Supplemental Table 2: Age-adjusted incidence, U.S. population 2014 to 2018 years, for male colon and rectum, 5-year strata

INTRODUCTION:Embedded pragmatic clinical trials are an ideal way to develop and evaluate evidence-based interventions in the nursing home (NH) environment to facilitate streamlining implementation after study completion. However, there is minimal information available about the necessary and sufficient conditions of "difference makers" for robust implementation of pragmatic interventions in the NH setting. METHODS:The "Aligning Patient Preferences-a Role Offering Alzheimer's patients, Caregivers, and Healthcare Providers Education and Support" (APPROACHES) embedded pragmatic trial is designed to test and evaluate a staff-led advance care planning (ACP) intervention for residents with dementia in 128 NHs (64 intervention, 64 control). Coincidence Analysis, a case-based approach to data analysis that draws upon Boolean algebra and set theory, was applied to identify key difference-makers for robust implementation. This analysis focused on the 44 intervention NHs that implemented at least one of two implementation processes: site visits and/or monthly calls. RESULTS:Eighteen of 44 (41%) sites in the analysis robustly implemented the APPROACHES intervention as reflected by > 75% of residents having a documented ACP conversation. The Coincidence Analysis revealed two pathways directly linked with robust pragmatic implementation: (1) no executive director turnover during the observation period combined with site participation in monthly calls with peers; and (2) higher rates of baseline hospitalization (3.96-7.0 per 1000 resident-days alive) combined with a low number of certified beds. In contrast, leadership instability as reflected by administrator turnover, high number of certified beds, and a lack of participation in monthly calls with peers was associated with poorer performance. DISCUSSION:Findings from this study suggest that leadership stability and engagement with peers were essential drivers of robust implementation of the APPROACHES ACP Specialist intervention. Coincidence Analysis is a useful tool for understanding how implementation conditions are associated with robust implementation in embedded pragmatic clinical trials.

Supplemental Table 3: Recommended Screening Based on Revised SEER Rate for Complete Data from Full Cohort

BACKGROUND:Family visits with nursing home residents have been shown to improve residents' quality of life. However, little is known about the association between in-person family visits and physical (e.g., pain) and behavioral symptoms (e.g., agitation) among residents with cognitive impairment. Using data from a large clinical trial of a palliative care program in Maryland and Indiana, we examined the association between family visits and staff-reported resident symptom burden. METHODS:Using cross-sectional baseline data from an ongoing multi-state clinical trial involving 194 nursing home residents with cognitive impairment, we conducted bivariate analyses to examine the association between in-person family visits (family involvement) as reported by family members and staff-reported resident symptom burden. Linear regression models assessed the association between symptom burden and family visits in an adjusted framework. The model controlled for other relevant covariates, including resident race, gender, and age, and the care partner's relationship to the resident. Staff-reported symptom burden was measured using a modified version of the Comfort Assessment in Dying End of Life in Dementia (CAD-EOLD) scale. Family involvement was measured by the average weekly frequency of in-person visits reported by the family over the past month. RESULTS:On average, spouses visited 5 days per week, children 2 days per week, and other family members 1.5 days a week. In bivariate analyses, there was a weak but statistically significant and positive correlation between family involvement and symptom burden (r = 0.16, p = 0.04). However, in the adjusted model, the association was not statistically significant (b = 0.16, p = 0.09). CONCLUSION:Bivariate analyses suggest a significant and positive correlation between family visitation and symptom burden. However, this finding was not in the expected direction. Family visitation was associated with residents experiencing greater symptom burden. The association was not statistically significant in the adjusted model. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT04520698.

Supplemental Table 1: Final Models

BACKGROUND:Lower cervical cancer screening rates are associated with higher cervical cancer mortality among women living in rural compared with urban areas (defined by rural-urban community codes). The study purpose was to examine the effectiveness of a mailed digital video disc (DVD) versus DVD plus patient navigation (PN) versus usual care (UC) on increasing the percentage of rural women up to date (UTD) with cervical cancer screening guidelines. METHODS:Rural women (ages 50-74 years) who were not UTD for cervical cancer screening (n = 553) were consented and randomized 2:2:1 (DVD, DVD + PN, and UC, respectively). Baseline and 12-month surveys included sociodemographic characteristics, history of previous cervical cancer screening, and cervical cancer screening knowledge and beliefs. Screening status was assessed by medical record review at baseline and 12 months after randomization. RESULTS:The mean age of participants was 59.8 years. After controlling for covariates, women randomized to the DVD + PN group had greater odds [OR = 5.01; 95% confidence interval (CI), 2.38-11.50] of being UTD with cervical cancer screening compared with UC at 12 months after randomization. Other significant covariates in the model included having a college versus high school or lower education (OR = 2.36; 95% CI, 1.08-5.63), private (OR = 4.16; 95% CI, 1.28-19.1) or no insurance (OR = 8.74; 95% CI, 1.77-51.9) versus public insurance, normal (OR = 3.25; 95% CI, 1.46-7.24) or overweight (OR = 2.15; 95% CI, 1.05-4.42) versus obese body mass index, and positive screening intention in the next six months (OR = 2.59; 95% CI, 1.48-4.52). CONCLUSIONS:A DVD + PN intervention increased the percentage of rural women UTD with cervical cancer screening compared with UC or DVD only. IMPACT:Women who have a high school or lower education, were on public insurance, obese, and not planning to be screened need increased attention to become UTD with cervical cancer screening.

ABSTRACT Objectives The End‐of‐Life Dementia—Comfort Assessment in Dying (EOLD‐CAD) scale is one of the few outcome instruments designed to capture symptom burden and well‐being among nursing home residents with dementia; however, psychometric evaluations of the EOLD‐CAD are limited. Although the instrument is often used to assess outcomes prospectively, it was originally developed and tested as a postmortem assessment. The purpose of this study is to evaluate the instrument properties of the EOLD‐CAD using staff reports from a large sample of nursing home residents with cognitive impairment prior to death. Methods Using data from the multi‐state UPLIFT clinical trial, this study evaluated the psychometric properties of the EOLD‐CAD from 168 nursing home staff members reporting outcomes for 611 living residents with moderate to severe cognitive impairment. Staff also reported on resident quality‐of‐life using two different single item measures. We conducted confirmatory factor analysis (CFA) and assessed construct validity, inter‐item reliability, and observer report bias. Results CFA produced a four‐factor solution. All factor loadings were > 0.40, ranging from 0.61–0.95 for Physical Distress, 0.71–0.91 for Dying Symptoms, 0.61–0.78 for Emotional Distress, and 0.89–0.94 for Well‐Being. Model indices suggest a good fit to the data with root mean square error of approximation (RMSEA) = 0.053 (95% CI = (0.044, 0.062)), comparative fit index (CFI) = 0.971, and standardized root mean square residual (SRMR) = 0.093, with the SRMR slightly above the conventional threshold of > 0.08. Based on intraclass correlation coefficients (ICC), patterns of observer reports were identified among staff who provided data for multiple residents. ICCs were notably high (> 0.60) for Well‐Being items. The EOLD‐CAD elicited a Cronbach's alpha of 0.73, and the instrument was negatively correlated with items measuring resident quality of life. Conclusions We found that when the EOLD‐CAD was completed by nursing home staff familiar with the respective residents, observer‐based patterns were detectable. Such patterns were adjusted for in our CFA, from we found that the EOLD‐CAD exhibited multidimensionality with a four‐factor structure capturing: Physical Distress, Emotional Distress, Dying Symptoms, and Well‐Being. In addition to the CFA, the EOLD‐CAD demonstrated generally valid and reliable psychometric properties in our population of long‐stay nursing home residents with moderate to severe cognitive impairment. Trial Registration ClinicalTrials.gov: NCT04520698

INTRODUCTION:The Merit-Based Incentive Payment System (MIPS) affects Medicare reimbursements for over 600,000 clinicians, including ~ 15,000 orthopedic surgeons in the United States. MIPS policies are rapidly evolving, yet limited research exists to guide orthopedic surgeons in optimizing performance. This study evaluates whether recent MIPS policy changes have led to increased payment adjustments for orthopedic surgeons and examines the role of MIPS in enhancing care quality. METHODS:A retrospective analysis of 2021-2022 MIPS performance data from nearly 9000 orthopedic surgeons assessed the impact of policy changes on payment adjustments using McNemar's test and mixed effects logistic regression. RESULTS:Raising the MIPS performance threshold to 75 points significantly reduced the likelihood of receiving bonus payments (χ 2 = 803.21, degrees of freedom = 1; P < .01). Surgeons in smaller practices had 60% lower odds of earning bonus payments (odds ratio, 0.40; 95% confidence interval, 0.33-0.48; P < .008), though this disparity was smaller than previously reported. The updated complex patient bonus scoring policy showed the strongest positive effect on the likelihood of receiving bonus payments (odds ratio, 6.49; 95% confidence interval, 3.31-12.76; P < .017). Nonetheless, MIPS continues to fall short in encouraging the reporting of specialty-specific, outcome-based, and patient-experience measures. DISCUSSION:Raising the MIPS performance threshold further may lead to greater dissatisfaction. Despite some improvements, equity gaps remain for small and rural practitioners. However, the revised complex patient bonus policy effectively rewards clinicians caring for high-risk populations.

BACKGROUND:To comprehensively evaluate the longitudinal progression of cumulative burden of morbidity (CBM) in testicular cancer survivors (TCS) following standard-dose cisplatin-based chemotherapy and the impact of modifiable risk factors on morbidity and early mortality. METHODS:Participants completed first-line chemotherapy at or longer than 6 months before baseline assessments with comprehensive questionnaires and physical examinations. Based on follow-up assessments (median: 7 years later), longitudinal progression of adverse health outcomes (AHOs) and CBM score (encompassing AHO number and severity) were examined. Baseline health behaviors and AHOs were evaluated for associations with mortality using mixed-effects parametric proportional-hazards regression to identify modifiable risk factors. RESULTS:Among 616 TCS longitudinally assessed, 23% experienced worsening CBM postchemotherapy (median = 11 years, interquartile range = 7-15). Declines were driven by worsening treatment-related AHOs: tinnitus (29.7%), hearing loss (24.4%), Raynaud's disease (22.6%), neuropathy (18.5%), and neuropathic pain (10.7%). Baseline factors associated with worsening neuropathy included lack of aerobic physical activity (odds ratio [OR] = 1.98, 95% confidence interval [CI] = 1.06 to 3.72), and obesity (OR = 1.85, 95% CI = 1.17 to 2.92). These were also related to worsening neuropathic pain (OR = 2.82, P = .009 and OR = 2.29, P = .023). Twenty-nine deaths occurred among 1830 5-year TCS (4.2% cumulative hazard) (median age = 48 years, range = 22-74). Participants reporting neuropathic pain (hazard ratio [HR] = 3.64, 95% CI = 1.45 to 9.10), no aerobic (HR = 6.56, 95% CI = 2.73 to 15.8), or no low-impact physical activity (HR = 3.96, 95% CI = 1.40 to 11.2) had significantly higher mortality, as did TCS indicating fair (HR = 9.23, 95% CI = 3.08 to 27.8) or poor (HR = 18.5, 95% CI = 3.30 to 103) health. Relationships between pain and mortality were mediated through lowered physical activity (P = .036). CONCLUSIONS:Clinically actionable factors associated with early mortality identify high-risk TCS in need of closer monitoring and targeted interventions. The significant relationship between neuropathic pain and mortality, mediated by low physical activity, is the first to our knowledge in TCS.

CONTEXT:Evaluation of palliative care programs in nursing homes often includes symptom assessments. For residents with cognitive impairment, proxy symptom reports, such as those from family members or nursing home staff, may be used as outcome measures. OBJECTIVES:This analysis compares differences between family and staff proxy reports of symptoms of nursing home residents with moderate to severe cognitive impairment. METHODS:Data were collected as part of a clinical trial, conducted in 16 nursing homes (NHs) in Indiana and Maryland (U.S.). We calculated the difference in total modified End-of-Life Dementia Comfort Assessment in Dying (EOLD-CAD) scores between family and staff respondents for 194 residents, and quantified characteristics associated with discordance. RESULTS:About half of responding staff were licensed nurses and 37% were certified nursing assistants. Adult children of residents were the most common (57%) family respondents. There was fair agreement between the respondent groups (kappa = 0.26) for the total modified EOLD-CAD scale. Overall, family members reported higher symptom burden than staff. Some symptoms, including discomfort, pain, restlessness and agitation, were reported as more burdensome by both groups of proxies vs. symptoms such as gurgling or choking. Proxy symptom reports on residents with more advanced cognitive impairment were less likely to be substantially discordant (OR = 0.50, 95% CI 0.26, 0.99, P = 0.047). CONCLUSION:Proxies are often used to report symptom experiences for people living with cognitive impairment. Multiple perspectives may be needed to obtain a fuller picture of symptom burden in this population. REGISTRATION:CLINICALTRIALS.GOV: NCT04520698.

To test the association of autonomic nervous system (ANS) dysregulation symptoms and diabetes distress (DD) in adults with type 1 diabetes (T1D; study 1) and type 2 diabetes (T2D; study 2). A total of 556 adults with T1D and 299 with T2D completed the Body Perception Questionnaire (BPQ) to assess ANS reactivity symptoms, diabetes distress (via Diabetes Distress Scale T1 [DDS-T1], and DDS-17), anxiety (via General Anxiety Disorder 7 [GAD-7]) scale, depression (via Patient Health Questionnaire-8 [PHQ-8]), and demographic variables via internet surveys. In study 1, participants’ mean age was 45.1 (SD 15.7) years and most were female (73.2%) and White (95.3%). The mean self-reported A1c was 6.7% (SD = 1.0%); mean duration of T1D diagnosis 20.6 (SD 14.7) years; and 72.5% of participants reported using an insulin pump. The mean DDS-T1 score was 2.3 (SD 0.8; moderate severity). The BPQ mean T score was 48.9 (SD 8.4) for supradiaphragmatic and 50.6 (SD 8.9) for subdiaphragmatic reactivity subscales. In study 2, participants’ mean age was 60.2 (SD 13.6) years, 58.7% were female, and 82.9% were White. The mean self-reported A1c was 7.0% (SD 1.2%), and 51.8% of participants were treated with oral hypoglycemic agents and 39.9% used oral and injectable medications. The mean duration of T2D diagnosis was 15.0 (SD 10.0) years. The mean DDS-17 score was 2.3 (SD 1.0; moderate severity) and BPQ mean T score was 49.9 (SD 9.4) for supradiaphragmatic and 52.0 (SD 8.8) for subdiaphragmatic reactivity subscales. Controlling for covariates, severity of DDS-T1/DDS-17 significantly predicted elevations in ANS symptom T scores on all subscales (P ≤ 0.05 for all), with “high” DDS having the highest BPQ scores. These findings demonstrate a relationship between ANS reactivity and DDS in T1D and T2D samples.

Supplemental Methods 1: Contains details pertaining to data analysis

This cohort study examines whether there are survival differences among patients with postcolonoscopy colorectal cancer based on cancer location.

Supplemental Table 1: Contains descriptive data for all candidate variables in cases and controls

Abstract We aimed to develop a metric for estimating risk for early-onset colorectal cancer (EOCRC) to help decide whether and how to screen persons < age 50. We used risk prediction models derived and validated on male veterans to calculate the RRs for six scenarios: one low-risk scenario (no risk factors present), four intermediate risk scenarios (some risk factors present), and one high-risk scenario (all risk factors present) for three age groups (35–39, 40–44, and 45–49 years). For each scenario, we estimated absolute colorectal cancer risk using Surveillance Epidemiology and End Results colorectal cancer incidence rates and each scenario’s RR. We identified the current Surveillance Epidemiology and End Results 5-year age group to which the revised estimate was closest and refer to the midpoint of this group as the “colon age.” When the revised estimate equals or exceeds that for 50- to 54-year-olds and for 70- to 74-year-olds, respective recommendations were made for (any) colorectal cancer screening and screening with colonoscopy. Among the scenarios, there was inconsistency between the two models for the 35 to 39 and 40 to 44 age groups, with only the 15-variable model recommending screening for the higher-risk 35- to 39-year-olds. Both models recommended screening for some intermediate risk and high-risk 40- to 44-year-olds. The models were well aligned on whether and how to screen most 45- to 49-year-olds. Using risk factors for EOCRC with colorectal cancer incidence rates, “colon age” may be useful for shared decision-making about whether and how to screen male veterans <50 years. For 45- to 49-year-olds, the 7-variable model may be preferred by patients, providers, and health systems. Prevention Relevance: A new metric known as “colon age” expresses risk of EOCRC based on biological risk and may be useful for providers to explain and for patients to understand colorectal cancer risk when considering whether and how to be screened for colorectal cancer prior to age 45 or 50.

Outcomes1. Discuss the conditions associated with the successful pragmatic implementation of an advance care planning intervention in the nursing home.2. Describe the use of Coincidence Analysis, an innovative mathematical, cross-case approach that draws upon Boolean algebra, logic, and set theory to identify the bundles of conditions that consistently distinguish high performing sites from lower performing sites.Key MessageUsing a novel analytical approach, we identified the conditions associated with the successful pragmatic implementation of an ACP intervention across 64 nursing homes. Leadership stability and staff engagement were key conditions, as were greater opportunities for improvement and a more manageable caseload, highlighting the complexity of implementation.ImportanceThe “Aligning Patient Preferences – a Role Offering Alzheimer's patients, Caregivers, and Healthcare Providers Education and Support” (APPROACHES) project was a pragmatic trial designed to test and evaluate a staff-led advance care planning (ACP) intervention for residents with ADRD.(1) Understanding the conditions associated with successfully implementing interventions in nursing homes is of importance to researchers, policy makers, and health system leaders encouraging uptake of evidence-based programs.Objective(s)To identify the conditions associated with successful implementation of APPROACHES in the NH setting.Scientific Methods UtilizedAPPROACHES was delivered by specially trained ACP Specialists who were employed by the facility and supported by a corporate lead between September 1, 2022 - August 31, 2023. Our primary outcome measure was the number of residents with documentation of an ACP encounter in the EHR divided by the total number of beds in the NH. We used Coincidence Analysis, an innovative mathematical, cross-case approach that draws upon Boolean algebra, logic, and set theory to identify the bundles of conditions relevant to implementation that distinguished high from lower performing sites (2). Successful implementation was defined as >75% of residents had documented ACP encounters in their chart at the end of the intervention period.ResultsTwenty of 64 sites (31%) successfully implemented the intervention. Our Coincidence Analysis identified 2 solutions linked with successful implementation: a) no executive director turnover and site participation in monthly peer support calls; and b) higher baseline hospitalization rate (3.96 – 7.2 per 1000 resident days) and small number of certified beds.Conclusion(s)Leadership stability and engagement with peers were drivers of successful implementation. Greater improvement opportunities and a more manageable caseload may also help explain successful implementation.ImpactThese findings contribute to our understanding of conditions for successful implementation of ACP interventions in the nursing home setting and highlight the complexity of implementing evidence-based interventions in this setting.KeywordsAdvanced care planning/shared decision making/Educational, training and supervision

Background/Objective: Low-risk chest pain (LRCP), i.e. chest pain that does not pose an imminent risk or have a cardiovascular cause, constitutes the majority (80%) of cases of chest pain presenting to the emergency department (ED). Past research shows that in patients withLRCP without a history of cardiovascular disease, many will meet criteria for panic or generalized anxiety disorder. The purpose of this project is to examine the psychiatric comorbidities of patients with LRCP including differences by severity of anxiety. Methods: Baseline data collected in the Patient-Centered Treatment of Anxiety after Low-Risk Chest Pain in the Emergency Room (PACER) study were analyzed to determine: the rates of depression, somatization, posttraumatic stress disorder (PTSD), disability, and low self-efficacyin relation to increasing levels of anxiety (low anxiety but positive for panic disorder vs moderate vs severe anxiety). Also, anxiety severity groups are compared for demographic and other patient characteristics to identify potential predictors of anxiety severity. Results: In 265 patients with LRCP who screened positive for panic disorder and/or generalized anxiety disorder, the proportion with low, moderate and severe anxiety symptoms was 9%, 44% and 47%, respectively. Overall, 57% (n=150) also screened positive for depression, 54%(n=144) for somatization syndrome, and 56% (n=149) for PTSD. Rates of depression, somatization, PTSD, and disability increased as the level of anxiety increased. Compared to patients with low to moderate anxiety, patients with severe anxiety were more likely to have depression (odds ratio = 3.0), somatization (OR = 2.7), PTSD (OR = 2.6), disability (OR = 2.4), and low self-efficacy (OR = 3.5). Conclusion and Potential Implications: Patients with LRCP and anxiety are likely to have other psychiatric comorbidities. Additionally, as rates of comorbidities increase with the anxiety severity, detection and management of anxiety is essential to provide optimal care for low-riskchest pain.

PurposeTo assess the comparative effectiveness of a tailored, interactive digital video disc (DVD) intervention versus DVD plus patient navigation (PN) intervention versus usual care (UC) on the uptake of colorectal cancer (CRC) screening among females living in Midwest rural areas.MethodsAs part of a larger study, 663 females (ages 50-74) living in rural Indiana and Ohio and not up-to-date (UTD) with CRC screening at baseline were randomized to one of three study groups. Demographics , health status/history, and beliefs and attitudes about CRC screening were measured at baseline. CRC screening was assessed at baseline and 12 months from medical records and self-report. Multivariable logistic regression was used to determine whether females in each group were UTD for screening and which test they completed.ResultsAdjusted for covariates, females in the DVD plus PN group were 3.5x more likely to complete CRC screening than those in the UC group (odds ratio [OR] 3.62; 95% confidence interval [CI]: 2.09, 6.47) and baseline intention to receive CRC screening (OR 3.45, CI: 2.21,5.42) at baseline. Adjusting for covariates, there was no difference by study arm whether females who became UTD for CRC screening chose to complete a colonoscopy or fecal occult blood test/fecal immunochemical test.ConclusionsMany females living in the rural Midwest are not UTD for CRC screening. A tailored intervention that included an educational DVD and PN improved knowledge, addressed screening barriers, provided information about screening test options, and provided support was more effective than UC and DVD-only to increase adherence to recommended CRC screening.

The 3-item pain intensity (P), interference with the enjoyment of life (E), and interference with general activity (G), or PEG, has become one of the most widely used measures of pain severity and interference. The minimally important differences (MID) and responsiveness of the PEG are essential metrics for solidifying its role in research and clinical care. The current study aims to establish the MID and responsiveness of the PEG by synthesizing data from 1,710 participants across 6 controlled trials. MIDs were estimated using absolute score changes among individuals reporting their pain was "a little better" on a retrospective global change anchor as well as distribution-based estimates using standard deviation thresholds and 1 and 2 standard errors of measurement. Responsiveness was assessed using standardized response means, area under the curve, and treatment effect sizes. MID estimates for the PEG ranged from 0.60 to 1.1 when using 0.35 SD, and 0.78 to 1.22 using 1 standard error of measurement. MID estimates using the global anchor had somewhat more variability but most estimates ranged from 1.0 to 1.75. Responsiveness effect sizes were generally large (> .80) for standardized response means and moderate (> .50) for treatment effect. Similarly, the most area under the curve values demonstrated an acceptable level of scale responsiveness (>=.70). Importantly, MID estimates and responsiveness of the PEG and BPI scales were largely comparable when aggregating data across trials. Our synthesis indicates that 1 point is a reasonable MID estimate on these 0- to 10-point pain scales, with 2 points being an upper bound.