Research Types and New Trends on the Omaha System Published From 2012 to 2019: A Scoping Review.

The Omaha System is a popular and standard term used in community health. This scoping review aimed to update the research types and identify new usage trends for the Omaha System through articles published between 2012 and 2019. The bibliography databases PubMed, CINAHL, Scopus, PsycInfo, Ovid, and ICHUSHI and the Omaha System's Web site were used to search for publications. Research articles published between 2012 and 2019 that included "Omaha System" in the title or abstract and were written in English or Japanese were included in this review. After excluding duplicate articles, 305 articles were screened and 82 were included in our analysis. There was a median of 10.3 articles per year. The percentages for each type of use of the Omaha System to "analyze client problem," "analyze clinical process," "analyze client outcomes," and "advanced classification research" were 18.3%, 12.2%, 23.2%, and 4.9%, respectively. The reclassification of the type "others" (41.5%) included "use the Omaha System data for assessment for other than clients," "use the Omaha System data as structured data," "encode by the Omaha System code," "adopt the OS framework," "clinical information system," and "literature review." This newly reclassified category will help capture future research trends using the Omaha System.

Evaluating the quality of data from the Japanese National Clinical Database 2011 via a comparison with regional government report data and medical charts.

PURPOSE: The aim of this study was to examine the quality of data from the National Clinical Database (NCD) via a comparison with regional government report data and medical charts. METHODS: A total of 1,165,790 surgical cases from 3007 hospitals were registered in the NCD in 2011. To evaluate the NCD's data coverage, we retrieved regional government report data for specified lung and esophageal surgeries and compared the number with registered cases in the NCD for corresponding procedures. We also randomly selected 21 sites for on-site data verification of eight demographic and surgical data components to assess the accuracy of data entry. RESULTS: The numbers of patients registered in the NCD and regional government report were 46,143 and 48,716, respectively, for lung surgeries and 7494 and 8399, respectively, for esophageal surgeries, leading to estimated coverages of 94.7% for lung surgeries and 89.2% for esophageal surgeries. According to on-site verification of 609 cases at 18 sites, the overall agreement between the NCD data components and medical charts was 97.8%. CONCLUSION: Approximately, 90-95% of the specified lung surgeries and esophageal surgeries performed in Japan were registered in the NCD in 2011. The NCD data were accurate relative to medical charts.

Verification of Data Accuracy in Japan Congenital Cardiovascular Surgery Database Including Its Postprocedural Complication Reports.

BACKGROUND: Japan Congenital Cardiovascluar Surgical Database (JCCVSD) is a nationwide registry whose data are used for health quality assessment and clinical research in Japan. We evaluated the completeness of case registration and the accuracy of recorded data components including postprocedural mortality and complications in the database via on-site data adjudication. METHODS: We validated the records from JCCVSD 2010 to 2012 containing congenital cardiovascular surgery data performed in 111 facilities throughout Japan. We randomly chose nine facilities for site visit by the auditor team and conducted on-site data adjudication. We assessed whether the records in JCCVSD matched the data in the source materials. RESULTS: We identified 1,928 cases of eligible surgeries performed at the facilities, of which 1,910 were registered (99.1% completeness), with 6 cases of duplication and 1 inappropriate case registration. Data components including gender, age, and surgery time (hours) were highly accurate with 98% to 100% concordance. Mortality at discharge and at 30 and 90 postoperative days was 100% accurate. Among the five complications studied, reoperation was the most frequently observed, with 16 and 21 cases recorded in the database and source materials, respectively, having a sensitivity of 0.67 and a specificity of 0.99. CONCLUSIONS: Validation of JCCVSD database showed high registration completeness and high accuracy especially in the categorical data components. Adjudicated mortality was 100% accurate. While limited in numbers, the recorded cases of postoperative complications all had high specificities but had lower sensitivity (0.67-1.00). Continued activities for data quality improvement and assessment are necessary for optimizing the utility of these registries.

Development and external validation of preoperative risk models for operative morbidities after total gastrectomy using a Japanese web-based nationwide registry.

BACKGROUND: Total gastrectomy is a relatively difficult and invasive procedure among gastrointestinal surgeries, and major morbidities following total gastrectomy can be serious and fatal. This study aimed to develop and validate preoperative risk models of morbidities associated with total gastrectomy using a Japanese web-based nationwide registry. METHODS: The national clinical database was used to retrieve the records of 39,253 patients who underwent total gastrectomy in 1,841 hospitals between January 1, 2011 and December 31, 2012. RESULTS: Mean patient age was 69.1 years, and 73.8% of the patients were male. The overall morbidity rate was 21.5%, which included 8.1% with surgical site infection (SSI), 4.5% with anastomotic leak, 5.0% with pancreatic fistula, 3.7% with pneumonia, 1.9% with prolonged ventilation, and 1.2% with renal failure. Sex, splenectomy, and Brinkman index were selected as common risk factors for SSI, anastomotic leak, and pancreatic fistula. Pancreatectomy was the most significant preoperative risk factor in the risk model of SSI and pancreatic fistula. Need of assistance with activities of daily living, chronic obstructive pulmonary disease, previous cerebrovascular disease, American Society of Anesthesiologists score class 3 and over, presence of esophageal cancer, and body mass index more than 25 were selected as common risk factors for pneumonia, prolonged ventilation over 48 h, and renal failure. CONCLUSIONS: We have created the first reported risk models of morbidities associated with total gastrectomy, using a Japanese nationwide database. The risk models developed in this study may be useful to preoperatively predict operative morbidities in patients undergoing total gastrectomy.

Young adult breast cancer patients have a poor prognosis independent of prognostic clinicopathological factors: a study from the Japanese Breast Cancer Registry.

PURPOSE: The aim of this study was to investigate whether young age at onset of breast cancer is an independent prognostic factor in patients from the Japanese Breast Cancer Registry, after adjustment of known clinicopathological prognostic factors. METHODS: Of the 53,670 patients registered between 2004 and 2006 and surveyed after a 5-year follow-up prognosis, 25,898 breast cancer patients (48.3 %), who were obtained prognostic data, were examined. Clinicopathological factors were compared between young adult (YA; <35 years), middle-aged adult (MA; 35-50 years), and older adult (OA; >50 years) patients. Five-year disease-free survival (DFS) and overall survival (OS) rates were studied. RESULTS: YA patients were associated with an advanced TNM stage and aggressive characteristics (e.g. human epidermal growth factor receptor 2 (HER2)-positive or oestrogen receptor (ER)-negative breast cancers) compared to MA and OA patients (P < 0.001). The 5-year DFS and OS rates were 79.4 % and 90.8, 88.5 and 95.0 %, and 87.8 % and 91.6 % for YA, MA, and OA patients, respectively. From the multivariable regression analysis, young age at onset was confirmed as an independent prognostic factor for both DFS (hazard ratio 1.73, 95 % confidence interval 1.42-2.10; P < 0.001) and OS (hazard ratio 1.58, 95 % confidence interval 1.16-2.15; P = 0.004). CONCLUSIONS: Young age at onset is an independent negative prognostic factor in breast cancer. Further studies are required to develop new therapeutic strategies for YA breast cancer patients.

Distinct breast cancer characteristics between screen- and self-detected breast cancers recorded in the Japanese Breast Cancer Registry.

The rate of breast cancer screening for women of all ages in Japan is increasing. However, little is known about the biological differences between screen- and self-detected tumors. We used data from the Japanese Breast Cancer Registry (JBCR), a nationwide registry of newly diagnosed breast cancer cases in Japan, to investigate patients diagnosed between January 1, 2004 and December 31, 2011. We compared the clinicopathological features of tumors and assessed yearly trends regarding the proportion of screen-detected cases during the study period. We found that 31.8 % (65,358/205,544) of cancers were detected by screening. Asymptomatic tumors detected by screening (asymptomatic) were more likely to have favorable prognostic features than those that were self-detected (ductal carcinoma in situ [DCIS]: 19.8 versus 4.1 %, node-negative: 77.0 versus 61.6 %, and estrogen receptor-positive [ER+]: 82.0 versus 72.9 %, respectively). All these findings were statistically significant (p < .001). The proportion of breast cancers detected by screening among all cases increased from 21.7 % in 2004 to 37.1 % in 2011. During the same time period, the proportion of screen-detected DCIS increased from 41.5 to 66.0 % and that of ER+ cancers increased from 23.2 to 39.7 %. This study demonstrated that low-risk tumors, including DCIS, ER+, and lower TNM stage, account for a substantial proportion of clinical screening-detected cancers. The differences in biological characteristics between screen- and self-detected cancers may account in part for the limited efficacy of breast cancer screening programs aimed at improving breast cancer mortality.

Body mass index and survival after diagnosis of invasive breast cancer: a study based on the Japanese National Clinical Database-Breast Cancer Registry.

Few studies have reported the association between body mass index (BMI) and outcome among Asian breast cancer patients. We analyzed data for 20,090 female invasive breast cancer patients who had been followed-up for a median period of 6.7 years entered in the National Clinical Database-Breast Cancer Registry between 2004 and 2006. We used mainly the WHO criteria for BMI (kg/m(2) ) categories; <18.5 (underweight), ≥18.5-<21.8 (reference), ≥21.8-<25, ≥25-<30 (overweight), and ≥30 (obese). We divided normal weight patients into two subgroups because this category includes many patients compared to others. The timing of BMI measurement was not specified. The Cox proportional hazards model and cubic spline regression were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Smoking, alcohol, and physical activity were not controlled. A total of 1418 all-cause, 937 breast cancer-specific deaths, and 2433 recurrences were observed. Obesity was associated with an increased risk of all-cause (HR: 1.46; 95% CI: 1.16-1.83) and breast cancer-specific death (HR: 1.47; 95% CI: 1.11-1.93) for all patients, and with all-cause (HR: 1.47; 95% CI: 1.13-1.92) and breast cancer-specific death (HR: 1.58; 95% CI: 1.13-2.20) for postmenopausal patients. Being underweight was associated with an increased risk of all-cause death for all (HR: 1.41; 95% CI: 1.16-1.71) and for postmenopausal patients (HR: 1.45; 95% CI: 1.15-1.84). With regard to subtype and menopausal status, obesity was associated with an increased risk of breast cancer-specific death for all cases of luminal B tumor (HR: 2.59; 95% CI: 1.51-4.43; Pheterogeneity of Luminal B vs. Triple negative = 0.016) and for postmenopausal patients with luminal B tumor (HR: 3.24; 95% CI: 1.71-6.17). Being obese or underweight is associated with a higher risk of death among female breast cancer patients in Japan.

Operative mortality and complication risk model for all major cardiovascular operations in Japan.

BACKGROUND: The Japan Cardiovascular Surgery Database (JCVSD) is a nationwide benchmarking project to improve the quality of cardiovascular surgery in Japan. This study aimed to develop new JACVD risk models not only for operative mortality but also for each postoperative complication for coronary artery bypass grafting (CABG) operations, valve operations, and thoracic aortic operations. METHODS: We analyzed 24,704 isolated CABG operations, 26,137 valve operations, and 18,228 thoracic aortic operations. Risk models were developed for each operation for operative death, permanent stroke, renal failure, prolonged ventilation (>24 hours), deep sternal wound infection, and reoperation for bleeding. The population was divided into an 80% development sample and a 20% validation sample. The statistical model was constructed by multiple logistic regression analysis. Model discrimination was tested using the area under the receiver operating characteristic curve (C index). RESULTS: The 30-day mortality rates for isolated CABG, valve, and thoracic aortic operations were 1.5%, 2.5%, and 6.0%, respectively, and operative mortality rates were 2.4%, 3.8%, and 8.4%, respectively. The C indices for the end points of isolated CABG, valve, and aortic thoracic operations were 0.6358 for (deep sternal infection) to 0.8655 (operative mortality), 0.6114 (reoperation for bleeding) to 0.8319 (operative death), and 0.6311 (gastrointestinal complication) to 0.7591 (operative death), respectively. CONCLUSIONS: These risk models increased the discriminatory power of former models. Thus, our models can be said to reflect the current state of Japan. With respect to major complications, useful feedback can now be provided through the Japan Cardiovascular Surgery Database Web-based system.

Predictors of 90-day mortality after congenital heart surgery: the first report of risk models from a Japanese database.

OBJECTIVE: The purpose of this study was to develop risk models for congenital heart surgery short-term and midterm outcomes from a nationwide integrated database drawn from hospitals in Japan. METHODS: The Japan Congenital Cardiovascular Surgery Database collects clinical information from institutions throughout Japan specializing in congenital heart surgery. Variables and definitions used in the Japan Congenital Cardiovascular Surgery Database are almost identical to those of the Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery database for congenital heart surgery. We used logistic regression to develop risk models, which were then validated through spilt-sample validation. In addition to procedural complexity categories by Risk Adjustment in Congenital Heart Surgery (RACHS-1) score, we incorporated patient characteristics to predict surgical outcome. RESULTS: Among 8923 congenital heart operations performed at 69 sites with cardiac surgical programs, 30-day mortalities by RACHS-1 category were as follows: I, 0.1% (n=1319); II, 0.5% (n=3211); III, 2.2% (n=3285); IV, 4.3% (n=818); and V and VI, 8.6% (n=290). From the test data set (n=7223), we developed 3 risk models (30-day mortality, 90-day mortality, and 90-day and in-hospital mortality) with 11 variables, including age category, RACHS-1 category, preoperative risk factors, number of surgical procedures, unplanned reoperations, status of surgery, surgery type, asplenia, and prematurity (<35 weeks). For the performance metrics of the risk models, C statistic values of 30-day, 90-day, and 90-day and in-hospital mortalities for the test data set were 0.85, 0.85, and 0.84, respectively. When only the RACHS-1 score was used for discrimination, the C statistic values of 30-day, 90-day, and 90-day and in-hospital mortalities for the validation data set were 0.73, 0.73, and 0.77, respectively. CONCLUSIONS: The proposed risk scores and categories have high discrimination power for predicting mortality, demonstrating improvement relative to existing consensus-based methods. Risk models incorporating these measures may be useful for comparing mortality outcomes cross institutions or countries with mixed cases.

Challenges and prospects of a clinical database linked to the board certification system.

In Japan, the National Clinical Database (NCD) was founded in April 2010 as the parent body of the database system linked to the board certification system. Registration began in 2011, and to date, more than 3,300 facilities have enrolled and more than one million cases are expected to enroll each year. Given the broad impact of this database initiative, considering the social implications of their activities is important. In this study, we identified and addressed issues arising from data collection and analysis, with a primary focus on providing high-quality healthcare to patients and the general public. Improvements resulting from NCD initiatives have been implemented in clinical settings throughout Japan. Clinical research using such database as well as evidence-based policy recommendations can impact businesses, the government and insurance companies. The NCD project is realistic in terms of effort and cost, and its activities are conducted lawfully and ethically with due consideration of its effects on society. Continuous evaluation on the whole system is essential. Such evaluation provides the validity of the framework of healthcare standards as well as ensures the reliability of collected data to guarantee the scientific quality in clinical databases.

Results of data verification of the Japan congenital cardiovascular database, 2008 to 2009.

BACKGROUND: Since 2008, data concerning pediatric cardiovascular surgeries performed in Japan have been collected in the Japan Congenital Cardiovascular Surgery Database (JCCVSD). We assessed the quality of the JCCVSD data through data verification activities conducted in 2010. METHODS: During 2008 to 2009, 3345 patients with 4327 procedures at 25 hospitals were registered in the JCCVSD. Among them, six sites were selected for data verification. The completeness of case registration was assessed by comparison with original operational logs. Also, data accuracy of patient demographics, surgical outcomes, and processes were assessed with 10% of the registered cases by comparison with medical records. RESULTS: Verification of case registration completeness involved 968 (28.9%) patients and 1279 (29.1%) procedures. As to completeness, we confirmed 1266 (99.0%) of the 1279 procedures. Data accuracy was verified for 129 (3.9%) patients. Accuracy of status of discharge and 30 and 90 days after surgery were very high (99.2%, 100%, and 100%, respectively). Data items with numeric information exhibited lower exact accuracy due to typing error and inconsistent use of rounding; however, the differences between the submitted and the original data were not statistically significant. CONCLUSIONS: High completeness and acceptable range of data accuracy were verified for the data submitted to the JCCVSD in 2008 to 2009. The high accuracy regarding follow-up outcomes was especially noteworthy. The initial success of the JCCVSD should be strengthened through further sophistication of registration protocol, continual training of data managers and auditors, and rigorous expansion of verification activities.

[Utilization of clinical database for quality improvement in health care].

Measurement and feedback of clinical performance is one of the important activities in clinical database. In addition, clinical database is used for developing medical guidelines, research for public policy and clinical research, and also various kinds of information can be provided to the public. On the other hand, risk adjustment for data analysis is a key issue in the clinical database. From these viewpoints, this article described the activities for quality improvement, examples of research, and planning of clinical research using the clinical database.

Probiotic Beverage with Soy Isoflavone Consumption for Breast Cancer Prevention: A Case-control Study.

The purpose of this study is to evaluate how beverages containing Lactobacillus casei Shirota (BLS) and soy isoflavone consumption since adolescence affected the incidence of breast cancer. In a population-based case-control study, three hundred and six cases with breast cancer and 662 controls aged 40 to 55 were matched for age and residential area and included in the analyses. Diet, lifestyle and other breast cancer risk factors were investigated using the self-administered questionnaire and interview. Odds ratios (ORs) of BLS and soy isoflavone consumption for breast cancer incidence were independently and jointly estimated using a conditional logistic regression. The ORs of BLS consumption (≥ four times a week against < four times a week) was 0.65 and statistically significant (p = 0.048). The analysis of association between soy consumption and breast cancer incidence showed the more the isoflavone consumption is, the lower the odds of breast cancer becomes. Adjusted ORs for breast cancer in the second, the third and the fourth quartiles of soy consumption against the first quartile were 0.76, 0.53 and 0.48, respectively (trend test, p = 0.0002). The BLS-isoflavone interaction was not statistically significant; however, a biological interaction was suggested. Regular consumption of BLS and isoflavones since adolescence was inversely associated with the incidence of breast cancer in Japanese women.

[Total quality management of clinical database].

Data entry system should be constructed considering utility, accuracy, propriety, and feasibility. The methods for developing useful and accurate clinical databases are 1)system development based on the concept of "error proofing", 2)system test by real users, 3)guidances for participants, and 4)incentive for accurate data entry. In terms of propriety, to gain patient's consent on data collection and to publicly announce objectives and methods of clinical database are necessary. Confidentiality and anonymization of data are also important. Balancing efficacy and propriety for maximization of patients' and societal benefit is one of the important responsibilities of database management organizations. In addition, assessment of data quality such as audit and feedback is useful for enhancing accuracy and reliability of clinical databases.

[Quality management and participation into clinical database].

Quality management is necessary for establishing useful clinical database in cooperation with healthcare professionals and facilities. The ways of management are 1) progress management of data entry, 2) liaison with database participants (healthcare professionals), and 3) modification of data collection form. In addition, healthcare facilities are supposed to consider ethical issues and information security for joining clinical databases. Database participants should check ethical review boards and consultation service for patients.

[Work flow of registry in participating facilities and data audit in clinical database].

Clinical database needs quality control and quality assurance of data. Medical staffs of facilities in clinical database need to confirm definitions of data submitted to clinical database and criteria of registered cases, and decide how to entry data before data entry. Especially good communication between surgeons and data managers becomes an important factor of data quality in facilities. Also, we need quality improvement initiatives based on high quality data. Clinical database has to assurance data quality. The indicators of data quality are, for examples, completeness of registration and accuracy of data entry and data quality is evaluated on data verification between data of clinical database and medical records in facilities. From these viewpoints, this article described about work flow of registry for participating facilities and medical staffs.

[The research purposes and design of clinical database].

We discussed clarification of research purposes and designing of data collection form in large clinical databases. Research purposes are 1)assessment of healthcare quality, 2)evaluation of diagnosis and treatment, and 3)evaluation of health policy. In designing clinical databases, the researchers should consider the following themes;assurance of clinical utility, international collaboration, alleviation of data entry burden and assurance of scientific accuracy.

[The aim and features of clinical database].

Clinical database is a project aiming at quality improvement in medicine. It combines systematic collection of clinical data, analysis and feedback to medical practitioners. Medical professionals can clarify their challenges and deal with quality improvement based on feedback. Large and comprehensive clinical databases have been founded in many countries recently. The databases can be used for various purposes; quality indicator, support tool for medical decision-making, policy decision-making and evaluation, clinical research and public reporting. Administrators must pay attention to scientific, ethical and political perspectives. In this manuscript, the authors discussed definitions and issues of large clinical databases.