Real-World Data Quality Framework for Oncology Time to Treatment Discontinuation Use Case: Implementation and Evaluation Study.

BACKGROUND: The importance of real-world evidence is widely recognized in observational oncology studies. However, the lack of interoperable data quality standards in the fragmented health information technology landscape represents an important challenge. Therefore, adopting validated systematic methods for evaluating data quality is important for oncology outcomes research leveraging real-world data (RWD). OBJECTIVE: This study aims to implement real-world time to treatment discontinuation (rwTTD) for a systemic anticancer therapy (SACT) as a new use case for the Use Case Specific Relevance and Quality Assessment, a framework linking data quality and relevance in fit-for-purpose RWD assessment. METHODS: To define the rwTTD use case, we mapped the operational definition of rwTTD to RWD elements commonly available from oncology electronic health record-derived data sets. We identified 20 tasks to check the completeness and plausibility of data elements concerning SACT use, line of therapy (LOT), death date, and length of follow-up. Using descriptive statistics, we illustrated how to implement the Use Case Specific Relevance and Quality Assessment on 2 oncology databases (Data sets A and B) to estimate the rwTTD of an SACT drug (target SACT) for patients with advanced head and neck cancer diagnosed on or after January 1, 2015. RESULTS: A total of 1200 (24.96%) of 4808 patients in Data set A and 237 (5.92%) of 4003 patients in Data set B received the target SACT, suggesting better relevance of the former in estimating the rwTTD of the target SACT. The 2 data sets differed with regard to the terminology used for SACT drugs, LOT format, and target SACT LOT distribution over time. Data set B appeared to have less complete SACT records, longer lags in incorporating the latest data, and incomplete mortality data, suggesting a lack of fitness for estimating rwTTD. CONCLUSIONS: The fit-for-purpose data quality assessment demonstrated substantial variability in the quality of the 2 real-world data sets. The data quality specifications applied for rwTTD estimation can be expanded to support a broad spectrum of oncology use cases.

The Impact of Prolonged Operative Time Associated With Minimally Invasive Colorectal Surgery: A Report From the Surgical Care Outcomes Assessment Program.

BACKGROUND: Increased operative time in colorectal surgery is associated with worse surgical outcomes. Laparoscopic and robotic operations have improved outcomes, despite longer operative times. Furthermore, the definition of "prolonged" operative time has not been consistently defined. OBJECTIVE: The first objective was to define prolonged operative time across multiple colorectal operations and surgical approaches. The second was to describe the impact of prolonged operative time on length of stay and short-term outcomes. DESIGN: A retrospective cohort study. SETTING: Forty-two hospitals in the Surgical Care Outcomes Assessment Program from 2011 to 2019. PATIENTS: There were a total of 23,098 adult patients (age 18 years or older) undergoing 6 common, elective colorectal operations: right colectomy, left/sigmoid colectomy, total colectomy, low anterior resection, IPAA, or abdominoperineal resection. MAIN OUTCOME MEASURES: Prolonged operative time defined as the 75th quartile of operative times for each operation and approach. Outcomes were length of stay, discharge home, and complications. Adjusted models were used to account for factors that could impact operative time and outcomes across the strata of open and minimally invasive approaches. RESULTS: Prolonged operative time was associated with longer median length of stay (7 vs 5 days open, 5 vs 4 days laparoscopic, 4 vs 3 days robotic) and more frequent complications (42% vs 28% open, 24% vs 17% laparoscopic, 27% vs 13% robotic) but similar discharge home (86% vs 87% open, 94% vs 94% laparoscopic, 93% vs 96% robotic). After adjustment, each additional hour of operative time above the median for a given operation was associated with 1.08 (1.06-1.09) relative risk of longer length of stay for open operations and 1.07 (1.06-1.09) relative risk for minimally invasive operations. LIMITATIONS: Our study was limited by being retrospective, resulting in selection bias, possible confounders for prolonged operative time, and lack of statistical power for subgroup analyses. CONCLUSIONS: Operative time has consistent overlap across surgical approaches. Prolonged operative time is associated with longer length of stay and higher probability of complications, but this negative effect is diminished with minimally invasive approaches. See Video Abstract . EL IMPACTO DEL TIEMPO OPERATORIO PROLONGADO ASOCIADO CON LA CIRUGA COLORRECTAL MNIMAMENTE INVASIVA UN INFORME DEL PROGRAMA DE EVALUACIN DE RESULTADOS DE ATENCIN QUIRRGICA: ANTECEDENTES:El aumento del tiempo operatorio en la cirugía colorrectal se asocia con peores resultados quirúrgicos. Las operaciones laparoscópicas y robóticas han mejorado los resultados, a pesar de los tiempos operatorios más prolongados. Además, la definición de tiempo operatorio "prolongado" no se ha definido de manera consistente.OBJETIVO:Primero, definir el tiempo operatorio prolongado a través de múltiples operaciones colorrectales y enfoques quirúrgicos. En segundo lugar, describir el impacto del tiempo operatorio prolongado sobre la duración de la estancia y los resultados a corto plazo.DISEÑO:Estudio de cohorte retrospectivo.ESCENARIO:42 hospitales en el Programa de Evaluación de Resultados de Atención Quirúrgica de 2011-2019.PACIENTES:23 098 pacientes adultos (de 18 años de edad y mayores), que se sometieron a seis operaciones colorrectales electivas comunes: colectomía derecha, colectomía izquierda/sigmoidea, colectomía total, resección anterior baja, anastomosis ileoanal con bolsa o resección abdominoperineal.PRINCIPALES MEDIDAS DE RESULTADO:Tiempo operatorio prolongado definido como el cuartil 75 de tiempos operatorios para cada operación y abordaje. Los resultados fueron la duración de la estancia hospitalaria, el alta domiciliaria y las complicaciones. Se usaron modelos ajustados para tener en cuenta los factores que podrían afectar tanto el tiempo operatorio como los resultados en los estratos de abordajes abiertos y mínimamente invasivos.RESULTADOS:El tiempo operatorio prolongado se asoció con una estancia media más prolongada (7 vs. 5 días abiertos, 5 vs. 4 días laparoscópicos, 4 vs. 3 días robóticos), complicaciones más frecuentes (42 % vs. 28 % abiertos, 24 % vs. 17 % laparoscópica, 27% vs. 13% robótica), pero similar alta domiciliaria (86% vs. 87% abierta, 94% vs. 94% laparoscópica, 93% vs. 96% robótica). Después del ajuste, cada hora adicional de tiempo operatorio por encima de la mediana para una operación determinada se asoció con un riesgo relativo de 1,08 (1,06, 1,09) de estancia hospitalaria más larga para operaciones abiertas y un riesgo relativo de 1,07 (1,06, 1,09) para operaciones mínimamente invasivas.LIMITACIONES:Nuestro estudio estuvo limitado por ser retrospectivo, lo que resultó en un sesgo de selección, posibles factores de confusión por un tiempo operatorio prolongado y falta de poder estadístico para los análisis de subgrupos.CONCLUSIONES:El tiempo operatorio tiene una superposición constante entre los enfoques quirúrgicos. El tiempo operatorio prolongado se asocia con una estadía más prolongada y una mayor probabilidad de complicaciones, pero este efecto negativo disminuye con los enfoques mínimamente invasivos. ( Traducción-Dr. Mauricio Santamaria ).

Evaluation of a Natural Language Processing Model to Identify and Characterize Patients in the United States With High-Risk Non-Muscle-Invasive Bladder Cancer.

PURPOSE: Treatment of non-muscle-invasive bladder cancer (NMIBC) is guided by risk stratification using clinical and pathologic criteria. This study aimed to develop a natural language processing (NLP) model for identifying patients with high-risk NMIBC retrospectively from unstructured electronic medical records (EMRs) and to apply the model to describe patient and tumor characteristics. METHODS: We used three independent EMR-derived data sets including adult patients with a bladder cancer diagnosis in 2011-2020 for NLP model development and training (n = 140), validation (n = 697), and application for the retrospective cohort analysis (n = 4,402). Deep learning methods were used to train NLP recognition of medical chart terminology to identify seven high-risk NMIBC criteria; model performance was assessed using the F1 score, weighted across features. An algorithm was then used to classify each patient as high-risk NMIBC (yes/no). Manually reviewed records served as the gold standard. RESULTS: The F1 scores after model training were >0.7 for all but one uncommon feature (prostatic urethral involvement). The highest area under the receiver operating curves (AUC) was observed for Ta (0.897) and T1 (0.897); the lowest AUC was for carcinoma in situ (CIS; 0.617). For high-risk NMIBC classification, positive predictive value was 79.4%, negative predictive value was 93.2%, and false-positive rate was 8.9%. Sensitivity and specificity were 83.7% and 91.1%, respectively. Of 748 patients manually confirmed as having high-risk NMIBC, 196 (26%) had CIS (of whom 19% also had T1 and 23% also had Ta disease); 552 tumors (74%) had no associated CIS. CONCLUSION: The NLP model, combined with a rule-based algorithm, identified high-risk NMIBC with good performance and will enable future work to study real-world treatment patterns and clinical outcomes for high-risk NMIBC.

Minimally-invasive approach to emergent colorectal surgery in aging adults: A report from the Surgical Care Outcomes Assessment Program.

BACKGROUND: Despite known benefits of minimally invasive surgery(MIS) in elective settings, MIS use in emergency colorectal surgery(CRS) is limited. Older adults are more likely to require emergent CRS, and MIS is used less frequently with increasing age. METHODS: A retrospective cohort was constructed of emergent CRS cases performed between 2011 and 2019. Discharge(DC) disposition, adverse events, and length of stay(LOS) between MIS and open surgery were compared and stratified by age. Adjustment was made for selected confounders using inverse probability weighting. RESULTS: Of 6913 emergent CRS cases across 50 hospitals, 1616(23%) were approached MIS. MIS cases were more likely [OR(95%CI)] to DC home [<65yo:1.7(1.3,2.2); 65-74:1.5(1.1,1.9); 75+:1.2(0.9,1.5)] and have fewer adverse events [<65yo:0.6(0.5,0.8); 65-74:0.7(0.5,0.9); 75+:0.7(0.5,0.9)]. LOS was shorter [Mean difference in days(95%CI)] [<65yo: 2.2(-2.9,-1.4); 65-74: 0.9(-2.7,1.0); 75+: 0.7(-1.7,0.2)]. CONCLUSIONS: MIS in emergent CRS is associated with increased DC to home, fewer adverse events, and shorter LOS. Benefits persisted with age after adjustment, suggesting an opportunity for improved MIS delivery in older adults.

Associating sleep problems with advanced cancer diagnosis, and immune checkpoint treatment outcomes: a pilot study.

BACKGROUND: Sleep problems (SP) are common in cancer patients but have not been previously assessed in patients receiving immune checkpoint inhibitors (ICI). METHODS: We collected questionnaire data on sleep apnea risk, insomnia, and general sleep patterns. We used an adjusted multivariate Poisson regression to calculate prevalence ratios (PRs) and associated 95% confidence intervals (CIs) for associations between these SP and metastatic versus localized cancer stage (M1 vs. M0), and adjusted logistic regression models to calculate ORs for associations between SP with the number of ICI infusions completed (6 + vs. < 6). RESULTS: Among 32 patients who received ICI treatment, the prevalence of low, intermediate, and high-risk OSA risk was 36%, 42%, and 21%, respectively. Overall, 58% of participants reported clinically significant insomnia. We did not find a significant association between intermediate or high risk OSA (vs. low risk) and metastatic cancer status (PR = 1.01 (95% CI: 0.28, 3.67)). Patients in the cohort who reported taking > 15 min to fall asleep were 3.6 times more likely to be diagnosed with metastatic cancer compared to those reporting shorter sleep latency (95% CI (1.74, 7.35)). We did not find a significant association between SP and number of ICI infusions completed. CONCLUSION: Our data associating sleep apnea risk, insomnia, and sleep patterns with more advanced cancer encourages further exploration in larger-scale observational studies and suggests interventional clinical trials focused on sleep quality improvement that could result in better outcomes for these patients.

Sleep problems and risk of cancer incidence and mortality in an older cohort: The Cardiovascular Health Study (CHS).

BACKGROUND: Sleep problems (SP) can indicate underlying sleep disorders, such as obstructive sleep apnea, which may adversely impact cancer risk and mortality. METHODS: We assessed the association of baseline and longitudinal sleep apnea and insomnia symptoms with incident cancer (N = 3930) and cancer mortality (N = 4580) in the Cardiovascular Health Study. We used Cox proportional hazards regression to calculate adjusted hazard ratios (HR) and 95% confidence intervals (CI) to evaluate the associations. RESULTS: Overall, 885 incident cancers and 804 cancer deaths were identified over a median follow-up of 12 and 14 years, respectively. Compared to participants who reported no sleep apnea symptoms, the risk of incident cancer was inversely associated [(HR (95%CI)] with snoring [0.84 (0.71, 0.99)]. We noted an elevated prostate cancer incidence for apnea [2.34 (1.32, 4.15)] and snoring [1.69 (1.11, 2.57)]. We also noted an elevated HR for lymphatic or hematopoietic cancers [daytime sleepiness: 1.81 (1.06, 3.08)]. We found an inverse relationship for cancer mortality with respect to snoring [0.73 (0.62, 0.8)] and apnea [(0.69 (0.51, 0.94))]. We noted a significant inverse relationship between difficulty falling asleep and colorectal cancer death [0.32 (0.15, 0.69)] and snoring with lung cancer death [0.56 (0.35, 0.89)]. CONCLUSIONS: The relationship between SP and cancer risk and mortality was heterogeneous. Larger prospective studies addressing more cancer sites, molecular type-specific associations, and better longitudinal SP assessments are needed for improved delineation of SP-cancer risk dyad.

Colorectal Cancer Anatomical Site and Sleep Quality.

PURPOSE: Sleep quality in relation to anatomic site among colorectal cancer (CRC) patients is not well understood, though discerning the relationship could contribute to improved survivorship care. METHODS: We ascertained sleep quality (Pittsburgh Sleep Quality Index) and other personal characteristics within an ongoing population-based study of CRC patients identified through a cancer registry (N = 1453). Differences in sleep quality by CRC site were analyzed using chi-square and ANOVA tests. We used logistic regression to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for the association of tumor site with sleep quality concerns, adjusting for patient attributes and time since diagnosis. RESULTS: Sleeping problems were reported by 70% of CRC patients. Overall, participants with rectal (vs. colon) cancer were more likely (OR (95% CI)) to report general trouble sleeping (1.58 (1.19, 2.10)). Rectal cancer patients were also more likely than colon cancer patients to report changes in sleep patterns after cancer diagnosis (1.38 (1.05, 1.80)), and trouble sleeping specifically due to getting up to use the bathroom (1.53 (1.20, 1.96)) or pain (1.58 (1.15, 2.17)), but were less likely to report trouble sleeping specifically due to issues with breathing/coughing/snoring (0.51 (0.27, 0.99)). CONCLUSION: Overall, rectal cancer patients were more likely to have sleep complications compared to colon cancer patients. This suggests sleep-focused survivorship care may be adapted according to CRC site to ensure patients receive appropriate support.

The impact of a population-based prevention program on cardiovascular events: Findings from the heart of new Ulm project.

BACKGROUND: Cardiovascular disease (CVD) and its associated risk factors are the principal drivers of mortality and healthcare costs in the United States with rural residents experiencing higher CVD death rates than their urban counterparts. METHODS: The purpose of this study was to examine incidence of major CVD events over 9 years of implementation of the Heart of New Ulm (HONU) Project, a rural population-based CVD prevention initiative. HONU interventions were delivered at individual, organizational, and community levels addressing clinical risk factors, lifestyle behaviors and environmental changes. The sample included 4,056 residents of New Ulm matched with 4,056 residents from a different community served by the same health system. The primary outcome was a composite of major CVD events (myocardial infarction, ischemic stroke, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG), and CVD-related death). Secondary outcomes were the individual CVD events and procedures. RESULTS: The proportion of residents in New Ulm with a major CVD event (7.79%) was not significantly different than the comparison community (8.43%, P = .290). However, the total number of events did differ by community with fewer events in New Ulm than the comparison community (447 vs 530, P = .005), with 48 fewer strokes (84 vs 132, P = .001) and 42 fewer PCI procedures (147 vs 189, P = 0.019) in New Ulm. Incidence of ischemic stroke was lower in the New Ulm community (1.85 vs 2.61, P = .020) than in the comparison community. Other specific CVD events did not have significantly different incidence or frequencies between the 2 communities. CONCLUSION: In HONU, the proportion of residents experiencing a CVD event was not significantly lower than a match comparison community. However, there was a significant reduction in the total number of CVD events in New Ulm, driven primarily by lower stroke, PCI, and CABG events in the intervention community.

Predictive lifestyle markers for efficacy of cancer immune checkpoint inhibitors: a commentary.

Lifestyle factors could plausibly modulate the host immune system, the tumor microenvironment and, hence, immune checkpoint inhibitor (ICI) response. As such, these factors should be considered in ICI studies.

Five-year relative survival in sleep apnea patients with a subsequent cancer diagnosis.

STUDY OBJECTIVES: In vitro and animal studies suggest that intermittent hypoxia characterizing sleep apnea contributes to accelerated cancer progression. However, the impact of sleep apnea on survival subsequent to cancer diagnosis is unknown. METHODS: We identified a cohort of 1,575 adults diagnosed with sleep apnea between 2005 and 2014 with a subsequent cancer diagnosis via linkage of the University of Washington Medicine system and a population-based cancer registry serving the same Seattle-Puget Sound region. We computed age-standardized 5-year relative survival after cancer diagnosis for all cancers combined, and for specific cancer sites, for both the sleep apnea cohort and the general Seattle-Puget Sound population, and we used US life tables as the reference population. Relative survival was estimated by sex, cancer stage, and health care engagement. RESULTS: Five-year overall relative survival for cancer was more favorable in the sleep apnea cohort than in the general population [83.6%, 95% confidence interval (CI): 79.8%-86.8% vs 71.6%, 95% CI: 71.3%-71.9%]; this pattern was applicable to most specific cancer sites. However, 5-year relative survival was slightly less favorable in the sleep apnea cohort among patients with melanoma (97.7%, 95% CI: 84.6%-99.7% vs 99.2%, 95% CI: 98.8%-99.5%) and cancer of the corpus uteri (84.0%, 95% CI: 58.2%-94.5% vs 84.6%, 95% CI: 83.1%-86.0%). CONCLUSIONS: The fact that survival after cancer, overall and for most cancer sites, was more favorable in patients with sleep apnea warrants larger community-based studies to further tease out effects of sleep apnea and treatment on site-specific survival for different cancer types, particularly in patients with melanoma or uterine cancer.

Obstructive sleep apnea severity and subsequent risk for cancer incidence.

In vitro and animal models suggest that obstructive sleep apnea (OSA) increases cancer risk. However, the impact of OSA severity on cancer risk is poorly understood. We conducted a case-cohort study (a variant of the case-control study design), nested in a cohort of patients with a clinical diagnosis of OSA. OSA patients diagnosed between 2005 and 2013 were linked to a population-based cancer registry to identify cancers diagnosed subsequent to OSA between 2005 and 2015. Medical records were reviewed for a representative sample of 1162 OSA patients from this cohort (including 24 with subsequent cancer), and for an additional 304 OSA patients diagnosed with cancer; information regarding OSA severity indicators, including apnea-hypopnea index (AHI) was abstracted from these records. Adjusted Cox proportional hazards regression were used to calculate hazard ratios (HR) and 95% confidence intervals (CI) for associations of OSA severity indicators on cancer incidence. Compared with individuals in the lowest AHI category (5-14.9), indicating mild OSA, the adjusted HR (95% CI) for cancer incidence associated with having moderate (15-29.9) or severe (30+) OSA were 0.72 (0.40-1.29) and 0.87 (0.52-1.45) respectively. Associations with other severity indicators were not significantly associated with cancer. However, the proportion of patients with severe OSA (AHI ≥30) was consistently higher across numerous cancer sites relative to the subcohort, suggesting increased cancer risk relative to patients with less severe OSA. The absence of significant associations with OSA severity measures suggest that the underlying mechanisms deserve further investigation.

Population-level changes in lifestyle risk factors for cardiovascular disease in the Heart of New Ulm Project.

Lifestyle significantly influences development of cardiovascular disease (CVD), but limited data exists demonstrating lifestyle improvements in community-based interventions. This study aims to document how lifestyle risk factors changed at the population level in the context of Heart of New Ulm (HONU), a community-based CVD prevention initiative in Minnesota. HONU intervened across worksites, healthcare and the community/environment to reduce CVD risk factors. HONU collected behavioral measures including smoking, physical activity, fruit/vegetable consumption, alcohol use and stress at heart health screenings from 2009 to 2014. All screenings were documented in the electronic health record (EHR). Changes at the community level for the target population (age 40-79) were estimated using weights created from EHR data and modeled using generalized estimating equation models. Screening participants were similar to the larger patient population with regard to age, race, and marital status, but were slightly healthier in regards to BMI, LDL cholesterol, blood pressure, and less likely to smoke. Community-level improvements were significant for physical activity (62.8% to 70.5%, p < 0.001) and 5+ daily fruit/vegetable servings (16.9% to 28.1%, p < 0.001), with no significant change in smoking, stress, alcohol or BMI. By leveraging local EHR data and integrating it with patient-reported outcomes, improvements in nutrition and physical activity were identified in the HONU population, but limited changes were noted for smoking, alcohol consumption and stress. Systematically documenting behaviors in the EHR will help healthcare systems impact the health of the communities they serve, both at the individual and population level.

Impact of ENHANCED (diEtitiaNs Helping pAtieNts CarE for Diabetes) Telemedicine Randomized Controlled Trial on Diabetes Optimal Care Outcomes in Patients with Type 2 Diabetes.

BACKGROUND: Clinical care for type 2 diabetes has improved but remains suboptimal. Collaborative, team-based models that maximize skills of different disciplines may improve care for individuals with diabetes, but few have been tested using rigorous research designs. OBJECTIVE: To investigate the efficacy of a registered dietitian nutritionist-led telemedicine program compared with that of a control group in terms of diabetes optimal care goals. DESIGN: A randomized controlled trial in which participants were assigned to a control or intervention group. PARTICIPANTS/SETTING: One hundred eighteen adults with type 2 diabetes (mean age, 60 years; 45% female) participated in the study between April 2016 and December 2017. Participants were recruited from separate primary care clinics in two rural Minnesota communities. INTERVENTION: For those assigned to the intervention, registered dietitian nutritionists used a treatment protocol to initiate and titrate therapies for blood glucose, hypertension, and lipid levels in addition to providing medical nutrition therapy; telemedicine visits supplemented usual care. MAIN OUTCOME MEASURES: Primary outcomes included composite and individual diabetes optimal care goals: hemoglobin A1c, blood pressure, not using tobacco, and taking a statin and aspirin (as appropriate). Secondary measures included physical activity, breakfast, fruits and vegetables, whole grains, body mass index, low-density lipoprotein, and medication adherence. STATISTICAL ANALYSIS: Mixed-model regression was used to examine outcomes between baseline and 1-year follow-up. RESULTS: A modest but significantly greater improvement in the number of diabetes optimal care measures met at follow-up was found in the intervention group (3.7 vs 3.2 in the control group [P=0.017]). Among individual measures, the intervention group had significantly greater medication use, with 2.5 and 2.2 higher odds (compared with the control group) of taking a statin [95% CI, 1.0 to 6.24]) and aspirin [95% CI, 0.90 to 5.19] as appropriate, respectively. CONCLUSIONS: ENHANCED (diEtitiaNs Helping pAtieNts CarE for Diabetes) findings suggest that registered dietitian nutritionists following medication treatment protocols can effectively improve care for adults with type 2 diabetes and can serve an instrumental role as part of the health care team in providing evidence-based, patient-centered care.

Sleep apnea and subsequent cancer incidence.

PURPOSE: In vitro and animal models suggest that the physiological effects of sleep apnea could contribute to cancer risk, yet epidemiologic studies have been inconsistent. METHODS: We identified a cohort of adults diagnosed with sleep apnea between 2005 and 2014 using regional administrative databases. Linking this cohort to a population-based cancer registry, we identified first incident cancers diagnosed after sleep apnea diagnosis through 2015. We calculated age-sex standardized cancer incidence ratios (SIRs) to compare the observed number of cancers among those with sleep apnea with expected population estimates over a comparable period. RESULTS: Among 34,402 individuals with sleep apnea, 1,575 first incident cancers were diagnosed during follow-up (mean ± SD; 5.3 ± 2.0 years). Compared to the general population, cancer incidence (SIR 1.26, 95% CI 1.20-1.32) was elevated among sleep apnea patients. We observed significantly elevated incidence for kidney (SIR 2.24, 95% CI 1.82-2.72), melanoma (SIR 1.71, 95% CI 1.42-2.03), breast (SIR 1.43, 95% CI 1.76-2.00), and corpus uteri (SIR 2.80, 95% CI 2.24-2.47) while risk for lung (SIR 0.66, 95% CI 0.54-0.79) and colorectal cancer (SIR 0.71, 95% CI 0.56-0.89) was lower. CONCLUSION: These findings suggest an elevated cancer burden, particularly at certain sites, among individuals with diagnosed sleep apnea. Results should be interpreted with caution due to unmeasured confounders (e.g., BMI, diabetes).

Assessing the impact of the heart of New Ulm Project on cardiovascular disease risk factors: A population-based program to reduce cardiovascular disease.

The Heart of New Ulm Project (HONU), is a population-based project designed to reduce modifiable cardiovascular disease (CVD) risk factors in the rural community of New Ulm, MN. HONU interventions address multiple levels of the social-ecological model. The community is served by one health system, enabling the use of electronic health record (EHR) data for surveillance. The purpose of this study was to assess if trends in CVD risk factors and healthcare utilization differed between a cohort of New Ulm residents age 40-79 and matched controls selected from a similar community, using EHR data from baseline (2008-2009) through three follow up time periods (2010-2011, 2012-2013, 2014-2015). Matching, using covariate balance sparse technique, yielded a sample of 4077 New Ulm residents and 4077 controls. We used mixed effects longitudinal models to examine trends over time between the two groups. Blood pressure, total cholesterol, low-density lipoprotein-cholesterol, and triglycerides showed better management in New Ulm over time compared to the controls. The proportion of residents in New Ulm with controlled blood pressure increased by 6.2 percentage points compared to an increase of 2 points in controls (p < 0.0001). As the cohort aged, 10-year ASCVD risk scores increased less in New Ulm (5.1) than the comparison community (5.9). The intervention and control community did not differ with regard to inpatient stays, smoking, or glucose. Findings suggest efficacy for the HONU project interventions for some outcomes.

Changing the restaurant food environment to improve cardiovascular health in a rural community: implementation and evaluation of the Heart of New Ulm restaurant programme.

OBJECTIVE: The goals of the present study were to: (i) describe the implementation of a programme to improve the restaurant food environment in a rural community; and (ii) describe how practices changed in community restaurants. DESIGN: The intervention included a baseline assessment of all community restaurants (n 32) and a report on how they could increase the availability and promotion of healthful options. The assessment focused on sixteen healthy practices (HP) derived from the Nutrition Environment Measures Survey for Restaurants. Restaurants were invited to participate at gold, silver or bronze levels based on the number of HP attained. Participating restaurants received dietitian consultation, staff training and promotion of the restaurant. All community restaurants were reassessed 1·5 years after baseline. SETTING: The restaurant programme was part of the Heart of New Ulm Project, a community-based CVD prevention programme in a rural community. SUBJECTS: All community restaurants (n 32) were included in the study. RESULTS: Over one-third (38 %) of community restaurants participated in the programme. At baseline, 22 % achieved at least a bronze level. This increased to 38 % at follow-up with most of the improvement among participating restaurants that were independently owned. Across all restaurants in the community, the HP showing the most improvement included availability of non-fried vegetables (63-84 %), fruits (41-53 %), smaller portions and whole grains. CONCLUSIONS: Findings demonstrate successes and challenges of improving healthful food availability and promotion in a community-wide restaurant programme.

Reach and effectiveness of the HeartBeat Connections telemedicine pilot program.

Introduction Innovative care delivery programs that support primary care providers are needed to reduce the burden of cardiovascular disease (CVD). HeartBeat Connections (HBC) is a primary prevention telemedicine program utilizing registered dietitian nutritionists (RDNs) and registered nurses (RNs) to deliver health coaching and medication therapy protocols for dyslipidaemia and hypertension among patients at high risk for developing CVD. Methods This retrospective cohort study documents the reach and six-month effectiveness of the HBC program for improving CVD risk factors. The sample included 1028 high-risk individuals aged 40-79 (without CVD or diabetes) served between 2010 and 2013 (326 participants, 702 eligible non-participants). Mixed-model analyses of variance were used to compare changes in outcome measures between baseline and six-month follow-up for participants and non-participants. Outcomes were also examined for three groups: non-participants, participants with 1-4 encounters, and participants with > 5 encounters. Results Nearly one-third of all eligible patients participated. There were no significant differences over time between HBC participants and non-participants in blood pressure or body mass. A higher proportion of HBC participants quit using tobacco (7.0 vs. 3.2%, p = 0.004) and achieved the low-density lipoprotein (LDL) program goal of < 100 mg/dL (8.9 vs. -1.1%, p = 0.009). Also, more favourable improvements in total and LDL cholesterol were observed among HBC participants with higher program engagement ( p < 0.05). Discussion The HBC telemedicine program resulted in significant improvement in some, but not all, CVD risk factors over six months. HBC reached many high-CVD-risk patients in the target region, which may confer population-level health benefits if this program can be scaled and sustained. Innovative, collaborative care delivery models like HBC can serve as a platform to systematically target and proactively engage at-risk populations, perhaps reducing patients' CVD risk.

Lifestyle changes and prevention of metabolic syndrome in the Heart of New Ulm Project.

Prior research has shown that unhealthy lifestyles increase the risk for developing a number of chronic diseases, but there are few studies examining how lifestyle changes impact metabolic syndrome. This study analyzed the association between two-year changes in key lifestyle risk metrics and incident metabolic syndrome in adults. A retrospective cohort study was conducted using data from metabolic syndrome free adults in the Heart of New Ulm Project (New Ulm, MN). The outcome was incident metabolic syndrome observed two years after baseline in 2009. The primary predictor was change in optimal lifestyle score based on four behavioral risk factors, including smoking, alcohol use, fruit/vegetable consumption, and physical activity. In the analytical sample of 1059 adults, 12% developed metabolic syndrome by 2011. Multivariable regression models (adjusted for baseline lifestyle score, age, sex, education, cardiovascular disease, and diabetes) revealed that a two-year decrease in optimal lifestyle score was associated with significantly greater odds of incident metabolic syndrome (OR = 2.92; 95% CI: 1.69, 5.04; p < 0.001). This association was primarily driven by changes in obesity, fruit/vegetable consumption, and alcohol intake. As compared to improving poor lifestyle habits, maintaining a healthy lifestyle seemed to be most helpful in avoiding metabolic syndrome over the two-year study timeframe.

Clinical implications of the American College of Cardiology/American Heart Association guidelines for the treatment of blood cholesterol for a rural community: Data from the Heart of New Ulm Project.

BACKGROUND: The 2013 American College of Cardiology (ACC)/AHA cholesterol guidelines represented a significant paradigm shift in the approach to the treatment of cholesterol in the United States. OBJECTIVE: To assess prevalence of indications for statin therapy according to the ACC/AHA cholesterol guidelines in a rural community. METHODS: A cross-sectional analysis was performed using data from the Heart of New Ulm Project, a population-based intervention aimed at reducing modifiable Adult Treatment Panel (ATP) III guidelines for the treatment of cholesterol for cardiovascular disease (ASCVD) risk factors in New Ulm, MN. Indications for statin therapy according to the ACC/AHA guidelines were determined using electronic health record data for area residents aged 40 to 79 years with visits in 2012 to 2013. There were 7855 adults aged 40 to 79 years in the target population, of which 4350 (55.4%) had a clinic visit with a fasting lipid panel. RESULTS: In our study sample (mean age 59.6 [10.4] years, 53.0% female), 2606 (59.9%) met one of the 4 major indications for statin therapy (19.2% clinical ASCVD, 15.5% diabetes, 1.1% low-density lipoprotein cholesterol ≥ 190 mg/dL, and 24.0% ≥ 7.5% 10-year ASCVD risk). Of those with an indication, 63.3% were on a statin (10.9% on a high-intensity statin). Of the 1375 patients (31.6%) who were not statin eligible (10-year ASCVD risk <5%), 29.5% were on a statin. CONCLUSIONS: In a community sample of individuals using health care, 60% were statin eligible according to ACC/AHA guidelines and two-thirds of these patients were prescribed a statin. In addition, almost 30% of those ineligible were taking a statin, suggesting the guidelines may provide an opportunity to decrease statin use in those at low ASCVD risk.

Measures of Patient Activation and Social Support in a Peer-Led Support Network for Women With Cardiovascular Disease.

PURPOSE: Social support has been associated with beneficial effects on many disease states and overall health and well-being. However, there is limited research exploring the impact of peer-led support models among women living with coronary heart disease. This study describes the structure of peer-led support groups offered by WomenHeart (WH): The National Coalition for Women Living with Heart Disease, and assesses WH participants' quality of life and social, emotional, and physical health. METHODS: Participants were recruited from 50 WH groups. A 70-item online survey was administered, and the main analytic sample included 157 women. Multivariate logistic regression was used to examine the association between patient activation levels (lower activation levels: 1, 2 vs higher activation levels: 3, 4) and social support scores (range: lowest 8 to highest 34), adjusting for age. RESULTS: High levels of social support, patient activation, physical activity, and low levels of stress, anxiety, and depression were reported. Those who were at or above the median for the social support measures (indicating high levels of social support) had greater odds of high levels of patient activation (level 3 or 4) than individuals reporting low levels of social support (OR = 2.23; 95% CI, 1.04-4.76; P = .012). CONCLUSIONS: Women who regularly attended a support group by a trained peer leader were highly engaged in their health care and had low levels of stress, anxiety, and depression. These findings lend credibility to the value of the peer support model and could potentially be replicated in other disease states to enhance patient care.