Diabetes Is a Risk Factor for Peptic Ulcer Bleeding
Diabetes Is a Risk Factor for Peptic Ulcer Bleeding
The National Health Insurance (NHI) program in Taiwan, started in 1995, covers over 99% of Taiwan's 23 million population. The NHI Research Database (NHIRD), established by both of the Bureau of NHI and the National Health Research Institute, is one of largest administrative health-care databases worldwide and is open to scientists for research purposes. The present study analyzed data from the Longitudinal Health Insurance Database (LHID2000) of the NHIRD. The LHID2000 included a cohort dataset of 1 000 000 randomly sampled subjects who were alive in 2000.
All enrollees were traced retrospectively to 1996 and followed up to 2007. There were no statistically significant differences in sex, age, and health-care costs distribution between patients in the LHID2000 and those in the original NHIRD. Comprehensive health-care data included enrollment files, claims data, registry for drug prescription, and catastrophic illness files.
In the cohort dataset, each patient's original identification number was encrypted for privacy. Because this cohort dataset consisted of de-identified secondary data released to the public for research purposes, this study did not require patients' informed consent. It has been approved by the Institutional Review Board of Taipei Veterans General Hospital (VGHIRB 2012–2010-010AC).
The study group was composed of type II diabetic subjects (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes: 250.x0 and 250.x2) identified after January 1, 2000. Subjects with inflammatory bowel disease (ICD-9-CM codes: 556.x and 555.x), malignancy of gastrointestinal tract (ICD-9-CM codes: 150.xx, 151.xx, 152.xx, 153.xx, and 154.xx), or any gastrointestinal tract bleeding (ICD-9-CM codes: 530.7, 530.82, 531.0, 531.00, 531.01, 531.2531.2x, 531.4, 531.4x, 531.6531.6x, 532.0, 532.00, 532.01, 532.2532.2x, 532.4, 532.4x, 532.6532.6x, 533.0, 533.00, 533.01, 533.2533.2x, 533.4, 533.4x, 533.6533.6x, 534.0, 534.00, 534.01, 534.2534.2x, 534.4, 534.4x, 534.6534.6x, 535.X1, 537.8x, 562.02, 562.03, 562.12, 562.13, 569.3, 569.8x, and 578.x) as the major diagnosis during hospitalization before January 1, 2000 were excluded.
Using the same exclusion criteria, the control group was composed of patients without diabetes before and after enrollment from the database. They were matched with the study subjects in a ratio of 1:2 and in terms of age, sex, and enrollment time.
Other recorded covariates included age, sex, coronary artery disease (ICD-9-CM codes: 410.xx-414.xx), hypertension (ICD-9-CM codes: 401.xx-405.xx), heart failure (ICD-9-CM codes: 428.00–428.9), cirrhosis (ICD-9-CM codes 571.2, 571.5, and 571.6), chronic kidney disease (ICD-9-CM codes: 585, 250.4x, 274.1, 403.x1, 404.x2, 404.x3, 440.1, 582.0, 582.4, and 582.8x), and history of uncomplicated PUD (ICD-9-CM codes 531.30, 531.70, 531.90, 532.30, 532.70, 532.90, 533.30, 533.70, and 533.90).
Medication (low-dose acetylsalicylic acid [ASA], non-steroidal anti-inflammatory drugs [NSAIDs], steroid, clopidogrel, ticlopidine, and coumadin) were identified and classified by the National Drug Code and the Anatomic Therapeutic Chemical Code, which is an internationally accepted classification system of drugs coordinated by the World Health Organization Collaborating Center for Drug Statistics Methodology. Use of ulcerogenic medications was defined as prescription of these medication more than 6 weeks within 12 weeks before the index date (end-point or censoring).
The primary end-point was the occurrence of administrative claims of PUB as the major diagnosis during hospitalization. Ulcer bleeding was validated by endoscopic examination and therapy, with ICD-9-CM codes of 531.0, 531.00, 531.01, 531.2x, 531.4x, 531.6x, 532.0, 532.00, 532.01, 532.2x, 532.4x, 532.6x, 533.0, 533.00, 533.01, 533.2x, 533.4x, 533.6x, 534.0, 534.00, 534.01, 534.2x, 534.4x, and 534.6x.
Microsoft SQL Server 2005 (Redmond, Seattle, WA, USA) was used for data management and computing. All statistical analyses were performed using the SPSS software (Version 18.0, SPSS, Inc., Chicago, IL, USA). Demographic data were expressed as frequency (percentage) or as mean ± standard deviation. Parametric continuous data between the study and control groups were compared by Student's t-test, while categorical data were compared by chi-square test and Yates' correction or Fisher's exact test, as appropriate. Cumulative hazard was assessed using the Kaplan–Meier analysis, with significance based on log-rank test. Multiple regression analysis was conducted using Cox proportional hazard regression analysis to identify the risk factors of PUB.
Methods
Data Sources
The National Health Insurance (NHI) program in Taiwan, started in 1995, covers over 99% of Taiwan's 23 million population. The NHI Research Database (NHIRD), established by both of the Bureau of NHI and the National Health Research Institute, is one of largest administrative health-care databases worldwide and is open to scientists for research purposes. The present study analyzed data from the Longitudinal Health Insurance Database (LHID2000) of the NHIRD. The LHID2000 included a cohort dataset of 1 000 000 randomly sampled subjects who were alive in 2000.
All enrollees were traced retrospectively to 1996 and followed up to 2007. There were no statistically significant differences in sex, age, and health-care costs distribution between patients in the LHID2000 and those in the original NHIRD. Comprehensive health-care data included enrollment files, claims data, registry for drug prescription, and catastrophic illness files.
In the cohort dataset, each patient's original identification number was encrypted for privacy. Because this cohort dataset consisted of de-identified secondary data released to the public for research purposes, this study did not require patients' informed consent. It has been approved by the Institutional Review Board of Taipei Veterans General Hospital (VGHIRB 2012–2010-010AC).
Study Group
The study group was composed of type II diabetic subjects (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] codes: 250.x0 and 250.x2) identified after January 1, 2000. Subjects with inflammatory bowel disease (ICD-9-CM codes: 556.x and 555.x), malignancy of gastrointestinal tract (ICD-9-CM codes: 150.xx, 151.xx, 152.xx, 153.xx, and 154.xx), or any gastrointestinal tract bleeding (ICD-9-CM codes: 530.7, 530.82, 531.0, 531.00, 531.01, 531.2531.2x, 531.4, 531.4x, 531.6531.6x, 532.0, 532.00, 532.01, 532.2532.2x, 532.4, 532.4x, 532.6532.6x, 533.0, 533.00, 533.01, 533.2533.2x, 533.4, 533.4x, 533.6533.6x, 534.0, 534.00, 534.01, 534.2534.2x, 534.4, 534.4x, 534.6534.6x, 535.X1, 537.8x, 562.02, 562.03, 562.12, 562.13, 569.3, 569.8x, and 578.x) as the major diagnosis during hospitalization before January 1, 2000 were excluded.
Control Group
Using the same exclusion criteria, the control group was composed of patients without diabetes before and after enrollment from the database. They were matched with the study subjects in a ratio of 1:2 and in terms of age, sex, and enrollment time.
Other recorded covariates included age, sex, coronary artery disease (ICD-9-CM codes: 410.xx-414.xx), hypertension (ICD-9-CM codes: 401.xx-405.xx), heart failure (ICD-9-CM codes: 428.00–428.9), cirrhosis (ICD-9-CM codes 571.2, 571.5, and 571.6), chronic kidney disease (ICD-9-CM codes: 585, 250.4x, 274.1, 403.x1, 404.x2, 404.x3, 440.1, 582.0, 582.4, and 582.8x), and history of uncomplicated PUD (ICD-9-CM codes 531.30, 531.70, 531.90, 532.30, 532.70, 532.90, 533.30, 533.70, and 533.90).
Medication (low-dose acetylsalicylic acid [ASA], non-steroidal anti-inflammatory drugs [NSAIDs], steroid, clopidogrel, ticlopidine, and coumadin) were identified and classified by the National Drug Code and the Anatomic Therapeutic Chemical Code, which is an internationally accepted classification system of drugs coordinated by the World Health Organization Collaborating Center for Drug Statistics Methodology. Use of ulcerogenic medications was defined as prescription of these medication more than 6 weeks within 12 weeks before the index date (end-point or censoring).
Incidence of Hospitalization for PUB
The primary end-point was the occurrence of administrative claims of PUB as the major diagnosis during hospitalization. Ulcer bleeding was validated by endoscopic examination and therapy, with ICD-9-CM codes of 531.0, 531.00, 531.01, 531.2x, 531.4x, 531.6x, 532.0, 532.00, 532.01, 532.2x, 532.4x, 532.6x, 533.0, 533.00, 533.01, 533.2x, 533.4x, 533.6x, 534.0, 534.00, 534.01, 534.2x, 534.4x, and 534.6x.
Statistical Analysis
Microsoft SQL Server 2005 (Redmond, Seattle, WA, USA) was used for data management and computing. All statistical analyses were performed using the SPSS software (Version 18.0, SPSS, Inc., Chicago, IL, USA). Demographic data were expressed as frequency (percentage) or as mean ± standard deviation. Parametric continuous data between the study and control groups were compared by Student's t-test, while categorical data were compared by chi-square test and Yates' correction or Fisher's exact test, as appropriate. Cumulative hazard was assessed using the Kaplan–Meier analysis, with significance based on log-rank test. Multiple regression analysis was conducted using Cox proportional hazard regression analysis to identify the risk factors of PUB.
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