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.

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.

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.

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.

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).

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.

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.

Respiratory Muscle Weakness as a Risk Factor for Pneumonia in Older People.

INTRODUCTION: The respiratory muscle strength regulates the effectiveness of coughing, which clears the airways and protects people from pneumonia. Sarcopenia is an aging-related loss of muscle mass and function, the worsening of which is associated with malnutrition. The loss of respiratory and swallowing muscle strength occurs with aging, but its effect on pneumonia is unclear. This study aimed to determine the risks of respiratory muscle weakness on the onset and relapse of pneumonia in older people in conjunction with other muscle-related factors such as malnutrition. METHODS: We conducted a longitudinal study with 47 pneumonia inpatients and 35 non-pneumonia controls aged 70 years and older. We evaluated the strength of respiratory and swallowing muscles, muscle mass, and malnutrition (assessed by serum albumin levels and somatic fat) during admission and confirmed pneumonia relapse within 6 months. The maximal inspiratory and expiratory pressures determined the respiratory muscle strength. Swallowing muscle strength was evaluated by tongue pressure. Bioelectrical impedance analysis was used to evaluate the muscle and fat mass. RESULTS: The respiratory muscle strength, body trunk muscle mass, serum albumin level, somatic fat mass, and tongue pressure were significantly lower in pneumonia patients than in controls. Risk factors for the onset of pneumonia were low inspiratory respiratory muscle strength (odds ratio [OR], 6.85; 95% confidence interval [CI], 1.56-30.11), low body trunk muscle mass divided by height2 (OR, 6.86; 95% CI, 1.49-31.65), and low serum albumin level (OR, 5.46; 95% CI, 1.51-19.79). For the relapse of pneumonia, low somatic fat mass divided by height2 was a risk factor (OR, 20.10; 95% CI, 2.10-192.42). DISCUSSION/CONCLUSIONS: Respiratory muscle weakness, lower body trunk muscle mass, and malnutrition were risk factors for the onset of pneumonia in older people. For the relapse of pneumonia, malnutrition was a risk factor.

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.

Validation study of the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 for patients with testicular cancer.

OBJECTIVE: To validate the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 in Japanese-speaking testicular cancer survivors. METHODS: A total of 200 testicular cancer survivors were recruited at eight high-volume institutions in Japan. The participants completed the Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 and the International Index of Erectile Function 15 questionnaires. A total of 40 participants completed a retest of the questionnaires 2 weeks after the first response. The psychometric properties of the Japanese version including test-retest reliability, internal consistency and concurrent validity were evaluated. RESULTS: The mean age at response was 43 years (range 22-74 years), and the mean period after treatment was 77 months (range 0-416 months). The response rate for each item, except sexual function, was high, and the percentage of missing values was less than 3.5%. For test-retest reliability, seven of 12 scales met the criteria (intraclass correlation 0.70-0.86). For internal consistency, four of seven scales met the criteria (Cronbach's alpha 0.62-0.91). For concurrent validity, treatment side effects of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 were related to some domains of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. The sex-related subscales of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 were moderately correlated with some International Index of Erectile Function 15 domains. CONCLUSIONS: The psychometric properties of the Japanese version are equivalent to the properties of the original European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26. The Japanese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Testicular Cancer 26 questionnaire is a useful tool to assess the health-related quality of life of testicular cancer patients.

Response Shift-Adjusted Treatment Effect on Health-Related Quality of Life in a Randomized Controlled Trial of Taxane Versus S-1 for Metastatic Breast Cancer: Structural Equation Modeling.

OBJECTIVE: We investigated the quantification of the response shift-adjusted treatment effect on quality-of-life (QOL) data in a randomized controlled trial of taxane versus S-1 for patients with metastatic breast cancer (SELECT-BC). METHODS: This study was a secondary data analysis of a previously published trial. The response shift-adjusted treatment effect on health-related QOL (HRQOL) data measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was estimated using structural equation modeling techniques in addition to quantifying the "true" treatment effect. Measurement invariances in the values of the common factor loadings, intercepts, and residual variances between before treatment and at the 3-, 6-, and 12-month visits were considered the response shift effects. RESULTS: In the taxane group, we observed positive recalibration effects for role functioning and positive reprioritization and negative recalibration effects for emotional functioning. The observed change of -4.56 for role functioning comprised +2.26 response shifts and -6.82 "true" change. The observed change of +9.41 for emotional functioning comprised +12.43 response shifts and -1.17 "true" change. In the S-1 group, we observed positive reprioritization and negative recalibration effects for emotional functioning and positive reprioritization effects for social functioning. The observed change of +10.54 for emotional functioning comprised +10.07 response shifts and +0.47 "true" change. The observed change of +2.43 for social functioning comprised +3.50 response shifts and -1.07 "true" change. CONCLUSION: Detailed analysis of the response shift effects will improve the evaluation reliability of observed HRQOL data during clinical trials.

Selection process for botulinum toxin injections in patients with chronic-stage hemiplegic stroke: a qualitative study.

BACKGROUND: Botulinum toxin (BT) injection is a new treatment for spasticity with hemiplegia after stroke. How a patient decides to receive BT injections after becoming aware of the treatment remains unclear. In this exploratory qualitative study, we aimed to investigate patients' decision-making about treatment strategies in collaboration with family and health professionals and to identify conflicts in patients' feelings about BT treatment. METHODS: The study included six patients with stroke sequelae. Data were collected using comprehensive interviews and were analyzed using the grounded theory approach and trajectory equifinality modeling. RESULTS: After patients learned about BT treatment, they clearly exhibited the following two concurrent perceptions: "the restriction of one's life due to disabilities" and "the ability to do certain things despite one's disabilities." Some patients reported a "fear of not being able to maintain the status quo owing to the side effects of BT." To alleviate this fear, timely support from family members was offered, and patients overcame anxiety through creative thinking. However, there were also expressions that revealed patients' difficulties dealing with negative events. These factors influenced the patients' development of "expectations of BT" or "hesitations about BT." CONCLUSIONS: To establish treatment strategies in collaboration with patients, healthcare professionals should show supportive attitudes and have discussions with patients and their family members to help patients resolve their conflicts and should establish treatment strategies that maintain the positive aspects of patients' lives.

Effects of occupational status on social adjustment after laryngectomy in patients with laryngeal and hypopharyngeal cancer.

PURPOSE: This study was performed to examine the relationship of social adjustment with occupation and life changes in patients with laryngeal and hypopharyngeal cancer, from before laryngectomy to 1 year after hospital discharge. METHODS: The subjects were 27 patients with laryngeal and hypopharyngeal cancer who were admitted to hospital for laryngectomy and provided informed consent for participation in the study. The patients answered questionnaire surveys before surgery, and 3, 6, and 12 months after hospital discharge. Regarding social adjustment, social functioning (SF) and mental health (MH) in SF-36V2 were used as dependent variables, and time, occupation status, age, family structure, and sex as independent variables. Repeated measures analysis of variance was used to examine the main effect, and second- and third-order interactions were also examined. RESULTS: The age of the subjects was 62.9 ± 6.4 years and about 30% had an occupation. Loss of voice was the reason for 30% leaving work. In an examination of the main effects of the four variables, only age was significant regarding SF, and SF was favorable in subjects aged ≥ 64 years old. Regarding MH, age and family structure were significant, and MH was higher in older subjects who lived alone. The interaction between time and the other 3 variables was not significant. Only time/age/occupation was significant for MH. Regarding SF, a weak interaction was suggested, but it was not significant. CONCLUSION: Older subjects showed better social adjustment, and those who lived alone had better MH. These findings may have been due to a reduced environmental influence. MH of subjects with an occupation decreased more at 3 months or later after hospital discharge, compared to those without an occupation. Especially for younger patients, development of new approaches is required to allow families and colleagues of patients to understand the difficulties of patients with laryngeal and hypopharyngeal cancer.

[Psychometric properties of the diet-related quality of life (DRQOL) scale and its short version among older adults].

Objectives　The purpose of this study was to examine the psychometric properties of the diet-related quality of life (DRQOL) scale among older adults. Specifically, the study was conducted to confirm the scale's factor structure and construct a short version of the scale. Further, the scale's internal consistency and gender- and age-based differences as well as the validity of the DRQOL scale and its short version were examined.Methods　We surveyed a random sample of community-dwelling older Japanese adults (aged 60-84 years; N=1,200; response rate: 70.8%) and used the data of 780 participants (367 men and 413 women). We used the DRQOL scale, comprising 18 items that were measured using a five-point Likert-type scale. Additionally, we assessed subjective well-being, diet satisfaction, appetite, meal restriction, mastication, number of meals with others, frequency of using ready-made and instant food, information gathering regarding food, and dietary variety scores as external criterion variables; socioeconomic status and health habits were used to describe basic participant characteristics.Results　Confirmatory factor analysis revealed a replication of the four-factor structure of the measure ("pleasure from a meal," "eating satisfaction," "circumstances of meal," and "diet diversity"). A short version of the measure comprising 8 items was developed. The DRQOL scale, its subscales, and its short version had high Cronbach's alpha coefficients as indicators of reliability (0.94; 0.86, 0.89, 0.77, and 0.72; and 0.90, respectively). There were significant sex differences in the scores of all constructs, and no significant age-based differences. The DRQOL scale scores had weak-to-moderate correlations with the external criterion variables mentioned above.Conclusion　Overall, this study confirmed the psychometric properties of the DRQOL scale, including factor structure, reliability, gender and age differences, and its validity among older adults using data from the general population in Japan. In addition, a short version of the DRQOL scale was developed. Future studies should examine the factors associated with the DRQOL. The predictive validity of the scale, with health outcomes as external criteria, should be examined to test its usefulness for epidemiological surveys among older adults in community settings.

[Development of a leisure activity scale for contemporary older adults: Examination of its association with cognitive function].

Objectives　Leisure activities are important for older adults, not only to maintain their subjective well-being but also to prevent bedridden states. This study aimed to develop a leisure activity scale for contemporary older adults and examine its psychometric properties, based on a previous study from Iwasa et al. (2018). As people who actively engage in leisure activities are reportedly less likely to experience cognitive decline, the relationship between the scale score and cognitive function should be assessed while developing the scale. Specifically, the study was conducted to examine the reliability of the scale and its factor structure, confirm basic statistical characteristics, examine the scale's gender- and age-based differences, and the relationship between the scale score and cognitive function.Methods　We surveyed Japanese older adults living in a community (aged 70-84 years; N=594) and used data from 306 participants (151 men and 155 women). We developed and administered a scale comprising 11 items that were measured using a 4-point Likert-type scale. Additionally, we used cognitive function scales including the Mini-Mental State Examination (MMSE), the Memory Impairment Screen (MIS), and the Word Fluency Test. Covariates in tests for independent associations between the leisure activity scale score and cognitive function were socioeconomic status, chronic disease, functional capacity, and living alone. We conducted two web surveys with two-week intervals for test-retest reliability purposes and used data from 192 of those participants (aged 70-79 years; 101 men and 91 women).Results　A confirmatory factor analysis upheld the fact that the scale was comprised of one factor. The scale obtained high indicators of reliability: Cronbach's alpha coefficient (0.81) and test-retest reliability (0.81). The mean, standard deviation, median, skewness, and kurtosis of the scale score were 14.44, 7.13, 15, -0.12, and -0.73, respectively. The analysis of variance for the scale score indicated significant age-based differences (i.e., the score for those who were 70-74 years old was higher than for those who were 80-84 years old) and no significant gender differences. Multiple regression analyses demonstrated that the scale score was significantly and independently correlated with MMSE (ß=0.31), MIS (ß=0.24), and word fluency (ß=0.25).Conclusion　This study confirmed the psychometric properties of the leisure activity scale, including factor structure, reliability, basic statistical characteristics, no gender differences, significant age-based differences, and relationship to cognitive function. Future studies should examine the longitudinal relationship between the leisure activity scale score and cognition among older adults in community settings.

Social support and substitute voice acquisition on psychological adjustment among patients after laryngectomy.

The objective is to clarify whether social support and acquisition of alternative voice enhance the psychological adjustment of laryngectomized patients and which part of the psychological adjustment structure would be influenced by social support. We contacted 1445 patients enrolled in a patient association using mail surveys and 679 patients agreed to participate in the study. The survey items included age, sex, occupation, post-surgery duration, communication method, psychological adjustment (by the Nottingham Adjustment Scale Japanese Laryngectomy Version: NAS-J-L), and the formal support (by Hospital Patient Satisfaction Questionnaire-25: HPSQ-25). Social support and communication methods were added to the three-tier structural model of psychological adjustment shown in our previous study, and a covariance structure analysis was conducted. Formal/informal supports and acquisition of alternative voice influence only the "recognition of oneself as voluntary agent", the first tier of the three-tier structure of psychological adjustment. The results suggest that social support and acquisition of alternative voice may enhance the recognition of oneself as voluntary agent and promote the psychological adjustment.

Parallel processing of cognitive and physical demands in left and right prefrontal cortices during smartphone use while walking.

BACKGROUND: Smartphone use while walking is becoming a public concern owing to an increased risk of falling that can result from cognitive-motor interference. We evaluated prefrontal cortex (PFC) activity in participants playing a smartphone game while walking, in order to elucidate the role of the PFC in the allocation of attention between physical and cognitive demands. Sixteen young and 15 older adults participated in this study. Participants were instructed to perform a touch number-selecting game on a smartphone while walking. The numbers of correct and mistake responses were analyzed as a measure of cognitive performance. Linear trunk accelerations were measured by another smartphone and analyzed for step time and acceleration magnitude as an assay of gait performance. PFC activity during the task was measured using a wearable 16-channel near-infrared spectroscopy system. RESULTS: Smartphone game playing while walking decreased the cognitive and gait performances compared with performances of single-task condition in older group more than in young group. There was no difference in PFC activation during smartphone use while walking between young and older groups, but age appeared to mediate correlation magnitude between PFC activation and changes in performance. In young adults, multiple regression analysis revealed an association of the right PFC with a reduction in acceleration magnitude (ß = 0.581, p = 0.023), and an association of the left PFC with an increase in game-playing mistakes (ß = -0.556, p = 0.032) during smartphone use while walking. In older adults, multiple regression analysis revealed an association of the middle PFC with a prolongation of step time (ß = -0.550, p = 0.042) and of the left PFC with a reduction in acceleration magnitude (ß = -0.648, p = 0.012). CONCLUSION: In young adults, the left PFC inhibited inappropriate action and the right PFC stabilized gait performance. In older adults, a less-lateralized PFC activity pattern suppressed the deterioration of gait performance, but this resulted in impairment on a simultaneous cognitive task. These results suggest that lateralization of motor and cognitive tasks aids in efficient task completion during a complex action such as using a smartphone while walking.

[Patient-reported Outcomes after Laser In Situ Keratomileusis Surgery].

PURPOSE: To evaluate patient-reported quality of vision before and after laser in situ keratomileusis (LASIK) surgery. SUBJECTS AND METHODS: This study involved 140 patients who underwent LASIK surgery at Baptist Eye Clinic, Kyoto, Japan. Each patient was asked to respond to the Refractive Status and Vision Profile (RSVP) questionnaire prior to surgery and at 6-months and 5.5-years postoperative. In each patient, we defined the eye with better uncorrected visual acuity (VA) or with less refractive error as the better eye, and the other eye as the worse eye. RESULTS: Even in the worse eyes, the percentage of eyes with an uncorrected VA of decimal 0.5 or greater was 93.5% at 6-months and 88.6% at 5.5-ears postoperative. The mean preoperative total RSVP score was 37.1, yet that score significantly improved at 6-months postoperative (p< 0 .001) and remained the same throughout the 5.5-year follow-up period. CCONCLUSION The patient-reported quality of vi-ion post LASIK surgery was improved and remained improved throughout the 5.5-year follow-up period.

Characteristics and clinical relevance of postgastrectomy syndrome assessment scale (PGSAS)-45: newly developed integrated questionnaires for assessment of living status and quality of life in postgastrectomy patients.

BACKGROUND: Lack of a suitable instrument to comprehensively assess symptoms, living status, and quality of life in postgastrectomy patients prompted the authors to develop postgastrectomy syndrome assessment scale (PGSAS)-45. METHODS: PGSAS-45 consists of 45 items in total: 8 items from SF-8, 15 items from GSRS, and an additional 22 items selected by 47 gastric surgeons. Using the PGSAS-45, a multi-institutional survey was conducted to determine the prevalence of postgastrectomy syndrome and its impact on everyday life among patients who underwent various types of gastrectomy. Eligible data were obtained from 2,368 patients operated and followed at 52 institutions in Japan. Of these, data from 1,777 patients were used in the current study in which symptom subscales of the PGSAS-45 were determined. We also considered the characteristics of the postgastrectomy syndrome and to what extent these symptoms influence patients' living status and quality of life (QOL). RESULTS: By factor analysis, 23 symptom-related items of PGSAS-45 were successfully clustered into seven symptom subscales that represent esophageal reflux, abdominal pain, meal-related distress, indigestion, diarrhea, constipation, and dumping. These seven symptom subscales and two other subscales measuring quality of ingestion and dissatisfaction for daily life, respectively, had good internal consistency in terms of Cronbach's α (0.65-0.88). CONCLUSION: PGSAS-45 provides a valid and reliable integrated index for evaluation of symptoms, living status, and QOL in gastrectomized patients.

Relationship of type of work with health-related quality of life.

PURPOSE: To examine the relation of work type with health-related quality of life (HRQoL) in healthy workers. METHODS: We cross-sectionally examined 4427 (3605 men and 822 women) healthy workers in Japan, aged 19-69 years. We assessed HRQoL based on scores for five scales of the SF-36. Multiple regression was applied to examine the relation of work type (nighttime, shift, day to night, and daytime) with the five HRQoL norm-based scores, lower scores of which indicate poorer health status, adjusted for confounding factors, including sleeping duration. RESULTS: Shiftwork was inversely related to role physical [regression estimate (ß) = -2.12, 95 % confidence intervals (CI) -2.94, -1.30, P < 0.001], general health (ß = -1.37, 95 % CI -2.01, -0.72, P < 0.001), role emotional (ß = -1.24, 95% CI -1.98, -0.50, P < 0.001), and mental health (ß = -1.31, 95% CI -2.01, -0.63, P < 0.001) independent of confounding factors, but not to vitality. Day-to-nighttime work was inversely related to all the five HRQoL subscales (Ps 0.012 to <0.001). CONCLUSION: Shiftwork was significantly inversely related to four out of the five HRQoL, except for vitality, and day-to-nighttime work was significantly inversely related to all five HRQoL, independent of demographic and lifestyle factors.