Surgical Experience Disparity Between Male and Female Surgeons in Japan.

Importance: Women are vastly underrepresented in surgical leadership and management in Japan. The lack of equal opportunities for surgical training is speculated to be the main reason for this disparity; however, this hypothesis has not been investigated thus far. Objective: To examine gender disparity in the number of surgical experiences among Japanese surgeons. Design, Setting, and Participants: This retrospective, multicenter cross-sectional study used data from the National Clinical Database, which contains more than 95% of all surgical procedures in Japan. Participants included male and female gastroenterological surgeons who performed appendectomy, cholecystectomy, right hemicolectomy, distal gastrectomy, low anterior resection, and pancreaticoduodenectomy between January 1, 2013, and December 31, 2017. Exposures: Differences in the number of surgical experiences between male and female surgeons. Main Outcomes and Measures: The primary outcomes were the total number of operations and number of operations per surgeon by gender and years of experience. Data were analyzed from March 18 to August 31, 2021. Results: Of 1 147 068 total operations, 83 354 (7.27%) were performed by female surgeons and 1 063 714 (92.73%) by male surgeons. Among the 6 operative procedures, the percentage of operations performed by female surgeons were the highest for appendectomy (n = 20 648 [9.83%]) and cholecystectomy (n = 41 271 [7.89%]) and lowest for low anterior resection (n = 4507 [4.57%]) and pancreaticoduodenectomy (n = 1329 [2.64%]). Regarding the number of operations per surgeon, female surgeons had fewer surgical experiences for all 6 types of operations in all years after registration, except for appendectomy and cholecystectomy in the first 2 years after medical registration. The largest gender disparity for each surgical procedure was 3.17 times more procedures for male vs female surgeons for appendectomy (at 15 years after medical registration), 4.93 times for cholecystectomy (at 30-39 years), 3.65 times for right hemicolectomy (at 30-39 years), 3.02 times for distal gastrectomy (at 27-29 years), 6.75 times for low anterior resection (at 27-29 years), and 22.2 times for pancreaticoduodenectomy (at 30-39 years). Conclusions and Relevance: This cross-sectional study found that female surgeons had less surgical experience than male surgeons in Japan, and this gap tended to widen with an increase in years of experience, especially for medium- and high-difficulty operations. Gender disparity in surgical experience needs to be eliminated, so that female surgeons can advance to leadership positions.

Laparoscopic Colectomy for a Patient with Situs Inversus Totalis: The Usefulness of Preoperative Assessment.

BACKGROUND Situs inversus totalis (SIT) is a rare congenital anomaly in which the patient's internal organs are positioned in a mirror image of their normal locations. Laparoscopic surgery for a patient with SIT requires modification of the standard procedure. Several studies have recently reported surgical techniques for laparoscopic colectomy in patients with SIT. Herein, we present the case of a patient with congenital SIT who underwent laparoscopic colectomy for transverse colon cancer with intracorporeal anastomosis and discuss the usefulness of preoperative assessment. CASE REPORT A 63-year-old woman with SIT was referred to our department for surgical intervention following endoscopic submucosal dissection of transverse colon cancer. We performed a successful laparoscopic colectomy with intracorporeal anastomosis. Our team had no prior experience performing laparoscopic surgery on a patient with SIT; however, preoperative image training using a horizontally flipped video of a normal laparoscopic colectomy enabled the operation to be performed safely. Preoperative image training is very useful for gaining an understanding of images similar to the actual field of view before surgery. The patient was discharged without complications on the eighth postoperative day. CONCLUSIONS Careful preoperative assessment that takes into consideration the mirror-image anatomy and the contemplated laparoscopic procedure should allow patients with SIT to fully benefit from minimally invasive surgery.

Cost-effectiveness of 12 months of capecitabine as adjuvant chemotherapy for stage III colon cancer: preplanned cost-effectiveness analysis of the JFMC37-0801 study.

OBJECTIVES: We evaluated the cost-effectiveness of a 12-month regimen of oral capecitabine versus a standard 6-month regimen as postoperative adjuvant chemotherapy for stage III colon cancer. METHODS: We utilized patient-level data from a multi-institutional randomized controlled trial (JFMC37-0801) that investigated prolonged oral fluoropyrimidine monotherapy. The analysis considered three health states: stable disease, post-metastasis, and death. A parametric statistical model with a cure model was used to estimate the survival curve. The analysis was conducted from the Japanese public healthcare payer's perspective, considering only direct medical costs. A lifetime horizon was used, with a discount rate of 2% for both cost and health outcomes. Health outcomes were evaluated in terms of quality-adjusted life-years (QALYs). RESULTS: The estimated cure rates for colon cancer were 0.726 [95% confidence interval (CI) 0.676-0.776] and 0.694 (95% CI 0.655-0.733) with the 12- and 6-month regimens, respectively; and the estimated 5-year relapse-free survival rates were 74.4% and 69.8%, respectively. The estimated lifetime cost for 12 months of capecitabine was JPY 3.365 million (USD 31,159), compared with JPY 3.376 million (USD 31,262) for 6 months. The estimated QALY were 12.48 and 11.77 for the 12- and 6-month regimens, respectively. Thus, the 12-month capecitabine regimen was dominant. Using a willingness-to-pay threshold of JPY 5 million per QALY, we determined a 97.4% probability that the 12-month capecitabine regimen is more cost-effective than the 6-month regimen. CONCLUSIONS: Twelve months of capecitabine is the favorable option for postoperative adjuvant chemotherapy for stage III colon cancer from the perspective of cost-effectiveness.

Effects of Goshajinkigan (TJ-107) for oxaliplatin-induced peripheral neurotoxicity using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire in a Phase II, multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: The aim of the present study was to evaluate the efficacy of TJ-107 for oxaliplatin-induced peripheral neurotoxicity in prospective, multi-institutional, randomized, double-blind, placebo-controlled Phase II trials using the functional assessment of cancer therapy/gynecologic oncology group 12-item neurotoxicity questionnaire (FACT-GOG-NTX-12). PATIENTS AND METHODS: The patients who were registered to the Goshajinkigan oxaliplatin neurotoxicity evaluation study (UMIN000002211) were analyzed. A NTX-12 from the validated FACT/GOG-NTX-12 was assessed before treatment and at the end of every 2 cycles. RESULTS: The comparisons of the median scores for TJ-107 and the placebo at 8 and 26 weeks were as follows: numbness or tingling in the hands (P = 0.5820), numbness or tingling in the feet (P = 0.3236), feeling of discomfort in the hands (P = 0.8219), feeling of discomfort in the feet (P = 0.5361), joint pain or muscle cramps (P = 0.1974), feeling weak all over (P = 0.2771), trouble hearing (P = 0.2832), ringing or buzzing in ears (P = 0.1031), trouble buttoning buttons (P = 0.1653), trouble feeling the shape of small objects when held in hand (P = 0.2919), trouble walking (P = 0.5406), and pain in the hands or feet when exposed to cold temperatures (P = 0.1872). CONCLUSION: There might be no clinically significant difference between the use of TJ-107 and the severity and quality of life for patients treated with oxaliplatin.

Central statistical monitoring of investigator-led clinical trials in oncology.

Investigator-led clinical trials are pragmatic trials that aim to investigate the benefits and harms of treatments in routine clinical practice. These much-needed trials represent the majority of all trials currently conducted. They are however threatened by the rising costs of clinical research, which are in part due to extensive trial monitoring processes that focus on unimportant details. Risk-based quality management focuses, instead, on "things that really matter". We discuss the role of central statistical monitoring as part of risk-based quality management. We describe the principles of central statistical monitoring, provide examples of its use, and argue that it could help drive down the cost of randomized clinical trials, especially investigator-led trials, whilst improving their quality.

Validity of the Japanese version of functional assessment of cancer therapy-gastric (FACT-Ga) and its sensitivity to ascites volume change: a retrospective analysis of Japanese clinical trial participants.

PURPOSE: The functional assessment of cancer therapy-gastric (FACT-Ga) questionnaire was designed to evaluate quality of life (QOL) in patients with gastric cancer. We aimed to explore the reliability and validity of FACT-Ga in Japanese patients, and assess the sensitivity of the gastric cancer subscale for detecting changes in cancer-related variables over time. METHODS: The Japanese version of FACT-Ga was used, and data were obtained from Japanese patients who participated in either of two clinical trials: treatment for advanced or recurrent gastric cancer with ascites (advanced-GC group), or adjuvant chemotherapy after curative resection of gastric cancer (adjuvant group). Psychometric data including data used to determine reliability, internal consistency, and clinical validity were analyzed. Clinical validity was evaluated by comparing subscale scores for patients in the two groups, and by comparing subscale scores for patients with different performance status scores. Correlation between gastric cancer subscale scores and gastric cancer-related variables was also examined. In addition, sensitivity of the gastric cancer subscale to changes in ascites volume, abdominal girth, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) was examined by evaluating their correlation in the advanced-GC group. RESULTS: We collected data on 156 patients (62 advanced-GC group patients and 94 adjuvant group patients). Response rates for the subscales were over 80 % at most time points for both the groups. Cronbach's coefficient alpha revealed good internal consistency for each subscale. At baseline, the adjuvant group had higher QOL scores than the advanced-GC group (P < 0.05), and QOL scores for patients with different performance status scores differed significantly. Changes in gastric cancer subscale scores showed statistically significant correlation with changes in ascites volume (Spearman's rank correlation coefficient, 0.5; P < 0.05). CONCLUSIONS: FACT-Ga is reliable and clinically valid for Japanese patients with gastric cancer. Detection of QOL changes that correlate with ascites volume changes suggests that it could be used more broadly; FACT-Ga scores could be used as an endpoint for patients with gastric cancer-related ascites.

Associations of socioeconomic determinants with community clinic awareness and visitation among women: evidence from Bangladesh Demographic and Health Survey-2011.

BACKGROUND: Although Bangladesh has achieved tremendous success in health care over the last four decades, it still lagged behind in the areas of maternal and child malnutrition and primary health care (PHC). To increase access to PHC, the Bangladesh government established approximately 18,000 community clinics (CCs). The purpose of this study was to examine the associations of socioeconomic determinants of women aged 12-49 years with the CCs awareness and visitation. METHODS: We analyzed secondary data provided by Bangladesh Demographic and Health Survey-2011. A two-stage cluster sampling was used to collect the data. A total of 18,222 ever married women aged 12-49 years were identified from selected households and 17,842 were interviewed. The main outcome measures of our study were awareness and visitation of CCs. Bivariate logistic regression was used to calculate odds ratio (OR) and 95% confidence interval (CI) to examine the associations between the awareness and visiting CCs with socioeconomic determinants. RESULTS: Low prevalence of awareness about CC (18 %) was observed among studied women and only 17 % of them visited CCs. Significant associations (P < 0.05) with CCs awareness and visitation were observed among aged 20-29 years (adjusted OR = 1.18; 95% CI = 1.03-1.35 and adjusted OR = 1.49; 95% CI = 1.05-2.11), primary education (adjusted OR = 1.20; 95% CI = 1.08-1.34 and adjusted OR = 1.37; 95% CI = 1.05-1.78), and poorest family (adjusted OR = 1.21; 95% CI = 1.03-1.42 and adjusted OR = 2.36; 95% CI = 1.56-3.55, respectively), after controlling potential confounders. CONCLUSIONS: Awareness and visitation of CCs were found to be positively associated with lower economic conditions, young age, and primary education. Awareness and access to CCs might be increased through community activities that involve health care workers. The government should also lower barriers to PHC access through CCs by providing adequate logistics, such as human resources and equipment.

Disease-free survival as a surrogate for overall survival in adjuvant trials of gastric cancer: a meta-analysis.

BACKGROUND: In investigations of the effectiveness of surgery and adjuvant chemotherapy for gastric cancers, overall survival (OS) is considered the gold standard endpoint. However, the disadvantage of using OS as the endpoint is that it requires an extended follow-up period. We sought to investigate whether disease-free survival (DFS) is a valid surrogate for OS in trials of adjuvant chemotherapy for gastric cancer. METHODS: The GASTRIC group initiated a meta-analysis of individual patient data collected in randomized clinical trials comparing adjuvant chemotherapy vs surgery alone for patients with curatively resected gastric cancer. Surrogacy of DFS was assessed through the correlation between the endpoints as well as through the correlation between the treatment effects on the endpoints. External validation of the prediction based on DFS was also evaluated. RESULTS: Individual patient data from 14 randomized clinical trials that included a total of 3288 patients were analyzed. The rank correlation coefficient between DFS and OS was 0.974 (95% confidence interval [CI] = 0.971 to 0.976). The coefficient of determination between the treatment effects on DFS and on OS was as high as 0.964 (95% CI = 0.926 to 1.000), and the surrogate threshold effect based on adjusted regression analysis was 0.92. In external validation, the six hazard ratios for OS predicted according to DFS were in very good agreement with those actually observed for OS. CONCLUSIONS: DFS is an acceptable surrogate for OS in trials of cytotoxic agents for gastric cancer in the adjuvant setting.

Knowledge, attitudes and barriers of physicians, policy makers/regulators regarding use of opioids for cancer pain management in Thailand.

The efficacy of opioids for cancer pain has been proven and the World Health Organization (WHO) three-step ladder has been recommended for cancer pain relief. However, undertreatment of cancer pain has still been reported in Thailand. Identification of barriers to opioid use by the physicians and policy makers/regulators, and their level of knowledge and attitudes concerning its use are influential factors for cancer pain management (CPM). This study was performed to assess the knowledge and attitudes physicians and policy makers/regulators have regarding use of opioids for CPM. Barriers to opioid availability were also studied. A self-administered questionnaire was mailed to 300 physicians and distributed to 58 policy makers/regulators from September to October 2011. A total of 219 physicians and 47 policy makers/ regulators completed the questionnaire. Of the physicians 62.1% had inadequate knowledge and 33.8% had negative attitudes. Physicians who did not know the WHO three-step ladder were more likely to have less knowledge than those having used the WHO three-step ladder (OR = 13.0, p < 0.001). Policy makers/regulators also had inadequate knowledge (74.5%) and negative attitudes (66.0%). Policy makers/ regulators who never had CPM training were likely to have more negative attitudes than those having had training within less than one year (OR = 35.0, p = 0.005). Lack of training opportunities and periodic shortages of opioids were the greatest barriers to opioid availability for physicians and policy makers/ regulators, respectively. The strengthening of ongoing educational programs regarding opioid use for CPM, and cooperation among key groups are needed.

Job satisfaction of health-care workers at health centers in Vientiane Capital and Bolikhamsai Province, Lao PDR.

The aim of this study was to assess job satisfaction levels among health-care workers and factors correlated with their overall job satisfaction. This cross-sectional study was conducted from July to September 2011 with 164 health-care workers using self-administered questionnaires on a six-point Likert scale. Categorical variables were reported using frequencies and median (interquartile range), while continuous data were using means and standard deviations. Spearman rho coefficients were computed to correlate the overall job satisfaction for each factor, Kruskal-Wallis and Mann-Whitney U tests were used to evaluate the differences between demographic characteristics on overall job satisfaction. Of the 164 respondents, the majority were females (65.85%). Other dominant variables were married (76.83%), age > or =41 years old (44.51%), certified heath professional level (96.30%), nurse profession (59.10%), and working experience < or =5 years (55.49%). Participants were satisfied with 17 factors, but dissatisfied with salary levels at a mean score of (3.25). The highest satisfaction reported was for the freedom to choose the method of working with a mean score of 4.99, followed by the amount of variety on the job (4.96), amount of responsibility (4.90), and relationships with co-workers (4.90). The correlation coefficient between overall job satisfaction and main factors for job satisfaction-conflict resolution at work, relationships with co-workers, and organizational structure were (0.79), (0.76), and (0.71), respectively. There were statistically significant differences in age group, working experience and position (P<0.05). In conclusion, health-care workers at health centers in Lao PDR were generally satisfied with their job except for their salary. The main factors that correlate with their overall job satisfaction were conflict resolutions at work, relationships with other co-workers, and organizational structure.

Elderly health and its correlations among Uzbek population.

This study was conducted from November, 2007 to May, 2008 to evaluate the health status of the elderly and correlated factors affecting their health. We collected data from 682 individuals 65 years or older (214 male) from greater Tashkent City in Uzbekistan. The study revealed that 75.4% of the respondents were aged <75 years and that 16.8% of them were not educated. About three-quarters of the respondents rated themselves as 'healthy'. The odds ratios (ORs) and 95% confidence intervals (CIs) were estimated through a logistic regression model to determine correlations of elderly health, and adjusted for age and sex. The elderly who had additional income were 2.6 times (95% CI = 1.8-4.0) more likely to be healthy. Similarly, those <75 years old (OR = 1.5, 95% CI = 1.0-2.2), were able to do everyday duties (OR = 6.0, 95% CI = 3.8-9.3), and those who were married (OR = 4.1, 95% CI = 1.7-9.7) were also healthy. Conversely, males (OR = 0.6, 95% CI = 0.4-0.9) and the elderly who were supported by sources other than their own income from work were not healthy. We concluded that having a strong family relationship and adhering to a traditional lifestyle are important for protecting elderly health in Uzbekistan. Substantial financial support and personal care are necessary for the elderly. Creating a healthy atmosphere for them at an individual and family level could ensure a better quality life for the elderly in Uzbekistan.

Cardiovascular disease risk factors among rural Kazakh population.

Cardiovascular diseases (CVDs) have remained a leading cause of mortality in Kazakhstan. The objectives of the present study were to estimate the prevalence of CVD risk factors (RFs) among the Kazakh population, and their ability to identify those CVD RFs. We interviewed 611 subjects aged 25-65 years using a structured self-administered questionnaire from April to July, 2008. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated to determine associations between CVD RFs and its correlations, such as socioeconomic status and level of knowledge of CVD RFs through a logistic regression model. Mean age of the respondents was 43.2 years, and 49.8% were male. Tobacco smoking, overweight (body mass index > or = 25.0), hypertension (systolic blood pressure > or =140 mm Hg and diastolic blood pressure > or =90 mm Hg), and alcohol drinking were identified as important CVD RFs. Risk of overweight was greatest among the population aged 45-54 years, with an OR of 5.3 (95% CI = 3.1-9.2). The overweight population was significantly associated with higher income (OR = 1.6, 95% CI = 1.1-2.4) and knowledge of RF (OR = 1.7, 95% CI = 1.2-2.4), with p < 0.05. Only 25.0% of respondents had good knowledge about CVD RFs. Alcohol drinking was inversely related to the level of knowledge about CVD RFs (OR = 0.7, 95% CI = 0.5-0.9). We concluded that CVD RFs were very high among the Kazakh population, although their level of knowledge to identify those RFs was very low. Increasing knowledge about CVD RFs through awareness campaign activities can reduce CVD-related morbidity and mortality and ensure a better quality of life for the Kazakh population.

An assessment of antibiotics prescribed at the secondary health-care level in the Kyrgyz Republic.

This study was undertaken to evaluate the pattern of antibiotic prescriptions in a secondary health care setting in Kyrgyzstan. A retrospective analysis was performed of antibiotic prescriptions in 251 inpatient records of patients admitted to the Sokuluk Territorial Hospital. A total of 19 different antibiotics were prescribed. Penicillin G (24.9%), gentamicin (16.1%), metronidazole (15.6%) and cefazolin (14.5%) were those most frequently prescribed. The major indications for antibiotics were diseases of the respiratory system (28.0%), injury, poisoning and certain other consequences from external causes (25.5%), and diseases of the digestive system (14.3%). Almost three-quarters of the antibiotics were used parenterally, 252 of which (58.9%) were administered intramuscularly and 70 (16.4%) intravenously. Forty-five percent of the patients received two antibiotics, and 12.0% received three antibiotics during their stay at the hospital. Antibiotic therapy proved inappropriate for 184 patients (73.3%). The most common reason given for inappropriateness was the unjustified (not indicated) use of antibiotics in 143 (48.6%) cases. There was a significantly higher inappropriate choice of antibiotics in gynecology (OR = 2.70, 95% CI = 1.02-7.69) when compared with that in other wards. Although antibiotics were prescribed in all cases post-operatively, none of those patients were given pre-operative prophylactic antibiotics when indicated. We concluded that antibiotic prescriptions were seriously inappropriate in the Kyrgyz Republic with prescribing patterns failing to strictly adhere to the national guidelines. Adoption of an international standard and locally conformable guidelines of antibiotic use can help correct such problems.

A phase I/II trial of a WT1 (Wilms' tumor gene) peptide vaccine in patients with solid malignancy: safety assessment based on the phase I data.

OBJECTIVE: We conducted a phase I study to investigate the safety of a weekly WT1 tumor vaccine therapy in patients with solid tumors that had been refractory to all other anti-cancer therapies. METHODS: Skin-test-negative patients were intradermally injected weekly for 12 weeks with 3.0 mg of an HLA-A*2402-restricted modified 9-mer WT1 peptide emulsified in Montanide ISA51 adjuvant. We estimated the Bayesian posterior probability of the occurrence of grade 3 or 4 toxicity when receiving the weekly WT1 vaccination. This analysis provided the basis for making a decision to terminate the phase I study and switch to phase II. Moreover, we performed an exploratory assessment of the anti-tumor effects of WT1 treatment. RESULTS: Ten patients received 114 vaccinations with WT1 on a weekly schedule. No grade 3 or 4 toxicities were observed. Based on the Bayesian approach, it was highly likely that the probability of grade 3 or 4 toxicity was below 20% (the posterior probability = 0.914). Fifteen grade 2 and two grade 1 toxicities were observed; all of these incidents, however, were determined by the Independent Data and Safety Monitoring Committee to be unrelated to the WT1 treatment. One patient exhibited a partial response; five additional patients had stable disease while receiving weekly WT1 treatment. CONCLUSION: This paper confirms that the potential toxicities of the treatment schedule of weekly WT1 vaccination are acceptable and suggested a potential anti-tumor effect. Consequently, we validated the decision to continue to the phase II trial.

Assessment and data analysis of health-related quality of life in clinical trials for gastric cancer treatments.

This review contains a practical guide as well as a number of design and analytical methods for conducting health-related quality of life assessments in clinical trials for gastric cancer treatment. Although we address issues specific to the assessment of gastric cancer, many are applicable to clinical trials for different cancer types.