Evolving partnership: A National Center for Global Health and Medicine Resilient Training Model for clinical research professionals during the COVID-19 pandemic.

The clinical trial industry has encountered challenging circumstances in which the increasing number of trials outpaces the number of trial specialists. For instance, there has been an unprecedented demand for clinical trials following the Covid-19 pandemic, which has worsened the global shortage of qualified personnel. It is therefore imperative to produce more qualified clinical trial professionals. An adaptive and collaborative training model was implemented by the National Center for Global Health and Medicine through the Department of International Trials. This aimed at building capacity among health workers in developing countries and providing them with the skills to be able to conduct all phases of the clinical trial from protocol design to publication of results. It also seeks to foster collaboration and partnership between local health workers and international experts. Since 2016, we have implemented a Japan-led training program, and since 2020, the COVID-19 pandemic has ushered in a shift from a single Train-the-trainer model (ToT) to a mixed model, the Evolving Partnership Training (ePT). In this model, we applied four different methods: train-the-trainer, needs-oriented training, open symposiums, and advanced learning. The total number of training participants increased exponentially from a total of 41 between 2016-2020 to 2,810 in 2021. Our experience has proven that despite the constraint of the pandemic, the ePT is a viable approach compared to a single method for providing quality training and increasing the number of participants.

Knowledge, attitude, perception, and factors associated with the risk perception of COVID-19 among nursing college students in Japanese universities: A cross-sectional study.

Background and Aim: The spread of coronavirus disease 2019 (COVID-19) in the world has brought different attitudes and perceptions among social strata. Nursing students being future first-line healthcare workers are more at risk of being infected and exposed to various stressors from shared information. The objectives of this study were to evaluate the knowledge, attitude, and perception of COVID-19 among nursing students and to estimate predictors of their risk perception. Methods: We conducted an online survey among undergraduate nursing students at three selected Japanese Universities. Data on knowledge, attitude, and perception toward COVID-19 were collected using a structured questionnaire. We performed multiple logistic regression analyses to identify factors associated with the risk perception toward COVID-19 infection. Results: Of the 414 nursing students who participated in the study, 368 (90.4%) reported that the media including radio, television, internet, and/or social media were the main source of knowledge. Fever (96.1%) and dry cough (89.6%) were reported as the main symptoms. Regarding the attitude toward the treatment and preventive measures, almost 92.8% of participants recommended the use of vaccines. Being female appeared to be three times associated with the fear of getting infected (adjusted odds ratio [aOR]:3.03; 95% confidence interval [CI]: 1.21-7.58). Students who took part in extracurricular activities reported that they feared being infected with COVID-19 (aOR:2.62; 95% CI:1.33-5.16). Other factors did not show an association. Conclusion: Knowledge and attitude of nursing students toward COVID-19 were accurate for the majority of them, with the main source of information being the media. Practicing extracurricular activities and being female were associated with the fear of the disease. Efficient and controlled communication is needed during widespread disease outbreaks.

Boosting multiregional clinical trials (MRCT) in Asia through the establishment of the Japan-led network for clinical research, the ARO alliance for ASEAN & East Asia (ARISE).

There is an increasing demand for clinical research, and this demand has particularly increased during the novel coronavirus infection (COVID-19) pandemic. In the light of these events, fostering international cooperation has become essential. The ARO Alliance for ASEAN & East Asia (ARISE) is a Japan-led international network for clinical research in Asia that was established to encourage and facilitate multiregional clinical trials. The Department of International Trials of the National Center for Global Health and Medicine (NCGM) launched ARISE in December 2021 to pursue efficacious, high-quality clinical research and ensure rapid responses to health emergencies, with the timely provision of new medicinal products to patients in Asia.

Gestational weight gain mediates the effects of energy intake on birth weight among singleton pregnancies in the Japan Environment and Children's Study.

BACKGROUND: Extra energy intake is commonly recommended for pregnant women to support fetal growth. However, relevant data regarding variations in energy intake and expenditure, body mass index and gestational weight gain (GWG) are frequently not considered. This study aimed to investigate how energy intake during pregnancy and gestational weight gain (GWG) are associated with birth weight. METHODS: Early pregnant women were recruited into a Japanese nationwide prospective birth cohort study between 2011 and 2014. We analysed data of 89,817 mother-child pairs of live-born non-anomalous singletons after excluding births before 28 weeks or after 42 weeks. Energy intake during pregnancy was estimated from self-administered food frequency questionnaires (FFQ) and was stratified into low, medium, and high. Participants completed the FFQ in mid-pregnancy (mean 27.9 weeks) by recalling food consumption at the beginning of pregnancy. Effects of energy intake on birth weight and mediation by GWG were estimated using the Karlson-Holm-Breen method; the method separates the impact of confounding in the comparison of conditional and unconditional parameter estimates in nonlinear probability models. Relative risks and risk differences for abnormal birth size were calculated. RESULTS: Mean daily energy intake, GWG, and birth weight were 1682.1 (533.6) kcal, 10.3 (4.0) kg, and 3032.3 (401.4) g, respectively. 6767 and 9010 women had small-for-gestational-age and large-for-gestational-age infants, respectively. Relative to low energy intake, moderate and high intakes increased adjusted birth weights by 13 g and 24 g, respectively: 58 and 69% of these effects, respectively, were mediated by GWG. Compared with the moderate energy intake group, the low energy intake group had seven more women per 1000 women with a small-for-gestational-age birth, whereas the high energy intake group had eight more women per 1000 women with a large-for-gestational-age birth. CONCLUSION: GWG mediates the effect of energy intake on birth weight. All pregnant women should be given adequate nutritional guidance for optimal GWG and fetal growth.

Association between nausea and vomiting of pregnancy and postpartum depression: the Japan Environment and Children's Study.

OBJECTIVE: Postpartum depression (PPD) is a global emotional distress that affects women and their offspring regardless of their culture. The association between nausea and vomiting of pregnancy (NVP) and PPD has been widely described only for the severe form of NVP. We aimed to assess the relationship between PPD and NVP with regards to its severity. METHODS: Data from the Japan Environment and Children's Study (JECS), a birth cohort study, were analyzed. PPD was assessed using the Edinburgh Postnatal Depression Scale (EPDS). Multiple logistic regression models were performed to assess the association between NVP and PPD. RESULTS: Out of the 80,396 women included in the study 14% had PPD. Among them 4,640 (42.1%) had mild NVP; 3,295 (29.9%) had moderate NVP whereas 1,481 (13.4%) had severe NVP. All forms of NVP were associated with PPD and the association gradually increased with the severity of NVP symptoms with odd ratio (OR): 1.26; 95% confidence interval (CI): 1.18-1.35 for mild, OR: 1.28; 95% CI: 1.19-1.38 for moderate and OR: 1.54; 95% CI: 1.42-1.68 for severe NVP. CONCLUSION: Japanese women with NVP were more susceptible to develop PPD and the more severe the NVP symptoms were, the greater the risk of PPD. Thus, close monitoring of NVP-affected women is recommended.

Exogenous oxytocin used to induce labor has no long-term adverse effect on maternal-infant bonding: Findings from the Japan Environment and Children's Study.

BACKGROUND: This study investigated the association between exogenous oxytocin use for labor induction and adverse maternal-infant bonding (MIB). METHODS: Data on 19 700 mother-infant pairs were collected, in which the infants were live-birth singletons, born in cephalic position and at >37 weeks of gestation; the drug used to induce labor was noted. Between 2011 and 2014, Japanese pregnant women were enrolled in a nationwide prospective birth cohort study, the Japan Environment and Children's Study. The Japanese version of the Mother-to-infant Bonding Scale (MIBS-J) was administered and demographic information was collected through medical record transcripts. MIBS-J scores were obtained at one month, six months, and one year after delivery. We estimated the risk of adverse MIB between use of oxytocin and other methods for labor induction using multiple linear regression analyses; interaction and mediation analyses to assess the relationship among MIBS-J scores also followed. RESULTS: Exogenous oxytocin was used during labor on 15 252 (77.4%) participants. After adjusting for confounders, there were no significant differences in adverse MIB between groups for which exogenous oxytocin was used and not used for labor induction. LIMITATION: The MIBS-J scores at one and six months were compiled using five instead of 10 questions. Moreover, detailed information was unavailable; for example, the questionnaire did not ask for the dosage and timing of the drugs used to induce labor. CONCLUSIONS: Exogenous oxytocin is a safe and vital drug to induce labor, and has been shown in this study to have no significant impact on long-term adverse MIB.

Knowledge, attitudes and practices towards menopause among Congolese middle-aged and postmenopausal women.

INTRODUCTION: with the increase in life expectancy, women will live longer during their postmenopausal period. To improve their quality of life, they should be aware of what challenges they will be facing. This study aimed to evaluate the knowledge, attitudes and practices of middle-aged women towards menopause. METHODS: in this cross-sectional study, data collected using a multistage clustered random sampling from 54 health centres in the Democratic Republic of Congo were used. Participants filled a questionnaire derived from the menopause rating scale and from local beliefs. The knowledge, attitudes and practices towards menopause were evaluated among pre- and postmenopausal women. RESULTS: of the 353 women, both pre- and postmenopausal women knew the definition of menopause but for the symptoms, postmenopausal women were more informed than premenopausal. For the attitudes and practices towards menopause, while both had equally positive attitudes, the premenopausal women did not know which practice to adopt. CONCLUSION: Congolese women had limited knowledge, positive attitudes and unconventional practices towards menopause. Health-care providers, therefore, need to dispense appropriate advice to middle-aged women before the advent of menopause.

Malaria rapid diagnostic test (HRP2/pLDH) positivity, incidence, care accessibility and impact of community WASH Action programme in DR Congo: mixed method study involving 625 households.

BACKGROUND: Malaria is one of the most prevalent and deadliest illnesses in sub-Saharan Africa. Despite recent gains made towards its control, many African countries still have endemic malaria transmission. This study aimed to assess malaria burden at household level in Kongo central province, Democratic Republic of Congo (DRC), and the impact of community participatory Water, Sanitation and Hygiene (WASH) Action programme. METHODS: Mixed method research was conducted in two semi-rural towns, Mbanza-Ngungu (a WASH action site) and Kasangulu (a WASH control site) in DRC between 1 January 2017 through March 2018, involving 625 households (3,712 household members). Baseline and post-intervention malaria surveys were conducted with the use of World Bank/WHO Malaria Indicator Questionnaire. An action research consisting of a six-month study was carried out which comprised two interventions: a community participatory WASH action programme aiming at eliminating mosquito breeding areas in the residential environment and a community anti-malaria education campaign. The latter was implemented at both study sites. In addition, baseline and post-intervention malaria rapid diagnostic test (RDT) was performed among the respondents. Furthermore, a six-month hospital-based epidemiological study was conducted at selected referral hospitals at each site from 1 January through June 2017 to determine malaria trend. RESULTS: Long-lasting insecticide-treated net (LLIN) was the most commonly used preventive measure (55%); 24% of households did not use any measures. Baseline malaria survey showed that 96% of respondents (heads of households) reported at least one episode occurring in the previous six months; of them only 66.5% received malaria care at a health setting. In the Action Research, mean incident household malaria cases decreased significantly at WASH action site (2.3 ± 2.2 cases vs. 1.2 ± 0.7 cases, respectively; p < 0.05), whereas it remained unchanged at the Control site. Similar findings were observed with RDT results. Data collected from referral hospitals showed high malaria incidence rate, 67.4%. Low household income (ORa = 2.37; 95%CI: 1.05-3.12; p < 0.05), proximity to high risk area for malaria (ORa = 5.13; 95%CI: 2-29-8.07; p < 0.001), poor WASH (ORa = 4.10; 95%CI: 2.11-7.08; p < 0.001) were predictors of household malaria. CONCLUSION: This research showed high prevalence of positive malaria RDT among the responders and high household malaria incidence, which were reduced by a 6-month WASH intervention. DRC government should scale up malaria control strategy by integrating efficient indoor and outdoor preventive measures and improve malaria care accessibility.

Prevalence of chronic obstructive pulmonary disease (COPD) among Congolese cement workers exposed to cement dust, in Kongo Central Province.

Chronic exposure to cement dust may induce adverse health effects, including a significant decrease in lung function. The study investigated whether the prevalence of COPD and respiratory symptoms was associated with working at different tasks exposed to varying levels of cement dust. The cross-sectional study was carried out among 223 exposed and 156 less exposed workers from two cement factories from November 20 to December 15, 2016 in DRC. Workers completed a questionnaire and spirometry was performed. Multivariate analysis was performed to evaluate the association between occupation exposed to cement dust, COPD, and respiratory symptoms, after adjustment for confounders. Morning cough and cough on most days for as much as 3 months each year were significantly higher in the exposed group (p < 0.05) (p = 0.001) than in the less exposed group. As compared to the less exposed group, the prevalence of COPD was higher among the exposed group, 28.2 and 9.6% respectively (p < 0.001). A significant association with COPD, aOR 14.49 (5.33; 39.40), aOR 3.37 (1.44; 7.89), and aOR 3.09 (1.58; 6.05) was found among cleaning, transportation, and production workers, respectively. Working at certain tasks exposed to cement dust is associated with the higher prevalence of COPD and respiratory symptoms. A greater risk is being among cleaning, transportation, and production workers. This suggests the necessity to prioritize the quality of preventive measures in each work area.

Occupation exposed to road-traffic emissions and respiratory health among Congolese transit workers, particularly bus conductors, in Kinshasa: a cross-sectional study.

OBJECTIVES: Road-traffic emissions (RTE) induce adverse health effects, notably respiratory symptoms and respiratory diseases, as a result of pollutants deposited into the respiratory tract. The aim of this study was to evaluate the association between occupation groups of Congolese transit workers exposed to RTE, particularly bus conductors and respiratory health, in Kinshasa. METHODS: A cross-sectional study was conducted from 2015 April 20th to May 14th, whose participants were bus conductors (n = 110), bus drivers (n = 107), taxi-motorcyclists (n = 102) and high school teachers (control group; n = 106). Subjects had completed the American Thoracic Society respiratory symptom questionnaire. Lung function test was performed by spirometry. Air pollutants levels of PM2.5, NO2 and SO2 were measured between 7:30 and 8:30 and 16:30-17:30 using a portable gas monitor. Multivariate analysis was performed to evaluate the association between occupation exposed to RTE and impaired pulmonary function, after adjustment by plausible confounders. RESULTS: The prevalence of mixed syndrome was 21.9% for bus conductors, 10.9% for bus drivers, 15.4% for taxi-motorcyclists and 7.1% for high school teachers with (p < 0.05). The risk of developing a mixed syndrome was seven times higher among bus conductors [OR = 7.64; 95% CI: 1.83-31.67; p < 0.05] than other groups. Additionally, the prevalence of respiratory syndromes increased with the duration of exposure. CONCLUSIONS: Occupation exposed to RTE is associated with impaired pulmonary function and the prevalence of respiratory symptoms among transit workers, especially bus conductors. Furthermore, this association increases with the duration of exposure suggesting the necessity to regulate these categories of occupations and to apply preventives measures.

Preconception gynecological risk factors of postpartum depression among Japanese women: The Japan Environment and Children's Study (JECS).

BACKGROUND: Postpartum depression is one of the major causes of disability among women who are on their childbearing years. Identifying people at risk of postpartum depression may improve its management. The objective of this study was to determine the probable association between postpartum depression and some preconception gynecological morbidities. METHODS: Data from a nationwide birth cohort study, the Japan Environment and Children's study (JECS), up to one month of postpartum were analyzed. To assess postpartum depression, the Edinburgh Postnatal Depression Scale (EPDS) was used; 11 preconception gynecological morbidities were considered as risk factors. Covariates included psychiatric illness history, psychosocial factors, some pregnancy adverse outcomes, birth outcomes, socio-demographic and health behavioral factors. RESULTS: Except for the prevalence of previous miscarriage, leiomyoma and polycystic ovarian syndrome, depressive women had more gynecological morbidities compared to non-depressive ones. In logistic regression model, endometriosis (OR, 1.27; 95%CI: 1.15-1.41), dysmenorrhea (OR, 1.13; 95%CI: 1.06-1.21) and abnormal uterine bleeding (OR, 1.21; 95%CI: 1.15-1.29) were associated with postpartum depression. LIMITATIONS: CONCLUSION: Women with endometriosis and menstrual problems were at risk of developing postpartum depression. This study suggests a perinatal mental health screening for predisposed women.