Annals of clinical epidemiology最新文献

Background: Many patients who get discharged from the intensive care unit experience physical dysfunction that persists even after discharge. Physical dysfunction is associated with skeletal muscle atrophy and accompanying intensive care unit-acquired weakness in the early stages of intensive care unit admission, and early diagnosis and prevention with early mobilization are crucial. However, the amount of physical activity required for early mobilization remains controversial in critically ill patients. This study aims to reveal the optimal mobilization quantification score dose associated with physical dysfunction after hospital discharge.

Methods: This is a multicenter prospective cohort study planned in 22 facilities; all consecutive patients admitted to the participating facilities between June 2024 and May 2025 will be included. Adult patients on ventilator management for at least 2 days and who will consent to this study will be included. Patients' mobility level and duration will be documented by the mobilization quantification score during their intensive care unit stay, and physical dysfunction will be assessed using muscle mass changes from day one to seven with ultrasonography and the Short-Form 12 Health Survey at 3 months after hospital discharge. The primary outcome is physical dysfunction at 3 months.

Results and conclusion: Mobilization quantification score dose and muscle mass evaluation with ultrasonography will enable the quantification of the early mobilization intervention. This study will lay the foundation for future randomised studies.

The Ministry of Health, Labor, and Welfare, Japan, launched the Diagnosis Procedure Combination system in 2002. Detailed information on the Diagnosis Procedure Combination data was reported in Annals of Clinical Epidemiology in 2019. In this report, I provide updated information on the Diagnosis Procedure Combination. The data included the discharge abstracts and administrative claims data for each inpatient. Several entities (including the Ministry, academic groups, and private companies) independently collected anonymized Diagnosis Procedure Combination data. The advantages of Diagnosis Procedure Combination data include detailed process and clinical data, which enable researchers to conduct clinical epidemiology and health services research. Diagnoses are recorded using the International Classification of Diseases-10th Revision codes, and several indices based on these codes can be used. Several clinical measures are available for specific diseases including stroke, respiratory failure, heart failure, pneumonia, liver cirrhosis, pancreatitis, burns, and multiple organ failure. Scores for consciousness, activities of daily living, functional independence, and dementia are also available. Studies that use Diagnosis Procedure Combination data are interdisciplinary and include clinical medicine, epidemiology, statistics, and medical informatics.

Background: Approximately 30% of coronavirus disease 2019 COVID-19 patients develop fatigue and psychological symptoms. We previously demonstrated the efficacy of donepezil, an acetylcholinesterase inhibitor that is widely used to treat dementia, in basic research.

Methods: This is a multicenter, double-blind, randomized, controlled, phase II clinical trial in which 120 patients with COVID-19 will be randomized in a 1:1 ratio to a donepezil or placebo group. Inclusion criteria are as follows: (1) Adult. (2) With COVID-19 infection who had an upper respiratory tract infection, fever, or cough in the acute phase. (3) With a global binary fatigue score ≥4 on the Chalder Fatigue Scale assessment (4) Within 52 weeks of the onset of COVID-19. (5) Patients who provide consent themselves. In the donepezil group, a low dose (3 mg/day) is administered for the first week and is increased to 5 mg/day for 2 weeks. The control group receives placebo for 3 weeks. The primary endpoint is a change in and the absolute value of the Chalder Fatigue Scale score after 3 weeks of treatment. Secondary endpoints are a change in and the absolute value of the Chalder Fatigue Scale score after 8 weeks of treatment, the other mental scores after 3 and 8 weeks of treatment, a symptom survey, adverse events, and medication compliance rate.

Results: This study protocol is ongoing and the results will be analyzed in April 2024.

Conclusions: The off-label use of donepezil at the default dose for dementia has potential for the treatment of post-COVID-19 condition.

Background: Large electronic databases have been widely used in recent years; however, they can be susceptible to bias due to incomplete information. To address this, validation studies have been conducted to assess the accuracy of disease diagnoses defined in databases. However, such studies may be constrained by potential misclassification in references and the interdependence between diagnoses from the same data source.

Methods: This study employs latent class modeling with Bayesian inference to estimate the sensitivity, specificity, and positive/negative predictive values of different diagnostic definitions. Four models are defined with/without assumptions of the gold standard and conditional independence, and then compared with breast cancer study data as a motivating example. Additionally, simulations that generated data under various true values are used to compare the performance of each model with bias, Pearson-type goodness-of-fit statistics, and widely applicable information criterion.

Results: The model assuming conditional dependence and non-gold standard references exhibited the best predictive performance among the four models in the motivating example data analysis. The disease prevalence was slightly higher than that in previous findings, and the sensitivities were significantly lower than those of the other models. Additionally, bias evaluation showed that the Bayesian models with more assumptions and the frequentist model performed better under the true value conditions. The Bayesian model with fewer assumptions performed well in terms of goodness of fit and widely applicable information criteria.

Conclusions: The current assessments of outcome validation can introduce bias. The proposed approach can be adopted broadly as a valuable method for validation studies.

The Ministry of Health, Labour, and Welfare, Japan launched a national administrative claims database in 2009, which is called the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). Detailed information on the NDB was reported in Annals of Clinical Epidemiology in 2019. The present report provides updated information on the NDB. In 2020, the provision of data to private companies, as well as public sectors and academic entities, was legislated. As of 2024, the Ministry of Health, Labour, and Welfare is planning linkage of NDB data with several other national databases. Our previous literature review identified a total of 126 original articles using the NDB and NDB Open Data published from 2013 to 2022. Our updated review identified 94 original articles using the NDB and NDB Open Data in the recent two years. Studies using the NDB are gradually increasing, but there is still room for enhancing NDB studies on various subject areas.

Background: This registry aims to allow for a prospective non-interventional observational study of ulcerative colitis. This will facilitate monitoring of the current state of ulcerative colitis in Japan and improving the long-term disease course and adverse events associated with current treatment options.

Methods: Inclusion of patients from five centres in Japan is planned. The study is expected to take place from July 15, 2020, to November 30, 2024. Background, demographics, and medical history/information will be collected from electronic medical records at enrolment. Medical information including medications, laboratory data, and disease activity will be collected automatically from electronic medical records throughout the study. Patient-reported quality of life data will be collected directly from patients via smartphone. Efficacy endpoints (clinical remission rate, clinical improvement rate, and endoscopic healing rate) and safety endpoints (incidence of adverse events and specific ulcerative colitis-related events) will be collected according to treatment administered. Treatment categories include no treatment, 5-aminosalicylic acids, corticosteroids, immunomodulators, immunosuppressants, anti-tumour necrosis alpha agents, cytapheresis, Janus kinase inhibitors, anti-integrin antibodies, and anti-interleukin-12/23 antibodies.

Conclusions: The dataset will include cross-sectional and longitudinal data and is expected to capture the state of ulcerative colitis in Japan. Patients will be included on a large scale, and the registry will be established automatically from electronic medical records and direct patient input, facilitating the accurate recording of medical information for patients with ulcerative colitis in Japan and minimizing limitations intrinsic to databases that require manual data entry, such as the burden on participating investigators and entry of data with errors/typos.

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.