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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.

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.

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.

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 mixedeffects 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.

Background Shared decision making requires evidence to be conveyed to the patient in a way they can easily understand and compare. Patient decision aids facilitate this process. This article reviews the current evidence for how to present numerical probabilities within patient decision aids. Methods Following the 2013 review method, we assembled a group of 9 international experts on risk communication across Australia, Germany, the Netherlands, the United Kingdom, and the United States. We expanded the topics covered in the first review to reflect emerging areas of research. Groups of 2 to 3 authors reviewed the relevant literature based on their expertise and wrote each section before review by the full authorship team. Results Of 10 topics identified, we present 5 fundamental issues in this article. Although some topics resulted in clear guidance (presenting the chance an event will occur, addressing numerical skills), other topics (context/evaluative labels, conveying uncertainty, risk over time) continue to have evolving knowledge bases. We recommend presenting numbers over a set time period with a clear denominator, using consistent formats between outcomes and interventions to enable unbiased comparisons, and interpreting the numbers for the reader to meet the needs of varying numeracy. Discussion Understanding how different numerical formats can bias risk perception will help decision aid developers communicate risks in a balanced, comprehensible manner and avoid accidental “nudging” toward a particular option. Decisions between probability formats need to consider the available evidence and user skills. The review may be useful for other areas of science communication in which unbiased presentation of probabilities is important.

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 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.

Background Detection of cystic lesions of the pancreas has outpaced our ability to stratify low-grade cystic lesions from those at greater risk for pancreatic cancer, raising a concern for overtreatment. Methods We developed a Markov decision model to determine the cost-effectiveness of guideline-based management for asymptomatic pancreatic cysts. Incremental costs per quality-adjusted life year gained and survival were calculated for current management guidelines. A sensitivity analysis estimated the effect on cost-effectiveness and mortality if overtreatment of low-grade cysts is avoided, and the sensitivity and specificity thresholds required of methods of cyst stratification to improve costs expended. Results “Surveillance” using current management guidelines had an incremental cost-effectiveness ratio of $171,143/quality adjusted life year compared with no surveillance or operative treatment (“do nothing”). An incremental cost-effectiveness ratio for surveillance decreases to $80,707/quality adjusted life year if the operative overtreatment of low-grade cysts was avoided. Assuming a societal willingness-to-pay of $100,000/quality adjusted life year, the diagnostic specificity for high-risk cysts must be >67% for surveillance to be preferred over surgery and “do nothing.” Changes in sensitivity alone cannot make surveillance cost-effective. Most importantly, survival in surveillance is worse than “do nothing” for 3 years after cyst diagnosis, although long-term survival is improved. The disadvantage is eliminated when overtreatment of low-grade cysts is avoided. Conclusion Current management of pancreatic cystic lesions is not cost-effective and may increase mortality owing to overtreatment of low-grade cysts. The specificity for risk stratification for high-risk cysts must be greater than 67% to make surveillance cost-effective.

Background Conversation aids can facilitate shared decision-making and improve patient-centered outcomes. However, few examples exist of sustained use of conversation aids in routine care due to numerous barriers at clinical and organizational levels. We explored factors that will promote the sustained use of two early-stage breast cancer conversation aids. We examined differences in opinions between the two conversation aids and across socioeconomic strata. Methods We nested this study within a randomized controlled trial that demonstrated the effectiveness of two early-stage breast cancer surgery conversation aids, one text-based and one picture-based. These conversation aids facilitated more shared decision-making and improved the decision process, among other outcomes, across four health systems with socioeconomically diverse patient populations. We conducted semi-structured interviews with a purposive sample of patient participants across conversation aid assignment and socioeconomic status (SES) and collected observations and field notes. We interviewed trial surgeons and other stakeholders. Two independent coders conducted framework analysis using the NOrmalization MeAsure Development through Normalization Process Theory. We also conducted an inductive analysis. We conducted additional sub-analyses based on conversation aid assignment and patient SES. Results We conducted 73 semi-structured interviews with 43 patients, 16 surgeons, and 14 stakeholders like nurses, cancer center directors, and electronic health record (EHR) experts. Patients and surgeons felt the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid (EHR, email, patient portal, before consultation). Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision-making. Intervention surgeons reported using the conversation aids did not lengthen their typical consultation time. Most intervention surgeons felt using the conversation aids enhanced their usual care after using it a few times, and most patients felt it appeared part of their normal routine. Conclusions Key factors that will guide the future sustained implementation of the conversation aids include adapting to existing clinical workflows, flexibility of use, patient characteristics, and communication preferences. Trial registration ClinicalTrials.gov Identifier: NCT03136367, registered on May 2, 2017

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.

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.

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).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.Primary outcomes are quality of SDM, patient decision making, and patient knowledge. Secondary outcomes include anticoagulation choice, adherence, and clinical events.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.

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.

Breast cancer risk reduction has been validated by large-scale clinical trials, but uptake remains low. A risk communication tool could provide personalized risk-reduction information for high-risk women. A low-literacy-friendly, visual, and personalized tool was designed as part of the Women Informed to Screen Depending On Measures of risk (WISDOM) study. The tool integrates genetic, polygenic, and lifestyle factors, and quantifies the risk-reduction from undertaking medication and lifestyle interventions. The development and design process utilized feedback from clinicians, decision-making scientists, software engineers, and patient advocates. We piloted the tool with 17 study participants, collecting quantitative and qualitative feedback. Overall, participants felt they better understood their personalized breast cancer risk, were motivated to reduce their risk, and considered lifestyle interventions. The tool will be used to evaluate whether risk-based screening leads to more informed decisions and higher uptake of risk-reduction interventions among those most likely to benefit.

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.

Background Decision aid developers have to convey complex task-specific numeric information in a way that minimizes bias and promotes understanding of the options available within a particular decision. Whereas our companion paper summarizes fundamental issues, this article focuses on more complex, task-specific aspects of presenting numeric information in patient decision aids. Methods As part of the International Patient Decision Aids Standards third evidence update, we gathered an expert panel of 9 international experts who revised and expanded the topics covered in the 2013 review working in groups of 2 to 3 to update the evidence, based on their expertise and targeted searches of the literature. The full panel then reviewed and provided additional revisions, reaching consensus on the final version. Results Five of the 10 topics addressed more complex task-specific issues. We found strong evidence for using independent event rates and/or incremental absolute risk differences for the effect size of test and screening outcomes. Simple visual formats can help to reduce common judgment biases and enhance comprehension but can be misleading if not well designed. Graph literacy can moderate the effectiveness of visual formats and hence should be considered in tool design. There is less evidence supporting the inclusion of personalized and interactive risk estimates. Discussion More complex numeric information. such as the size of the benefits and harms for decision options, can be better understood by using incremental absolute risk differences alongside well-designed visual formats that consider the graph literacy of the intended audience. More research is needed into when and how to use personalized and/or interactive risk estimates because their complexity and accessibility may affect their feasibility in clinical practice.

Five percent of the patient population accounts for 50% of U.S. healthcare expenditures. High-need, high-cost patients are medically complex for numerous reasons, often including behavioral health needs. Intensive outpatient care programs (IOCPs) are emerging, innovative clinics which provide patient-centered care leveraging multidisciplinary teams. The overarching goals of IOCPs are to reduce emergency department visits and hospitalizations (and related costs), and improve care continuity and patient outcomes. The purpose of this review was to examine the effectiveness of IOCPs on multiple outcomes to inform clinical care. A systematic search of the literature was conducted to identify articles. Six studies were included that varied in rigor of research design, analysis, and measurement of outcomes. Most studies reported results on healthcare utilization (n = 4) and costs (n = 3), with fewer reporting results on patient-reported and health-related outcomes (n = 2). Overall, there were decreasing trends in emergency department visits and hospitalizations. However, results on healthcare utilization varied based on time of follow-up, with shorter follow-up times yielding more significant results. Two of the three studies that evaluated costs found significant reductions associated with IOCPs, and the third was cost-neutral. Two studies reported improvements in patient-reported outcomes (e.g., satisfaction, depression, and anxiety). Overall, these programs reported positive impacts on healthcare utilization and costs; however, few studies evaluated patient characteristics and behaviors (e.g., engagement in care) which may serve as key mechanisms of program effectiveness. Future research should examine patient characteristics, behaviors, and clinic engagement metrics to inform clinical practice.

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 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.

Background Women of lower socioeconomic status (SES) with early‐stage breast cancer are more likely to report poorer physician‐patient communication, lower satisfaction with surgery, lower involvement in decision making, and higher decision regret compared to women of higher SES. The objective of this study was to understand how to support women across socioeconomic strata in making breast cancer surgery choices. Methods We conducted a 3‐arm (Option Grid, Picture Option Grid, and usual care), multisite, randomized controlled superiority trial with surgeon‐level randomization. The Option Grid (text only) and Picture Option Grid (pictures plus text) conversation aids were evidence‐based summaries of available breast cancer surgery options on paper. Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care were measured from T0 (pre‐consultation) to T5 (1‐year after surgery. Results Sixteen surgeons saw 571 of 622 consented patients. Patients in the Picture Option Grid arm (n = 248) had higher knowledge (immediately after the visit [T2] and 1 week after surgery or within 2 weeks of the first postoperative visit [T3]), an improved decision process (T2 and T3), lower decision regret (T3), and more SDM (observed and self‐reported) compared to usual care (n = 257). Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm. Subgroup analyses suggested that the Picture Option Grid had more impact among women of lower SES and health literacy. Neither intervention affected concordance, treatment choice, or anxiety. Conclusions Paper‐based conversation aids improved key outcomes over usual care. The Picture Option Grid had more impact among disadvantaged patients. Lay Summary The objective of this study was to understand how to help women with lower incomes or less formal education to make breast cancer surgery choices.Compared with usual care, a conversation aid with pictures and text led to higher knowledge. It improved the decision process and shared decision making (SDM) and lowered decision regret. A text‐only conversation aid led to an improved decision process, more coordinated care, and higher SDM compared to usual care. The conversation aid with pictures was more helpful for women with lower income or less formal education.Conversation aids with pictures and text helped women make better breast cancer surgery choices., A paper‐based pictorial conversation aid (pictures plus text) is beneficial to all patients with early‐stage breast cancer and particularly to disadvantaged patients. Between‐surgeon variation suggests that the maximal impact of such interventions requires standardized physician training combined with these interventions.

Background: Use of preoperative breast magnetic resonance imaging (MRI) among women with a new breast cancer has increased over the past decade. MRI use is more frequent in younger women and those with lobular carcinoma, but associations with breast density and family history of breast cancer are unknown. Materials and Methods: Data for 3075 women ages >65 years with stage 0-III breast cancer who underwent breast conserving surgery or mastectomy from 2005 to 2010 in the Breast Cancer Surveillance Consortium were linked to administrative claims data to assess associations of preoperative MRI use with mammographic breast density and first-degree family history of breast cancer. Multivariable logistic regression estimated adjusted odds ratios (OR) and 95% confidence intervals (95% CI) for the association of MRI use with breast density and family history, adjusting for woman and tumor characteristics. Results: Overall, preoperative MRI use was 16.4%. The proportion of women receiving breast MRI was similar by breast density (17.6% dense, 16.9% nondense) and family history (17.1% with family history, 16.5% without family history). After adjusting for potential confounders, we found no difference in preoperative MRI use by breast density (OR = 0.95 for dense vs. nondense, 95% CI: 0.73–1.22) or family history (OR = 0.99 for family history vs. none, 95% CI: 0.73–1.32). Conclusions: Among women aged >65 years with breast cancer, having dense breasts or a first-degree relative with breast cancer was not associated with greater preoperative MRI use. This utilization is in keeping with lack of evidence that MRI has higher yield of malignancy in these subgroups.

Decades of persuasive messages have reinforced the importance of traditional screening mammography at regular intervals. A potential new paradigm, risk-based screening, adjusts mammography frequency based on a woman’s estimated breast cancer risk in order to maximize mortality reduction while minimizing false positives and overdiagnosis. Women’s views of risk-based screening are unknown. To explore women’s views and personal acceptability of a potential risk-based mammography screening paradigm. Four semi-structured focus group discussions about screening mammography and surveys before provision of information about risk-based screening. We analyzed coded focus group transcripts using a mixed deductive (content analysis) and inductive (grounded theory) approach. Convenience sample of 29 women (40–74 years old) with no personal history of breast cancer recruited by print and online media in New Hampshire and Vermont. Twenty-seven out of 29 women reported having undergone mammography screening. All participants were white and most were highly educated. Some women accepted the idea that early cancer detection with traditional screening was beneficial—although many also reported hearing inconsistent recommendations from clinicians and mixed messages from media reports about mammography. Some women were familiar with a risk-based screening paradigm (primarily related to cervical cancer, n = 8) and thought matching screening mammography frequency to personal risk made sense (n = 8). Personal acceptability of risk-based screening was mixed. Some believed risk-based screening could reduce the harms of false positives and overdiagnosis (n = 7). Others thought screening less often might result in missing a dangerous diagnosis (n = 14). Many (n = 18) expressed concerns about the feasibility of risk-based screening and questioned whether breast cancer risk estimates could be accurate. Some suspected that risk-based mammography was motivated by a desire to save money (n = 6). Some women thought risk-based screening made sense. Willingness to abandon traditional screening for the new paradigm was mixed. Broad acceptability of risk-based screening will require clearer communication about its rationale and feasibility and consistent messages from the health care team.

As local therapies improve, contralateral breast cancer (CBC) risk for women with ductal carcinoma in situ (DCIS) may exceed the risk of a second ipsilateral breast cancer. We sought to determine whether estrogen-receptor (ER) status influenced CBC risk. We identified women aged 40–79 with DCIS diagnosed between 1990 and 2002 using the Surveillance, Epidemiology, and End Results database. We used multivariable competing risk regression to examine predictors of time from index DCIS to CBC (invasive or in situ). Multivariable competing risk regression found ER status to be a highly significant predictor of CBC. The 10-year cumulative incidence was estimated to be 5.3% (95% CI 4.8–5.8%) among ER positive (ER+) cases and 3.3% (95% CI 2.6–4.0%) among ER negative (ER−). This finding suggests that ER+ DCIS may represent a field effect that confers increased propensity for developing cancer across breast tissue, regardless of laterality. In contrast, ER− DCIS may represent an isolated local event. Given that the majority of DCIS is ER+, and only a minority of DCIS patients receive hormonal therapy, consideration of ER status may influence treatment and surveillance approaches.

BACKGROUND: Breast cancer risk assessment tools and risk reduction strategies have advanced significantly over the past few decades but are underutilized in practice, due in part to limited acceptability by patients and physicians. We implemented a tablet-based Breast Cancer Risk Education Intervention (BreastCARE) tailored towards increasing patients’ knowledge about their individual risk of developing breast cancer, increasing patient-physician discussion of breast cancer risk reduction practices, and increasing participation in recommended screening. METHODS: We surveyed patients and physicians who received the BreastCARE intervention and analyzed their satisfaction and acceptability of the intervention. We compared patient satisfaction measures by race/ethnicity and used multivariable logistic regression models to examine the effect of race/ethnicity on measures of patient satisfaction with the tablet-based risk assessment and with the breast cancer risk report. We also compared measures of physician satisfaction by resident vs. attending/NP status. Finally, we identified patients’ and physicians’ suggestions for implementation. RESULTS: Overall, both patients and physicians were highly satisfied with BreastCARE, with some variation by patient race/ethnicity and breast cancer risk status. The risk assessment tool and accompanying risk report helped transmit complex information in an efficient way. CONCLUSIONS: Patient self-administered risk assessment with a health education component at the point of care is acceptable for both patients and physicians, and represents a novel approach to facilitating health promotion. This risk assessment tool should be made routine in primary care accompanied by results that are easy for the patient to understand and actionable for the clinician.

Background Treatment costs and profits are rarely considered when making treatment decisions despite trends to shift costs directly onto patients. We sought to understand whether out-of-pocket costs and provider profit disclosures impacted patients' care preferences, and how patients preferred to incorporate these issues in their decision making. Methods We surveyed previous breast cancer patients and unaffected individuals about their preferences for four treatment scenarios (screening with MRI, peg-filgrastim to prevent infection related to chemotherapy, cold cap to reduce hair loss due to chemotherapy, and alternate chemotherapy for adjuvant therapy) that offered varying degrees of clinical benefit. Participants rated their level of interest in each treatment before any disclosure, after disclosure of out-of-pocket costs, and after disclosure of provider profit. Results Of 216 participants, 33% had a history of cancer. While interest in all treatment options was high initially (68–92% across the four scenarios), it dropped significantly after disclosure of out-of-pocket costs and provider profit. For three scenarios (MRI, peg-filgrastim, cold cap) interest declined to less than 30%. For the chemotherapy drug scenario, where the alternate treatment offered the most clinical benefit, interest was reduced to a lesser extent. Conclusion Patients expressed significantly less interest in four distinct cancer treatments after disclosure of out-of-pocket costs and provider profit. Discussions about these issues are desired in the clinical encounter. As the economic burden of cancer care shifts to patients, communication about costs and provider profit may be needed to ensure that patients are fully informed when making treatment decisions.

IntroductionThe University of Utah (UofU) Health intensive outpatient clinic (IOC) is a primary care clinic for medically complex (high-cost, high-need) patients with Medicaid. The clinic consists of a multidisciplinary care team aimed at providing coordinated, comprehensive and patient-centred care. The protocol outlines the quantitative design of an evaluation study to determine the IOC’s effects on reducing healthcare utilisation and costs, as well as improving patient-reported health outcomes and quality of care.Methods and analysisHigh-risk patients, with high utilisation and multiple chronic illnesses, were identified in the Medicaid ACO population managed by the UofU Health plans for IOC eligibility. A prospective, case-control study design is being used to match 100 IOC patients to 200 control patients (receiving usual care within the UofU) based on demographics, health utilisation and medical complexity for evaluating the primary outcome of change in healthcare utilisation and costs. For the secondary outcomes of patient health and care quality, a prepost design will be used to examine within-person change across the 18 months of follow-up (ie, before and after IOC intervention). Logistic regression and hierarchical, longitudinal growth modelling are the two primary modelling approaches.Ethics and disseminationThis work has received ethics approval by the UofU Institutional Review Board. Results from the evaluation of primary and secondary outcomes will be disseminated in scientific research journals and presented at national conferences.

Up to 30% of patients who have ulcerative colitis are faced with the complex decision between end ileostomy and IPAA. We developed a decision aid to encourage shared decision making between patients and surgeons.The aim of this study is to determine whether a decision aid is effective and acceptable for surgical patients with ulcerative colitis and their treating surgeons.This was a prospective cohort study.Patients and surgeons were enrolled from 3 colorectal surgery clinics.Consecutive adult patients with ulcerative colitis who were candidates for IPAA and end ileostomy were selected.Patients used a multilingual decision aid before meeting with the surgeon.We measured changes in knowledge, treatment preference, and stage of decision making, as well as preparation for decision making, patient satisfaction, and surgeon satisfaction after using the decision aid.Twenty-five patients were enrolled; 5 had previously undergone subtotal colectomy. After using the decision aid, patients' knowledge scores improved by 39% (p0.006), 6 patients changed their treatment preference, and 8 reported increased certainty in treatment preference. The median for preparation for decision making was 75 of 100. Patient satisfaction with the decision aid (median score, 37/41) and surgeon satisfaction with the clinical encounter (median score, 38/45) were high. Patients who previously underwent subtotal colectomy had lower preparation for decision-making scores (median score, 58 vs 78 for surgery-naïve patients, p = 0.06), and did not report increased certainty in treatment preference after using the decision aid.The study included a small sample with no comparison group.A novel decision aid for surgical patients with ulcerative colitis appears to be effective and acceptable in patients and surgeons from diverse clinical settings. Patients who have not yet initiated surgical treatment seem to benefit most. Future studies to validate the knowledge questionnaire and test the decision aid in a randomized fashion are warranted.

Study design Cost-effectiveness analysis. Objective To examine the cost-effectiveness of operative versus non-operative treatment of type-II odontoid fractures in patients older than 64 years old. Summary of background data Significant controversy exists regarding the optimum treatment of geriatric patients with type-II odontoid fractures. Operative treatment leads to lower rates of non-union but carries surgical risks. Non-operative treatment does not carry surgical risks but has higher non-union rates. Methods A decision-analytic model was created to compare operative and non-operative treatment of type-II odontoid fractures among three age cohorts (65-74, 75-84, >84) based on expected costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs; cost per QALY gained). Age-specific mortality rates for both treatments, costs for treatment, and complication rates were taken from the literature, and data from 2010 US life tables were used for age-specific life expectancy. Costs of complications were estimated using data obtained at a level-I trauma center using micro-costing. Sensitivity analyses of all model parameters were conducted. Results Among the 65- to 74-year-old cohort, operative treatment was more costly ($53,407 vs. $30,553) and more effective (12.00 vs. 10.11 QALY), with an ICER of $12,078/QALY. Among the 75- to 84-year-old cohort, operative treatment was more costly ($51,308 vs. $29,789) and more effective (6.85 vs. 6.31 QALY), with an ICER of $40,467/QALY. Among the over-84 cohort, operative treatment was dominated by non-operative treatment as it was both more costly ($45,978 vs. $28,872) and less effective (2.48 vs. 3.73 QALY). The model was robust to sensitivity analysis across reasonable ranges for utility of union, disutility of complications and delayed surgery, and probabilities of non-union and complications. Conclusion Operative treatment is cost-effective in patients age 65 to 84 when using $100,000/QALY as a benchmark but less effective and more costly than non-operative treatment in patients older than 84 years. Level of evidence 2.

Introduction. Breast cancer is the second most common malignancy in women. The Decision Quality Instrument (DQI) measures the extent to which patients are informed and involved in breast surgery decisions and receive treatment that aligns with their preferences. There are limited data on the performance of the DQI in women of lower socioeconomic status (SES). Our aims were to 1) examine (and if necessary adapt) the readability, usability, and acceptability of the DQI and 2) explore whether it captures factors important to breast cancer surgery decisions among women of lower SES (relevance). Methods. We conducted semistructured cognitive interviews with women of lower SES (based on insurance status, income, and education) who had completed early-stage breast cancer treatments at three cancer centers. We used a two-step thematic analysis with dual independent coding. The study team (including Patient Partners and a Community Advisory Board) reviewed and refined suggested changes. The revised DQI was presented in two focus groups of breast cancer survivors. Results. We conducted 39 interviews. Participants found most parts of the DQI to be helpful and easy to understand. We made the following suggested changes: 1) added a glossary of key terms, 2) added two answer choices and an open text question in the goals and concerns subscale, 3) reworded the treatment intention question, and 4) revised the knowledge subscale instructions since several women disliked the wording and were unsure of what was expected. Discussion. The readability, usability, acceptability, and relevance of a measure that was primarily developed and validated in women of higher SES required adaptation for optimal use by women of lower SES. Further research will test these adaptations in lower SES populations.

Identification of mutations that increase lifetime risk of breast and ovarian cancer is critical to improving women's health. Because these mutations are relatively rare in the general population, there is a need for efficient methods to identify appropriate women to undergo genetic testing. The objective of this study was to assess the feasibility, accuracy, and performance of the NCCN guideline-based Tool for Risk Assessment for breast and ovarian Cancer (N-TRAC)-a patient-facing assessment for those affected and unaffected by cancer. This study enrolled a prospective cohort of 100 affected and 100 unaffected women that used N-TRAC in a clinical setting. Recommendations for referral to genetic counseling based on N-TRAC and other standard risk assessment methods were compared.Seventy-seven of the 100 affected women and 35 of the 100 unaffected women were identified as high risk by N-TRAC. The average completion time was approximately 2 min for both groups. N-TRAC accuracy for family history was exceptional in both groups (kappa > 0.96). N-TRAC and other risk assessment methods do not always identify the same high risk population. N-TRAC is an accurate and feasible tool that can assist in identifying women at increased risk for hereditary breast and ovarian cancer and may lead to more informed decision-making.

Author(s): Forcino, Rachel C; Barr, Paul J; O'Malley, A James; Arend, Roger; Castaldo, Molly G; Ozanne, Elissa M; Percac-Lima, Sanja; Stults, Cheryl D; Tai-Seale, Ming; Thompson, Rachel; Elwyn, Glyn | Abstract: IntroductionCollaboRATE is a brief patient survey focused on shared decision making. This paper aims to (i) provide insight on facilitators and challenges to implementing a real-time patient survey and (ii) evaluate CollaboRATE scores and response rates across multiple clinical settings with varied patient populations.MethodAll adult patients at three United States primary care practices were eligible to complete CollaboRATE post-visit. To inform key learnings, we aggregated all mentions of unanticipated decisions, problems and administration errors from field notes and email communications. Mixed-effects logistic regression evaluated the impact of site, clinician, patient age and patient gender on the CollaboRATE score.ResultsWhile CollaboRATE score increased only slightly with increasing patient age (OR 1.018, 95% CI 1.014-1.021), female patient gender was associated with significantly higher CollaboRATE scores (OR 1.224, 95% CI 1.073-1.397). Clinician also predicts CollaboRATE score (random effect variance 0.146). Site-specific factors such as clinical workflow and checkout procedures play a key role in successful in-clinic implementation and are significantly related to CollaboRATE scores, with Site 3 scoring significantly higher than Site 1 (OR 1.759, 95% CI 1.216 to 2.545) or Site 2 (z=-2.71, 95% CI -1.114 to -0.178).DiscussionThis study demonstrates that CollaboRATE can be used in diverse primary care settings. A clinic's workflow plays a crucial role in implementation. Patient experience measurement risks becoming a burden to both patients and administrators. Episodic use of short measurement tools could reduce this burden.

Objective The purpose was to examine recent advances in measuring value concordance and to highlight best practices. Methods The paper updates a prior systematic review. A systematic review of the literature from 2008 to 2012 identified articles that reported a relationship between patients’ preferences concerning health outcomes and/or medical treatments, and treatment (intended or actual). Relevant articles were independently abstracted by two reviewers. Results The search identified 3635 unique citations, the full text of 187 articles was examined, and 63 articles covering 61 studies were included, nearly a third more articles than identified in the original review. There were 72 different value concordance calculations, the majority of which were clearly reported with significance. More studies assessed knowledge, reported on the association between value concordance and knowledge, and included a decision aid compared to those in the original review. Conclusion There is increased reporting of value concordance in the literature. However, large differences exist in the way that the measure is defined and calculated. The variability makes it difficult to draw conclusions about the quality of care across studies. Practice implications Value concordance is a critical component of patient-centered care, and further attention is needed to establish standards for measurement and reporting.

Background. National Surgical Adjuvant Breast and Bowel Project (NSABP) B-43 is an ongoing randomized clinical trial that compares breast conserving surgery, radiation therapy, and two infusions of trastuzumab to breast-conserving surgery and radiation only for HER2+ ductal carcinoma in situ (DCIS). We sought to identify, from a societal perspective, the level of risk reduction observed in this trial that would be required to make treating HER2+ DCIS patients with trastuzumab cost-effective. Methods. We developed a Markov decision-analytic model to evaluate these treatment strategies in terms of life expectancy, quality-adjusted life years (QALYs), costs, and the incremental cost-effectiveness ratio (ICER) over 15 years. The results of NSABP B-43 are pending. We therefore assumed the hazard reduction to be 36%, based on the statistical considerations of the trial protocol and explored this in sensitivity analyses. A series of one and two-way sensitivity tests were conducted. Results. The baseline ICER for switching from a breast-conserving surgery and radiation strategy without trastuzumab treatment to a breast-conserving surgery and radiation strategy with trastuzumab treatment is $1.57 million per life-year gained and $299,616.73 per QALY gained. Compared to a societal willingness-to-pay threshold of $100,000 per QALY gained, adding Herceptin treatment is not cost-effective in the treatment of DCIS under these baseline conditions. In a one-way sensitivity test, we found that the Herceptin strategy only became cost-effective at an 88.3% risk reduction for local recurrence. The model was not sensitive to any costs or probabilities within 20% of baseline values. The model was sensitive to the utilities of having had breast-conserving surgery and radiation with and without trastuzumab treatment. It was not sensitive to other utilities within 0.05 of baseline values. Conclusions. High risk DCIS treated with breast-conserving surgery and radiation has a low risk of local recurrence as demonstrated in multiple randomized trials. The addition of a costly drug in order to reduce this small risk further is very unlikely to be cost-effective and could be considered overtreatment of a non-fatal disease that is sufficiently managed with local treatment. Prospective cost-effectiveness analyses have the potential to guide allocation of valuable resources for breast cancer research, and should be regularly integrated into the protocol design of large clinical trials. Citation Format: Michael D Alvarado, Mitchell T Hayes, Rajni Sethi, Elissa Ozanne. NSABP B-43 is unlikely to produce a cost-effective treatment strategy for HER2+ DCIS [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-10-03.

Purpose: Treatment decisions regarding Ductal Carcinoma in Situ (DCIS) are complex, and patients often have inaccurate and incomplete understanding of the risks and benefits they face. Our objective was to create a web-based decision aid (onlineDeCISion.org) that can be used in clinical practice to guide both clinicians and their patients with these decisions. Methods: We developed a web-based clinical decision aid to provide tailored information about DCIS treatment choices including an individual patient’s risk of recurrence, likelihood of long-term breast preservation and survival outcomes following up to 6 different treatment strategies for DCIS (lumpectomy, lumpectomy with radiation, lumpectomy with tamoxifen, lumpectomy with radiation and tamoxifen, and mastectomy with or without breast reconstruction). The decision aid is populated by our previously developed simulation model of DCIS outcomes. A theoretical framework and best-practices for web-based decision tools guided the development of the decision aid including semi-structured interviews and usability testing with a diverse group of multidisciplinary clinicians and patient advocates. Results: The decision aid was designed to include these key features: 1) descriptions of treatment options; 2) ability to input patient health-adjusted age; 3) tailored likelihood of time-specific (10-year and lifetime) recurrence and survival outcomes; and 4) projections of downstream effects of each treatment. The decision aid provides default recurrence risks based on clinical trial data but allows clinicians to customize 10-year DCIS and invasive recurrence risks to retain flexibility to display expected outcomes for individual patients. These estimates can be based on the patient’s actual age, or age adjusted for health status, allowing for a more realistic expectation of the benefits each treatment holds. Conclusion: Our web-based decision aid displays tailored outcomes following different treatment strategies for DCIS, allowing patients to be better informed about the tradeoffs of treatments available to them and select treatments consonant with their personal preferences, improving the quality of decision making for DCIS. The interactive design features allow users of the decision aid the ability to address uncertainty around risks of recurrence and comorbidity risks and facilitate the use of the decision aid across diverse populations. While the decision aid warrants further evaluation, the results of our study promise to improve decision making in patients with DCIS. Citation Format: Elissa M Ozanne, Natasha K Stout, Katharine Schneider, Djøra Soeteman, Deborah Schrag, Michael Fordis, Rinaa S Punglia. onlineDeCISion.org: An interactive web-based clinical decision aid for DCIS treatment [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-10-01.

Background & Aims Endoscopic intervention or pharmacologic inhibition of cyclooxygenase might be used to prevent progression of Barrett's esophagus (BE) to esophageal adenocarcinoma (EAC). We investigated whether patients with BE prefer endoscopic therapy or chemoprevention of EAC. Methods Eighty-one subjects with nondysplastic BE were given a survey that described 2 scenarios. The survey explained that treatment A (ablation), endoscopy, reduced lifetime risk of EAC by 50%, with 5% risk for esophageal stricture, whereas treatment B (aspirin) reduced lifetime risk of EAC by 50% and the risk of heart attack by 30%, yet increased the risk for ulcer by 75%. Subjects indicated their willingness to undergo either treatment A and/or treatment B if endoscopic surveillance were required every 3–5 years, every 10 years, or were not required. Visual aids were included to represent risk and benefit percentages. Results When surveillance was required every 3–5 years, more subjects were willing to undergo treatment A than treatment B (78%, 63 of 81 vs 53%, 43 of 81; P Conclusions In a simulated scenario, patients with BE preferred endoscopic intervention over chemoprevention for EAC. Further investigation of the shared decision-making process regarding preventive strategies for patients with BE may be warranted.

Background and study aims The objective of this study was to assess patient involvement in decision-making, decision confidence, and decision regret among patients who had undergone endoscopic eradication therapy (EET) or esophagectomy for Barrett’s esophagus (BE) associated neoplasia. Patients and methods Patients with BE high grade dysplasia or intramucosal (T1a) adenocarcinoma who had undergone EET or esophagectomy were invited to complete a survey. Results The cohort included 50 subjects, 70 % (35/50) of whom had undergone EET and 30 % (15/50) of whom had undergone esophagectomy. Subjects who underwent esophagectomy were more likely to report post-treatment dysphagia (47 % vs 14 %, P = 0.03), post-treatment dietary modification (73 % vs 6 %, P Conclusions Patients who have undergone EET or surgery for BE neoplasia report a high degree of involvement in the decision-making process. Although EET patients report fewer symptom-specific outcomes, measures of decision confidence and decision regret do not differ between the two treatment groups.