Implementation of a Multilingual Electronic Medical Questionnaire: For Use Inside or Outside the Hospital.

We implemented a multilingual medical questionnaire system, which allows patients to answer questionnaires both in and out of the hospital. The response data are sent to and stored as structured data on the server in hospital information system, and could be converted to Japanese and quoted as part of progress notes in the electronic medical record.

Practical use of a multicenter clinical research support system connected to electronic medical records.

BACKGROUND: Electronic medical records (EMRs) are widely used, but in many cases, they are used within a network physically separated from the Internet. Multicenter clinical studies use Internet-connected electronic data capture (EDC) systems to collect data, where data entered into the EMR are manually transcribed into the EDC system. In addition, medical images for clinical research are also collected manually. Variations in EMRs and differing data structures among vendors hamper the use of data for clinical research. METHODS: We solved this problem by developing a network infrastructure for clinical research between Osaka University Hospital and affiliated hospitals in the Osaka area and introducing a clinical data collection system (CDCS). In each hospital's EMR network, we implemented a CRF reporter that accumulated data for clinical research using a template and then sent the data to a management server in the Osaka University Hospital Data Center. To organize the patient profile data and clinical laboratory data stored in each EMR for use in clinical research, the data are retrieved from the template by an interface module developed by each vendor, according to our common data output interface specification. The data entered into the CRF reporter template for clinical research are also recorded in the EMR progress notes and sent to the data management server. This network infrastructure can also be used as a medical image collection system that automatically collects images for research from PACS at each hospital. These systems are managed under common subject numbers issued by the CDCS. RESULTS: A network infrastructure was established among 19 hospitals, and a CRF reporter was incorporated into the EMR. A medical image transfer system was introduced in 13 hospitals. Since 2013, 28 clinical studies have been conducted using this system, and data for 9,987 cases have been collected as of December 31, 2020. CONCLUSION: Incorporating a CRF reporter with medical image transfer system into the EMR has proven useful for collecting research data.

Detecting Adverse Drug Events Through the Chronological Relationship Between the Medication Period and the Presence of Adverse Reactions From Electronic Medical Record Systems: Observational Study.

BACKGROUND: Medicines may cause various adverse reactions. An enormous amount of money and effort is spent investigating adverse drug events (ADEs) in clinical trials and postmarketing surveillance. Real-world data from multiple electronic medical records (EMRs) can make it easy to understand the ADEs that occur in actual patients. OBJECTIVE: In this study, we generated a patient medication history database from physician orders recorded in EMRs, which allowed the period of medication to be clearly identified. METHODS: We developed a method for detecting ADEs based on the chronological relationship between the presence of an adverse event and the medication period. To verify our method, we detected ADEs with alanine aminotransferase elevation in patients receiving aspirin, clopidogrel, and ticlopidine. The accuracy of the detection was evaluated with a chart review and by comparison with the Roussel Uclaf Causality Assessment Method (RUCAM), which is a standard method for detecting drug-induced liver injury. RESULTS: The calculated rates of ADE with ALT elevation in patients receiving aspirin, clopidogrel, and ticlopidine were 3.33% (868/26,059 patients), 3.70% (188/5076 patients), and 5.69% (226/3974 patients), respectively, which were in line with the rates of previous reports. We reviewed the medical records of the patients in whom ADEs were detected. Our method accurately predicted ADEs in 90% (27/30patients) treated with aspirin, 100% (9/9 patients) treated with clopidogrel, and 100% (4/4 patients) treated with ticlopidine. Only 3 ADEs that were detected by the RUCAM were not detected by our method. CONCLUSIONS: These findings demonstrate that the present method is effective for detecting ADEs based on EMR data.

Screening of anticancer drugs to detect drug-induced interstitial pneumonia using the accumulated data in the electronic medical record.

Because drug-induced interstitial pneumonia (DIP) is a serious adverse drug reaction, its quantitative risk with individual medications should be taken into due consideration when selecting a medicine. We developed an algorithm to detect DIP using medical record data accumulated in a hospital. Chest computed tomography (CT) is mainly used for the diagnosis of IP, and chest X-ray reports, KL-6, and SP-D values are used to support the diagnosis. The presence of IP in the reports was assessed by a method using natural language-processing, in which IP was estimated according to the product of the likelihood ratio of characteristic keywords in each report. The sensitivity and the specificity of the method for chest CT reports were 0.92 and 0.97, while those for chest X-ray reports were 0.83 and 1, respectively. The occurrence of DIP was estimated by the patterns of presence of IP before, during, and after the administration of the target medicine. The occurrence rate of DIP in cases administered Gefitinib; Methotrexate (MTX); Tegafur, Gimeracil, and Oteracil potassium (TS-1); and Tegafur and Uracil (UTF) was 6.0%, 2.3%, 1.4%, and 0.7%, respectively. The estimated DIP cases were checked by having the medical records independently reviewed by medical doctors. By chart review, the positive predictive values of DIP against Gefitinib, MTX, TS-1, and UFT were 69.2%, 44.4%, 58.6%, and 77.8%, respectively. Although the cases extracted by this method included some that did not have DIP, this method can estimate the relative risk of DIP between medicines.

Method to Identify Diagnostic Rules for Pancreatic Cancer Using Laboratory Data Based on Bayesian Estimation.

Early diagnosis and treatment of pancreatic cancer is challenging. We attempted to find diagnostic rules for pancreatic cancer from laboratory data in the Osaka University Hospital's data warehouse using Bayesian estimation. We calculated the pretest odds based on the number of laboratory tests and the cutoff value at which the diagnostic accuracy is over 20%. By this method, we identified diagnostic rules of 6 types for one item and 79 types for 2 items. Pancreatic cancer is difficult to detect from only general laboratory tests. However, this method may be promising in early diagnosis.

Estimating the Ratio of Patients with a Certain Disease Between Hospitals for the Allocation of Patients to Clinical Trials Using Health Insurance Claims Data in Japan.

In clinical trials, investigating the ratio of patients with each disease who are treated in a hospital is important for determining the number of patients who are allocated to hospitals. The Japanese health insurance claims data includes standardized disease and medicine data. However, the disease data has some problems in terms of reliability, because the healed diseases are sometimes not deleted or because a disease that a patient does not actually have is registered to claim the cost of the examination. On the other hand, therapeutic medicines are administered to target particular diseases. In this study, we developed a system for estimating the number of patients with each disease using the disease data and the therapeutic medicine data. We converted the ICD-10 code to a 4-grade classification code so that we could predict the diseases in the shallow layer (e.g. gastrointestinal disease) when it was difficult to predict the precise diseases in the deep layer (e.g. gastric ulcers). A table showing the disease code and the corresponding therapeutic medicine code was provided by the Japan Pharmaceutical Information Center (JAPIC). We calculated the disease probability score from the diseases and therapeutic medicines and recorded the predicted disease. For the system evaluation, we used the health insurance claims data from Osaka University Hospital for January 2015. A total of 58,526 diseases were predicted from the health insurance claims data of 18,393 patients. One hundred twenty patients were randomly extracted for use in a chart review that was performed by an expert physician. Two hundred twenty-four of 329 predicted diseases, were correctly predicted; 56 were reasonably predicted, and 49 were incorrectly predicted. The main disease was correctly predicted in 71 patients. In conclusion, we could estimate the number of patients with each disease using the health insurance claims data with a certain degree of accuracy.

Development of a database and processing method for detecting hematotoxicity adverse drug events.

Adverse events are detected by monitoring the patient's status, including blood test results. However, it is difficult to identify all adverse events based on recognition by individual doctors. We developed a system that can be used to detect hematotoxicity adverse events according to blood test results recorded in an electronic medical record system. The blood test results were graded based on Common Terminology Criteria for Adverse Events (CTCAE) and changes in the blood test results (Up, Down, Flat) were assessed according to the variation in the grade. The changes in the blood test and injection data were stored in a database. By comparing the date of injection and start and end dates of the change in the blood test results, adverse events related to a designated drug were detected. Using this method, we searched for the occurrence of serious adverse events (CTCAE Grades 3 or 4) concerning WBC, ALT and creatinine related to paclitaxel at Osaka University Hospital. The rate of occurrence of a decreased WBC count, increased ALT level and increased creatinine level was 36.0%, 0.6% and 0.4%, respectively. This method is useful for detecting and estimating the rate of occurrence of hematotoxicity adverse drug events.

A template-based computerized instruction entry system helps the comunication between doctors and nurses.

In a hospital, doctors and nurses shares roles in treating admitted patients. Communication between them is necessary and communication errors become the problem in medical safety. In Japan, verbal instruction is prohibited and doctors write their instruction on paper instruction slips. However, because it is difficult to ascertain revision history and the active instructions on instruction slips, human errors can occur. We developed template-based computerized instruction entry system to reduce ward workloads and contribute to medical safety. Templates enable us to input the instructions easily and standardize the descriptions of instructions. By standardizing and combine the instruction into one template for one instruction item, the systems could prevent instructions overlap. We created sets of templates (e.g., admission set, preoperative set), so that doctors could enter their instructions easily. Instructions entered via any of the sets can be subdivided into separate items by the system before being submitted, and can also be changed on a per-item basis. The instructions were displayed as calendar form. Calendar form represents the instruction shift and current active instructions. We prepared 382 standardized instruction templates. In our system, 66% of instructions were entered via templates, and 34% were entered as free-text comments. Our system prevents communication errors between medical staff.

Cross-institutional document exchange system using clinical document architecture (CDA) with virtual printing method.

Recently one patient received care from several hospitals at around the same time. When the patient visited a new hospital, the new hospital's physician tried to get patient information the previous hospital. Thus, patient information is frequently exchanged between them. Many types of healthcare facilities have implemented an electronic medical record system, but in Japan, healthcare information exchange is often done by paper. In other words, after a clinical doctor prints a referral document and sends it to another hospital's physician, another hospital's doctor receives it and scans to store the EMR in his own hospital's system. It is a wasteful way to exchange healthcare information about a patient. In order to solve this problem, we have developed a cross-institutional document exchange system using clinical document architecture (CDA) with a virtual printing method.