Clinical impacts of an integrated electronic health record-based smoking cessation intervention during hospitalisation.

OBJECTIVE: To assess the effects of an electronic health record (EHR) intervention that prompts the clinician to prescribe nicotine replacement therapy (NRT) at hospital admission and discharge in a large integrated health system. DESIGN: Retrospective cohort study using interrupted time series (ITS) analysis leveraging EHR data generated before and after implementation of the 2015 EHR-based intervention. SETTING: Kaiser Permanente Northern California, a large integrated health system with 4.2 million members. PARTICIPANTS: Current smokers aged ≥18 hospitalised for any reason. EXPOSURE: EHR-based clinical decision supports that prompted the clinician to order NRT on hospital admission (implemented February 2015) and discharge (implemented September 2015). MAIN OUTCOMES AND MEASURES: Primary outcomes included the monthly percentage of admitted smokers with NRT orders during admission and at discharge. A secondary outcome assessed patient quit rates within 30 days of hospital discharge as reported during discharge follow-up outpatient visits. RESULTS: The percentage of admissions with NRT orders increased from 29.9% in the year preceding the intervention to 78.1% in the year following (41.8% change, 95% CI 38.6% to 44.9%) after implementation of the admission hard-stop intervention compared with the baseline trend (ITS estimate). The percentage of discharges with NRT orders increased acutely at the time of both interventions (admission intervention ITS estimate 15.5%, 95% CI 11% to 20%; discharge intervention ITS estimate 13.4%, 95% CI 9.1% to 17.7%). Following the implementation of the discharge intervention, there was a small increase in patient-reported quit rates (ITS estimate 5.0%, 95% CI 2.2% to 7.8%). CONCLUSIONS: An EHR-based clinical decision-making support embedded into admission and discharge documentation was associated with an increase in NRT prescriptions and improvement in quit rates. Similar systemic EHR interventions can help improve smoking cessation efforts after hospitalisation.

Vulvar cancer survival by primary treatment modality: A retrospective cohort study.

OBJECTIVE: To compare survival and complications for women with vulvar cancer treated with primary radiation vs surgery. METHODS: Retrospective cohort study of Kaiser Permanente members diagnosed with vulvar squamous cell carcinoma (SCC) between 2008 and 2018 and treated with primary surgery (PS only), surgery with adjuvant radiation (PS + RT), or primary radiation (PRT). Primary outcomes were 1- and 3-year overall (OS) and progression-free (PFS) survival. Multivariable regression adjusted for age, stage, comorbidities, and smoking. RESULTS: We included 201 women: 114 PS only (56.7%), 36 PS + RT (17.9%), and 51 PRT (25.4%). PS only patients had less advanced disease. Crude 1- and 3-year OS were 96.5% and 82.6% for PS only compared to 72.2% and 48.3% for PS + RT and 72.6% and 53.9% for PRT (p < 0.001). There were no statistical differences in hazard of death when controlling for stage and other covariates (PRT vs PS only: aHR 1.35, 95% CI 0.61-2.99; PS + RT vs PS only: aHR 1.28, 95% CI 0.60-2.75; PS + RT vs PRT: aHR 0.95, CI 0.48-1.90). Older age and stage III disease were poor prognostic factors. Risk of lymphedema was elevated with PS + RT (36.1% vs 20.2% for PS only and 9.8% for PRT, p = 0.011). Wound infection was more likely in surgical groups, whereas hospital readmission and blood transfusion were more common with PRT. CONCLUSIONS: Vulvar cancer survival was not statistically different among women treated with primary radiation compared to primary surgery when controlling for stage. Surgery followed by adjuvant radiation demonstrated elevated rates of lymphedema. Primary radiation therapy may be an acceptable alternative to primary surgery in women who are likely to need adjuvant therapy.

Trends in Smoking-Specific Lung Cancer Incidence Rates Within a US Integrated Health System, 2007-2018.

BACKGROUND: At least 10% of lung cancers arise in adults who have never used tobacco. Data remain inconclusive on whether lung cancer incidence has been increasing among adults who have never used tobacco. RESEARCH QUESTION: How have age-adjusted incidence rates of lung cancer changed temporally, especially among adults who have never used tobacco? STUDY DESIGN AND METHODS: Trends in lung cancer incidence were examined using linked electronic health record and cancer registry data on a dynamic cohort of adults ≥ 30 years of age at risk of incident lung cancer between January 1, 2007, and December 31, 2018, from an integrated health-care system in northern California. Truncated age-adjusted lung cancer incidence rates and average annual percentage change (AAPC) in rates were estimated, overall and separately for adults who have ever and never used tobacco by age, sex, and race or ethnicity. RESULTS: The cohort included 3,751,348 adults (52.5% female, 48.0% non-Hispanic White, 63.1% have never used tobacco), among whom 18,627 (52.7% female, 68.6% non-Hispanic White, 15.4% have never used tobacco) received a diagnosis of lung cancer. The overall lung cancer incidence rate declined from 91.1 to 63.7 per 100,000 person-years between 2007 and 2009 and between 2016 and 2018 (AAPC, -3.9%; 95% CI, -4.2% to -3.6%). Among adults who have ever used tobacco, incidence rates declined overall from 167.0 to 113.4 per 100,000 person-years (AAPC, -4.2%; 95% CI, -4.4% to -3.9%) and, to varying degrees, within all age, sex, and racial or ethnic groups. Among adults who have never used tobacco, incidence rates were relatively constant, with 3-year-period estimates ranging from 19.9 to 22.6 per 100,000 person-years (AAPC, 0.9%; 95% CI, -0.3% to 2.1%). Incidence rates for adults who have never used tobacco seemed stable over time, within age, sex, and racial or ethnic groups, except for those of Asian and Pacific Islander (API) origin (AAPC, 2.0%; 95% CI, 0.1%-3.9%), whose rates were about twice as high compared with their counterparts. INTERPRETATION: These observed trends underscore the need to elucidate further the cause of lung cancer in adults who have never used tobacco, including why incidence is higher and rising in API adults who have never used tobacco.

Effect of Thoracic Surgery Regionalization on 1- and 3-Year Survival after Cancer Esophagectomy.

OBJECTIVE: The aim of this study was to investigate whether our previously reported improvements in short-term cancer esophagectomy outcomes after large-scale regionalization in the United States translated to longer-term survival benefit. BACKGROUND: Regionalization is associated with better early postoperative outcomes following cancer esophagectomy; however, data regarding its effect on long-term survival are mixed. METHODS: We retrospectively reviewed 461 patients undergoing cancer esophagectomy before (2009-2013, N = 272) and after (2014-2016, N = 189) regionalization. Kaplan-Meier curves and chi-square tests were used to describe 1- and 3-year survival in each era. Hierarchical logistic regression models examined the adjusted effect of regionalization on mortality. RESULTS: Compared to pre-regionalization patients, post-regionalization patients had significantly higher 1-year survival (83.1% vs 73.9%, P = 0.02) but not 3-year survival (52.9% vs 58.2%, P = 0.26).Subgroup analysis by cancer stage revealed that 1-year survival benefit was only significant among mid-stage (IIB-IIIB) patients, whereas differences in 3-year survival only approached significance among early-stage (IA-IIA) patients.In multivariable analysis, only regionalization was a predictor of lower mortality at 1 year [odds ratio (OR) 0.54, 95% confidence interval (CI) 0.29-1.00], and only thoracic specialty at 3years (OR 0.62, 95% CI 0.38-0.99). Older age, more advanced stage, and complications were associated with higher 1- and 3-year mortality. Comorbidity, minimally invasive approach, surgeon volume, facility volume, and neoadjuvant treatment were not significant in this model. CONCLUSIONS: Regionalization was associated with improved 1-year survival after cancer esophagectomy, independent of factors such as morbidity or volume in our adjusted models. This survival benefit did not persist at 3 years, likely due to the aggressive nature of the disease.

Sociodemographic and clinical characteristics associated with never-smoking status in patients with lung cancer: findings from a large integrated health system.

Background: Evidence is limited characterizing sociodemographically diverse patient populations with lung cancer in relation to smoking status. Methods: In a cross-sectional analysis of adults diagnosed with lung cancer at ages ≥30 years from 2007-2018 within an integrated healthcare system, overall and sex-specific prevalence of never smoking were estimated according to sociodemographic and clinical characteristics. Adjusted prevalence ratio (aPR) and 95% confidence interval (CI) were also estimated using modified Poisson regression to identify patient characteristics associated with never smoking, overall and by sex. Similar analyses were conducted to explore whether prevalence and association patterns differed between non-Hispanic White and Asian/Pacific Islander patients. Results: Among 17,939 patients with lung cancer, 2,780 (15.5%) never smoked and 8,698 (48.5%) had adenocarcinoma. Overall prevalence of never smoking was higher among females than males (21.2% vs. 9.2%, aPR 2.13, 95% CI: 1.98-2.29); Asian/Pacific Islander (aPR 2.85, 95% CI: 2.65-3.07) and Hispanic (aPR 1.72, 95% CI: 1.51-1.95) than non-Hispanic White patients; patients who primarily spoke Spanish (aPR 1.60, 95% CI: 1.32-1.94), any Asian language (aPR 1.20, 95% CI: 1.10-1.30), or other languages (aPR 1.84, 95% CI: 1.27-2.65) than English; patients living in the least vs. most deprived neighborhoods (aPR 1.36, 95% CI: 1.24-1.50); and patients with adenocarcinoma (aPR 2.57, 95% CI: 2.18-3.03), other non-small cell lung cancer (NSCLC) (aPR 2.00, 95% CI: 1.63-2.45), or carcinoid (aPR 3.60, 95% CI: 2.96-4.37) than squamous cell carcinoma tumors. Patterns of never smoking associated with sociodemographic, but not clinical factors, differed by sex. The higher prevalence of never smoking associated with Asian/Pacific Islander race/ethnicity was more evident among females (aPR 3.30, 95% CI: 2.95-3.47) than males (aPR 2.25, 95% CI: 1.92-2.63), whereas the higher prevalence of never smoking associated with living in the least deprived neighborhoods was more evident among males (aPR 1.93, 95% CI: 1.56-2.38) than females (aPR 1.18, 95% CI: 1.06-1.31). Associations between primary language and never-smoking status were found only among females. Overall and sex-specific prevalence and association patterns differed between Asian/Pacific Islander and non-Hispanic white patients. Conclusions: Our findings suggest that patterns of never-smoking status associated with sociodemographic and clinical characteristics are different across sex and race/ethnicity among patients with lung cancer. Such data are critical to increasing awareness and expediting diagnosis of this disease.

Patient- and Procedure-Specific Variables Associated With Removal or Revision of Radial Head Arthroplasty.

Introduction The purpose of this retrospective review was to identify risk factors associated with removal or revision following radial head arthroplasty. Methods Patients undergoing primary radial head arthroplasty between 2009 and 2015 with a minimum follow-up of 1 year were identified. Descriptive and bivariate statistics were used to analyze the characteristics of patients requiring implant removal or revision and multivariable analysis was performed to calculate hazard ratios. Results There were 312 patients included in the final cohort with a median follow-up of 3.8 years. Thirty-five patients (11.2%) underwent prosthesis removal or revision. There was an increased percentage of implants removed or revised in patients under age 40, with surgery performed for chronic indications compared to acute trauma, and with the use of press-fit stems compared to polished. Discussion It appears younger patient age, chronic surgical indications, and certain aspects of prosthesis design may influence rates of removal or revision.

Comparison of coronary revascularization strategies in older adults presenting with acute coronary syndromes.

BACKGROUND: The optimal coronary revascularization strategy to maximize the patient-centered outcome of days alive and out of hospital (DAOH), in multimorbid older (≥65-years) adults after an acute coronary syndrome (ACS) is incompletely understood. METHODS: Using Kaiser Permanente Northern California Health Plan databases, we identified 3871 patients ≥65-years presenting with ACS between 1/1/2010-3/1/2018 who underwent coronary revascularization with either coronary artery bypass grafting (CABG, N = 1575) or multivessel percutaneous coronary intervention (PCI, N = 2296). Selection bias was accounted for through propensity score modeling techniques and inverse probability of treatment weighting. Cox proportional hazards models were fit to evaluate the association of revascularization type with outcomes. PRIMARY OUTCOMES: Absolute DAOH and the relative risk of achieving ≥90%DAOH during three time intervals. SECONDARY OUTCOMES: All-cause mortality, recurrent MI, stroke, rehospitalization, repeat revascularization, and dialysis initiation. RESULTS: CABG (compared to PCI) was associated with greater absolute number of DAOH, significant after the first year (mean difference at 1-year: +5.8 days, 95% confidence interval [CI], -1.6 to 13 days; 3-years: +56 days, 95%CI, +25 to +88 days; 5-years: + 131 days, 95%CI, +57 to +205 days). The relative risk of achieving ≥90% DAOH significantly favored CABG after the first year (1-year:1.02, 95%CI, 0.98-1.05; 3-years:1.06, 95%CI 1.002-1.11, 5-years:1.12, 95%CI, 1.03-1.22), and was related to lower incidences of all-cause mortality, repeat revascularization, rehospitalization, incident dialysis, and nonfatal MI with CABG. CONCLUSIONS: In older adults with multivessel or left main coronary artery disease who presented with ACS, CABG, after the first year, was associated with a greater absolute number of DAOH-a geriatric and patient-centered outcome, compared to PCI. CABG patients also had a higher probability of achieving ≥90%DAOH-with lower all-cause mortality, recurrent MI, repeat revascularization, new dialysis, and rehospitalization rates. Future randomized trials should study the impact of optimal revascularization strategies on the quality of life of older adults with multimorbidity.

Association between menorrhagia and risk of intrauterine device-related uterine perforation and device expulsion: results from the Association of Uterine Perforation and Expulsion of Intrauterine Device study.

BACKGROUND: Intrauterine devices are effective instruments for contraception, and 1 levonorgestrel-releasing device is also indicated for the treatment of heavy menstrual bleeding (menorrhagia). OBJECTIVE: To compare the incidence of intrauterine device expulsion and uterine perforation in women with and without a diagnosis of menorrhagia within the first 12 months before device insertion STUDY DESIGN: This was a retrospective cohort study conducted in 3 integrated healthcare systems (Kaiser Permanente Northern California, Southern California, and Washington) and a healthcare information exchange (Regenstrief Institute) in the United States using electronic health records. Nonpostpartum women aged ≤50 years with intrauterine device (eg, levonorgestrel or copper) insertions from 2001 to 2018 and without a delivery in the previous 12 months were studied in this analysis. Recent menorrhagia diagnosis (ie, recorded ≤12 months before insertion) was ascertained from the International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification codes. The study outcomes, viz, device expulsion and device-related uterine perforation (complete or partial), were ascertained from electronic medical records and validated in the data sources. The cumulative incidence and crude incidence rates with 95% confidence intervals were estimated. Cox proportional hazards models estimated the crude and adjusted hazard ratios using propensity score overlap weighting (13-16 variables) and 95% confidence intervals. RESULTS: Among 228,834 nonpostpartum women, the mean age was 33.1 years, 44.4% of them were White, and 31,600 (13.8%) had a recent menorrhagia diagnosis. Most women had a levonorgestrel-releasing device (96.4% of those with and 78.2% of those without a menorrhagia diagnosis). Women with a menorrhagia diagnosis were likely to be older, obese, and have dysmenorrhea or fibroids. Women with a menorrhagia diagnosis had a higher intrauterine device-expulsion rate (40.01 vs 10.92 per 1000 person-years) than those without, especially evident in the first few months after insertion. Women with a menorrhagia diagnosis had a higher cumulative incidence (95% confidence interval) of expulsion (7.00% [6.70-7.32] at 1 year and 12.03% [11.52-12.55] at 5 years) vs those without (1.77% [1.70-1.84] at 1 year and 3.69% [3.56-3.83] at 5 years). The risk of expulsion was increased for women with a menorrhagia diagnosis vs for those without (adjusted hazard ratio, 2.84 [95% confidence interval, 2.66-3.03]). The perforation rate was low overall (<1/1000 person-years) but higher in women with a diagnosis of menorrhagia vs in those without (0.98 vs 0.63 per 1000 person-years). The cumulative incidence (95% confidence interval) of uterine perforation was slightly higher for women with a menorrhagia diagnosis (0.09% [0.06-0.14] at 1 year and 0.39% [0.29-0.53] at 5 years) than those without it (0.07% [0.06-0.08] at 1 year and 0.28% [0.24-0.33] at 5 years). The risk of perforation was slightly increased in women with a menorrhagia diagnosis vs in those without (adjusted hazard ratio, 1.53; 95% confidence interval, 1.10-2.13). CONCLUSION: The risk of expulsion is significantly higher in women with a recent diagnosis of menorrhagia. Patient education and counseling regarding the potential expulsion risk is recommended at insertion. The absolute risk of perforation for women with a recent diagnosis of menorrhagia is very low. The increased expulsion and perforation rates observed are likely because of causal factors of menorrhagia.

Design of the Association of Uterine Perforation and Expulsion of Intrauterine Device study: a multisite retrospective cohort study.

BACKGROUND: Intrauterine devices are effective and safe, long-acting reversible contraceptives, but the risk of uterine perforation occurs with an estimated incidence of 1 to 2 per 1000 insertions. The European Active Surveillance Study for Intrauterine Devices, a European prospective observational study that enrolled 61,448 participants (2006-2012), found that women breastfeeding at the time of device insertion or with the device inserted at ≤36 weeks after delivery had a higher risk of uterine perforation. The Association of Uterine Perforation and Expulsion of Intrauterine Device (APEX-IUD) study was a Food and Drug Administration-mandated study designed to reflect current United States clinical practice. The aims of the APEX-IUD study were to evaluate the risk of intrauterine device-related uterine perforation and device expulsion among women who were breastfeeding or within 12 months after delivery at insertion. OBJECTIVE: We aimed to describe the APEX-IUD study design, methodology, and analytical plan and present population characteristics, size of risk factor groups, and duration of follow-up. STUDY DESIGN: APEX-IUD study was a retrospective cohort study conducted in 4 organizations with access to electronic health records: Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and Regenstrief Institute in Indiana. Variables were identified through structured data (eg, diagnostic, procedural, medication codes) and unstructured data (eg, clinical notes) via natural language processing. Outcomes include uterine perforation and device expulsion; potential risk factors were breastfeeding at insertion, postpartum timing of insertion, device type, and menorrhagia diagnosis in the year before insertion. Covariates include demographic characteristics, clinical characteristics, and procedure-related variables, such as difficult insertion. The first potential date of inclusion for eligible women varies by research site (from January 1, 2001 to January 1, 2010). Follow-up begins at insertion and ends at first occurrence of an outcome of interest, a censoring event (device removal or reinsertion, pregnancy, hysterectomy, sterilization, device expiration, death, disenrollment, last clinical encounter), or end of the study period (June 30, 2018). Comparisons of levels of exposure variables were made using Cox regression models with confounding adjusted by propensity score weighting using overlap weights. RESULTS: The study population includes 326,658 women with at least 1 device insertion during the study period (Kaiser Permanente Northern California, 161,442; Kaiser Permanente Southern California, 123,214; Kaiser Permanente Washington, 20,526; Regenstrief Institute, 21,476). The median duration of continuous enrollment was 90 (site medians 74-177) months. The mean age was 32 years, and the population was racially and ethnically diverse across the 4 sites. The mean body mass index was 28.5 kg/m2, and of the women included in the study, 10.0% had menorrhagia ≤12 months before insertion, 5.3% had uterine fibroids, and 10% were recent smokers; furthermore, among these women, 79.4% had levonorgestrel-releasing devices, and 19.5% had copper devices. Across sites, 97,824 women had an intrauterine device insertion at ≤52 weeks after delivery, of which 94,817 women (97%) had breastfeeding status at insertion determined; in addition, 228,834 women had intrauterine device insertion at >52 weeks after delivery or no evidence of a delivery in their health record. CONCLUSION: Combining retrospective data from multiple sites allowed for a large and diverse study population. Collaboration with clinicians in the study design and validation of outcomes ensured that the APEX-IUD study results reflect current United States clinical practice. Results from this study will provide valuable information based on real-world evidence about risk factors for intrauterine devices perforation and expulsion for clinicians.

Sexual function, menopausal symptoms, depression and cancer worry in women with BRCA mutations.

OBJECTIVES: Assess sexual function, menopausal symptoms, and depression in women with BRCA mutations associated with oophorectomy and menopause status. METHODS: Women age 40 and older with BRCA mutations completed a questionnaire with validated measures of sexual activity, menopausal symptoms, depression, and cancer worry. These measures were compared between those with intact ovaries and those who had undergone pre- or post-menopausal risk-reducing salpingo-oophorectomy (RRSO). RESULTS: Of the 244 women, 21 had intact ovaries and 223 had undergone RRSO. Women with intact ovaries had less menopausal symptoms (Menopausal Symptom Checklist (MSCL) score 14 versus 23, P = .01) but more cancer worry than women who had undergone RRSO (median Cancer Worry Scale (CWS) score 5 versus 4, P < .0001) with no significant difference in sexual activity or function. Compared with women with postmenopausal RRSO, women with premenopausal RRSO were more likely to be sexually active (56.3% versus 42.0%, P =.04) but had similar sexual functioning, including frequency, pleasure and discomfort. Women with premenopausal RRSO were also more likely to report menopausal symptoms (MSCL score 26 versus 19, P = .04) and depression (PHQ-8 score 4 versus 2, P < .001). Factors associated with sexual activity included younger age, lower BMI, living with a partner, and lower depression scores. Higher current depression score was associated with history of depression and more menopausal symptoms. CONCLUSIONS: Risk-reducing surgery decreases cancer risk and worry in women with BRCA mutations. Among women undergoing oophorectomy, factors such as age and history of depression were related to reduced sexual activity and increased depression, but menopausal status was not related.

Risk Factors for Recurrent Community-associated Clostridiodes Difficile Infection in Children.

BACKGROUND: Recurrence of community-associated (CA) Clostridiodes difficile infection (CDI) approaches 30%. Studies on risk factors and treatment of choice for pediatric CA-CDI are scarce with variable recommendations. METHODS: This was a retrospective cohort study of the electronic health records of children 1-17 years with stool specimens sent for C. difficile at Kaiser Permanente Northern California from January 01, 2012 to December 31, 2016. Children with (1) CA disease, (2) confirmatory C. difficile laboratory testing with no other identified causes of diarrhea and (3) clinical symptoms consistent with CDI were defined as cases. Recurrent CA-CDI was defined using the above-described case criteria and onset of diarrhea within 8 weeks of primary CA-CDI. RESULTS: Of the 7350 children with stool samples sent for C. difficile testing, 408 had primary CA-CDI. Forty-five (11%) experienced a recurrence. Using multivariable logistic regression, inflammatory bowel disease [odds ratio (OR) 7.5; 95% confidence interval (CI): 2.6-21.1] and cancer (OR 6.3; 95% CI: 1.6-24.1) diagnoses were risk factors for recurrent disease. Compared with children of Caucasian race, those with multi/other/unknown race had an OR of 3.03 (95% CI: 1.04-8.82) of recurrence. There was no statistically significant difference in the type or duration of therapy as a predictor for recurrent CA CDI. Six percent of children who received metronidazole were switched to vancomycin due to subjective metronidazole allergy or intolerance or metronidazole treatment failure. CONCLUSIONS: Recurrent CA-CDI in children in our population is less common than previously reported. This study supports first-line treatment with the standard, short course metronidazole in most cases of primary CA-CDI.

Regionalization of thoracic surgery improves short-term cancer esophagectomy outcomes.

BACKGROUND: Some studies have found that outcomes from cancer esophagectomy are better at higher-volume centers than at lower-volume centers. Reports on outcomes following systematic centralization have largely demonstrated subsequent improvements, but these originate in nationalized healthcare systems that are not very comparable to the heterogeneous private-payer systems that predominate in the United States. We examined how regionalization of thoracic surgery to Centers of Excellence (CoE) within our American integrated healthcare system changed overall care for our patients, and whether it changed outcomes. METHODS: We conducted a retrospective chart review of 461 consecutive patients undergoing cancer esophagectomy between 2009-2016, spanning the 2014 shift to regionalization. High-volume was defined as ≥5 esophagectomies per year. We compared characteristics of the surgeon, hospital, and operation pre- and post-regionalization using Chi-square or Fisher's exact test for categorical variables and Kruskal-Wallis test for age. We evaluated their associations with patient outcomes with hierarchical linear and logistic mixed models, which adjusted for clustering within surgeon and facility levels and relevant covariates. RESULTS: While there was no difference in their baseline demographics, patients undergoing esophagectomy post-regionalization were much more likely to have their surgery performed at a designated Center of Excellence (78.8% of cases versus 34.2%, P<0.001), at a high-volume hospital (92.1% from 75.7%, P<0.001), by a high-volume surgeon (78.8% from 58.8%, P<0.001), by a board-certified thoracic surgeon (82.5% from 64.0%, P<0.001), and by minimally-invasive, versus open, approach (60.8% from 22.1%, P<0.001). Post-regionalization patients were in higher American Society of Anesthesiologists classes (P=0.03) and trended toward higher-stage disease (P=0.14), indicative of the inclusion of higher-complexity patients. Despite that, regionalization was associated with improved short-term outcomes, most notably: average minimally-invasive esophagectomy (MIE) operative time decreased by 2 hours (-135.9 minutes, 95% CI: -172.2, -99.7 minutes); length of stay (LOS) decreased by 2.3 days (95% CI: -3.4, -1.2 days); and 30-day complication rate decreased significantly, from 50.7% to 30.2% (OR 0.45, 95% CI: 0.25, 0.79). Regionalization was the only variable significantly and independently associated with all three outcomes in our adjusted multivariable models. Mortality, both at 30 and 90 days, decreased modestly but was low pre-regionalization, and the difference did not reach significance. CONCLUSIONS: Regionalization of thoracic surgery in our hospital system resulted in esophagectomies being performed by more experienced surgeons at higher-volume centers, with a concomitant improvement in short-term outcomes. Patients undergoing esophagectomy, particularly MIE, post-regionalization benefited significantly from decreased LOS and perioperative complication rate. Our results suggest that, in a large integrated healthcare system, regionalization significantly improves overall outcomes for patients undergoing cancer esophagectomy.

Undertreatment of women with locoregionally advanced head and neck cancer.

BACKGROUND: It is difficult to predict whether a patient with head and neck cancer (HNC) is more likely to die of the cancer or another comorbidity. Competing event models can help to identify individual patients or groups of patients who may be undertreated or overtreated in clinical practice. METHODS: Patients with HNC (n = 884), aged 18 to 85 years and diagnosed from 2000 to 2015 with stage II to IVB disease according to the seventh edition of the American Joint Committee on Cancer system, were identified. With a generalized competing event (GCE) model that controlled for age, sex, tumor site, surgical treatment, and Charlson Comorbidity Index (CCI), the association between these factors and the relative hazard for cancer mortality was determined. Logistic regression models were used to estimate the odds of receiving platinum-based chemoradiotherapy or a less intensive therapy, with adjustments made for age, sex, tumor site, CCI, stage, smoking, and alcohol abuse history. RESULTS: Compared with men, women had an increased relative hazard ratio for death from HNC versus other causes, which was reported as an adjusted ω+ ratio comparing women with men (ω+ ratio, 1.95; 95% CI, 1.09-3.49), even though they were less likely to receive intensive chemoradiotherapy than men (adjusted odds ratio, 0.69; 95% CI, 0.48-0.99). CONCLUSIONS: These findings indicate that women in this cohort may be undertreated in clinical practice and potentially miss the opportunity for their HNC to be aggressively treated. This study supports the use of GCE models to identify patients who are potentially undertreated and may also help to guide future research in health disparities.

Progel Use is Not Associated with Decreased Incidence of Postoperative Air Leak after Nonanatomic Lung Surgery.

CONTEXT: Progel Pleural Air Leak Sealant (CR Bard, Warwick, RI) is a US Food and Drug Administration-approved hydrogel designed for application to surgical staple lines to prevent air leak after lung surgery. This product has demonstrated efficacy in reducing intraoperative air leaks compared with standard air leak closure methods. However, the impact on chest tube duration and length of hospital stay has not been reported. OBJECTIVE: To evaluate the effect on rates of postoperative air leak, chest tube duration, and hospital stay in surgical patients with and without use of Progel. DESIGN: Retrospective study of 176 patients aged 18 to 80 years who underwent video-assisted thoracoscopic wedge resections between 2014 and 2016. Eighty-four (48%) cases using Progel were included, as well as a representative sample of non-Progel cases (n = 92; 52%). MAIN OUTCOME MEASURE: Presence of postoperative lung air leak. RESULTS: No difference existed between the Progel and non-Progel groups in the rate of postoperative air leak (20/84, 23.81% Progel; 16/92, 17.39% non-Progel; p = 0.33). The length of time patients had a chest tube was similar (23.5 vs 23 hours, p = 0.721), as was percentage of patients with a less than 2-day hospitalization (77.17% non-Progel vs 82.14% Progel, p = 0.414). CONCLUSION: Our results suggest that Progel, used routinely in patients undergoing nonanatomic lung resection, does not have a significant impact on postoperative air leak, chest tube duration, or length of hospital stay. Further studies are warranted to evaluate the utility of Progel in reducing postoperative complications after thoracoscopic wedge resection in those treated for air leak or in the reduction of postoperative air leak in high-risk patients.

Risk of cardiovascular disease in women with BRCA1 and BRCA2 mutations.

OBJECTIVE: Estimate the prevalence of cardiovascular disease risk factors and endpoints in women with BRCA mutations. METHODS: Women, age 40 and older, with BRCA mutations identified in Kaiser Permanente Northern California completed a questionnaire and underwent a lipid and fasting glucose panel. Bivariable analysis of clinical and demographic factors was performed. The Atherosclerotic Cardiovascular Disease (ASCVD) calculator was used to predict 10-year risk of a cardiovascular event. RESULTS: Of the 233 women, 19 women had intact ovaries (median age 56.0) and 214 had undergone risk-reducing salpingo-oophorectomy (RRSO). Among the 108 women with RRSO under age 50 (median age 51.0), compared to the 106 women who had RRSO at or over age 50 (median age 63.5) 6.5% vs 10.4% reported diabetes (p = 0.30), 23.2% versus 28.3% had elevated fasting blood glucose (p = 0.39), 21.3% versus 34.0% reported hypertension (p = 0.04) with median systolic blood pressure of 118 mmHg versus 125.5 mmHg (p < 0.009), 25% versus 32% reported hyperlipidemia (p = 0.40), and 42% versus 49% had any abnormal lipid test (p = 0.28). An elevated 10-year ASCVD risk of over 10% was seen in 6.1% versus 24.8% respectively (p = 0.0001). CONCLUSION: Women who underwent RRSO at age of 50 and over, had higher ASCVD 10-year risk than women who underwent RRSO at younger ages most likely owing to older age at study entry. The ASCVD risks for women with BRCA mutation who had RRSO did not suggest increased risk associated with being a BRCA mutation carrier.

Bone loss in women with BRCA1 and BRCA2 mutations.

OBJECTIVE: Estimate the prevalence and identify risk factors for bone loss in women with BRCA mutations. METHODS: Women, age 40 and older, with BRCA mutations identified from the Breast Cancer Surveillance database at Kaiser Permanente Northern California were invited to participate and undergo a dual-energy x-ray absorptiometry scan to assess for bone loss (osteopenia or osteoporosis). Multivariable logistic regression analysis was performed to assess clinical factors associated with bone loss. RESULTS: Of the 238 women in the final cohort, 20 women had intact ovaries (median age 54.5years) and 218 had undergone risk reducing salpingo-oophorectomy (RRSO) (median age 57). The prevalence of bone loss was 55% in the no RRSO group and 72.5% in the RRSO group (P=0.10). In multivariable analysis, only higher body mass index (OR 0.6 per 5kg/m2, 95% CI: 0.4-0.7) and nonwhite race compared to white (OR 0.5, 95% CI: 0.2-0.9) were protective for bone loss while older age (OR 1.5 per 10years, 95% CI: 1.1-2.1) and selective estrogen receptor modulator use (3.1, 95% CI: 1.2-10.1) were associated with increased odds of bone loss. Among women with RRSO, bone loss was more frequent in women who had postmenopausal (n=106) compared to women who had premenopausal RRSO (n=112), (82.1% and 63.4% respectively, P=0.002). In multivariable analysis, only BMI was protective of bone loss (OR 0.5, 95%, CI: 0.4-0.7) but neither age nor menopausal status at RRSO were associated with bone loss. CONCLUSION: Bone loss is common in women with BRCA mutations who undergo RRSO.

Feasibility and Acceptability of Screening for Adverse Childhood Experiences in Prenatal Care.

INTRODUCTION: Adverse childhood experiences (ACEs) are common among pregnant women and contribute to increased risk for negative perinatal outcomes, yet few clinicians screen prenatal patients for ACEs. The purpose of this study was to evaluate the feasibility and acceptability of screening for ACEs in standard prenatal care. METHODS: We evaluated a 4-month pilot (March 2016-June 2016) to screen pregnant women (at ∼14-23 weeks of gestation) for ACEs and resiliency in two Kaiser Permanente Northern California medical centers (N = 480). We examined the acceptability of the screening to patients through telephone surveys (N = 210) and to clinicians through surveys and focus groups (N = 26). RESULTS: Most eligible patients (78%) were screened. Patients who received the screening were significantly more likely to be non-Hispanic White, Asian, or of "Other" or "Unknown" race/ethnicity than African American or Hispanic race/ethnicity (p = 0.02). Among those screened, 88% completed the questionnaires; 54% reported 0 ACEs, 28% reported 1-2 ACEs, and 18% reported ≥3 ACEs. Most patients were somewhat or very comfortable completing the questionnaires (91%) and discussing ACEs with their clinician (93%), and strongly or somewhat strongly agreed that clinicians should ask their prenatal patients about ACEs (85%). Clinicians reported significant pre- to postpilot increases in comfort discussing ACEs, providing education, and offering resources (ps < 0.01). Clinicians' willingness to screen for ACEs was contingent on adequate training, streamlined workflows, inclusion of resilience screening, and availability of mental health, parenting, and social work resources. CONCLUSION: ACEs screening as part of standard prenatal care is feasible and generally acceptable to patients. Women's health clinicians are willing to screen patients for ACEs when appropriately trained and adequate behavioral health referral resources are available.

Salpingectomy for Sterilization: Change in Practice in a Large Integrated Health Care System, 2011-2016.

OBJECTIVE: To evaluate the utilization rate of salpingectomy for cesarean deliveries and postpartum and interval tubal sterilization procedures. METHODS: This is a retrospective cohort study using the electronic medical record to identify women older than 18 years of age undergoing surgical sterilization from June 2011 to May 2016 in an integrated health care system. The primary objective is to describe the change in utilization rate of salpingectomy for tubal sterilization procedures over time and after a systemwide practice recommendation was issued in 2013. Rates of salpingectomy and tubal occlusion were calculated for each of the five 1-year intervals in the study. Secondary outcomes included blood loss, operating time, length of stay, readmission, and emergency department visits. RESULTS: A total of 10,741 tubal sterilization procedures were identified. There was an increase in salpingectomies from 0.4% (8/1,938; 95% CI 0.2-0.8) to 35.5% (902/2,538; 95% CI 33.7-37.4) of tubal sterilization procedures performed over the study period (test for trend, P<.001). Salpingectomy instead of tubal occlusion increased at cesarean delivery from 0.1% (1/1,141; 95% CI 0.0-0.5) to 9.2% (125/1,354; 95% CI 7.8-10.9) (test for trend, P<.001); postpartum from 0% (0/124; 95% CI 0.0-3.0) to 4.5% (9/201; 95% CI 2.4-8.3) (test for trend, P=.003); and as an interval (nonpartum) tubal sterilization procedure from 1% (7/673; 95% CI 0.5-2.1) to 78% (768/983; 95% CI 75.4-80.6) (test for trend, P<.001). Median operative minutes was increased from 52 (95% CI 51-52) to 61.5 (95% CI 57-64), from 33 (95% CI 32-34) to 50 (95% CI 35-64), and from 30 (95% CI 29-30) to 33 (95% CI 32-33), respectively, for salpingectomy compared with tubal occlusion at cesarean delivery and postpartum and interval sterilization. Median blood loss was similar for salpingectomy and tubal occlusion at cesarean delivery (660 mL; 95% CI 600-700 mL compared with 700 mL; 95% CI 680-700 mL) and interval sterilization (both 5 mL; 95% CI 5-5 mL) but was more for salpingectomy postpartum (250 mL; 95% CI 200-500 mL compared with 200 mL; 95% CI 200-200 mL). CONCLUSION: There was a significant increase in salpingectomy for sterilization from June 2011 to May 2016. In the final year of the study, salpingectomy accounted for 78% of interval laparoscopic tubal sterilization procedures and 9% of intrapartum and postpartum procedures.

The Effect of California's Breast Density Notification Legislation on Breast Cancer Screening.

PURPOSE: Half of US states mandate women be notified if they have dense breasts on their mammogram, yet guidelines and data on supplemental screening modalities are limited. Breast density (BD) refers to the extent that breast tissue appears radiographically dense on mammograms. High BD reduces the sensitivity of screening mammography and increases breast cancer risk. The aim of this study was to determine the potential impact of California's 2013 BD notification legislation on breast cancer screening patterns. METHODS: We conducted a cohort study of women aged 40 to 74 years who were members of a large Northern California integrated health plan (approximately 3.9 million members) in 2011-2015. We calculated pre- and post-legislation rates of screening mammography and magnetic resonance imaging (MRI). We also examined whether women with dense breasts (defined as BI-RADS density c or d) had higher MRI rates than women with nondense breasts (defined as BI-RADS density a or b). RESULTS: After adjustment for race/ethnicity, age, body mass index, medical facility, neighborhood median income, and cancer history, there was a relative 6.6% decrease (relative risk [RR] 0.934, confidence interval [CI] 0.92-0.95) in the rate of screening mammography, largely driven by a decrease among women <50 years. While infrequent, there was a relative 16% increase (RR 1.16, CI 1.07-1.25) in the rate of screening MRI, with the greatest increase among the youngest women. In the postlegislation period, women with extremely dense breasts (BI-RADS d) had 2.77 times (CI 1.93-3.95) the odds of a MRI within 9 months of a screening mammogram compared with women with nondense breasts (BI-RADS b). CONCLUSIONS: In this setting, MRI rates increased in the postlegislation period. In addition, women with higher BD were more likely to have supplementary MRI. The decrease in mammography rates seen primarily among younger women may have been due to changes in national screening guidelines.

Experience With Opportunistic Salpingectomy in a Large, Community-Based Health System in the United States.

OBJECTIVE: To evaluate the trend in uptake of salpingectomy at the time of hysterectomy and assess physicians' attitudes toward the practice. METHODS: This was a retrospective cohort study using the electronic medical record to identify women 18 years of age or older undergoing hysterectomy from June 2011 to May 2014 in a large integrated health care delivery system. The primary outcome was the change in rate of opportunistic salpingectomy over time and after a systemwide practice recommendation was issued in May 2013. Secondary outcomes included data on blood loss, operating time, and length of stay. RESULTS: Of the 12,143 hysterectomies performed over the 3-year study period, 7,498 were performed without oophorectomy. There was a statistically significant rise in rate of salpingectomy over time from 14.7% for June 2011 to May 2012 to 44.6% from June 2012 to May 2013 and to 72.7% from June 2013 to May 2014 (P<.001). Sixty-one percent of laparoscopic hysterectomies were performed with salpingectomy, whereas only 25% of abdominal and 17% of vaginal hysterectomies had salpingectomies. Median estimated blood loss was lower in the salpingectomy group, 100 compared with 150 mL (P<.01). There was a significantly shorter median operating time (147 compared with 154 minutes, P=.002) for laparoscopic hysterectomy with bilateral salpingectomy compared with laparoscopic hysterectomy alone. CONCLUSION: Rates of salpingectomy increased significantly over time, consistent with the high reported acceptance rate reported by health care providers and highlighting the importance of physician education to improve compliance with risk-reducing clinical strategies.