Exploration and example interpretation of real-world herbal prescription classification based on similarity matching algorithm / 中国中药杂志

In observational studies, herbal prescriptions are usually studied in the form of "similar prescriptions". At present, the classification of prescriptions is mainly based on clinical experience judgment, but there are some problems in manual judgment, such as lack of unified criteria, labor consumption, and difficulty in verification. In the construction of a database of integrated traditional Chinese and western medicine for the treatment of coronavirus disease 2019(COVID-19), our research group tried to classify real-world herbal prescriptions using a similarity matching algorithm. The main steps include 78 target prescriptions are determined in advance; four levels of importance labeling shall be carried out for the drugs of each target prescription; the combination, format conversion, and standardization of drug names of the prescriptions to be identified in the herbal medicine database; calculate the similarity between the prescriptions to be identified and each target prescription one by one; prescription discrimination is performed based on the preset criteria; remove the name of the prescriptions with "large prescriptions cover the small". Through the similarity matching algorithm, 87.49% of the real prescriptions in the herbal medicine database of this study can be identified, which preliminarily proves that this method can complete the classification of herbal prescriptions. However, this method does not consider the influence of herbal dosage on the results, and there is no recognized standard for the weight of drug importance and criteria, so there are some limitations, which need to be further explored and improved in future research.

Observaciones en el mundo real sobre la efectividad del sistema flash de monitorización de glucosa en la práctica clínica en Chile / Real-world observations of the effectiveness of the flash glucose monitoring in clinical practice in Chile

OBJETIVO: Evaluar el tiempo en rango de glucosa y su asociación con otras medidas del control glicémico establecidas por el consenso internacional del tiempo en rango en usuarios de vida real del sistema flash de monitorización de glucosa FreeStyle LibreTM en Chile. MÉTODOS: Se analizaron los datos provenientes de la base de datos Freestyle Libre™ entre diciembre de 2014 y enero de 2022. Las lecturas se dividieron en 10 grupos (deciles) del mismo tamaño (cada decil contenía aproximadamente 498 usuarios) en función del tiempo en rango. Para cada decil se calculó la media de determinaciones diarias, el promedio de glucosa, la HbA1c, la desviación estándar de glucosa, el coeficiente de variación de la glucosa, el tiempo en rango, el tiempo de glucosa (porcentaje) por encima de 250 mg/dL (TA250), el tiempo de glucosa (porcentaje) por encima de 180 mg/dL (TA180), el tiempo por debajo (porcentaje) de 70 mg/dL (TB70) y el tiempo por debajo (porcentaje) de 54 mg/dL (TB54). RESULTADOS: Desde diciembre de 2014 hasta enero de 2022 hubo 4984 lectores. El grupo con el mayor tiempo en rango mostró significativamente una menor glucosa promedio que el grupo con el tiempo en rango más bajo (decil 1: media 248,3 mg/dL, decil 10: media 113,2 mg/L, diferencia ­135,1 mg/dL, p<0.05). Asimismo, el mayor tiempo en rango se asoció con una menor desviación estándar (decil 1: media 93,7mg/dL, decil 10: media 26,7mg/L, diferencia: -67,0 mg/ dL, p<0,05), menor coeficiente de variación (decil 1: media 37,8%, decil 10: media 23,3%, diferencia: -14,5%, p<0,05), menor TA250 (decil 1: media 46,5%, decil 10: media 0,2%, diferencia: -46,3%, p<0.05), menor TA180 (decil 1: media 73,9%, decil 10: media 3,8%, diferencia: -70,1%, p<0.05), menor TB70 (decil 5: mediana 6,13%, decil 10: mediana 1,70%, diferencia: -4,43%, p<0.05) y menor TB54 (decil 5: mediana 1,79%, decil 10: mediana 0,12%, diferencia: -1,67%, p<0.05). El mayor tiempo en rango se asoció también significativamente con más determinaciones diarias (decil 1: media 11,4, decil 10: media 16,6, diferencia: 5,2, p<0,05). La frecuencia media de las determinaciones entre todos los lectores fue de 14,7 determinaciones diarias. CONCLUSIONES: En los pacientes con diabetes en Chile, el empleo del sistema flash de monitorización demuestra la asociación entre el mayor tiempo en rango, la reducción de la variabilidad de la glucosa y un menor riesgo de hiperglucemias e hipoglicemias y también con un mayor compromiso.

OBJECTIVE: To evaluate glucose time in range and its association with other metrics of glucose control established by the International Consensus on TIR amongst real-life patients using the Flash Glucose Monitoring system FreeStyle LibreTM in Chile. METHODS: Data from the Freestyle Libre™ database between December 2014 and January 2022 were analyzed. Readers were divided into 10 groups (deciles) of the same size (each decile had approximately 498 users) according to time in range. For each decile of time in range, the mean of daily scans, average glucose, estimated HbA1c, glucose standard deviation, glucose coefficient of variation, time in range, glucose time (percentage) above 250 mg/dL (TA250), and glucose time (percentage) above 180 mg/dL (TA180), and the median of glucose time (percentage) below 70 mg/dL (TB70) and glucose time (percentage) below 54 mg/dL (TB54), were calculated. RESULTS: From December 2014 to January 2022, there were 4984 readers. The group with the highest TIR showed significantly lower average glucose than the group with the lowest TIR (decile 1: mean 248.3 mg/dL, decile 10: mean 113.2 mg/L, difference: ­135.1 mg/dL, p<0.05). In addition, more time in range was associated with a lower glucose standard deviation (decile 1: mean 93.7 mg/dL, decile 10: mean 26.7 mg/L, difference: -67.0 mg/dL, p<0.05), lower glucose coefficient of variation (decile 1: mean 37.8%, decile 10: mean 23.3%, difference: -14.5%, p<0.05), lower TA250 (decile 1: mean 46.5%, decile 10: mean 0.2%, difference: -46.3%, p<0.05),lower TA180 (decile 1: mean 73.9%, decile 10: mean 3.8%, difference: -70.1%, p<0.05), lower TB70 (decile 5: median 6.13%, decile 10: median 1.70%, difference: -4.43%, p<0.05) and lower TB54 (decile 5: median 1.79%, decile 10: median 0.12%, difference: -1.67%, p<0.05). Greater TIR was also associated with significantly more daily scans (decile 1: mean 11.4, decile 10: mean 16.6, difference: 5.2, p<0.05). Mean scan frequency amongst all readers was 14.7 daily scans. CONCLUSIONS: In patients with diabetes from Chile, the use of the flash glucose monitoring system demonstrates the association between greater TIR, reduced glucose variability, and reduced risk of hyperglycemia and hypoglycemia, and also its association with greater engagement.

Discuss Application of Real-world Data from the Boao Lecheng Pilot Zone to Support Premarket Clinical Evaluation of Medical Device / 中国医疗器械杂志

The real-world data of Hainan Boao Lecheng International Tourism Pilot Zone has the advantage of supporting pre-market clinical evaluation of medical devices. Based on the relevant requirements of clinical evaluation of medical devices and based on the practical experience of pilot devices in the early stage, the application of Boao Lecheng real-world data in the pre-market clinical evaluation path of medical devices from the perspective of review is discussed. At the same time, the elements that should be considered in real-world study design and the way of data quality evaluation are proposed. Expect to provide a reference in order to allow registration applicants to use real world data wisely to help declare device registration for marketing.

Development and validation of ischemic heart disease and stroke prognostic models using large-scale real-world data from Japan

BACKGROUND@#Previous cardiovascular risk prediction models in Japan have utilized prospective cohort studies with concise data. As the health information including health check-up records and administrative claims becomes digitalized and publicly available, application of large datasets based on such real-world data can achieve prediction accuracy and support social implementation of cardiovascular disease risk prediction models in preventive and clinical practice. In this study, classical regression and machine learning methods were explored to develop ischemic heart disease (IHD) and stroke prognostic models using real-world data.@*METHODS@#IQVIA Japan Claims Database was searched to include 691,160 individuals (predominantly corporate employees and their families working in secondary and tertiary industries) with at least one annual health check-up record during the identification period (April 2013-December 2018). The primary outcome of the study was the first recorded IHD or stroke event. Predictors were annual health check-up records at the index year-month, comprising demographic characteristics, laboratory tests, and questionnaire features. Four prediction models (Cox, Elnet-Cox, XGBoost, and Ensemble) were assessed in the present study to develop a cardiovascular disease risk prediction model for Japan.@*RESULTS@#The analysis cohort consisted of 572,971 invididuals. All prediction models showed similarly good performance. The Harrell's C-index was close to 0.9 for all IHD models, and above 0.7 for stroke models. In IHD models, age, sex, high-density lipoprotein, low-density lipoprotein, cholesterol, and systolic blood pressure had higher importance, while in stroke models systolic blood pressure and age had higher importance.@*CONCLUSION@#Our study analyzed classical regression and machine learning algorithms to develop cardiovascular disease risk prediction models for IHD and stroke in Japan that can be applied to practical use in a large population with predictive accuracy.

Evaluation of Screening Model for Advanced Colorectal Adenoma and Traditional Chinese Medicine Tongue Image Analysis Based on Real World Data / 中医杂志

ObjectiveTo evaluate the effectiveness and consistency of three commonly used early colorectal cancer screening models for advanced colorectal adenoma as a noninvasive means， and to assess the predictive value of traditional Chinese medicine （TCM） tongue images in the models. MethodsPatients diagnosed with colorectal adenoma who underwent colonoscopy and pathological examination were selected as the study participants. Basic clinical data and tongue image were collected. The prediction models of Asia-Pacific colorectal screening （APCS） model， its revision （M-APCS） and colorectal neoplasia predict （CNP） model were applied to compare the predictive effects of the three models on advanced stage adenomas of the colon， the differences in clinical data and traditional Chinese medicine tongue characteristics among patients with different degrees of adenomas， and the similarities and differences in tongue characteristics among the models. The discriminative ability of the three risk models was evaluated using the area under the curve （AUC） and receiver operating characteristic （ROC） curves. The calibration was assessed using the Kuder-Richardson coefficient and the Hosmer-Lemeshow test for consistency analysis. ResultsA total of 227 patients with adenoma were analyzed， including 104 patients （45.82%） with advanced adenoma. In the detection of advanced adenoma， those with greasy coating （70 cases， 67.3%） were higher than those without greasy coating （34 cases， 32.7%， P＜0.05）. After multivariate analysis， the odds ratio （OR） value of non-greasy coating was 0.371 （0.204~0.673， P＜0.01）， indicating that non-greasy coating was a protective factor for advanced adenomas. Among the three risk models， the detection rate of advanced adenoma in the high-risk group with APCS was the highest （63.3%）， which was 1.49 times and 2.04 times that of the medium-risk group （42.6%） and the low-risk group （31.1%， P＜0.01）. The detection rate of advanced adenomas in high-risk groups of M-APCS and CNP was slightly higher than that in moderate or low risk groups （P＞0.05）. The proportion of yellow and greasy coating in high-risk group was higher than that in the medium-risk or low-risk group （P＜0.05）. For the ability to distinguish advanced and non-advanced adenomas， the AUC of APCS was 0.629 （95% CI： 0.556~0.702） and was higher than that of M-APCS （0.591） and CNP （0.586）. In calibration evaluation， Cronbach's alpha was 0.919 （＞0.7）， which indicated that the three models were consistent. In the correlation matrix， the correlation coefficients between APCS model and M-APCS model， and CNP model were 0.794 and 0.717， respectively， and the correlation coefficients between M-APCS model and CNP model were 0.873， Hosmer-Lemeshow χ2 =2.552， P＞0.05， which suggested that the three models had good calibration ability. ConclusionAll three models demonstrate the efficiency to identify advanced colorectal adenoma， and their calibration ability is considered to be good. Among the three models， the APCS exhibits the highest recognition efficiency， however， the recognition accuracy of the APCS model needs improvement. The presence of a greasy coating is identified as one of the potential predictors of advanced adenoma. Consequently， it can be considered for inclusion in the risk model of advanced colorectal adenoma to enhance the accuracy.

The prediction capability of a cataract surgery risk stratification model based on a large electronic medical record dataset

Purpose: The aim of this study was to develop a risk stratification system that predicts visual outcomes (uncorrected corrected visual acuity at one week and five weeks postoperative) in patients undergoing cataract surgery. Methods: This was a retrospective analysis in a multitier ophthalmology network. Data from all patients who underwent phacoemulsification or manual small-incision cataract surgery between January 2018 and December 2019 were retrieved from an electronic medical record system. There were 122,911 records; 114,172 (92.9%) had complete data included. Logistic regression analyzed unsatisfactory postoperative outcomes using a main effects model only. The final model was cross-checked using forward stepwise selection. The Hosmer朙emeshow goodness of fit test, the Bayesian information criterion, and Nagelkerke抯 R2 assessed model fit. Dispersion was calculated from deviance and degrees of freedom and C-stat from receiving operating characteristics analysis. Results: The final phacoemulsification model (n = 48,169) had a dispersion of 1.08 with a Hosmer朙emeshow goodness of fit of 0.20, a Nagelkerke R2 of 0.19, and a C-stat of 0.72. The final manual small-incision cataract surgery model (n = 66,003) had a dispersion of 1.05 with a Hosmer朙emeshow goodness of fit of 0.00015, a Nagelkerke R2 of 0.14, and a C-stat of 0.68. Conclusion: The phacoemulsification model had reasonable model fit; the manual small-incision cataract surgery model had poor fit and was likely missing variables. The predictive capability of these models based on a large, real-world cataract surgical dataset was suboptimal to determine which patients could benefit most from sight-restoring surgery. Appropriate patient selection for cataract surgery in developing settings should still rely on clinician thought processes, intuition, and experience, with more complex cases allocated to more experienced surgeons

Índices de internações, de mortalidade e de custos associados à doença pulmonar obstrutiva crônica (DPOC) no Distrito Federal após mudança do Protocolo Estadual de 2018 ­ Dados do mundo real / Hospitalization, mortality rates and costs associated with chronic obstructive pulmonary disease (COPD) in Distrito Federal, Brazil, before and after the change in 2018 state COPD protocol version ­ Real-world data

Objetivo: Avaliar os índices de hospitalização, mortalidade e custos associados à doença pulmonar obstrutiva crônica (DPOC) após mudança do Protocolo de Atenção à Saúde da Secretaria do Distrito Federal (SES-DF) em 2018 por um medicamento da mesma classe terapêutica, porém em dispositivo inalatório diferente. Métodos: Foi realizado um estudo observacional, transversal, em uma coorte de pacientes adultos internados em dois períodos específicos: gosto/2017 a julho/2018 (MAT 1 ­ vigência do Protocolo antigo) e agosto/2018 a julho/2019 (MAT 2 ­ vigência do novo Protocolo). Foram avaliados pacientes internados com diagnóstico principal de DPOC de acordo com a Classificação Estatística Internacional de Doenças e Problemas Relacionados com a Saúde Versão 10 (CID-10) estabelecida pelo protocolo de atenção à saúde e registrada no Datasus. Os desfechos avaliados foram número de internações, mortalidade e custos totais associados à internação por DPOC. Resultados: Após análise dos dados relacionados à DPOC, a comparação entre MAT 1 (agosto/2017 a julho/2018) e MAT 2 (agosto/2018 a julho/2019) resultou no aumento na ocorrência de importantes desfechos: +131,3% no número de internações com passagens em unidade de terapia intensiva (UTI) (n = 16 no MAT 1 vs. n = 37 no MAT 2, p < 0,01), +101,0% na frequência de internações com passagem em UTI sobre o total de internações (2,4% no MAT 1 vs. 4,8% no MAT 2, p = 0,01), +566,7% nos óbitos de pacientes internados em UTI (n = 3 no MAT 1 vs. n = 20 no MAT 2, p < 0,01) e +52,9% nos custos totais de internação (R$ 828.761 no MAT 1 vs. R$ 1.267.318 no MAT 2, p = 0,03). Conclusão: Durante os períodos analisados, houve aumento no uso de UTI, na mortalidade em UTI e nos custos totais relacionados à DPOC. A atualização do protocolo alterou tanto o dispositivo inalatório (névoa suave para pó seco) quanto a molécula (tiotrópio para glicopirrônio) e poderia ser um dos fatores responsáveis por esses desfechos, no entanto as limitações desta análise observacional não podem determinar um impacto causal da mudança do protocolo, pois outras variáveis também podem ter levado às diferenças descritas.

Objective: Evaluate the rates of hospitalization, mortality and costs associated with chronic obstructive pulmonary disease (COPD) before and after the change in COPD Treatment Protocol of State Health Secretariat of Distrito Federal (SES-DF). Methods: An observational, cross-sectional study was conducted in a cohort of hospitalized adult patients in two specific periods: August/2017 to July/2018 (MAT 1 ­ old version of Protocol in place) and August/2018 to July/2019 (MAT 2 - after the new Protocol version). Hospitalized patients with COPD as primary diagnosis according to International Statistical Classification of Diseases and Related Health Problems Version 10 (ICD-10) established by COPD Treatment Protocol and registered in DATASUS database were evaluated. The outcomes assessed were the number of hospitalizations, mortality and total costs ssociated with COPD hospitalizations. Results: After analyzing the data related to COPD, the comparison between MAT 1 (August/2017 to July/2018) and MAT 2 (August/2018 to July/2019) periods resulted in an increase in the occurrence of relevant outcomes: +131.3% in the number of hospitalizations with intensive care unit (ICU) admissions (n = 16 in MAT 1 vs. n = 37 in MAT 2, p < 0.01), +101.0% in the frequency of hospitalizations with ICU admissions over total number of hospitalizations (2.4% in MAT 1 vs. 4.8% in MAT 2, p = 0.01), +566.7% in deaths of patients admitted in ICU (n = 3 in MAT 1 vs. n = 20 in MAT 2, p < 0.01), +52.9% in total costs associated with COPD hospitalizations (R$ 828,761 in MAT 1 vs. R$ 1,267,318 in MAT 2, p = 0.03). Conclusion: During the analyzed periods, an increase in ICU usage, mortality in ICU and total costs related to COPD was observed. The update in the protocol switched the inhaler device (from soft mist to dry powder) and also the molecule (tiotropium to glycopyrronium) and could be potentially one of the factors responsible for these endpoints, however the limitations of this observational analysis cannot determine a causal impact of the protocol change as other variables could also have led to the differences described.

Lupus en Argentina. Pacientes no respondedores al tratamiento estándar y belimumab como posible opción. Datos del registro RELESSAR / Lupus in Argentina. Non-responders to standard treatment and belimumab as a possible option. RELESSAR record data

Introducción: el lupus es una enfermedad compleja y varias veces de difícil abordaje. Alcanzar la remisión es uno de los objetivos, incorporando opciones terapéuticas. Objetivos: describir las características generales de los pacientes según el estado de la enfermedad y el uso de belimumab. Materiales y métodos: estudio de corte transversal, registro RELESSAR. Se definió el estado de la enfermedad como: remisión: SLEDAI=0 y sin corticoides; baja actividad de la enfermedad: SLEDAI >0 y ≤4 y sin corticoides; control no óptimo: SLEDAI >4 y cualquier dosis de corticoides. Resultados: se incluyeron 1.277 pacientes, 23,4% en remisión, 12,6% en baja actividad y 63,8% con control no óptimo. En este último grupo eran más jóvenes y con menor duración de la enfermedad; presentaban mayores índices de actividad y cronicidad, y mayor empleo de inmunosupresores. Solo el 22,3% de los pacientes con criterio potencial de uso de belimumab (lupus eritematoso sistémico activo a pesar del tratamiento estándar) lo recibía en ese momento. Las variables asociadas a hospitalizaciones fueron: terapia con corticoides, ciclofosfamida y mayor SLICC. Conclusiones: se refleja la complejidad del manejo de estos pacientes y se visualizan aspectos estructurales como la desigualdad. El uso del belimumab resultaría beneficioso en los pacientes seleccionados.

Introduction: lupus is a complex disease and often difficult to approach. Achieving remission is one of the objectives, incorporating therapeutic options. Objectives: to describe the characteristics of the patients and the use of belimumab, according to the status of the disease. Materials and methods: cross-sectional study. Patients of the RELESSAR registry. Stratification: Remission: SLEDAI=0 and without corticosteroids. Low disease activity SLEDAI> 0 and ≤4 and without corticosteroids and non-optimal control: SLEDAI> 4 and any dose of corticosteroids. Results: a total of 1,277 patients were included, 23.4% in remission, 12.6% in low disease activity and 63.8% in non-optimal control. The last group was younger and had a shorter duration of the disease. They had higher activity and chronicity indices and greater use of immunosuppressants. Only 22.3% of the patients with potential criteria for the use of belimumab (activity disease despite standard treatment) were receiving it. The variables associated with hospitalizations were: corticosteroids, cyclophosphamide and higher SLICC. Those associated with severe infection: mycophenolate mofetil, azathioprine, corticosteroids, and higher SLICC. Conclusions: the complexity of the management of these patients is reflected, visualizing structural aspects such as inequality. The use of belimumab could be beneficial in selected patients.

Research Trends and Future Issues Related to Pre-analysis Data Preprocessing in Large-scale Real-World Data ―With the Goal of Using it in Clinical Research― / 薬剤疫学

In recent years, the utilization of health care databases has been increasing worldwide. It is expected that Real World Data (RWD) will soon be effectively used for clinical research in Japan. On the other hand, database studies that use accumulated existing data such as electronic medical records, Diagnosis Procedure Combinations (DPCs), and health insurance claims, require extremely high loads of data preprocessing before statistical analysis is possible. So far, there is insufficient literature that describes the challenges of RWD preprocessing from an academic point of view. In this review paper, the challenges of database study are classified into three categories：（1）data content,（2）data structure, and（3）large-volume data handling. We then investigated existing preprocessing research and systematically introduced them. Most data preprocessing research targeted the improvement and reliability of the database itself through supplementing data contents required for each clinical research. There is very little research with the primary purpose of solving problems related to data structures and large-volume data processing. As the use of RWD for clinical research increases, the importance of the data preprocessing field will be recognized. In the future, we expect to see more research focused on RWD, which can enable the growth of clinical researches using RWD.

3 ．Utilization of the Tokushukai Medical Database / 薬剤疫学

The Tokushukai Group is one of the largest hospital groups in Japan. By connecting all the hospitals via a network, the group has been able to achieve centralized management of clinical information. The Tokushukai Group has been utilizing the data in various ways, such as participation in clinical trials, development of anticancer drug protocol systems, participation in BioBank Japan, and provision of data to MID‒NET®. These days, the Tokushukai Group has started to provide the data, named as the “Tokushukai Medical Database (TMD)”, to academia and industries for research purposes. The TMD mainly consists of inpatient and outpatient administrative claims data, Diagnosis Procedure Combination (DPC) data, electronic health records including blood test results and vital signs, and hospital-based cancer registry information. The strengths of the TMD include the availability of blood test results and vital signs in an standardized format, and the possibility to go back to each patient's electronic medical record from their claims data and DPC data, with the permission of headquarters and the ethics committee in the Tokushukai group. By taking advantage of these strengths, there have been increasing number of studies in the TMD, such as research on acute kidney injury defined as blood test results, hyperkalemia in dialysis patients, and validation study on rheumatoid arthritis. The issues newly raised during the utilization of data (e.g., echocardiography data not standardized) are expected to be resolved with the update of the network system for a wider range of research topics in the future.

2 ． Overview of the DeSC Database and Utilization for Clinical Epidemiology and Pharmacoepidemiology Research / 薬剤疫学

Studies using real-world data are recently increasing worldwide. Various types of real-world data are available in Japan. Administrative claims databases include the National Database (NDB) and other types of databases including several commercially available databases. This article describes the DeSC database, newly constructed by DeSC Healthcare Co., Ltd. in 2020. One of the features of the DeSC database is that it includes data from the National Health Insurance, Health Insurance, and Advanced Elderly Medical Service System. In the present article, we referred to our previous study on population representativeness of the DeSC database and explained its overview. Estimated prevalence of some diseases were described for each type of insurance. Furthermore, we discussed the use of the DeSC database for clinical epidemiology and pharmacoepidemiology research.

Application of bayesian network in nursing real-world data and implementation of tetrad / 中国实用护理杂志

Objective:It introduced the application of bayesian network in real-world data and the implementation of Tetrad software, so as to provide methodological application reference for medical researchers.Methods:Real-world data for diabetes diagnosis had been taken as an example. UCI machine learning database Pima-Indian-diabetes data set was used as case data, Bayesian network ratiocination was carried out according to the construction order of bayesian network of Tetrad software.Results:When the screening age was over 30 years old, impaired glucose tolerance, abnormal serum insulin two hours after meal, body weight index and family genetic index were large, the probability of diabetes onset from 34.99% to 83.33%.Conclusions:The bayesian network realized by Tetrad software provides a powerful tool for causal inference of real-world data, and promoted the objective and quantitative interpretation of the dependence between variables.

Research on cost-benefit analysis of in-hospital falls: based on real world data / 中国实用护理杂志

Objective:Based on the real-world clinical data of hospital electronic medical records, to analyze the length of stay and healthcare costs associated with in-hospital falls and fall injuries in hospitals.Methods:Based on the electronic medical record system of the First Affiliated Hospital of Nanjing Medical University, a retrospective cohort study was conducted on patients admitted to these departments reported falls in nursing management information system from January 2017 to December 2019. A total of 38 481 patients from 74 units were enrolled in this study. The patients′ characteristics, falls, falls injury, and explore the length of hospital stay and bottom-up direct cost were analyzed.Results:A total of 243 cases (0.6%) fell and 154 cases (63.4%) were injured by falls from January 2017 to December 2019. Compared with non-fallers, the median length of stay of patients with falls was 19 days, which was significantly increased compared with 7 days of patients without falls ( Z=-15.18, P<0.05). The median hospitalization cost of patients with falls was 39 000 yuan, which was significantly higher than 16 300 yuan of patients without falls ( Z=-11.47, P<0.01). There was no statistical difference between non-injuried fallers and injuried fallers for length of stay and healthcare costs ( Z=-0.92, -0.64, P>0.05). Linear regression model analysis showed that gender, age, comorbidity, inpatient department unit, reason of hospitalization were significantly correlated with inpatient cost and length of stay ( F=280.05, 217.31, all P<0.05). Conclusions:Patients who have an in-hospital fall have significantly longer hospital stays and higher direct costs, mainly can be attributed to the fall itself, not the injury. Our findings have important financial implications for real world in light of optimal intervention strategies, resource allocation and economic evaluation of fall prevention.

Prognostic factors in patients with advanced differentiated thyroid cancer treated with multikinase inhibitors - a single Brazilian center experience

ABSTRACT Objective: The aim of this study was to describe the real-world experience multikinase inhibitors (MKI) in the treatment advanced differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAIR) therapy. Subjects and methods: We reviewed the records of all patients with MKI-treated DTC from 2010 to 2018. Progression free survival (PFS), response rates (RR) and adverse events (AE) profiles were assessed. Clinical parameters were compared between groups with different outcomes (disease progression and death) to identify possible prognostic factors and benefit from treatment. Results: Forty-four patients received MKI for progressive RAIR DTC. Median PFS was 24 months (10.2-37.7) and median overall survival (OS) was 31 months. Best overall response was complete response in one patient (4.5%), partial response in nine (20.4%), stable disease in twenty-two (50%), and progressive disease (PD) in twelve (27.3%). Seventy-two point 7 percent patients had clinical benefit and AE were mild in most cases (82.7%). Progressive patients were more likely to have FDG positive target lesion than those who did not progress (p = 0.033) and higher maximum SUV on target lesions (p = 0.042). Presence of lung-only metastasis and lower thyroglobulin (Tg) during treatment was associated with stable disease (p = 0.015 and 0,049, respectively). Patients with shorter survival had larger primary tumor size (p = 0.015) and higher maximum SUV on target lesions (p = 0.023). Conclusion: Our findings demonstrate safety and effectiveness of MKI in patients with advanced RAIR DTC. We were able to identify as possible prognostic markers of better outcomes: absence of FDG uptake on target lesions, lower maximum SUV on PET-CT, presence of lung-only metastasis and lower Tg during treatment.

A real-world data analysis of the use of hepatoprotective drugs in outpatients in six cities of China from 2015 to 2019 / 临床肝胆病杂志

Objective To investigate the use of hepatoprotective drugs in China in recent years, and to put forward related suggestions. Methods The outpatient prescription data of hepatoprotective drugs were collected from 85 hospitals in 6 cities of China from 2015 to 2019, and a real-world data analysis was performed to analyze the payment method, issuing department, drug category, and use of hepatoprotective drugs. Results A total of 1 113 575 prescriptions were extracted, involving 38 hepatoprotective drugs such as compound glycyrrhizin, polyene phosphatidylcholine, and bicyclol. Hepatoprotective drugs were mainly in tertiary hospitals, and the highest number of prescriptions containing hepatoprotective drugs were observed in department of infectious diseases, department of gastroenterology, and department of tuberculosis. Anti-inflammatory hepatoprotective drugs accounted for the highest proportion of all prescriptions, mainly compound glycyrrhizin, polyene phosphatidylcholine, and bicyclol. Of all prescriptions, 253 429 (22.76%) had the combination of multiple hepatoprotective drugs, with the highest number of 6 drugs, among which polyene phosphatidylcholine combined with bicyclol accounted for the highest proportion. Conclusion There are large quantities of hepatoprotective drugs used by outpatients in China. At present, the hepatoprotective drugs are clinically applied rationally, but there are still some problems to be solved, such as the combination of drugs.

Recommendations for Conducting Post-Marketing Database Study in Japan Based on the Critical Appraisal of Published Articles from Overseas Real-World Data (RWD) Analyses / 薬剤疫学

Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan； however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.

Risk of Hyperkalemia due to the Administration of Angiotensin Ⅱ Type 1 Receptor Blocker and Calcium Channel Blocker： Retrospective Cohort Study Based on Japanese Medical Information Database / 薬剤疫学

Objective：To assess the risk for hyperkalemia caused by treatment with angiotensin Ⅱ Type 1 receptor blockers （ARB） in clinical practice with Japanese medical database.Design：A cohort study in patients treated with ARB alone and those treated with calcium channel blockers （CCB） alone as control.Methods：The Diagnosis Procedure Combination （DPC） database provided by Medical Data Vision Co., Ltd. was used to identify patients who received a diagnosis of hypertension (ICD-10 codes, I10 to I15) and were treated with ARB or CCB from April 2008 to June 2017. A logistic regression model was applied to estimate adjusted odds ratios （OR） and their 95％ confidence intervals （CI） in these patients. The outcome in the logistic model was hyperkalemia （serum potassium≧5.5 mEq/L） and the covariates were sex, age, renal insufficiency, hepatic insufficiency, and baseline serum potassium levels. And, subgroup analysis was also performed in patients with and without renal insufficiency.Results：The incidence of hyperkalemia （per 1000 person-years） with ARB was 39.4 and that with CCB was 32.6. And, median periods from the index date to the date of occurrence of hyperkalemia for both exposure and control groups were 36 days （Min-Max：12-85） and 51.5 days（Min-Max：8-88）respectively. However, treatment with ARB was not associated with occurrence of hyperkalemia （OR 1.26, 95％CI： 0.58-2.75). The risk for hyperkalemia among those with renal insufficiency was higher （OR 3.31, 95％CI： 1.39-7.88）and as baseline serum potassium increased, the risk increased as well （OR 9.20, 95％CI： 3.52-24.10). And, the subgroup analysis also showed that rare occurrence of hyperkalemia by ARB and elevation risk for hyperkalemia by baseline serum potassium.Conclusion：The clinical data showed rare occurrence of hyperkalemia caused by ARB, indicating that renal insufficiency and baseline serum potassium levels affected the onset of the disease in clinical practice. Previous studies also reported the effects of renal insufficiency and other factors on the onset of hyperkalemia. ARB should be prescribed carefully in patients with these factors, as is conventionally done.

Recommendations for Conducting Post-Marketing Database Study in Japan Based on the Critical Appraisal of Published Articles from Overseas Real-World Data (RWD) Analyses / 薬剤疫学

Real-world data (RWD), such as a health insurance claim database and electronic medical record database, which records daily medical care information, is one of the most important data sources in pharmacoepidemiological studies. In Japan, a post-marketing database study has been added as a new category of post-marketing surveillance since April 2018. It is expected that the post-marketing database studies will be conducted in the actual risk management plan； however, at this point, few have reached the stage of publishing study results. On the other hand, overseas, many database research results using RWD have already been reported. Although it is necessary to keep in mind that there are differences in the characteristics of the databases (e.g., data contents, structures) and the differences in the medical environment between overseas and Japan, we think that critically reviewing these reports has a reference value for the planning, execution, and interpretation of the results in performing post-marketing database studies in Japan. The purpose of this report is to examine the characteristics and cautions of the database studies through a critical review of published articles of overseas RWD studies and to make recommendations that are useful for conducting post-marketing database studies in Japan. We hope this article will become a help in the planning and implementation of future post-marketing database studies.

A capacidade de leitos hospitalares no Brasil, as internações no SUS, a migração demográfica e os custos dos procedimentos / Hospitals beds in Brazil, SUS inpatients, demographic migration and procedures costs

Objetivo: Avaliar, por meio de dados de vida real, a capacidade dos leitos hospitalares brasileiros versus as recomendações da Organização Mundial de Saúde (OMS), como esses leitos estão sendo utilizados, de onde vêm os pacientes, quanto isso custa, as diferentes patologias que têm chegado aos hospitais e o percentual de tempo de internação em leitos de cuidado intensivo. Métodos: Estudo retrospectivo histórico realizado entre julho de 2018 e junho de 2019 a partir de dados obtidos do Datasus e subsequentemente processados em MySQL para diferentes perspectivas. Todos os índices foram construídos por meio de quintis de dias de internação e posteriormente subdivididos em análises mais específicas, confrontadas com literatura específica do assunto e diferentes diretrizes internacionais. Resultados: O Sistema Único de Saúde (SUS) teve um total de 9.275.680 pacientes únicos internados durante o período de análise, tendo um custo total de R$ 183 bilhões, totalizando 63.817.613 de diárias hospitalares com uma média de 6,3 dias de internação, R$ 1.972,73 de custo médio por internação e R$ 286,73 de custo médio diário. Conclusão: O SUS e toda a sua estrutura em perspectiva histórica são bem recentes. Cabe ainda aprimorar os processos de atenção de rede primária (portas de entrada), bem como desenvolver e disseminar os processos de desospitalização (portas de saída/reintrodução para a atenção primária).

Objective: Through real-world evidence, evaluate the hospital beds capacity in Brazil versus WHO recommendations, how these hospital beds are used, where patients come from, how much does this cost, which different diseases are coming and the Intensive Units utilization. Methods: Retrospective study realized between July 2018 and June 2019 through Datasus data and processed on MySQL to different perspectives. All indexes have been organized on quintiles internment days and then sub analyzed in different perspectives, comparing with local literature and with international Guidelines. Results: National Health System (SUS) had 9.275.680 unique patients during the analyzed period, with a total cost of R$ 183 billions, and 63.817.613 hospitalization days diaries charged. The average length of stay was 6.3 days and it cost R$ 1.972,73 per patient. Conclusion: National Health System (SUS) is very recent on historic perspective. Whole system needs to improve primary health flows (entrance door) as well as develop and disseminate at home care process (exit door/reintroduction to primary care).

A Critical Literature Review And Audit Of Real World Data To Inform The Relationship Between Mental Ill-Health And Type-2 Diabetes Favourable Prognosis

Objective: The aim of this scoping study was to identify gaps in the current literature and understand the T2DM and MIH comorbidity trends in the local population from the West Midlands, UK to inform future studies. Methods: This project was a scoping study of two parts; a critical review and a clinical audit. A thematic approach was used to group studies based on their overall study outcome. The clinical audit data was used to compare the local patient population to the patterns identified in the literature reviewed. Results: The reviewed studies reported a relationship between T2DM control and both depression and anxiety, but did not agree on its significance. The clinical audit of 71 patients diagnosed with T2DM showed that 73% of males presented with poor diabetes control (HbA1c>7) compared to females (46%). Conversely, females exhibited a higher prevalence of MIH (45%) compared to males (31%). Conclusion: From both this audit of the literature and local data, it remains unclear whether mental-ill health is a major driver for medication non-adherence behaviour and uncontrolled diabetes. Further studies are recommended to further understand this comorbidity.