Comparative Effectiveness of Left Atrial Appendage Occlusion Versus Oral Anticoagulation by Sex.

BACKGROUND: The comparative real-world outcomes of older patients with atrial fibrillation (AF) treated with anticoagulation compared with left atrial appendage occlusion (LAAO) may be different from those in clinical trials because of differences in anticoagulation strategies and patient demographics, including a greater proportion of women. We sought to compare real-world outcomes between older patients with AF treated with anticoagulation and those treated with LAAO by sex. METHODS: Using Medicare claims data from 2015 to 2019, we identified LAAO-eligible beneficiaries and divided them into sex subgroups. Patients receiving LAAO were matched 1:1 to those receiving anticoagulation alone through propensity score matching. The risks of mortality, stroke or systemic embolism, and bleeding were compared between matched groups with adjustment for potential confounding characteristics in Cox proportional hazards models. RESULTS: Among women, 4085 LAAO recipients were matched 1:1 to those receiving anticoagulation; among men, 5378 LAAO recipients were similarly matched. LAAO was associated with a significant reduction in the risk of mortality for women and men (hazard ratio [HR], 0.509 [95% CI, 0.447-0.580]; and HR, 0.541 [95% CI, 0.487-0.601], respectively; P<0.0001), with a similar finding for stroke or systemic embolism (HR, 0.655 [95% CI, 0.555-0.772]; and HR, 0.649 [95% CI, 0.552-0.762], respectively; P<0.0001). Bleeding risk was significantly greater in LAAO recipients early after implantation but lower after the 6-week periprocedural period for women and men (HR, 0.772 [95% CI, 0.676-0.882]; and HR, 0.881 [95% CI, 0.784-0.989], respectively; P<0.05). CONCLUSIONS: In a real-world population of older Medicare beneficiaries with AF, compared with anticoagulation, LAAO was associated with a reduction in the risk of death, stroke, and long-term bleeding among women and men. These findings should be incorporated into shared decision-making with patients considering strategies for reduction in AF-related stroke.

The Association Between Oncology Outreach and Timely Treatment for Rural Patients with Breast Cancer: A Claims-Based Approach.

BACKGROUND: Oncology outreach is a common strategy for increasing rural access to cancer care, where traveling oncologists commute across healthcare settings to extend specialized care. Examining the extent to which physician outreach is associated with timely treatment for rural patients is critical for informing outreach strategies. METHODS: We identified a 100% fee-for-service sample of incident breast cancer patients from 2015 to 2020 Medicare claims and apportioned them into surgery and adjuvant therapy cohorts based on treatment history. We defined an outreach visit as the provision of care by a traveling oncologist at a clinic outside of their primary hospital service area. We used hierarchical logistic regression to examine the associations between patient receipt of preoperative care at an outreach visit (preoperative outreach) and > 60-day surgical delay, and patient receipt of postoperative care at an outreach visit (postoperative outreach) and > 60-day adjuvant delay. RESULTS: We identified 30,337 rural-residing patients who received breast cancer surgery, of whom 4071 (13.4%) experienced surgical delay. Among surgical patients, 14,501 received adjuvant therapy, of whom 2943 (20.3%) experienced adjuvant delay. In adjusted analysis, we found that patient receipt of preoperative outreach was associated with reduced odds of surgical delay (odds ratio [OR] 0.75, 95% confidence interval [CI] 0.61-0.91); however, we found no association between patient receipt of postoperative outreach and adjuvant delay (OR 1.04, 95% CI 0.85-1.25). CONCLUSIONS: Our findings indicate that preoperative outreach is protective against surgical delay. The traveling oncologists who enable such outreach may play an integral role in catalyzing the coordination and timeliness of patient-centered care.

Communicating visit information to family caregivers: How does method matter? A national survey.

OBJECTIVES: The clinic visit is a critical point of contact for family caregivers. However, only 37% of family caregivers are able to accompany patients to visits. When they cannot attend, caregivers receive visit information to assist with their caregiving. However, little is known about how method of receiving information from clinic visits is associated with important caregiver outcomes. This study sought to determine whether mode of receiving clinic visit information (speaking with the patient, attending the visit, or using an after-visit summary [AVS]) was associated with changes in caregiver burden, caregiver preparedness, and the positive aspects of caregiving. METHODS: Cross-sectional web-based survey of a national sample of adult family caregivers. Multiple linear regression models determined associations between communication modes and caregivers' burden, preparedness, and positive aspects of caregiving, adjusting for sociodemographic covariates. RESULTS: Respondents (N = 340) were mostly male (58%), White (59%), ranged from 18 to 85 years old, and supported patients with conditions including diabetes, dementia, and cancer. Speaking with patients was associated with increases in positive aspects of caregiving (95% CI = 2.01, 5.42) and an AVS was associated with increases in positive aspects of caregiving (95% CI = 0.4, 3.56) and preparedness for caregiving (95% CI = 0.61, 3.15). Using any method of receiving information from visits was associated with the greatest increase in preparedness, compared to not receiving visit information. We did not observe an association between method of communication and caregiver burden. SIGNIFICANCE OF RESULTS: Method of communicating visit information is associated with improvements in caregiver preparedness and the positive aspects of caregiving, though caregiver burden may be unaffected by information exchange. Given the limitations of current communication methods, future work should explore directionality of the associations we found and identify visit communication strategies with caregivers that optimize caregiver and patient outcomes.

Using a Video Game Intervention to Increase Hospitalists' Advance Care Planning Conversations with Older Adults: a Stepped Wedge Randomized Clinical Trial.

BACKGROUND: Guidelines recommend Advance Care Planning (ACP) for seriously ill older adults to increase the patient-centeredness of end-of-life care. Few interventions target the inpatient setting. OBJECTIVE: To test the effect of a novel physician-directed intervention on ACP conversations in the inpatient setting. DESIGN: Stepped wedge cluster-randomized design with five 1-month steps (October 2020-February 2021), and 3-month extensions at each end. SETTING: A total of 35/125 hospitals staffed by a nationwide physician practice with an existing quality improvement initiative to increase ACP (enhanced usual care). PARTICIPANTS: Physicians employed for ≥ 6 months at these hospitals; patients aged ≥ 65 years they treated between July 2020-May 2021. INTERVENTION: Greater than or equal to 2 h of exposure to a theory-based video game designed to increase autonomous motivation for ACP; enhanced usual care. MAIN MEASURE: ACP billing (data abstractors blinded to intervention status). RESULTS: A total of 163/319 (52%) invited, eligible hospitalists consented to participate, 161 (98%) responded, and 132 (81%) completed all tasks. Physicians' mean age was 40 (SD 7); most were male (76%), Asian (52%), and reported playing the game for ≥ 2 h (81%). These physicians treated 44,235 eligible patients over the entire study period. Most patients (57%) were ≥ 75; 15% had COVID. ACP billing decreased between the pre- and post-intervention periods (26% v. 21%). After adjustment, the homogeneous effect of the game on ACP billing was non-significant (OR 0.96; 95% CI 0.88-1.06; p = 0.42). There was effect modification by step (p < 0.001), with the game associated with increased billing in steps 1-3 (OR 1.03 [step 1]; OR 1.15 [step 2]; OR 1.13 [step 3]) and decreased billing in steps 4-5 (OR 0.66 [step 4]; OR 0.95 [step 5]). CONCLUSIONS: When added to enhanced usual care, a novel video game intervention had no clear effect on ACP billing, but variation across steps of the trial raised concerns about confounding from secular trends (i.e., COVID). TRIAL REGISTRATION: Clinicaltrials.gov; NCT04557930, 9/21/2020.

A novel causal mediation analysis approach for zero-inflated mediators.

Mediation analyses play important roles in making causal inference in biomedical research to examine causal pathways that may be mediated by one or more intermediate variables (ie, mediators). Although mediation frameworks have been well established such as counterfactual-outcomes (ie, potential-outcomes) models and traditional linear mediation models, little effort has been devoted to dealing with mediators with zero-inflated structures due to challenges associated with excessive zeros. We develop a novel mediation modeling approach to address zero-inflated mediators containing true zeros and false zeros. The new approach can decompose the total mediation effect into two components induced by zero-inflated structures: the first component is attributable to the change in the mediator on its numerical scale which is a sum of two causal pathways and the second component is attributable only to its binary change from zero to a non-zero status. An extensive simulation study is conducted to assess the performance and it shows that the proposed approach outperforms existing standard causal mediation analysis approaches. We also showcase the application of the proposed approach to a real study in comparison with a standard causal mediation analysis approach.

Constructing within and between hospital physician social networks for modeling physician research participation.

BACKGROUND: Physician participation in clinical trials is essential for the progress of modern medicine. However, the demand for physician research partners is outpacing physicians' interest in participating in scientific studies. Understanding the factors that influence physician participation in research is crucial to addressing this gap. METHODS: In this study, we used a physician's social network, as constructed from patient billing data, to study if the research choices of a physician's immediate peers influence their likelihood to participate in scientific research. We analyzed data from 348 physicians across 40 hospitals. We used logistic regression models to examine the relationship between a physician's participation in clinical trials and the participation of their social network peers, adjusting for age, years of employment, and influences from other hospital facilities. RESULTS: We found that the likelihood of a physician participating in clinical trials increased dramatically with the proportion of their social network-defined colleagues at their primary hospital who were participating ([Formula: see text] for a 1% increase in the proportion of participating peers, [Formula: see text]). Additionally, physicians who work regularly at multiple facilities were more likely to participate ([Formula: see text], [Formula: see text]) and increasingly so as the extent to which they have social network ties to colleagues at hospitals other than their primary hospital increases ([Formula: see text], [Formula: see text]). These findings suggest an inter-hospital peer participation process. CONCLUSION: Our study provides evidence that the social structure of a physician's work-life is associated with their decision to participate in scientific research. The results suggest that interventions aimed at increasing physician participation in clinical trials could leverage the social networks of physicians to encourage participation. By identifying factors that influence physician participation in research, we can work towards closing the gap between the demand for physician research partners and the number of physicians willing to participate in scientific studies.

The impact of adding cost information to a conversation aid to support shared decision making about low-risk prostate cancer treatment: Results of a stepped-wedge cluster randomised trial.

BACKGROUND: Decision aids help patients consider the benefits and drawbacks of care options but rarely include cost information. We assessed the impact of a conversation-based decision aid containing information about low-risk prostate cancer management options and their relative costs. METHODS: We conducted a stepped-wedge cluster randomised trial in outpatient urology practices within a US-based academic medical center. We randomised five clinicians to four intervention sequences and enroled patients newly diagnosed with low-risk prostate cancer. Primary patient-reported outcomes collected postvisit included the frequency of cost conversations and referrals to address costs. Other patient-reported outcomes included: decisional conflict postvisit and at 3 months, decision regret at 3 months, shared decision-making postvisit, financial toxicity postvisit and at 3 months. Clinicians reported their attitudes about shared decision-making pre- and poststudy, and the intervention's feasibility and acceptability. We used hierarchical regression analysis to assess patient outcomes. The clinician was included as a random effect; fixed effects included education, employment, telehealth versus in-person visit, visit date, and enrolment period. RESULTS: Between April 2020 and March 2022, we screened 513 patients, contacted 217 eligible patients, and enroled 117/217 (54%) (51 in usual care, 66 in the intervention group). In adjusted analyses, the intervention was not associated with cost conversations (ß = .82, p = .27), referrals to cost-related resources (ß = -0.36, p = .81), shared decision-making (ß = -0.79, p = .32), decisional conflict postvisit (ß = -0.34, p= .70), or at follow-up (ß = -2.19, p = .16), decision regret at follow-up (ß = -9.76, p = .11), or financial toxicity postvisit (ß = -1.32, p = .63) or at follow-up (ß = -2.41, p = .23). Most clinicians and patients had positive attitudes about the intervention and shared decision-making. In exploratory unadjusted analyses, patients in the intervention group experienced more transient indecision (p < .02) suggesting increased deliberation between visit and follow-up. DISCUSSION: Despite enthusiasm from clinicians, the intervention was not significantly associated with hypothesised outcomes, though we were unable to robustly test outcomes due to recruitment challenges. Recruitment at the start of the COVID-19 pandemic impacted eligibility, sample size/power, study procedures, and increased telehealth visits and financial worry, independent of the intervention. Future work should explore ways to support shared decision-making, cost conversations, and choice deliberation with a larger sample. Such work could involve additional members of the care team, and consider the detail, quality, and timing of addressing these issues. PATIENT OR PUBLIC CONTRIBUTION: Patients and clinicians were engaged as stakeholder advisors meeting monthly throughout the duration of the project to advise on the study design, measures selected, data interpretation, and dissemination of study findings.

The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines.

BACKGROUND: Clinical and real-world effectiveness data for the COVID-19 vaccines have shown that they are the best defense in preventing severe illness and death throughout the pandemic. However, in the US, some groups remain more hesitant than others about receiving COVID-19 vaccines. One important group is long-term care workers (LTCWs), especially because they risk infecting the vulnerable and clinically complex populations they serve. There is a lack of research about how best to increase vaccine confidence, especially in frontline LTCWs and healthcare staff. Our aims are to: (1) compare the impact of two interventions delivered online to enhanced usual practice on LTCW COVID-19 vaccine confidence and other pre-specified secondary outcomes, (2) determine if LTCWs' characteristics and other factors mediate and moderate the interventions' effect on study outcomes, and (3) explore the implementation characteristics, contexts, and processes needed to sustain a wider use of the interventions. METHODS: We will conduct a three-arm randomized controlled effectiveness-implementation hybrid (type 2) trial, with randomization at the participant level. Arm 1 is a dialogue-based webinar intervention facilitated by a LTCW and a medical expert and guided by an evidence-based COVID-19 vaccine decision tool. Arm 2 is a curated social media web application intervention featuring interactive, dynamic content about COVID-19 and relevant vaccines. Arm 3 is enhanced usual practice, which directs participants to online public health information about COVID-19 vaccines. Participants will be recruited via online posts and advertisements, email invitations, and in-person visits to care settings. Trial data will be collected at four time points using online surveys. The primary outcome is COVID-19 vaccine confidence. Secondary outcomes include vaccine uptake, vaccine and booster intent for those unvaccinated, likelihood of recommending vaccination (both initial series and booster), feeling informed about the vaccines, identification of vaccine information and misinformation, and trust in COVID-19 vaccine information provided by different people and organizations. Exploration of intervention implementation will involve interviews with study participants and other stakeholders, an in-depth process evaluation, and testing during a subsequent sustainability phase. DISCUSSION: Study findings will contribute new knowledge about how to increase COVID-19 vaccine confidence and effective informational modalities for LTCWs. TRIAL REGISTRATION: NCT05168800 at ClinicalTrials.gov, registered December 23, 2021.

Pediatric Mental Health Hospitalizations at Acute Care Hospitals in the US, 2009-2019.

Importance: Approximately 1 in 6 youth in the US have a mental health condition, and suicide is a leading cause of death among this population. Recent national statistics describing acute care hospitalizations for mental health conditions are lacking. Objectives: To describe national trends in pediatric mental health hospitalizations between 2009 and 2019, to compare utilization among mental health and non-mental health hospitalizations, and to characterize variation in utilization across hospitals. Design, Setting, and Participants: Retrospective analysis of the 2009, 2012, 2016, and 2019 Kids' Inpatient Database, a nationally representative database of US acute care hospital discharges. Analysis included 4 767 840 weighted hospitalizations among children 3 to 17 years of age. Exposures: Hospitalizations with primary mental health diagnoses were identified using the Child and Adolescent Mental Health Disorders Classification System, which classified mental health diagnoses into 30 mutually exclusive disorder types. Main Outcomes and Measures: Measures included number and proportion of hospitalizations with a primary mental health diagnosis and with attempted suicide, suicidal ideation, or self-injury; number and proportion of hospital days and interfacility transfers attributable to mental health hospitalizations; mean lengths of stay (days) and transfer rates among mental health and non-mental health hospitalizations; and variation in these measures across hospitals. Results: Of 201 932 pediatric mental health hospitalizations in 2019, 123 342 (61.1% [95% CI, 60.3%-61.9%]) were in females, 100 038 (49.5% [95% CI, 48.3%-50.7%]) were in adolescents aged 15 to 17 years, and 103 456 (51.3% [95% CI, 48.6%-53.9%]) were covered by Medicaid. Between 2009 and 2019, the number of pediatric mental health hospitalizations increased by 25.8%, and these hospitalizations accounted for a significantly higher proportion of pediatric hospitalizations (11.5% [95% CI, 10.2%-12.8%] vs 19.8% [95% CI, 17.7%-21.9%]), hospital days (22.2% [95% CI, 19.1%-25.3%] vs 28.7% [95% CI, 24.4%-33.0%]), and interfacility transfers (36.9% [95% CI, 33.2%-40.5%] vs 49.3% [95% CI, 45.9%-52.7%]). The percentage of mental health hospitalizations with attempted suicide, suicidal ideation, or self-injury diagnoses increased significantly from 30.7% (95% CI, 28.6%-32.8%) in 2009 to 64.2% (95% CI, 62.3%-66.2%) in 2019. Length of stay and interfacility transfer rates varied significantly across hospitals. Across all years, mental health hospitalizations had significantly longer mean lengths of stay and higher transfer rates compared with non-mental health hospitalizations. Conclusions and Relevance: Between 2009 and 2019, the number and proportion of pediatric acute care hospitalizations due to mental health diagnoses increased significantly. The majority of mental health hospitalizations in 2019 included a diagnosis of attempted suicide, suicidal ideation, or self-injury, underscoring the increasing importance of this concern.

A national evaluation of geographic accessibility and provider availability of obesity medicine diplomates in the United States between 2011 and 2019.

BACKGROUND/OBJECTIVES: Obesity is a pressing health concern within the United States (US). Obesity medicine "diplomates" receive specialized training, yet it is unclear if their accessibility and availability adequately serves the need. The purpose of this research was to understand how accessibility has evolved over time and assess the practicality of serving an estimated patient population with the current distribution and quantity of diplomates. METHODS: Population-weighted Census tracts in US counties were mapped to the nearest facility on a road network with at least one diplomate who specialized in adult (including geriatric) care between 2011 and 2019. The median travel time for all Census tracts within a county represented the primary geographic access measure. Availability was assessed by estimating the number of diplomates per 100 000 patients with obesity and the number of facilities able to serve assigned patients under three clinical guidelines. RESULTS: Of the 3371 diplomates certified since 2019, 3036 were included. The median travel time (weighted for county population) fell from 28.5 min [IQR: 13.7, 68.1] in 2011 to 9.95 min [IQR: 7.49, 18.1] in 2019. There were distinct intra- and inter-year travel time variations by race, ethnicity, education, median household income, rurality, and Census region (all P < 0.001). The median number of diplomates per 100 000 with obesity grew from 1 [IQR: 0.39, 1.59] in 2011 to 5 [IQR: 2.74, 11.4] in 2019. In 2019, an estimated 1.7% of facilities could meet the recommended number of visits for all mapped patients with obesity, up from 0% in 2011. CONCLUSIONS: Diplomate geographic access and availability have improved over time, yet there is still not a high enough supply to serve the potential patient demand. Future studies should quantify patient-level associations between travel time and health outcomes, including whether the number of available diplomates impacts utilization.

Social network correlates of free and purchased insecticide-treated bed nets in rural Uganda.

BACKGROUND: Malaria is a major cause of mortality and morbidity in Uganda. Despite Uganda's efforts to distribute bed nets, only half of households have achieved the World Health Organization (WHO) Universal Coverage Criteria (one bed net for every two household members). The role of peer influence on bed net ownership remains underexplored. Data on the complete social network of households were collected in a rural parish in southwestern Uganda to estimate the association between household bed net ownership and peer household bed net ownership. METHODS: Data on household sociodemographics, bed net ownership, and social networks were collected from all households across one parish in southwestern Uganda. Bed nets were categorized as either purchased or free. Purchased and free bed net ownership ratios were calculated based on the WHO Universal Coverage Criteria. Using network name generators and complete census of parish residents, the complete social network of households in the parish was generated. Linear regression models that account for network autocorrelation were fitted to estimate the association between households' bed net ownership ratios and bed net ownership ratios of network peer households, adjusting for sociodemographics and network centrality. RESULTS: One thousand seven hundred forty-seven respondents were interviewed, accounting for 716 households. The median number of peer households to which a household was directly connected was 7. Eighty-six percent of households owned at least one bed net, and 41% of households met the WHO Universal Coverage Criterion. The median bed net ownership ratios were 0.67 for all bed nets, 0.33 for free bed nets, and 0.20 for purchased bed nets. In adjusted multivariable models, purchased bed net ownership ratio was associated with average household wealth among peer households (b = 0.06, 95% CI 0.03, 0.10), but not associated with average purchased bed net ownership ratio of peer households. Free bed net ownership ratio was associated with the number of children under 5 (b = 0.08, 95% CI 0.05, 0.10) and average free bed net ownership ratios of peer households (b = 0.66, 95% CI 0.46, 0.85). CONCLUSIONS: Household bed net ownership was associated with bed net ownership of peer households for free bed nets, but not for purchased bed nets. The findings suggest that public health interventions may consider leveraging social networks as tools for dissemination, particularly for bed nets that are provided free of charge.

Using a mixed-effect model with a parameter-space of heterogenous dimension to evaluate whether accountable care organizations are associated with greater uniformity across constituent practices.

Accountable care organization (ACO) legislation was designed to improve patient outcomes by inducing greater coordination of care and adoption of best practices. Therefore, it is of interest to assess whether greater uniformity occurs among practices comprising an ACO post ACO formation. We develop a mixed-effect model with a difference-in-difference design to evaluate the effect of a patient receiving care from an ACO on patient outcomes and adapt this model to examine whether an ACO is associated with increased uniformity across its constituent practices. The task is complicated by the organizations within an ACO forming an additional layer in the multilevel model, due to medical practices and hospitals that form an ACOs being nested within the ACO, making the number of levels of the model variable and the dimension of the parameter space time-varying. We develop the model and a procedure for testing the hypothesis that ACO formation was associated with increased uniformity among its constituent practices. We apply our procedure to a cohort of medicare beneficiaries followed over 2009-2014. Although there is extensive heterogeneity of becoming an ACOs across practices, we find that the formation of an ACO appears to be associated with greater uniformity of patient outcomes among its constituent practices.

Characterizing the Prevalence of Obesity Misinformation, Factual Content, Stigma, and Positivity on the Social Media Platform Reddit Between 2011 and 2019: Infodemiology Study.

BACKGROUND: Reddit is a popular social media platform that has faced scrutiny for inflammatory language against those with obesity, yet there has been no comprehensive analysis of its obesity-related content. OBJECTIVE: We aimed to quantify the presence of 4 types of obesity-related content on Reddit (misinformation, facts, stigma, and positivity) and identify psycholinguistic features that may be enriched within each one. METHODS: All sentences (N=764,179) containing "obese" or "obesity" from top-level comments (n=689,447) made on non-age-restricted subreddits (ie, smaller communities within Reddit) between 2011 and 2019 that contained one of a series of keywords were evaluated. Four types of common natural language processing features were extracted: bigram term frequency-inverse document frequency, word embeddings derived from Bidirectional Encoder Representations from Transformers, sentiment from the Valence Aware Dictionary for Sentiment Reasoning, and psycholinguistic features from the Linguistic Inquiry and Word Count Program. These features were used to train an Extreme Gradient Boosting machine learning classifier to label each sentence as 1 of the 4 content categories or other. Two-part hurdle models for semicontinuous data (which use logistic regression to assess the odds of a 0 result and linear regression for continuous data) were used to evaluate whether select psycholinguistic features presented differently in misinformation (compared with facts) or stigma (compared with positivity). RESULTS: After removing ambiguous sentences, 0.47% (3610/764,179) of the sentences were labeled as misinformation, 1.88% (14,366/764,179) were labeled as stigma, 1.94% (14,799/764,179) were labeled as positivity, and 8.93% (68,276/764,179) were labeled as facts. Each category had markers that distinguished it from other categories within the data as well as an external corpus. For example, misinformation had a higher average percent of negations (ß=3.71, 95% CI 3.53-3.90; P<.001) but a lower average number of words >6 letters (ß=-1.47, 95% CI -1.85 to -1.10; P<.001) relative to facts. Stigma had a higher proportion of swear words (ß=1.83, 95% CI 1.62-2.04; P<.001) but a lower proportion of first-person singular pronouns (ß=-5.30, 95% CI -5.44 to -5.16; P<.001) relative to positivity. CONCLUSIONS: There are distinct psycholinguistic properties between types of obesity-related content on Reddit that can be leveraged to rapidly identify deleterious content with minimal human intervention and provide insights into how the Reddit population perceives patients with obesity. Future work should assess whether these properties are shared across languages and other social media platforms.

What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata.

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.

Women Who Are Young, Non-White, and with Lower Socioeconomic Status Report Higher Financial Toxicity up to 1 Year After Breast Cancer Surgery: A Mixed-Effects Regression Analysis.

PURPOSE: We examined self-reported financial toxicity and out-of-pocket expenses among adult women with breast cancer. METHODS: Patients spoke English, Spanish, or Mandarin Chinese, were aged 18+ years, had stage I-IIIA breast cancer, and were eligible for breast-conserving and mastectomy surgery. Participants completed surveys about out-of-pocket costs and financial toxicity at 1 week, 12 weeks, and 1 year postsurgery. RESULTS: Three hundred ninety-five of 448 eligible patients (88.2%) from the parent trial completed surveys. Excluding those reporting zero costs, crude mean ± SD out-of-pocket costs were $1,512 ± $2,074 at 1 week, $2,609 ± $6,369 at 12 weeks, and $3,308 ± $5,000 at 1 year postsurgery. Controlling for surgery, cancer stage, and demographics with surgeon and clinic as random effects, higher out-of-pocket costs were associated with higher financial toxicity 1 week and 12 weeks postsurgery (p < .001). Lower socioeconomic status (SES) was associated with lower out-of-pocket costs at each time point (p = .002-.013). One week postsurgery, participants with lower SES reported financial toxicity scores 1.02 points higher than participants with higher SES (95% confidence interval [CI], 0.08-1.95). Black and non-White/non-Black participants reported financial toxicity scores 1.91 (95% CI, 0.46-3.37) and 2.55 (95% CI, 1.11-3.99) points higher than White participants. Older (65+ years) participants reported financial toxicity scores 2.58 points lower than younger (<65 years) participants (95% CI, -3.41, -1.74). Younger participants reported significantly higher financial toxicity at each time point. DISCUSSION: Younger age, non-White race, and lower SES were associated with higher financial toxicity regardless of costs. Out-of-pocket costs increased over time and were positively associated with financial toxicity. Future work should reduce the impact of cancer care costs among vulnerable groups. IMPLICATIONS FOR PRACTICE: This study was one of the first to examine out-of-pocket costs and financial toxicity up to 1 year after breast cancer surgery. Younger age, Black race, race other than Black or White, and lower socioeconomic status were associated with higher financial toxicity. Findings highlight the importance of addressing patients' financial toxicity in several ways, particularly for groups vulnerable to its effects.

Association Between Beta-Blockers and Mortality and Readmission in Older Patients with Heart Failure: an Instrumental Variable Analysis.

BACKGROUND: The demographics of heart failure are changing. The rate of growth of the "older" heart failure population, specifically those ≥ 75, has outpaced that of any other age group. These older patients were underrepresented in the early beta-blocker trials. There are several reasons, including a decreased potential for mortality benefit and increased risk of side effects, why the risk/benefit tradeoff may be different in this population. OBJECTIVE: We aimed to determine the association between receipt of a beta-blocker after heart failure discharge and early mortality and readmission rates among patients with heart failure and reduced ejection fraction (HFrEF), specifically patients aged 75+. DESIGN AND PARTICIPANTS: We used 100% Medicare Parts A and B and a random 40% sample of Part D to create a cohort of beneficiaries with ≥ 1 hospitalization for HFrEF between 2008 and 2016 to run an instrumental variable analysis. MAIN MEASURE: The primary measure was 90-day, all-cause mortality; the secondary measure was 90-day, all-cause readmission. KEY RESULTS: Using the two-stage least squared methodology, among all HFrEF patients, receipt of a beta-blocker within 30-day of discharge was associated with a - 4.35% (95% CI - 6.27 to - 2.42%, p < 0.001) decrease in 90-day mortality and a - 4.66% (95% CI - 7.40 to - 1.91%, p = 0.001) decrease in 90-day readmission rates. Even among patients ≥ 75 years old, receipt of a beta-blocker at discharge was also associated with a significant decrease in 90-day mortality, - 4.78% (95% CI - 7.19 to - 2.40%, p < 0.001) and 90-day readmissions, - 4.67% (95% CI - 7.89 to - 1.45%, p < 0.001). CONCLUSION: Patients aged ≥ 75 years who receive a beta-blocker after HFrEF hospitalization have significantly lower 90-day mortality and readmission rates. The magnitude of benefit does not appear to wane with age. Absent a strong contraindication, all patients with HFrEF should attempt beta-blocker therapy at/after hospital discharge, regardless of age.

Time dependent hazard ratio estimation using instrumental variables without conditioning on an omitted covariate.

BACKGROUND: Estimation that employs instrumental variables (IV) can reduce or eliminate bias due to confounding. In observational studies, instruments result from natural experiments such as the effect of clinician preference or geographic distance on treatment selection. In randomized studies the randomization indicator is typically a valid instrument, especially if the study is blinded, e.g. no placebo effect. Estimation via instruments is a highly developed field for linear models but the use of instruments in time-to-event analysis is far from established. Various IV-based estimators of the hazard ratio (HR) from Cox's regression models have been proposed. METHODS: We extend IV based estimation of Cox's model beyond proportionality of hazards, and address estimation of a log-linear time dependent hazard ratio and a piecewise constant HR. We estimate the marginal time-dependent hazard ratio unlike other approaches that estimate the hazard ratio conditional on the omitted covariates. We use estimating equations motivated by Martingale representations that resemble the partial likelihood score statistic. We conducted simulations that include the use of copulas to generate potential times-to-event that have a given marginal structural time dependent hazard ratio but are dependent on omitted covariates. We compare our approach to the partial likelihood estimator, and two other IV based approaches. We apply it to estimation of the time dependent hazard ratio for two vascular interventions. RESULTS: The method performs well in simulations of a stepwise time-dependent hazard ratio, but illustrates some bias that increases as the hazard ratio moves away from unity (the value that typically underlies the null hypothesis). It compares well to other approaches when the hazard ratio is stepwise constant. It also performs well for estimation of a log-linear hazard ratio where no other instrumental variable approaches exist. CONCLUSION: The estimating equations we propose for estimating a time-dependent hazard ratio using an IV perform well in simulations. We encourage the use of our procedure for time-dependent hazard ratio estimation when unmeasured confounding is a concern and a suitable instrumental variable exists.

Variation in Rates of Hospital Admission from the Emergency Department Among Medicare Patients at the Regional, Hospital, and Physician Levels.

STUDY OBJECTIVE: Rates of admission from the emergency department (ED) vary widely across regions of the country, hospitals within regions, and physicians within hospitals. Our objective was to determine the extent to which variation in admission decisions was described by differences in admission rates at these 3 levels. This understanding will serve to better target interventions to modify rates of admission where appropriate. METHODS: In this cross-sectional observational cohort study, we analyzed Medicare fee-for-service claims for ED visits from 2012 to 2015 in a 20% random sample of beneficiaries. We first estimated the total regional-, hospital-, and physician-level variations in rates of admission and their proportions of the total variation after adjusting for patient and each level's covariates. We then estimated the extent to which each level's characteristics accounted for variation at that respective level. RESULTS: Our study sample included 5,778,218 visits with 45,491 physicians at 3,480 EDs across 306 hospital referral regions. The mean rate of admission was 38.9% and ranged from 21.4% to 53.0% for physicians at the 10th and 90th percentile of the distribution, respectively. The residual (unexplained) variations at the regional, hospital, and physician levels were 13.3% (95% confidence interval [CI], 11.2 to 15.5%), 60.1% (57.1 to 62.9%), and 26.7% (26.4 to 26.9%), respectively. Regional, hospital, and physician characteristics accounted for 9.1% (95% CI, -5.6 to 23.8%), 51.1% (48.8 to 53.5%), and 2.7% (1.3 to 4.1%), respectively, of the explained variation at their respective levels. CONCLUSION: Within-area variation, both across hospitals within a region and across physicians within a hospital, is a more substantial component of observed variation in admission rates from the ED than regional level variation. These findings suggest that variation in admission rates is at least in part related to institutional norms and cultures as well as heterogeneity of physician decisionmaking within hospitals, both of which could be targets of interventions to modify rates of admission.

Cardiology providers' recommendations for treatments and use of patient decision aids for multivessel coronary artery disease.

BACKGROUND: Rates of recommending percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) vary across clinicians. Whether clinicians agree on preferred treatment options for multivessel coronary artery disease patients has not been well studied. METHODS AND RESULTS: We distributed a survey to 104 clinicians from the Northern New England Cardiovascular Study Group through email and at a regional meeting with 88 (84.6%) responses. The survey described three clinical vignettes of multivessel coronary artery disease patients. For each patient vignette participants selected appropriate treatment options and whether they would use a patient decision aid. The likelihood of choosing PCI only or PCI/CABG over CABG only was modeled using a multinomial regression. Across all vignettes, participants selected CABG only as an appropriate treatment option 24.2% of the time, PCI only 25.4% of the time, and both CABG or PCI as appropriate treatment options 50.4% of the time. Surgeons were less likely to choose PCI over CABG (RR 0.14, 95% CI 0.03, 0.59) or both treatments over CABG only (RR 0.10, 95% CI 0.03, 0.34) relative to cardiologists. Overall, 65% of participants responded they would use a patient decision aid with each vignette. CONCLUSIONS: There is a lack of consensus on the appropriate treatment options across cardiologists and surgeons for patients with multivessel coronary artery disease. Treatment choice is influenced by both patient characteristics and clinician specialty.

Validation of the Emotional Tone Index for Families (ETIF): A Multi-Informant Measure of Emotional Closeness.

Despite the importance of emotional closeness (EC) in families, few researchers have accurately measured the construct in a systemic way. Additionally, existing measures rely on ratings from one informant, typically the mother, to provide information on closeness within the entire family system. We examined EC in 140 individuals (37 families) using the Emotional Tone Index for Families (ETIF), a novel, multi-informant measure that obtains bidirectional information about EC within every family relationship. The parent identified as most familiar with the family also completed two widely used single-informant measures: The McMaster Family Assessment Device and the Family Adaptability and Cohesion Evaluation Scales, version IV. The ETIF exhibited good test-retest reliability, high internal consistency, and concurrent validity with the single-informant measures. Though the primary respondent scores correlated highly with overall family closeness, results revealed only a modest association between closeness ratings within each dyad and parents rated higher levels of closeness toward their children than children rated closeness toward parents. These findings suggest that ratings from multiple informants provide valuable information about discrepancies in perceived closeness between family members and other complex family dynamics that cannot be captured by single-informant measures. Limitations, future directions, and implications for practice are discussed.

A pesar de la importancia de la cercanía emocional en las familias, pocos investigadores han medido con precisión el constructo de una manera sistémica. Además, las herramientas de medición existentes dependen de las valoraciones de un informante, normalmente la madre, para proporcionar información sobre la cercanía dentro de todo el sistema familiar. Analizamos la cercanía emocional en 140 personas (37 familias) usando el Índice de Tono Emocional para las Familias (ITEF), una herramienta de medición novedosa que obtiene información bidireccional sobre la cercanía emocional dentro de cada relación familiar por parte de varios informantes. El progenitor identificado como el más familiarizado con la familia también completó dos evaluaciones de un solo informante ampliamente utilizadas: el Dispositivo de McMaster de Evaluación Familiar (McMaster Family Assessment Device) y las Escalas de Evaluación de la Cohesión y la Adaptabilidad Familiar (Family Adapatability and Cohesion Evaluation Scales), versión IV. El ITEF demostró buena fiabilidad de prueba-reprueba, una alta coherencia interna y validez simultánea con las evaluaciones de un solo informante. Aunque los puntajes del encuestado principal se correlacionaron en gran medida con la cercanía familiar general, los resultados revelaron solo una asociación modesta entre las valoraciones de cercanía dentro de cada díada, y los padres indicaron niveles más altos de cercanía hacia sus hijos de lo que los hijos lo hicieron hacia sus padres. Estos resultados sugieren que las valoraciones de varios informantes proporcionan información valiosa acerca de las discrepancias en la cercanía percibida entre los miembros de la familia y otra dinámica familiar compleja que no puede captarse mediante las mediciones de un solo informante. Se explican las limitaciones, las futuras direcciones y las implicancias para la práctica.