Outcomes of New York City Care Calls: A Prospective Randomized Controlled Effectiveness Trial of Telephone-Delivered Type 2 Diabetes Self-Management Support.

PURPOSE: The purpose of the 12-month randomized controlled trial was to evaluate the effectiveness of a Telephonic Self-Management Support (T-SMS) program among adults with type 2 diabetes (T2D). METHODS: Eight hundred twelve adults with T2D participated in NYC Care Calls (mean age = 59.2, SD = 10.8; female = 57%; mean A1C = 9.3, SD = 1.8; Latino = 86%) and were randomly assigned to T-SMS or enhanced usual care (EUC). A1C (primary outcome), blood pressure, and body mass index (secondary outcomes) were extracted from electronic medical records. Secondary patient-reported outcomes, including depressive symptoms, diabetes distress, medication adherence, and self-management activities, were assessed by telephone in English or Spanish. For T-SMS, the number of assigned phone calls was based on baseline A1C, depressive symptoms, and/or diabetes distress. Analyses were conducted under the intention-to-treat principle. RESULTS: A1C decreased over 12 months in both T-SMS (0.72% percentage points; 95% CI, 0.53-0.91) and EUC (0.66% percentage points; 95% CI, 0.46-0.85; Ps < .001). Diabetes distress and self-management also improved over time in both arms (Ps < .05). Compared to EUC, participants in the T-SMS arm did not differ in outcomes. CONCLUSIONS: The T-SMS and EUC groups were found not to have an appreciable outcome difference. It is unclear whether improvements in A1C across both conditions represent a secular trend or indicate that print-based educational intervention may have a positive impact on self-management and well-being.

Collaborative Modeling to Compare Different Breast Cancer Screening Strategies: A Decision Analysis for the US Preventive Services Task Force.

Importance: The effects of breast cancer incidence changes and advances in screening and treatment on outcomes of different screening strategies are not well known. Objective: To estimate outcomes of various mammography screening strategies. Design, Setting, and Population: Comparison of outcomes using 6 Cancer Intervention and Surveillance Modeling Network (CISNET) models and national data on breast cancer incidence, mammography performance, treatment effects, and other-cause mortality in US women without previous cancer diagnoses. Exposures: Thirty-six screening strategies with varying start ages (40, 45, 50 years) and stop ages (74, 79 years) with digital mammography or digital breast tomosynthesis (DBT) annually, biennially, or a combination of intervals. Strategies were evaluated for all women and for Black women, assuming 100% screening adherence and "real-world" treatment. Main Outcomes and Measures: Estimated lifetime benefits (breast cancer deaths averted, percent reduction in breast cancer mortality, life-years gained), harms (false-positive recalls, benign biopsies, overdiagnosis), and number of mammograms per 1000 women. Results: Biennial screening with DBT starting at age 40, 45, or 50 years until age 74 years averted a median of 8.2, 7.5, or 6.7 breast cancer deaths per 1000 women screened, respectively, vs no screening. Biennial DBT screening at age 40 to 74 years (vs no screening) was associated with a 30.0% breast cancer mortality reduction, 1376 false-positive recalls, and 14 overdiagnosed cases per 1000 women screened. Digital mammography screening benefits were similar to those for DBT but had more false-positive recalls. Annual screening increased benefits but resulted in more false-positive recalls and overdiagnosed cases. Benefit-to-harm ratios of continuing screening until age 79 years were similar or superior to stopping at age 74. In all strategies, women with higher-than-average breast cancer risk, higher breast density, and lower comorbidity level experienced greater screening benefits than other groups. Annual screening of Black women from age 40 to 49 years with biennial screening thereafter reduced breast cancer mortality disparities while maintaining similar benefit-to-harm trade-offs as for all women. Conclusions: This modeling analysis suggests that biennial mammography screening starting at age 40 years reduces breast cancer mortality and increases life-years gained per mammogram. More intensive screening for women with greater risk of breast cancer diagnosis or death can maintain similar benefit-to-harm trade-offs and reduce mortality disparities.

Retrospective cohort study of wrong-patient imaging order errors: how many reach the patient?

Studying near-miss errors is essential to preventing errors from reaching patients. When an error is committed, it may be intercepted (near-miss) or it will reach the patient; estimates of the proportion that reach the patient vary widely. To better understand this relationship, we conducted a retrospective cohort study using two objective measures to identify wrong-patient imaging order errors involving radiation, estimating the proportion of errors that are intercepted and those that reach the patient. This study was conducted at a large integrated healthcare system using data from 1 January to 31 December 2019. The study used two outcome measures of wrong-patient orders: (1) wrong-patient orders that led to misadministration of radiation reported to the New York Patient Occurrence Reporting and Tracking System (NYPORTS) (misadministration events); and (2) wrong-patient orders identified by the Wrong-Patient Retract-and-Reorder (RAR) measure, a measure identifying orders placed for a patient, retracted and rapidly reordered by the same clinician on a different patient (near-miss events). All imaging orders that involved radiation were extracted retrospectively from the healthcare system data warehouse. Among 293 039 total eligible orders, 151 were wrong-patient orders (3 misadministration events, 148 near-miss events), for an overall rate of 51.5 per 100 000 imaging orders involving radiation placed on the wrong patient. Of all wrong-patient imaging order errors, 2% reached the patient, translating to 50 near-miss events for every 1 error that reached the patient. This proportion provides a more accurate and reliable estimate and reinforces the utility of systematic measure of near-miss errors as an outcome for preventative interventions.

Benefits and Harms of Mammography Screening in 75 + Women to Inform Shared Decision-making: a Simulation Modeling Study.

BACKGROUND: Guidelines recommend shared decision-making (SDM) around mammography screening for women ≥ 75 years old. OBJECTIVE: To use microsimulation modeling to estimate the lifetime benefits and harms of screening women aged 75, 80, and 85 years based on their individual risk factors (family history, breast density, prior biopsy) and comorbidity level to support SDM in clinical practice. DESIGN, SETTING, AND PARTICIPANTS: We adapted two established Cancer Intervention and Surveillance Modeling Network (CISNET) models to evaluate the remaining lifetime benefits and harms of screening U.S. women born in 1940, at decision ages 75, 80, and 85 years considering their individual risk factors and comorbidity levels. Results were summarized for average- and higher-risk women (defined as having breast cancer family history, heterogeneously dense breasts, and no prior biopsy, 5% of the population). MAIN OUTCOMES AND MEASURES: Remaining lifetime breast cancers detected, deaths (breast cancer/other causes), false positives, and overdiagnoses for average- and higher-risk women by age and comorbidity level for screening (one or five screens) vs. no screening per 1000 women. RESULTS: Compared to stopping, one additional screen at 75 years old resulted in six and eight more breast cancers detected (10% overdiagnoses), one and two fewer breast cancer deaths, and 52 and 59 false positives per 1000 average- and higher-risk women without comorbidities, respectively. Five additional screens over 10 years led to 23 and 31 additional breast cancer cases (29-31% overdiagnoses), four and 15 breast cancer deaths avoided, and 238 and 268 false positives per 1000 average- and higher-risk screened women without comorbidities, respectively. Screening women at older ages (80 and 85 years old) and high comorbidity levels led to fewer breast cancer deaths and a higher percentage of overdiagnoses. CONCLUSIONS: Simulation models show that continuing screening in women ≥ 75 years old results in fewer breast cancer deaths but more false positive tests and overdiagnoses. Together, clinicians and 75 + women may use model output to weigh the benefits and harms of continued screening.

Population simulation modeling of disparities in US breast cancer mortality.

BACKGROUND: Populations of African American or Black women have persistently higher breast cancer mortality than the overall US population, despite having slightly lower age-adjusted incidence. METHODS: Three Cancer Intervention and Surveillance Modeling Network simulation teams modeled cancer mortality disparities between Black female populations and the overall US population. Model inputs used racial group-specific data from clinical trials, national registries, nationally representative surveys, and observational studies. Analyses began with cancer mortality in the overall population and sequentially replaced parameters for Black populations to quantify the percentage of modeled breast cancer morality disparities attributable to differences in demographics, incidence, access to screening and treatment, and variation in tumor biology and response to therapy. RESULTS: Results were similar across the 3 models. In 2019, racial differences in incidence and competing mortality accounted for a net ‒1% of mortality disparities, while tumor subtype and stage distributions accounted for a mean of 20% (range across models = 13%-24%), and screening accounted for a mean of 3% (range = 3%-4%) of the modeled mortality disparities. Treatment parameters accounted for the majority of modeled mortality disparities: mean = 17% (range = 16%-19%) for treatment initiation and mean = 61% (range = 57%-63%) for real-world effectiveness. CONCLUSION: Our model results suggest that changes in policies that target improvements in treatment access could increase breast cancer equity. The findings also highlight that efforts must extend beyond policies targeting equity in treatment initiation to include high-quality treatment completion. This research will facilitate future modeling to test the effects of different specific policy changes on mortality disparities.

Effect of restricting electronic health records on clinician efficiency: substudy of a randomized clinical trial.

A prior randomized controlled trial (RCT) showed no significant difference in wrong-patient errors between clinicians assigned to a restricted electronic health record (EHR) configuration (limiting to 1 record open at a time) versus an unrestricted EHR configuration (allowing up to 4 records open concurrently). However, it is unknown whether an unrestricted EHR configuration is more efficient. This substudy of the RCT compared clinician efficiency between EHR configurations using objective measures. All clinicians who logged onto the EHR during the substudy period were included. The primary outcome measure of efficiency was total active minutes per day. Counts were extracted from audit log data, and mixed-effects negative binomial regression was performed to determine differences between randomized groups. Incidence rate ratios (IRRs) were calculated with 95% confidence intervals (CIs). Among a total of 2556 clinicians, there was no significant difference between unrestricted and restricted groups in total active minutes per day (115.1 vs 113.3 min, respectively; IRR, 0.99; 95% CI, 0.93-1.06), overall or by clinician type and practice area.

Effects of a Sleep Health Education Program for Children and Parents on Child Sleep Duration and Difficulties: A Stepped-Wedge Cluster Randomized Clinical Trial.

Importance: Preschool-aged children often lack sufficient sleep and experience sleep difficulties. A consistent bedtime routine, falling asleep alone, and other sleep practices reduce difficulties and increase sleep duration. Objective: To evaluate the effects of a preschool-based sleep health literacy program on children's sleep duration and difficulties and on parent sleep knowledge, attitudes, self-efficacy, and beliefs 9 and 12 months after the program. Design, Setting, and Participants: This stepped-wedge cluster randomized clinical trial was implemented across the 2018-2019 school year. Head Start preschool personnel delivered interventions and collected outcomes data at baseline and 4 follow-ups. Seven Head Start agencies across New York State were randomized to implement interventions in either fall 2018 or winter and spring 2019. Outcomes were ascertained at 9- and 12-month follow-up. From March 19 through September 28, 2018, Head Start staff recruited (a) English- or Spanish-speaking parents (b) of children 3 years of age on or about September 2018 (c) who planned to remain at the site through the school year. Altogether, 519 parent-child (aged 3 years) dyads completed baseline and (any) follow-up data. Interventions: A 2-week classroom curriculum for children, a 1-hour parent workshop, and 1-on-1 parent discussions at home or school. Main Outcomes and Measures: Outcomes were the pre- vs postintervention differences measured at baseline and 9-month follow-up for parent-reported child school-night sleep duration per sleep logs, mild or moderate sleep difficulties per a validated questionnaire, and the total and domain scores for parent sleep knowledge, attitudes, self-efficacy, and beliefs. A modified intention-to-treat analysis excluding participants with only baseline data was used. Results: The mean (SD) age at enrollment of 519 children was 2.7 (0.1) years, 264 (50.9%) were girls, 196 (37.8%) lived in Spanish-speaking households, and 5 (0.9%) identified as Alaskan Native or American Indian, 17 (3.2%) as Asian American or Pacific Islander, 57 (10.8%) as Black, 199 (37.8%) as White, and 63 (12.0%) as other. Mean sleep durations increased nonsignificantly from baseline by 5.6 minutes (95% CI, -2.3 to 13.6 minutes; P = .17) at 9-month follow-up and by 6.8 minutes (95% CI, 0.2-13.7 minutes; P = .06) at 12-month follow-up. There was a slight improvement in parental knowledge (1.13 unit increase from baseline; 95% CI, 0.13-2.12 units), but no significant outcomes for parent sleep attitudes (0.16 unit increase from baseline; 95% CI, -0.46 to 0.77 units), self-efficacy (-0.13 unit decrease from baseline; 95% CI, -1.02 to 0.76 units) and beliefs (-0.20 unit decrease from baseline; 95% CI, -0.56 to 0.16 units). Intervention effects for child sleep difficulties were not significant (odds ratio, 1.13; 95% CI, 0.62-2.09). Fewer than 1 in 4 parents accurately perceived their child's sleep difficulty at 12 months. Conclusions and Relevance: The findings of this large pragmatic, stepped-wedge cluster randomized clinical trial, albeit largely negative, may have implications for the sustained impact, focus, and potential population-level effects of sleep education programs. Future research should evaluate the effects of more recurrent programming that emphasizes recognition of sleep problems and whether small increments of sleep across months and years in early childhood have meaningful effects. Trial Registration: ClinicalTrials.gov Identifier: NCT03556462.

Breast Cancer Screening Among Childhood Cancer Survivors Treated Without Chest Radiation: Clinical Benefits and Cost-Effectiveness.

BACKGROUND: Early initiation of breast cancer screening is recommended for high-risk women, including survivors of childhood cancer treated with chest radiation. Recent studies suggest that female survivors of childhood leukemia or sarcoma treated without chest radiation are also at elevated early onset breast cancer risk. However, the potential clinical benefits and cost-effectiveness of early breast cancer screening among these women are uncertain. METHODS: Using data from the Childhood Cancer Survivor Study, we adapted 2 Cancer Intervention and Surveillance Modeling Network simulation models to reflect the elevated risks of breast cancer and competing mortality among leukemia and sarcoma survivors. Costs and utility weights were based on published studies and databases. Outcomes included breast cancer deaths averted, false-positive screening results, benign biopsies, and incremental cost-effectiveness ratios. RESULTS: In the absence of screening, the lifetime risk of dying from breast cancer among survivors was 6.8% to 7.0% across models. Early initiation of annual mammography with breast magnetic resonance imaging screening between ages 25 and 40 years would avert 52.6% to 64.3% of breast cancer deaths. When costs and quality-of-life impacts were considered, screening starting at age 40 years was the only strategy with an incremental cost-effectiveness ratio below the $100 000 per quality-adjusted life-year (QALY) gained cost-effectiveness threshold ($27 680 to $44 380 per QALY gained across models). CONCLUSIONS: Among survivors of childhood leukemia or sarcoma, early initiation of breast cancer screening at age 40 years may reduce breast cancer deaths by half and is cost-effective. These findings could help inform screening guidelines for survivors treated without chest radiation.

Identifying Equitable Screening Mammography Strategies for Black Women in the United States Using Simulation Modeling.

BACKGROUND: Screening mammography guidelines do not explicitly consider racial differences in breast cancer epidemiology, treatment, and survival. OBJECTIVE: To compare tradeoffs of screening strategies in Black women versus White women under current guidelines. DESIGN: An established model from the Cancer Intervention and Surveillance Modeling Network simulated screening outcomes using race-specific inputs for subtype distribution; breast density; mammography performance; age-, stage-, and subtype-specific treatment effects; and non-breast cancer mortality. SETTING: United States. PARTICIPANTS: A 1980 U.S. birth cohort of Black and White women. INTERVENTION: Screening strategies until age 74 years with varying initiation ages and intervals. MEASUREMENTS: Outcomes included benefits (life-years gained [LYG], breast cancer deaths averted, and mortality reduction), harms (mammographies, false positives, and overdiagnoses), and benefit-harm ratios (tradeoffs) by race. Efficiency (benefits per unit resource), mortality disparity reduction, and equity in tradeoffs were evaluated. Equitable strategies for Black women were defined as those with tradeoffs closest to benchmark values for screening White women biennially from ages 50 to 74 years. RESULTS: Biennial screening from ages 45 to 74 years was most efficient for Black women, whereas biennial screening from ages 40 to 74 years was most equitable. Initiating screening 10 years earlier in Black versus White women reduced Black-White mortality disparities by 57% with similar LYG per mammogram for both populations. Selection of the most equitable strategy was sensitive to assumptions about disparities in real-world treatment effectiveness: The less effective treatment was for Black women, the more intensively Black women could be screened before tradeoffs fell short of those experienced by White women. LIMITATION: Single model. CONCLUSION: Initiating biennial screening in Black women at age 40 years reduces breast cancer mortality disparities and yields benefit-harm ratios that are similar to tradeoffs of White women screened biennially from ages 50 to 74 years. PRIMARY FUNDING SOURCE: National Cancer Institute at the National Institutes of Health.

Development and Validation of a Simulation Model-Based Clinical Decision Tool: Identifying Patients Where 21-Gene Recurrence Score Testing May Change Decisions.

PURPOSE: There is a need for industry-independent decision tools that integrate clinicopathologic features, comorbidities, and genomic information for women with node-negative, invasive, hormone receptor-positive, human epidermal growth factor receptor-2-negative (early-stage) breast cancer. METHODS: We adapted an extant Cancer Intervention and Surveillance Modeling Network simulation model to estimate the 10-year risk of distant recurrence, breast cancer-specific mortality, other-cause mortality, and life-years gained with chemoendocrine versus endocrine therapy. We simulated outcomes for 1,512 unique patient subgroups based on all possible combinations of age, tumor size, grade, and comorbidity level; simulations were performed with and without 21-gene recurrence scores (RSs). Model inputs were derived from clinical trials, large US cohort studies, registry, and claims data. External validation was performed by comparing results to observed rates in two independent sources. We highlight results for one scenario where treatment choice may be uncertain. RESULTS: Chemoendocrine versus endocrine therapy in a 65-69-year-old woman with a small (≤ 2 cm), intermediate-grade tumor, and mild comorbidities provides a 1.3% absolute reduction in 10-year distant recurrence risk, with 0.23 life-years gained. With these tumor features, a woman like this will have a 28% probability of having an RS 16-20, 18% RS 21-25, and 11% RS 26+. If testing is done, and her RS is 16-20, chemoendocrine therapy reduces 10-year distant recurrence risk to 1%, with 0.20 life-years gained, a similar result as without testing. The absolute benefits would increase to 4.8%-5.5% if the RS was 26+. The model closely reproduced observed rates in both independent data sets. CONCLUSION: Our validated clinical decision tool is flexible, readily adaptable to include new therapies, and can support discussions about genomic testing and early breast cancer treatment.

Wrong-Patient Orders in Obstetrics.

OBJECTIVE: To compare rates of wrong-patient orders among patients on obstetric units compared with reproductive-aged women admitted to medical-surgical units. METHODS: This was an observational study conducted in a large health system in New York between January 1, 2016, and December 31, 2018. The primary outcome was near-miss wrong-patient orders identified using the National Quality Forum-endorsed Wrong-Patient Retract-and-Reorder measure. All electronic orders placed for eligible patients during the study period were extracted retrospectively from the health system data warehouse, and the unit of analysis was the order session (consecutive orders placed by a single clinician for a patient within 60 minutes). Multilevel logistic regression models were used to estimate odds ratios (ORs) and 95% CIs comparing the probability of retract-and-reorder events in obstetric and medical-surgical units, overall, and in subgroups defined by clinician type and order timing. RESULTS: Overall, 1,329,463 order sessions were placed during the study period, including 676,643 obstetric order sessions (from 45,436 patients) and 652,820 medical-surgical order sessions (from 12,915 patients). The rate of 79.5 retract-and-reorder events per 100,000 order sessions in obstetric units was significantly higher than the rate in the general medical-surgical population of 42.3 per 100,000 order sessions (OR 1.98, 95% CI 1.64-2.39). The obstetric retract-and-reorder event rate was significantly higher for attending physicians and house staff compared with advanced practice clinicians. There were no significant differences in error rates between day and night shifts. CONCLUSION: Order errors occurred more frequently on obstetric units compared with medical-surgical units. Systems strategies shown to decrease these events in other high-risk specialties should be explored in obstetrics to render safer maternity care.

Impact of the COVID-19 Pandemic on Breast Cancer Mortality in the US: Estimates From Collaborative Simulation Modeling.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has disrupted breast cancer control through short-term declines in screening and delays in diagnosis and treatments. We projected the impact of COVID-19 on future breast cancer mortality between 2020 and 2030. METHODS: Three established Cancer Intervention and Surveillance Modeling Network breast cancer models modeled reductions in mammography screening use, delays in symptomatic cancer diagnosis, and reduced use of chemotherapy for women with early-stage disease for the first 6 months of the pandemic with return to prepandemic patterns after that time. Sensitivity analyses were performed to determine the effect of key model parameters, including the duration of the pandemic impact. RESULTS: By 2030, the models project 950 (model range = 860-1297) cumulative excess breast cancer deaths related to reduced screening, 1314 (model range = 266-1325) associated with delayed diagnosis of symptomatic cases, and 151 (model range = 146-207) associated with reduced chemotherapy use in women with hormone positive, early-stage cancer. Jointly, 2487 (model range = 1713-2575) excess breast cancer deaths were estimated, representing a 0.52% (model range = 0.36%-0.56%) cumulative increase over breast cancer deaths expected by 2030 in the absence of the pandemic's disruptions. Sensitivity analyses indicated that the breast cancer mortality impact would be approximately double if the modeled pandemic effects on screening, symptomatic diagnosis, and chemotherapy extended for 12 months. CONCLUSIONS: Initial pandemic-related disruptions in breast cancer care will have a small long-term cumulative impact on breast cancer mortality. Continued efforts to ensure prompt return to screening and minimize delays in evaluation of symptomatic women can largely mitigate the effects of the initial pandemic-associated disruptions.

Reflecting on 20 years of breast cancer modeling in CISNET: Recommendations for future cancer systems modeling efforts.

Since 2000, the National Cancer Institute's Cancer Intervention and Surveillance Modeling Network (CISNET) modeling teams have developed and applied microsimulation and statistical models of breast cancer. Here, we illustrate the use of collaborative breast cancer multilevel systems modeling in CISNET to demonstrate the flexibility of systems modeling to address important clinical and policy-relevant questions. Challenges and opportunities of future systems modeling are also summarized. The 6 CISNET breast cancer models embody the key features of systems modeling by incorporating numerous data sources and reflecting tumor, person, and health system factors that change over time and interact to affect the burden of breast cancer. Multidisciplinary modeling teams have explored alternative representations of breast cancer to reveal insights into breast cancer natural history, including the role of overdiagnosis and race differences in tumor characteristics. The models have been used to compare strategies for improving the balance of benefits and harms of breast cancer screening based on personal risk factors, including age, breast density, polygenic risk, and history of Down syndrome or a history of childhood cancer. The models have also provided evidence to support the delivery of care by simulating outcomes following clinical decisions about breast cancer treatment and estimating the relative impact of screening and treatment on the United States population. The insights provided by the CISNET breast cancer multilevel modeling efforts have informed policy and clinical guidelines. The 20 years of CISNET modeling experience has highlighted opportunities and challenges to expanding the impact of systems modeling. Moving forward, CISNET research will continue to use systems modeling to address cancer control issues, including modeling structural inequities affecting racial disparities in the burden of breast cancer. Future work will also leverage the lessons from team science, expand resource sharing, and foster the careers of early stage modeling scientists to ensure the sustainability of these efforts.

The development and validation of a resource consumption score of an emergency department consultation.

BACKGROUND: Emergency Department (ED) visits and health care costs are increasing globally, but little is known about contributing factors of ED resource consumption. This study aims to analyse and to predict the total ED resource consumption out of the patient and consultation characteristics in order to execute performance analysis and evaluate quality improvements. METHODS: Characteristics of ED visits of a large Swiss university hospital were summarized according to acute patient condition factors (e.g. chief complaint, resuscitation bay use, vital parameter deviations), chronic patient conditions (e.g. age, comorbidities, drug intake), and contextual factors (e.g. night-time admission). Univariable and multivariable linear regression analyses were conducted with the total ED resource consumption as the dependent variable. RESULTS: In total, 164,729 visits were included in the analysis. Physician resources accounted for the largest proportion (54.8%), followed by radiology (19.2%), and laboratory work-up (16.2%). In the multivariable final model, chief complaint had the highest impact on the total ED resource consumption, followed by resuscitation bay use and admission by ambulance. The impact of age group was small. The multivariable final model was validated (R2 of 0.54) and a scoring system was derived out of the predictors. CONCLUSIONS: More than half of the variation in total ED resource consumption can be predicted by our suggested model in the internal validation, but further studies are needed for external validation. The score developed can be used to calculate benchmarks of an ED and provides leaders in emergency care with a tool that allows them to evaluate resource decisions and to estimate effects of organizational changes.

Trade-Offs Between Harms and Benefits of Different Breast Cancer Screening Intervals Among Low-Risk Women.

BACKGROUND: A paucity of research addresses breast cancer screening strategies for women at lower-than-average breast cancer risk. The aim of this study was to examine screening harms and benefits among women aged 50-74 years at lower-than-average breast cancer risk by breast density. METHODS: Three well-established, validated Cancer Intervention and Surveillance Network models were used to estimate the lifetime benefits and harms of different screening scenarios, varying by screening interval (biennial, triennial). Breast cancer deaths averted, life-years and quality-adjusted life-years gained, false-positives, benign biopsies, and overdiagnosis were assessed by relative risk (RR) level (0.6, 0.7, 0.85, 1 [average risk]) and breast density category, for US women born in 1970. RESULTS: Screening benefits decreased proportionally with decreasing risk and with lower breast density. False-positives, unnecessary biopsies, and the percentage overdiagnosis also varied substantially by breast density category; false-positives and unnecessary biopsies were highest in the heterogeneously dense category. For women with fatty or scattered fibroglandular breast density and a relative risk of no more than 0.85, the additional deaths averted and life-years gained were small with biennial vs triennial screening. For these groups, undergoing 4 additional screens (screening biennially [13 screens] vs triennially [9 screens]) averted no more than 1 additional breast cancer death and gained no more than 16 life-years and no more than 10 quality-adjusted life-years per 1000 women but resulted in up to 232 more false-positives per 1000 women. CONCLUSION: Triennial screening from age 50 to 74 years may be a reasonable screening strategy for women with lower-than-average breast cancer risk and fatty or scattered fibroglandular breast density.

Individualized quality of life benefit and cost-effectiveness estimates of proton therapy for patients with oropharyngeal cancer.

BACKGROUND: Proton therapy is a promising advancement in radiation oncology especially in terms of reducing normal tissue toxicity, although it is currently expensive and of limited availability. Here we estimated the individual quality of life benefit and cost-effectiveness of proton therapy in patients with oropharyngeal cancer treated with definitive radiation therapy (RT), as a decision-making tool for treatment individualization. METHODS AND MATERIALS: Normal tissue complication probability models were used to estimate the risk of dysphagia, esophagitis, hypothyroidism, xerostomia and oral mucositis for 33 patients, comparing delivered photon intensity-modulated RT (IMRT) plans to intensity-modulated proton therapy (IMPT) plans. Quality-adjusted life years (QALYs) lost were calculated for each complication while accounting for patient-specific conditional survival probability and assigning quality-adjustment factors based on complication severity. Cost-effectiveness was modeled based on upfront costs of IMPT and IMRT, and the cost of acute and/or long-term management of treatment complications. Uncertainties in all model parameters and sensitivity analyses were included through Monte Carlo sampling. RESULTS: The incremental cost-effectiveness ratios (ICERs) showed considerable variability in the cost of QALYs spared between patients, with median $361,405/QALY for all patients, varying from $54,477/QALY to $1,508,845/QALY between individual patients. Proton therapy was more likely to be cost-effective for patients with p16-positive tumors ($234,201/QALY), compared to p16-negative tumors ($516,297/QALY). For patients with p16-positive tumors treated with comprehensive nodal irradiation, proton therapy is estimated to be cost-effective in ≥ 50% of sampled cases for 8/9 patients at $500,000/QALY, compared to 6/24 patients who either have p16-negative tumors or receive unilateral neck irradiation. CONCLUSIONS: Proton therapy cost-effectiveness varies greatly among oropharyngeal cancer patients, and highlights the importance of individualized decision-making. Although the upfront cost, societal willingness to pay and healthcare administration can vary greatly among different countries, identifying patients for whom proton therapy will have the greatest benefit can optimize resource allocation and inform prospective clinical trial design.

Distress and Type 2 Diabetes Self-Care: Putting the Pieces Together.

BACKGROUND: Conflicting research emphasizes depression, diabetes distress, or well-being in relation to diabetes self-care and risk for poor health outcomes. PURPOSE: The purpose of this study was to test whether a latent variable for general psychological distress derived from shared variance of depression symptoms, diabetes distress, and well-being predicts a latent variable of diabetes self-care and to examine evidence for unique effects once shared effects are adjusted for. METHODS: Adults with suboptimally controlled diabetes were recruited from the South Bronx, NY, for a telephonic diabetes self-management support trial. Baseline diabetes self-care, medication adherence, depression symptoms, diabetes distress, and well-being were measured by validated self-report. Structural equation modeling specified a latent variable for general psychological distress derived from shared variance of depression symptoms, diabetes distress, and well-being. Diabetes self-care was a latent variable indicated by diet, glucose self-monitoring, and medication adherence. RESULTS: Participants (N = 627, 65% female) were predominantly ethnic minority (70% Hispanic; 45% Black) and 77% reported household income <$20K/year. Mean (standard deviation) age = 56 (12) years; A1c = 9.1% (1.9%); body mass index = 32 (8) kg/m2. The latent variable for psychological distress was a robust predictor of poorer diabetes self-care (coefficient = -0.59 [confidence interval = -0.71, -0.46], p < .001) with good model fit. Unique paths from depression symptoms, diabetes distress, and well-being (all ps > .99) to self-care were not observed. CONCLUSIONS: In this population of disadvantaged adults with suboptimally controlled diabetes, general psychological distress was strongly associated with poorer diabetes self-care and fully accounted for the effects of depression, diabetes distress, and positive well-being. This suggests that general distress may underlie previously reported associations between these constructs and diabetes self-care.

Personalizing Breast Cancer Screening Based on Polygenic Risk and Family History.

BACKGROUND: We assessed the clinical utility of a first-degree breast cancer family history and polygenic risk score (PRS) to inform screening decisions among women aged 30-50 years. METHODS: Two established breast cancer models evaluated digital mammography screening strategies in the 1985 US birth cohort by risk groups defined by family history and PRS based on 313 single nucleotide polymorphisms. Strategies varied in initiation age (30, 35, 40, 45, and 50 years) and interval (annual, hybrid, biennial, triennial). The benefits (breast cancer deaths averted, life-years gained) and harms (false-positive mammograms, overdiagnoses) were compared with those seen with 3 established screening guidelines. RESULTS: Women with a breast cancer family history who initiated biennial screening at age 40 years (vs 50 years) had a 36% (model range = 29%-40%) increase in life-years gained and 20% (model range = 16%-24%) more breast cancer deaths averted, but 21% (model range = 17%-23%) more overdiagnoses and 63% (model range = 62%-64%) more false positives. Screening tailored to PRS vs biennial screening from 50 to 74 years had smaller positive effects on life-years gained (20%) and breast cancer deaths averted (11%) but also smaller increases in overdiagnoses (10%) and false positives (26%). Combined use of family history and PRS vs biennial screening from 50 to 74 years had the greatest increase in life-years gained (29%) and breast cancer deaths averted (18%). CONCLUSIONS: Our results suggest that breast cancer family history and PRS could guide screening decisions before age 50 years among women at increased risk for breast cancer but expected increases in overdiagnoses and false positives should be expected.

Mental health stigma and barriers to care in World Trade Center responders: Results from a large, population-based health monitoring cohort.

BACKGROUND: Nearly 20 years after the terrorist attacks of September 11, 2001, multiple studies have documented the adverse mental consequences among World Trade Center (WTC) rescue, recovery, and clean-up workers. However, scarce research has examined mental health stigma and barriers to care in WTC-exposed individuals, and no known study has examined whether rates of endorsement may differ between police and "nontraditional" responders, the latter comprising a heterogeneous group of workers and volunteers. OBJECTIVE: To identify the prevalence and correlates of mental health stigma and barriers to care in WTC responders. METHODS: Mental health stigma and barriers to care and their correlates were examined in 6,777 police and 6,272 nontraditional WTC responders. RESULTS: Nontraditional responders endorsed more stigma or barriers to care concerns than police responders. Within a subsample who screened positive for a psychiatric disorder, police were more likely than nontraditional responders to endorse "concerns that negative job consequences might result" (17.9% vs. 9.1%), while nontraditional responders were more likely to endorse "I don't know where to go to find counseling services" (18.4% vs.6.6%). Within this subsample, mental health service need and more severe WTC-related posttraumatic stress disorder symptoms were associated with increased likelihood of endorsing stigma or barriers; pre-9/11 psychiatric history and non-Hispanic Black race/ethnicity were associated with lower likelihood of endorsing stigma or barriers. CONCLUSIONS: Results of this study underscore the burden of mental health stigma and barriers to care in WTC responders, and highlight the need for targeted interventions to address these concerns and promote mental healthcare utilization in this population.

Acculturation, coping, and PTSD in Hispanic 9/11 rescue and recovery workers.

Objective: Research examining the responders of the World Trade Center terrorist attacks of 9/11 has found that Hispanic responders are at greater risk for posttraumatic stress disorder (PTSD) than non-Hispanic White responders. However, no studies have examined how acculturation may influence the relationship between coping and PTSD in Hispanic 9/11 responders. This novel study is the first to examine differences in coping and PTSD among Hispanic responders by level of acculturation. Methods: The sample is composed of 845 Hispanic 9/11 responders who were seen at the World Trade Center Health Program and participated in a web-based survey. Using logistic and multiple linear regression, we examined how acculturation is related to their coping strategies and risk for PTSD. We also tested for interaction to examine whether level of acculturation moderated the relationship between coping and PTSD symptom severity. Results: Key findings revealed that higher acculturation is associated with the use of substances, venting, and humor to cope, while lower acculturation is associated with the use of active coping and self-distraction in this sample. We also found that less acculturated responders were more likely to experience more severe PTSD. Lastly, our findings revealed that Hispanics who are more acculturated and used substances to cope had more severe PTSD than less acculturated responders. Conclusion: These findings highlight the need to consider the role of acculturation in Hispanic responders' coping and PTSD. (PsycInfo Database Record (c) 2020 APA, all rights reserved).