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AnteayerBMJ Open

Neurological outcomes with hypothermia versus normothermia in patients with moderate initial illness severity following resuscitation from out-of-hospital cardiac arrest: protocol for a multicentre randomised controlled trial (R-CAST OHCA)

Por: Naito · H. · Nishikimi · M. · Okada · Y. · Maeyama · H. · Kiguchi · T. · Yorifuji · T. · Nishida · K. · Matsui · S. · Kuroda · Y. · Nishiyama · K. · Iwami · T. · Nakao · A. · JAAM R-CAST OHCA Trial Group · Nishikimi · Otani · Ryosuke · Yumoto · Hayakawa · Sakurai · Fukushima · Tanaka
Introduction

Temperature control is a fundamental intervention for neuroprotection following resuscitation from cardiac arrest. However, evidence regarding the efficacy of hypothermia in post-cardiac arrest syndrome (PCAS) remains unclear. Retrospective studies suggest that the clinical effectiveness of hypothermia may depend on the severity of PCAS. The R-CAST OHCA trial aims to compare the efficacy of hypothermia versus normothermia in improving 30-day neurological outcomes in patients with moderately severe PCAS following out-of-hospital cardiac arrest.

Methods and analysis

The multicentre, single-blind, parallel-group, superiority, randomised controlled trial (RCT) is conducted with the participation of 35 emergency and critical care centres and/or intensive care units at academic and non-academic hospitals. The study enrols moderately severe PCAS patients, defined as those with a revised post-Cardiac Arrest Syndrome for induced Therapeutic Hypothermia score of 5.5–15.5. A target number of 380 participants will be enrolled. Participants are randomised to undergo either hypothermia or normothermia within 3 hours after return of spontaneous circulation. Patients in the hypothermia group are cooled and maintained at 34°C until 28 hours post-randomisation, followed by rewarming to 37°C at a rate of 0.25°C/hour. Patients in the normothermia group are maintained at normothermia (36.5°C–37.7°C). Total periods of intervention, including the cooling, maintenance and rewarming phases, will occur 40 hours after randomisation. Other treatments for PCAS can be determined by the treating physicians. The primary outcome is a favourable neurological outcome, defined as Cerebral Performance Category 1 or 2 at 30 days after randomisation and compared using an intention-to-treat analysis.

Ethics and dissemination

This study has been approved by the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee (approval number: R2201-001). Written informed consent is obtained from all participants or their authorised surrogates. Results will be disseminated via publications and presentations.

Trial registration number

jRCT1062220035.

Epidemiology and risk of psychiatric disorders in patients with polymyositis and dermatomyositis: a nationwide population-based cohort study in Taiwan

Por: Lee · I.-P. · Lee · Y.-T. · Wu · F.-Y. · Su · C.-F. · Kao · J.-H. · Lin · S.-H. · Chang · Y.-S.
Objectives

To evaluate the incidence and risk factors for psychiatric disorders, including depression and anxiety, and assess the risk of suicide in patients with polymyositis (PM) and dermatomyositis (DM).

Design

Retrospective cohort study.

Setting

Data were obtained from Taiwan’s National Health Insurance Research Database (NHIRD) between 2000 and 2018.

Participants

A total of 3477 patients with PM/DM and 13 908 age- and sex-matched non-PM/DM controls were included in the study.

Primary and secondary outcome measures

The primary outcome was the incidence and risk of psychiatric disorders in patients with PM/DM compared with controls. Secondary outcomes included the identification of risk factors for psychiatric disorders, mortality and suicide risk in the PM/DM cohort.

Results

The incidence rate ratio (IRR) of psychiatric disorders was significantly higher in the PM/DM cohort than in controls (IRR 1.62, 95% CI 1.39 to 1.89), with depression being the most prevalent disorder (IRR 2.25, 95% CI 1.83 to 2.75). Key risk factors included female sex, intravenous steroid therapy, and high-dose oral steroid use. Additionally, the PM/DM cohort exhibited a higher mortality rate (IRR 3.4, 95% CI 3.15 to 3.67) and elevated suicide risk (IRR 1.99, 95% CI 0.96 to 3.86) compared with controls.

Conclusion

Patients with PM/DM face a significantly higher risk of psychiatric disorders, mortality and suicide. Integrating mental healthcare into the routine management of PM/DM is crucial to improving patient outcomes and reducing mortality. Future research should focus on the impact of early psychiatric interventions on survival outcomes in this population.

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