BACKGROUND: Supporting the mental health of researchers is essential to maintaining human resources and advancing science. This study investigated the association between Japanese medical researchers' perceptions of research evaluation processes and their psychological well-being. METHODS: We performed a web-based self-administered questionnaire survey. The questionnaires were distributed to each academic society through the Japanese Association of Medical Sciences from December 2022 to January 2023. These questionnaires targeted medical researchers. Exposure was the medical researchers' perceptions of quantitative indicators for evaluating medical research and researchers. The outcome was psychological well-being, measured using the Japanese version of the World Health Organization-Five Well-Being Index (WHO-5). Multivariable-adjusted logistic regressions were conducted to investigate the association between individual attitudes toward research evaluation and psychological well-being. Stratified analyses by research fields, i.e., clinical, basic, and social medicine, were also performed. RESULTS: A total of 3,139 valid responses were collected. After excluding 176 responses from research fields of other than clinical, basic, or social medicine, 2,963 researchers (2,185 male, 737 female, and 41 other) were analyzed. Prevalence of poor well-being (WHO-5 score <13) was 28.3% in the researchers. The highest number of medical researchers was in clinical medicine (n = 500) followed by basic medicine (n = 217) and social medicine (n = 121). Medical researchers who considered research funding slightly important/not important for researcher evaluation had poorer psychological well-being than those who considered it especially important (slightly important: adjusted odds ratio (aOR) 1.33, 95% confidence interval (CI) 1.03-1.71; not important: aOR 1.53, 95%CI 1.10-2.12). This tendency was stronger among basic medical researchers than clinical or social medical researchers. The research field significantly modified the relationship between research funding received and interaction with poor psychological well-being both additively (P = 0.030) and multiplicatively (P = 0.024). CONCLUSIONS The discrepancy between medical researchers' attitudes toward research evaluation and the current state of research evaluation in their research community may worsen their psychological well-being. The influence of this discrepancy differs among clinical, basic, and social medicine. Appropriate evaluation of medical research and researchers in each field can facilitate improving their psychological well-being via the resolution of this discrepancy.
Humans ; Japan ; Female ; Male ; Cross-Sectional Studies ; Adult ; Research Personnel/statistics & numerical data* ; Middle Aged ; Biomedical Research ; Surveys and Questionnaires ; Mental Health ; Psychological Well-Being ; East Asian People

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/ day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8).The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.

Objective: To assess the efficacy of the FIGO 2018 classification system for nodal-specific classifications for early-stage cervical cancer; specifically, to examine the impact of nodal metastasis on survival and the effect of postoperative treatments, according to histological subtypes. Methods: This society-based retrospective observational study in Japan examined 16,539 women with the 2009 FIGO stage IB1 cervical cancer who underwent primary surgical treatment from 2004 to 2015. Associations of cause-specific survival (CSS) with nodal metastasis and postoperative adjuvant therapy were examined according to histology type (squamous cell carcinoma [SCC], n=10,315; and non-SCC, n=6,224). Results: The nodal metastasis rate for SCC was higher than that for non-SCC (10.7% vs. 8.3%, p<0.001). In multivariable analysis, the impact of nodal metastasis on CSS was greater for non-SCC tumors (adjusted-hazard ratio [HR], 3.11; 95% confidence interval [CI], 2.40–4.02) than for SCC tumors (adjusted-HR, 2.20; 95% CI, 1.70–2.84; p<0.001). Propensity score matching analysis showed significantly lower CSS rates for women with pelvic nodal metastasis from non-SCC tumors than from SCC tumors (5-year CSS rate, 75.4% vs. 90.3%, p<0.001). The CSS rates for women with nodal metastasis in SCC histology were similar between the postoperative concurrent chemoradiotherapy/radiotherapy and chemotherapy groups (89.2% vs. 86.1%, p=0.42), whereas those in non-SCC histology who received postoperative chemotherapy improved the CSS (74.1% vs. 67.7%, p=0.043). Conclusion The node-specific staging system in the 2018 FIGO cervical cancer classification is applicable to both non-SCC tumors and SCC tumors; however, the prognostic significance of nodal metastases and efficacy of postoperative therapies vary according to histology.

Objective: The study compared the treatment outcomes of surgery versus radiotherapy, including concurrent chemoradiotherapy, in stage Ib2–IIb cervical adenocarcinoma patients in Japan. Methods: Of 57,470 patients diagnosed with stage I–IV cervical cancer from January 2001–December 2011, 1,932 patients with stage Ib2–IIb cervical adenocarcinoma were initially treated by surgery or radiotherapy. The primary endpoint was 5-year overall survival (OS) in all and 614 propensity score-matched (PSM) patients (307 per group). We compared OS and prognosis factors based on age, primary stage, and treatment arm. Results: In Japan, >80% (n=1,573) of stage Ib2–IIb cervical adenocarcinoma patients underwent surgery. The 5-year OS of surgery vs. radiotherapy groups were 82.1% (n=704) vs. 79.7% (n=59) (hazard ratio [HR]=1.494; 95% confidence interval [CI]=0.826–2.702; p=0.181) for stage Ib2, 76.6% (n=239) vs. 66.7% (n=54) (HR=1.679; 95% CI=0.986–2.858; p=0.053) for stage IIa, and 71.1% (n=630) vs. 58.9% (n=246) (HR=1.711; 95% CI=1.341–2.184; p<0.001) for stage IIb. In 614 PSM patients balanced for age and carcinoma stage Ib2–IIb, the 5-year OS of surgery vs. radiation groups was 73.0% (n=307) vs. 65.5% (n=307) (HR=1.394; 95% CI=1.044–1.860; p=0.023). In multivariable analysis, age (HR=1.293; 95% CI=1.045–1.601; p=0.018), treatment arm, radiotherapy (HR=1.556; 95% CI=1.253–1.933; p<0.001), and stage IIb (HR=1.783; 95% CI=1.443–2.203; p=0.018) were independent prognosis factors for 5-year OS in stage Ib2–IIb adenocarcinoma patients. Conclusion Age (>65 years), treatment arm (radiotherapy), and stage IIb significantly affect OS in cervical adenocarcinoma patients. Surgery may be considered for <65-year-old patients with stage IIb adenocarcinoma.

Objective: To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs. Results: Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%. Conclusion Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified.

The expansion of home medical care and the growth in sales of OTC, coupled with Japan’s aging society and the need to reduce medical costs has broadened the role of the pharmacist to include physical assessment. In response, the Kindai University Faculty of Pharmacy, implemented the Physical Assessment Practical Training Course (PAPTC) to improve the physical assessment skills of pharmacy students and practicing pharmacists. In order to investigate pharmacy students’ and practicing pharmacists’ perceptions of PAPTC, a questionnaire using a five-part, forced- choice Lykert type scale was conducted. The results of the questionnaire were analyzed using factor analysis and cluster analysis. The total number of respondents was 456. Three hundred thirteen of the respondents were students, and 143 of the respondents were practicing pharmacists. Factor analysis revealed four factors which we titled, “Physical Assessment Skills”, “Physical Assessment Course”, “Pharmacist Jobs” and, “Knowledge Required by Pharmacist”. Subsequently, cluster analysis identified two distinct groups. Group A which constituted primarily of pharmacy students, and Group B which consisted primarily of practicing pharmacists. Each group displayed notable differences in perceptions related to PAPTC. These differences may be influenced by perceptions toward “skills” and/or “knowledge”. These findings suggest that in order to better address the motivational needs of the participants, PAPTC should be divided into two courses. One, for knowledge-based instruction, and other for skill-based practice.

The expansion of home medical care and the growth in sales of OTC, coupled with Japan’s aging society and the need to reduce medical costs has broadened the role of the pharmacist to include physical assessment. In response, the Kindai University Faculty of Pharmacy, implemented the Physical Assessment Practical Training Course (PAPTC) to improve the physical assessment skills of pharmacy students and practicing pharmacists. In order to investigate pharmacy students’ and practicing pharmacists’ perceptions of PAPTC, a questionnaire using a five-part, forced- choice Lykert type scale was conducted. The results of the questionnaire were analyzed using factor analysis and cluster analysis. The total number of respondents was 456. Three hundred thirteen of the respondents were students, and 143 of the respondents were practicing pharmacists. Factor analysis revealed four factors which we titled, “Physical Assessment Skills”, “Physical Assessment Course”, “Pharmacist Jobs” and, “Knowledge Required by Pharmacist”. Subsequently, cluster analysis identified two distinct groups. Group A which constituted primarily of pharmacy students, and Group B which consisted primarily of practicing pharmacists. Each group displayed notable differences in perceptions related to PAPTC. These differences may be influenced by perceptions toward “skills” and/or “knowledge”. These findings suggest that in order to better address the motivational needs of the participants, PAPTC should be divided into two courses. One, for knowledge-based instruction, and other for skill-based practice.

Objective: This study aimed to clarify the circumstances and challenges in home care-oriented hospital nurse training on the basis of results of hospital nurse self-evaluations of nursing activities implemented in preparation for home care.

Methods: Group interviews were conducted with 13 nurses at 9 different hospitals, and the results were qualitatively and inductively analyzed.

Results and Discussion: Six categories for actual nursing activities implemented in preparation for home care were extracted. These categories were "I leave home care to other medical professionals," "No form of inter-hospital cooperation has been established," "There is disparity in cooperation with home-visiting nurses," "Social resources are not being used due to a lack of knowledge," "Able to develop a perspective of home care through workshop participation, years of experience, and interest," and "Competency is lacking despite knowledge of home care." Home care was apparently not being utilized by hospital nurses due to a lack of knowledge of social resources and a lack of interdisciplinary cooperation.

Conclusions: Challenges in nurse training implemented in preparation for home care included compensating for the lack of practical knowledge of social resources and devising a duty system and inter-facility exchanges to allow nurses to build experience in other areas and departments. The results of this study suggested the need for organizational training initiatives and for improvement of the quality of individuals in order to put acquired knowledge into practice.