55 results on '"Kristin M. Sheffield"'
Search Results
2. Real-world treatment patterns and outcomes of abemaciclib for the treatment of HR+, HER2− metastatic breast cancer
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Yajun Emily Zhu, Yu-Jing Huang, Andrew D. Seidman, Claudia Morato Guimaraes, Gebra Cuyun Carter, Kristin M Sheffield, Anala Gossai, Erik Rasmussen, Shreya Balakrishna, Emily Nash Smyth, Sarah Rybowski, Aaron B Cohen, Raina Mathur, and Lee Bowman
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Oncology ,medicine.medical_specialty ,Receptor, ErbB-2 ,Aminopyridines ,Breast Neoplasms ,030204 cardiovascular system & hematology ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Breast cancer ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,030212 general & internal medicine ,Abemaciclib ,business.industry ,Retrospective cohort study ,General Medicine ,medicine.disease ,Metastatic breast cancer ,humanities ,body regions ,Receptors, Estrogen ,chemistry ,Baseline characteristics ,Benzimidazoles ,Female ,business - Abstract
This retrospective observational study described baseline characteristics, real-world treatment patterns, and outcomes among patients with metastatic breast cancer treated with abemaciclib in the United States.De-identified electronic health record-derived data were used to describe patients who began abemaciclib treatment on or after 30 June 2016 and ≥4 months before data cutoff (31 December 2018). Real-world response (rwR) and real-world progression assessments were abstracted from clinical documentation. Descriptive statistics were used to calculate the real-world best response. The Kaplan-Meier method estimated real-world time to first response (rwTTFR) and real-world progression-free survival (rwPFS).The median age of 118 female patients at abemaciclib initiation was 66.5 years (interquartile range, 57.0, 73.0). The breakdown of patients who received abemaciclib in first, second, third, or later lines was 28.8%, 21.2%, 20.3%, and 29.7%, respectively. Patients received abemaciclib as monotherapy (12.7%) or in combination with endocrine therapy: fulvestrant (59.3%); aromatase inhibitor (22.9%); aromatase inhibitor and fulvestrant (5.1%). There were 68 patients (57.6%) with ≥1 rwR assessment: 41.2% with a real-world complete response or real-world partial response. Median rwTTFR was 3.6 months (95% confidence interval, 3.5, 5.2). Twelve-month rwPFS probability was 61.7%.This study represents utilization and outcomes associated with abemaciclib approximately 1 year following FDA approval. Treatment patterns demonstrated heterogeneity and, as in clinical trials, patients appeared to benefit from abemaciclib treatment in the real world. More research investigating outcomes associated with abemaciclib treatment is needed, with larger samples and longer follow-up to enable closer evaluation by subgroup, regimen, and line of therapy.
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- 2021
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3. HSR21-051: Treatment Outcomes Among HR+/HER2- Advanced/Metastatic Breast Cancer Patients Receiving CDK 4 & 6 Inhibitors in a United States Clinical Practice Setting
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Paula D. Ryan, Yu-Jing Huang, Kristin M Sheffield, Gebra Cuyun Carter, Jonathan Rajkumar, Lavanya Sudharshan, Gregory L Price, Claudia Morato Guimaraes, Emily Nash Smyth, and Sarah Rybowski
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Oncology ,medicine.medical_specialty ,biology ,business.industry ,Treatment outcome ,medicine.disease ,Metastatic breast cancer ,Clinical Practice ,Cyclin-dependent kinase ,Internal medicine ,medicine ,biology.protein ,business - Published
- 2021
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4. Real-world survival outcomes of heavily pretreated patients with refractory HR+, HER2−metastatic breast cancer receiving single-agent chemotherapy—a comparison with MONARCH 1
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Xiaohong I Li, Maura N. Dickler, Hans Wildiers, Martin Frenzel, Yu-Jing Huang, Sara M. Tolaney, Debra A. Patt, Véronique Diéras, Esther Zamora, Joyce O'Shaughnessy, Kristin M Sheffield, Valerie Andre, Li Li, Gebra Cuyun Carter, Javier Cortes, Denise A. Yardley, Hope S. Rugo, Institut Català de la Salut, [Rugo HS] Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA. [Dieras V] Centre Eugene Marquis UNICANCER, Rennes Cedex, France. [Cortes J] 3 IOB Institute of Oncology, Quironsalud Group, Madrid, Spain. 4 IOB Institute of Oncology, Quironsalud Group, Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Patt D] Texas Oncology, Austin, TX, USA. US Oncology, Dallas, TX, USA. [Wildiers H] Department of General Medical Oncology, University Hospital Gasthuisberg, Leuven, Belgium. [O'Shaughnessy J] Texas Oncology, US Oncology, Baylor University Medical Center, Dallas, TX, USA. [Zamora E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
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Oncology ,Cancer Research ,medicine.medical_specialty ,Receptor, ErbB-2 ,Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES] ,Population ,Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores] ,Breast Neoplasms ,Mama - Càncer - Quimioteràpia ,Other subheadings::Other subheadings::/drug therapy [Other subheadings] ,Vinorelbine ,Single-arm trial ,chemistry.chemical_compound ,Breast cancer ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Electronic health records ,Humans ,Overall survival ,education ,Capecitabine ,Proportional Hazards Models ,Real-world evidence ,neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES] ,education.field_of_study ,Real-world control arm ,business.industry ,Hazard ratio ,Retrospective cohort study ,Metastatic breast cancer ,medicine.disease ,Clinical Trial ,Abemaciclib ,Retrospective study ,chemistry ,Cohort ,Female ,business ,medicine.drug ,Eribulin - Abstract
Purpose In MONARCH 1 (NCT02102490), single-agent abemaciclib demonstrated promising efficacy activity and tolerability in a population of heavily pretreated women with refractory HR+, HER2− metastatic breast cancer (MBC). To help interpret these results and put in clinical context, we compared overall survival (OS) and duration of therapy (DoT) between MONARCH 1 and a real-world single-agent chemotherapy cohort. Methods The real-world chemotherapy cohort was created from a Flatiron Health electronic health records-derived database based on key eligibility criteria from MONARCH 1. The chemotherapies included in the cohort were single-agent capecitabine, gemcitabine, eribulin, or vinorelbine. Results were adjusted for baseline demographics and clinical differences using Mahalanobis distance matching (primary analysis) and entropy balancing (sensitivity analysis). OS and DoT were analyzed using the Kaplan–Meier method and Cox proportional hazards regression. Results A real-world single-agent chemotherapy cohort (n = 281) with eligibility criteria similar to the MONARCH 1 population (n = 132) was identified. The MONARCH 1 (n = 108) cohort was matched to the real-world chemotherapy cohort (n = 108). Median OS was 22.3 months in the abemaciclib arm versus 13.6 months in the matched real-world chemotherapy cohort with an estimated hazard ratio (HR) of 0.54. The median DoT was 4.1 months in MONARCH 1 compared to 2.9 months in the real-world chemotherapy cohort with HR of 0.76. Conclusions This study demonstrates an approach to create a real-world chemotherapy cohort suitable to serve as a comparator for trial data. These exploratory results suggest a survival advantage and place the benefit of abemaciclib monotherapy in clinical context.
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- 2020
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5. Primary tumor location and survival in colorectal cancer: A retrospective cohort study
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Kristin M Sheffield, Li Li, David Lenis, Afsaneh Barzi, Himani Aggarwal, Rachael Sorg, and Rebecca A. Miksad
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Oncology ,medicine.medical_specialty ,Survival ,Bevacizumab ,Colorectal cancer ,Cetuximab ,Colorectal neoplasms ,03 medical and health sciences ,0302 clinical medicine ,FOLFOX ,Internal medicine ,Retrospective Cohort Study ,Electronic health records ,Medicine ,neoplasms ,Splenic flexure ,business.industry ,Gastroenterology ,Prognosis ,medicine.disease ,Primary tumor ,digestive system diseases ,Retrospective studies ,Irinotecan ,030220 oncology & carcinogenesis ,FOLFIRI ,030211 gastroenterology & hepatology ,Cohort study ,business ,medicine.drug - Abstract
BACKGROUND Primary tumor location is a prognostic factor for metastatic colorectal cancer (mCRC). Post hoc analyses of mCRC clinical trials, including FIRE-3, CALGB/SWOG 80405, suggest that primary tumor location is also predictive of survival benefit with cetuximab or bevacizumab in combination with 5-fluorouracil-based chemotherapy. AIM Evaluate prognostic/predictive roles of primary tumor location in real-world mCRC patients treated with cetuximab or bevacizumab plus 5-fluorouracil-based chemotherapy. METHODS This retrospective cohort study selected patients with KRAS wild-type mCRC who initiated first-line therapy with cetuximab or bevacizumab in combination with 5-fluorouracil/leucovorin/irinotecan (FOLFIRI) or 5-fluorouracil/ leucovorin/oxaliplatin (FOLFOX) between January 2013 and April 2017 from the Flatiron Health electronic health record-derived database of de-identified patient-level data in the United States. Primary tumor location was abstracted from patients’ charts. Left-sided primary tumor location (LPTL) was defined as tumors that originated in the splenic flexure, descending colon, sigmoid colon, or rectum; right-sided primary tumor location (RPTL) was defined as tumors that originated from the appendix, cecum, ascending colon, hepatic flexure, or transverse colon. Propensity score matching was used to balance the baseline demographic and clinical characteristics between patients treated with cetuximab and patients treated with bevacizumab. Kaplan-Meier and Cox regression methods were used for survival analyses. RESULTS A total of 1312 patients met the selection criteria. Of 248 cetuximab plus FOLFIRI or FOLFOX patients, 164 had LPTL and 84 had RPTL; of 1064 bevacizumab plus FOLFIRI or FOLFOX patients, 679 had LPTL and 385 had RPTL. Cetuximab LPTL and RPTL patients were more likely to receive FOLFIRI vs bevacizumab patients (LPTL: 64.0% vs 24.3%; RPTL: 76.2% vs 24.9%, P < 0.001). Stage at initial diagnosis was different between cetuximab RPTL vs bevacizumab RPTL patients (P < 0.001); cetuximab RPTL patients were more likely to have stage III disease (44.0% vs 22.6%), while bevacizumab RPTL patients were more likely to have stage IV disease (65.7% vs 48.8%). Cetuximab RPTL patients were more likely to have a documented history of adjuvant chemotherapy vs bevacizumab RPTL patients (47.6% vs 22.3%, P < 0.001). In the propensity score-matched sample, median overall survival (OS) was 29.7 mo (95%CI: 26.9-35.2) for LPTL patients vs 18.3 mo (95%CI: 15.8-21.3) for RPTL patients (P < 0.001). Median OS was 29.7 mo (95%CI: 27.4-NA) for cetuximab LPTL patients vs 29.1 mo (95%CI: 26.6-35.6) for bevacizumab LPTL patients (HR = 0.87; 95%CI: 0.63-1.19; P = 0.378) and 17.0 mo (95%CI: 12.0-32.6) for cetuximab RPTL patients vs 18.8 mo (95%CI: 15.8-22.3) for bevacizumab RPTL patients (HR = 1.00; 95%CI: 0.68-1.46; P = 0.996). The interaction of treatment and primary tumor location was not significant in the Cox regression. CONCLUSION In this real-world mCRC cohort, the prognostic role of primary tumor location was substantiated, but not the predictive role for treatment with cetuximab vs bevacizumab in combination with 5-fluorouracil-based chemotherapy.
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- 2020
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6. Abstract P2-08-12: Initial real world treatment patterns and outcomes of Abemaciclib for the treatment of HR+,HER2- metastatic breast cancer
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Shrujal Baxi, Raina Mathur, Yajun Emily Zhu, Yu-Jing Huang, Emily Nash Smith, Andrew D. Seidman, Gebra Cuyun Carter, Amy Lee Chong, Anala Gossai, Kristin M Sheffield, Aaron B. Cohen, Lee Bowman, and Sarah Rybowski
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0301 basic medicine ,Cancer Research ,medicine.medical_specialty ,education.field_of_study ,Aromatase inhibitor ,Fulvestrant ,medicine.drug_class ,business.industry ,Population ,Cancer ,Retrospective cohort study ,medicine.disease ,Metastatic breast cancer ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Breast cancer ,Oncology ,Interquartile range ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,education ,business ,medicine.drug - Abstract
Background: Abemaciclib is a selective continually dosed cyclin-dependent kinase 4 and 6 (CDK 4&6) inhibitor approved as a single agent and in combination with endocrine therapy for the treatment of HR+,HER2- metastatic breast cancer (MBC). To date, few publications have reported the real world (rw) use of abemaciclib. This retrospective observational study aimed to describe baseline characteristics, treatment patterns, and outcomes among MBC patients treated with abemaciclib in the US. Methods: HR+,HER2- MBC patients who initiated treatment with abemaciclib on or after 6/30/2016 and at least 4 months prior to the data cutoff date (12/31/2018) were selected from the de-identified Flatiron Health electronic-health record-derived database for US patients. The data were predominantly from a community oncology setting. Baseline demographic and clinical characteristics were recorded at the start of abemaciclib therapy. Using technology-enabled abstraction, rw tumor response (rwTR) assessments on abemaciclib were collected to calculate rw best response (rwBR) which was defined as rw complete (rwCR) or partial response (rwPR). Time to first response (rwTTFR) was estimated using the Kaplan-Meier method. Descriptive statistics were used to summarize baseline characteristics and treatment patterns. Results: 118 female MBC patients were treated with abemaciclib. Baseline characteristics are shown in Table 1. Median age at abemaciclib initiation was 66.5 years (interquartile range [IQR] 57-73). 28.8% of patients received abemaciclib in first line (1L), 21.2% in second line (2L), 20.3% in third line (3L), and 29.7% in later lines (4+L). 12.7% of patients (n=15) received abemaciclib as a monotherapy, occurring mostly in later lines. Patients also received abemaciclib in combination with endocrine therapy, including fulvestrant (59.3%), or aromatase inhibitor (22.9%), or other treatment (5.1%). 24.6% of patients received prior treatment with a different CDK 4&6 inhibitor. Most patients (81.3%) had a starting dose of 150 mg of abemaciclib, while other starting doses included 200 mg (8.4%), 100 mg (4.2%), 50 mg (3.4%), or unknown dose (2.5%). During treatment, 6.8%, and 21.2% of patients had a dose reduction or schedule change, respectively. Of the patients with a schedule change (n=25), 72% changed from twice to once daily. Among all abemaciclib patients who had at least 1 rwTR assessment (n=68), 41.2% had a rwBR. Although not statistically significant, there was a trend toward higher rates of rwBR in 1L (65.0%) compared to 2L (37.4%), 3L (35.7%), and 4+L (22.3%). Median rwTTFR was 3.6 months (95% CI: 3.5-5.2). Conclusions: This is one of the first studies describing rw utilization of abemaciclib, and it provides initial insights into scheduling and dosing in an rw population. There is evidence of response to abemaciclib even in later lines. Future research will be needed as treatment patterns evolve and longer follow-up periods are available to further describe patient outcomes. Table 1: Baseline patient characteristicsAbemaciclibN = 118%Race:White63.6Non-white20.3Unknown/missing16.1Stage at initial diagnosis:I11.9II16.1III28.8IV34.7Not documented8.5Tumor grade at initial diagnosis:Grade 19.3Grade 245.8Grade 322.9Unknown/not documented22.0Time between initial and metastatic diagnosis dates among patients who were not metastatic at initial diagnosisa:< 2 years20.8≥ 2 years79.2Menopausal statusb:Post-menopausal93.2Pre-menopausal6.8Modified Charlson comorbidity index (CCI) statusc:0/Unknown72.0116.928.53+2.5Number of sites of metastases, median [IQR]d2.0 [1.0:3.0]Presence of lung metastases34.7Presence of liver metastases22.9Presence of brain metastases7.6Follow-up time (months), median [IQR]6.4 [4.1:9.5]a: Patients not metastatic at initial diagnosis (n=77)b: Derived using age and evidence of gonadotropin-releasing hormone agonistc: Excludes cancer diagnosisd: Interquartile Range (IQR) Citation Format: Gebra Cuyun Carter, Kristin M Sheffield, Anala Gossai, Yu-Jing Huang, Yajun Emily Zhu, Lee Bowman, Emily Nash Smith, Raina Mathur, Aaron B Cohen, Shrujal Baxi, Sarah Rybowski, Amy Lee Chong, Andrew D Seidman. Initial real world treatment patterns and outcomes of Abemaciclib for the treatment of HR+,HER2- metastatic breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P2-08-12.
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- 2020
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7. HSR19-077: Primary Tumor Location (PTL) and Survival Outcomes in a Real World Cohort of KRAS Wild-Type (WT) Metastatic Colorectal Cancer (mCRC) Patients in the United States
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Himani Aggarwal, Rachael Sorg, David Lenis, Rebecca A. Miksad, Li Li, and Kristin M Sheffield
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Oncology ,medicine.medical_specialty ,business.industry ,Colorectal cancer ,Wild type ,medicine.disease ,medicine.disease_cause ,Primary tumor ,Internal medicine ,Cohort ,medicine ,KRAS ,business - Abstract
Background: PTL is a prognostic factor for mCRC. Recent data suggest PTL is also predictive of survival benefit with cetuximab (CET) and bevacizumab (BEV). This study evaluated the prognostic and predictive effect of PTL in patients with KRAS WT mCRC who initiated first-line (1L) therapy with CET vs BEV in the real world. Methods: This retrospective study selected patients with KRAS WT mCRC who initiated 1L therapy with CET or BEV + FOLFIRI or FOLFOX between January 2013 and April 2017 from Flatiron Health’s electronic health record-derived database. PTL was abstracted from patients’ charts. Left-sided PTL (LPTL): splenic flexure to rectum; right-sided PTL (RPTL): cecum to splenic flexure. Propensity score matching was used to balance treatment cohorts on baseline characteristics. Kaplan Meier and Cox regression methods were used for survival analyses. Results: 1,312 patients met the selection criteria. Of 248 CET + FOLFIRI or FOLFOX patients, 164 had LPTL and 84 had RPTL; of 1,064 BEV + FOLFIRI or FOLFOX patients, 679 had LPTL and 385 had RPTL. CET LPTL and RPTL patients were more likely to receive FOLFIRI vs BEV patients (LPTL: 64.0% vs 24.3%; PPPPPP=.378), and 17.0 months (95% CI, 12.0–32.6) for CET RPTL vs 18.8 months (95% CI, 15.8–22.3) for BEV RPTL patients (HR, 1.00; 95% CI, 0.68–1.46; P=.996). The interaction of treatment and PTL was not significant in the Cox regression. Conclusions: This study found a prognostic effect of PTL but not a predictive effect. LPTL patients had significantly longer OS vs RPTL patients. However, the treatment effect for CET vs BEV by PTL was not significantly different. Future research is needed to examine differences between real-world and clinical trial populations that may have contributed to divergent results.
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- 2019
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8. Abstract P6-18-19: Real-world survival of heavily pretreated patients with refractory HR+, HER2- metastatic breast cancer receiving single-agent chemotherapy - A comparison with MONARCH 1
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V.A. Andre, Xi Li, Kristin M Sheffield, Joyce A. O'Shaughnessy, Sara M. Tolaney, RE Derbyshire, Esther Zamora, DY Yardley, Li Li, Y-J Huang, J. Cortés, Maura N. Dickler, Martin Frenzel, HS Rugo, Véronique Diéras, Hans Wildiers, Gebra Cuyun Carter, and Debra A. Patt
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Oncology ,Cancer Research ,education.field_of_study ,medicine.medical_specialty ,business.industry ,Population ,Hazard ratio ,medicine.disease ,Vinorelbine ,Metastatic breast cancer ,Gemcitabine ,Breast cancer ,Tolerability ,Internal medicine ,Cohort ,medicine ,education ,business ,medicine.drug - Abstract
Background In MONARCH 1 (NCT02102490), abemaciclib demonstrated promising single-agent activity and tolerability in a population of heavily pretreated women with refractory HR+, HER2- metastatic breast cancer (MBC).1 Confirmed objective response rate (ORR) was 19.7% (95% CI: 13.3, 27.5) and at 18 months minimum follow-up median overall survival (OS) was 22.3 months. Due to the single-arm trial design of MONARCH 1, there is a need to view these results in clinical context relative to available treatment options. This study compared the OS results of abemaciclib in MONARCH 1 vs that in a real-world single-agent chemotherapy cohort with similar patient and disease characteristics. Methods MONARCH 1 study design and key eligibility criteria were previously described.1 The real-world cohort was based on Flatiron Health electronic health records-derived, nationally representative (USA-based) database comprising patient-level structured and unstructured data, curated via technology-enabled abstraction, for patients with MBC between January 1, 2011 through February 28, 2018. A real-world single-agent chemotherapy cohort was created based on the key eligibility criteria of MONARCH 1 and included patients diagnosed with HR+, HER2- MBC who received single-agent chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) following 1-2 prior chemotherapy regimens in the metastatic setting, had an ECOG PS of 0-1, and no prior CDK4 & 6 therapy. The index date was the start of the eligible single-agent chemotherapy, and patients were followed from the index date until date of death, loss to follow-up, or end of the database, whichever occurred earlier. OS results were adjusted using 2 methods (Mahalanobis distance matching and entropy balancing with bootstrapping) to account for baseline demographic and clinical differences between the real-world and trial cohorts. Results A real-world cohort (n=281) with eligibility criteria similar to the MONARCH 1 population (n=132) was identified. A subsequent matching based on Mahalanobis distance was performed to match MONARCH 1 population (n=108) with the real-world cohort (n=108). The matched cohorts demonstrated similar patient and disease characteristics. Median OS was 22.3 months in the abemaciclib arm vs 13.6 months in the matched cohort with an estimated hazard ratio (HR) of 0.54 (95% CI: 0.37, 0.77). Results of a sensitivity analysis performed using entropy balancing were consistent with an adjusted median OS of 12.7 months in the real-world cohort (n=281)with HR of 0.57 (95% CI from bootstrapping: 0.44, 0.78). Conclusion Methodological advances to adjust for potential biases, and improvements in data quality, have evolved enabling the ability to leverage a real-world cohort as an external comparator arm. This study demonstrates the ability to create a real-world chemotherapy cohort suitable to serve as a comparator for MONARCH 1. These exploratory results suggest a survival advantage and adequately place the clinical benefit of abemaciclib monotherapy in clinical context. References Dickler et al, CCR 2017 Citation Format: Rugo H, Dieras V, Cortes J, Patt D, Wildiers H, O'Shaughnessy J, Zamora E, Yardley DY, Carter GC, Sheffield KM, Li L, Andre VA, Derbyshire RE, Li XI, Frenzel M, Huang Y-J, Dickler MN, Tolaney SM. Real-world survival of heavily pretreated patients with refractory HR+, HER2- metastatic breast cancer receiving single-agent chemotherapy - A comparison with MONARCH 1 [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-18-19.
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- 2019
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9. Abstract P2-08-38: Influence of prognostic factors on outcomes among metastatic breast cancer patients treated with CDK4&6 inhibitors in routine clinical practice
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Li Li, D Kuk, Gebra Cuyun Carter, Kim Saverno, Andrew D. Seidman, Gregory L Price, Y-J Huang, LA Battiato, Emily Nash Smyth, Kristin M Sheffield, and SS Baxi
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Oncology ,Cancer Research ,medicine.medical_specialty ,education.field_of_study ,Fulvestrant ,Proportional hazards model ,business.industry ,Population ,Cancer ,medicine.disease ,Metastatic breast cancer ,Metastasis ,Breast cancer ,Internal medicine ,medicine ,Progression-free survival ,education ,business ,medicine.drug - Abstract
Background: Evidence suggests that there are clinical features associated with a less favorable prognosis among patients with HR+/HER2- metastatic breast cancer (MBC) such as metastases to non-bone sites, including liver and lung, and negative progesterone receptor (PgR-) status. The objective of this study was to compare baseline characteristics and outcomes between those with and without these clinical factors among a cohort of HR+/HER2- MBC patients treated with a CDK4&6 inhibitor (CDK4&6i). Methods: This was a retrospective analysis of the Flatiron Health electronic health records-derived database for US patients diagnosed with MBC between 1/1/2011 and 9/30/2017. The study included a random sample of patients with HR+/HER2- MBC who were treated with a CDK4&6i on or after 6/30/2016. Baseline variables, including demographics, comorbidities, and sites of metastasis, were recorded at start of the first CDK4&6i containing line of therapy in the metastatic setting on or after this date. Dates of real-world progression were abstracted from patient charts. Descriptive statistics and appropriate statistical tests were used to compare baseline characteristics between patients with or without select clinical factors associated with unfavorable outcomes. In patients who received a CDK4&6i-based therapy, Kaplan–Meier methods and univariable Cox proportional hazards models were used to assess real-world progression free survival (rwPFS) by line from start of line to the date of first progression or death within line (unadjusted for treatment and other potential confounders). Results: 518 patients were included in this study. Median age at metastatic diagnosis was 66y (IQR; 59-73y); 99% female and 11.4% had PgR- status. At baseline, 20.5%, 46.3%% and 65.8% of patients had liver, visceral (defined as liver and/or lung), and non-bone only metastases, respectively. Among a total of 207 patients who received a CDK4&6i as initial therapy in the metastatic setting, 69.1% received it in combination with an aromatase inhibitor, 29.5% received it in combination with fulvestrant, and 1.4% as monotherapy. Within the same group, 58 had disease progression or died during first line (1L); median rwPFS measured from start of 1L was not reached (95% CI: 10.7 months, NA). Univariable analyses revealed the presence of liver metastases was associated with a higher risk of progression or death compared to no liver metastases (HR: 2.04, 95% CI: 1.13 - 3.68). Having non bone-only metastases was associated with a higher risk of progression or death compared to having bone-only metastases (HR: 2.23, 95% CI: 1.20 – 4.15). Univariable analyses did not reveal any statistically significant differences in first-line rwPFS by PgR status or presence of visceral metastases. Results from other lines of therapy are forthcoming. Conclusion: In a real world data set, and consistent with prior prospective data, presence of liver and non-bone only metastases were associated with a higher risk of progression among patients with HR+/HER2- MBC receiving initial therapy with a CDK4&6i. The heterogeneity of prognoses among this population reinforces the need to consider these clinical features in treatment decisions for optimal patient outcomes. Citation Format: Saverno KR, Carter GC, Li L, Battiato LA, Huang Y-J, Smyth EN, Price GL, Sheffield KM, Baxi SS, Kuk D, Seidman AD. Influence of prognostic factors on outcomes among metastatic breast cancer patients treated with CDK4&6 inhibitors in routine clinical practice [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P2-08-38.
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- 2019
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10. Predicting optimal treatment regimens for patients with HR+/HER2- breast cancer using machine learning based on electronic health records
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Gebra Cuyun Carter, Ilya Lipkovich, Zhanglin Lin Cui, Douglas E. Faries, Zbigniew Kadziola, and Kristin M Sheffield
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Adult ,Receptor, ErbB-2 ,Comparative effectiveness research ,Breast Neoplasms ,Machine learning ,computer.software_genre ,01 natural sciences ,Systemic therapy ,Machine Learning ,010104 statistics & probability ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Electronic Health Records ,Humans ,0101 mathematics ,business.industry ,Health Policy ,Optimal treatment ,Hazard ratio ,medicine.disease ,Metastatic breast cancer ,Discontinuation ,Regimen ,030220 oncology & carcinogenesis ,Female ,Artificial intelligence ,business ,computer - Abstract
Aim: To predict optimal treatments maximizing overall survival (OS) and time to treatment discontinuation (TTD) for patients with metastatic breast cancer (MBC) using machine learning methods on electronic health records. Patients/methods: Adult females with HR+/HER2- MBC on first- or second-line systemic therapy were eligible. Random survival forest (RSF) models were used to predict optimal regimen classes for individual patients and each line of therapy based on baseline characteristics. Results: RSF models suggested greater use of CDK4 & 6 inhibitor-based therapies may maximize OS and TTD. RSF-predicted optimal treatments demonstrated longer OS and TTD compared with nonoptimal treatments across line of therapy (hazard ratios = 0.44∼0.79). Conclusion: RSF may help inform optimal treatment choices and improve outcomes for patients with HR+/HER2- MBC.
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- 2021
11. Development and validation of coding algorithms to identify patients with incident lung cancer in United States healthcare claims data
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Julie Beyrer, Kristin M Sheffield, David R. Nelson, Ana L. Hincapie, Yu-Jing Huang, and Tim Ellington
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medicine.medical_specialty ,Lung Neoplasms ,Epidemiology ,Logistic regression ,Medicare ,030226 pharmacology & pharmacy ,Odds ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Lung cancer ,Aged ,Aged, 80 and over ,business.industry ,Cancer ,Gold standard (test) ,Missing data ,medicine.disease ,Regression ,United States ,business ,Delivery of Health Care ,Algorithms ,SEER Program - Abstract
Our aim was to develop and validate a practical US healthcare claims algorithm for identifying incident lung cancer that improves on positive predictive value (PPV) and sensitivity observed in past studies.Patients newly diagnosed with lung cancer in Surveillance, Epidemiology, and End Results (SEER) (gold standard) were linked with Medicare claims. A 5% Medicare "other cancer" sample and noncancer sample served as controls. A split-sample validation approach was used. Rules-based, regression, and machine learning models for developing algorithms were explored. Algorithms were developed in the model building subset. Rules-based algorithms and those with the highest F scores were evaluated in the validation subset. F scores were compared for 1000 bootstrap samples. Misclassification was evaluated by calculating the odds of selection by the algorithm among true positives and true negatives.A practical single-score algorithm derived from a logistic regression model had sensitivity = 78.22% and PPV = 78.50% (F score: 78.36). The algorithm was most likely to misclassify older patients (ages ≥80 years) or with missing data in the SEER registry, shorter follow-up time in Medicare (3 months), insurance through Veterans Affairs,1 cancer in SEER, or certain Charlson comorbidities (dementia, chronic pulmonary disease, liver disease, or myocardial infarction).In this dataset, a practical point-based algorithm for identifying incident lung cancer demonstrated significant and substantial improvement (7.9% and 23.9% absolute improvement in sensitivity and PPV, respectively) compared with a current standard.
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- 2020
12. Minimization of olaratumab drug waste using real-world data
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Julie Beyrer, Bradley J. Mills, Kathleen Stafford, Amine Ale-Ali, Kristin M Sheffield, and Ian A. Watson
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Male ,medicine.medical_specialty ,Body Surface Area ,Population ,Urology ,Antineoplastic Agents ,Soft Tissue Neoplasms ,Vial ,Drug Costs ,03 medical and health sciences ,0302 clinical medicine ,Cost Savings ,Interquartile range ,medicine ,Humans ,030212 general & internal medicine ,Dosing ,Drug packaging ,education ,Aged ,Retrospective Studies ,Pharmacology ,Body surface area ,education.field_of_study ,business.industry ,Health Policy ,Soft tissue sarcoma ,Body Weight ,Antibodies, Monoclonal ,Sarcoma ,Middle Aged ,medicine.disease ,Surgery ,030220 oncology & carcinogenesis ,Female ,business ,Olaratumab ,medicine.drug - Abstract
Purpose Results of a study in which population-based body weight and body surface area (BSA) data were used for vial size optimization to reduce drug waste associated with administration of the i.v. anticancer agent olaratumab are reported. Methods A retrospective observational study was conducted to determine weight and BSA distributions in a large sample of U.S. oncology patients using data from a large electronic medical record database. Body weight and BSA values at the time of initial systemic anticancer therapy were used to compute olaratumab dose requirements in a cohort of patients with soft tissue sarcoma; those data were analyzed to derive estimates of drug waste likely to result from the use of various proposed olaratumab vial sizes in combination with an existing 500-mg size. Weight and BSA distributions were calculated for additional cohorts of patients with 7 other cancer types. Results Median weight values in men ( n = 1,179) and women ( n = 1,078) with soft tissue sarcoma were 82.55 kg (interquartile range [IQR], 72.58–95.53 kg) and 68.69 kg (IQR, 58.51–84.28 kg), respectively. Modeling of olaratumab dosing scenarios indicated that use of the 500-mg vial only would result in estimated average drug waste of 234 mg per patient per administration; analysis of various potential vial size combinations showed that waste could be reduced by 87.6% with the addition of a 190-mg vial size. Conclusion Analysis of real-world patient weight and BSA data allowed olaratumab vial size optimization to enable maximal dosing flexibility with minimal drug waste.
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- 2017
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13. MS3 PREDICTING OPTIMAL TREATMENT REGIMENS FOR HR+/HER2- BREAST CANCER BASED ON ELECTRONIC HEALTH RECORDS USING RANDOM FOREST
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Zhanglin Lin Cui, Kristin M Sheffield, Ilya Lipkovich, Douglas E. Faries, Zbigniew Kadziola, G. Cuyun Carter, B. Ratitch, and Xia Li
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Oncology ,medicine.medical_specialty ,Breast cancer ,business.industry ,Health Policy ,Optimal treatment ,Internal medicine ,Public Health, Environmental and Occupational Health ,medicine ,Health records ,medicine.disease ,business ,Random forest - Published
- 2020
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14. Perceptions of overdetection of breast cancer among women 70 years of age and older in the USA: a mixed-methods analysis
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James S. Goodwin, Alai Tan, Monique R. Pappadis, Susan C. Weller, Diana S. Hoover, Ashley J. Housten, Sharon H. Giordano, Shilpa Krishnan, Kristin M Sheffield, Robert J. Volk, and Elizabeth Jaramillo
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Gerontology ,Preventative Medicine ,mammography screening ,media_common.quotation_subject ,Decision Making ,Ethnic group ,Breast Neoplasms ,Medical Overuse ,Mixed methods analysis ,Nonprobability sampling ,Interviews as Topic ,03 medical and health sciences ,0302 clinical medicine ,Breast cancer ,Perception ,Medicine ,Humans ,Mass Screening ,030212 general & internal medicine ,Overdiagnosis ,preventative medicine ,Qualitative Research ,media_common ,Aged ,Aged, 80 and over ,business.industry ,Research ,General Medicine ,Patient Acceptance of Health Care ,medicine.disease ,Texas ,early detection of cancer ,030220 oncology & carcinogenesis ,Female ,business ,Qualitative research ,Mammography - Abstract
Objectives Current research on the perceptions of overdiagnosis or overdetection of breast cancer has largely been conducted outside of the USA and with women younger than 70 years. Therefore, we explored older women’s perceptions about the concept of overdetection of breast cancer and its influence on future screening intentions. Design Mixed-methods analysis using purposive sampling based on race/ethnicity, age and educational level. Semistructured interviews, including two hypothetical scenarios illustrating benefits and harms of screening and overdetection, were analysed using inductive and deductive thematic approaches. An inferential clustering technique was used to assess overall patterns in narrative content by sociodemographic characteristics, personal screening preferences or understanding of overdetection. Setting Houston/Galveston, Texas, USA. Participants 59 English-speaking women aged 70 years and older with no prior history of breast cancer. Results Very few women were familiar with the concept of overdetection and overtreatment. After the scenarios were presented, half of the women still demonstrated a lack of understanding of the concept of overdetection. Many women expressed suspicion of the concept, equating it to rationing. Women who showed understanding of overdetection were more likely to express an intent to discontinue screening, although 86% of the women stated that hearing about overdetection did not influence their screening decision. Themes identified did not differ by race/ethnicity, education, age or screening preferences. Differences were identified between women who understood overdetection and women who did not (r=0.23, p Conclusions Many older women did not understand the concept of overdetection, in addition to being suspicious of or resistant to the concept. Providing older women with descriptions of overdetection may not be sufficient to influence screening intentions.
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- 2018
15. Surgeon and Facility Variation in the Use of Minimally Invasive Breast Biopsy in Texas
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James S. Goodwin, Gabriela M. Vargas, Yong Fang Kuo, Deepak Adhikari, Taylor S. Riall, Christopher J. Zimmermann, Abhishek D. Parmar, Kristin M. Sheffield, and Nina P. Tamirisa
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Breast biopsy ,medicine.medical_specialty ,Biopsy ,Breast surgery ,medicine.medical_treatment ,Patient characteristics ,Breast Neoplasms ,Medicare ,Article ,Cohort Studies ,Breast cancer ,Claims data ,Humans ,Minimally Invasive Surgical Procedures ,Medicine ,Breast ,Aged ,Retrospective Studies ,Surgeons ,medicine.diagnostic_test ,business.industry ,Retrospective cohort study ,Guideline ,medicine.disease ,Texas ,United States ,Surgery ,Health Facilities ,business ,Cohort study - Abstract
Objective and background Minimally invasive breast biopsy (MIBB) rates remain well below guideline recommendations of more than 90% and vary across geographic areas. Our aim was to determine the variation in use attributable to the surgeon and facility and determine the patient, surgeon, and facility characteristics associated with the use of MIBB. Methods We used 100% Texas Medicare claims data (2000-2008) to identify women older than 66 years with a breast biopsy (open or minimally invasive) and subsequent breast cancer diagnosis/operation within 1 year. The percentage of patients undergoing MIBB as the first diagnostic modality was estimated for each surgeon and facility. Three-level hierarchical generalized linear models (patients clustered within surgeons within facilities) were used to evaluate variation in MIBB use. Results A total of 22,711 patients underwent a breast cancer operation by 1226 surgeons at 525 facilities. MIBB was the initial diagnostic modality in 62.4% of cases. Only 7.0% of facilities and 12.9% of surgeons used MIBB for more than 90% of patients. In 3-level models adjusted for patient characteristics, the percentage of patients who received MIBB ranged from 7.5% to 96.0% across facilities (mean = 50.1%, median = 49.2%) and from 8.0% to 87.0% across surgeons (mean = 50.3%, median = 50.9%). The variance in MIBB use was attributable to facility (8.8%) and surgeon (15.4%) characteristics. Lower surgeon and facility volume, longer surgeon years in practice, and smaller facility bed size were associated with lower rates of MIBB use. Conclusions Identification of surgeon and facility characteristics associated with low use of MIBB provides potential targets for interventions to improve MIBB rates and decrease variation in use. Type of study Retrospective cohort.
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- 2015
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16. PREOP-Gallstones
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Yong Fang Kuo, Gabriela M. Vargas, Abhishek D. Parmar, Taylor S. Riall, Deepak Adhikari, Nina P. Tamirisa, Kristin M. Sheffield, Robert A. Davee, and James S. Goodwin
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Male ,medicine.medical_specialty ,Elective cholecystectomy ,genetic structures ,Decision Making ,Gallstones ,Medicare ,Risk Assessment ,Article ,Older patients ,Cholelithiasis ,Recurrence ,Humans ,Medicine ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,General surgery ,Background data ,Age Factors ,Retrospective cohort study ,Nomogram ,Prognosis ,medicine.disease ,United States ,Surgery ,Nomograms ,Elective Surgical Procedures ,Female ,Elective Surgical Procedure ,business ,Risk assessment - Abstract
The decision regarding elective cholecystectomy in older patients with symptomatic cholelithiasis is complicated. We developed and validated a prognostic nomogram to guide shared decision making for these patients.We used Medicare claims (1996-2005) to identify the first episode of symptomatic cholelithiasis in patients older than 65 years who did not undergo hospitalization or elective cholecystectomy within 2.5 months of the episode. We described current patterns of care and modeled their risk of emergent gallstone-related hospitalization or cholecystectomy at 2 years. Model discrimination and calibration were assessed using a random split sample of patients.We identified 92,436 patients who presented to the emergency department (8.3%) or physician's office (91.7%) and who were not immediately admitted. The diagnosis for the initial episode was biliary colic/dyskinesia (65.3%), acute cholecystitis (26.6%), choledocholithiasis (5.7%), or gallstone pancreatitis (2.4%). The 2-year emergent gallstone-related hospitalization rate was 11.1%, with associated in-hospital morbidity and mortality rates of 56.5% and 6.5%. Factors associated with gallstone-related acute hospitalization included male sex, increased age, fewer comorbid conditions, complicated biliary disease on initial presentation, and initial presentation to the emergency department. Our model was well calibrated and identified 51% of patients with a risk less than 10% for 2-year complications and 5.4% with a risk more than 40% (C statistic, 0.69; 95% confidence interval, 0.63-0.75).Surgeons can use this prognostic nomogram to accurately provide patients with their 2-year risk of developing gallstone-related complications, allowing patients and physicians to make informed decisions in the context of their symptom severity and its impact on their quality of life.
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- 2015
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17. KRAS mutation as a prognostic factor and predictive factor in advanced/metastatic non-small cell lung cancer: A systematic literature review and meta-analysis
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Min-Hua Jen, Matthew Chenoweth, William J. John, Jeroen P. Jansen, Catherine Muehlenbein, Kristin M Sheffield, Adina Rojubally, Li Li, Mark Steven Leusch, M.E. Boye, Eric Druyts, Gebra Cuyun Carter, and Rebecca Ellen Goulding
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0301 basic medicine ,Oncology ,KRAS mutations ,Cancer Research ,medicine.medical_specialty ,Lung Neoplasms ,DNA Mutational Analysis ,medicine.disease_cause ,law.invention ,Proto-Oncogene Proteins p21(ras) ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Carcinoma, Non-Small-Cell Lung ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Biomarkers, Tumor ,Humans ,Medicine ,Progression-free survival ,Stage (cooking) ,Lung cancer ,Protein Kinase Inhibitors ,neoplasms ,RC254-282 ,Neoplasm Staging ,Randomized Controlled Trials as Topic ,business.industry ,Hazard ratio ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Prognosis ,medicine.disease ,Effect modifier ,Progression-Free Survival ,respiratory tract diseases ,ErbB Receptors ,Clinical trial ,Observational Studies as Topic ,030104 developmental biology ,030220 oncology & carcinogenesis ,Meta-analysis ,Mutation ,Systematic review ,KRAS ,business ,Non-small-cell lung cancer ,Predictive factors - Abstract
KRAS (Kirsten Rat Sarcoma) is the most common oncogenic mutation detected in patients with non-small cell lung cancer (NSCLC). However, the role of KRAS as either a prognostic factor or predictive factor (modifier of treatment effects) in NSCLC is not well established at this time. This systematic literature review (SLR) and meta-analysis synthesized the available evidence regarding the role of KRAS mutation as a predictive factor and/or prognostic factor of survival and response outcomes in patients with advanced/metastatic (stage IIIB-IV) NSCLC. Relevant clinical trials and observational studies were identified by searching MEDLINE, Embase and Cochrane Register of Controlled Trials. Meta-analyses were performed using data extracted from multivariable and univariable analyses from clinical studies to assess the empirical evidence of KRAS mutation status as a prognostic or/and predicitive factor. 43 selected studies were identified by the SLR and included in this meta-analysis. Pairwise meta-analyses of hazard ratios (HRs) reported in randomized controlled trials (RCTs) did not demonstrate a significant prognostic effect of mutant KRAS on overall survival (OS) (HR=1.10; 95% CI [0.88, 1.38]) or progression free survival (PFS) (HR=1.03; 95% CI [0.80, 1.33]). However, when conducting meta-analyses on HRs reported in observational studies, a statistically significant negative prognostic effect of mutant KRAS was observed (OS HR=1.71; 95% CI [1.07, 2.84]; PFS HR=1.18; 95% CI [1.02, 1.36]). Meta-analyses of objective response rate (ORR) in RCTs demonstrated a negative prognostic effect of mutant KRAS (RR=0.38; 95% CI [0.16, 0.63]). Limited data were available to evaluate the role of KRAS mutation as a predictive factor. In conclusion, this research offers evidence that KRAS mutation may be a negative prognostic factor for survival and response outcomes in patients with advanced/metastatic NSCLC, but further research is needed to address conflicting results on the importance of KRAS mutations as a predictive factor.
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- 2020
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18. Impact of liver-directed therapy in colorectal cancer liver metastases
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Nina P. Tamirisa, Kristin M. Sheffield, Taylor S. Riall, Abhishek D. Parmar, Gabriela M. Vargas, and Kimberly M. Brown
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Male ,Oncology ,Antimetabolites, Antineoplastic ,medicine.medical_specialty ,Colorectal cancer ,medicine.medical_treatment ,Leucovorin ,Kaplan-Meier Estimate ,Adenocarcinoma ,Medicare ,Disease-Free Survival ,Article ,International Classification of Diseases ,Internal medicine ,medicine ,Humans ,Registries ,Aged ,Neoplasm Staging ,Proportional Hazards Models ,Aged, 80 and over ,Chemotherapy ,Proportional hazards model ,business.industry ,Liver Neoplasms ,Odds ratio ,medicine.disease ,Combined Modality Therapy ,Embolization, Therapeutic ,Primary tumor ,Comorbidity ,United States ,Cancer registry ,Vitamin B Complex ,Catheter Ablation ,Female ,Surgery ,Fluorouracil ,Colorectal Neoplasms ,business - Abstract
There is a paucity of data on the current management and outcomes of liver-directed therapy (LDT) in older patients presenting with stage IV colorectal cancer (CRC). The aim of the study was to evaluate treatment patterns and outcomes in use of LDT in the setting of improved chemotherapy.We used Cancer Registry and linked Medicare claims to identify patients aged ≥66 y undergoing surgical resection of the primary tumor and chemotherapy after presenting with stage IV CRC (2001-2007). LDT was defined as liver resection and/or ablation-embolization.We identified 5500 patients. LDT was used in 34.9% of patients; liver resection was performed in 1686 patients (30.7%), and ablation-embolization in 554 patients (10.1%), with 322 patients having both resection and ablation-embolization. Use of LDT was negatively associated with increasing year of diagnosis (odds ratio [OR] = 0.96, 95% confidence interval [CI] 0.93-0.99), age85 y (OR = 0.61, 95% CI 0.45-0.82), and poor tumor differentiation (OR = 0.73, 95% CI 0.64-0.83). LDT was associated with improved survival (median 28.4 versus 21.1 mo, P 0.0001); however, survival improved for all patients over time. We found a significant interaction between LDT and period of diagnosis and noted a greater survival improvement with LDT for those diagnosed in the late (2005-2007) period.Older patients with stage IV CRC are experiencing improved survival over time, independent of age, comorbidity, and use of LDT. However, many older patients deemed to be appropriate candidates for resection of the primary tumor and receipt of systemic chemotherapy did not receive LDT. Our data suggest that improved patient selection may be positively impacting outcomes. Early referral and optimal selection of patients for LDT has the potential to further improve survival in older patients presenting with advanced colorectal cancer.
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- 2014
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19. Trajectory of care and use of multimodality therapy in older patients with pancreatic adenocarcinoma
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Nina P. Tamirisa, Abhishek D. Parmar, Taylor S. Riall, Kristin M. Sheffield, and Gabriela M. Vargas
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Kaplan-Meier Estimate ,Multimodality Therapy ,Adenocarcinoma ,Article ,Cohort Studies ,Pancreatic cancer ,Epidemiology ,medicine ,Humans ,Combined Modality Therapy ,Aged ,Aged, 80 and over ,Chemotherapy ,business.industry ,Age Factors ,Antineoplastic Protocols ,medicine.disease ,Surgery ,Pancreatic Neoplasms ,Radiation therapy ,Chemotherapy, Adjuvant ,Female ,Radiotherapy, Adjuvant ,business ,SEER Program ,Cohort study - Abstract
Multimodality therapy with chemotherapy and operative resection is recommended for patients with locoregional pancreatic cancer but is not received by many patients.To evaluate patterns in the use and timing of chemotherapy and resection and factors associated with receipt of multimodality therapy in older patients with locoregional pancreatic cancer.We used Surveillance, Epidemiology, and End Results-linked Medicare data (1992-2007) to identify patients with locoregional pancreatic adenocarcinoma. Multimodality therapy was defined as receipt of both chemotherapy and pancreatic resection. Logistic regression was used to determine factors independently associated with receipt of multimodality therapy. Log-rank tests were used to identify differences in survival for patients stratified by type and timing of treatment.We identified 10,505 patients with pancreatic adenocarcinoma. 5,358 patients (51.0%) received either chemotherapy or surgery, with 1,166 patients (11.1%) receiving both modalities. Resection alone was performed in 1,138 patients (10.8%), and chemotherapy alone was given to 3,054 (29.1%) patients. In patients undergoing resection as the initial treatment modality, 49.4% never received chemotherapy; 97.4% of patients who underwent chemotherapy as the initial treatment modality never underwent resection. The use of multimodality therapy increased from 7.4% of patients in 1992-1995 to 13.8% of patients in 2004-2007 (P.0001). The 2-year survival was 41.0% for patients receiving multimodality therapy, 25.1% with resection alone, and 12.5% with chemotherapy alone (P.0001). Of the patients receiving multimodality therapy, chemotherapy was delivered in the adjuvant setting in 93.1% and in the neoadjuvant setting in 6.9%, with similar 2-year survival with either approach (neoadjuvant vs adjuvant, 46.9% vs 40.6%; P = .16). Year of diagnosis, white race, less comorbidity, and no vascular invasion were independently associated with receipt of multimodality therapy.Only half of older patients with locoregional pancreatic cancer receive any treatment, and fewer than one quarter of treated patients receive multimodality therapy. Nearly all patients receiving chemotherapy as the initial treatment modality did not undergo resection, whereas half of those undergoing resection first received chemotherapy. When multimodality therapy is used, the vast majority of patients had chemotherapy in the adjuvant setting with a similar survival, regardless of approach.
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- 2014
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20. Cost-Effectiveness of Elective Laparoscopic Cholecystectomy Versus Observation in Older Patients Presenting with Mild Biliary Disease
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Taylor S. Riall, Kristin M. Sheffield, Nina P. Tamirisa, Mark D. Coutin, Gabriela M. Vargas, and Abhishek D. Parmar
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medicine.medical_specialty ,Cost effectiveness ,Cost-Benefit Analysis ,medicine.medical_treatment ,Article ,Biliary disease ,Postoperative Complications ,Cholelithiasis ,Recurrence ,medicine ,Humans ,Intraoperative Complications ,Watchful Waiting ,Healthcare Cost and Utilization Project ,health care economics and organizations ,Aged ,Probability ,business.industry ,General surgery ,Decision Trees ,Gastroenterology ,Perioperative ,medicine.disease ,Quality-adjusted life year ,Hospitalization ,Cholecystectomy, Laparoscopic ,Elective Surgical Procedures ,Surgery ,Cholecystectomy ,Quality-Adjusted Life Years ,Elective Surgical Procedure ,business ,Watchful waiting - Abstract
Our objective was to determine the probability threshold for recurrent symptoms at which elective cholecystectomy compared to observation in older patients with symptomatic cholelithiasis is the more effective and cost-effective option. We built a decision model of elective cholecystectomy versus observation in patients >65 presenting with initial episodes of symptomatic cholelithiasis that did not require initial hospitalization or cholecystectomy. Probabilities for subsequent hospitalization, emergency cholecystectomy, and perioperative complications were based on previously published probabilities from a 5 % national sample of Medicare patients. Costs were estimated from Medicare reimbursements and from the Healthcare Cost and Utilization Project. Utilities (quality-adjusted life years, QALYs) were obtained from established literature estimates. Elective cholecystectomy compared to observation in all patients was associated with lower effectiveness (−0.10 QALYs) and had an increased cost of $3,422.83 per patient at 2-year follow-up. Elective cholecystectomy became the more effective option when the likelihood for continued symptoms exceeded 45.3 %. Elective cholecystectomy was both more effective and less costly when the probability for continued symptoms exceeded 82.7 %. An individualized shared decision-making strategy based on these data can increase elective cholecystectomy rates in patients at high risk for recurrent symptoms and minimize unnecessary cholecystectomy for patients unlikely to benefit.
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- 2014
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21. Trends in Treatment and Survival in Older Patients Presenting with Stage IV Colorectal Cancer
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Gabriela M. Vargas, Abhishek D. Parmar, Yimei Han, Kimberly M. Brown, Kristin M. Sheffield, Aakash Gajjar, and Taylor S. Riall
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Male ,Oncology ,medicine.medical_specialty ,Time Factors ,Organoplatinum Compounds ,Bevacizumab ,Colorectal cancer ,medicine.medical_treatment ,Antineoplastic Agents ,Antibodies, Monoclonal, Humanized ,Irinotecan ,Medicare ,Article ,Internal medicine ,medicine ,Humans ,Registries ,Survival rate ,Aged ,Neoplasm Staging ,Aged, 80 and over ,Chemotherapy ,Rectal Neoplasms ,business.industry ,Gastroenterology ,medicine.disease ,Primary tumor ,United States ,Cancer registry ,Oxaliplatin ,Survival Rate ,Chemotherapy, Adjuvant ,Colonic Neoplasms ,Camptothecin ,Female ,Surgery ,business ,medicine.drug - Abstract
Trends in the use of modern chemotherapeutic regimens, primary tumor resection, and the timing of chemotherapy and resection in older patients with stage IV colorectal cancer have not been evaluated. We used Cancer Registry- and Medicare-linked data (2000–2009) to describe time trends in resection of the primary tumor and receipt of chemotherapy in patients ≥66 presenting with stage IV colorectal cancer (N = 16,168). The mean age was 77.8 ± 7.3 years; 53.8 % were women and 82.9 % were white. Primary cancer sites were colon in 83.4 % and rectum in 16.6 %. Resection of the primary tumor decreased from 64.6 to 57.1 % (P
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- 2013
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22. Evaluating comparative effectiveness with observational data
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Taylor S. Riall, Yong Fang Kuo, Abhishek D. Parmar, Kristin M. Sheffield, James S. Goodwin, Yimei Han, Praveen Guturu, and Gabriela M. Vargas
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Male ,Oncology ,Cancer Research ,medicine.medical_specialty ,Adenocarcinoma ,Article ,Endosonography ,Internal medicine ,Pancreatic cancer ,medicine ,Humans ,Selection Bias ,Survival analysis ,Aged ,Aged, 80 and over ,business.industry ,Proportional hazards model ,Confounding ,Hazard ratio ,Cancer ,Confounding Factors, Epidemiologic ,medicine.disease ,Survival Analysis ,Surgery ,Pancreatic Neoplasms ,Observational Studies as Topic ,Treatment Outcome ,Data Interpretation, Statistical ,Propensity score matching ,Female ,Observational study ,business ,SEER Program - Abstract
BACKGROUND A previous observational study reported that endoscopic ultrasound (EUS) is associated with improved survival in older patients with pancreatic cancer. The objective of this study was to reevaluate this association using different statistical methods to control for confounding and selection bias. METHODS Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data (1992-2007) was used to identify patients with locoregional pancreatic cancer. Two-year survival in patients who did and did not receive EUS was compared by using standard Cox proportional hazards models, propensity score methodology, and instrumental variable analysis. RESULTS EUS was associated with improved survival in both unadjusted (hazard ratio [HR] = 0.67, 95% confidence interval [CI] = 0.63-0.72) and standard regression analyses (HR = 0.78, 95% CI = 0.73-0.84) which controlled for age, sex, race, marital status, tumor stage, SEER region, Charlson comorbidity, year of diagnosis, education, preoperative biliary stenting, chemotherapy, radiation, and pancreatic resection. Propensity score adjustment, matching, and stratification did not attenuate this survival benefit. In an instrumental variable analysis, the survival benefit was no longer observed (HR = 1.00, 95% CI = 0.73-1.36). CONCLUSIONS These results demonstrate the need to exercise caution in using administrative data to infer causal mortality benefits with diagnostic and/or treatment interventions in cancer research. Cancer 2013;119:3861–3869. © 2013 American Cancer Society.
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- 2013
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23. Analysis of venous thromboembolic events after saphenous ablation
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Lois A. Killewich, Taylor S. Riall, Casey A. Boyd, Jaime Benarroch-Gampel, and Kristin M. Sheffield
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medicine.medical_specialty ,Radiofrequency ablation ,business.industry ,medicine.medical_treatment ,Odds ratio ,medicine.disease ,Ablation ,Confidence interval ,Pulmonary embolism ,law.invention ,Surgery ,Catheter ,medicine.anatomical_structure ,law ,Varicose veins ,medicine ,Radiology ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,Vein ,business - Abstract
Venous thromboembolic events after saphenous vein ablation procedures for varicose veins have been reported. Current knowledge of these events is based on single-institution studies or studies with small numbers of patients.The National Surgical Quality Improvement Program (NSQIP) database (2005-2009) was used to identify 3874 patients who underwent radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) of the saphenous veins with or without stab phlebectomy. Outcome variables included documented postoperative deep vein thrombosis (DVT) or pulmonary embolism (PE). Bivariate and multivariate logistic regression analyses were performed to identify factors associated with venous thromboembolic events after ablation procedures.Procedures for lower extremity varicose veins included RFA in 2897 patients (74.8%) and EVLA in 977 (25.2%). Patients who underwent RFA were more likely to be older, obese, diabetic, hypertensive, and to have undergone procedures involving more than one vein (24% vs 4%; P .0001). Patients who underwent EVLA were more likely to have received general anesthesia (56.9% vs 40.8%; P .0001) and to have undergone concomitant stab phlebectomy (44.9% vs 31.7%; P .0001). The incidences of DVT (1.74% vs 1.52%; P = .63) and pulmonary embolus (0.07% vs 0%; P.99) were similar between EVLA and RFA. No significant predictors of DVT in the postoperative period were identified on bivariate or multivariate analyses. In the subgroup of 2514 patients who underwent ablation procedures without stab phlebectomy, those undergoing EVLA showed a trend toward a higher incidence of DVT (2.6% vs 1.4%; P = .057). After adjusting for patient demographics, DVT was 2.4 times more likely to develop in patients presenting with lower extremity ulcers than in those without ulcers (odds ratio, 2.4; 95% confidence interval, 1.01-6.11; P = .04). Although not statistically significant, the multivariate model found that when only ablation procedures were performed, EVLA was associated with an 83% increase in odds of DVT compared with RFA (odds ratio, 1.83; 95% confidence interval, 0.95-3.52; P = .06).The incidence of venous thromboembolic events after saphenous ablation is low. However, given that patients with lower extremity ulcers experienced an increased risk of DVT, care should be taken to ensure that the ablation catheter is positioned an appropriate distance from the saphenofemoral or sapheno-popliteal junction and that periprocedural preventative measures, such as anticoagulation prophylaxis, early ambulation, and lower extremity compression, are emphasized. The finding of a trend toward increased venous thromboembolic events in patients undergoing EVLA warrants further investigation in a large patient population.
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- 2013
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24. Receipt of Cancer Screening Is a Predictor of Life Expectancy
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James S. Goodwin, Kristin M Sheffield, Shuang Li, and Alai Tan
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Gerontology ,Male ,medicine.medical_specialty ,01 natural sciences ,03 medical and health sciences ,0302 clinical medicine ,Life Expectancy ,Predictive Value of Tests ,Neoplasms ,Cancer screening ,Internal Medicine ,medicine ,Mammography ,Humans ,Mass Screening ,030212 general & internal medicine ,0101 mathematics ,Intensive care medicine ,Early Detection of Cancer ,Aged ,Retrospective Studies ,Original Research ,Receipt ,Aged, 80 and over ,medicine.diagnostic_test ,business.industry ,010102 general mathematics ,Capsule Commentary ,Cancer ,Retrospective cohort study ,Prostate-Specific Antigen ,medicine.disease ,United States ,3. Good health ,Prostate-specific antigen ,Predictive value of tests ,Life expectancy ,Female ,Kallikreins ,business ,Follow-Up Studies - Abstract
Obtaining cancer screening on patients with limited life expectancy has been proposed as a measure for low quality care for primary care physicians (PCPs). However, administrative data may underestimate life expectancy in patients who undergo screening.To determine the association between receipt of screening mammography or PSA and overall survival.Retrospective cohort study from 1/1/1999 to 12/31/2012. Receipt of screening was assessed for 2001-2002 and survival from 1/1/2003 to 12/31/2012. Life expectancy was estimated as of 1/1/03 using a validated algorithm, and was compared to actual survival for men and women, stratified by receipt of cancer screening.A 5 % sample of Medicare beneficiaries aged 69-90 years as of 1/1/2003 (n = 906,723).Receipt of screening mammography in 2001-2002 for women, or a screening PSA test in 2002 for men.Survival from 1/1/2003 through 12/31/2012.Subjects were stratified by life expectancy based on age and comorbidity. Within each stratum, the subjects with prior cancer screening had actual median survivals higher than those who were not screened, with differences ranging from 1.7 to 2.1 years for women and 0.9 to 1.1 years for men. In a Cox model, non-receipt of screening in women had an impact on survival (HR = 1.52; 95 % CI = 1.51, 1.54) similar in magnitude to a diagnosis of complicated diabetes or heart failure, and was comparable to uncomplicated diabetes or liver disease in men (HR = 1.23; 1.22, 1.25).Receipt of cancer screening is a powerful marker of health status that is not captured by comorbidity measures in administrative data. Because life expectancy algorithms using administrative data underestimate the life expectancy of patients who undergo screening, they can overestimate the problem of cancer screening in patients with limited life expectancy.
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- 2016
25. The effect of depression on stage at diagnosis, treatment, and survival in pancreatic adenocarcinoma
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Yimei Han, Casey A. Boyd, Yong Fang Kuo, Jaime Benarroch-Gampel, Kristin M. Sheffield, and Taylor S. Riall
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Male ,Oncology ,medicine.medical_specialty ,Comorbidity ,Disease ,Adenocarcinoma ,Article ,Cohort Studies ,Treatment Refusal ,Sex Factors ,Pancreatic cancer ,Internal medicine ,Epidemiology ,medicine ,Humans ,Survival rate ,Depression (differential diagnoses) ,Aged ,Neoplasm Staging ,Depression ,business.industry ,Age Factors ,Cancer ,medicine.disease ,Surgery ,Pancreatic Neoplasms ,Survival Rate ,Female ,business - Abstract
Depression has been associated with delayed presentation, inadequate treatment, and poor survival in patients with cancer.Using Surveillance, Epidemiology and End Results and Medicare linked data (1992-2005), we identified patients with pancreatic adenocarcinoma (N = 23,745). International classification of diseases, 9th edition, clinical modification codes were used to evaluate depression during the 3 to 27 months before the diagnosis of cancer. The effect of depression on receipt of therapy and survival was evaluated in univariate and multivariate models.Of patients with pancreatic cancer in our study, 7.9% had a diagnosis of depression (N = 1,868). Depression was associated with increased age, female sex, white race, single or widowed status, and advanced stage disease (P.0001). In an adjusted model, patients with locoregional disease and depression had 37% lower odds of undergoing surgical resection (odds ratio, 0.63; 95% confidence interval, 0.52-0.76). In patients with locoregional disease, depression was associated with lower 2-year survival (hazard ratio, 1.20; 95% confidence interval, 1.09-1.32). After adjusting for surgical resection, this association was attenuated (hazard ratio, 1.14; 95% confidence interval, 1.04-1.26). In patients who underwent surgical resection, depression was a significant predictor of survival (hazard ratio, 1.34; 95% confidence interval, 1.04-1.73). Patients with distant disease and depression had 21% lower odds of receiving chemotherapy (odds ratio, 0.79; 95% confidence interval, 0.70-0.90). After adjusting for chemotherapy for distant disease, depression was no longer a significant predictor of survival (hazard ratio, 1.03; 95% confidence interval, 0.97-1.09).The decreased survival associated with depression appears to be mediated by a lower likelihood of appropriate treatment in depressed patients. Accurate recognition and treatment of pancreatic cancer patients with depression may improve treatment rates and survival.
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- 2012
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26. Hospital and Medical Care Days in Pancreatic Cancer
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Kristin M. Sheffield, Daniel W. Branch, James S. Goodwin, Yimei Han, Yong Fang Kuo, Casey A. Boyd, and Taylor S. Riall
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Male ,medicine.medical_specialty ,MEDLINE ,Adenocarcinoma ,Article ,Cohort Studies ,Surgical oncology ,Patient-Centered Care ,Pancreatic cancer ,medicine ,Humans ,Survival rate ,Aged ,Neoplasm Staging ,Patient Care Team ,business.industry ,General surgery ,Cancer ,Length of Stay ,Prognosis ,medicine.disease ,Pancreatic Neoplasms ,Survival Rate ,medicine.anatomical_structure ,Oncology ,Female ,Surgery ,business ,Pancreas ,Follow-Up Studies ,SEER Program ,Cohort study - Abstract
Little is known about resource utilization (number of days in the hospital or medical care) between diagnosis and death in patients with pancreatic cancer.Using Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data, we identified 25,476 patients with pancreatic cancer (1992-2005). Hospital and medical care days per person-month from the time of diagnosis were described, stratified by stage, treatment, and survival duration.Hospital/medical care days vary by length of survival and treatment strategy in patients with pancreatic cancer. For all stages, patients were in the hospital a mean of 6.4 days and received medical care a total of 9.0 days in the first month after diagnosis, decreasing to 1.7 and 3.7 days per month, respectively, by the end of the first year. Hospital/medical care days per month of life were higher in patients with shorter survival but increased sharply at the end of life in all patients, regardless of duration of survival. In patients with locoregional disease, resection was associated with a higher number of hospital/medical care days during the first 4 months after diagnosis, but fewer at the end of the first year. For distant disease, hospital days were similar but days in medical care were higher for patients receiving chemotherapy, increasing especially at the end of life.This study is the first to quantify hospital/medical care days in patients with pancreatic cancer by stage, treatment, and survival. This information will provide realistic expectations and allow for treatment decisions based on patient preferences.
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- 2012
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27. PS02.15 Evaluating the Uptake of Newly Marketed Drugs Using Real-World Data: An Example of Anti-PD-1s in Advanced Non-Small Cell Lung Cancer
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Yajun Emily Zhu, Y. Fang, Kristin M Sheffield, Yu-Jing Huang, G. Cuyun Carter, and Katherine B. Winfree
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Pulmonary and Respiratory Medicine ,Oncology ,medicine.medical_specialty ,business.industry ,Internal medicine ,medicine ,Non small cell ,Lung cancer ,medicine.disease ,business ,Real world data - Published
- 2017
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28. Colonoscopist and Primary Care Physician Supply and Disparities in Colorectal Cancer Screening
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Yu-Li Lin, Jaime Benarroch-Gampel, Taylor S. Riall, Yong Fang Kuo, Kristin M. Sheffield, and James S. Goodwin
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Male ,Gerontology ,Multivariate analysis ,Colorectal cancer ,Ethnic group ,Colonoscopy ,Medicare ,Health Services Accessibility ,Physicians, Primary Care ,White People ,Odds ,medicine ,Humans ,Mass Screening ,Healthcare Disparities ,Early Detection of Cancer ,Mass screening ,Aged ,medicine.diagnostic_test ,business.industry ,Health Policy ,Primary care physician ,Hispanic or Latino ,medicine.disease ,Texas ,United States ,Black or African American ,Colorectal cancer screening ,Multivariate Analysis ,Linear Models ,Female ,Colorectal Neoplasms ,business ,Research Article ,Demography - Abstract
OBJECTIVE. : To determine whether racial/ethnic disparities in colonoscopy use vary by physician availability. DATA SOURCE. : We used 100 percent Texas Medicare claims data for 2003-2007. STUDY DESIGN. : We identified beneficiaries aged 66-79 in 2007, examined racial/ethnic differences in colonoscopy use from 2003 to 2007, and estimated the percentage of white, black, and Hispanic beneficiaries who underwent colonoscopy by level of physician availability and area income. PRINCIPAL FINDINGS. : For the 974,879 beneficiaries, colonoscopy use was higher in whites (40.7 percent) compared to blacks (35.0 percent) and Hispanics (28.7 percent, p< .001). For whites, increasing availability of colonoscopists and primary care physicians (PCPs) was associated with higher colonoscopy use. For blacks and Hispanics, colonoscopy use was unchanged or decreased with increases in colonoscopist and PCP availability. In multilevel models, the odds of colonoscopy were 20 percent lower for blacks (OR 0.80, 95 percent CI 0.79-0.82) and 32 percent lower for Hispanics (OR 0.68, 95 percent CI 0.66-0.69) compared to whites; adjusting for availability of colonoscopists or PCPs did not attenuate racial/ethnic disparities. We found greater racial/ethnic disparities in areas with greater colonoscopist and PCP availability. CONCLUSIONS. : Greater area availability of colonoscopists and PCPs is associated with increased use of colonoscopy in whites but decreased use in minorities, resulting in larger racial/ethnic disparities.
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- 2011
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29. Gallstone pancreatitis in older patients: Are we operating enough?
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Taylor S. Riall, Dong Zhang, Kristin M. Sheffield, Casey A. Boyd, Courtney M. Townsend, Jaime Benarroch-Gampel, and Marc D. Trust
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Male ,medicine.medical_specialty ,Databases, Factual ,medicine.medical_treatment ,Gallstones ,Kaplan-Meier Estimate ,Medicare ,Patient Readmission ,Article ,Cohort Studies ,Sphincterotomy, Endoscopic ,Postoperative Complications ,Recurrence ,Risk Factors ,Acute care ,Outcome Assessment, Health Care ,medicine ,Humans ,Geriatric Assessment ,Survival rate ,Aged ,Proportional Hazards Models ,Retrospective Studies ,Aged, 80 and over ,Cholangiopancreatography, Endoscopic Retrograde ,First episode ,Endoscopic retrograde cholangiopancreatography ,medicine.diagnostic_test ,business.industry ,General surgery ,Retrospective cohort study ,medicine.disease ,United States ,Survival Rate ,Treatment Outcome ,Cholecystectomy, Laparoscopic ,Pancreatitis ,Multivariate Analysis ,Practice Guidelines as Topic ,Female ,Surgery ,Cholecystectomy ,Guideline Adherence ,business ,Follow-Up Studies - Abstract
The recommended therapy for mild gallstone pancreatitis is cholecystectomy on initial hospitalization.Using a 5% national Medicare sample (1996-2005), we evaluated adherence to current recommendations for gallstone pancreatitis (cholecystectomy rates on initial hospitalization and the use of endoscopic retrograde cholangiopancreatography [ERCP]/sphincterotomy). We evaluated predictors of cholecystectomy, gallstone-related readmissions, and 2-year mortality.Adherence to current guidelines was low. Only 57% of 8,452 Medicare beneficiaries presenting to an acute care hospital with a first episode of mild gallstone pancreatitis underwent cholecystectomy on initial hospitalization. Of the patients who did not undergo cholecystectomy, 55% were never evaluated by a surgeon. Likewise, only 28% of patients who did not undergo cholecystectomy had a sphincterotomy. The 2-year readmission rates were higher among patients who did not undergo cholecystectomy (44% vs 4%; P.0001), and 33% of these patients required cholecystectomy after discharge. In the no cholecystectomy group, ERCP prevented readmissions (hazard ratio, 0.53; 95% confidence interval, 0.47-0.61) and when readmissions occurred they were less likely to be for gallstone pancreatitis in patients who had an ERCP (27.8% vs 53.2%; P.0001). On multivariate analysis, patients who were older, black, admitted to a nonsurgical service, lived in certain US regions, and had specific comorbidities were less likely to undergo cholecystectomy.Adherence to current recommendations for the management of mild gallstone pancreatitis is low in older patients. Our data suggest that40% of patients who did not undergo cholecystectomy would have benefited from early definitive therapy. Implementation of policies to increase adherence to guidelines would prevent gallstone-related morbidity and mortality in older patients.
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- 2011
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30. Implementation of a Critical Pathway for Complicated Gallstone Disease: Translation of Population-Based Data into Clinical Practice
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Courtney M. Townsend, Taylor S. Riall, Kenia E. Ramos, William J. Mileski, Carlos J. Jimenez, Clarisse D. Djukom, Kristin M. Sheffield, and Thomas D. Kimbrough
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Adult ,Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Population ,Comorbidity ,Gallstones ,Patient Readmission ,Article ,Postoperative Complications ,medicine ,Humans ,Cholecystectomy ,education ,Cholangiopancreatography, Endoscopic Retrograde ,education.field_of_study ,Chi-Square Distribution ,Evidence-Based Medicine ,business.industry ,General surgery ,Gallbladder ,Length of Stay ,Middle Aged ,medicine.disease ,Genetic translation ,Surgery ,medicine.anatomical_structure ,Pancreatitis ,Critical Pathways ,Female ,business ,Chi-squared distribution - Abstract
Evidence-based guidelines recommend cholecystectomy during initial hospitalization for complicated gallstone disease. Previous studies and quality initiative data from our institution demonstrated that only 40% to 75% of patients underwent cholecystectomy on index admission.In January 2009, we implemented a critical pathway to improve cholecystectomy rates for all patients emergently admitted for acute cholecystitis, mild gallstone pancreatitis, or common bile duct stones. We compared cholecystectomy rates during initial hospitalization, time to cholecystectomy, length of initial stay, and readmission rates in prepathway (January 2005 to February 2008) and postpathway patients (January 2009 to May 2010).Demographic and clinical characteristics were similar between prepathway (n = 455) and postpathway patients (n = 112). Cholecystectomy rates during initial hospitalization increased from 48% to 78% after pathway implementation (p0.0001). There were no differences in operative mortality or operative complications between the 2 groups. For patients undergoing cholecystectomy on initial hospitalization, the mean length of stay decreased after pathway implementation (7.1 days to 4.5 days; p0.0001), primarily due to a decrease in the time from admission to cholecystectomy (4.1 days to 2.1 days; p0.0001). Thirty-three percent of prepathway and 10% of postpathway patients required readmission for gallstone-related problems or operative complications (p0.0001), and each readmission generated an average of $19,000 in additional charges.Implementation of a multidisciplinary critical pathway improved cholecystectomy rates on initial hospitalization and lowered costs by shortening length of stay and markedly decreasing readmission rates for gallstone-related problems. Broader implementation of similar pathways offers the potential to translate evidence-based guidelines into clinical practice and minimize the cost of medical care.
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- 2011
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31. End-of-life care in Medicare beneficiaries dying with pancreatic cancer
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Taylor S. Riall, Catherine D. Cooksley, Jamie Benarroch-Gampel, Yong Fang Kuo, Casey A. Boyd, and Kristin M. Sheffield
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Cancer Research ,medicine.medical_specialty ,Chemotherapy ,business.industry ,medicine.medical_treatment ,MEDLINE ,Cancer ,medicine.disease ,Intensive care unit ,law.invention ,Oncology ,law ,Internal medicine ,Pancreatic cancer ,Acute care ,Epidemiology ,medicine ,Intensive care medicine ,business ,End-of-life care - Abstract
BACKGROUND: The authors' goal was to characterize hospice enrollment and aggressiveness of care for pancreatic cancer patients at the end of life. METHODS: Surveillance, Epidemiology, and End Results and linked Medicare claims data (1992-2006) were used to identify patients with pancreatic cancer who had died (n = 22,818). The authors evaluated hospice use, hospice enrollment ≥4 weeks before death, and aggressiveness of care as measured by receipt of chemotherapy, acute care hospitalization, and intensive care unit (ICU) admission in the last month of life. RESULTS: Overall, 56.9% of patients enrolled in hospice, and 35.9% of hospice users enrolled for 4 weeks or more. Hospice use increased from 36.2% in 1992-1994 to 67.2% in 2004-2006 (P < .0001). Admission to the ICU and receipt of chemotherapy in the last month of life increased from 15.5% to 19.6% (P < .0001) and from 8.1% to 16.4% (P < .0001), respectively. Among patients with locoregional disease, those who underwent resection were less likely to enroll in hospice before death and much less likely to enroll early. They were also more likely to receive chemotherapy (14% vs 9%, P < .0001), be admitted to an acute care hospital (61% vs 53%, P < .0001), and be admitted to an ICU (27% vs 15%, P < .0001) in the last month of life. CONCLUSIONS: Although hospice use increased over time, there was a simultaneous decrease in early enrollment and increase in aggressive care at the end of life for patients with pancreatic cancer. Cancer 2011;. © 2011 American Cancer Society.
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- 2011
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32. Resection Benefits Older Adults with Locoregional Pancreatic Cancer Despite Greater Short-Term Morbidity and Mortality
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Kristin M. Sheffield, James S. Goodwin, Yong Fang Kuo, Taylor S. Riall, and Courtney M. Townsend
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Geriatrics ,medicine.medical_specialty ,education.field_of_study ,business.industry ,medicine.medical_treatment ,Hazard ratio ,Population ,Retrospective cohort study ,medicine.disease ,Comorbidity ,Surgery ,Pancreatectomy ,Epidemiology ,medicine ,Geriatrics and Gerontology ,education ,business ,Survival rate - Abstract
OBJECTIVES: To evaluate time trends in surgical resection rates and operative mortality in older adults diagnosed with locoregional pancreatic cancer and to determine the effect of age on surgical resection rates and 2-year survival after surgical resection. DESIGN: Retrospective cohort study using data from the Surveillance, Epidemiology, and End Results (SEER) and linked Medicare claims database (1992�2005). SETTING: Secondary data analysis of population-based tumor registry and linked claims data. PARTICIPANTS: Medicare beneficiaries aged 66 and older diagnosed with locoregional pancreatic cancer (N=9,553), followed from date of diagnosis to time of death or censorship. MEASUREMENTS: Percentage of participants undergoing surgical resection, 30-day operative mortality after resection, and 2-year survival according to age group. RESULTS: Surgical resection rates increased significantly, from 20% in 1992 to 29% in 2005, whereas 30-day operative mortality rates decreased from 9% to 5%. After controlling for multiple factors, participants were less likely to be resected with older age. Resection was associated with lower hazard of death, regardless of age, with hazard ratios of 0.46, 0.51, 0.47, 0.43, and 0.35 for resected participants younger than 70, 70 to 74, 75 to 79, 80 to 84, and 85 and older respectively compared with unresected participants younger than 70 (P
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- 2011
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33. PS02.18 Characterization of Patients with KRAS-Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Community Practice Setting
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Julie Beyrer, M.E. Boye, Li Li, Kristin M Sheffield, L. Zhang, Cliff Molife, William J. John, G. Cuyun Carter, K. Frantz, Catherine Muehlenbein, and Shirish M. Gadgeel
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Pulmonary and Respiratory Medicine ,Oncology ,medicine.medical_specialty ,business.industry ,non-small cell lung cancer (NSCLC) ,medicine.disease ,medicine.disease_cause ,Internal medicine ,medicine ,Community practice ,KRAS ,Intensive care medicine ,business - Published
- 2017
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34. Overall survival (OS) in patients (pts) with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP): A real-world retrospective study
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Paolo Abada, Allicia C. Girvan, Aditya Raju, Pamela Landsman-Blumberg, Kristin Hennenfent, Aafia Chaudhry, Eileen Farrelly, Catherine K Herren, Lee Bowman, and Kristin M Sheffield
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Cancer Research ,medicine.medical_specialty ,Elevated alpha-fetoprotein ,business.industry ,Retrospective cohort study ,medicine.disease ,Gastroenterology ,digestive system diseases ,Survival benefit ,Oncology ,Hepatocellular carcinoma ,Internal medicine ,medicine ,Overall survival ,In patient ,business ,neoplasms - Abstract
e15658 Background: HCC is associated with a worse prognosis in pts with high baseline AFP levels. The relationship between elevated baseline AFP and survival benefit with systemic HCC treatments in the real world setting is poorly characterized. Methods: A retrospective analysis of clinical outcomes among newly diagnosed advanced HCC pts treated in US community-based oncology practice settings was conducted. Pts treated with sorafenib or best-supportive care (BSC) between 10/1/2007 and 12/31/2013 were identified in the International Oncology Network electronic medical record (EMR) database and were followed until date of death, date of last visit, or 06/30/2014 (end of study). Baseline demographics, clinical characteristics, and AFP (≤ or > 400 ng/mL), plus date of death were extracted from the EMR and physician progress notes. Treatment differences in OS were evaluated and stratified by AFP, AST/ALT, and bilirubin using unadjusted Cox proportional hazards regression models. Results: A total of 370 advanced HCC pts receiving sorafenib (217) or BSC (153) were identified. The mean age was 65.6 years and 77.0% were male. Cirrhosis (38.4%), hepatitis C (36.8%), and alcoholic liver disease (22.4%) were common hepatic-related comorbidities. 45.1% of pts had elevated AFP ( > 400 ng/mL) at baseline. The sorafenib cohort had significantly longer median OS time than the BSC cohort (29.6 vs 19.7 weeks, p= 0.048). OS for sorafenib vs BSC cohorts with AFP≤400 ng/mL and AFP > 400 ng/mL were 45.1 vs 25.3 weeks ( p= 0.128) and 25.3 vs 13.1 weeks ( p =0.197), respectively. Cox models revealed a consistent effect of sorafenib vs. BSC, regardless of AFP level (AFP ≤400ng/mL: HR = 0.79 (95% CI 0.55-1.13), p= 0.200; AFP > 400 ng/mL: HR = 0.80 (95% CI 0.53-1.52), p= 0.297). Conclusions: This study supports the poor prognosis for advanced HCC pts with baseline AFP levels > 400 ng/mL compared to baseline AFP ≤400 ng/mL. Limitations with retrospective, real-world studies require caution in interpretation, but this analysis suggests an OS benefit with sorafenib treatment compared to BSC. There remains an unmet need for effective therapies for advanced HCC associated with elevated AFP levels.
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- 2017
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35. Factors associated with delayed gastric emptying after pancreaticoduodenectomy
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Gabriela M. Vargas, Henry A. Pitt, Taylor S. Riall, Kristin M. Sheffield, E. Molly Kilbane, Abhishek D. Parmar, and Bruce L. Hall
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Male ,Reoperation ,medicine.medical_specialty ,Percutaneous ,Gastroparesis ,Time Factors ,medicine.medical_treatment ,030230 surgery ,Pancreaticoduodenectomy ,03 medical and health sciences ,Pancreatic Fistula ,0302 clinical medicine ,Risk Factors ,Sepsis ,medicine ,Odds Ratio ,Humans ,Prospective Studies ,Prospective cohort study ,Aged ,Chi-Square Distribution ,Gastric emptying ,Hepatology ,business.industry ,fungi ,Gastroenterology ,Odds ratio ,Original Articles ,Middle Aged ,medicine.disease ,United States ,3. Good health ,Surgery ,Logistic Models ,Treatment Outcome ,Gastric Emptying ,Pancreatic fistula ,030220 oncology & carcinogenesis ,Pancreatectomy ,Multivariate Analysis ,Female ,business - Abstract
BackgroundThe factors associated with delayed gastric emptying (DGE) after a pancreaticoduodenectomy (PD) are not definitively known.MethodsFrom November 2011 through to May 2012, data were prospectively collected on 711 patients undergoing a pancreaticoduodenectomy or total pancreatectomy as part of the American College of Surgeons‐National Surgical Quality Improvement Program Pancreatectomy Demonstration Project. Bivariate and multivariate models were employed to determine the factors that predicted DGE.ResultsIn the 711 patients, the overall rate of DGE was 20.1%. In a bivariate analysis, intra‐operative factors such as pylorus‐preservation (47.1% versus 43.7%, P = 0.40), intra‐operative drain placement (85.5%, versus 85.1%, P = 0.91) and an antecolic compared with a retrocolic gastrojejunostomy (60.1% versus 65.1%, P = 0.26) were not different between the DGE and no DGE groups. Pancreatic fistula formation (31.2% versus 10.1%), post‐operative sepsis (21.7% versus 7.0%), organ space surgical site infection (SSI) (23.9% versus 7.9%), need for percutaneous drainage (23.0% versus 10.6%) and reoperation (10.6% versus 3.1%) were higher in patients with DGE (P < 0.0001). In a multivariable model, only pancreatic fistula, post‐operative sepsis and reoperation were independently associated with DGE.DiscussionIn this multicentre study, only post‐operative complications were associated with DGE. Neither pylorus preservation nor route of enteric reconstruction (antecolic versus retrocolic) was associated with delayed gastric emptying.
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- 2013
36. Potentially inappropriate screening colonoscopy in Medicare patients: variation by physician and geographic region
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Yimei Han, Taylor S. Riall, James S. Goodwin, Kristin M. Sheffield, and Yong Fang Kuo
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Male ,medicine.medical_specialty ,Attitude of Health Personnel ,Ethnic group ,Colonoscopy ,Health Services Misuse ,Medicare ,Article ,Cohort Studies ,Internal Medicine ,Medicine ,Humans ,Aged ,Retrospective Studies ,Aged, 80 and over ,medicine.diagnostic_test ,business.industry ,Multilevel model ,Retrospective cohort study ,medicine.disease ,Texas ,United States ,Emergency medicine ,Cohort ,Geographic regions ,Regression Analysis ,Residence ,Female ,Medical emergency ,business ,Cohort study - Abstract
Importance Inappropriate use of colonoscopy involves unnecessary risk for older patients and consumes resources that could be used more effectively. Objectives To determine the frequency of potentially inappropriate colonoscopy in Medicare beneficiaries in Texas and to examine variation among physicians and across geographic regions. Design, Setting, and Participants This retrospective cohort study used 100% Medicare claims data for Texas and a 5% sample from the United States from 2000 through 2009. We identified Medicare beneficiaries aged 70 years or older who underwent a colonoscopy from October 1, 2008, through September 30, 2009. Main Outcome Measures Colonoscopies were classified as screening in the absence of a diagnosis suggesting an indication for the procedure. Screening colonoscopy was considered potentially inappropriate on the basis of patient age or occurrence too soon after colonoscopy with negative findings. The percentage of patients undergoing potentially inappropriate screening colonoscopy was estimated for each colonoscopist and hospital service area. Results A large percentage of colonoscopies performed in older adults were potentially inappropriate: 23.4% for the overall Texas cohort and 9.9%, 38.8%, and 24.9%, respectively, in patients aged 70 to 75, 76 to 85, or 86 years or older. There was considerable variation across the 797 colonoscopists in the percentages of colonoscopies performed that were potentially inappropriate. In a multilevel model including patient sex, race or ethnicity, number of comorbid conditions, educational level, and urban or rural residence, 73 colonoscopists had percentages significantly above the mean (23.9%), ranging from 28.7% to 45.5%, and 119 had percentages significantly below the mean (23.9%), ranging from 6.7% to 18.6%. The colonoscopists with percentages significantly above the mean were more likely to be surgeons, graduates of US medical schools, medical school graduates before 1990, and higher-volume colonoscopists than those with percentages significantly below the mean. Colonoscopist rankings were fairly stable over time (2006-2007 vs 2008-2009). There was also geographic variation across Texas and the United States, with percentages ranging from 13.3% to 34.9% in Texas and from 19.5% to 30.5% across the United States. Conclusions and Relevance Many colonoscopies performed in older adults may be inappropriate. The likelihood of undergoing potentially inappropriate colonoscopy depends in part on where patients live and what physician they see.
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- 2013
37. Physician follow-up and observation of guidelines in the post treatment surveillance of colorectal cancer
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Abhishek D. Parmar, Gabriela M. Vargas, Kimberly M. Brown, Kristin M. Sheffield, Taylor S. Riall, and Yimei Han
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Male ,medicine.medical_specialty ,Colorectal cancer ,MEDLINE ,Colonoscopy ,Physical examination ,Multimodal Imaging ,Physicians, Primary Care ,Article ,Carcinoembryonic antigen ,medicine ,Humans ,Stage (cooking) ,Aged ,Aged, 80 and over ,biology ,medicine.diagnostic_test ,business.industry ,General surgery ,Cancer ,medicine.disease ,Surgery ,Carcinoembryonic Antigen ,Positron emission tomography ,Positron-Emission Tomography ,biology.protein ,Female ,Guideline Adherence ,Neoplasm Recurrence, Local ,business ,Colorectal Neoplasms ,Tomography, X-Ray Computed ,Follow-Up Studies - Abstract
Guidelines for post resection surveillance of colorectal cancer recommend a collection of the patient's history and physical examination, testing for carcinoembryonic antigen (CEA), and colonoscopy. No consistent guidelines exist for the use of abdominal computed tomography (CT) and position emission tomography (PET)/PET-CT. The goal of our study was to describe current trends, the impact of oncologic follow-up on guideline adherence, and the patterns of use of nonrecommended tests.We used Texas Cancer Registry-Medicare-linked data (2000-2009) to identify physician visits, CEA testing, colonoscopy, abdominal CT, and PET/PET-CT scans in patients ≥ 66 years old with stage I-III colorectal cancer who underwent curative resection. Compliance with guidelines was assessed with a composite measure of physician visits, CEA tests, and colonoscopy use from start of surveillance.In patients who survived 3 years, the overall compliance with guidelines was 25.1%. In patients seen regularly by a medical oncologist, compliance with guidelines increased to 61.5% compared with 8.8% for those not seen by a medical oncologist regularly (P.0001). The use of abdominal CT and PET/PET-CT increased from 57.5% and 9.5%, respectively, in 2001 to 65.8% and 24.6% (P.0001) in 2006. Patients who saw a medical oncologist were more likely to get cross-sectional imaging than those who did not (P.0001).Compliance with current minimum guidelines for post treatment surveillance of colorectal cancer is low and the use of nonrecommended testing has increased over time. Both compliance and use of nonrecommended tests are markedly increased in patients seen by a medical oncologist. The comparative effectiveness of CT and PET/PET-CT in the surveillance of colorectal cancer patients needs further examination.
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- 2013
38. Quality of post-treatment surveillance of early stage breast cancer in Texas
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Kristin M. Sheffield, Celia Chao, Yimei Han, Taylor S. Riall, Abhishek D. Parmar, and Gabriela M. Vargas
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medicine.medical_specialty ,Population ,Physical examination ,Breast Neoplasms ,Article ,Breast cancer ,medicine ,Mammography ,Humans ,Stage (cooking) ,education ,Aged ,Neoplasm Staging ,Aged, 80 and over ,education.field_of_study ,medicine.diagnostic_test ,business.industry ,Cancer ,Ductal carcinoma ,medicine.disease ,Magnetic Resonance Imaging ,Positron emission tomography ,Positron-Emission Tomography ,Surgery ,Female ,Radiology ,Neoplasm Recurrence, Local ,business ,Tomography, X-Ray Computed - Abstract
Only annual mammography and physical examination are recommended for the post-treatment surveillance of early stage breast cancer.We used Texas Cancer Registry-Medicare linked data (2001-2007) to identify physician visits and use of mammography, magnetic resonance imaging (MRI), computed tomography (CT), and positron emission tomography (PET) CT in patients ≥ 66 years old with ductal carcinoma in situ and stage I-III ductal carcinoma who underwent curative-intent operations. We also evaluated the trends in use of recommended and nonrecommended tests.We identified 8,598 patients with resected ductal carcinoma in situ (37.3%) or invasive ductal cancer (62.7%). Breast-conserving therapy was performed in 59%. Only 55% saw a physician twice a year for 2 years and underwent annual mammography for 2 consecutive years in the surveillance period. Mammography use decreased from 81% in 2001 to 75% in 2007 (P.0001), and breast MRI use rose from 0.5% to 7.0% (P.0001). For asymptomatic patients, the use of CT/MRI of the abdomen, chest, and head was 27%, 23%, and 22%, and this slightly increased during the study period. There was a significant increase in PET/PET CT use, from 2% in 2001 to 9% in 2007 (P.0001). There was a concomitant decrease in bone scan use from 21% in 2001 to 13% in 2007 (P.0001).Adherence to evidence-based guidelines has been substandard and the use of nonrecommended tests has persisted over the study period. The rise in PET use and attendant decrease in bone scan implicates a population receiving PET scan in lieu of bone scan for surveillance of asymptomatic metastatic disease. In an elderly population of breast cancer patients in Texas, these findings imply both underuse and overuse.
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- 2013
39. MINI01.19: Cost Analysis of Pemetrexed-Platinum with Maintenance vs. Paclitaxel-Carboplatin-Bevacizumab with Maintenance in Patients with Lung Cancer
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Kristin M Sheffield, Catherine Muehlenbein, Stewart Wetmore, Lisa M. Hess, Collin Churchill, Yajun Emily Zhu, and Katherine B. Winfree
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Pulmonary and Respiratory Medicine ,Oncology ,medicine.medical_specialty ,Bevacizumab ,business.industry ,medicine.disease ,Pemetrexed ,Internal medicine ,medicine ,Cost analysis ,In patient ,Paclitaxel carboplatin ,business ,Lung cancer ,medicine.drug - Published
- 2016
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40. Variation in the Use of Intraoperative Cholangiography during Cholecystectomy
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Yimei Han, Taylor S. Riall, Kristin M. Sheffield, Courtney M. Townsend, James S. Goodwin, and Yong Fang Kuo
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Adult ,Male ,medicine.medical_specialty ,Adolescent ,medicine.medical_treatment ,Gallstones ,Article ,Cohort Studies ,Young Adult ,Case mix index ,Cholangiography ,Interquartile range ,medicine ,Humans ,Cholecystectomy ,Young adult ,Practice Patterns, Physicians' ,Aged ,Aged, 80 and over ,Intraoperative Care ,Common bile duct ,medicine.diagnostic_test ,business.industry ,General surgery ,Middle Aged ,medicine.disease ,Texas ,Hospitals ,Surgery ,surgical procedures, operative ,medicine.anatomical_structure ,Logistic Models ,Linear Models ,Female ,business ,Cohort study - Abstract
The role of intraoperative cholangiography (IOC) in prevention of common bile duct (CBD) injuries and the management of CBD stones is controversial, and current variation in use of IOC has not been well described.Multilevel hierarchical models using data from the Texas Hospital Inpatient Discharge Public Use data files (2001 to 2008) were used to evaluate the percentage of variance in the use of IOC that was attributable to patient, surgeon, and hospital factors.A total of 176,981 cholecystectomies were performed in 212 hospitals in Texas. There was wide variation in IOC use, ranging from 2.4% to 98.4% of cases among surgeons and 3.7% to 94.8% of cases among hospitals, even after adjusting for case mix differences. The percentage of variance in IOC use attributable to the surgeon was 20.7% and an additional 25.7% was attributable to the hospital. IOC use was associated with increased age, gallstone pancreatitis or CBD stones, Hispanic race, decreased illness severity, insurance, and later year of cholecystectomy. ERCP (24.0% vs 14.9%, p0.0001) and CBD exploration (1.63% vs 0.42%, p0.0001) were more commonly performed in patients undergoing IOC.Uncertainty regarding the benefit of IOC leads to wide variation in use across surgeons and hospitals. The surgeon and hospital are more important determinants of IOC use than measured patient characteristics. Our study highlights the need for further evaluation of comparative effectiveness of IOC in the prevention of CBD injuries and retained stones, taking into account patient risk factors, surgeon skill, cost, and availability of local expertise.
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- 2012
41. Population-Based Analysis of Venous Thrombotic Events Following Saphenous Ablation
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Lois A. Killewich, Jaime Benarroch-Gampel, Taylor S. Riall, Casey A. Boyd, and Kristin M. Sheffield
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medicine.medical_specialty ,Radiofrequency ablation ,business.industry ,Incidence (epidemiology) ,medicine.medical_treatment ,medicine.disease ,Ablation ,Pulmonary embolism ,law.invention ,Surgery ,Small saphenous vein ,Catheter ,law ,Concomitant ,Varicose veins ,medicine ,medicine.symptom ,business ,Cardiology and Cardiovascular Medicine - Abstract
Background: Venous thrombotic events following great and small saphenous vein ablation procedures for varicose veins have been reported. Current knowledge of these events is based on single institution studies with small sample sizes. Methods: The National Surgical Quality Improvement Program (NSQIP) database (2005-2009) was used to identify a total of 3,874 patients who underwent radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) of the great and small saphenous veins with or without stab phlebectomy. Outcome variables included clinically documented postoperative deep vein thrombosis (DVT) or pulmonary embolism (PE). Bivariate and multivariate logistic regression analyses were performed to identify factors associated with venous thrombotic events after ablation procedures. Results: A total of 2,897 (74.8%) patients underwent RFA and 977 (25.2%) underwent EVLA for lower extremity varicose veins. Patients who underwent RFA were more likely to be older (53.8 y vs 51.8 y, P .0001), obese (42.8% vs 38%, P .009), diabetic (8.5% vs 6.4%, P .01) hypertensive (31.9% vs 26.8%, P .002) and to have undergone procedures involving both veins (24% vs 4%, P .0001). Patients who underwent EVLA were more likely to have received general anesthesia (56.9% vs 40.8%, P .0001), to have undergone concomitant stab phlebectomy (44.9% vs 31.7%, P .0001), and had longer operative times (63.6 min vs. 57.3 min, P .0001). The incidence of DVT (1.74% vs 1.52%, P .63) and pulmonary embolus (0.07% vs 0%, P 1) were similar between EVLA and RFA. No significant predictors of DVT in the postoperative period were identified on bivariate or multivariate analyses. In the subgroup of patients who underwent ablation procedures only (no stab phlebectomy, N 2514), there was a trend toward higher incidence of DVT in patients undergoing EVLA (2.6% vs 1.4%, P .057). After adjusting for patient demographics, patients presenting with lower extremity ulcers were 2.4 times more likely to develop DVT compared to those without ulcers (OR 2.4, 95% CI 1.01-6.11, P .04). In the multivariate model when only ablation procedures were performed, EVLA was associated with an 83% increase in odds of DVT compare to RFA, although not statistically significant (OR 1.83, 95% CI 0.95-3.52, P .06). Conclusions: The incidence of venous thrombotic events after saphenous ablation is low. However, given that patients with lower extremity ulcers experienced an increased risk of DVT, care should be taken to ensure that the ablation catheter is positioned an appropriate distance from the sapheno-femoral or sapheno-popliteal junction, and postprocedural preventative measures such as early ambulation and lower extremity compression should be emphasized. The finding of a trend toward increased venous thrombotic events in patients undergoing EVLA warrants further investigation in a large patient population.
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- 2012
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42. Surveillance of pancreatic cancer patients after surgical resection
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Kristin M. Sheffield, James S. Goodwin, Taylor S. Riall, Clarisse D. Djukom, Yu Li Lin, and Kristen T. Crowell
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Male ,medicine.medical_specialty ,Office Visits ,Adenocarcinoma ,Medicare ,Article ,Cohort Studies ,Pancreatic cancer ,Cause of Death ,Epidemiology ,medicine ,Adjuvant therapy ,Humans ,Postoperative Period ,Survival rate ,Aged ,business.industry ,General surgery ,Primary care physician ,Cancer ,Chemoradiotherapy, Adjuvant ,medicine.disease ,United States ,Pancreatic Neoplasms ,Survival Rate ,Oncology ,Lymphatic Metastasis ,Population Surveillance ,Surgery ,Female ,Neoplasm Recurrence, Local ,business ,Tomography, X-Ray Computed ,Chemoradiotherapy ,Cohort study - Abstract
There are no clear recommendations to guide posttreatment surveillance in patients with pancreatic cancer. Our goal was to describe the posttreatment surveillance patterns in patients undergoing curative-intent resection for pancreatic cancer. We used Surveillance, Epidemiology, and End Results (SEER)–Medicare linked data (1992–2005) to identify CT scans and physician visits in patients with pancreatic cancer who underwent curative resection (n = 2393). Surveillance began 90 days after surgery, and patients were followed for 2 years at 6-month intervals. Patients were censored if they died, experienced recurrence of disease, or entered hospice. A total of 2045 patients survived uncensored to the beginning of the surveillance period. CT scan use decreased from 20.9% of patients in month 4 to 6.4% in month 27. There was no temporal pattern in CT use to suggest regular surveillance. Twenty-three percent of patients did not receive a CT scan in the year after surgery, increasing to 42% the second year. Patients who underwent adjuvant therapy and patients diagnosed in later years had higher CT scan use over the surveillance periods. Most patients visited both a primary care physician and a cancer specialist in each 6-month surveillance period. Patients who visited cancer specialists were more likely to have any CT scan and to be scanned more frequently. Current surveillance patterns after resection for pancreatic cancer reflect the lack of established guidelines, implying a need for evaluation and standardization of surveillance protocols. The lack of a temporal pattern in CT testing suggests that most were obtained to evaluate symptoms rather than for routine surveillance.
- Published
- 2011
43. 415 Patients with Adenosquamous Carcinoma of the Pancreas: A Population-Based Analysis of Prognosis and Survival
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Jaime Benarroch-Gampel, Kristin M. Sheffield, Casey A. Boyd, Taylor S. Riall, and Catherine D. Cooksley
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Oncology ,Adult ,Male ,medicine.medical_specialty ,Adenosquamous carcinoma ,Population ,Pancreatic Adenosquamous Carcinoma ,Article ,Carcinoma, Adenosquamous ,Internal medicine ,medicine ,Carcinoma ,Humans ,education ,Survival rate ,Aged ,Neoplasm Staging ,education.field_of_study ,business.industry ,Retrospective cohort study ,Middle Aged ,medicine.disease ,Prognosis ,Pancreatic Neoplasms ,Survival Rate ,medicine.anatomical_structure ,Adenocarcinoma ,Surgery ,Female ,Pancreas ,business - Abstract
Adenosquamous carcinoma of the pancreas is rare. Our understanding of the disease and its prognosis comes mainly from small retrospective studies.Using the Surveillance, Epidemiology, and End Results (SEER) database (1988 to 2007), we identified patients with adenosquamous carcinoma (n = 415) or adenocarcinoma (n = 45,693) of the pancreas. The demographics, tumor characteristics, resection status, and survival were compared between the groups.Compared with patients with adenocarcinoma, patients with adenosquamous carcinoma were more likely to have disease located in the pancreatic body and tail (44.6% versus 53.5%, P0.0001). While the stage distribution was similar between the two groups, adenosquamous carcinomas were more likely to be poorly differentiated (71% versus 45%, P0.0001), node positive (53% versus 47%, P0.0001), and larger (5.7 versus 4.3 cm, P0.0001). For locoregional disease, resection increased over time from 26% in 1988 to 56% in 2007. The overall 2-y survival was 11% in both groups. Following resection, patients with adenosquamous carcinoma had worse 2-y survival (29% versus 36%, P0.0001). Resection was the strongest independent predictor of survival for patients with locoregional pancreatic adenosquamous carcinoma (HR 2.35, 95% CI = 1.47-3.76).This is the first population-based study to evaluate outcomes in adenosquamous carcinoma of the pancreas. Compared with pancreatic adenocarcinoma, adenosquamous carcinoma was more likely to occur in the pancreatic tail, be poorly differentiated, larger, and node positive. The long-term survival following surgical resection is significantly worse for adenosquamous cancers; however, patients with adenosquamous carcinoma can still benefit from surgical resection, which is the strongest predictor of survival.
- Published
- 2011
44. Management of Synchronous Colorectal Cancer Liver Metastases in Older Patients
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Nina P. Tamirisa, Abhishek D. Parmar, Taylor S. Riall, Kimberly M. Brown, Kristin M. Sheffield, and Gabriela M. Vargas
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Oncology ,medicine.medical_specialty ,Older patients ,business.industry ,Colorectal cancer ,Internal medicine ,medicine ,Surgery ,business ,medicine.disease - Published
- 2014
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45. Neighborhood Context and Cognitive Decline in Older Mexican Americans: Results From the Hispanic Established Populations for Epidemiologic Studies of the Elderly
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Kristin M. Sheffield and M. Kristen Peek
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Gerontology ,Male ,Longitudinal study ,Epidemiology ,Original Contributions ,Health Status ,Population ,Social class ,Odds ,Interviews as Topic ,Residence Characteristics ,Risk Factors ,Mexican Americans ,medicine ,Southwestern United States ,Humans ,Longitudinal Studies ,Cognitive decline ,education ,Socioeconomic status ,Aged ,Aged, 80 and over ,education.field_of_study ,Cognitive disorder ,Cognition ,Censuses ,social sciences ,medicine.disease ,Logistic Models ,Socioeconomic Factors ,Female ,Psychology ,Cognition Disorders - Abstract
In previous research on cognitive decline among older adults, investigators have not considered the potential impact of contextual variables, such as neighborhood-level conditions. In the present investigation, the authors examined the association between 2 neighborhood-context variables-socioeconomic status and percentage of Mexican-American residents-and individual-level cognitive function over a 5-year follow-up period (1993-1998). Data were obtained from the Hispanic Established Populations for Epidemiologic Studies of the Elderly, a longitudinal study of community-dwelling older Mexican Americans (n = 3,050) residing in the southwestern United States. Individual records were linked with 1990 US Census tract data, which provided information on neighborhood characteristics. Hierarchical linear growth-curve models and hierarchical logistic models were used to examine relations between individual- and neighborhood-level variables and the rate and incidence of cognitive decline. Results showed that baseline cognitive function and rates of cognitive decline varied significantly across US Census tracts. Respondents living in economically disadvantaged neighborhoods experienced significantly faster rates of cognitive decline than those in more advantaged neighborhoods. Odds of incident cognitive decline decreased as a function of neighborhood percentage of Mexican-American residents and increased with neighborhood economic disadvantage. The authors conclude that neighborhood context is associated with late-life cognitive function and that the effects are independent of individual-level risk factors.
- Published
- 2009
46. PS38. Increased Rate of Myocardial Infarction with Carotid Endarterectomy Under General Anesthesia: A Population-Based Study
- Author
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Taylor S. Riall, Lois A. Killewich, Lorraine Choi, Jaime Benarroch-Gampel, Kristin M. Sheffield, and Casey A. Boyd
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medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Carotid endarterectomy ,medicine.disease ,Population based study ,Internal medicine ,Anesthesia ,medicine ,Cardiology ,Surgery ,Myocardial infarction ,business ,Cardiology and Cardiovascular Medicine - Published
- 2012
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47. Mo1575 Cost-Effectiveness of Elective Cholecystectomy vs. Observation in Older Patients Presenting With Mild Biliary Disease
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Gabriela M. Vargas, Abhishek D. Parmar, Nina P. Tamirisa, Kristin M. Sheffield, Mark D. Coutin, and Taylor S. Riall
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Biliary disease ,medicine.medical_specialty ,Elective cholecystectomy ,Hepatology ,Older patients ,business.industry ,Cost effectiveness ,General surgery ,Gastroenterology ,Medicine ,business ,medicine.disease ,Surgery - Published
- 2014
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48. Trajectory of Care and Use of Multimodality Therapy in Patients with Locoregional Pancreatic Adenocarcinoma
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Gabriela M. Vargas, Abhishek D. Parmar, Kristin M. Sheffield, Nina P. Tamirisa, and Taylor S. Riall
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Oncology ,medicine.medical_specialty ,business.industry ,Internal medicine ,medicine ,Adenocarcinoma ,Surgery ,In patient ,Multimodality Therapy ,Radiology ,medicine.disease ,business - Published
- 2014
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49. Association Between Cholecystectomy With vs Without Intraoperative Cholangiography and Risk of Common Duct Injury
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Yimei Han, Yong Fang Kuo, James S. Goodwin, Courtney M. Townsend, Taylor S. Riall, and Kristin M. Sheffield
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medicine.medical_specialty ,medicine.diagnostic_test ,business.industry ,medicine.medical_treatment ,General surgery ,Biliary dyskinesia ,Retrospective cohort study ,General Medicine ,Biliary colic ,medicine.disease ,Logistic regression ,Surgery ,Cholangiography ,Cholecystitis ,Medicine ,Cholecystectomy ,medicine.symptom ,business ,Cohort study - Abstract
Importance Significant controversy exists regarding routine intraoperative cholangiography in preventing common duct injury during cholecystectomy. Objective To investigate the association between intraoperative cholangiography use during cholecystectomy and common duct injury. Design, Setting, and Participants Retrospective cohort study of all Texas Medicare claims data from 2000 through 2009. We identified Medicare beneficiaries 66 years or older who underwent inpatient or outpatient cholecystectomy for biliary colic or biliary dyskinesia, acute cholecystitis, or chronic cholecystitis. We compared results from multilevel logistic regression models to the instrumental variable analyses. Interventions Intraoperative cholangiography use during cholecystectomy was determined at the level of the patients (yes/no), hospitals (percentage intraoperative cholangiography use for all cholecystectomies at the hospital), and surgeons (percentage use for all cholecystectomies performed by the surgeon). Percentage of use at the hospital and percentage of use by surgeon were the instrumental variables. Main Outcomes and Measures Patients with claims for common duct repair operations within 1 year of cholecystectomy were considered as having major common duct injury. Results Of 92 932 patients undergoing cholecystectomy, 37 533 (40.4%) underwent concurrent intraoperative cholangiography and 280 (0.30%) had a common duct injury. The common duct injury rate was 0.21% among patients with intraoperative cholangiography and 0.36% among patients without it. In a logistic regression model controlling for patient, surgeon, and hospital characteristics, the odds of common duct injury for cholecystectomies performed without intraoperative cholangiography were increased compared with those performed with it (OR, 1.79 [95% CI, 1.35-2.36]; P P = .31). Conclusions and Relevance When confounders were controlled with instrumental variable analysis, there was no statistically significant association between intraoperative cholangiography and common duct injury. Intraoperative cholangiography is not effective as a preventive strategy against common duct injury during cholecystectomy.
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- 2013
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50. Post-Treatment Surveillance in Locoregional Breast Cancer: Guideline Adherence and Patterns in Use of Non-Recommended Testing
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Taylor S. Riall, Celia Chao, Gabriela M. Vargas, Kristin M. Sheffield, Abhishek D. Parmar, and Yimei Han
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medicine.medical_specialty ,Breast cancer ,business.industry ,Guideline adherence ,medicine ,Surgery ,Post treatment ,Intensive care medicine ,medicine.disease ,business - Published
- 2013
- Full Text
- View/download PDF
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