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Aims: During intraoperative bleeding in endoscopic submucosal dissection (ESD), switching to spray coagulation may be beneficial compared with the continuous use of swift coagulation and can reduce the need for hemostatic forceps. We retrospectively assessed the effectiveness of spray modes on intraoperative bleeding during gastric ESD. Methods and Results: A total of 316 bleeding events (156 in the Swift group and 160 in the Spray group) were consecutively recorded. In the Swift group, hemostasis was performed using the swift mode with a retracted tip of the needle-type knife, followed by the hemostatic forceps. In the Spray group, bleeding was treated in a stepwise manner: the swift mode, the spray mode, and the hemostatic forceps. All bleeding events were assigned to one of two groups by an endoscopist who retrospectively reviewed the videos. We compared the use of hemostatic forceps, the total hemostatic time, and the cumulative hemostasis rate between the two groups.The use of hemostatic forceps was significantly lower in the Spray group than in the Swift group (32.7% vs. 13.8%, P < 0.001). There was no significant difference in the total hemostatic time (Swift group, 20 s.; Spray group, 16 s.; P = 0.42), whereas the cumulative hemostasis rate with the knife was significantly higher in the Spray group (P = 0.007). Conclusion: The results suggested that spray coagulation from the tip of the needle-type knife could reduce the use of hemostatic forceps. In gastric ESD, spray coagulation may facilitate the hemostasis of intraoperative bleeding.

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BACKGROUND: Eculizumab has been approved for atypical haemolytic-uraemic syndrome (aHUS) in Japan since 2013. Post-marketing surveillance enrolled patients with aHUS who received ≥ 1 dose of eculizumab to assess eculizumab safety and effectiveness. METHODS: We evaluated serious adverse events and effectiveness endpoints, i.e., haematologic normalization, a decrease of ≥ 25% in serum creatinine (sCr) levels, and complete thrombotic microangiopathy (TMA) response in adult patients with aHUS without other underlying diseases. In addition, the difference of baseline characteristics between patients who did and did not meet effectiveness endpoints was examined. RESULTS: In this safety and effectiveness analysis, 79 adult patients were included; median age was 54.0 years, median treatment duration was 30 weeks. Total exposure time of eculizumab was 75.51 patient-years, and 94 serious adverse events were reported in 39 patients. No unexpected safety signals were identified in this population. Mean platelet count, lactate dehydrogenase and estimated glomerular filtration rate significantly improved after 7 days of treatment. Complete TMA response, haematologic normalization and the improvement of sCr levels were met by 35.3%, 40.4% and 51.3% of patients, respectively. Median treatment duration was shorter in patients who did not achieve complete TMA response (6 weeks) than in patients who did (114 weeks). Multivariate analysis suggested that the time from the most recent TMA episode to start of eculizumab treatment was negatively associated with kidney function improvement. CONCLUSIONS: No unexpected safety signals of eculizumab were identified in Japanese patients with aHUS in a real-world setting. Renal outcomes were negatively associated with the time from the most recent TMA episode to the initiation of eculizumab treatment.

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[This corrects the article DOI: 10.1055/a-2284-9492.].

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Endoscopic hand suturing (EHS) was first developed to firmly close a mucosal defect following endoscopic submucosal dissection and has the potential for expanded applications. This study aimed to investigate the feasibility and safety of EHS in various clinical settings. In this single-center pilot study, 15 patients who had diseases with potential indications for EHS were prospectively recruited. Technical success, clinical success after the procedure, and severe EHS-related adverse events (AEs) were evaluated. EHS was applied for defect closure after gastric subepithelial lesion removal under laparoscopic observation (n = 9), defect closure after rectal endoscopic full-thickness resection (EFTR) (n = 2), defect closure after thoracoscopy-assisted esophageal EFTR (n = 1), mucosal closure for gastric ulcer bleeding (n = 1), mucosal closure after peroral endoscopic myotomy (POEM) (n = 1), and postoperative anastomotic leak (n = 1). EHS was completed without severe AEs and the clinical courses were also favorable in 13 patients (87%). The median suturing time was 61 minutes. In patients with POEM and anastomotic leak, EHS was discontinued because of the narrow lumen. In conclusion, EHS appears feasible and safe in situations.

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BACKGROUND: Tumor size impacts the technical difficulty and histological curability of colorectal endoscopic submucosal dissection (ESD); however, the preoperative evaluation of tumor size is often different from histological assessment. Analyzing influential factors on failure to obtain an accurate tumor size evaluation could help prepare optimal conditions for safer and more reliable ESD. AIM: To investigate the tumor size discrepancy between endoscopic and pathological evaluations and the influencing factors. METHODS: This was a retrospective study conducted at a single institution. A total of 377 lesions removed by colorectal ESD at our hospital between April 2018 and March 2022 were collected. We first assessed the difference in size with an absolute percentage of the scaling discrepancy. Subsequently, we compared the clinicopathological characteristics of the correct scaling group (> -33% and < 33%) with that of the incorrect scaling group (< -33% or > 33%), which was further subdivided into the underscaling group (-33% or less of the discrepancy) and overscaling group (33% or more of the discrepancy), respectively. As secondary outcome measures, parameters on size estimation were compared between the underscaling and correct scaling groups, as well as between the overscaling and correct scaling groups. Finally, multivariate analysis was performed in terms of the following relevant parameters on size estimation: Pathological size, location, and possible influential factors (P < 0.1) in the univariate analysis. RESULTS: The mean of absolute percentage in the scaling discordance was 21%, and 91 lesions were considered to be incorrectly estimated in size. The incorrect scaling was significantly remarkable in larger lesions (40 mm vs 28 mm; P < 0.001) and less experience (P < 0.001), and these two factors were influential on the underscaling (75 lesions; P < 0.001). Conversely, compared with the correct scaling group, 16 lesions in the overscaling group were significantly small (20 mm vs 28 mm; P < 0.001), and the small lesion size was influential on the overscaling (P = 0.002). CONCLUSION: Lesions indicated for colorectal ESD tended to be underestimated in large tumors, but overestimated in small ones. This discrepancy appears worth understanding for optimal procedural preparation.

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BACKGROUND AND AIMS: An increasing number of patients are undergoing gastric endoscopic submucosal dissection (ESD) with active prescriptions of direct oral anticoagulants (DOACs). Only a few reports have described the effects of DOAC intake on postoperative bleeding. We aimed to investigate the bleeding risk associated with DOACs after gastric ESD. METHODS: Clinical studies published up to April 2022 showing bleeding rates after gastric ESD in patients taking DOACs were identified using electronic searches. The primary outcome was the rate of bleeding after gastric ESD in patients receiving DOACs compared to those not receiving antithrombotic therapy. In this meta-analysis, odds ratios (ORs) were calculated and pooled using a random effects model. The secondary outcome was the difference in the bleeding rate between patients treated with DOACs and those treated with warfarin and antiplatelet drugs. RESULTS: Seven studies were included in this meta-analysis. The pooled analysis showed that DOACs had a higher bleeding rate than non-thrombotic therapy (17.0% vs. 3.4%; OR 5.72; 95% confidence interval [CI], 4.33-7.54; I2 = 0%). The bleeding risk associated with DOAC administration was similar to that associated with warfarin (17.0% vs. 20.0%; OR 0.83; 95% CI 0.59-1.18; I2 = 0%), whereas it was higher than that associated with antiplatelet administration (16.9% vs. 11.0%; OR 1.63; 95% CI 1.14-2.34; I2 = 8%). CONCLUSIONS: This meta-analysis reveals that the bleeding risk of DOACs is higher than that of non-antithrombotics and antiplatelets, whereas it is comparable to that of warfarin. Gastric ESD in patients on anticoagulants requires careful postoperative management.

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BACKGROUND: Subclinical stricture after esophageal endoscopic submucosal dissection (ESD) makes the detection and re-ESD of metachronous lesions difficult. This study aimed to investigate the effectiveness of prophylactic steroid use after esophageal ESD for mucosal defects with a circumference less than 75% for the prevention of symptomatic and asymptomatic stricture. METHODS: In 80 retrospectively enrolled patients, we collected paired endoscopic images of a mucosal defects immediately after resection and a scar thereafter. After calculating circumference by image analysis software, all patients were classified into three groups in reference to mucosal defect circumference (MDC; ≤ 50%, 50-75%, ≥ 75%). Frequency of steroid use and symptomatic stricture were compared, and in < 75% MDC patients, a degree of asymptomatic stricture with or without steroid was compared by calculating a scar contraction rate (SCR). RESULTS: In the ≤ 50% (43 patients), 50-75% (27 patients) and ≥ 75% (10 patients) MDC groups, steroids were used in 12%, 59% and 100%, respectively, and symptomatic stricture occurred in 0%, 7% and 40%, respectively. In < 75% MDC patients, SCR in the steroid cohort was significantly lower than that in the nonsteroid cohort (42% vs. 65%, p = 0.002). No steroid-related adverse events occurred. CONCLUSION: Steroid use even for mucosal defects with < 75% circumference appears effective for the reduction of the risk on both symptomatic and asymptomatic stricture after esophageal ESD.

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BACKGROUND: Eculizumab was approved for atypical haemolytic uraemic syndrome (aHUS) in Japan in 2013. Post-marketing surveillance (PMS) was mandated by regulatory authorities to assess the safety and effectiveness of eculizumab in patients with aHUS in a real-world setting. METHODS: Paediatric patients in the PMS cohort who were <18 years of age at the first administration of eculizumab and diagnosed with aHUS [excluding Shiga toxin-producing Escherichia coli HUS, thrombotic thrombocytopaenic purpura and secondary thrombotic microangiopathy (TMA)] were included in the effectiveness and safety analysis. Clinical endpoints of effectiveness [complete TMA response, TMA event-free status, platelet (PLT) count and lactate dehydrogenase (LDH) normalization, serum creatinine (sCr) decrease and estimated glomerular filtration rate (eGFR) improvement] were analysed in patients treated with at least one dose of eculizumab. Serious adverse events (SAEs) were also evaluated. RESULTS: A total of 40 paediatric patients (median age 5 years) were included. The median eculizumab treatment duration was 66 weeks. PLT count, LDH and eGFR significantly improved at 10 days post-treatment. Complete TMA response, haematologic normalization, sCr decrease, eGFR improvement and TMA event-free status were achieved by 73.3%, 73.3%, 70.0%, 78.3% and 77.5% of patients, respectively. Discontinuation criteria were met by 18 patients: 13 patients maintained treatment discontinuation at the end of observation and 5 patients, including 1 patient with aHUS relapse, continued the treatment but extended the treatment interval. During eculizumab treatment, 59 SAEs (0.66/person-year) were reported. Although four deaths were reported, none of them were related to eculizumab. CONCLUSION: Eculizumab was well tolerated and effective for paediatric patients with aHUS in the real-world setting in Japan.

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INTRODUCTION: Endoscopic suturing of a mucosal defect is expected to prevent postoperative bleeding after endoscopic submucosal dissection (ESD). Endoscopic suturing causes mucosal deformity, which may interfere with endoscopic surveillance thereafter. We retrospectively investigated long-term chronological changes in mucosal suturing by endoscopic suturing. METHODS: Forty-three patients who underwent endoscopic hand suturing (EHS) after gastric ESD at three institutions were enrolled. First, our hypothesis that the suturing sites healed via inflammation, disappearance of mucosal inversion, and flattening was validated. Subsequently, the duration required to reach each healing step was evaluated. RESULTS: A total of 137 follow-up endoscopies were assessed, in which all cases showed the hypothesized chronological course on the suturing sites. The 95th percentiles of the duration when showing the disappearance of the inflammatory change and the inverted change were 63 days and 15.5 months after the procedure, respectively. DISCUSSION/CONCLUSION: The data show that the mucosal deformity induced by EHS disappeared within 16 months. Endoscopic suturing is thus considered to have a negligible effect on endoscopic surveillance following the procedure.

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BACKGROUND AND AIMS: Surgery is recommended in early gastric cancer (EGC) after noncurative endoscopic submucosal dissection (ESD), although observation can be an alternative. We aimed to develop a tailor-made treatment strategy for noncurative EGCs by comparing the lymph node metastasis risk (LNMR) and the surgical risk. METHODS: We retrospectively identified 485 patients with differentiated-type, noncurative EGCs removed by ESD and classified them into two groups: a surgery-preferable group and an observation-preferable group, according to the clinical courses. Subsequently, LNMR and surgery-related death risk were assessed using a published scoring system and a risk calculator for gastrectomy, respectively. Finally, we investigated the optimal cutoff value of the risk difference (LNMR minus surgery-related death risk) to efficiently allocate these cases into either of two groups, surgery-preferable or observation-preferable. RESULTS: In 485 patients (surgery in 322, observation in 163), 57 and 428 patients were classified into the surgery-preferable group and the observation-preferable group, respectively. The optimal cutoff value of the risk difference (LNMR minus surgery-related death risk) to allocate the cases to the two preferable groups was 7.85 with the highest area under the curve (0.689). When cases with >7.85 LNMR over the surgery-related death risk were allocated into the surgery-preferable group and vice versa, the discriminability was 73.2%, which was sufficiently higher than that in the clinical decision (44.5%). CONCLUSION: Personalized comparison of LNMR and surgery-related death risk is helpful to provide a favorable treatment option for each patient with EGCs after noncurative ESD.

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PURPOSE: This study investigated the effect of 1 year of intradialytic exercise on older hemodialysis patients with geriatric issues. METHODS: Forty-six patients aged ≥ 70 years were non-randomly assigned to two groups (exercise group: 27, control group: 19). Intradialytic exercise consisted of 30 min of aerobic exercise using a cycle ergometer, and resistance training comprising four exercises using an elastic tube three times per week for 1 year. Handgrip strength, leg extremity muscle strength, 10-m walk speed, short physical performance battery, serum albumin, Geriatric Nutritional Risk Index (GNRI), geriatric depression scale, frailty, and mobility were each assessed before and after the intervention. RESULTS: The control group exhibited a significant reduction in handgrip strength, 10-m walking speed, serum albumin, and GNRI after intervention compared to baseline (p < 0.05). Conversely, no significant reductions were observed in the exercise group. The ΔGNRI (effect size, 0.69; 95% confidence interval [CI] - 5.21, - 0.1; p < 0.05) and Δserum albumin (effect size, 0.72; 95% CI - 0.31, - 0.02; p < 0.05) before and after the intervention declined significantly less in the exercise group than in the control group. Other between-group values were not significantly different. The number of frail patients and patients requiring walking assistance exhibited no significant intra-group or between-group differences before and after the intervention. CONCLUSION: Intradialytic exercise prevented the worsening of nutritional status and physical function in the exercise group compared to the control group. Exercise therapy during dialysis is an important aspect of patient care that helps prevent functional decline in older patients.

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BACKGROUND: It is unclear whether prophylactic endoscopic closure after colorectal endoscopic submucosal dissection (ESD) reduces the risk of postoperative adverse events due to variability in lesion characteristics. Therefore, we conducted a retrospective study using propensity score matching to evaluate the efficacy of prophylactic clip closure in preventing postoperative adverse events after colorectal ESD. METHODS: This single-center retrospective cohort study included 219 colorectal neoplasms which were removed by ESD. The patients were allocated into the closure and non-closure groups, which were compared before and after propensity-score matching. Post-ESD adverse events including major and minor bleeding and delayed perforation were compared between the two groups. RESULTS: In this present study, 97 and 122 lesions were allocated to the closure and non-closure groups, respectively, and propensity score matching created 61 matched pairs. The rate of adverse events was significantly lower in the closure group than in the non-closure group (8% vs. 28%, P = 0.008). Delayed perforation occurred in two patients in the non-closure group, whereas no patient in the closure group developed delayed perforation. In contrast, there were no significant differences in other postoperative events including the rate of abdominal pain; fever, white blood cell count, and C-reactive protein; and appetite loss between the two groups. CONCLUSIONS: Propensity score matching analysis demonstrated that prophylactic closure was associated with a significantly reduced rate of adverse events after colorectal ESD. When technically feasible, mucosal defect closure after colorectal ESD may result in a favorable postoperative course.

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Previous reports have shown the benefits of intradialytic exercise to patients undergoing hemodialysis. However, most of those studies assessed the effects of exercise in middle-aged patients and little is known about advanced-age patients undergoing hemodialysis. Therefore, the present randomized controlled trial was performed to determine the effectiveness of exercise therapy in advanced-age patients undergoing hemodialysis. This non-blinded, randomized controlled parallel trial enrolled a total of 101 patients who were randomly assigned to intradialytic exercise (n = 51) or usual care (n = 50) groups. The training program included both resistance and aerobic exercises and was performed three times per week for 6 months. The aerobic exercise intensity was adjusted to a target Borg score of 13 for 20 minutes. Four types of resistance exercises were performed using elastic tubing, with three sets of 10 exercises performed at moderate intensity (13/20 on the Borg scale). The usual care group received standard care. Lower extremity muscle strength, Short Physical Performance Battery score, and 10-m walking speed were the outcomes and were evaluated before the hemodialysis session and after 6 months of training. There were statistically significant improvements in Short Physical Performance Battery score (effect size, 0.57; 95% confidence interval, 0.15‒1.95) in the exercise group relative to the control group. There were no statistically significant differences in lower extremity muscle strength or in the 10-m walking speed between the two groups. These findings suggest that 6 months of intradialytic training could improve physical function in older patients undergoing hemodialysis.

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In the present study, we newly synthesized three types of novel fullerene derivatives: pyridinium-type derivatives trans-3a and 4a-5b, piperidinium-type derivative 9, and proline-type derivatives 10a-12. Among the assessed compounds, 5a, 10e, 10f, 10i, 11a-d, and 12 were found to inhibit both HIV reverse transcriptase and HIV protease (HIV-PR), with IC50 values in the low micromolar range being observed. Regarding HIV-PR inhibition activity, proline-type derivatives 11a-11d and 12, bearing an alkyl chain between the hydroxylmethylcarbonyl (HMC) moiety and pyrrolidine ring, were more potent than other derivatives. This result might indicate that connecting HMC moieties with proline-type fullerene derivatives through properly sized alkyl chain leads to improved HIV-PR inhibitory activity.

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BACKGROUND: To examine the clinical characteristics, including complications, of patients older than 75 years of age with proton pump inhibitor-resistant reflux esophagitis. METHODS: Patients who were resistant to standard-dose proton pump inhibitors were enrolled in the present study. Eligible patients (n = 26) were divided into those who were older (n = 11) and younger (n = 15) than 75 years of age. Clinical characteristics including complications (hemorrhage and stricture), body mass index, the severity of reflux esophagitis, Helicobactor pylori infection, gastric mucosal atrophy, hiatal hernia, kyphosis, and the use of antithrombotic agents were examined. The efficacy of 20 mg vonoprazan for proton pump inhibitor-resistant reflux esophagitis was also investigated. RESULTS: The severity of reflux esophagitis was significantly higher in the elderly group than in the non-elderly group. No other significant differences were observed between the groups. The proportion of patients with hemorrhage was significantly larger in the elderly group than in the non-elderly group. Similarly, the proportion of patients with stricture was significantly larger in the elderly group than in the non-elderly group. Nine out of 10 patients in the elderly group and all patients in the non-elderly group achieved healing after the 4-week administration of 20 mg vonoprazan. No significant differences were observed in healing rates between the groups. CONCLUSION: Among patients with proton pump inhibitor-resistant reflux esophagitis, the rates of severe reflux esophagitis and complications (hemorrhage and/or stricture) were significantly higher in elderly patients than in non-elderly patients. Regardless of age, 20 mg vonoprazan was effective for proton pump inhibitor-resistant reflux esophagitis.

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Boerhaave syndrome, the spontaneous perforation of the esophagus, is an emergency, life-threatening condition. Current endoscopic treatment options include clipping and stenting, but the use of polyglycolic acid (PGA) sheets for treating the condition has not been reported. In recent years, PGA sheets have been used after endoscopic submucosal dissection to prevent perforations and stricture formation in patients treated for early-stage carcinoma. We report the cases of two patients with Boerhaave syndrome who were successfully treated using PGA sheets. The present clinical outcomes suggest that the use of PGA sheets is feasible and safe for treating patients with Boerhaave syndrome, and that they may be another treatment option.

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Engineered muscle tissues used as transplant tissues in regenerative medicine should have a three-dimensional and cell-dense structure like native tissue. For fabricating a 3D cell-dense muscle tissue from myoblasts, we proposed the electrospun type I collagen microfiber scaffold of the string-shape like a harp. The microfibers were oriented in the same direction to allow the myoblasts to align, and were strung at low density with micrometer intervals to create space for the cells to occupy. To realize this shape of the scaffold, we employed in situ cross-linking during electrospinning process for the first time to collagen fibers. The collagen microfibers in situ cross-linked with glutaraldehyde stably existed in the aqueous media and completely retained the original shape to save the spaces between the fibers for over 14 days. On the contrary, the conventional cross-linking method by exposure to a glutaraldehyde aqueous solution vapor partially dissolved and damaged the fiber to lose a low-density shape of the scaffold. Myoblasts could penetrate into the interior of the in situ cross-linked string-shaped scaffold and form the cell-dense muscle tissues. Histochemical analysis showed the total area occupied by the cells in the cross section of the tissue was approximately 73 %. Furthermore, the resulting muscle tissue fabricated from primary myoblasts showed typical sarcomeric cross-striations and the entire tissue continuously pulsated by autonomous contraction. Together with the in situ cross-linking, the string-shaped scaffold provides an efficient methodology to fabricate a cell-dense 3D muscle tissue, which could be applied in regenerative medicine in future.

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We report the case of a 70-year-old Japanese male diagnosed with advanced lung adenocarcinoma harboring the echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase fusion gene. As soon as crizotinib was administered, tumor shrank immediately. On Day 25, he developed interstitial lung disease. Bronchoalveolar lavage fluid analysis demonstrated elevated lymphocytes fractionation. A drug lymphocyte stimulating test for crizotinib with the bronchoalveolar lavage lymphocytes was negative. Crizotinib administration was discontinued, but a life-threatening flare of tumor growth occurred. Since there was no alternative treatment for the lung cancer, we restarted crizotinib in combination with prednisolone. The patient experienced neither disease progression nor recurrence of interstitial lung disease at 6 months. In cases in which no alternate treatment is known, crizotinib retreatment combined with steroid therapy after crizotinib-induced interstitial lung disease could be considered after a careful consideration of the potential risks and benefits.

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BACKGROUND: The proportion of Japanese workers experiencing intense worry or stress during working life is in excess of 60%, and the incidence of psychiatric disorders and suicide due to psychological burden from work duties is increasing. To confirm whether the stress response measured by the Brief Job Stress Questionnaire (BJSQ) can identify risk for depression, a cohort study was conducted to evaluate whether the stress response measured by BJSQ was associated with the onset of depression. METHODS: A total of 1,810 participants aged 20-70 years in 2005 completed the stress response of the BJSQ and were followed-up until August, 2007 by examining sick pay records. Depression was defined by a description in sick pay records that included "depression" or "depressive symptoms" as a reason for sick leave according to a physician's medical certificate. The participants were divided into quartiles (Ql, Q2, Q3, and Q4) according to the total stress response score of BJSQ at baseline. Furthermore, the participants were divided into a higher score category (Q4) and a lower score category (Q1-Q3). Risk ratios of the stress response of the BJSQ for onset of depression were calculated using a multivariable Cox proportional hazard model. RESULTS: Among 1,810 participants, 14 developed depression during a mean of 1.8 years of follow-up. The risk ratio was 2.96 (95% confidence interval [CI], 1.04-8.42, p for trend = 0.002) when the higher stress response score category of BJSQ was compared with the low stress response score category for sick leave due to depression. After adjusting for gender, age, marital status, and having children, the risk ratios were similar to no adjustment. CONCLUSIONS: These findings suggest that the stress response measured by the BJSQ can demonstrate risk for the onset of depression.

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