Osaka Medical and Pharmaceutical University

Informed consent is crucial for clinical trial participation. However, there have been no qualitative studies of participants’ experiences in randomized control trials of acute and critical care, particularly during the COVID-19 pandemic, when clinical trials were significant public health measures. This study aimed to explore the experiences of critically ill patients in Japan who participated in an international clinical trial for COVID-19 therapeutics. A qualitative research method using conventional content analysis was employed. Data were collected through semi-structured interviews of participants in the anticoagulation domain of the Randomized, Embedded, Multi-factorial, Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP). All participants had been hospitalized in a Japanese ICU due to severe COVID-19, been deemed competent, and given prospective informed consent to participate. Ten trial participants were recruited, and data saturation was achieved. Three categories emerged: (1) trial participation without awareness or adequate understanding, (2) interpretation of trial participation experience with reference to personal circumstances, and (3) emotions and thoughts evoked by trial participation. Details of the trials or interventions were poorly understood. Some participants were unaware they had consented to participate. While some expressed interest in future trials, others remained uncertain about their trial participation. Critically ill trial patients struggled to understand trial details during the informed consent process. Future research should optimize this process and ongoing patient support to balance autonomy and public health needs in health emergencies. Not applicable.

Large type 3 (≥ 8cm) and type 4 gastric cancers are associated with extremely poor prognoses. The phase III JCOG0501 trial, which evaluated neoadjuvant S-1 plus cisplatin, failed to demonstrate any survival benefits. Docetaxel, oxaliplatin, and S-1 (DOS) have been explored as more effective perioperative regimens for these tumors. Eligible patients had large type 3 or type 4 gastric cancer without distant metastases, except for positive peritoneal cytology (CY). Patients received three cycles of neoadjuvant DOS (docetaxel 40mg/m2, oxaliplatin 100mg/m2, and oral S-1 at 80mg/m2/day for 14days), followed by gastrectomy with ≥ D2 lymphadenectomy and one year of adjuvant docetaxel plus S-1. The primary endpoint was the 3year progression-free survival (PFS) rate, with an expected value of 60% and a threshold of 45%. A one-sample log-rank test was performed with an α level of 0.10. Of the 48 patients enrolled, 27 had type 4 tumors (56.2%), and 10 (20.8%) had CY1. Overall, 91.7% of patients completed neoadjuvant DOS. R0 resection rate was achieved in 89.6% of patients, a pathological response grade ≥ 1b in 66.7%, and negative CY conversion in 80.0%. The 3-year PFS rate was 37.5% (95% confidence interval [CI], 24.1-50.6%; 80% CI 28.6-46.4%; p = 0.960), and the 3-year overall survival rate was 52.1% (95% CI 37.2-65.0%). Although neoadjuvant DOS therapy demonstrated favorable pathological responses, the 3-year PFS did not exceed the predefined threshold, and a survival benefit was not demonstrated.

The standard treatment for locally advanced rectal cancer (RC) in Japan is TME with or without lateral lymph node dissection (LLND) and subsequent adjuvant chemotherapy. The efficacy of chemotherapy after TME without LLND remains unclear, so we aimed to assess this efficacy. We retrospectively reviewed patients who underwent TME without LLND and received adjuvant chemotherapy between January 2010 and December 2020 at our institution. Relapse-free survival (RFS) and overall survival (OS) were assessed. Prognostic factors for RFS, including tumor location, chemotherapy regimen, and T and N factors were analyzed using univariate and multivariate analyses. Of 197 patients, 117 were eligible. The median age was 66 years (range 26–82). Tumor locations were Ra and Rb in 67 (57%) and 50 (43%) patients. Eighty (68%) and 37 (32%) patients received fluoropyrimidine monotherapy (single agent) and oxaliplatin-based therapy (doublet) as adjuvant chemotherapy. The 3-year RFS rate and 3-year OS rate were 73.6% (95% confidence interval [CI], 64.7–81.0%) and 95.5% (95% CI, 89.6–98.1%), respectively. In the univariate and multivariate analysis, none of these variables were identified as independent prognostic factors for RFS. TME without LLND followed by adjuvant chemotherapy in patients with RC demonstrated favorable 3-year RFS and OS rates.

To compare the efficacy and safety of rituximab (RTX) to those of intravenous cyclophosphamide (IVCY) as remission induction therapy in patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) and severe renal impairment. Using the REVEAL cohort, this retrospective multicentre study enrolled 96 newly diagnosed patients with AAV and an estimated glomerular filtration rate of <30 mL/min/1.73 m2. The patients were divided into RTX and IVCY groups. Matching weights were used to adjust for baseline characteristics. The primary outcome was a 2-year composite of all-cause mortality or end-stage kidney disease (ESKD). Secondary outcomes included all-cause mortality, ESKD, relapse, and hospitalisation-requiring infections. Outcomes were assessed using multivariable Cox proportional hazards models. In the weighted population, the hazard ratio (HR) for RTX versus IVCY was 0.73 (95% confidence interval: 0.31-1.72) for the primary composite outcome, with no significant intergroup difference. Similarly, intergroup differences in the HRs for all-cause mortality, ESKD, relapses, and hospitalisation-requiring infections were not significant. RTX and IVCY demonstrated comparable efficacy in preventing mortality and ESKD in this high-risk population. RTX is a viable option for patients with AAV and severe renal impairment.

Chronic background mucosal inflammation contributes to colorectal cancer (CRC) development in ulcerative colitis (UC), but its prognostic impact is unclear. We evaluated whether background mucosal inflammation documented at cancer diagnosis is associated with oncologic outcomes. This retrospective study analyzed 1189 UC patients diagnosed with CRC using a nationwide, multicenter database in Japan. Patients were classified as CRC within the UC-involved area (within-area) or outside the UC-involved area (outside-area), based on tumor location relative to the UC disease extent documented endoscopically at cancer diagnosis. The primary end point was 5-year recurrence-free survival (RFS), and the secondary end point was 5-year cancer-specific survival (CSS). In within-area cases, inflammation severity was assessed using the Mayo Endoscopic Score (MES), stratified as Inactive, Mild-Moderate, and Severe. Of the 723 eligible patients, 683 had within-area and 40 outside-area CRC. Five-year RFS was significantly lower in within-area than outside-area CRCs (75.1% vs 87.6%, P = 0.022). Multivariable Cox regression analysis of RFS revealed this classification as an independent prognostic factor (hazard ratio = 2.99, 95% confidence interval: 1.09-8.18, P = 0.030). A significant difference was also observed in 5-year CSS (P = 0.038). Among within-area cases, higher MES was associated with stepwise declines in RFS (P = 0.150), and a similar, statistically significant gradient in CSS (P = 0.048). Background mucosal inflammation at cancer diagnosis is associated with significantly worse prognosis of CRC in UC patients. Systematic endoscopic assessment at cancer diagnosis may aid prognostic stratification and inform management.

This study aimed to evaluate the association between coronal pelvic and sagittal spinal radiographic parameters and the rapid progression of hip arthrosis (RPHA). In this retrospective case-control study, 92 patients (92 hips) who underwent hip arthroplasty were analysed. RPHA was defined as ≥ two millimeters of femoral head collapse or ≥ 50% narrowing of the hip joint space within 12 months. Patients were classified into two groups: the study group (n = 29) and the control group (n = 63), which comprised patients without RPHA during a minimum follow-up period of 12 months before the operation. Linear regression and receiver operating characteristic (ROC) curve analyses were performed to identify radiographic predictors of RPHA. RPHA was significantly associated with lumbar lordosis (p = 0.001), pelvic tilt (p = 0.012), sacro-femoral-pubic angle (SFP; p = 0.003), and T1 pelvic angle (p < 0.001). The predictive accuracy of SFP, based on the area under the ROC curve, was statistically comparable to that of established sagittal alignment parameters (p > 0.05). Patients with SFP < 62° had a significantly higher prevalence of RPHA than those with SFP ≥ 62° (p = 0.007). SFP, measurable from standard anteroposterior pelvic radiographs, may represent a simple and practical alternative to sagittal spinopelvic parameters for identifying radiographic features associated with RPHA.

This study investigated the association between preoperative radiological parameters, including paraspinal muscle sarcopenia, and the development of adjacent segmental disease (ASD) after microsurgical decompression (MSD) without fusion for lumbar spinal stenosis (LSS). Patients who underwent MSD for single-level LSS and were followed-up for ≥ 5 years at our institution were retrospectively reviewed. Paraspinal muscle volumes were calculated as the total cross-sectional area of each muscle divided by the L3 vertebral body area. The paraspinal muscle quality (percentage of psoas fat infiltration [PMFI%] and percentage of multifidus muscle fat infiltration [MFMFI%]) was calculated as the hyperintensity area divided by the cross-sectional area of each muscle in the preoperative L3 vertebral body level on axial T2-weighted magnetic resonance image. The preoperative radiological factors including the abovementioned parameters, which can affect the development of ASD requiring surgery after MSD for LSS, were statistically analyzed. In total, 97 patients with a mean age of 69.1 ± 7.99 years and a median follow-up period of 7.00 (5.00-9.00) years were included in the analysis. The preoperative radiographical factors, including paraspinal muscle volumes, did not influence the development of postoperative ASD. However, the preoperative PMFI% and MFMFI% were significantly related to postoperative ASD. Based on a multivariate analysis, MFMFI% was independently associated with the development of postoperative ASD. A higher paraspinal muscular fat infiltration is an important predictive factor of ASD after single-level MSD for LSS and after fusion surgery. Therefore, spine-specific sarcopenia can have a significant effect on surgical prognosis.