To evaluate the time-dependent predictive performance of inflammatory markers for 30-day all-cause mortality in patients with suspected infection.

Retrospective cohort study.

The ambulatory care division of the department of general medicine or the emergency department of a single acute care hospital in Japan, from April 2015 to March 2017.

The participants were 977 consecutive adult patients with suspected infection defined as those who underwent at least two sets of blood culture.

The primary outcome, ascertained from electronic medical records, was 30-day all-cause mortality. The predictive performance of three inflammatory markers (C-reactive protein (CRP), neutrophil-to-lymphocyte ratio and red cell distribution width (RDW)) was assessed across four time intervals from symptom onset to hospital presentation: ≤6, >6 to ≤24, >24 to ≤72, and >72 hours.

Time from symptom onset to hospital presentation influenced the predictive performance of inflammatory markers for 30-day all-cause mortality, and CRP ≥15 mg/dL was the most useful for identifying patients at higher risk of mortality within 6 hours (positive likelihood ratio (LR+) 7.7); however, this association weakened over time (LR+ 1.3 at >72 hours). Conversely, RDW ≥16% became more informative later in the course (LR+ 4.1 at >72 hours). For identifying patients at lower risk of 30-day all-cause mortality, CRP

These findings suggest the potential utility of CRP for ruling in high-risk patients within 6 hours from symptom onset, and of RDW for both ruling in and ruling out patients after 72 hours, thereby suggesting that time-dependent variations are important when interpreting inflammatory markers in emergency care settings. However, caution is needed when interpreting these findings because of the retrospective design of this study and potential selection bias.

Accumulating evidence suggests that glucagon-like peptide-1 (GLP-1) receptor agonists may have therapeutic effects against Parkinson’s disease (PD); however, clinical evidence has not yet been established and remains controversial. This clinical study aims to assess the efficacy, disease-modifying effects, safety and optimal dose of oral semaglutide tablets, a GLP-1 receptor agonist, in idiopathic patients with PD.

The MOST-ABLE study is a phase 2, multicentre, double-blind, randomised, placebo-controlled trial of oral semaglutide tablets in 99 participants with PD. Patients with PD (Hoehn & Yahr stages 1–2.5) at eight sites in Japan will be randomly assigned in a 1:1:1 ratio to one of three groups: oral semaglutide tablets (7 mg or 14 mg) or placebo. The study drugs will be administered once daily as an add-on to conventional medical treatment for PD. After 36 weeks of treatment, the participants will be treated without the study drugs for 12 weeks. The efficacy outcomes include Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Parkinson’s Disease Questionnaire-39, cognitive tests and dopamine transporter imaging. The primary endpoint is the change in the MDS-UPDRS part 3 score in the practically defined off-medication state from baseline at 48 weeks between the treatment allocation groups. The safety and tolerability will also be evaluated.

The study protocol was approved by the Pharmaceuticals and Medical Devices Agency of Japan and the study was approved by the institutional review boards at the University of Osaka Hospital and each study site. All participants are required to provide informed consent. The results will be disseminated in peer-reviewed journals, presented at scientific meetings and presented to patients in a lay summary format.

jRCT2051230090 (https://jrct.mhlw.go.jp/latest-detail/jRCT2051230090), universal trial number U1111-1271-3794.

Shared decision-making (SDM) requires that individuals are correctly and smoothly supported to make decisions. However, in Japan, development of decision aids (DAs) to support implementation of SDM is lagging behind Western countries, and there are few reports focused on breast reconstruction. Thus, it is unclear if SDM using a DA in the context of the unique national character and medical culture in Japan is useful in decision-making for breast reconstruction, including whether or not to undergo reconstruction. The aim of this multicentre collaborative study is to investigate the clinical effectiveness of SDM using a DA for patients with breast cancer considering reconstruction, from the perspectives of decisional conflict and postoperative quality of life.

A multisite trial will be conducted at 12 facilities certified by the Japanese Society of Breast Oncoplastic Surgery. A cluster-randomised controlled trial is planned at centres that have implemented SDM with DAs and those that have not implemented SDM, but use a conventional surgical explanation and informed consent to make decisions about reconstruction methods. The study participants will be female patients aged ≥20 years with newly diagnosed stage 0–III breast cancer who are interested in breast reconstruction. Data collection includes baseline and follow-up patient surveys and medical record review. The effectiveness of the DA at reducing conflict and regret in decision-making (primary outcome) will be evaluated using the decision conflict scale.

This protocol has been approved by the Kyoto University Central Institutional Review Board, and permission for performance of the study has been obtained from the Ethics Review Board at each participating centre. We plan to disseminate the findings through journal publications and national meetings, including a presentation of the research results at the Japanese Society of Breast Oncoplastic Surgery. Our findings will advance the science of medical decision-making and have the potential to reduce socioeconomic health disparities.

UMIN000052161.