Cerebral Small Vessel Disease Burden for Bleeding Risk during Antithrombotic Therapy: Bleeding with Antithrombotic Therapy 2 Study.

OBJECTIVE: This study was undertaken to determine the excess risk of antithrombotic-related bleeding due to cerebral small vessel disease (SVD) burden. METHODS: In this observational, prospective cohort study, patients with cerebrovascular or cardiovascular diseases taking oral antithrombotic agents were enrolled from 52 hospitals across Japan between 2016 and 2019. Baseline multimodal magnetic resonance imaging acquired under prespecified conditions was assessed by a central diagnostic radiology committee to calculate total SVD score. The primary outcome was major bleeding. Secondary outcomes included bleeding at each site and ischemic events. RESULTS: Of the analyzed 5,250 patients (1,736 women; median age = 73 years, 9,933 patient-years of follow-up), antiplatelets and anticoagulants were administered at baseline in 3,948 and 1,565, respectively. Median SVD score was 2 (interquartile range = 1-3). Incidence rate of major bleeding was 0.39 (per 100 patinet-years) in score 0, 0.56 in score 1, 0.91 in score 2, 1.35 in score 3, and 2.24 in score 4 (adjusted hazard ratio [aHR] for score 4 vs 0 = 5.47, 95% confidence interval [CI] = 2.26-13.23), that of intracranial hemorrhage was 0.11, 0.33, 0.58, 0.99, and 1.06, respectively (aHR = 9.29, 95% CI = 1.99-43.35), and that of ischemic event was 1.82, 2.27, 3.04, 3.91, and 4.07, respectively (aHR = 1.76, 95% CI = 1.08-2.86). In addition, extracranial major bleeding (aHR = 3.43, 95% CI = 1.13-10.38) and gastrointestinal bleeding (aHR = 2.54, 95% CI = 1.02-6.35) significantly increased in SVD score 4 compared to score 0. INTERPRETATION: Total SVD score was predictive for intracranial hemorrhage and probably for extracranial bleeding, suggesting the broader clinical relevance of cerebral SVD as a marker for safe implementation of antithrombotic therapy. ANN NEUROL 2024;95:774-787.

EMpowerment of PArents in THe Intensive Care: A multicentre validation study in Japan.

BACKGROUND: The importance of assessing family satisfaction in paediatric intensive care units (PICUs) is becoming increasingly recognised. The survey, EMpowerment of Parents in THe Intensive Care "EMPATHIC-30", was designed to assess family satisfaction and has been translated and implemented in several countries but not yet in Japan. OBJECTIVES: The objective of this study was to translate, culturally adapt, and validate the EMPATHIC-30 questionnaire in Japanese and to identify potential factors for family-centred care satisfaction. METHODS: We translated and adapted for patient-reported outcome measures via a 10-step process outlined by the Principles of Good Practice. Four paediatric PICUs in Japan participated in the validation study, and the parental enrolment criterion was a child with a PICU stay of >24 h. Reliability was measured by Cronbach's α, and congruent validity was tested with overall satisfaction-with-care scales by correlation analysis. Multivariate linear regression modelling was conducted to identify factors related to each domain of the Japanese EMPATHIC-30. RESULTS: A total of 163 parents (mean age: 31.9 ± 5.4 years; 81% were mothers) participated. The five domains of the Japanese EMPATHIC-30 showed high reliability (α = 0.87 to 0.97) and congruent validity, demonstrating high correlations with overall satisfaction in nurses (r = 0.75) and doctors (r = 0.76). Multivariate modelling found that elective admission, mechanical ventilation, and parents who had experience of a family member in an adult intensive care unit had higher satisfaction scores in all five domains (p < 0.05). Moreover, Buddhists assigned higher satisfaction scores in the Care and Treatment domain (p = 0.03). CONCLUSIONS: The Japanese EMPATHIC-30 questionnaire has demonstrated adequate reliability and validity measures. We also identified that elective admission, mechanical ventilation, and having previous adult intensive care unit experience of a family member were factors in assigning higher scores for all satisfaction domains. PICU clinicians need to be cognisant of ethical, cultural, and religious factors relating to the critically ill child and their family.

Translation and Adaptation of the Japanese Version of the Revised Parental Stressor Scale: Pediatric Intensive Care Unit.

Introduction The physical, cognitive, and psychiatric disorders that occur in patients after leaving the intensive care unit (ICU) are collectively called post-intensive care syndrome (PICS). Moreover, PICS-family (PICS-F) refers to the long-term psychological and social disorders that occur in the family. The symptoms of PICS-F can be psychological, and stress is a known cause of these symptoms. The Parental Stressor Scale: Pediatric Intensive Care Unit (PSS: PICU) was developed to assess stress levels and related factors among the families of patients admitted to the PICU. It has been translated into several languages and was revised in 2021. However, a Japanese version of the revised PSS: PICU (J-R-PSS: PICU) has not yet been developed. This study aimed to develop a J-R-PSS: PICU and to test its acceptability for clinical use. Materials and methods A back-translation method, involving initial translation, review by bilingual experts, and subsequent re-translation to ensure accuracy, was used to develop the J-R-PSS: PICU. Families with patients in the PICU for >48 hours between November and December 2021 and those who were transferred out of the ICU were recruited. Moreover, the study documents with a QR code for a web questionnaire were provided and explained to family members. Stress scores and stressors of family members were collected from web questionnaires using the PSS: PICU as the primary endpoint. Other information about the patients and their families was collected from clinical records and questionnaires. Participants and an expert panel evaluated the clarity of each item, and the expert panel evaluated the relevance of each item. Results Twenty family members who met the inclusion criteria and provided informed consent were included. The J-R-PSS: PICU was developed using a back-translation method. For clarity, all items were clarified after a single modification by an interdisciplinary team. For relevance, all the items had a content validity index at an item level of ≥0.8 and a scale level of 0.94. Alpha coefficients were 0.93 for the overall scale and 0.69-0.97 for its subscales. Conclusion We developed the J-R-PSS: PICU with high content validity and internal consistency using a back-translation method.

Blood pressure during long-term cilostazol-based dual antiplatelet therapy after stroke: a post hoc analysis of the CSPS.com trial.

We determined the associations of follow-up blood pressure (BP) after stroke as a time-dependent covariate with the risk of subsequent ischemic stroke, as well as those of BP levels with the difference in the impact of long-term clopidogrel or aspirin monotherapy versus additional cilostazol medication on secondary stroke prevention. In a sub-analysis of a randomized controlled trial (CSPS.com), patients between 8 and 180 days after stroke onset were randomly assigned to receive aspirin or clopidogrel alone, or a combination of cilostazol with aspirin or clopidogrel. The percent changes, differences, and raw values of follow-up BP were examined. The primary efficacy outcome was the first recurrence of ischemic stroke. In a total of 1657 patients (69.5 ± 9.3 years, female 29.1%) with median 1.5-year follow-up, ischemic stroke recurred in 74 patients. The adjusted hazard ratio for ischemic stroke of a 10% systolic BP (SBP) increase from baseline was 1.19 (95% CI 1.03-1.36), that of a 10 mmHg SBP increase was 1.14 (1.03-1.28), and that of SBP as the raw value with the baseline SBP as a fixed (time-independent) covariate was 1.14 (1.00-1.31). Such significant associations were not observed in diastolic BP-derived variables. The estimated adjusted hazard ratio curves for the outcome showed the benefit of dual therapy over a wide SBP range between ≈120 and ≈165 mmHg uniformly. Lower long-term SBP levels after ischemic stroke were associated with a lower risk of subsequent ischemic events. The efficacy of dual antiplatelet therapy including cilostazol for secondary stroke prevention was evident over a wide SBP range.