Comparison of olanzapine 2.5 mg and 5 mg in the prevention of chemotherapy-induced nausea and vomiting: a Japanese nationwide database study.

BACKGROUND: Olanzapine is prescribed as prophylaxis for chemotherapy-induced nausea and vomiting at a dose of 2.5 or 5 mg in Asian countries. We compared the effectiveness of olanzapine 2.5 mg and 5 mg in preventing chemotherapy-induced nausea and vomiting among patients receiving high-emetogenic chemotherapy for lung cancer. METHODS: Using a Japanese national inpatient database, we identified patients who received olanzapine doses of 2.5 or 5 mg during high-emetogenic chemotherapy for lung cancer between January 2016 and March 2021. We conducted a 1:1 propensity score-matched analysis with adjustment for various factors, including those affecting olanzapine metabolism. The outcomes were additional antiemetic drug administration (within 2-5 days after chemotherapy initiation), length of hospital stay, and total hospitalization costs. RESULTS: Olanzapine 2.5 and 5.0 mg were used in 2905 and 4287 patients, respectively. The propensity score-matched analysis showed that olanzapine 2.5 mg administration was significantly associated with a higher proportion of additional antiemetic drug administration (36% vs. 31%, p < 0.001) than olanzapine 5 mg. The median length of hospital stay was 8 days in both groups. Total hospitalization cost did not differ significantly between the two doses of olanzapine (5061 vs. 5160 USD, p = 0.07). The instrumental variable analysis demonstrated compatible results. CONCLUSION: Prophylactic use of olanzapine 2.5 mg during chemotherapy for lung cancer was associated with a higher rate of additional antiemetic drugs than olanzapine 5 mg.

Treatment and Outcomes of 844 Cases of Pneumothorax in Heritable Connective Tissue Disorders.

BACKGROUND: Characteristics, practice patterns, and clinical outcomes of secondary spontaneous pneumothorax (SSP) with heritable connective tissue disorders (Marfan, Ehlers-Danlos, and Birt-Hogg-Dubé syndromes) are unclear. METHODS: A nationwide Japanese inpatient database that included data of 524 patients with SSP (884 hospitalizations) and 137,821 with primary spontaneous pneumothorax between July 2010 and March 2020 was used in this study. Hospitalization for SSP (n = 884) was categorized into surgical (n = 459) and nonsurgical (n = 425) groups, and the patient characteristics, treatment, and outcomes were compared between the groups. Multivariable analyses were performed to evaluate risk factors for pneumothorax recurrence. We also compared the characteristics of patients with different underlying heritable connective tissue disorders. RESULTS: Compared with the nonsurgical group, the surgical group had less frequent readmission for pneumothorax (26% vs 44%; hazard ratio, 0.47; 95% CI, 0.38-0.58). Young patients (2.46; 1.83-3.32) or those with Birt-Hogg-Dubé syndrome (2.53; 1.77-3.63) had a high risk of recurrence. Pneumothorax occurred frequently in teenagers with Marfan syndrome, in those aged 20 to 39 years with Ehlers-Danlos syndrome, and in those aged ≥40 years with Birt-Hogg-Dubé syndrome. CONCLUSIONS: Detailed information on the characteristics and clinical course of SSP in heritable connective tissue disorders will aid in the clinical decision-making process.

Interstitial Pneumonitis Following Sequential Administration of Programmed Death-1/Programmed Death-Ligand1 Inhibitors and Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors For Non-Small Cell Lung Cancer: A Matched-Pair Cohort Study Using a Nationwide Inpatient Database.

BACKGROUND: It is unclear whether the sequential administration of programmed death (PD)-1/programmed death-ligand 1 (PD-L1) inhibitors and epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) is associated with the development of severe interstitial pneumonitis (IP). PATIENTS AND METHODS: We identified 69,107 eligible patients with non-small cell lung cancer (NSCLC) from a Japanese national inpatient database, who initiated EGFR-TKI therapy. The study population was divided into the PD-1/PD-L1 inhibitor and non-prior PD-1/PD-L1 groups based on PD-1/PD-L1 administration before EGFR-TKI therapy. We conducted 1:4 matched-pair cohort analyses (n = 9,725) to compare the incidence of IP and in-hospital mortality within 90 days of administration of EGFR-TKI between the two groups after adjusting for the clinical background. Furthermore, we performed subgroup analyses categorized according to the duration of prior PD-1/PD-L1 inhibitor use. RESULTS: IP occurred in 4.4% of patients in the matched-pair cohort. PD-1/PD-L1 inhibitor-use before EGFR-TKI therapy was significantly associated with IP (odds ratio [OR], 1.79; 95% confidence interval [CI], 1.34-2.38) and in-hospital mortality (OR, 2.10; 95% CI, 1.72-2.55). Prior PD-1/PD-L1 inhibitor use in an interval of <6 months before EGFR-TKI administration was associated with a higher risk of IP than EGFR-TKI administration without prior PD-1/PD-L1 inhibitor. In-hospital mortality was higher in patients with prior PD-1/PD-L1 inhibitor use than that in those without prior PD-1/PD-L1 inhibitor use, irrespective of the treatment duration. CONCLUSION: Sequential use of PD-1/PD-L1 inhibitors and EGFR-TKIs in patients with non-small cell lung cancer was significantly associated with IP compared to EGFR-TKIs without prior PD-1/PD-L1 inhibitor administration.

Survival trends and patient characteristics between 2004 and 2016 for breast cancer in Japan based on the National Clinical Database-Breast Cancer Registry.

This is a prognostic report by the Japanese Breast Cancer Society on breast cancer extracted from the National Clinical Database-Breast Cancer Registry of Japan. Here, we present a summary of 457,878 breast cancer cases registered between 2004 and 2016. The median follow-up duration was 5.6 years. The median age at the start of treatment was 59 years (5-95%: 38-82 years) and increased from 57 years between 2004 and 2008 to 60 years between 2013 and 2016. The proportion of patients with Stage 0-II disease increased from 74.5% to 78.3%. The number of cases with estrogen and progesterone receptor positivity increased from 74.8% to 77.9% and 60.5% to 68.1%, respectively. Regarding (neo-)adjuvant chemotherapy, the taxane (T) or taxane-cyclophosphamide (C) regimen increased by 2.4% to 8.2%, but the (fluorouracil (F)) adriamycin (A)-C-T/(F) epirubicin (E)C-T and (F)AC/(F)EC regimens decreased by 18.6% to 15.2% and 13.5% to 5.0%, respectively. Regarding (neo-)adjuvant anti-human epidermal growth factor-2 (HER2)-targeted therapy, the use of trastuzumab increased from 4.6% to 10.5%. The rate of sentinel lymph node biopsy increased from 37.1% to 60.7%, while that of axillary dissection decreased from 54.5% to 22.6%. Improvements in disease-free and overall survival were observed in patients with HER2-positive breast cancer, but there was no apparent trend in patients with hormone receptor-positive, HER2-negative, or triple-negative breast cancers.

2020 Annual Report of National Clinical Database-Breast Cancer Registry: 10-year mortality of elderly breast cancer patients in Japan.

The Japanese Breast Cancer Society initiated the breast cancer registry in 1975, which transitioned to the National Clinical Database-Breast Cancer Registry in 2012. This annual report presents data from 2020 and analyzes the ten-year mortality rates for those aged 65 and older. We analyzed data from 93,784 breast cancer (BC) cases registered in 2020 and assessed 10-year mortality rates for 36,279 elderly patients diagnosed between 2008 and 2012. In 2020, 99.4% of BC cases were females with a median age of 61. Most (65%) were diagnosed at early stages (Stage 0 or I). Breast-conserving surgery rates varied with stages: 58.5% at cStage I, 30.8% at cStage II, and 13.1% at cStage III. Sentinel lymph node biopsy was done in 73.6% of cases, followed by radiotherapy in 70% of those post-conserving surgery and chemotherapy in 21.1% post-surgery. Pathology showed that 63.4% had tumors under 2.0 cm, 11.7% had pTis tumors, and 77.3% had no axillary lymph node metastasis. ER positivity was seen in 75.1%, HER2 in 14.3%, and 30% had a Ki67 positivity rate above 30%. Across all stages and subtypes, there was a trend where the 10-year mortality rates increased for individuals older than 65 years. In Stage I, many deaths were not directly linked to BC and, for those with HER2-type and triple-negative BC, breast cancer-related deaths increased with age. Within Stage II, patients older than 70 years with luminal-type BC often experienced deaths not directly linked to BC, whereas patients below 80 years with HER2-type and triple-negative BC, likely had breast cancer-related deaths. In Stage III, breast cancer-related deaths were more common, particularly in HER2 and triple-negative BC. Our prognostic analysis underscores distinct mortality patterns by stage, subtype, and age in elderly BC patients. It highlights the importance of personalized treatment strategies, considering subtype-specific aggressiveness, age-related factors, and comorbidities.

Association between body mass index and outcomes after autologous breast reconstruction: a nationwide inpatient database study in Japan.

BACKGROUND: Although autologous reconstruction following breast cancer surgery is common, little is known about the association between preoperative body mass index (BMI) and short-term surgical outcomes. This study investigated the association between BMI and short-term surgical outcomes in autologous breast reconstruction using a nationwide Japanese inpatient database. METHODS: We retrospectively identified female patients with breast cancer who underwent breast reconstruction using a pedicled flap or free flap from July 2010 to March 2020. Multivariable regression analyses and restricted cubic spline analyses were conducted to investigate the associations between BMI and short-term outcomes with adjustment for demographic and clinical backgrounds. RESULTS: Of the 13,734 eligible patients, 7.1% and 22.2% had a BMI of < 18.5 kg/m2 and > 25 kg/m2, respectively. Compared with BMI of 18.5-21.9 kg/m2, overweight (25.0-29.9 kg/m2) and obese (≥ 30.0 kg/m2) were significantly associated with higher occurrences of takebacks (odds ratio, 1.74 [95% confidence interval, 1.28-2.38] and 2.89 [1.88-4.43], respectively) and overall complications (1.37 [1.20-1.57] and 1.77 [1.42-2.20], respectively). In the restricted cubic spline analyses, BMI showed J-shaped associations with takebacks, overall complications, local complications, and wound dehiscence. BMI also demonstrated linear associations with postoperative surgical site infection, duration of anesthesia, duration of drainage, length of stay, and hospitalization costs. CONCLUSION: In autologous breast reconstruction following breast cancer surgery, a higher BMI was associated with takebacks, morbidity, a longer hospital stay, and higher total costs, whereas a lower BMI was associated with fewer surgical site infections, a shorter hospital stay, and lower total costs.

Annual report of the Japanese Breast Cancer Registry for 2019.

This is an annual report by the Japanese Breast Cancer Society regarding the clinical data on breast cancer extracted from the National Clinical Database-Breast Cancer Registry (NCD-BCR) of Japan. Here, we present an updated summary of 98,300 breast cancer cases registered in 2019. The median age at cancer diagnosis was 61 years (interquartile range 49-72 years), and 30.6% of the breast cancer patients were premenopausal. Of the 93,840 patients without distant metastases, 14,118 (15.0%) and 42,047 (44.8%) were diagnosed with stage 0 and I disease, respectively. Breast-conserving surgery was performed in 42,080 (44.8%) patients. Regarding axillary procedures, 62,677 (66.8%) and 7371 (7.9%) patients underwent sentinel node biopsy and axillary node dissection after biopsy, respectively. Whole breast irradiation was administered to 29,795 (70.8%) of the 42,080 patients undergoing breast-conserving surgery. Chest wall irradiation was administered to 5524 (11.1%) of the 49,637 patients who underwent mastectomy. Of the 6912 clinically lymph node-negative patients who received preoperative therapy, 5250 (76.0%) and 427 (6.2%) underwent sentinel node biopsy and axillary node dissection after biopsy, respectively; however, 602 (8.7%) patients initially underwent axillary node dissection without biopsy.

Treatment courses and outcomes of oesophageal atresia in patients with trisomy 18: a case series of 271 patients from a nationwide database in Japan.

OBJECTIVE: To describe characteristics, treatments and clinical outcomes of patients with trisomy 18 and oesophageal atresia, using a nationwide database in Japan. DESIGN: Descriptive study using a retrospective cohort. SETTING: A nationwide inpatient database including 90% of hospitals with neonatal intensive care units in Japan. PATIENTS: Patients hospitalised within a day after birth for both oesophageal atresia and trisomy 18 between July 2010 and March 2020. INTERVENTIONS: Radical surgery for oesophageal atresia. MAIN OUTCOME MEASURES: Characteristics, treatment course and outcomes. RESULTS: Among 271 patients with both oesophageal atresia and trisomy 18, 70 patients underwent radical surgery for oesophageal atresia. Patients who underwent radical surgery were less likely to have severe cardiac anomalies (17% vs 32%; p=0.020), but more likely to undergo cardiac surgery (21% vs 9.5%; p=0.012) than those who did not. The overall in-hospital mortality was lower (54% vs 79%; p<0.001) and the median age at death was higher (210 days vs 39 days; p<0.001) in patients who underwent radical surgery than the others. Postoperative mortality within 30 days after radical surgery was 5.7%. Patients who underwent radical surgery were likely to be discharged to home (50% vs 18%; p<0.001), whereas the age at home discharge (median 314 days vs 216 days; p=0.19) and the requirement for each home treatment did not differ significantly by radical surgery. CONCLUSION: This study provides information that will aid the clinical decision-making process for patients with oesophageal atresia and trisomy 18. Radical surgery may be a safe and feasible treatment option.

Antiemetic Effect of Rikkunshito, a Japanese Kampo Herbal Medicine, on Cisplatin-induced Nausea and Vomiting: A Nationwide Database Study in Japan.

Objective The effect of Rikkunshito, a Japanese herbal Kampo medicine, on chemotherapy-induced nausea and vomiting (CINV) has been evaluated in several small prospective studies, with mixed results. We retrospectively evaluated the antiemetic effects of Rikkunshito in patients undergoing cisplatin-based chemotherapy using a large-scale database in Japan. Methods The Diagnosis Procedure Combination inpatient database from July 2010 to March 2019 was used to compare adult patients with malignant tumors who had received Rikkunshito on or before the day of cisplatin administration (Rikkunshito group) and those who had not (control group). Antiemetics on days 2 and 3 and days 4 and beyond following cisplatin administration were used as surrogate outcomes for CINV. Patient backgrounds were adjusted using the stabilized inverse probability of treatment weighting, and outcomes were compared using univariable regression models. Results We identified 669 and 123,378 patients in the Rikkunshito and control groups, respectively. There were significantly fewer patients using intravenous 5-HT3-receptor antagonists in the Rikkunshito group (odds ratio, 0.38; 95% confidence interval, 0.16-0.87; p=0.023) on days 2 and 3 of cisplatin-based chemotherapy. Conclusion The reduced use of antiemetics on day 2 and beyond of cisplatin administration suggested a beneficial effect of Rikkunshito in palliating the symptoms of CINV.

Antimicrobial Prophylaxis With Ampicillin-sulbactam Compared With Cefazolin for Esophagectomy: Nationwide Inpatient Database Study in Japan.

OBJECTIVE: To assess the effect of antimicrobial prophylaxis with ampicillin-sulbactam (ABPC/SBT) compared with cefazolin (CEZ) on the short-term outcomes after esophagectomy. BACKGROUND: CEZ is widely used for antimicrobial prophylaxis in esophagectomy without procedure-specific evidence, whereas ABPC/SBT is preferred in some hospitals to target both aerobic and anaerobic oral bacteria. METHODS: Data of patients who underwent esophagectomy for cancer between July 2010 and March 2019 were extracted from a nationwide Japanese inpatient database. Overlap propensity score weighting was conducted to compare the short-term outcomes [including surgical site infection (SSI), anastomotic leakage, and respiratory failure] between antimicrobial prophylaxis with CEZ and ABPC/SBT after adjusting for potential confounders. Sensitivity analyses were also performed using propensity score matching and instrumental variable analyses. RESULTS: Among 17,772 eligible patients, 16,077 (90.5%) and 1695 (9.5%) patients were administered CEZ and ABPC/SBT, respectively. SSI, anastomotic leakage, and respiratory failure occurred in 2971 (16.7%), 2604 (14.7%), and 2754 patients (15.5%), respectively. After overlap weighting, ABPC/SBT was significantly associated with a reduction in SSI [odds ratio 0.51 (95% CI: 0.43-0.60)], anastomotic leakage [0.51 (0.43-0.61)], and respiratory failure [0.66 (0.57-0.77)]. ABPC/SBT was also associated with reduced respiratory complications, postoperative length of stay, and total hospitalization costs. The proportion of Clostridioides difficile colitis and noninfectious complications did not differ between the groups. Propensity score matching and instrumental variable analyses demonstrated equivalent results. CONCLUSIONS: The administration of ABPC/SBT as antimicrobial prophylaxis for esophagectomy was associated with better short-term postoperative outcomes compared with CEZ.

Effects of Milrinone on Neonates after Patent Ductus Arteriosus Ligation: A Retrospective Nationwide Database Study.

INTRODUCTION: Milrinone is administered after patent ductus arteriosus (PDA) ligation to prevent and treat postoperative hemodynamic instability (i.e., postligation cardiac syndrome). We aimed to explore the effectiveness of milrinone on in-hospital outcomes in infants who underwent PDA ligation using a nationwide inpatient database in Japan. METHODS: Using the Japanese Diagnosis Procedure Combination database, we identified patients who received milrinone after PDA ligation (n = 428) in neonatal intensive care units between July 2010 and March 2021 and those who did not (n = 3,392). We conducted a 1:4 propensity score-matched analysis with adjustment for background characteristics (e.g., gestational age, birth weight, comorbidities, preoperative treatments, and hospital background) to compare morbidities (bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, and retinopathy of prematurity), mortality, total hospitalization costs, and other outcomes. For sensitivity analysis, we performed an overlap propensity score-weighted analysis. RESULTS: In-hospital morbidity, bronchopulmonary dysplasia, intraventricular hemorrhage, and necrotizing enterocolitis occurred in 58%, 48%, 9.5%, and 7.1% of patients, respectively; the in-hospital mortality was 5.4%. After 1:4 propensity score matching, no significant difference was observed regarding mortality (7.1 vs. 5.7%), in-hospital morbidity (55 vs. 50%), bronchopulmonary dysplasia (44 vs. 41%), intraventricular hemorrhage (7.8 vs. 9.1%), necrotizing enterocolitis (8.5 vs. 8.9%), retinopathy of prematurity (21 vs. 22%), or total hospitalization costs (median: approximately 86,000 vs. 82,000 US dollars) between milrinone users (n = 425) and nonusers (n = 1,698). Sensitivity analyses yielded consistent results. CONCLUSIONS: Milrinone use after PDA ligation was not associated with improved in-hospital outcomes, such as mortality and morbidity.

Thrombotic risk of platinum combination chemotherapy with and without immune checkpoint inhibitors for advanced non-small cell lung cancer: a nationwide inpatient database study.

OBJECTIVES: To determine the associated thromboembolism risk with adding immune checkpoint inhibitors (ICI) to platinum combination chemotherapy compared with platinum combination chemotherapy alone in patients with advanced non-small cell lung cancer. MATERIALS AND METHODS: This study identified 75,807 patients with advanced non-small cell lung cancer from the Japanese Diagnosis Procedure Combination database who started platinum combination chemotherapy between July 2010 and March 2021. The incidence of venous thromboembolism (VTE), arterial thromboembolism (ATE), and all-cause mortality within 6 months after commencing platinum combination chemotherapy was compared between patients receiving chemotherapy with ICI (ICI group, n = 7,177) and without ICI (non-ICI group, n = 37,903). Survival time analysis was performed using the overlap weighting method with propensity scores to adjust for background factors. The subdistribution hazard ratio for developing thromboembolism was calculated using the Fine-Gray model with death as a competing risk. The hazard ratio for all-cause mortality was also calculated using the Cox proportional hazards model. RESULTS: Overall, VTE and ATE occurred in 761 (1.0%) and 389 (0.51%) patients, respectively; mortality was 11.7%. Propensity score overlap weighting demonstrated that the subdistribution hazard ratio (95% confidence interval) for VTE and ATE in the ICI group was 1.27 (1.01-1.60) and 0.96 (0.67-1.36), respectively, compared with the non-ICI group. The mortality hazard ratio in the ICI group was 0.68 (0.62-0.74). CONCLUSION: The addition of ICI to platinum combination therapy was associated with a higher risk of VTE compared with platinum combination therapy alone, while the risk of ATE might be comparable.

Outcomes Following Laparoscopic Versus Open Surgery for Pediatric Intussusception: Analysis Using a National Inpatient Database in Japan.

BACKGROUND: Laparoscopic surgery for pediatric intussusception has recently become more common as an alternative to open surgery. However, the differences in outcomes between laparoscopic and open surgery remain unclear. Thus, this study aimed to compare short-term surgical outcomes and recurrence rates between patients treated with laparoscopic and open surgery for pediatric intussusception. METHODS: Patients aged <18 years who underwent laparoscopic (n = 192) and open (n = 416) surgery for intussusception between April 2016 and March 2021 were retrospectively identified using a Japanese nationwide inpatient database. Propensity-score overlap weighting analyses were conducted to compare the outcomes between the laparoscopic and open surgery groups. The outcomes included in-hospital morbidity, reoperation, readmission for intussusception, bowel resection, the diagnosis of Meckel's diverticulum, duration of anesthesia, postoperative length of hospital stay, and total hospitalization costs. RESULTS: The laparoscopic surgery group was older, heavier, and had fewer congenital malformations and emergency admissions than the open surgery group did. Overlap weighting analyses showed no significant differences in in-hospital morbidity (odds ratio [95% confidence interval], 0.88 [0.35-2.23]), reoperation (1.88 [0.24-14.9]), readmission for intussusception within 30 days (0.80 [0.12-5.30]) and 1 year (0.90 [0.28-2.93]), bowel resection (0.69 [0.46-1.02]), the diagnosis of Meckel's diverticulum (0.97 [0.50-1.90]), duration of anesthesia (difference, 11 [-1-24] minutes), postoperative length of stay (difference, -1.9 [-4.2-0.4] days), or total hospitalization costs (difference, 612 [ -746-1970] US dollars) between the groups. CONCLUSIONS: In this large nationwide cohort, no significant differences in outcomes were observed between laparoscopic and open surgery. Laparoscopic surgery is an acceptable treatment option for pediatric intussusception. LEVELS OF EVIDENCE: Level III.

Proportion of early extubation and short-term outcomes after esophagectomy: a retrospective cohort study.

BACKGROUND: The proportion of early extubation after esophagectomy varies among hospitals; however, the impact on clinical outcomes is unclear. The aim of this retrospective study was to evaluate associations between the proportion of early extubation in hospitals and short-term outcomes after esophagectomy. Because there is no consensus regarding the optimal timing for extubation, the authors considered that hospitals' early extubation proportion reflects the hospital-level extubation strategy. MATERIALS AND METHODS: Data of patients who underwent oncologic esophagectomy (July 2010-March 2019) were extracted from a Japanese nationwide inpatient database. The proportion of patients who underwent early extubation (extubation on the day of surgery) at each hospital was assessed and grouped by quartiles: very low- (<11%), low- (11-37%), medium- (38-83%), and high-proportion (≥84%) hospitals. The primary outcome was respiratory complications; secondary outcomes included reintubation, anastomotic leakage, other major complications, and hospitalization costs. Multivariable regression analyses were performed, adjusting for patient demographics, cancer treatments, and hospital characteristics. A restricted cubic spline analysis was also performed for the primary outcome. RESULTS: Among 37 983 eligible patients across 545 hospitals, early extubation was performed in 17 931 (47%) patients. Early extubation proportions ranged from 0-100% across hospitals. Respiratory complications occurred in 10 270 patients (27%). Multivariable regression analyses showed that high- and medium-proportion hospitals were significantly associated with decreased respiratory complications [odds ratio, 0.46 (95% CI, 0.36-0.58) and 0.43 (0.31-0.60), respectively], reintubation, and hospitalization costs when compared with very low-proportion hospitals. The risk of anastomotic leakage and other major complications did not differ among groups. The restricted cubic spline analysis demonstrated a significant inverse dose-dependent association between the early extubation proportion and the risk of respiratory complications. CONCLUSION: A higher proportion of early extubation in a hospital was associated with a lower occurrence of respiratory complications, highlighting a potential benefit of early extubation after esophagectomy.

Long-Term Risk of Being Bedridden in Elderly Patients Who Underwent Oncologic Surgery: A Retrospective Study Using a Japanese Claims Database.

BACKGROUND: Although functional outcomes are important in surgery for elderly patients, the long-term functional prognosis following oncologic surgery is unclear. We retrospectively investigated the long-term, functional and survival prognosis following major oncologic surgery according to age among elderly patients. METHODS: We used a Japanese administrative database to identify 11,896 patients aged ≥ 65 years who underwent major oncological surgery between June 2014 and February 2019. We investigated the association between age at surgery and the postoperative incidence of bedridden status and mortality. Using the Fine-Gray model and restricted cubic spline functions, we conducted a multivariable, survival analysis with adjustments for patient background characteristics and treatment courses to estimate hazard ratios for the outcomes. RESULTS: During a median follow-up of 588 (interquartile range, 267-997) days, 657 patients (5.5%) became bedridden and 1540 (13%) died. Patients aged ≥ 70 years had a significantly higher incidence of being bedridden than those aged 65-69 years; the subdistribution hazard ratios of the age groups of 70-74, 75-79, 80-84, and ≥ 85 years were 3.20 (95% confidence interval [CI], 1.53-6.71), 3.86 (95% CI 1.89-7.89), 6.26 (95% CI 3.06-12.8), and 8.60 (95% CI 4.19-17.7), respectively. Restricted cubic spline analysis demonstrated an increase in the incidence of bedridden status in patients aged ≥ 65 years, whereas mortality increased in patients aged ≥ 75 years. CONCLUSIONS: This large-scale, observational study revealed that older age at oncological surgery was associated with poorer functional outcomes and higher mortality among patients aged ≥ 65 years.

Validation studies of Japanese administrative health care data: A scoping review.

PURPOSE: Large-scale administrative health care databases are increasingly being utilized for research. However, there has not been much literature that validated administrative data in Japan; a previous review identified six validation studies published between 2011 and 2017. We conducted a literature review of studies that assessed the validity of Japanese administrative health care data. METHODS: We searched for studies published by March 2022 that compared individual-level administrative data with a reference standard from another data source, as well as studies that validated administrative data using other data within the same database. The eligible studies were also summarized based on characteristics which included data types, settings, reference standard used, numbers of patients, and conditions validated. RESULTS: There were 36 eligible studies, including 29 that used external reference standard and seven that validated administrative data using other data within the same database. Chart review was the reference standard in 21 studies (range of the numbers of patients, 72-1674; 11 studies conducted in single institutions and nine studies in 2-5 institutions). Five studies used a disease registry as the reference standard. Diagnoses of cardiovascular diseases, cancer, and diabetes were frequently evaluated. CONCLUSIONS: Validation studies are being conducted at an increasing rate in Japan, although most of them are small scale. Further large-scale comprehensive validation studies are necessary to effectively utilize the databases for research.

Weight loss during neoadjuvant therapy and short-term outcomes after esophagectomy: a retrospective cohort study.

BACKGROUND: Neoadjuvant therapy (NAT) has become common worldwide for resectable advanced esophageal cancer and frequently involves weight loss. Although failure to rescue (death after major complications) is known as an emerging surgical quality measure, little is known about the impact of weight loss during NAT on failure to rescue. This retrospective study aimed to investigate the association of weight loss during NAT and short-term outcomes, including failure to rescue after esophagectomy. MATERIALS AND METHODS: Patients who underwent esophagectomy after NAT between July 2010 and March 2019 were identified from a Japanese nationwide inpatient database. Based on quartiles of percent weight change during NAT, patients were grouped into four categories of gain, stable, small loss, and loss (>4.5%). The primary outcomes were failure to rescue and in-hospital mortality. The secondary outcomes were major complications, respiratory complications, anastomotic leakage, and total hospitalization costs. Multivariable regression analyses were used to compare outcomes between the groups, adjusting for potential confounders, including baseline BMI. RESULTS: Among 15 159 eligible patients, in-hospital mortality and failure to rescue occurred in 302 (2.0%) and 302/5698 (5.3%) patients, respectively. Weight loss (>4.5%) compared to gain was associated with increased failure to rescue and in-hospital mortality [odds ratios 1.55 (95% CI: 1.10-2.20) and 1.53 (1.10-2.12), respectively]. Weight loss was also associated with increased total hospitalizations costs, but not with major complications, respiratory complications, and anastomotic leakage. In subgroup analyses, regardless of baseline BMI, weight loss (>4.8% in nonunderweight or >3.1% in underweight) was a risk factor for failure to rescue and in-hospital mortality. CONCLUSION: Weight loss during NAT was associated with failure to rescue and in-hospital mortality after esophagectomy, independent of baseline BMI. This emphasizes the importance of weight loss measurement during NAT to assess the risk for a subsequent esophagectomy.