Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Abstract Background The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general. Results Twenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as “difficult to understand,” and 65 items were evaluated as “difficult to answer” by at least one respondent. However, on further investigation, only 24 remarks were categorized as “comprehension difficulties” or “clarity” issues. Most of these remarks concerned patients’ difficulties with rating their experience of individual symptomatic events. Conclusions The study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items

Operating Characteristics of Cryogenic Loop Heat Pipes at Different Filling Pressures

Takeshi Yokouchi, Tohoku University, JapanXinyu Chang, Tohoku University, JapanHiroki Nagai, Tohoku University, JapanKimihide Odagiri, Japan Aerospace Exploration Agency(JAXA), JapanHiroyuki Ogawa, Japan Aerospace Exploration Agency(JAXA), JapanHosei Nagano, Nagoya University, JapanICES201: Two-Phase Thermal Control TechnologyThe 52nd International Conference on Environmental Systems was held in Calgary, Canada, on 16 July 2023 through 20 July 2023.A cryogenic loop heat pipe (CLHP) is a two-phase heat transport device for cooling equipment in cryogenic operating temperature regions, such as infrared detectors. Long-distance heat transport using a CLHP can decouple the heat source from the cryocooler, reducing the effects of vibration from the cryocooler. It is expected to improve the attitude control of the satellite and enable high-precision observations using optical instruments. In this study, a gravity-assisted CLHP has been designed, and its operational characteristics have been determined. The transport distance of the CLHP was 2m. In this report, we investigate the operating characteristics of the CLHP by changing the filling pressure of the CLHP. In addition, a one-dimensional thermal-mathematical model simulating the gas reservoir specific to the CLHP was constructed to investigate the effect of the filling pressure on the operating characteristics. In this study, the filling pressure was varied between 2.9 MPa and 3.4 MPa in 0.1 MPa increments. As a result, the maximum heat transport capacity was 25 W at 2.9 MPa-3.2 MPa and 30 W at 3.3 MPa-3.4 MPa, indicating that the heat transport capacity tends to increase as the filling pressure increases. The operating temperature increased with increasing filling pressure, with a maximum difference of 4.2 K. The effect on the operating characteristics was confirmed