How to select and understand guidelines for patient-reported outcomes: a scoping review of existing guidance.

BACKGROUND: Over the past few decades, patient-reported outcomes (PROs) have been used to understand patient health conditions better. Therefore, numerous PRO measures (questionnaires) and guidelines or guidance have been developed. However, it is challenging to select target guidance from among the many available guidance and to understand the chosen guidance. This study comprehensively collected the existing PRO guidance for clinical trials or studies and practices to support novice PRO users in academia, industry, clinical practice, and regulatory and reimbursement decision-making. METHODS: For the scoping review, we searched the MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf databases from 2009 to 2023. The eligibility criteria were PRO guidance for clinical trials, clinical practice, or application such as health technology assessment. Those guidance cover aspects such as quality of life (QOL), PRO, health-related QOL, health state utilities, psychometric requirements, implementation methods, analysis and interpretation, or clinical practice applications. After the systematic search, three researchers individually reviewed the collected data, and the reviewed articles and books were scrutinized using the same criteria. RESULTS: We collected the PRO guidance published in articles and books between 2009 and 2023. From the database searches, 1,455 articles and 387 books were identified, of which one book and 33 articles were finally selected. The collected PRO guidance was categorized into the adoption of PRO measures, design and reporting of trials or studies using PROs, implementation of PRO evaluation in clinical trials or studies or clinical practice, analysis and interpretation of PROs, and application of PRO evaluation. Based on this categorization, we suggest the following for novices: When selecting guidance, novices should clarify the "place" and "purpose" where the guidance will be used. Additionally, they should know that the terminology related to PRO and the scope and expectations of PROs vary by "places" and "purposes". CONCLUSIONS: From this scoping review of existing PRO guidance, we provided summaries and caveats to assist novices in selecting guidance that fits their purpose and understanding it.

A Randomized Controlled Trial of Betamethasone on Fatigue in Patients With Advanced Cancer.

CONTEXT: Fatigue is one of the most uncomfortable physical symptoms seen in patients with advanced cancer. Previous studies have reported on the efficacy of corticosteroids from Western countries. OBJECTIVES: To assess the effectiveness of 4mg betamethasone improving fatigue among Japanese patients with advanced cancer. METHODS: A randomized, double-blind, placebo-controlled trial enrolled eligible patients with advanced cancer expected to survive 1-2 months, with an Eastern Cooperative Oncology Group Performance Status of 2-3, and experiencing fatigue according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-15-palliative criteria. Participants received twice-daily oral administration of 2 mg betamethasone (4 mg/d) or placebo for seven days, with fatigue assessed using EORTC QLQ-C15-PAL subscale and numerical rating scale (NRS) score (at baseline and day seven). The trial was registered under the University Hospital Medical Information Network (UMIN)000011913. RESULTS: Among the 267 screened patients, 81 were eligible, of which 70 were evaluable (betamethasone, 33; placebo, 37). The mean difference in the EORTC-QLQ-C15-PAL fatigue subscale was -8.2 (95% CIs: -22.3, 0.0; P = 0.178) and in a NRS for fatigue was -1.2 (95% CIs: -2.5, -0.01; P = 0.048), respectively. Emotional function, appetite loss, and global-health were slightly better in the betamethasone group than in the placebo group. CONCLUSION: The impact of betamethasone 4 mg/d on alleviating fatigue in patients with advanced cancer in the last weeks of life did not reach statistical significance in the EORTC-QLQ-C15-PAL as the primary endpoint, however, it was significant in the NRS, the secondary endpoint.

Establishment of a post-disaster healthcare information booklet for the Turkey-Syrian earthquake, based on past disasters.

The scientific evidence based on experiences with past disasters points to the possibility of the occurrence of future mental health issues among those who were affected by the recent Turkey-Syria earthquake. However, post-disaster care information on factors that could give rise to mental health issues among those affected have yet to be provided. In March 2011, Tohoku University compiled and published a booklet with post-disaster healthcare information based on the experiences with the Great East Japan Earthquake. This study aimed to promote the introduction and use of this booklet for post-disaster care in Turkey and Syria by presenting the results of a satisfaction survey conducted with relevant Japanese organizations about the booklet. A total of 505 Japanese organizations participated in the satisfaction survey of, and evaluated, the booklet. The results indicated the need to consider the ease of understanding for the general public when providing information on post-disaster care through booklets. We hope that this study leads to the appropriate provision of easy-to-understand, post-disaster healthcare information to the victims of the Turkey-Syria earthquake and future disasters.

Perceptions regarding the concept and definition of patient-reported outcomes among healthcare stakeholders in Japan with relation to quality of life: a cross-sectional study.

Patient-reported outcomes (PROs) are frequently used in a variety of settings, including clinical trials and clinical practice. The definition of PRO and quality of life (QOL) and their relationship have been concluded through discussions among experts that has been the premise of PRO guidelines are not clearly stated in the guidelines. Therefore, the definition of PRO, especially in relation to QOL, is sometimes explained simply, as "PRO includes QOL," but this complicated matters. This study investigated the perceptions of PRO among various stakeholders (including patients and their families, the industry, clinicians, regulatory or health technology assessment personnel, and academic researchers) in Japan to clarify its definitions and that of QOL, including their relationship.We conducted a two-step survey: a qualitative interview survey and a web-based survey to ensure the validity of the survey. During the interviews, eight stakeholders described their perceptions and thoughts on PRO and its relationship to QOL, and their experience of using PRO. Overall 253 clinicians, 249 company employees, and 494 patients participated in the web survey to confirm how the findings of the interview survey supported the results.In the interview survey, patient advocates described various perspectives of PRO and QOL, including unexpected dynamic relationships, while the most other stakeholders explained PRO and QOL with the language used in the guidelines, but their responses were split. The web-based survey revealed that all stakeholders had a lower awareness of PRO than QOL. The most common perception of PRO, especially in the relationship to QOL, was "they did not fully overlap." Although there were differences in perceptions of the relationship between PRO and QOL among clinicians, company employees, and patients, all perceived PRO as a tool to facilitate communication in clinical practice.The present results are inconsistent with the simplified explanation of PRO, but consistent with the original PRO guideline definitions, which also considered the role of PRO in clinical practice. To make PRO a more potent tool, all stakeholders using PRO should confirm its definition and how it differs from QOL, have a unified recognition in each PRO use, and avoid miscommunication.

Sexual function using the EORTC QLQ-TC26 in testicular cancer survivors: A multi-institutional, cross-sectional study.

OBJECTIVE: To evaluate sexual function after treatment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 (EORTC QLQ-TC26) questionnaire in Japanese testicular cancer (TC) survivors in a multi-institutional, cross-sectional study. METHODS: This study enrolled TC survivors who visited any of eight high-volume institutions in Japan from 2018 to 2019. After obtaining informed consent, participants completed the EORTC QLQ-TC26 questionnaires. We evaluated sexual function after treatment for TC using the EORTC QLQ-TC26 and analyzed the impact of treatment on sexual function in TC survivors. RESULTS: A total of 567 TC survivors responded to the EORTC QLQ-TC26. Median age at the time of response was 43 years (interquartile range [IQR] 35-51 years), and median follow-up period after treatment was 5.2 years (IQR 2.2-10.0 years). Sexual function, particularly ejaculatory function, was significantly lower after post-chemotherapy retroperitoneal lymph node dissection (PC-RPLND) than after Surveillance or Chemotherapy groups (p < 0.05). In the PC-RPLND group, nerve-sparing procedure preserved postoperative ejaculatory function after RPLND compared with the non-nerve-sparing and offered improved ejaculatory function with time. On multivariate analysis, RPLND was a significant predictor of post-treatment ejaculatory dysfunction, particularly without nerve-sparing (odds ratio 3.0, 95% CI 1.2-7.7, p < 0.05). In addition, TC survivors with nerve-sparing RPLND had higher sexual activity than those without. CONCLUSION: This survey of the EORTC QLQ-TC26 showed that sexual function and activity in TC survivors after RPLND was reduced in the absence of nerve-sparing techniques.

Impact of diagnosis and treatment of uterine fibroids on quality of life and labor productivity: The Japanese online survey for uterine fibroids and quality of life (JOYFUL survey).

AIM: To investigate the impact of uterine fibroid diagnosis/treatment status on quality of life (QOL) and work productivity in women living in Japan. METHODS: Women aged 20-49 years who registered on Macromill were recruited via the opt-in method. They completed an online survey on demographic and uterine fibroid diagnosis/treatment status, 36-Item Short-Form Health Survey, Uterine Fibroid Symptom and Health-Related Quality of Life questionnaire (UFS-QOL), and World Health Organization Health and Work Performance Questionnaire. RESULTS: There were 4120 respondents: 1362 untreated, 249 with ongoing treatment, 449 with past treatment, 1030 with no uterine fibroids, and 1030 with unknown uterine fibroid status. A high proportion of women with ongoing treatment had moderate to severe uterine fibroid-like symptoms (symptom severity score of UFS-QOL ≥40 points), accompanied by reduced QOL. QOL was improved in women with past treatment. Uterine fibroids had a significant impact on physical and psychosocial aspects in the ongoing treatment group versus other groups. Using classification and regression tree analysis, anemia was identified as a plausible predictor of reduced QOL in the ongoing treatment group. Approximately 20% of women-even in groups other than the ongoing treatment group-experienced moderate to severe uterine fibroid-like symptoms. However, the diagnosis and treatment status of uterine fibroids had no clear impact on work productivity. CONCLUSIONS: Uterine fibroids, especially in association with anemia, were related to reduced QOL. Given that uterine fibroid-related reduced QOL is likely improved by appropriate treatment, women with uterine fibroid-like symptoms, such as menorrhagia, should be examined and treated.

Development of a Communication Tool between Patients and Physicians for Recognizing COPD Exacerbations in Japan.

In Japan, exacerbations are underreported compared with other countries, possibly due in part to a failure to recognize them. This study aimed to create a simple chronic obstructive pulmonary disease (COPD) Exacerbation Recognition Tool (CERT-J) specifically for Japanese patients. Patients ≥40 years with confirmed COPD or asthma-COPD overlap were included. Focus groups were held to identify words and phrases used by patients to describe symptoms associated with an exacerbation, resulting in candidate items being identified. Following cognitive debriefing, the items were refined based on item frequency, level of endorsement and effect of demographic factors. Exploratory factor analysis (EFA) was then performed to inform an expert panel's choice of items to form the new tool. A total of 41 patients were included in the focus groups and nine patients performed the cognitive debrief. Following this, the expert panel identified 26 items for testing in a further 100 patients (mean age 72 years, forced expiratory volume in 1 s 54.8% predicted and 1.8 exacerbations in the preceding 12 months). Eleven items were associated with breathlessness or activity limitation and seven of these were the most frequently endorsed. EFA identified four factors, with one (breathlessness) being dominant. The expert panel recommended that the CERT-J should include six items: breathlessness and activity limitation (3 items), cough (1 item) and phlegm (2 items). The final CERT-J should benefit patients with COPD by providing them with an increased understanding and recognition of exacerbations.Clinical Trial Registration: GSK K.K (jRCT1080224526).

Association between Low Forced Vital Capacity and High Pneumonia Mortality, and Impact of Muscle Power.

Impaired % predicted value forced vital capacity (% FVC) is related to higher all-cause mortality in aged adults, and strong muscle force may improve this relationship. A muscle disease, sarcopenia, causes higher mortality. We aimed to identify the unknown disease that relates impaired % FVC with higher mortality in aged adults among the three major leading causes of death, and the effect of strong leg force on this relationship. Cox proportional hazard model analyzed the longitudinal Tsurugaya cohort that registered 1048 aged Japanese for 11 years. The primary outcome was the relationship between % FVC and mortality by cancer, cardiovascular disease, or pneumonia. Exposure variables were % FVC or leg force divided by 80% or median values, respectively. The secondary outcome was the effects of leg force on the relationship. Among the diseases, % FVC < 80% was related only to higher pneumonia mortality (hazard ratio [HR], 4.09; 95% CI, 1.90-8.83) relative to the % FVC ≥ 80% group before adjustment. Adding the leg force as an explanatory variable reduced the HR to 3.34 (1.54-7.25). Weak leg force might indicate sarcopenia, and its prevention may improve higher pneumonia mortality risk related to impaired % FVC, which we may advise people in clinical settings.

How coaching training transforms nurses' behaviour: The effectiveness of coaching training according to objective measures.

AIM: To evaluate the transition of behavioural changes of participants before and after the training using a scale that can objectively evaluate coaching training for nurses. DESIGN: After a cross-sectional study, a quasi-experimental study was conducted. METHODS: We examined the reliability and validity of the Coaching Skill Assessment plus (CSAplus), which was developed to measure the effectiveness of coaching training for corporate leaders. Next, a repeated measures analysis of variance was conducted on two types of coaching training for nurses conducted at a university hospital, with the CSAplus scores of participants before, 1 month and 6 months after the training as the dependent variable. RESULTS: The CSAplus is a three-factor instrument with good reliability and validity. Participants' CSAplus scores improved after training, but there were differences in the magnitude and persistence of the training effects. PUBLIC CONTRIBUTION: Hospital staff, professional coaches and their clients were involved in data collection.

Nurturing Basic Societal Competencies in Speech-Language-Hearing Therapy Training Education: Effects of Coaching Classes.

INTRODUCTION: Nurturing "basic societal competencies" is important in the training education of speech-language-hearing therapists (SLHTs) to enable them to respond to fluctuating medical treatment scenarios. However, in the current training education for SLHTs, some students need assistance in terms of basic societal competencies, such as initiative, planning, and communication. In this study, the focus was on coaching theory, a method of interpersonal support through dialog, as a strategy for addressing the issues. The objective was to clarify whether coaching theory-based classes for SLHT students improve their basic societal competencies. METHODS: The participants were first- and third-year undergraduate SLHT students in Japan. The coaching and control groups comprised students enrolled in 2021 and 2020, respectively. The observation period for this prospective cohort study was from April to September 2020 and from April to September 2021. The coaching and control groups received 90-min coaching and remedial education classes, respectively, 11 times in 3 months. To establish students' knowledge and skills, follow-up sessions were conducted four times a month, and assignments were given during the subsequent summer vacation. The effects of the classes were based on Kirkpatrick's four-level evaluation model, with Levels 1, 2, 3, and 4 evaluating satisfaction with the class, learning proficiency, behavior modification, and result attainment, respectively. RESULTS: The coaching and control groups comprised 40 and 48 participants, respectively. In the evaluation of behavior modification (level 3) using the "PROG (progress report on generic skills) competency test (RIASEC Inc., Tokyo)," the interactions between time and group and the main effects of time were significant for the basic societal competencies of "relating with others" and "self-confidence." Multiple comparisons showed that the post-class scores were significantly higher than the pre-class scores in the coaching group (change of 0.9 for relating with others and 0.7 for self-confidence) and that the scores in the coaching group were significantly higher than those in the control group at the post-class. The interaction between time and group was significant for those "planning solutions," and the post-class score was significantly higher than the pre-class score in the coaching group (change of 0.8). CONCLUSION AND IMPLICATION: The coaching classes improved the students' basic societal competencies of relating with others, self-confidence, and planning solutions. This suggests that coaching classes are useful in the training education for SLHTs. Ultimately, nurturing students' basic societal competencies will develop human resources who could achieve quality clinical performance.

Neural and behavioral alterations of a real-time interpersonal distance (IPD) development process in differing social status interactions.

Background: Evidence showed neural changes in interpersonal distance (IPD) interaction, and neural activities are affected by relationships (such as friends or strangers). Behavior studies proved that social status strongly affects IPD between two persons. However, how the differing social status impacts neural alterations in the IPD interactions remains unknown. Objectives: The teacher-student relationship is a typical representation of the difference in social status. The present study aims to investigate the IPD performance and brain processes underlying real-time differing social status during the development process from teacher-student interactions. Materials and methods: We designed three within-subject experiments corresponding to the inclusion, control, and affection stages of IPD. Altogether, 38 valid healthy participants participated in three experiments with a teacher (differing social status condition, DS condition) and a peer student (peer social status condition, PS condition) separately. This study employed functional near-infrared spectroscopy (fNIRS) and modified real-time stop-distance paradigms to record IPD performance and neural processes. Results: For IPD performance, significantly larger IPD gaps were shown in the DS condition than in the PS condition, and IPD feedback affected IPD performance. For neural alterations, activated frontopolar area (FPA, BA10), dorsolateral prefrontal cortex (DLPFC, BA9/BA46), and Broca's area (BA45) were observed across the IPD stages. Importantly, brain activation shifts with the development of IPD. In addition, results showed that differences in Oxy-Hb changes were located in the FPA (BA10), DLPFC (BA9/BA46), and Broca's area (BA45) between the DS and PS conditions across IPD stages. Additionally, negative correlations were found between Oxy-Hb changes and IPD performance. Conclusion: We propose prefrontal cortex (PFC) and Broca's area involvement in IPD interactions, initially focusing on evaluation and action periods, and later on IPD-evaluation processes after feedback. In addition, a difference in Oxy-Hb activities implies the complexity of relationships and social status in IPD interactions.

High Mortality in an Older Japanese Population with Low Forced Vital Capacity and Gender-Dependent Potential Impact of Muscle Strength: Longitudinal Cohort Study.

Generally, weak muscle power is associated with high mortality. We aimed to evaluate the unknown association between % predicted value forced vital capacity (FVC% predicted) and mortality in asymptomatic older people, and the impact of muscle power on this association. We analyzed the Tsurugaya cohort that enrolled Japanese people aged ≥70 for 15 years with Cox proportional hazards model. Exposure variables were FVC% predicted and leg power. The outcome was all-cause mortality. The subjects were divided into quartiles by FVC% predicted or leg power, or into two groups by 80% for FVC% predicted or by the strongest 25% for leg power. Across 985 subjects, 262 died. The males with lower FVC% predicted exhibited higher mortality risks. The hazard ratio (HR) was 2.03 (95% CI 1.30−3.18) at the lowest relative to the highest groups. The addition of leg power reduced the HR to 1.78 (95% CI 1.12−2.80). In females, FVC% predicted under 80% was a risk factor and the HR was 1.67 (95% CI 1.05−2.64) without the effect of leg power. In FVC% predicted <80% males HRs were 2.44 (95% CI 1.48−4.02) in weak and 1.38 (95% CI 0.52−3.64) in strong leg power males, relative to ≥80% and strong leg power males. Low FVC% predicted was associated with high mortality with potential unfavorable effects of weak leg power in males.

Association of financial toxicity with quality of life in testicular cancer survivors.

OBJECTIVES: Most testicular cancer (TC) survivors have long-term survival. However, the association between financial toxicity (FT), which is an economic side effect of cancer treatment, and the quality of life (QOL) of TC survivors is still unclear. Thus, the impact of FT on the QOL of TC survivors was examined in a multi-institutional cross-sectional study. METHODS: We recruited TC survivors from eight high-volume institutions in Japan between January 2018 and March 2019. A total of 562 participants completed the EORTC QLQ-C30, EORTC QLQ-TC26 and the questionnaires on demographics, including annual income. Financial difficulty in the EORTC QLQ-C30 and low income were used to assess financial distress (FD) and financial burden (FB), respectively. FT was defined as FD and FB. The QOL scores were compared, and a multivariate logistic regression analysis for FT was performed. RESULTS: With severe FD, TC survivors had more treatment side effects, physical limitations, and anxiety concerning employment and future. The TC survivors who reported low income were worried about their jobs and the future. The QOL of the survivors with FT exhibited high impairment, except for sexual activity. In particular, the TC survivors with FT were physically limited and anxious concerning the future. The multivariate logistic regression analysis revealed that four or more chemotherapy cycles were substantial risk factors for FT (4 cycles, odds ratio (OR) = 4.17; ≥5 cycles, OR = 6.96). CONCLUSIONS: TC survivors who received multi-cycle chemotherapy were prone to experience FT, resulting in a decline in their health-related QOL.

Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study.

INTRODUCTION: Dysmenorrhea and endometriosis are common gynecologic disorders among women of reproductive age that significantly impact health-related quality of life (HRQL) as well as productivity. Although there are treatment options listed in Japanese guidelines, a gap remains in unmet medical needs for maximizing treatment outcome. The extended regimen of ethinylestradiol and drospirenone (EE/DRSP) (taken daily for up to 120 consecutive days) has been available in Japan for treating dysmenorrhea and/or endometriosis-associated pain since 2016. Yet, the effectiveness of its usage on HRQL has not been investigated elsewhere to date. Therefore, in this study, we aim to observe changes in HRQL of Japanese women treated with an extended regimen of EE/DRSP for dysmenorrhea and/or endometriosis-associated pain. METHODS: As part of a 2-year post-marketing surveillance study, women with dysmenorrhea or endometriosis-associated pelvic pain were prescribed extended EE/DRSP during routine clinical practice. Data were collected 1 month before and 3 and 6 months after initiating treatment. Primary outcomes were the Menstrual Distress Questionnaire (MDQ) (before, during, and after menstruation) in patients with dysmenorrhea, and the Endometriosis Impact Scale (EIS) and European Quality of Life 5-dimensions 5-level instrument (EQ-5D-5L) in patients with endometriosis. RESULTS: The study cohort included 315 patients (mean age 28.9 years) with dysmenorrhea and 262 patients (mean age 31.3 years) with endometriosis. Mean MDQ total scores before and during menstruation decreased significantly after 6 months with extended EE/DRSP; there was no improvement in after-menstruation MDQ score. Mean EIS domain scores improved significantly by 6 months, with improvement in most EIS individual item scores. Mean EQ-5D-5L scores increased slightly during 6 months of treatment. CONCLUSIONS: Extended EE/DRSP treatment improved HRQL outcomes in Japanese women with dysmenorrhea or endometriosis-associated pelvic pain. TRIAL REGISTRATION: Registered at ClinicalTrials.gov (NCT03126747) on June 2017.

Association Between Low Back Pain, Workaholism, and Work Engagement in Japanese Hospital Workers: A Quantitative Cross-sectional Study.

OBJECTIVE: This study aimed to examine the association between two types of heavy work investment, workaholism and work engagement, and low back pain prevalence. METHODS: We conducted a paper-based survey of Japanese hospital workers. The Dutch Workaholism Scale (DUWAS) and the Utrecht Work Engagement Scale (UWES) were used to classify the participants into four groups and perform multiple logistic regression analyses. RESULTS: Among 699 participants, the group with low DUWAS and high UWES at 37.1% had the lowest low back pain prevalence. In order, the groups with low DUWAS and UWES were at 51.7%; those with high DUWAS and UWES, 58.5%; and those with high DUWAS and low UWES, 62.4%, with multivariate-adjusted odds ratios of 1.77, 2.01, and 2.33, respectively. CONCLUSIONS: Low back pain prevalence among Japanese hospital workers was reduced by high levels of work engagement, even at high levels of workaholism.

Association of Personality with Cognitive Failure among Japanese Middle-Aged and Older Adults.

This study explored the associations between personality traits and cognitive failure (including minor lapses and prospective and retrospective memory failure) among middle-aged and older adults living in Japan. The participants were 373 adults, aged 40-84 (167 men and 206 women). The 15-item Japanese version of the Short Inventory of Minor Lapses was used to evaluate minor lapses, and the 16-item Japanese version of the Prospective and Retrospective Memory Questionnaire was used to assess prospective and retrospective memory failure. The participants' variables evaluated for their association with cognitive failure were gender, age, education, paid work, social network, chronic disease, sleep quality, and the Big Five personality traits (i.e., neuroticism, extraversion, openness, agreeableness, and conscientiousness). Multivariable regression analyses demonstrated that sleep quality (ß = -0.232), neuroticism (ß = 0.163), and conscientiousness (ß = -0.295) were related to minor lapses; age (ß = 0.152), sleep quality (ß = -0.168), and conscientiousness (ß = -0.290) were associated with prospective memory failure; and age (ß = 0.268), sleep quality (ß = -0.146), and conscientiousness (ß = -0.221) were associated with retrospective memory failure. These findings may facilitate the development of efficient strategies for the prevention of cognitive dysfunction and its adverse consequences for personal health.

Menstrual Symptoms, Health-Related Quality of Life, and Work Productivity in Japanese Women with Dysmenorrhea Receiving Different Treatments: Prospective Observational Study.

INTRODUCTION: Dysmenorrhea is a physical and mental burden for women, negatively affecting health-related quality of life (HRQL) and work productivity. However, data on HRQL and work productivity of Japanese women are scarce. METHODS: In this prospective observational study, 397 Japanese women received low-dose estrogen/progestin (LEP) or non-LEP treatment (non-steroidal anti-inflammatory drugs or Chinese herbal medicines) for primary/secondary dysmenorrhea and completed survey questionnaires online regarding menstrual symptoms, HRQL, and work productivity. Regression analysis was performed to compare the groups and evaluate outcomes over time using the paired t test. Subgroup analysis was performed using stratification by patient background, and correlations between improvement in menstrual symptoms/HRQL and work productivity were investigated using Spearman's rank correlation coefficient. RESULTS: Significant reductions in the modified Menstrual Distress Questionnaire (mMDQ) total score were shown in the LEP group (n = 251) (P < 0.01), but not the non-LEP group (n = 146). Significant improvements in HRQL, measured by the 36-Item Short-Form Health Survey v2.0 (SF-36v2.0), were shown in the LEP group, but not the non-LEP group. Improvements were seen in mental component summary and 7/8 domains (role physical, bodily pain, general health, role emotional, mental health, vitality, and social functioning) in the LEP group, but not the non-LEP group. There were no differences in the physical component summary and role functioning in either group. Improvements in work productivity, measured by the modified Work Productivity and Activity Impairment Questionnaire (mWPAI), were greater in the LEP group vs. non-LEP group. Regression analysis showed differences in improvements between the groups in the mMDQ total score, SF-36v2.0, and mWPAI. A correlation between mMDQ or HRQL and work productivity was seen. CONCLUSION: In Japanese women, dysmenorrhea is associated with reduced HRQL and work productivity. In real-world clinical practice, improvements in physical and mental menstrual symptoms, HRQL, and work productivity were observed with LEP treatment. TRIAL REGISTRATION: NCT04607382 (ClinicalTrials.gov).

Two types of sensorimotor strategies for whole-body movement in individuals with stroke: a pilot study.

PURPOSE: This study compared the sensory-motor interactions and strategies for whole-body movement in individuals with stroke who had damaged motor system area or sensory system area in the brain. METHODS: Participants with hemiparesis were asked to perform sit-to-stand movements while their vision was restricted, which can affect completion of the task. The participants were divided into two groups. The first group had no history of lesions in the sensory system area but did have a history of lesions in the motor system area (no damaged sensory-system: NDS). The second group had a history of lesions in the sensory system area of the brain (damaged sensory-system: DS). Center-of-pressure (COP) trajectories were measured to evaluate balance control in participants with and without vision, and numbers of sub-movements (i.e. numbers of segmented movements which reflect the degree of use of the feedback loops) were measured to evaluate feedforward and feedback control. Movement times were also measured. RESULTS: When vision was restricted, NDS participants showed increased variability in mediolateral COP trajectories during movement and utilized mainly feedforward control. In contrast, DS participants showed reduced variability in mediolateral COP trajectories during movement and utilized additional feedback control. CONCLUSIONS: These results demonstrate two types of strategies for whole-body movements in individuals with stroke. These differences may be attributed to whether the individual can compensate for vision with somatic senses and whether appropriate processing of somatosensory information has been lost. Individuals with hemiparesis created dexterous and flexible strategies to execute tasks successfully, depending on the characteristics of their sensorimotor disorders.

Fertility and reproductive technology use in testicular cancer survivors in Japan: A multi-institutional, cross-sectional study.

OBJECTIVE: To evaluate fertility and use of reproductive technology of testicular cancer survivors in a multi-institutional, cross-sectional study. METHODS: This study recruited testicular cancer survivors who were followed after treatment for testicular cancer at eight high-volume institutions between 2018 and 2019. The participants completed the questionnaires on marital status, fertility and use of reproductive technology. RESULTS: A total of 567 testicular cancer survivors, with a median age of 43 years, responded to the questionnaire. Chemotherapy was given to 398 survivors, including three cycles of cisplatin-based chemotherapy in 106 patients and four cycles in 147 patients. Among 153 survivors who attempted sperm cryopreservation, 133 (87%) could preserve sperm. Of the 28 survivors whose cryopreserved sperm was used, 17 (61%) fathered children. Of the 72 survivors who fathered children without the use of cryopreserved sperm, 59 (82%) fathered naturally. Whereas 33 (20%) of 169 survivors treated without chemotherapy fathered children without using cryopreserved sperm, 39 (10%) of 398 treated with chemotherapy fathered children (P < 0.05). Furthermore, the paternity rate was 12% and 5% in testicular cancer survivors with three and four cycles of cisplatin-based chemotherapy, respectively (P < 0.05). However, of 121 survivors who wanted to have children, 14 (12%) received counseling about infertility treatment. CONCLUSIONS: Testicular cancer survivors preserving their sperm have a higher paternity rate after chemotherapy, especially after four cycles, than those not using cryopreserved sperm. Physicians who give chemotherapy for testicular cancer need to take particular care not only with respect to recurrence of testicular cancer, but also to post-treatment fertility.

Impact of low luminance conditions on quality of life for the visually impaired: development of the Low Luminance Questionnaire Japanese version.

PURPOSE: This study aimed to develop a Japanese version of the Low Luminance Questionnaire (LLQ-J) and to evaluate its reliability and validity. STUDY DESIGN: Cross-sectional study. METHODS: LLQ-J was developed by standardized methods. A total of 101 patients comprising 55 with age-related macular degeneration, 25 with glaucoma, 15 with regressed proliferative diabetic retinopathy, and 6 with retinitis pigmentosa were included in this study. The patients completed the LLQ-J and Japanese version of the visual function Questionnaire-25 (VFQ-25). Using the LLQ-J data, floor and ceiling effects were computed. To examine internal consistency, some patients completed the LLQ-J a second time 2-4 weeks later and the data were analyzed for Cronbach's alpha and intra-class correlation coefficients (ICCs). Best-corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) were measured, and low-luminance deficit (LLD) was calculated. Criterion validity was also tested. RESULTS: No ceiling or floor effects were present in the LLQ-J data. Cronbach's alfa was 0.88, and ICCs were higher than 0.70 for all subscales. Moderate to high correlation was observed between LLQ-J and VFQ-25 (p < 0.01), confirming concurrent validity. "General dim lighting" and "Peripheral vision" were significantly associated with LLVA in the better eye (p < 0.05). "Mobility", "General dim lighting" and "Peripheral vision" were significantly associated with LLD (p < 0.05). "Emotional distress" was significantly associated with BCVA in the worse eye (p < 0.05). No subscales were associated with BCVA of the better eye. CONCLUSIONS: The LLQ-J is a valid and reliable questionnaire for assessing QOL under low luminance conditions.