The Sri Lanka Mother and Newborn Growth (S-MaNGro) Cohort: Protocol of a Nationwide Prospective Study.

Perinatal cohort studies with a prospective longitudinal design are critical for determining the effects of early-life exposures on offspring's health outcomes. The Sri Lanka Mother and Newborn Growth cohort study aims to investigate the impact of maternal nutritional and psychosocial factors on newborns' birth weight in the Sri Lankan context. This paper presents the methodology of participant recruitment, follow-ups, an overview of measurements, and planned data analyses.

A Dementia-Friendly Educational Program Using Virtual Reality for the General Public in Japan: A Randomized Controlled Trial for DRIVE.

Background And Objectives: Raising dementia awareness is essential for building a dementia-friendly community. However, existing studies have underexplored the effects of virtual reality (VR) dementia educational programs for the general public on enhancing positive attitude toward dementia. This study aimed to examine the effectiveness of a VR dementia-friendly educational program called the Drive for Dementia Readiness Inside Virtual Reality (DRIVE) program to improve attitude toward dementia of the general public.

Association of longitudinal pet ownership with wheezing in 3-year-old children using the distributed lag model: the Japan Environment and Children's Study.

Background: Time-varying exposures like pet ownership pose challenges for identifying critical windows due to multicollinearity when modeled simultaneously. The Distributed Lag Model (DLM) estimates critical windows for time-varying exposures, which are mainly continuous variables. However, applying complex functions such as high-order splines and nonlinear functions within DLMs may not be suitable for situations with limited time points or binary exposure, such as in questionnaire surveys.

Goodness-of-fit tests for modified Poisson regression possibly producing fitted values exceeding one in binary outcome analysis.

Modified Poisson regression, which estimates the regression parameters in the log-binomial regression model using the Poisson quasi-likelihood estimating equation and robust variance, is a useful tool for estimating the adjusted risk and prevalence ratio in binary outcome analysis. Although several goodness-of-fit tests have been developed for other binary regressions, few goodness-of-fit tests are available for modified Poisson regression. In this study, we proposed several goodness-of-fit tests for modified Poisson regression, including the modified Hosmer-Lemeshow test with empirical variance, Tsiatis test, normalized Pearson chi-square tests with binomial variance and Poisson variance, and normalized residual sum of squares test.

Pilot trial of an electronic patient-reported outcome monitoring system in patients with metastatic breast cancer undergoing chemotherapy.

Background: Electronic patient-reported outcomes monitoring (ePROM) is a useful communication tool for patients and healthcare providers in cancer chemotherapy. In this study, we examined the feasibility of our newly developed ePROM system, which we refer to as "Hibilog".

Methods: An ePROM app was developed by extracting 18 items from the Patient-Reported Outcome-Common Terminology Criteria for Adverse Events (PRO-CTCAE).

A risk-based subgroup analysis of the effect of adjuvant S-1 in estrogen receptor-positive, HER2-negative early breast cancer.

Purpose: The Phase III POTENT trial demonstrated the efficacy of adding S-1 to adjuvant endocrine therapy for estrogen receptor-positive, HER2-negative early breast cancer. We investigated the efficacy of S-1 across different recurrence risk subgroups.

Methods: This was a post-hoc exploratory analysis of the POTENT trial.

Real-world experience with 5-aminolevulinic acid for photodynamic diagnosis of bladder cancer (3rd report): Cost impact of transurethral resection of bladder tumor in Japan.

Background: Photodynamic diagnosis-assisted transurethral resection of bladder tumor (PDD-TURBT) showed improvement of diagnostic accuracy and treatment efficacy compared to white light TURBT (WL-TURBT). While PDD-TURBT is highly effective, PDD-TURBT requires the use of PDD device and light-sensitive substance precursor, which increases the medical cost compared to WL-TURBT. In this study, the impact on health care economic costs were examined between PDD-TURBT and WL-TURBT.

Using a Sample Size Calculation Framework for Clinical Prediction Models When Developing and Selecting Mapping Algorithms Based on Linear Regression.

Purpose: To propose using a framework for calculating the sample size for clinical prediction models when developing and selecting mapping algorithms from a health-related quality-of-life (HRQOL) measure onto the score of a preference-based measure (PBM) using linear regression.

Methods: The framework was summarized for health economics researchers. Mapping studies that mapped the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 onto the EQ-5D-3L index using linear regression were evaluated in terms of sample size.

Development and validation of a symptom illustration scale from the patient-reported outcome common terminology criteria for adverse events for patients with breast cancer.

Purpose: Emojis are commonly used for daily communication and may be useful in assessing patient-reported outcomes (PROs) in breast cancer. The purpose of this study is to develop and validate a Symptom Illustration Scale (SIS) as a new PRO measurement.

Methods: Eighteen original SIS items were developed from the PRO-CTCAE.

Impacts of the preceding cancer-specific health-related quality of life instruments on the responses to the subsequent EQ-5D-5L.

Background: In clinical studies, the EQ-5D-5L is often employed with disease-specific health-related quality of life instruments. The questions in the former are more general than the latter; however, it is known that responses to general questions can be influenced by preceding specific questions. Thus, the responses to the EQ-5D-5L have the possibility of being influenced by the preceding disease-specific health-related quality of life instruments.

Diagnostic ability using fatty liver and metabolic markers for metabolic-associated fatty liver disease stratified by metabolic/glycemic abnormalities.

Aims/introduction: Although several noninvasive predictive markers for fatty liver and metabolic markers have been used for fatty liver prediction, whether such markers can also predict metabolic-associated fatty liver disease (MAFLD) remains unclear. We aimed to examine the ability of existing fatty liver or metabolic markers to predict MAFLD.

Materials And Methods: Participants in a high-volume center in Tokyo were classified into groups with and without MAFLD, based on the presence of metabolic abnormalities and fatty liver diagnosed through abdominal ultrasonography, between 2008 and 2018.

A Randomized Control Trial for ReDeSign: A Dementia-Friendly Mobile Microlearning Training for Store Workers in Japan.

Background And Objectives: Dementia-friendly training should be incorporated in neighborhood stores for people living with dementia to maintain engagement in social activities. However, there is a lack of evidence of dementia-friendly training in these workplaces, and existing trainings have time constraints. We developed a mobile microlearning program based on stigma theory and the bystander intervention model.

Health-related quality of life and estimation of the minimally important difference in the Functional Assessment of Cancer Therapy-Endocrine Symptom score in postmenopausal ER+/HER2- metastatic breast cancer with low sensitivity to endocrine therapy.

Background: The HORSE-BC study previously demonstrated that second-line endocrine therapy (ET) for patients with acquired endocrine-resistant metastatic breast cancer (MBC) still provided a clinically meaningful benefit. Herein, we investigated the health-related quality of life (HRQOL) in the HORSE-BC study.

Methods: Patients with acquired endocrine-resistant MBC who were scheduled for second-line ET were recruited.

Gradient Boosted Tree Approaches for Mapping European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Onto 5-Level Version of EQ-5D Index for Patients With Cancer.

Objectives: This study aimed to develop direct and response mapping algorithms from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 onto the 5-level version of EQ-5D index based on the gradient boosted tree (GBT), a promising modern machine learning method.

Methods: We used the Quality of Life Mapping Algorithm for Cancer study data (903 observations from 903 patients) for training GBTs and testing their predictive performance. In the Quality of Life Mapping Algorithm for Cancer study, patients with advanced solid tumor were enrolled, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and 5-level version of EQ-5D were simultaneously evaluated.

Rigid real-time prospective motion-corrected three-dimensional multiparametric mapping of the human brain.

Purpose: To develop a rigid real-time prospective motion-corrected multiparametric mapping technique and to test the performance of quantitative estimates.

Methods: Motion tracking and correction were performed by integrating single-shot spiral navigators into a multiparametric imaging technique, three-dimensional quantification using an interleaved Look-Locker acquisition sequence with a T2 preparation pulse (3D-QALAS). The spiral navigator was optimized, and quantitative measurements were validated using a standard system phantom.

Simultaneous relaxometry and morphometry of human brain structures with 3D magnetic resonance fingerprinting: a multicenter, multiplatform, multifield-strength study.

Relaxation times and morphological information are fundamental magnetic resonance imaging-derived metrics of the human brain that reflect the status of the underlying tissue. Magnetic resonance fingerprinting (MRF) enables simultaneous acquisition of T1 and T2 maps inherently aligned to the anatomy, allowing whole-brain relaxometry and morphometry in a single scan. In this study, we revealed the feasibility of 3D MRF for simultaneous brain structure-wise morphometry and relaxometry.

Cost-Effectiveness of Trastuzumab With or Without Chemotherapy as Adjuvant Therapy in HER2-Positive Elderly Breast Cancer Patients: A Randomized, Open-Label Clinical Trial, the RESPECT Trial.

Background And Objective: Trastuzumab is a standard care as adjuvant chemotherapy (AdjCT) for patients with human epidermal growth factor receptor 2 (HER2)-positive primary breast cancer (BC) in Japan. However, no reports have evaluated its economics for patients with HER2-positive BC over 70 years of age. The objective of this study was to evaluate the cost-effectiveness of HER2-targeted trastuzumab + chemotherapy in Japan, comparing it with trastuzumab monotherapy.

Estimating Value-Based Price and Quantifying Uncertainty around It in Health Technology Assessment: Frequentist and Bayesian Approaches.

Background: Although several statistical methods have been developed to inform decision making on reimbursement under uncertainty (e.g., expected net benefit, cost-effectiveness acceptability curves, and expected value of perfect information [EVPI]), those for value-based pricing are limited.

Relational Design for Dementia and Job Significance (ReDeSign): Study protocol for a randomized controlled trial of an online dementia training for retail workers.

Background: The need for dementia training for retail workers has been recognized by dementia-friendly initiatives. However, evidence for dementia training in non-healthcare workplaces is lacking, and dissemination is challenging due to constraints on private companies' time and finances. The online training program ReDeSign (Relational Design for Dementia and Job Significance) applies mobile micro-learning methods and Relational Design Theory against time and financial constraints, respectively, and is designed to improve work-related outcomes.

Prevalence, Incidence Rate, and Risk Factors of Medication-Related Osteonecrosis of the Jaw in Patients With Osteoporosis and Cancer: A Nationwide Population-Based Study in Japan.

Purpose: Medication-related osteonecrosis of the jaw (MRONJ) is a rare but severe adverse event of antiresorptive agents. However, the precise prevalence and factors associated with the development of MRONJ remain unknown. The present study was performed to describe the prevalence, incidence rate, and risk factors of developing MRONJ.

Minimal important differences of EORTC QLQ-C30 for metastatic breast cancer patients: Results from a randomized clinical trial.

Purpose: To establish minimal important differences (MIDs) for the European Organisation for Research and Treatment for Cancer Quality of life Questionnaire core 30 (EORTC QLQ-C30) in patients with metastatic breast cancer.

Methods: The dataset was obtained from the SELECT BC-CONFIRM randomized clinical trial. Anchors obtained from patients (transition items) and clinicians (performance status) were used for anchor-based methods.

A simulation study of regression approaches for estimating risk ratios in the presence of multiple confounders.

Background: Risk ratio is a popular effect measure in epidemiological research. Although previous research has suggested that logistic regression may provide biased odds ratio estimates when the number of events is small and there are multiple confounders, the performance of risk ratio estimation has yet to be examined in the presence of multiple confounders.

Methods: We conducted a simulation study to evaluate the statistical performance of three regression approaches for estimating risk ratios: (1) risk ratio interpretation of logistic regression coefficients, (2) modified Poisson regression, and (3) regression standardization using logistic regression.

Non-parametric approach for frequentist multiple imputation in survival analysis with missing covariates.

In clinical and epidemiological studies using survival analysis, some explanatory variables are often missing. When this occurs, multiple imputation (MI) is frequently used in practice. In many cases, simple parametric imputation models are routinely adopted without checking the validity of the model specification.