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Shared decision-making using a decision aid for patients with breast cancer considering breast reconstruction: study protocol for a cluster-randomised controlled trial in Japan

Por: Sowa · Y. · Osaka · W. · Tsuge · I. · Komiya · T. · Saiga · M. · Taminato · M. · Nagura · N. · Shiraishi · T. · Seki · H. · Otsuki · Y. · Matsuoka · Y. · Tomita · S. · Akita · S. · Fujimoto · H. · Otani · K. · Yoshimura · K.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

UMIN000052161.

Visual perception and cognitive functioning in MCI and mild Alzheimers disease: a cross-sectional study protocol from the DEM-VIS study in Germany

Por: Roloff · J. · Stemmler · M. · Graessel · E. · Krakat · L. · Weis · J. · Lehfeld · H. · Jascenoka · J. C. · Daseking · M.
Introduction

Visual perception is a fundamental skill that plays a central role in sensing the external environment. Deficits can lead to impairments in everyday activities. Visual perception is known to be impaired in Alzheimer’s disease (AD). However, the extent to which visual perception is impaired in mild cognitive impairment (MCI), often a prodromal state of AD, has not been sufficiently investigated. This study aims to assess visual perceptual abilities in people with MCI and mild AD compared with healthy controls. It will also investigate whether executive functions, activities of daily living and intelligence are affected in this context, providing new insights into the research of visual perception together with MCI and mild AD.

Methods and analysis

People with MCI, mild AD and healthy controls will be assessed for cognitive deficits using the Syndrom-Kurztest (SKT). Visual perceptual performance will be assessed using the German version of the Developmental Test of Visual Perception-Adolescent and Adult: Second Edition (DTVP-A:2; Frostings Entwicklungstest der visuellen Wahrnehmung – Jugendliche und Erwachsene 2. Auflage). Activities of daily living will be assessed through the Erlangen Test of Activities of Daily Living in Persons with Mild Dementia or Mild Cognitive Impairment (ETAM) and the Bayer Activities of Daily Living Scale (B-ADL). Executive functions will be measured using the German adaptation of the Behaviour Rating Inventory of Executive Function - Adult (BRIEF-A) and intelligence will be assessed using the Matrix Reasoning and Vocabulary Test of the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV). Data analysis will involve descriptive analyses, linear regression analyses, multivariate analysis of variance, mediation analysis and structural equation modelling.

Ethics and dissemination

This study has received approval from the Ethics Committee of Helmut Schmidt University/University of the Federal Armed Forces Hamburg, Germany (number: 2023_009). Findings will be disseminated through peer-reviewed publications and presentations at national and international conferences.

Trial registration number

Registered at OSF https://doi.org/10.17605/OSF.IO/PM5AV

Changeover method for biosafety cabinets using ozone gas

by Mitsuru Mizuno, Daisuke Suda, Chima Matsumura, Ichiro Sekiya

This study evaluated the effectiveness of a biosafety cabinet equipped with an ozone generator, particularly during the transition periods between the production of cell products. As living cell products cannot undergo sterilization, maintaining an aseptic manufacturing environment is paramount. Raw materials, often derived from human tissues, are frequently contaminated with various resident bacteria, necessitating environmental resets after each process. The utility of this device against bacteria, including endotoxins, endospores, and fungi endemic to human tissues, could facilitate safe and reproducible production changeovers through a simplified, one-button operation. This study focused on bacteria resistant to conventional cleaning protocols, specifically targeting endospore-forming bacteria with robust resistance to disinfectants, spore-forming fungi, and included analyses of endotoxins. The effects of ozone exposure on Pseudomonas aeruginosa (an endotoxin-producing bacterium), Bacillus subtilis (an endospore-forming bacterium), and Aspergillus brasiliensis (a spore-forming fungus) were assessed. In the dedicated biosafety cabinet equipped with an ozone generator, the treatment group exposed to ozone showed a significant reduction in both colony-forming units and endotoxin levels in Pseudomonas aeruginosa at 1.0 × 104 colony-forming units (CFUs) compared to the control group. Moreover, the ozone treatment markedly decreased the colony formation of Bacillus subtilis endospores and Aspergillus brasiliensis spores. Given its effectiveness against endospores and endotoxins—among the most challenging bacterial derivatives to eliminate—the device demonstrates potential for enhanced bacterial control in Grade A biosafety cabinets within cell product manufacturing facilities. The system may substantially reduce operator stress by ensuring product safety through straightforward operational procedures and high reproducibility, although further validation is required.
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