XI. STRATEGIES FOR IMPROVING DIABETES CARE D iabetes is a chronic illness that requires continuing medical care and patient self-management education to prevent acute complications and to reduce the risk of long-term complications. Diabetes care is complex and requires that many issues, beyond glycemic control, be addressed. A large body of evidence exists that supports a range of interventions to improve diabetes outcomes. These standards of care are intended to provide clinicians, patients, researchers, payors, and other interested individuals with the components of diabetes care, treatment goals, and tools to evaluate the quality of care. While individual preferences, comorbidities, and other patient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to preclude more extensive evaluation and management of the patient by other specialists as needed. For more detailed information, refer to Bode (Ed.): Medical Management of Type 1 Diabetes (1), Burant (Ed): Medical Management of Type 2 Diabetes (2), and Klingensmith (Ed): Intensive Diabetes Management (3). The recommendations included are diagnostic and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabetes. A grading system (Table 1), developed by the American Diabetes Association (ADA) and modeled after existing methods, was utilized to clarify and codify the evidence that forms the basis for the recommendations. The level of evidence that supports each recommendation is listed after each recommendation using the letters A, B, C, or E.

Standards of Medical Care in Diabetes

Context Tumor recurrence is a major issue for patients with hepatocellular carcinoma (HCC) following curative liver resection. Objective To investigate the association between nucleoside analogue use and risk of tumor recurrence in patients with hepatitis B virus (HBV)−related HCC after curative surgery. Design, Setting, and Participants A nationwide cohort study between October 2003 and September 2010. Data from the Taiwan National Health Insurance Research Database. Among 100 938 newly diagnosed HCC patients, we identified 4569 HBV-related HCC patients who received curative liver resection for HCC between October 2003 and September 2010. Main Outcome Measures The risk of first tumor recurrence was compared between patients not taking nucleoside analogues (untreated cohort, n = 4051) and patients taking nucleoside analogues (treated cohort, n = 518). Cumulative incidences and hazard ratios (HRs) were calculated after adjusting for competing mortality. Results The treated cohort had a higher prevalence of liver cirrhosis when compared with the untreated cohort (48.6% vs 38.7%; P  Conclusion Nucleoside analogue use was associated with a lower risk of HCC recurrence among patients with HBV-related HCC after liver resection.

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Association between nucleoside analogues and risk of hepatitis B virus-related hepatocellular carcinoma recurrence following liver resection

Taiwan's National Health Insurance Research Database (NHIRD) exemplifies a population-level data source for generating real-world evidence to support clinical decisions and health care policy-making. Like with all claims databases, there have been some validity concerns of studies using the NHIRD, such as the accuracy of diagnosis codes and issues around unmeasured confounders. Endeavors to validate diagnosed codes or to develop methodologic approaches to address unmeasured confounders have largely increased the reliability of NHIRD studies. Recently, Taiwan's Ministry of Health and Welfare (MOHW) established a Health and Welfare Data Center (HWDC), a data repository site that centralizes the NHIRD and about 70 other health-related databases for data management and analyses. To strengthen the protection of data privacy, investigators are required to conduct on-site analysis at an HWDC through remote connection to MOHW servers. Although the tight regulation of this on-site analysis has led to inconvenience for analysts and has increased time and costs required for research, the HWDC has created opportunities for enriched dimensions of study by linking across the NHIRD and other databases. In the near future, researchers will have greater opportunity to distill knowledge from the NHIRD linked to hospital-based electronic medical records databases containing unstructured patient-level information by using artificial intelligence techniques, including machine learning and natural language processes. We believe that NHIRD with multiple data sources could represent a powerful research engine with enriched dimensions and could serve as a guiding light for real-world evidence-based medicine in Taiwan.

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Taiwan's National Health Insurance Research Database: past and future.

Validation of acute myocardial infarction cases in the national health insurance research database in taiwan.

Validating the diagnosis of acute ischemic stroke in a National Health Insurance claims database

Objective
The National Health Insurance Research Database (NHIRD) is commonly used for pharmacoepidemiological research in Taiwan. This study evaluated the validity of the database for patients with a principal diagnosis of ischemic stroke.

Study design and methods
This cross-sectional study compares records in the NHIRD with those in one medical center. Patients hospitalized for ischemic stroke in 1999 were identified from both databases. The discharge notes, laboratory data, and medication orders during admission and the first discharge visit were reviewed to validate ischemic stroke diagnoses and aspirin prescribing in the NHIRD. Agreement between the two databases in comorbidities of ischemic stroke diagnosis was evaluated using ICD-9 codes.

Results
Three hundred and seventy two cases were identified from the NHIRD; among them, 364 cases (97.85%) were confirmed as ischemic stroke by radiology examination and clinical presentation. Among these confirmed cases, 344 (94.51%) were assigned ‘ischemic stroke’ as the principal diagnosis in the NHIRD. The overall agreement of comorbid diagnoses between the databases was 48.39%. The PPV for selected conditions also varied widely, from 0.50 for fracture to 1.00 for colon cancer. The accuracy of recorded aspirin prescriptions was higher in first post-discharge visits (PPV = 0.94) than during hospitalization (PPV = 0.88).

Conclusion
The accuracy of the NHIRD in recording ischemic stroke diagnoses and aspirin prescriptions was high, and the NHIRD appears to be a valid resource for population research in ischemic stroke. Copyright © 2010 John Wiley & Sons, Ltd.

Validation of the National Health Insurance Research Database with ischemic stroke cases in Taiwan.

Background Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider. Objective To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes. Setting A 421-bed district hospital in Nantou City, Taiwan. Method We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann–Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P < 0.05. Main outcome measure The change in the mean HbA1c level from the baseline to the next level within 6 months after recruiting. Results Nonparametric data (Mann–Whitney test) showed that the mean HbA1c level significantly decreased (0.83 %) after 6 months for the intervention group compared with an increase of 0.43 % for the control group (P ≤ 0.001). Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups. Conclusion The pharmacist intervention program provided pharmaceutical services that improved long-term, safe control of blood sugar levels for ambulatory elderly patients with diabetes and did not increase medical expenses.

Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial

Objectives A study reported a significant association between oral fluoroquinolones and the development of retinal detachment among current users of oral fluoroquinolones (Etminan M, Forooghian F, Brophy JM et al. JAMA 2012; 307: 1414-9). However, other published studies have discordant results. This study aimed to investigate this association and to estimate the absolute risk of developing retinal detachment in patients exposed to oral fluoroquinolones. Methods A self-controlled case series study was conducted with data retrieved from the Hong Kong Clinical Data Analysis and Reporting System database and the Taiwan National Health Insurance Research Database. Hong Kong and Taiwanese patients who had prescriptions for oral fluoroquinolones and a procedure for retinal detachment between 2001 and 2012 and between 2000 and 2010, respectively, were defined as cases and included in the analysis. Results A total of 9 events were found during the fluoroquinolone-exposed period and 1407 events were found during the non-exposed period. The adjusted incidence rate ratio in the combined model was 1.26 (0.65-2.47). The crude absolute risk of experiencing retinal detachment whilst on oral fluoroquinolones was ∼1.3 per 200 000 prescriptions. Conclusions Our study does not support the association between the use of fluoroquinolones and the development of retinal detachment and our findings are strikingly similar to that of the study conducted in Denmark. Doubt is cast on the association between the use of fluoroquinolones and the development of retinal detachment. Therefore, the use of fluoroquinolones should not be precluded based on the current evidence on the risk of retinal detachment. The impact of different ethnicities on the response to fluoroquinolones should also be investigated.

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An investigation of the potential association between retinal detachment and oral fluoroquinolones: a self-controlled case series study

Objective The goal of the Asian Pharmacoepidemiology Network is to study the effectiveness and safety of medications commonly used in Asia using databases from individual Asian countries. An efficient infrastructure to support multinational pharmacoepidemiologic studies is critical to this effort. Study design and setting We converted data from the Japan Medical Data Center database, Taiwan's National Health Insurance Research Database, Hong Kong's Clinical Data Analysis and Reporting System, South Korea's Ajou University School of Medicine database, and the US Medicare 5% sample to the Observational Medical Outcome Partnership common data model (CDM). Results We completed and documented the process for the CDM conversion. The coordinating center and participating sites reviewed the documents and refined the conversions based on the comments. The time required to convert data to the CDM varied widely across sites and included conversion to standard terminology codes and refinements of the conversion based on reviews. We mapped 97.2%, 86.7%, 92.6%, and 80.1% of domestic drug codes from the USA, Taiwan, Hong Kong, and Korea to RxNorm, respectively. The mapping rate from Japanese domestic drug codes to RxNorm (70.7%) was lower than from other countries, and we mapped remaining unmapped drugs to Anatomical Therapeutic Chemical Classification System codes. Because the native databases used international procedure coding systems for which mapping tables have been established, we were able to map >90% of diagnosis and procedure codes to standard terminology codes. Conclusion The CDM established the foundation and reinforced collaboration for multinational pharmacoepidemiologic studies in Asia. Mapping of terminology codes was the greatest challenge, because of differences in health systems, cultures, and coding systems.

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Yea Huei Yang Kao

Papers

Validation of the National Health Insurance Research Database with ischemic stroke cases in Taiwan.

Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial

An investigation of the potential association between retinal detachment and oral fluoroquinolones: a self-controlled case series study

Applying a common data model to Asian databases for multinational pharmacoepidemiologic studies: opportunities and challenges.