Prevalence of concomitant rheumatologic diseases and autoantibody specificities among racial and ethnic groups in SLE patients.

Objective: Leveraging the Manhattan Lupus Surveillance Program (MLSP), a population-based registry of cases of systemic lupus erythematosus (SLE) and related diseases, we investigated the proportion of SLE with concomitant rheumatic diseases, including Sjögren's disease (SjD), antiphospholipid syndrome (APLS), and fibromyalgia (FM), as well as the prevalence of autoantibodies in SLE by sex and race/ethnicity. Methods: Prevalent SLE cases fulfilled one of three sets of classification criteria. Additional rheumatic diseases were defined using modified criteria based on data available in the MLSP: SjD (anti-SSA/Ro positive and evidence of keratoconjunctivitis sicca and/or xerostomia), APLS (antiphospholipid antibody positive and evidence of a blood clot), and FM (diagnosis in the chart). Results: 1,342 patients fulfilled SLE classification criteria. Of these, SjD was identified in 147 (11.0%, 95% CI 9.2-12.7%) patients with women and non-Latino Asian patients being the most highly represented. APLS was diagnosed in 119 (8.9%, 95% CI 7.3-10.5%) patients with the highest frequency in Latino patients. FM was present in 120 (8.9%, 95% CI 7.3-10.5) patients with non-Latino White and Latino patients having the highest frequency. Anti-dsDNA antibodies were most prevalent in non-Latino Asian, Black, and Latino patients while anti-Sm antibodies showed the highest proportion in non-Latino Black and Asian patients. Anti-SSA/Ro and anti-SSB/La antibodies were most prevalent in non-Latino Asian patients and least prevalent in non-Latino White patients. Men were more likely to be anti-Sm positive. Conclusion: Data from the MLSP revealed differences among patients classified as SLE in the prevalence of concomitant rheumatic diseases and autoantibody profiles by sex and race/ethnicity underscoring comorbidities associated with SLE.

Extrarenal symptoms associate with worse quality of life in patients enrolled in the AMP RA/SLE Lupus Nephritis Network.

OBJECTIVE: Lupus nephritis (LN) can occur as an isolated component of disease activity or be accompanied by diverse extrarenal manifestations. Whether isolated renal disease is sufficient to decrease health related quality of life (HRQOL) remains unknown. This study compared Patient-Reported Outcomes Measurement Information System 29-Item (PROMIS-29) scores in LN patients with isolated renal disease to those with extrarenal symptoms to evaluate the burden of LN on HRQOL and inform future LN clinical trials incorporating HRQOL outcomes. METHODS: A total of 181 LN patients consecutively enrolled in the multicentre multi-ethnic/racial Accelerating Medicines Partnership completed PROMIS-29 questionnaires at the time of a clinically indicated renal biopsy. Raw PROMIS-29 scores were converted to standardized T scores. RESULTS: Seventy-five (41%) patients had extrarenal disease (mean age 34, 85% female) and 106 (59%) had isolated renal (mean age 36, 82% female). Rash (45%), arthritis (40%) and alopecia (40%) were the most common extrarenal manifestations. Compared with isolated renal, patients with extrarenal disease reported significantly worse pain interference, ability to participate in social roles, physical function, and fatigue. Patients with extrarenal disease had PROMIS-29 scores that significantly differed from the general population by > 0.5 SD of the reference mean in pain interference, physical function, and fatigue. Arthritis was most strongly associated with worse scores in these three domains. CONCLUSION: Most patients had isolated renal disease and extrarenal manifestations associated with worse HRQOL. These data highlight the importance of comprehensive disease management strategies that address both renal and extrarenal manifestations to improve overall patient outcomes.

Clinical and Serologic Phenotyping and Damage Indices in Patients With Systemic Lupus Erythematosus With and Without Fibromyalgia.

OBJECTIVE: Given fibromyalgia (FM) frequently co-occurs with autoimmune disease, this study was initiated to objectively evaluate FM in a multiracial/ethnic cohort of patients with systemic lupus erythematosus (SLE). METHODS: Patients with SLE were screened for FM using the 2016 FM classification criteria during an in-person rheumatologist visit. We evaluated hybrid Safety of Estrogens in Lupus National Assessment (SELENA)-SLE Disease Activity Index (SLEDAI) scores, SLE classification criteria, and Systemic Lupus International Collaborating Clinics damage index. We compared patients with and without FM and if differences were present, compared patients with FM with patients with non-FM related chronic pain. RESULTS: 316 patients with SLE completed the FM questionnaire. 55 (17.4%) met criteria for FM. The racial composition of patients with FM differed from those without FM (P = 0.023), driven by fewer Asian patients having FM. There was no difference in SLE disease duration, SELENA-SLEDAI score, or active serologies. There was more active arthritis in the FM group (16.4%) versus the non-FM group (1.9%) (P < 0.001). The Widespread Pain Index and Symptom Severity Score did not correlate with degree of SLE activity (r = -0.016; 0.107) among patients with FM or non-FM chronic pain (r = 0.009; -0.024). Regarding criteria, patients with FM had less nephritis and more malar rash. Systemic Lupus International Collaborating Clinics damage index did not differ between groups. CONCLUSION: Except for arthritis, patients with SLE with FM are not otherwise clinically or serologically distinguishable from those without FM, and Widespread Pain Index and Symptom Severity Score indices do not correlate with SLEDAI. These observations support the importance of further understanding the underlying biology of FM in SLE.

Guideline concordant care for patients with locally advanced cervical cancer by disaggregated Asian American and Native Hawaiian/Pacific Islander groups: A National Cancer Database Analysis.

OBJECTIVE: Despite the within-group heterogeneity, Asian American (AA) and Native Hawaiian and Pacific Islander (NH/PI) patients are often grouped together. We compared the patterns of guideline-concordant care for locally advanced cervical cancer for disaggregated AA and NH/PI patients. METHODS: Patients with stage II-IVA cervical cancer between 2004 and 2020 were identified from the National Cancer Database. AA patients were disaggregated as East Asian (EA), South Asian (SA), and Southeast Asian (SEA). NH/PI patients were classified as a distinct racial subgroup. The primary outcome was the proportion undergoing guideline-concordant care, defined by radiation therapy with concurrent chemotherapy, brachytherapy, and completion of treatment within eight weeks. RESULTS: Of 48,116 patients, 2107 (4%) were AA and 171 (<1%) were NH/PI. Of the AA patients, 36% were SEA, 31% were EA, 12% were SA, and 21% could not be further disaggregated due to missing or unknown data. NH/PI patients were more likely to be diagnosed at an early age (53% NH/PI vs. 30% AA, p < 0.001) and have higher rates of comorbidities (18% NH/PI vs. 14% AA, p < 0.001). Within the AA subgroups, only 82% of SEA patients received concurrent chemotherapy compared to 91% of SA patients (p = 0.026). SA patients had the longest median OS (158 months) within the AA subgroups compared to SEA patients (113 months, p < 0.001). CONCLUSION: Disparities exist in the receipt of standard of care treatment for cervical cancer by racial and ethnic subgroups. It is imperative to disaggregate race and ethnicity data to understand potential differences in care and tailor interventions to achieve health equity.

Apexification Outcomes in the United States: A Retrospective Cohort Study.

INTRODUCTION: This epidemiological analysis used procedure codes from dental insurance claims data to identify apexification cases and evaluate survival at the tooth-level. METHODS: Dental insurance claims data from New York State (2006-2019) and Massachusetts (2013-2018) were used in an observational, retrospective cohort study to evaluate the provision and treatment outcomes of apexification. Statistical analyses included Kaplan-Meier survival estimates and Cox proportional hazards regression. Cox proportional hazard regression was used to evaluate the hazard of adverse event occurrence by age, gender, tooth type, placement of permanent restoration, and dental provider type. A sensitivity analysis evaluated potential bias in the survival estimates and adjusted hazard ratios (aHRs) due to differential loss to follow-up. Robust standard errors were used to account for potential dependence between teeth within an individual. RESULTS: The analytic cohort of 575 individuals included 632 teeth, with an average follow-up time of 64 months. The survival rates of apexification procedures were 95% at 1 year; 93% at 2 years; 90% at 3 years; and 86% at 5 years. Tooth retention following apexification was 98% at 1 year; 96% at 2 years; 95% at 3 years; and 90% at 5 years. Tooth type and subsequent placement of a permanent restoration were significant predictors of survival after apexification. CONCLUSIONS: The procedural and tooth survival outcomes of apexification were high and comparable to studies that analyzed clinical data on tooth survival following apexification.

The Pathways to Prevention program: nutrition as prevention for improved cancer outcomes.

Adequate nutrition is central to well-being and health and can enhance recovery during illness. Although it is well known that malnutrition, both undernutrition and overnutrition, poses an added challenge for patients with cancer diagnoses, it remains unclear when and how to intervene and if such nutritional interventions improve clinical outcomes. In July 2022, the National Institutes of Health convened a workshop to examine key questions, identify related knowledge gaps, and provide recommendations to advance understanding about the effects of nutritional interventions. Evidence presented at the workshop found substantial heterogeneity among published randomized clinical trials, with a majority rated as low quality and yielding mostly inconsistent results. Other research cited trials in limited populations that showed potential for nutritional interventions to reduce the adverse effects associated with malnutrition in people with cancer. After review of the relevant literature and expert presentations, an independent expert panel recommends baseline screening for malnutrition risk using a validated instrument following cancer diagnosis and repeated screening during and after treatment to monitor nutritional well-being. Those at risk of malnutrition should be referred to registered dietitians for more in-depth nutritional assessment and intervention. The panel emphasizes the need for further rigorous, well-defined nutritional intervention studies to evaluate the effects on symptoms and cancer-specific outcomes as well as effects of intentional weight loss before or during treatment in people with overweight or obesity. Finally, although data on intervention effectiveness are needed first, robust data collection during trials is recommended to assess cost-effectiveness and inform coverage and implementation decisions.

How to Perform Economic Evaluation in Implementation Studies: Imaging-Specific Considerations and Comparison of Financial Models.

Economic evaluation for implementation science merits unique considerations for a local context, including the main audience of local decision makers. This local context is in contrast with traditional methods for developing coverage policy for medical tests and interventions, which typically emphasize benefits and costs more broadly, for society. Regardless of the strength of evidence backing the efficacy or effectiveness of a clinical intervention, local context is paramount when implementing evidence-based practices. Understanding the costs throughout the processes of implementing a program will inform the decision of whether to plan for and adopt the program, how to sustain the program, and whether to scale up widely. To guide economic evaluation for implementation of evidence-based imaging practices, we describe approaches that consider local stakeholders' needs and connect these with outcomes of cost and clinical utility. Illustrative examples of implementation strategies and economic evaluation are explored in areas of cancer screening and care delivery.

Implementation of a relapse prevention program among smokers undergoing arthroplasty: lessons learned.

BACKGROUND: Surgery is a potent motivator to help people quit smoking to reduce the risk of complications. Many patients who smoke receive tobacco cessation counseling prior to surgery and are able to quit, but do not receive the same resources after surgery and often resume smoking. METHODS: We present a case study describing the recruitment process, study components, and lessons learned from StayQuit, a comprehensive relapse prevention program designed to prevent relapse after arthroplasty. Lessons learned were examined post hoc to determine challenges related to program implementation, using existing study procedures and information collected. RESULTS: While a comprehensive postoperative relapse prevention program may be beneficial to patients, implementation of StayQuit is unlikely to be feasible under current circumstances. The primary challenges to successful implementation of StayQuit focused on themes of lack of engagement in the preoperative Orthopedic Surgery Quit Smoking Program (OSQSP) and an environment unfavorable to in-person enrollment on the day of surgery. CONCLUSIONS: Postoperative relapse prevention programs may be beneficial for patients who quit smoking prior to elective surgery. To help guide implementation, it is important to consider surgeon behavior, the collaboration of clinical and non-clinical teams, and best practices for study enrollment in surgical settings.

A comparative analysis of public and private dental benefit payer types for the provision and outcomes of root canal therapy on permanent teeth of children and adolescents in Massachusetts.

BACKGROUND: Despite substantial increases in dental benefits and improvements in the use of dental services among children and adolescents in the United States, oral health disparities according to dental insurance payer type persist. METHODS: The authors used an all-payer claims (2013-2017) database to perform a comparative analysis of the provision and treatment outcomes of an endodontic procedure (root canal therapy) in the permanent teeth of a pediatric population aged 6 through 18 years, according to dental insurance payer type. Statistical analyses, including logistic regression, Cox proportional hazards regression, and the Kaplan-Meier method, were performed at person and tooth levels. RESULTS: Compared with privately insured children and adolescents, public-payer children and adolescent beneficiaries were more likely to have had root canal therapy (adjusted odds ratio, 1.91; 95% CI, 1.73 to 2.11) and had poorer treatment outcomes associated with the procedure (adjusted hazard ratio, 2.19; 95% CI, 1.53 to 3.14; P < .0001) during the study period. Those enrolled in private insurance were more likely to receive treatment from an endodontist (specialist in providing root canal therapy) (P < .0001). Amounts allowed and paid by the insurer were significantly higher for private payers (P < .001). CONCLUSIONS: There were significant differences in the provision and outcomes of endodontic treatment between privately and publicly insured children and adolescents. PRACTICAL IMPLICATIONS: Despite ostensibly equal access to care, differences in the provision of oral health care exist between privately and publicly insured patients. These differences may be contributing to persisting oral health disparities.

A comparative analysis of outcomes of root canal therapy for pediatric medicaid beneficiaries from New York State.

Objectives: This study investigated differences in the provision of root canal therapy and outcomes in a publicly insured cohort of children and adolescents. Methods: New York State Medicaid administrative claims from 2006 to 2018 were analyzed. Enrollees aged 6-18 were included in the study if they had initial non-surgical root canal therapy (NSRCT), in the permanent dentition, that allowed for at least 1 year of post-treatment follow-up. Descriptive analyses, multivariable logistic regression, and multivariable Cox proportional hazard models were used to examine the association between demographic variables (gender, age, race/ethnicity, and area-based factors) and dental treatment provision and outcomes. Results: Male gender was associated with having more than one initial NSRCT (adjusted odds ratio (aOR) = 1.06; 95% confidence interval (CI) = 1.02-1.10), as was rurality (aOR = 1.15; 95% CI = 1.06-1.24). Black/African American (AA) and Hispanic children were less likely than non-Hispanic white children to have multiple NSRCTs (aOR = 0.88; 95% CI = 0.83-0.93 and aOR = 0.78; 95% CI = 0.74-0.83). Being older or female conferred a lower hazard of an untoward event (aHR = 0.93; 95% CI = 0.92-0.94 and aHR = 0.86; 95% CI = 0.81-0.91). Compared to non-Hispanic white children, Hispanic and Black/AA children had a higher risk of untoward event (aHR = 1.31; 95% CI = 1.21-1.41 and aHR = 1.55; 95% CI = 1.43-1.67) while children of Asian descent had a lower incidence after initial NSRCT (aHR = 0.79; 95% CI = 0.71-0.88). Conclusion: Race/ethnicity was the strongest demographic predictor of provision of initial non-surgical root canal therapy, subsequent placement of a permanent restoration and the occurrence of an untoward event after NSRCT in this cohort.

The COVID-19 pandemic's intersectional impact on work life, home life and wellbeing: an exploratory mixed-methods analysis of Georgia women's experiences during the pandemic.

BACKGROUND: Women have been especially impacted by the COVID-19 pandemic. This exploratory study aimed to characterize women's adverse experiences related to their work, home lives, and wellbeing during the height of the COVID-19 pandemic and to describe demographic differences of those lived experiences. METHODS: Using the validated Epidemic-Pandemic Impacts Inventory, we collected data from reproductive-aged women in the state of Georgia about their exposure to adverse events during the pandemic. A latent class analysis (LCA) was performed to identify subgroups of women reporting similar adverse experiences and describe their sociodemographic characteristics. An optional open-ended question yielded qualitative data that were analyzed thematically and merged with subgroup findings. Data were collected from September 2020 to January 2021. RESULTS: 423 individuals aged 18-49 completed the survey with 314 (74.2%) providing qualitative responses. The LCA yielded 4 subgroups: (1) a "low exposure" subgroup (n = 123, 29.1%) with relatively low probability of adverse experiences across domains (e.g. financial insecurity, health challenges, barriers to access to healthcare, intimate partner violence (IPV)); (2) a "high exposure" subgroup (n = 46, 10.9%) with high probability of experiencing multiple adversities across domains including the loss of loved ones to COVID-19; (3) a "caregiving stress" subgroup (n = 104, 24.6%) with high probability of experiencing challenges with home and work life including increased partner conflict; and (4) a "mental health changes" subgroup (n = 150, 35.5%) characterized by relatively low probability of adverse experiences but high probability of negative changes in mental health and lifestyle. Individuals in subgroups 1 and 4, which had low probabilities of adverse experiences, were significantly more likely to be non-Hispanic white. Individuals in subgroup 2 were more likely to identify with a sexual or racial/ethnic minority population. Inductive coding of qualitative data yielded themes such as stress, mental health, financial impact, and adaptation/resilience, providing context for pandemic-related adversity. CONCLUSION: Though many individuals in our sample experienced hardship, minority populations were unequally impacted by pandemic-related adversity in work life, home life, and wellbeing. Recovery and future emergency preparedness efforts in Georgia must incorporate support mechanisms for mental health and IPV, focusing especially on the intersectional needs of racial, ethnic, and sexual minorities.

The COVID-19 pandemic's impact on sexual and reproductive health in Georgia, USA: An exploration of behaviors, contraceptive care, and partner abuse.

OBJECTIVE: Assessing access to sexual and reproductive health care during the COVID-19 pandemic, experiences with intimate partner violence (IPV), and exploring sociodemographic disparities STUDY DESIGN: From September 2020 to January 2021, we recruited 436 individuals assigned female at birth (18-49 years.) in Georgia, USA for an online survey. The final convenience sample was n = 423; a response rate could not be calculated. Survey themes included: sociodemographic and financial information, access to contraceptive services/care, IPV, and pregnancy. Respondents who reported a loss of health insurance, difficulty accessing contraception, barriers to medical care, or IPV were characterized as having a negative sexual and reproductive health experience during the pandemic. We explored associations between sociodemographic variables and negative sexual and reproductive health experiences. RESULTS: Since March 2020, 66/436 (16%) of respondents lost their health insurance, and 45% (89/436) reported income loss. Of our sample, 144/436 people (33%) attempted to access contraception. The pandemic made contraceptive access more difficult for 38/144 (26%) of respondents; however, 106/144 (74%) said it had no effect or positive effect on access. Twenty-one respondents reported IPV (5%). COVID-19 amplified negative views of unplanned pregnancy. Seventy-six people (18%) reported at least 1 negative sexual and reproductive health experience during the pandemic; people in an urban setting and those identifying as homo/bisexual were more likely to report negative experiences (24%, 28% respectively). CONCLUSION: Urban and sexual minority populations had negative sexual and reproductive health experiences during COVID-19 more than their counterparts. The pandemic has shifted perspectives on family planning, likely due to the diverse impacts of COVID-19, including loss of health insurance and income. IMPLICATION: Females across Georgia reported varying impacts of the COVID-19's pandemic on their sexual and reproductive health care. These findings could be utilized to propose recommendations for care and intimate partner violence support mechanisms, tailored to urban and sexual minority populations.

A novel opt-in vs opt-out approach to referral-based treatment of tobacco use in Veterans Affairs (VA) primary care clinics: A provider-level randomized controlled trial protocol.

To determine whether an opt-out approach is effective for referral to treatment for tobacco use, we designed a clinical reminder for nurses in a primary care setting that provides a referral for patients who smoke cigarettes. We will use a two-arm, cluster-randomized design to assign nurses at the VA New York Harbor Healthcare System to test which mode of referral (opt-in vs opt-out) is more effective. All patients will be referred to evidence-based treatment for tobacco cessation including counseling from the New York State Quitline, and VetsQuit, a text messaging-based system for tobacco cessation counseling. We will measure patient engagement with the referral both in the short and long term to determine if referral modality had an impact on tobacco cessation treatment. We will also measure nurse engagement with the referral before, during, and after the implementation of the reminder to determine whether an opt-out approach is cost effective at the health system level. At the conclusion of this project, we expect to have developed and tested an opt-out system for increasing tobacco cessation treatment for Veterans in VA primary care and to have a thorough understanding of factors associated with implementation. Trial Registration:Clinicaltrials.govIdentifierNCT03477435.

Cost data in implementation science: categories and approaches to costing.

A lack of cost information has been cited as a barrier to implementation and a limitation of implementation research. This paper explains how implementation researchers might optimize their measurement and inclusion of costs, building on traditional economic evaluations comparing costs and effectiveness of health interventions. The objective of all economic evaluation is to inform decision-making for resource allocation and to measure costs that reflect opportunity costs-the value of resource inputs in their next best alternative use, which generally vary by decision-maker perspective(s) and time horizon(s). Analyses that examine different perspectives or time horizons must consider cost estimation accuracy, because over longer time horizons, all costs are variable; however, with shorter time horizons and narrower perspectives, one must differentiate the fixed and variable costs, with fixed costs generally excluded from the evaluation. This paper defines relevant costs, identifies sources of cost data, and discusses cost relevance to potential decision-makers contemplating or implementing evidence-based interventions. Costs may come from the healthcare sector, informal healthcare sector, patient, participant or caregiver, and other sectors such as housing, criminal justice, social services, and education. Finally, we define and consider the relevance of costs by phase of implementation and time horizon, including pre-implementation and planning, implementation, intervention, downstream, and adaptation, and through replication, sustainment, de-implementation, or spread.

Epidemiological evaluation of the outcomes of initial root canal therapy in permanent teeth of a publicly insured paediatric population.

BACKGROUND: Previously published epidemiological outcome studies of nonsurgical root canal therapy (NSRCT) in the United States utilize data only from a single, private dental insurer for adult populations. AIM: This study aimed to investigate the outcomes of initial NSRCT, performed on permanent teeth, in a publicly insured paediatric population. DESIGN: New York State Medicaid administrative claims were used to follow 77 741 endodontic procedures in 51 545 patients aged 6-18, from the time of initial NSRCT until the occurrence of an untoward event (retreatment, apicoectomy, and extraction). The initial treatment and untoward events were identified by Current Dental Terminology codes. The Kaplan-Meier survival estimates were calculated at 1, 3, and 5 years. Hazard ratios for time to permanent restoration and restoration type were calculated using the Cox proportional hazards model. RESULTS: The median follow-up time was 44 months [range: 12-158 months]. Procedural, NSRCT, survival was 98% at 1 year, 93% at 3 years, and 88% at 5 years. Extraction was the most common untoward event. Teeth permanently restored with cuspal coverage had the most favorable treatment outcomes. CONCLUSIONS: Overall, 89% of teeth were retained and remained functional over a minimum follow-up time of 5 years. These results elucidate the expected outcomes of NSRCT in permanent teeth for paediatric patients with public-payer dental benefits.

Radiation Without Endocrine Therapy in Older Women With Stage I Estrogen-Receptor-Positive Breast Cancer is Not Associated With a Higher Risk of Second Breast Cancer Events.

PURPOSE: The omission of radiation therapy (RT) in older women with stage 1 estrogen-receptor-positive (ER+) breast cancer receiving endocrine therapy (ET) is an acceptable strategy based on randomized trial data. Less is known about the omission of ET with or without RT. METHODS AND MATERIALS: We analyzed surveillance, epidemiology, and end results (SEER)-Medicare data for 13,321 women age 66 years or older with stage I ER+ breast cancer from 2007 to 2012 who underwent breast-conserving surgery. Patients were classified into 4 groups: (1) ET + RT (reference); (2) ET alone; (3) RT alone; and (4) neither RT nor ET (NT). Second breast cancer events (SBCEs) were captured using the Chubak high-specificity algorithm. We used χ2 tests for descriptive statistics, multivariable multinomial logistic regression to estimate relative risk of undergoing a treatment, and multivariable, propensity-weighted competing-risks survival regression to estimate standardized hazard ratio (SHR) of SBCE. We set significance at P ≤ .01. RESULTS: Most women underwent both treatments, with 44% undergoing ET + RT, 41% RT alone, 6.6% ET alone, and 8.6% NT, but practice patterns varied over time. From 2007 to 2012, RT decreased from 49% to 30%, whereas ET alone and ET + RT increased (ET alone, 5.4%-9.6%; ET + RT, 38%-51%). Compared with patients age 66 to 69 years, patients age 80 to 85 years were more likely to receive NT (odds ratio [OR], 8.9), RT (OR, 1.9), or ET (OR, 8.8) versus ET + RT (P < .01). Three percent of subjects had an SBCE (2.2% ET + RT, 3.0% RT alone, 3.2% ET alone, 7.0% NT). Relative to ET + RT, NT and ET alone were associated with higher SBCE (NT: SHR, 3.7, P < .001; ET alone: SHR, 2.2, P = .008), whereas RT was not associated with a higher SBCE (SHR 1.21; P = .137). Clinical factors associated with higher SBCE were HER2 positivity and pT1c (SHR, 1.7; P = .006). CONCLUSIONS: Treatment with RT alone in older women with stage I ER+ disease is decreasing. RT alone is not associated with an increased risk for SBCE. By contrast, NT and ET are both associated with higher SBCE in multivariable analysis with propensity weighting. Further study of the omission of endocrine therapy in this patient population is warranted.

The cost, survival, and quality-of-life implications of guideline-discordant imaging for prostate cancer.

BACKGROUND: National Comprehensive Cancer Network (NCCN) guidelines for incident prostate cancer staging imaging have been widely circulated and accepted as best practice since 1996. Despite these clear guidelines, wasteful and potentially harmful inappropriate imaging of men with prostate cancer remains prevalent. AIM: To understand changing population-level patterns of imaging among men with incident prostate cancer, we created a state-transition microsimulation model based on existing literature and incident prostate cancer cases. METHODS: To create a cohort of patients, we identified incident prostate cancer cases from 2004 to 2009 that were diagnosed in men ages 65 and older from SEER. A microsimulation model allowed us to explore how this cohort's survival, quality of life, and Medicare costs would be impacted by making imaging consistent with guidelines. We conducted a probabilistic analysis as well as one-way sensitivity analysis. RESULTS: When only imaging high-risk men compared to the status quo, we found that the population rate of imaging dropped from 53 to 38% and average per-person spending on imaging dropped from $236 to $157. The discounted and undiscounted incremental cost-effectiveness ratios indicated that ideal upfront imaging reduced costs and slightly improved health outcomes compared with current practice patterns, that is, guideline-concordant imaging was less costly and slightly more effective. CONCLUSION: This study demonstrates the potential reduction in cost through the correction of inappropriate imaging practices. These findings highlight an opportunity within the healthcare system to reduce unnecessary costs and overtreatment through guideline adherence.

Implementation of a multi-level community-clinical linkage intervention to improve glycemic control among south Asian patients with uncontrolled diabetes: study protocol of the DREAM initiative.

BACKGROUND: A number of studies have identified patient-, provider-, and community-level barriers to effective diabetes management among South Asian Americans, who have a high prevalence of type 2 diabetes. However, no multi-level, integrated community health worker (CHW) models leveraging health information technology (HIT) have been developed to mitigate disease among this population. This paper describes the protocol for a multi-level, community-clinical linkage intervention to improve glycemic control among South Asians with uncontrolled diabetes. METHODS: The study includes three components: 1) building the capacity of primary care practices (PCPs) to utilize electronic health record (EHR) registries to identify patients with uncontrolled diabetes; 2) delivery of a culturally- and linguistically-adapted CHW intervention to improve diabetes self-management; and 3) HIT-enabled linkage to culturally-relevant community resources. The CHW intervention component includes a randomized controlled trial consisting of group education sessions on diabetes management, physical activity, and diet/nutrition. South Asian individuals with type 2 diabetes are recruited from 20 PCPs throughout NYC and randomized at the individual level within each PCP site. A total of 886 individuals will be randomized into treatment or control groups; EHR data collection occurs at screening, 6-, 12-, and 18-month. We hypothesize that individuals receiving the multi-level diabetes management intervention will be 15% more likely than the control group to achieve ≥0.5% point reduction in hemoglobin A1c (HbA1c) at 6-months. Secondary outcomes include change in weight, body mass index, and LDL cholesterol; the increased use of community and social services; and increased health self-efficacy. Additionally, a cost-effectiveness analysis will focus on implementation and healthcare utilization costs to determine the incremental cost per person achieving an HbA1c change of ≥0.5%. DISCUSSION: Final outcomes will provide evidence regarding the effectiveness of a multi-level, integrated EHR-CHW intervention, implemented in small PCP settings to promote diabetes control among an underserved South Asian population. The study leverages multisectoral partnerships, including the local health department, a healthcare payer, and EHR vendors. Study findings will have important implications for the translation of integrated evidence-based strategies to other minority communities and in under-resourced primary care settings. TRIAL REGISTRATION: This study was registered with clinicaltrials.gov: NCT03333044 on November 6, 2017.

Protocol: A multi-modal, physician-centered intervention to improve guideline-concordant prostate cancer imaging.

BACKGROUND: Almost half of Veterans with localized prostate cancer receive inappropriate, wasteful staging imaging. Our team has explored the barriers and facilitators of guideline-concordant prostate cancer imaging and found that (1) patients with newly diagnosed prostate cancer have little concern for radiographic staging but rather focus on treatment and (2) physicians trust imaging guidelines but are apt to follow their own intuition, fear medico-legal consequences, and succumb to influence from imaging-avid colleagues. We used a theory-based approach to design a multi-level intervention strategy to promote guideline-concordant imaging to stage incident prostate cancer. METHODS: We designed the Prostate Cancer Imaging Stewardship (PCIS) intervention: a multi-site, stepped wedge, cluster-randomized trial to determine the effect of a physician-focused behavioral intervention on Veterans Health Administration (VHA) prostate cancer imaging use. The multi-level intervention, developed according to the Theoretical Domains Framework (TDF) and Behavior Change Wheel, combines traditional physician behavior change methods with novel methods of communication and data collection. The intervention consists of three components: (1) a system of audit and feedback to clinicians informing individual clinicians and their sites about how their behavior compares to their peers' and to published guidelines, (2) a program of academic detailing with the goal to educate providers about prostate cancer imaging, and (3) a CPRS Clinical Order Check for potentially guideline-discordant imaging orders. The intervention will be introduced to 10 participating geographically distributed study sites. DISCUSSION: This study is a significant contribution to implementation science, providing VHA an opportunity to ensure delivery of high-quality care at the lowest cost using a theory-based approach. The study is ongoing. Preliminary data collection and recruitment have started; analysis has yet to be performed. TRIAL REGISTRATION: CliniclTrials.gov NCT03445559. Prospectively registered on February 26, 2018.

Clinical Trial Protocol for a Randomized Trial of Community Health Worker-led Decision Coaching to Promote Shared Decision-making on Prostate Cancer Screening Among Black Male Patients and Their Providers.

We propose a randomized controlled trial to evaluate the effectiveness of a community health worker-led decision-coaching program to facilitate shared decision-making for prostate cancer screening decisions by Black men at a primary care federally qualified health center.