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BACKGROUND AND AIMS: Risk factors for pancreatic cancer among patients with pancreatic cysts are incompletely characterized. The primary aim of this study was to evaluate risk factors for development of pancreatic cancer among patients with pancreatic cysts. METHODS: We conducted a retrospective case-control study of U.S. veterans with a suspected diagnosis of branch-duct intraductal papillary mucinous neoplasm from 1999 to 2013. RESULTS: Age (hazard ratio [HR], 1.03 per year; 95% confidence interval [CI], 1.00-1.06), larger cyst size at cyst diagnosis (HR, 1.03 per mm; 95% CI, 1.01-1.04), cyst growth rate (HR, 1.22 per mm/y; 95% CI, 1.14-1.31), and pancreatic duct dilation (5-9.9 mm: HR, 3.78; 95% CI, 1.90-7.51; ≥10 mm: HR, 13.57; 95% CI, 5.49-33.53) were found to be significant predictors for pancreatic cancer on multivariable analysis. CONCLUSIONS: Age, cyst size, cyst growth rate, and high-risk or worrisome features were associated with a higher risk of developing pancreatic cancer. Applying current and developing novel strategies is required to optimize early detection of pancreatic cancer after cyst diagnosis.
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Carcinoma Ductal Pancreático , Cisto Pancreático , Neoplasias Pancreáticas , Humanos , Estudos de Casos e Controles , Estudos Retrospectivos , Neoplasias Pancreáticas/diagnóstico , Neoplasias Pancreáticas/epidemiologia , Neoplasias Pancreáticas/complicações , PâncreasRESUMO
BACKGROUND AND AIMS: Traditional serrated adenomas (TSAs) may confer increased risk for colorectal cancer (CRC). Our objective with this study was to examine clinical characteristics and long-term outcomes associated with TSA diagnosis. METHODS: We conducted a retrospective cohort study of U.S. Veterans ≥18 years of age with ≥1 TSA between 1999 and 2018. Baseline characteristics, colonoscopy findings, and diagnosis of incident and fatal CRC were abstracted. Advanced neoplasia was defined by CRC or adenoma with high-grade dysplasia, villous histology, or size ≥1 cm. Follow-up was through CRC diagnosis, death, or end of study (December 31, 2018). RESULTS: A total of 853 Veterans with a baseline TSA were identified; 74% were ≥60 years of age, 96% were men, 14% were Black, and 73% were non-Hispanic White. About 64% were current or former smokers. Over 2044 total person-years at follow-up, there were 11 incident CRC cases and 1 CRC death. Cumulative CRC incidence was 1.34% (95% confidence interval [CI], 0.67%-2.68%), and cumulative CRC death was 0.12% (95% CI, 0.00%-0.35%). Among the subset of 378 TSA patients with ≥1 surveillance colonoscopy, 65.1% had high-risk neoplasia on follow-up. CRC incidence among TSA patients was significantly higher than in a comparison cohort of patients with normal baseline colonoscopy at baseline (hazard ratio, 3.70; 95% CI, 1.63-8.41) and similar to a comparison cohort with baseline conventional advanced adenoma (hazard ratio, 0.86; 95% CI, 0.45-1.64). CONCLUSION: Individuals with TSA have substantial risk for CRC based on their cumulative CRC incidence, as well as significant risk of developing other high-risk neoplasia at follow-up surveillance colonoscopy. These data underscore importance of current recommendations for close colonoscopy surveillance after TSA diagnosis.
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Adenoma , Pólipos do Colo , Neoplasias Colorretais , Neoplasias Gastrointestinais , Masculino , Humanos , Feminino , Estudos de Coortes , Pólipos do Colo/patologia , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/patologia , Estudos Retrospectivos , Fatores de Risco , Adenoma/diagnóstico , ColonoscopiaRESUMO
BACKGROUND AND AIMS: Postpolypectomy risk stratification for subsequent metachronous advanced neoplasia (MAN) is imprecise and does not account for colonoscopist adenoma detection rate (ADR). Our aim was to assess association of ADR with MAN and create a prediction model for postpolypectomy risk stratification incorporating ADR and other factors. METHODS: We conducted a retrospective cohort study of individuals with baseline polypectomy and subsequent surveillance colonoscopy from 2004 to 2016 within the U.S. Department of Veterans Affairs (VA). Clinical factors, polyp findings, and baseline colonoscopist ADR were considered for the model. Model performance (sensitivity, specificity, and area under the curve) for identifying individuals with MAN was compared with 2020 U.S. Multi-Society Task Force on Colorectal Cancer (USMSTF) surveillance recommendations. RESULTS: A total of 30,897 individuals were randomly assigned 2:1 into independent model training and validation sets. Increasing age, male sex, diabetes, current smoking, adenoma number, polyp location, adenoma ≥10 mm or with tubulovillous/villous features, and decreasing colonoscopist ADR were independently associated with MAN. A range of 1.48- to 1.66-fold increased risk for MAN was observed for ADR in the lowest 3 quintiles (ADR <19.7%-39.3%) vs the highest quintile (ADR >47.0%). When the final model selected based on the training set was applied to the validation set, improved sensitivity and specificity over 2020 USMSTF risk stratification were achieved (P = .001), with an area under the curve of 0.62 (95% confidence interval, 0.60-0.64). CONCLUSIONS: Colonoscopist ADR is associated with MAN. Combining clinical factors and ADR for risk stratification has potential to improve postpolypectomy risk stratification. Improving ADR is likely to improve postpolypectomy outcomes.
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Adenoma , Pólipos do Colo , Neoplasias Colorretais , Segunda Neoplasia Primária , Pólipos , Humanos , Masculino , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/cirurgia , Estudos Retrospectivos , Adenoma/diagnóstico , Adenoma/epidemiologia , Colonoscopia , Pólipos do Colo/diagnóstico , Pólipos do Colo/cirurgiaRESUMO
INTRODUCTION: Colorectal cancer (CRC) incidence and mortality rates are increasing in adults aged <50 years. Young-onset adenoma (YOA)-adenoma detected in adults younger than 50 years-may signify increased CRC risk, but this association has not been widely studied. Our aim was to compare the risk of incident and fatal CRC in adults aged <50 years with YOA diagnosis compared with those with a normal colonoscopy. METHODS: We conducted a cohort study of US Veterans aged 18-49 years who received colonoscopy between 2005 and 2016. The primary exposure of interest was YOA. Primary outcomes included incident and fatal CRC. We used Kaplan-Meier curves to calculate cumulative incident and fatal CRC risk and Cox models to examine relative CRC risk. RESULTS: The study cohort included 54,284 Veterans aged <50 years exposed to colonoscopy, among whom 13% (n = 7,233) had YOA at start of follow-up. Cumulative 10-year CRC incidence was 0.11% (95% confidence interval [CI]: 0.00%-0.27%) after any adenoma diagnosis, 0.18% (95% CI: 0.02%-0.53%) after advanced YOA diagnosis, 0.10% (95% CI: 0.00%-0.28%) after nonadvanced adenoma diagnosis, and 0.06% (95% CI: 0.02%-0.09%) after normal colonoscopy. Veterans with advanced adenoma had 8-fold greater incident CRC risk than those with normal colonoscopy (hazard ratio: 8.0; 95% CI: 1.8-35.6). Across groups, no differences in fatal CRC risk were observed. DISCUSSION: Young-onset advanced adenoma diagnosis was associated with 8-fold increased incident CRC risk compared with normal colonoscopy. However, cumulative CRC incidence and mortality at 10 years among individuals with either young onset non-advanced or advanced adenoma diagnosis were both relatively low.
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Adenoma , Neoplasias Colorretais , Adulto , Humanos , Estudos de Coortes , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Colonoscopia , Risco , Incidência , Adenoma/diagnóstico , Adenoma/epidemiologia , Detecção Precoce de Câncer , Fatores de RiscoRESUMO
BACKGROUND: Delays in colonoscopy work-up for red flag signs or symptoms of colorectal cancer (CRC) during the COVID-19 pandemic are not well characterized. AIMS: To examine colonoscopy uptake and time to colonoscopy after red flag diagnosis, before and during the COVID-19 pandemic. METHODS: Cohort study of adults ages 50-75 with iron deficiency anemia (IDA), hematochezia, or abnormal stool blood test receiving Veterans Health Administration (VHA) care from April 2019 to December 2020. Index date was first red flag diagnosis date, categorized into "pre" (April-December 2019) and "intra" (April-December 2020) policy implementation prioritizing diagnostic procedures, allowing for a 3-month "washout" (January-March 2020) period. Outcomes were colonoscopy completion and time to colonoscopy pre- vs. intra-COVID-19, examined using multivariable Cox models with hazard ratios (aHRs) and 95% confidence intervals (CIs). RESULTS: There were 52,539 adults with red flag signs or symptoms (pre-COVID: 25,154; washout: 7527; intra-COVID: 19,858). Proportion completing colonoscopy was similar pre- vs. intra-COVID-19 (27.0% vs. 26.5%; p = 0.24). Median time to colonoscopy among colonoscopy completers was similar for pre- vs. intra-COVID-19 (46 vs. 42 days), but longer for individuals with IDA (60 vs. 49 days). There was no association between time period and colonoscopy completion (aHR: 0.99, 95% CI 0.95-1.03). CONCLUSIONS: Colonoscopy work-up of CRC red flag signs and symptoms was not delayed within VHA during the COVID-19 pandemic, possibly due to VHA policies supporting prioritization and completion. Further work is needed to understand how COVID-19 policies on screening and surveillance impact CRC-related outcomes, and how to optimize colonoscopy completion after a red flag diagnosis.
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COVID-19 , Neoplasias Colorretais , Veteranos , Adulto , Humanos , Pessoa de Meia-Idade , Idoso , Estudos de Coortes , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/prevenção & controle , Pandemias , COVID-19/epidemiologia , Ferro , Colonoscopia , Detecção Precoce de Câncer/métodosRESUMO
BACKGROUND AND AIMS: Pancreatic cancer incidence and mortality among patients with pancreas cysts are unclear. The aims of this study are to evaluate incidence of pancreatic cancer and cause-specific mortality among patients with pancreatic cysts using a large national cohort over a long follow-up period. METHODS: We conducted a retrospective cohort study of US Veterans diagnosed with a pancreatic cyst 1999-2013, based on International Classification of Diseases, 9th edition (ICD9) coding within national Department of Veterans Affairs (VA) data. Pancreatic cancer incidence was ascertained using VA cancer registry data, ICD-9 codes, and the National Death Index, a national centralized database of death records, including cause-specific mortality. RESULTS: Among 7211 Veterans with pancreatic cysts contributing 31,501 person-years of follow-up (median follow-up 4.4 years), 79 (1.1%) developed pancreatic cancer. A total of 1982 patients (27.5%) died during the study follow-up period. Sixty-three patients (3.2% of deaths; 0.9% of pancreas cyst cohort) died from pancreatic cancer, but the leading causes of death in the cohort were non-pancreatic cancer (n = 498, 25% of deaths) and cardiovascular disease (n = 398, 20% of deaths). CONCLUSIONS: Pancreas cancer incidence and pancreatic cancer-associated mortality are very low in a large national cohort of VA pancreatic cyst patients with long-term follow-up. Most deaths were from non-pancreas cancers and cardiovascular causes, and only a minority (3.2%) were attributable to pancreas cancer. Given death from pancreas cancer is rare, future research should focus on identifying criteria for selecting individuals at high risk for death from pancreatic cancer for pancreatic cyst surveillance.
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Cisto Pancreático , Neoplasias Pancreáticas , Estudos de Coortes , Humanos , Incidência , Pâncreas , Cisto Pancreático/epidemiologia , Neoplasias Pancreáticas/epidemiologia , Estudos Retrospectivos , Neoplasias PancreáticasRESUMO
BACKGROUND & AIMS: The incidence and mortality of early-onset colorectal cancer (CRC) are increasing. Adenoma detection, removal, and subsequent endoscopic surveillance might modify risk of CRC diagnosed before age 50 years (early-onset CRC). We conducted a systematic review of young-onset adenoma (YOA) prevalence, associated risk factors, and rate of metachronous advanced neoplasia after YOA diagnosis. METHODS: We performed a systematic search of multiple electronic databases through February 12, 2019 and identified studies of individuals 18 to 49 years old that reported prevalence of adenoma, risk factors for adenoma, and/or risk for metachronous advanced neoplasia. Summary estimates were derived using random effects meta-analysis, when feasible. RESULTS: The pooled overall prevalence of YOA was 9.0% (95% CI, 7.1%-11.4%), based on 24 studies comprising 23,142 individuals. On subgroup analysis, the pooled prevalence of YOA from autopsy studies was 3.9% (95% CI, 1.9%-7.6%), whereas the prevalence from colonoscopy studies was 10.7% (95% CI, 8.5%-13.5). Only advancing age was identified as a consistent risk factor for YOA, based on 4 studies comprising 78,880 individuals. Pooled rate of metachronous advanced neoplasia after baseline YOA diagnosis was 6.0% (95% CI, 4.1%-8.6%), based on 3 studies comprising 1493 individuals undergoing follow-up colonoscopy, with only 1 CRC case reported. Overall, few studies reported metachronous advanced neoplasia and no studies evaluated whether routine surveillance colonoscopy decreases risk of CRC. CONCLUSIONS: In a systematic review, we estimated the prevalence of YOA to be 9% and to increase with age. Risk for metachronous advanced neoplasia after YOA diagnosis is estimated to be 6%. More research is needed to understand the prevalence, risk factors, and risk of CRC associated with YOA.
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Adenoma , Pólipos do Colo , Neoplasias Colorretais , Adenoma/epidemiologia , Adolescente , Adulto , Colonoscopia , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/epidemiologia , Humanos , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Adulto JovemRESUMO
BACKGROUND & AIMS: Colorectal cancer (CRC) incidence and mortality are increasing among persons younger than 50 years old in the United States, but risk factors associated with early-onset CRC (EOCRC) have not been widely studied. METHODS: We conducted a case-control study of US veterans 18 to 49 years old who underwent colonoscopy examinations from 1999 through 2014. EOCRC cases were identified from a national cancer registry; veterans who were free of CRC at their baseline colonoscopy through 3 years of follow-up were identified as controls. We collected data on age, sex, race/ethnicity, body weight, body mass index (BMI), diabetes, smoking status, and aspirin use. Multivariate-adjusted EOCRC odds were estimated for each factor, with corresponding 95% confidence interval (CI) values. RESULTS: Our final analysis included 651 EOCRC cases and 67,416 controls. Median age was 45.3 years, and 82.3% were male. Higher proportions of cases were older, male, current smokers, nonaspirin users, and had lower BMIs, compared with controls (P < .05). In adjusted analyses, increasing age and male sex were significantly associated with increased risk of EOCRC, whereas aspirin use and being overweight or obese (relative to normal BMI) were significantly associated with decreased odds of EOCRC. In post hoc analyses, weight loss of 5 kg or more within the 5-year period preceding colonoscopy was associated with higher odds of EOCRC (odds ratio 2.23; 95% CI 1.76-2.83). CONCLUSIONS: In a case-control study of veterans, we found increasing age and male sex to be significantly associated with increased risk of EOCRC, and aspirin use to be significantly associated with decreased risk; these factors also affect risk for CRC onset after age 50. Weight loss may be an early clinical sign of EOCRC. More intense efforts are required to identify the factors that cause EOCRC and signs that can be used to identify individuals at highest risk.
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Neoplasias Colorretais/epidemiologia , Adolescente , Adulto , Fatores Etários , Idade de Início , Aspirina/uso terapêutico , Estudos de Casos e Controles , Colonoscopia/estatística & dados numéricos , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/fisiopatologia , Neoplasias Colorretais/prevenção & controle , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Sistema de Registros/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Estados Unidos/epidemiologia , Serviços de Saúde para Veteranos Militares/estatística & dados numéricos , Redução de Peso/fisiologia , Adulto JovemRESUMO
PURPOSE: Standardized approaches for rigorous validation of phenotyping from large-scale electronic health record (EHR) data have not been widely reported. We proposed a methodologically rigorous and efficient approach to guide such validation, including strategies for sampling cases and controls, determining sample sizes, estimating algorithm performance, and terminating the validation process, hereafter referred to as the San Diego Approach to Variable Validation (SDAVV). METHODS: We propose sample size formulae which should be used prior to chart review, based on pre-specified critical lower bounds for positive predictive value (PPV) and negative predictive value (NPV). We also propose a stepwise strategy for iterative algorithm development/validation cycles, updating sample sizes for data abstraction until both PPV and NPV achieve target performance. RESULTS: We applied the SDAVV to a Department of Veterans Affairs study in which we created two phenotyping algorithms, one for distinguishing normal colonoscopy cases from abnormal colonoscopy controls and one for identifying aspirin exposure. Estimated PPV and NPV both reached 0.970 with a 95% confidence lower bound of 0.915, estimated sensitivity was 0.963 and specificity was 0.975 for identifying normal colonoscopy cases. The phenotyping algorithm for identifying aspirin exposure reached a PPV of 0.990 (a 95% lower bound of 0.950), an NPV of 0.980 (a 95% lower bound of 0.930), and sensitivity and specificity were 0.960 and 1.000. CONCLUSIONS: A structured approach for prospectively developing and validating phenotyping algorithms from large-scale EHR data can be successfully implemented, and should be considered to improve the quality of "big data" research.
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Algoritmos , Registros Eletrônicos de Saúde , Big Data , Valor Preditivo dos Testes , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: Aspirin impacts risk for important outcomes such as cancer, cardiovascular disease, and gastrointestinal bleeding. However, ascertaining exposure to medications available both by prescription and over-the-counter such as aspirin for research and quality improvement purposes is a challenge. OBJECTIVES: Develop and validate a strategy for ascertaining aspirin exposure, utilizing a combination of structured and unstructured data. RESEARCH DESIGN: This is a retrospective cohort study. SUBJECTS: In total, 1,869,439 Veterans who underwent usual care colonoscopy 1999-2014 within the Department of Veterans Affairs. MEASURES: Aspirin exposure and dose were obtained from an ascertainment strategy combining query of structured medication records available in electronic health record databases and unstructured data extracted from free-text progress notes. Prevalence of any aspirin exposure and dose-specific exposure were estimated. Positive predictive value and negative predictive value were used to assess strategy performance, using manual chart review as the reference standard. RESULTS: Our combined strategy for ascertaining aspirin exposure using structured and unstructured data reached a positive predictive value and negative predictive value of 99.2% and 97.5% for any exposure, and 92.6% and 98.3% for dose-specific exposure. Estimated prevalence of any aspirin exposure was 36.3% (95% confidence interval: 36.2%-36.4%) and dose-specific exposure was 35.4% (95% confidence interval: 35.3%-35.5%). CONCLUSIONS: A readily accessible approach utilizing a combination of structured medication records and query of unstructured data can be used to ascertain aspirin exposure when manual chart review is impractical.
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Aspirina/uso terapêutico , Coleta de Dados/métodos , Registros Eletrônicos de Saúde/estatística & dados numéricos , Adulto , Idoso , Aspirina/efeitos adversos , Colonoscopia/estatística & dados numéricos , Bases de Dados Factuais , Prescrições de Medicamentos/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medicamentos sem Prescrição/uso terapêutico , Estudos Retrospectivos , Sensibilidade e Especificidade , Estados Unidos/epidemiologia , Veteranos/estatística & dados numéricosRESUMO
BACKGROUND & AIMS: The most commonly used noninvasive test for colorectal cancer (CRC) screening has been the guaiac fecal occult blood test (gFOBT). The fecal immunochemical test (FIT) detects CRC and colorectal polyps with higher levels of sensitivity than the gFOBT, and may be more acceptable to patients. However, the FIT has not replaced the gFOBT in many clinical settings. We analyzed data from a large healthcare system that replaced the gFOBT with the FIT to determine the effects on CRC screening. METHODS: We conducted a retrospective observational study of 7898 patients at the Veterans' Administration San Diego Healthcare System, 50-75 years old, who were offered stool-based CRC screening as part of primary care March 2014 through January 2015. Test orders and results were extracted from electronic health records; we performed manual reviews of colonoscopy and pathology reports for Veterans with positive results from the tests. Our primary outcome was test completion within 1 year of order; secondary outcomes were positive results and detection of advanced neoplasia by diagnostic colonoscopy. The primary analysis used an intention-to-screen approach, which included all patients with test orders; as-screened analyses were also performed. RESULTS: Among 7898 patients, 3236 had gFOBT and 4662 FIT orders. In the intention to screen analysis, a significantly higher proportion of subjects completed a FIT (42.6%) than a gFOBT (33.4%) (P < .001); advanced neoplasia was detected in a significantly higher proportion of subjects offered a FIT (0.79%) than a gFOBT (0.28%) (P = .003). The numbers needed to invite to achieve 1 additional completed test and identify 1 additional patient with advanced neoplasia were 11 and 196, respectively. CONCLUSIONS: In a retrospective study of patients at a Veterans' administration healthcare system, replacing the gFOBT with the FIT increased the proportion of patients who completed CRC screening. Replacement of the gFOBT with the FIT should be strongly considered by all healthcare systems.
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Neoplasias Colorretais/diagnóstico , Testes Diagnósticos de Rotina/métodos , Detecção Precoce de Câncer/métodos , Fezes/química , Sangue Oculto , Idoso , California , Testes Diagnósticos de Rotina/estatística & dados numéricos , Detecção Precoce de Câncer/estatística & dados numéricos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos RetrospectivosRESUMO
Background and Aims: There are limited contemporary population-based data on Helicobacter pylori epidemiology and outcomes in the United States. Our primary aim was to create a validated cohort of veterans with H pylori testing or treatment using Veterans Health Administration data. Methods: Using Veterans Health Administration structured and unstructured data, we developed and validated 4 algorithms for H pylori infection (3 algorithms) and treatment status (1 algorithm). During the development phase, we iteratively modified each algorithm based on a manual review of random sets of electronic health records (reference standard). The a priori validation goal was to achieve a one-sided 95% confidence lower bound (LB) for positive predictive value (PPV) and/or negative predictive value (NPV) >90%. We applied the Bonferroni correction when both PPV and NPV were relevant. Results: For H pylori infection, we achieved 99.0% PPV (LB = 94.6%) and 100% NPV (LB = 96.4%) for discriminating H pylori positive vs negative status using structured (ie, laboratory tests) and 95% PPV (LB = 90.3%) and 97.9% NPV (LB = 93.9%) using unstructured (ie, histopathology reports) data. Diagnostic codes achieved 98% PPV (LB = 93.0%) for H pylori diagnosis. The treatment algorithm was composed of multiple antimicrobial combinations and overall achieved ≥98% PPV (LB = 93.0%) for H pylori treatment, except for amoxicillin/levofloxacin (PPV<60%). Application of these algorithms yielded nearly 1.2 million veterans with H pylori testing and/or treatment between 1999 and 2018. Conclusion: We assembled a validated national cohort of veterans who were tested or treated for H pylori infection. This cohort can be used for evaluating H pylori epidemiology and treatment patterns, as well as complications of chronic infection.
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OBJECTIVE: To conduct an anatomic site-specific case-control study of candidate colorectal cancer (CRC) risk factors. DESIGN: Case-control study of US veterans with >1 colonoscopy during 1999-2011. Cases had cancer registry-identified CRC at colonoscopy, while controls were CRC free at colonoscopy and within 3 years of colonoscopy. Primary outcome was CRC, stratified by anatomic site: proximal, distal, or rectal. Candidate risk factors included age, sex, race/ethnicity, body mass index, height, diabetes, smoking status, and aspirin exposure summarised by adjusted ORs and 95% CIs. RESULTS: 21 744 CRC cases (n=7017 rectal; n=7039 distal; n=7688 proximal) and 612 646 controls were included. Males had significantly higher odds relative to females for rectal cancer (OR=2.84, 95% CI 2.25 to 3.58) than distal cancer (OR=1.84, 95% CI 1.50 to 2.24). Relative to whites, blacks had significantly lower rectal cancer odds (OR=0.88, 95% CI 0.82 to 0.95), but increased distal (OR=1.27, 95% CI 1.19 to 1.37) and proximal odds (OR=1.62, 95% CI 1.52 to 1.72). Diabetes prevalence was more strongly associated with proximal (OR=1.29, 95% CI 1.22 to 1.36) than distal (OR=1.15, 95% CI 1.08 to 1.22) or rectal cancer (OR=1.12, 95% CI 1.06 to 1.19). Current smoking was more strongly associated with rectal cancer (OR=1.81, 95% CI 1.68 to 1.95) than proximal cancer (OR=1.53, 95% CI 1.43 to 1.65) or distal cancer (OR=1.46, 95% CI 1.35 to 1.57) compared with never smoking. Aspirin use was significantly more strongly associated with reduced rectal cancer odds (OR=0.71, 95% CI 0.67 to 0.76) than distal (OR=0.85, 95% CI 0.81 to 0.90) or proximal (OR=0.91, 95% CI 0.86 to 0.95). CONCLUSION: Candidate CRC risk factor associations vary significantly by anatomic site. Accounting for site may enable better insights into CRC pathogenesis and cancer control strategies.
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INTRODUCTION: Metformin may be associated with reduced colorectal cancer (CRC) risk, but findings from previous studies have been inconsistent and had insufficient sample sizes to examine whether the association differs by anatomic site. This study examined whether metformin was associated with reduced CRC risk, both overall and stratified by anatomic site, in a large sample of persons with diabetes who underwent colonoscopy. METHODS: We performed a case-control study of US Veterans with prevalent diabetes who underwent colonoscopy between 1999 and 2014 using Department of Veterans Affairs electronic health record data. Cases were defined by presence of CRC at colonoscopy, while controls had normal colonoscopy. The primary exposure was metformin use at time of colonoscopy (yes/no). Association of metformin exposure with CRC (further stratified by proximal, distal, or rectal subsite) was examined using multivariable and multinomial logistic regression and summarized by odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: We included 6,650 CRC patients and 454,507 normal colonoscopy patients. CRC cases were older and had lower metformin exposure. Metformin was associated with 8% relative reduction in CRC odds (OR: 0.92, 95% CI: 0.87-0.96). By subsite, metformin was associated with a 14% statistically significant reduced rectal cancer odds (OR: 0.86, 95% CI: 0.78-0.94) but no reduced distal or proximal cancer odds. DISCUSSION: Metformin was associated with reduced CRC odds-particularly rectal cancer-in a large sample of persons with diabetes undergoing colonoscopy.
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Neoplasias Colorretais/epidemiologia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Detecção Precoce de Câncer , Metformina/farmacologia , Medição de Risco/métodos , Programa de SEER , Idoso , Neoplasias Colorretais/diagnóstico , Neoplasias Colorretais/prevenção & controle , Feminino , Seguimentos , Humanos , Hipoglicemiantes/farmacologia , Incidência , Masculino , Pessoa de Meia-Idade , Razão de Chances , Estudos Retrospectivos , Fatores de Risco , Estados Unidos/epidemiologiaRESUMO
PURPOSE: Cancer ascertainment using large-scale electronic health records is a challenge. Our aim was to propose and apply a structured approach for evaluating multiple candidate approaches for cancer ascertainment using colorectal cancer (CRC) ascertainment within the US Department of Veterans Affairs (VA) as a use case. METHODS: The proposed approach for evaluating cancer ascertainment strategies includes assessment of individual strategy performance, comparison of agreement across strategies, and review of discordant diagnoses. We applied this approach to compare three strategies for CRC ascertainment within the VA: administrative claims data consisting of International Classification of Diseases, Ninth Revision (ICD9) diagnosis codes; the VA Central Cancer Registry (VACCR); and the newly accessible Oncology Domain, consisting of cases abstracted by local cancer registrars. The study sample consisted of 1,839,043 veterans with index colonoscopy performed from 1999 to 2014. Strategy-specific performance was estimated based on manual record review of 100 candidate CRC cases and 100 colonoscopy controls. Strategies were further compared using Cohen's κ and focused review of discordant CRC diagnoses. RESULTS: A total of 92,197 individuals met at least one CRC definition. All three strategies had high sensitivity and specificity for incident CRC. However, the ICD9-based strategy demonstrated poor positive predictive value (58%). VACCR and Oncology Domain had almost perfect agreement with each other (κ, 0.87) but only moderate agreement with ICD9-based diagnoses (κ, 0.51 and 0.57, respectively). Among discordant cases reviewed, 15% of ICD9-positive but VACCR- or Oncology Domain-negative cases had incident CRC. CONCLUSION: Evaluating novel strategies for identifying cancer requires a structured approach, including validation against manual record review, agreement among candidate strategies, and focused review of discordant findings. Without careful assessment of ascertainment methods, analyses may be subject to bias and limited in clinical impact.
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Colonoscopia/métodos , Neoplasias Colorretais/diagnóstico , Demandas Administrativas em Assistência à Saúde , Idoso , Neoplasias Colorretais/patologia , Registros Eletrônicos de Saúde , Feminino , Humanos , Classificação Internacional de Doenças , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Estados Unidos , United States Department of Veterans AffairsRESUMO
OBJECTIVE: To describe a framework for leveraging big data for research and quality improvement purposes and demonstrate implementation of the framework for design of the Department of Veterans Affairs (VA) Colonoscopy Collaborative. METHODS: We propose that research utilizing large-scale electronic health records (EHRs) can be approached in a 4 step framework: 1) Identify data sources required to answer research question; 2) Determine whether variables are available as structured or free-text data; 3) Utilize a rigorous approach to refine variables and assess data quality; 4) Create the analytic dataset and perform analyses. We describe implementation of the framework as part of the VA Colonoscopy Collaborative, which aims to leverage big data to 1) prospectively measure and report colonoscopy quality and 2) develop and validate a risk prediction model for colorectal cancer (CRC) and high-risk polyps. RESULTS: Examples of implementation of the 4 step framework are provided. To date, we have identified 2,337,171 Veterans who have undergone colonoscopy between 1999 and 2014. Median age was 62 years, and 4.6 percent (n = 106,860) were female. We estimated that 2.6 percent (n = 60,517) had CRC diagnosed at baseline. An additional 1 percent (n = 24,483) had a new ICD-9 code-based diagnosis of CRC on follow up. CONCLUSION: We hope our framework may contribute to the dialogue on best practices to ensure high quality epidemiologic and quality improvement work. As a result of implementation of the framework, the VA Colonoscopy Collaborative holds great promise for 1) quantifying and providing novel understandings of colonoscopy outcomes, and 2) building a robust approach for nationwide VA colonoscopy quality reporting.