Annals of Clinical Epidemiology
Online ISSN : 2434-4338
Volume 5, Issue 3
Displaying 1-4 of 4 articles from this issue
SEMINAR
  • Sugihiro Hamaguchi, Aya Watanabe, Yohei Nakamoto, Tetsuro Aita, Toru N ...
    Article type: SEMINAR
    2023 Volume 5 Issue 3 Pages 65-73
    Published: 2023
    Released on J-STAGE: July 04, 2023
    Advance online publication: April 08, 2023
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    The rapid spread of a novel type of coronavirus infection, coronavirus disease 2019 (COVID-19) has made it difficult to implement the results of clinical trials in real-world situations. After the emergence of the Omicron variant and messenger RNA vaccine, a combination of less virulent but more contagious viruses and more people with protective immunity has resulted in a larger number of patients with less severe, mild-to-moderate COVID-19. Many patients with severe conditions did not have extensive viral pneumonia frequently seen in the “pre-Omicron” era but had serious complications due to aggravation of underlying comorbidities or secondary bacterial infections. Most clinical trials for new antiviral drugs were conducted in the “pre-Omicron” period based on a different set of background patient characteristics than the ones seen in the Omicron period. Understanding situational differences due to the gap in the timing between clinical trials and the practical use of drugs for COVID-19 will assist in developing an effective treatment strategy in real-world practice. In this seminar, we reviewed antiviral treatments for mild-to-moderate COVID-19 from the viewpoint of the difference in patient backgrounds between clinical trials and real-world studies, focusing on drugs currently used in Japan.

ORIGINAL ARTICLE
  • Satoshi Kasuya, Shotaro Aso, Isao Takahashi
    Article type: ORIGINAL ARTICLE
    2023 Volume 5 Issue 3 Pages 74-79
    Published: 2023
    Released on J-STAGE: July 04, 2023
    Advance online publication: April 08, 2023
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    BACKGROUND

    Extracorporeal membrane oxygenation (ECMO) has been used for decades, but optimal anticoagulation control remains unknown. This study aimed to compare shorter target activated coagulation time (ACT) criteria with the usual target ACT criteria in terms of complications.

    METHODS

    We retrospectively identified patients who received ECMO between 1 January 2013 and 31 December 2018 in an acute tertiary care hospital. Patients were divided into two groups: (I) those whose target ACT was 160–180 sec and (II) those whose target ACT was 180–220 sec. Cox proportional hazard models and Fine–Gray models adjusted for propensity score to account for the competing risk of death were used to compare the incidence of hemorrhage during ECMO between the groups.

    RESULTS

    We identified 74 patients, 25 of whom were managed with target ACT 160–180 sec, and 49 of whom were managed with target ACT 180–220 sec. In crude analysis, the proportions of patients with hemorrhage in the under 180-sec group were significantly more than those in the over 180-sec group [60.0% (15/25) vs. 28.6% (14/49), p = 0.009]. Shorter target ACT was not associated with hemorrhage during ECMO in either Cox regression (hazard ratio, 1.67; 95% confidence interval, 0.59–4.80; p = 0.336) or Fine–Gray model (hazard ratio, 1.58; 95% confidence interval, 0.64–3.91; p = 0.324).

    CONCLUSIONS

    The shorter ACT target was not associated with improved hemorrhage and inappropriate coagulation than the usual target ACT criteria. This study is the first to compare the ACT target of patients with ECMO.

  • Worapot Srimanan, Warissara Kitsirilarp
    Article type: ORIGINAL ARTICLE
    2023 Volume 5 Issue 3 Pages 80-87
    Published: 2023
    Released on J-STAGE: July 04, 2023
    Advance online publication: April 08, 2023
    JOURNAL OPEN ACCESS FULL-TEXT HTML

    BACKGROUND

    The study aimed to examine the incidence and risk factors associated with retinopathy of prematurity at Phramongkutklao Hospital.

    METHODS

    A retrospective review was conducted on the medical records of premature infants screened for retinopathy of prematurity between January 2011 and December 2021. The screening examination was performed on infants who met the screening criteria, and retinopathy of prematurity was diagnosed according to the International Classification of Retinopathy of Prematurity. Maternal, obstetric, neonatal, and medical data were retrieved. Logistic regression analysis was used to identify the risk factors associated with retinopathy of prematurity.

    RESULTS

    A total of 403 premature infants were screened. The mean ± SD birth weight and gestational ages were 1,538 ± 543 grams and 31 ± 3 weeks, respectively. The incidence of any retinopathy of prematurity and stages 2 and 3 were 13.6%, 3.5%, and 10.1%, respectively. Multiple logistic regression analysis demonstrated that gestational age (adjusted odds ratio = 1.98, 95% CI:1.15–3.39), low birth weight (adjusted odds ratio = 0.99, 95% CI: 0.99–1.00), and phototherapy (adjusted odds ratio = 0.41, 95% CI: 0.17–1.00) were significant factors associated with the development of retinopathy of prematurity, after controlling for other confounding factors.

    CONCLUSIONS

    The incidence of total retinopathy of prematurity cases in this population was 13.6%. Overall, retinopathy of prematurity cases classified as stage 2 equated to 3.5% and stage 3 to 4.1%. Our data suggest that factors associated with retinopathy of prematurity consist of birth weight, gestational age, and phototherapy.

  • Hiroki Maki, Hidetaka Wakabayashi, Keisuke Maeda, Mariko Nakamichi, Ka ...
    Article type: ORIGINAL ARTICLE
    2023 Volume 5 Issue 3 Pages 88-94
    Published: 2023
    Released on J-STAGE: July 04, 2023
    JOURNAL OPEN ACCESS FULL-TEXT HTML

    BACKGROUND

    The Comorbidity Polypharmacy Score (CPS) is calculated by the number of drugs carried plus the number of comorbidities on admission and divided into three categories (minor, 0–7; moderate, 8–14; and severe, 15+). This study investigates whether CPS can predict the clinical outcomes in older patients with hip fractures undergoing surgery.

    METHODS

    This retrospective longitudinal study used a multicenter hospital-based database containing the Diagnosis Procedure Combination. Consecutive patients with hip fractures (ICD-10 codes S720 and S721) who were aged ≥65 years between April 2014 and August 2020 were included. We evaluated the predictive association between the CPS and Barthel Index (BI) efficiency. The primary outcome was defined as the BI efficiency, and the secondary outcome was the length of hospital stay.

    RESULTS

    We enrolled 11,564 patients, and 80.5% of them were female. The mean age was 83.9 ± 6.5 years. The BI efficiency was the lowest in the CPS severe group with a median [interquartile range] of 0.67 [0.10, 1.43]. The length of hospital stay was the highest in the CPS severe group, with a median of 35 [21, 58]. Additionally, multiple linear regression analysis revealed that the CPS was independently associated with the BI efficiency (β = −0.100, 95% CI: −0.040, −0.029; P < 0.001) and the length of hospital stay (β = 0.047, 95% CI: 0.199, 0.366; P < 0.001).

    CONCLUSIONS

    An increased CPS score is associated with low BI efficiency and longer length of hospital stay in patients with hip fractures.

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