Annals of clinical epidemiology最新文献

Background: This article aims to introduce the Real World Database-a new clinical database in Japan.

Methods: The Health, Clinic, and Education Information Evaluation Institute and Real World Data Co., Ltd. began developing the Real World Database in 2015. This is an electronic medical record database linked to claims data and discharge abstract data from medical institutions in Japan. The institutions agreed to collect data from 218 medical institutions as of June 2021.

Results: In 2019, 82 medical institutions provided data, which showed that 2,184,666 patients received treatment at medical institutions. There were also 334,437 inpatients with at least one hospital stay and 2,011,628 outpatients with at least one visit. More than 200 laboratory test results were available.

Discussion: This database is a potential data source for producing descriptive studies, comparative effectiveness studies, studies of adverse effects, and prediction studies.

Conclusions: The Real World Database provides an opportunity and strategy to produce real-world evidence for Japan.

Background: Delayed vaccination is a well-studied and critical public health issue. However, limited studies have explored whether familial factors influence vaccination delay. This study aimed to determine whether family structure and comorbidities affect the refusal or delayed receipt of measles-rubella and varicella vaccines.

Methods: We gathered data on all children from birth to 13 months of age between 2006 and 2020 using vaccination records linked with the administrative healthcare claims data from a Japanese city. Multivariable logistic regression analyses were conducted to examine the association of refusal or delay in receiving the first-dose measles-rubella and varicella vaccines with the following factors: the child's sex; presence of parents, siblings, and grandparents; parental and grandparental comorbidities; chronic pediatric comorbidities in the child and siblings; and year of vaccination.

Results: We identified a total of 14,241 eligible children. Refusal or delayed receipt of the first-dose measles-rubella vaccine was associated with an adjusted odds ratio of 2.46 (95% confidence interval, 1.86-3.24) for maternal absence and 1.61 (1.44-1.80) for paternal absence. Similarly, the refusal or delay in receiving the first-dose varicella vaccine was associated with an adjusted odds ratio of 2.04 (95% confidence interval, 1.01-4.16) for maternal absence and 1.37 (1.12-1.69) for paternal absence. The presence of siblings and maternal comorbidities were significantly associated with vaccination delays.

Conclusion: The absence of a parent, the presence of siblings, and maternal comorbidities were associated with the refusal or delay in receiving measles-rubella and varicella vaccines. Strategies for vaccine recommendation should therefore consider family structure and maternal comorbidities.

Background: Although intravitreal anti-vascular endothelial growth factor therapy is currently considered the first-line treatment for chorioretinal vascular diseases in Japan, information regarding its treatment pattern is scarce. This study investigated the patterns of anti-vascular endothelial growth factor treatment for chorioretinal vascular diseases.

Methods: A health insurance claims database from acute care hospitals was used to estimate treatment intervals and continuation and drop-out rates regarding the anti-vascular endothelial growth factor. Patients aged ≥50 years diagnosed with neovascular age-related macular degeneration or aged ≥18 years diagnosed with diabetic macular edema or retinal vein occlusion were analyzed.

Results: Data were included for 76,535, 49,704, and 37,681 patients with neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, respectively; exactly 8,111, 2,283, and 6,896 received the treatment, respectively. The mean and median interval ranges during the maintenance phase by treatment initiation year were 94-100 and 73-80, 111-120 and 98-102, and 97-103 and 87-93 days for neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, respectively, without any trend over time. A tendency to increase the treatment continuation rate was indicated in later years by Kaplan-Meier curves. The drop-out rate in the treatment initiation year (2016) was 32% from 63% (2009), 53% from 69% (2014), and 36% from 47% (2013) for neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, respectively.

Conclusions: For all these diseases, the treatment intervals did not change remarkably, and a tendency toward improved treatment continuation was suggested.

Background: In real-world clinical practice, treatments selected for patients with autosomal dominant polycystic kidney disease (ADPKD) in the chronic kidney disease (CKD) without kidney replacement therapy (KRT) have not been reported. This study investigated the oral treatments used in these patients and the changes in their use in recent years. Additionally, we studied the factors affecting tolvaptan dose reduction or discontinuation.

Methods: This retrospective cohort study was conducted using the medical records of 160 hospitals in Japan. Patients with ADPKD or polycystic kidney disease registered on the database between January 2014 and December 2020 were selected. Changes in prescription proportions over time were assessed using the Cochran-Armitage test. We focused on patients prescribed with >15 mg of tolvaptan daily to identify the factors related to its dose reduction or discontinuation and used Multivariate Cox regression analysis to evaluate them.

Results: Tolvaptan use in patients with ADPKD in the CKD without KRT stage has increased. As of 2020, 25% of patients were treated with tolvaptan. Overall, 3639 patients with ADPKD were enrolled in the database, of whom 156 were treated with tolvaptan. Of these, 64 patients (41%) reduced or discontinued tolvaptan during the observation period. The presence of an estimated glomerular filtration rate <60 mL/min/1.73 m² at the beginning of the treatment was associated with a higher risk of tolvaptan dose reduction or discontinuation.

Conclusion: The proportion of patients with ADPKD treated with high-dose tolvaptan is increasing. However, patients with late-stage CKD tended to reduce or discontinue tolvaptan.

Background: We aimed to develop and externally validate a novel machine learning model that can classify CT image findings as positive or negative for SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR).

Methods: We used 2,928 images from a wide variety of case-control type data sources for the development and internal validation of the machine learning model. A total of 633 COVID-19 cases and 2,295 non-COVID-19 cases were included in the study. We randomly divided cases into training and tuning sets at a ratio of 8:2. For external validation, we used 893 images from 740 consecutive patients at 11 acute care hospitals suspected of having COVID-19 at the time of diagnosis. The dataset included 343 COVID-19 patients. The reference standard was RT-PCR.

Results: In external validation, the sensitivity and specificity of the model were 0.869 and 0.432, at the low-level cutoff, 0.724 and 0.721, at the high-level cutoff. Area under the receiver operating characteristic was 0.76.

Conclusions: Our machine learning model exhibited a high sensitivity in external validation datasets and may assist physicians to rule out COVID-19 diagnosis in a timely manner at emergency departments. Further studies are warranted to improve model specificity.

Background: This study aimed to develop criteria for identifying patients with acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) from Japanese administrative data and validate the pre-existing criteria.

Methods: This retrospective, multi-center validation study was conducted at eight institutes in Japan to verify the diagnostic accuracy of the disease name for AE-IPF. We used the Japanese Diagnosis Procedure Combination data to identify patients with a disease name that could meet the diagnostic criteria for AE-IPF, who were admitted to the eight institutes from January 2016 to February 2019. As a reference standard, two respiratory physicians performed a chart review to determine whether the patients had a disease that met the diagnostic criteria for AE-IPF. Furthermore, two radiologists interpreted the chest computed tomography findings of cases considered AE-IPF and confirmed the diagnosis. We calculated the positive predictive value (PPV) for each disease name and its combination.

Results: We included 830 patients; among them, 216 were diagnosed with AE-IPF through the chart review. We combined the groups of disease names and yielded two criteria: the criteria with a high PPV (0.72 [95% confidence interval 0.62 to 0.81]) and that with a slightly less PPV (0.61 [0.53 to 0.68]) but more true positives. Pre-existing criteria showed a PPV of 0.40 (0.31 to 0.49).

Conclusion: The criteria derived in this study for identifying AE-IPF from Japanese administrative data show a fair PPV. Although these criteria should be carefully interpreted according to the target population, our findings could be utilized in future database studies on AE-IPF.

It is common clinical practice for physicians to refer to specific diagnostic criteria for day-to-day decision-making. In particular, whether or not to provide a particular treatment is often determined by the cutoff value of a relevant diagnostic marker. Regression discontinuity design (RDD) is a method for evaluating scenarios where intervention is determined by the certain cutoff value (e.g., threshold) of a continuous variable. RDD represents a powerful method for assessing intervention effects and outcomes. RDD is underutilized in clinical research and there are many opportunities to apply RDD in this setting. This article introduces the principles of RDD and provides examples of clinical studies that have used this design.

Background: Although outpatient cardiac rehabilitation has been shown to be effective, the participation status of older cardiac patients is unclear in real-world settings. We investigated the proportion and associated factors of outpatient cardiac rehabilitation participation among older patients with heart diseases after cardiac intervention.

Methods: We analyzed data from medical and long-term care insurance claims data from two municipalities in Japan. The data coverage period was between April 2014 and March 2019 in City A and between April 2012 and November 2016 in City B. We identified patients aged ≥65 years with post-operative acute myocardial infarction, angina pectoris, or heart valve disease. We estimated the proportion of cardiac rehabilitation participation and conducted logistic regression to identify factors (age, sex, type of cardiac disease, open-heart surgery, Charlson comorbidity index, long-term care need level, catecholamine use, inpatient cardiac rehabilitation, and hospital volume for cardiac rehabilitation) associated with outpatient cardiac rehabilitation participation.

Results: A total of 690 patients were included in this study. The proportion of patients receiving outpatient cardiac rehabilitation was 9.0% overall. Multivariable logistic regression analysis suggested that men (adjusted OR 3.98; 95% CI 1.69-9.37), acute myocardial infarction (adjusted OR 2.76; 95% CI 1.20-6.36; reference angina pectoris), inpatient cardiac rehabilitation (adjusted OR 17.01; 95% CI 5.33-54.24), and "hospital volume" for cardiac rehabilitation (adjusted OR 4.35; 95% CI 1.14-16.57 for high-volume hospitals; reference low-volume hospital) were independently associated with outpatient cardiac rehabilitation.

Conclusions: The participation rate of outpatient cardiac rehabilitation among older post-operative cardiac patients was suboptimal. Further studies are warranted to examine its generalizability and whether a targeted approach to a group of patients who are less likely to receive outpatient cardiac rehabilitation could improve the participation rate.

Background: This retrospective observational study validated case-finding algorithms for malignant tumors and serious infections in a Japanese administrative healthcare database.

Methods: Random samples of possible cases of each disease (January 2015-January 2018) from two hospitals participating in the Medical Data Vision Co., Ltd. (MDV) database were identified using combinations of ICD-10 diagnostic codes and other procedural/billing codes. For each disease, two physicians identified true cases among the random samples of possible cases by medical record review; a third physician made the final decision in cases where the two physicians disagreed. The accuracy of case-finding algorithms was assessed using positive predictive value (PPV) and sensitivity.

Results: There were 2,940 possible cases of malignant tumor; 180 were randomly selected and 108 were identified as true cases after medical record review. One case-finding algorithm gave a high PPV (64.1%) without substantial loss in sensitivity (90.7%) and included ICD-10 codes for malignancy and photographing/imaging. There were 3,559 possible cases of serious infection; 200 were randomly selected and 167 were identified as true cases after medical record review. Two case-finding algorithms gave a high PPV (85.6%) with no loss in sensitivity (100%). Both case-finding algorithms included the relevant diagnostic code and immunological infection test/other related test and, of these, one also included pathological diagnosis within 1 month of hospitalization.

Conclusions: The case-finding algorithms in this study showed good PPV and sensitivity for identification of cases of malignant tumors and serious infections from an administrative healthcare database in Japan.