased risk for food insecurity during the COVID-19 pandemic is common, and certain populations are particularly vulnerable. There are strong associations between being at risk for food insecurity and anxiety/depression. Interventions to increase access to healthful foods, especially among minority and low-income individuals, and ease the socioemotional effects of the outbreak are crucial to relieving the economic stress of this pandemic.

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BACKGROUND: We aimed to identify decision process measures associated with patient decisional regret regarding the decision to pursue elective colectomy or observation for diverticulitis. MATERIALS AND METHODS: This was a single-center cross-sectional survey study. We included adult patients treated for diverticulitis between 2014 and 2019 and excluded patients who required urgent or emergent colectomy. The primary outcome was regret regarding the decision to pursue elective surgery or observation for diverticulitis, measured using the Decision Regret Scale. We used multivariable linear regression to examine hypothesized predictors of decision regret, including decisional conflict (Decision Conflict Scale and its subscales), shared decision-making, and decision role concordance. RESULTS: Of 923 eligible patients, 133 were included in the analysis. Patients had a median of five episodes of diverticulitis (interquartile range 3-8), occurring a median of 2 y (interquartile range 1-3) before survey administration. Thirty-eight patients (29%) underwent elective surgery for diverticulitis. Decision regret (Decision Regret Scale score ≥25) was present in 42 patients (32%). After controlling for surgery, gender, health status, and years since treatment, decision regret was associated with decisional conflict and inversely associated with values clarity, decision role concordance, shared decision-making, and feeling informed, supported, and effective in decision-making (all P < 0.001). CONCLUSIONS: Nearly one-third of survey respondents experienced regret regarding the decision between elective surgery and observation for diverticulitis. Decision regret may be reduced through efforts to improve patient knowledge, values clarity, role concordance, and shared decision-making.

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BACKGROUND: Mechanical bowel preparation with antibiotics is associated with decreased surgical site infections (SSI) after colorectal surgery. However, antibiotics have side effects, such as vomiting. It is unknown how patient willingness to take antibiotics is affected by side effect severity. MATERIALS AND METHODS: This was a single-center study of 86 patients (37 undergoing colorectal surgery) using a modified standard gamble technique. We presented patients with four hypothetical scenarios, holding SSI reduction constant and varying antibiotic side effect severity. Patients reported willingness to take antibiotics using a scale from 0 to 100. Patients also reported the maximum level of side effects they would accept. We examined the association between side effect severity and willingness to take antibiotics with a multivariable mixed-effects regression model and investigated differences in surgical and nonsurgical patients. RESULTS: After adjusting for age, sex, and patient type, willingness scores decreased with increasing side effect severity. No side effects: 92 (CI 86,99), mild: 83 (CI 76,90), moderate: 76 (CI 69,83), and severe: 46 (CI 38,52), P < 0.001. Surgical patients were more willing to take antibiotics at all severity levels compared with nonsurgical patients, P < 0.001. Surgical (57%) and nonsurgical (58%) patients reported that they would accept moderate side effects. Patients with prior SSI (n = 5) would take antibiotics regardless of side effect severity. CONCLUSIONS: Increasing antibiotic side effect severity is associated with decreased willingness to take antibiotics during bowel preparation, despite a reduction in SSI. Adherence may be improved with strategies that increase patient education and decrease side effects during bowel preparation.

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