Annals of clinical epidemiology最新文献

Mendelian randomization (MR), i.e. instrumental variable analysis using genetic instruments, is an approach that incorporates population genetics to improve causal inference. Given that genetics are randomly allocated at conception, this resembles the randomization process in randomized controlled trials and hence is more resistant to unobserved confounding compared to conventional observational studies (e.g. cohort studies). The seminar paper briefly described the origin of MR and its underlying assumptions (relevance, independence, and exclusion restriction). This was followed by introducing one sample MR designs (in which instrument-exposure and instrument-outcome associations are derived from the same sample) and one sample MR design (in which instrument-exposure and instrument-outcome associations are derived from different samples). The seminar paper then summarized key aspects of MR studies, such as instrument selection, data sources for conducting MR studies, and statistical analyses. Variations of MR design were also introduced, such as how this design can inform the effect of drug targets (drug target MR). The STROBE-MR checklist and relevant MR guidelines were introduced. The seminar paper concluded by discussing the credibility crisis of MR studies.

Background: Polycythemia often develops in the highland areas. However, it remains to be clarified whether blood hemoglobin levels in the general population are affected by elevations above sea level of <1,000 m.

Methods: This ecological study targeting secondary medical areas in Japan considered residential altitude at 0-800 m as the exposure and the mean hemoglobin level of the inhabitants aged between 40-44 years as the main outcome, based on the data extracted from the nationwide Special Health Checkup for 2021. The secondary outcome was the proportion of examinees with low hemoglobin levels. The results were validated using a 2018 dataset.

Results: Individual data from approximately 1.21 million women and 1.93 million men in 335 secondary medical areas were summarized. When these areas were categorized into four groups by their altitude, the mean hemoglobin level at 600-800 m was elevated with a mean difference of 0.27 g/dL in women (p for trend <0.01) and with a mean difference of 0.21 g/dL in men (p for trend <0.01), compared to that at 0-200 m in 2021 dataset. Moreover, the proportion of women examinees with hemoglobin level <12.0 g/dL was 21.3% at 0-200 m and 17.6% at 600-800 m in 2021 (p for trend <0.01). These results were confirmed using the 2018 dataset.

Conclusions: As the residential altitude increased from sea level to 800 m, blood hemoglobin levels were slightly elevated, and anemia prevalence in women decreased, implying caution in hemoglobin measurements.

Background: The current report shows a comparison of changes in pre- and in-hospital procedures, treatments and outcomes of patients with out-of-hospital cardiac arrest (OHCA) during the SOS-KANTO study periods.

Method: This study included patients aged ≥18 years who experienced bystander-witnessed OHCA of cardiac etiology, which was confirmed by emergency medical service (EMS) providers at the scene, received cardiopulmonary resuscitation (CPR) from EMS providers, and were subsequently transported to the participating institutions.The primary outcome measure was patient survival with favorable neurological outcomes at 1 month from cardiac arrest. The secondary outcomes were the proportions of bystander CPR cases, advanced CPR procedures performed by EMS providers, pre-hospital return of spontaneous circulation (ROSC) rates, and post-resuscitation treatment administration.

Results: Data of 1,515 patients from the SOS-KANTO 2017 study and 2,189 patients from the 2012 study were analyzed. Bystander CPR and advanced CPR procedures were performed more frequently and reliably by EMS providers in the 2017 than in the 2012 study. The rate of pre-hospital ROSC to total ROSC was higher in the 2017 study (35.7% vs 29.0%), and in-hospital treatments and post-resuscitation care was provided more frequently in the 2017 study. However, the 2017 study showed no significant difference in the survival rate with favorable neurological outcomes at 1 month, compared with the 2012 study. (9.0% vs 8.5%).

Conclusion: High quality of prior to ROSC and post-resuscitation care following ROSC was maintained in the 2017 study. However, the 2017 study showed no significant difference in the survival rate with favorable neurological outcomes at 1 month, compared with the 2012 study.

Background: Reoperation after lumbar spine surgery is a major issue for both patients and physicians. It is uncertain whether fusion is superior to decompression alone for lumbar degenerative disease regarding reoperation rate. We aim to evaluate the reoperation rate after fusion surgery for lumbar degenerative disease compared with decompression alone.

Methods: This study was conducted under a retrospective cohort design in patients undergoing fusion or decompression alone in one or two levels for lumbar degenerative disease using a Japanese claims-based database. Primary outcome was reoperation incidence during the follow-up period, and secondary outcome was reoperation incidence within 90 days postoperatively. Confounding factors were handled using propensity score overlap weighting. Cumulative incidence of reoperation was calculated from the Kaplan-Meier curve and hazard ratios (HRs) and 95% confidence intervals (CIs) for reoperation were estimated using Cox proportional hazards regression models.

Results: 8497 patients (2051 patients in the fusion group and 6446 in the decompression alone group) were included in the study. There was no difference in reoperation rate between fusion and decompression alone (weighted HR 0.85 [95% CI 0.69 to 1.04]; p = 0.11).

Conclusions: Among patients with lumbar degenerative disease who underwent fusion or decompression alone, no significant difference was observed between the two groups.

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.