RESUMO
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.
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Neoplasias Esofágicas , Cirurgia Torácica , Humanos , Estudos Retrospectivos , Esofagectomia , Estadiamento de NeoplasiasRESUMO
OBJECTIVE: To assess the incidence rate of invasive bacterial infections in preterm infants and compare invasive bacterial infection rates and pathogens between preterm and full-term infants at age 7-90 days. STUDY DESIGN: This is a retrospective cohort study of the incidence rate of invasive bacterial infections among all infants born at Kaiser Permanente Northern California (KPNC), with blood and cerebrospinal fluid cultures collected between 7 and 90 days of chronological age from outpatient clinics, from emergency departments, and in the first 24 hours of hospitalization presenting for care between January 1, 2005, and December 31, 2017. Incidence rates of invasive bacterial infection by chronological age and postmenstrual age (PMA) and pathogens were compared between preterm and full-term infants. RESULTS: Between January 1, 2005, and December 31, 2017, a total of 479â729 infants were born at KPNC, including 440â070 full-term infants and 39â659 preterm infants. There were 283 cases of bacteremia in 282 infants. The incidence rate of invasive bacterial infection was significantly higher for preterm infants compared with full-term infants. The highest incidence rates of invasive bacterial infection were in preterm infants at chronological age 7-28 days and/or 37-39 weeks PMA. There was a trend toward lower rates of invasive bacterial infection with increasing PMA in preterm infants aged 61-90 days. Preterm infants aged 29-60 days or at ≥40 weeks PMA and those aged 61-90 days or at ≥43 weeks PMA had a rate of invasive bacterial infection equivalent to the overall rate seen in full-term infants of the same chronological age group. The distribution of pathogens causing bacteremia and meningitis did not differ between preterm and full-term infants. CONCLUSION: PMA and chronological age together were more useful than either alone in informing the incidence rate of invasive bacterial infection in preterm infants during the first 90 days of life.
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Bacteriemia , Infecções Bacterianas , Lactente , Recém-Nascido , Humanos , Recém-Nascido Prematuro , Estudos Retrospectivos , Infecções Bacterianas/epidemiologia , Infecções Bacterianas/microbiologia , Bactérias , Bacteriemia/epidemiologia , Bacteriemia/microbiologia , HospitalizaçãoRESUMO
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.
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Carcinoma de Células Escamosas , Neoplasias Vulvares , Humanos , Feminino , Neoplasias Vulvares/cirurgia , Estudos Retrospectivos , Vulva/patologia , Radioterapia Adjuvante , Carcinoma de Células Escamosas/cirurgiaRESUMO
BACKGROUND: Intrauterine devices, including levonorgestrel-releasing and copper devices, are highly effective long-acting reversible contraceptives. The potential risks associated with intrauterine devices are low and include uterine perforation and device expulsion. OBJECTIVE: This study aimed to evaluate the risk of perforation and expulsion associated with levonorgestrel-releasing devices vs copper devices in clinical practice in the United States. STUDY DESIGN: The Association of Perforation and Expulsion of Intrauterine Device study was a retrospective cohort study of women aged ≤50 years with an intrauterine device insertion during 2001 to 2018 and information on intrauterine device type and patient and medical characteristics. Of note, 4 research sites with access to electronic health records contributed data for the study: 3 Kaiser Permanente-integrated healthcare systems (Northern California, Southern California, and Washington) and 1 healthcare system using data from a healthcare information exchange in Indiana (Regenstrief Institute). Perforation was classified as any extension of the device into or through the myometrium. Expulsion was classified as complete (not visible in the uterus or abdomen or patient reported) or partial (any portion in the cervix or malpositioned). We estimated the crude incidence rates and crude cumulative incidence by intrauterine device type. The risks of perforation and expulsion associated with levonorgestrel-releasing intrauterine devices vs copper intrauterine devices were estimated using Cox proportional-hazards regression with propensity score overlap weighting to adjust for confounders. RESULTS: Among 322,898 women included in this analysis, the incidence rates of perforation per 1000 person-years were 1.64 (95% confidence interval, 1.53-1.76) for levonorgestrel-releasing intrauterine devices and 1.27 (95% confidence interval, 1.08-1.48) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 0.22% (95% confidence interval, 0.20-0.24) and 0.63% (95% confidence interval, 0.57-0.68) for levonorgestrel-releasing intrauterine devices and 0.16% (95% confidence interval, 0.13-0.20) and 0.55% (95% confidence interval, 0.44-0.68) for copper intrauterine devices, respectively. The incidence rates of expulsion per 1000 person-years were 13.95 (95% confidence interval, 13.63-14.28) for levonorgestrel-releasing intrauterine devices and 14.08 (95% confidence interval, 13.44-14.75) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 2.30% (95% confidence interval, 2.24-2.36) and 4.52% (95% confidence interval, 4.40-4.65) for levonorgestrel-releasing intrauterine devices and 2.30% (95% confidence interval, 2.18-2.44) and 4.82 (95% confidence interval, 4.56-5.10) for copper intrauterine devices, respectively. Comparing levonorgestrel-releasing intrauterine devices with copper intrauterine devices, the adjusted hazard ratios were 1.49 (95% confidence intervals, 1.25-1.78) for perforation and 0.69 (95% confidence intervals, 0.65-0.73) for expulsion. CONCLUSION: After adjusting for potential confounders, levonorgestrel-releasing intrauterine devices were associated with an increased risk of uterine perforation and a decreased risk of expulsion relative to copper intrauterine devices. Given that the absolute numbers of these events are low in both groups, these differences may not be clinically meaningful.
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Anticoncepcionais Femininos , Dispositivos Intrauterinos de Cobre , Dispositivos Intrauterinos Medicados , Dispositivos Intrauterinos , Perfuração Uterina , Feminino , Humanos , Expulsão de Dispositivo Intrauterino , Dispositivos Intrauterinos de Cobre/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel , Estudos Retrospectivos , Perfuração Uterina/epidemiologia , Perfuração Uterina/etiologiaRESUMO
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.
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Dispositivos Intrauterinos Medicados , Dispositivos Intrauterinos , Menorragia , Perfuração Uterina , Adulto , Feminino , Humanos , Expulsão de Dispositivo Intrauterino/efeitos adversos , Dispositivos Intrauterinos/efeitos adversos , Dispositivos Intrauterinos Medicados/efeitos adversos , Levanogestrel/uso terapêutico , Menorragia/epidemiologia , Menorragia/etiologia , Estudos Retrospectivos , Perfuração Uterina/epidemiologia , Perfuração Uterina/etiologiaRESUMO
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.
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Aleitamento Materno , Dispositivos Intrauterinos/efeitos adversos , Período Pós-Parto , Perfuração Uterina/etiologia , Adulto , Protocolos Clínicos , Feminino , Seguimentos , Humanos , Expulsão de Dispositivo Intrauterino , Modelos Logísticos , Pessoa de Meia-Idade , Padrões de Prática Médica , Projetos de Pesquisa , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Estados Unidos/epidemiologia , Perfuração Uterina/epidemiologiaRESUMO
OBJECTIVE: To assess which risk factors are associated with community-associated Clostridioides difficile infection (CDI) in children. STUDY DESIGN: This case control study was a retrospective review of all children 1-17 years of age with stool specimens sent for C difficile testing from January 1, 2012, to December 31, 2016. Cases and controls were children who had C difficile testing performed in the community or first 48 hours of hospital admission and >12 weeks after hospital discharge, with no prior positive C difficile testing in last 8 weeks, without other identified causes of diarrhea, and with clinical symptoms. Cases had positive confirmatory testing for C difficile. Controls had negative testing for C difficile and were matched to cases 1:1 by age and year of specimen collection. RESULTS: The overall incidence rate of community-acquired CDI in this cohort was 13.7 per 100 000 children per year. There was a substantial increase in community-acquired CDI from 9.6 per 100 000 children per year in 2012 to a peak of 16.9 per 100 000 children per year in 2015 (Cochran-Armitage test for trend P = .002). The risk factors for community-acquired CDI included non-Hispanic ethnicity; amoxicillin-clavulanate, cephalosporin, and clindamycin use within the previous 12 weeks; a previous positive C difficile test within 6 months; and increased health care visits in the last year. CONCLUSIONS: As rates of community-acquired CDI are increasing, enhanced antibiotic stewardship and recognition of health care disparities may ease the burden of community-acquired CDI.
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Clostridiales , Infecções por Bactérias Gram-Positivas/epidemiologia , Adolescente , Estudos de Casos e Controles , Criança , Pré-Escolar , Infecções Comunitárias Adquiridas/epidemiologia , Feminino , Humanos , Lactente , Masculino , Estudos Retrospectivos , Fatores de RiscoRESUMO
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.
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Neoplasias da Mama/psicologia , Depressão/psicologia , Menopausa/psicologia , Neoplasias Ovarianas/psicologia , Comportamento Sexual/psicologia , Adulto , Neoplasias da Mama/genética , Feminino , Genes BRCA1 , Genes BRCA2 , Humanos , Pessoa de Meia-Idade , Neoplasias Ovarianas/genética , Ovariectomia/psicologia , Qualidade de Vida/psicologia , Comportamento de Redução do Risco , Salpingectomia/psicologia , Inquéritos e QuestionáriosRESUMO
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.
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Neoplasias de Cabeça e Pescoço/mortalidade , Neoplasias de Cabeça e Pescoço/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , California/epidemiologia , Quimiorradioterapia , Comorbidade , Feminino , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
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 (pâ¯=â¯0.30), 23.2% versus 28.3% had elevated fasting blood glucose (pâ¯=â¯0.39), 21.3% versus 34.0% reported hypertension (pâ¯=â¯0.04) with median systolic blood pressure of 118â¯mmHg versus 125.5â¯mmHg (pâ¯<â¯0.009), 25% versus 32% reported hyperlipidemia (pâ¯=â¯0.40), and 42% versus 49% had any abnormal lipid test (pâ¯=â¯0.28). An elevated 10-year ASCVD risk of over 10% was seen in 6.1% versus 24.8% respectively (pâ¯=â¯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.
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Doenças Cardiovasculares/genética , Genes BRCA1/fisiologia , Genes BRCA2/fisiologia , Predisposição Genética para Doença/genética , Doenças Cardiovasculares/patologia , Feminino , Humanos , Pessoa de Meia-Idade , MutaçãoRESUMO
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.
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Genes BRCA1 , Genes BRCA2 , Síndrome Hereditária de Câncer de Mama e Ovário/cirurgia , Osteoporose/epidemiologia , Ovariectomia/estatística & dados numéricos , Procedimentos Cirúrgicos Profiláticos/estatística & dados numéricos , Moduladores Seletivos de Receptor Estrogênico/uso terapêutico , Absorciometria de Fóton , Fatores Etários , Idoso , Índice de Massa Corporal , Doenças Ósseas Metabólicas/epidemiologia , Feminino , Síndrome Hereditária de Câncer de Mama e Ovário/epidemiologia , Síndrome Hereditária de Câncer de Mama e Ovário/genética , Humanos , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Prevalência , Fatores de Proteção , Comportamento de Redução do Risco , Salpingectomia/estatística & dados numéricos , População BrancaRESUMO
PURPOSE: Real-world data (RWD) holds promise for ascribing a real-world (rw) outcome to a drug intervention; however, ascertaining rw-response to treatment from RWD can be challenging. Friends of Cancer Research formed a collaboration to assess available data attributes related to rw-response across RWD sources to inform methods for capturing, defining, and evaluating rw-response. MATERIALS AND METHODS: This retrospective noninterventional (observational) study included seven electronic health record data companies (data providers) providing summary-level deidentified data from 200 patients diagnosed with metastatic non-small cell lung cancer (mNSCLC) and treated with first-line platinum doublet chemotherapy following a common protocol. Data providers reviewed the availability and frequency of data components to assess rw-response (ie, images, radiology imaging reports, and clinician response assessments). A common protocol was used to assess and report rw-response end points, including rw-response rate (rwRR), rw-duration of response (rwDOR), and the association of rw-response with rw-overall survival (rwOS), rw-time to treatment discontinuation (rwTTD), and rw-time to next treatment (rwTTNT). RESULTS: The availability and timing of clinician assessments was relatively consistent across data sets in contrast to images and image reports. Real-world response was analyzed using clinician response assessments (median proportion of patients evaluable, 77.5%), which had the highest consistency in the timing of assessments. Relative consistency was observed across data sets for rwRR (median 46.5%), as well as the median and directionality of rwOS, rwTTD, and rwTTNT. There was variability in rwDOR across data sets. CONCLUSION: This collaborative effort demonstrated the feasibility of aligning disparate data sources to evaluate rw-response end points using clinician-documented responses in patients with mNSCLC. Heterogeneity exists in the availability of data components to assess response and related rw-end points, and further work is needed to inform drug effectiveness evaluation within RWD sources.
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Carcinoma Pulmonar de Células não Pequenas , Registros Eletrônicos de Saúde , Estudos de Viabilidade , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/patologia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/patologia , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Estudos Retrospectivos , Resultado do Tratamento , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Adulto , Metástase Neoplásica , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: Nontyphoidal Salmonella (NTS) infections are the most common culture-confirmed foodborne illness in the United States. Although extremes of age and chronic or immunosuppressing conditions are known risk factors for NTS bloodstream infection (BSI), further predictors of BSI and BSI with focal infection in children remain poorly understood. METHODS: This was a retrospective review of NTS-positive blood cultures collected from 1999 to 2018 and stool studies collected from 2009 to 2018 in children. Incidence rates and risk factors for NTS BSI with and without focal infection were determined. RESULTS: Incidence rates of NTS BSI have not decreased over the last 20 years. There were 211 cases of NTS BSI with an incidence rate of 1.4 per 100 000 children per year. Twenty-one (10%) had underlying comorbidities. S. heidelberg was the most common serotype occurring in 45 (21%) cases. Compared with children with uncomplicated NTS BSI, children with NTS BSI with focal infection were more likely to have an underlying comorbidity, less diarrhea, and higher absolute neutrophil count. On multivariable analysis, the only difference in having NTS BSI in children with NTS gastroenteritis who had blood cultures obtained was a longer duration of fever (4.4 vs 2.5 days), less bloody diarrhea, and S. heidelberg isolated from stool. Laboratory studies, group of NTS, and other symptoms were not significant. CONCLUSIONS: Clinicians should remain vigilant for NTS BSI in children with prolonged fevers. S. heidelberg is the most common cause of NTS BSI in children and a predictor of BSI in children with NTS gastroenteritis.
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Bacteriemia , Infecção Focal , Gastroenterite , Infecções por Salmonella , Sepse , Criança , Humanos , Salmonella , Infecções por Salmonella/epidemiologia , Infecções por Salmonella/diagnóstico , Diarreia/epidemiologia , Bacteriemia/epidemiologia , Febre , Gastroenterite/epidemiologiaRESUMO
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.
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Abandono do Hábito de Fumar , Humanos , Registros Eletrônicos de Saúde , Estudos Retrospectivos , Dispositivos para o Abandono do Uso de Tabaco , HospitalizaçãoRESUMO
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.
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Prestação Integrada de Cuidados de Saúde , Neoplasias Pulmonares , Adulto , Humanos , Feminino , Masculino , Incidência , Neoplasias Pulmonares/epidemiologia , Fumar/epidemiologia , EtnicidadeRESUMO
BACKGROUND: Previous studies that evaluated low gestational weight gain or weight loss among prepregnancy obesity classes have not determined the amount of gestational weight gain associated with the lowest risk of adverse perinatal outcomes and neonatal morbidity among singleton term births. OBJECTIVE: This study aimed to evaluate the relationship of specific gestational weight gain categories of weight loss, stable weight, and low gain considered below the 2009 Institute of Medicine guidelines to perinatal outcomes and neonatal morbidity for singleton, term live births among prepregnancy obesity classes. STUDY DESIGN: This was a retrospective cohort study of 18,476 women among 3 classes of prepregnancy obesity, based on measured prepregnancy weight, and delivering a live singleton pregnancy at ≥37 weeks of gestation at a Kaiser Permanente Northern California hospital (2009-2012). Variables from electronic medical records included perinatal outcomes, sociodemographics, and measured prepregnancy and delivery weights to calculate total gestational weight gain, used to define 5 gestational weight gain categories: weight loss (<-2.0 kg), stable weight (-2.0 to +1.9 kg), low gain (+2.0 to 4.9 kg), gain within guidelines (+5.0 to 9.1 kg; referent), and gain above guidelines (>9.1 kg). Logistic regression models estimated adjusted odds ratios and 95% confidence intervals of maternal and newborn perinatal outcomes (hypertensive disorders, cesarean delivery, size for gestational age, length of stay, neonatal intensive care unit admission) associated with gestational weight gain categories stratified by prepregnancy obesity classes 1, 2, and 3. RESULTS: Low gain occurred in 8%, 12%, and 13% of women in obesity class 1 (body mass index, 30.0-34.9), class 2 (body mass index, 35.0-39.9), and class 3 (body mass index, ≥40), respectively. Compared with gestational weight gain within Institute of Medicine guidelines, low gain was associated with similar or improved maternal and newborn perinatal outcomes for all obesity classes without increased odds of neonatal intensive care unit admission, neonatal length of stay ≥3 days, or small for gestational age. The percentages of small for gestational age for the low gain category were 4.4%, 3.0%, and 4.3% among prepregnancy obesity classes 1, 2, and 3, respectively, and comparable with the gestational weight gain within the guideline category (P>.05). The adjusted odds ratios of small-for-gestational age were not statistically significant for all obesity classes; class 1 (1.16; 95% confidence interval, 0.79-1.71) , class 2 (1.05; 95% confidence interval 0.58-1.93), and class 3 (2.03; 95% confidence interval 0.97-4.27). CONCLUSION: Lower gestational weight gain of +2.0 to 4.9 kg showed the most favorable perinatal outcomes, without higher small for gestational age or neonatal morbidity for all obesity classes.
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[This corrects the article DOI: 10.1016/j.xagr.2023.100246.].
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Introduction There is considerable variation in the approach to infants presenting to the emergency department (ED) with fever. The authors' primary aim was to develop a robust set of algorithms using community ED data to inform modifications of broader clinical guidance. Methods The authors report the development of California Febrile Infant Risk Stratification Tool (CA FIRST) using key components of the Roseville Protocol (ROS) and American Academy of Pediatrics (AAP) Clinical Practice Guideline (CPG). Expanded guidance was derived using a retrospective analysis of a cohort of 3527 febrile infants aged 7-90 days presenting to any Kaiser Permanente Northern California ED between 2010 and 2019 who underwent a core febrile infant evaluation. Results Melding ROS and AAP CPG algorithms in infants 7-60 days old, CA FIRST Algorithms had comparable performance characteristics to ROS and AAP CPG. CA FIRST enhancements included guidance on febrile infants 61-90 days old, high-risk infants, infants with bronchiolitis, and infants who received immunizations within the prior 48 hours. This retrospective analysis revealed that of 235 febrile infants 22-90 days old with respiratory syncytial virus and 221 who had fever in the 48 hours following vaccination, there were no cases of invasive bacterial infection. Discussion CA FIRST is a set of 13 algorithms providing a thoughtful and flexible approach to the febrile infant while minimizing unnecessary interventions. Conclusions CA FIRST Algorithms empower clinicians to manage most febrile infants. Algorithms are being modified as new data become available, imparting useful and ever-current educational information within a learning health care system.
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Sistema de Aprendizagem em Saúde , Lactente , Humanos , Criança , Estudos Retrospectivos , Espécies Reativas de Oxigênio , Febre/microbiologia , California , Medição de Risco , AlgoritmosAssuntos
Fototerapia/instrumentação , Fototerapia/métodos , Psoríase/terapia , Autocuidado/métodos , Adolescente , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-IdadeRESUMO
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.