Impact of treatment of hyperkalaemia on quality of life: design of a prospective observational cohort study of long-term management of hyperkalaemia in patients with chronic kidney disease or chronic heart failure in Japan.

INTRODUCTION: Hyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical adverse outcomes and to enable treatment with disease-modifying therapies including renin-angiotensin-aldosterone system inhibitors. However, the experiences of patients undergoing treatment of HK are not clearly understood. Optimising treatment decisions and improving long-term patient management requires a better understanding of patients' quality of life (QOL). Thus, the aims of this research are: (1) to describe treatment patterns and the impact of treatment on a patient's QOL, (2) to study the relationships between treatment patterns and the impact of treatment on a patient's QOL and (3) to study the relationships between the control of serum potassium (S-K) and the impact of treatment on a patient's QOL, in patients with HK. METHODS AND ANALYSIS: This is a prospective cohort study with 6 months of follow-up in 30-40 outpatient nephrology and cardiology clinics in Japan. The participants will be 350 patients with CKD or CHF who received their first potassium binders (PB) prescription to treat HK within the previous 6 months. Medical records will be used to obtain information on S-K, on treatment of HK with PBs and with diet, and on the patients' characteristics. To assess the impact of treatment on a patient's QOL, questionnaires will be used to obtain generic health-related QOL, CKD-specific and CHF-specific QOL, and PB-specific QOL. Multivariable regression models will be used to quantify how treatment patterns and S-K control are related to the impact of treatment on a patient's QOL. ETHICS AND DISSEMINATION: Institutional review boards at all participating facilities review the study protocol. Patient consent will be obtained. The results will be published in international journals. TRIAL REGISTRATION NUMBER: NCT05297409.

Translation and Validation Testing of the Constipation-Related Quality of Life Scale for Use in Japan.

Introduction Establishing a scale that can easily be used to appropriately measure the impact of constipation on the quality of life in Japan is a first step toward addressing this important health issue. We developed a Japanese language version of the Constipation-Related Quality of Life scale, which has 18 items and four subscales, and then subjected it to validation testing. Methods After translation according to a standardized and commonly used procedure, the Japanese version of the Constipation-Related Quality of Life scale was administered to people in an internet-based panel, in March 2023. The participants included 1,276 adults who had constipation (median age: 60 years, 690 {54.1%} males). The outcome measures included the Constipation-Related Quality of Life scale, the Constipation Scoring System (an index of constipation severity), and the Medical Outcomes Study (MOS) eight-item short form (a measure of generic health-related quality of life). Results Confirmatory factor analysis (four-factor model) indicated that all 18 Constipation-Related Quality of Life items had sufficiently high factor loadings (0.686-0.926). Internal consistency reliability was high (Cronbach's alpha: 0.86-0.94). Scores on the social impairment subscale and on the distress subscale of the Constipation-Related Quality of Life scale were significantly worse in the participants who had worse scores on the social functioning and mental health domains, respectively, of the MOS eight-item short form, which indicates good concurrent validity. Regarding criterion-based validity, the four subscale scores differed significantly among the four constipation-severity groups. The four subscale scores were also 1.16-4.53 times more sensitive than the MOS eight-item short form's mental component score to differences among the four constipation-severity groups (relative validity: 1.16-4.53), which indicates good discriminant validity. Conclusion The Japanese version of the Constipation-Related Quality of Life scale can be used with confidence in its factor structure, its concurrent, criterion-based, and discriminant validity, and its internal consistency reliability.

Development and Initial Psychometric Validation of the COVID-19 Pandemic Burden Index for Healthcare Workers.

BACKGROUND: The burden of COVID-19 on healthcare workers (HCWs) is reported to be increasing, yet the psychometric scales now in use evaluate only single aspects; few measure the pandemic-specific burden on HCWs comprehensively. OBJECTIVE: To develop a scale to quantify the physical, mental, and socioeconomic burden of the COVID-19 pandemic on HCWs. DESIGN: Scale development and cross-sectional survey. PARTICIPANTS: Consenting HCWs aged ≥20. MAIN MEASURES: Development of an item-list based on literature reviews and HCW panel input, evaluation of content validity and item selection using the Delphi method, psychometric testing conducted on HCWs, validity assessment by factor analyses and hypothesis verification, internal consistency evaluation by Cronbach's alpha, test-retest analysis, and interpretability assessment. KEY RESULTS: Through the Delphi process, a 29-item pilot scale was generated. In psychometric testing, data from 863 HCWs contributed to the development of the final version of this scale, called Pandemic Burden Index twenty for HCWs (PBI-20), a 20-item scale to measure six domains: fatigue, fear of infection, inadequacy as a medical professional, mental health concerns, prejudice or discrimination, and anxiety about one's livelihood and daily life. Factor analysis showed each factor corresponded to the six domains of this scale. Hypothesis verification showed the PBI-20 total score to be moderately to highly correlated with the Short Form 36 vitality score and mental health score and with intention of turnover. The PBI-20 had good internal consistency (Cronbach's alpha 0.92). Test-retest analysis showed the intraclass correlation coefficient to be 0.70 and the minimal important change to be -7.0. CONCLUSIONS: The psychometrically sound questionnaire we developed to measure pandemic-specific burdens for HCWs provides an understanding of comprehensive burdens on HCWs and may serve to evaluate interventions to reduce the burdens.

Validation of a new instrument for measuring disease-specific quality of life: A pilot study among patients with chronic kidney disease and hyperkalemia.

BACKGROUND: To prepare for a longitudinal study of the effects of potassium-lowering treatment on quality of life (QOL), we quantified the validity of a new disease-specific instrument for measuring QOL, using data from patients who had hyperkalemia (HK) due to chronic kidney disease (CKD) or chronic heart failure, and were also being treated with potassium binders (PBs). METHODS: In this cross-sectional study, the participants were 98 patients at five outpatient clinics in Japan. The outcome measures were the Medical Outcomes Study 36-item short-form (SF-36), a widely used generic measure of QOL, and the Quality of Life Disease-specific Impact Scale (QDIS-7), a recently-developed disease-specific measure of QOL. Internal-consistency reliability was quantified, and factor analysis was done to confirm hypothesized QOL dimensions. Validation tests used two external criteria: CKD stage, and PB formulation. PB formulation was used because different formulations are associated with different degrees of patients' burden. Using a previously-described method, we computed the relative validity (RV) of the two measures. RESULTS: Two factor scoring of the SF-36 and one factor scoring of the QDIS-7, as standardized from previous studies, were confirmed. The RVs showed that the QDIS-7 was much more valid than the SF-36, for discriminating between groups defined clinically (by CKD stage), and also between groups defined by PB formulation. Reliability was satisfactory: 0.73-0.95 for the SF-36 and 0.86 for the QDIS-7. CONCLUSIONS: The QDIS-7 with CKD or PB attributions was more valid than the SF-36 for measuring the effects of CKD and of PB formulation on QOL.

Association of Patients' Past Misdiagnosis Experiences with Trust in Their Current Physician Among Japanese Adults.

BACKGROUND: Previous qualitative research has described that previous misdiagnoses may reduce patient and their families' trust in healthcare. OBJECTIVE: To quantify the associations between patients or family members' misdiagnosis experiences and trust in their physician. DESIGN: Cross-sectional study. PARTICIPANTS: Adult Japanese people with non-communicable diseases (cancer, diabetes, depression, heart disease, and connective tissue disease), recruited using a web-based panel survey. MAIN MEASURES: Surveys assessed the patient and the patient's family's experience with misdiagnosis. Trust in the respondent's current physician was measured using the Japanese version of the 11-item Trust in Physician Scale. KEY RESULTS: Among 661 patients (response rate 30.1%), 23.2% had a personal history of misdiagnosis and 20.4% had a family history of misdiagnosis. In a multivariable-adjusted general linear model, patients or a family members' misdiagnosis experiences were associated with lower confidence in their current physician (mean difference -4.3, 95%CI -8.1 to -0.49 and -3.2, 95%CI -6.3 to -0.05, respectively). The impact of having a personal and a family member's experience of misdiagnosis on trust was additive, with no evidence of interaction (P for interaction = 0.494). CONCLUSIONS: The patient's or family members' misdiagnosis experiences reduced trust in the patient's current physicians. Interventions specifically targeting misdiagnosed patients are needed to restore trust.

Experiences of patients with cancer at health care facilities in Japan: results from a nationwide survey.

BACKGROUND: To elucidate the experience of patients with cancer from diagnosis to early survivorship in Japan using a nationwide questionnaire survey, and to inform the current progress of the cancer control programs. METHODS: The survey was sent to a representative sample of adult patients with cancer identified from the national database of hospital-based cancer registries. The patients' responses were compared across three groups: patients with rare cancers, patients aged < 40 years, and patients with non-rare cancers aged ≥40 years. RESULTS: Of 20,488 patients invited to participate in the survey, 8935 (43.6%) responded. Respondents reported an average score of 7.9 out of 10 on global ratings of care. Patients with rare cancers experienced a longer time to diagnosis but the shortest time from diagnosis to first treatment (p < 0.05). Patients aged < 40 years rated worse for the majority of the survey items, especially on items that related to communication with medical staff and items referring to early survivorship. CONCLUSION: The care experienced by patients with cancer in Japan varies on the basis of age group and cancer type. Efforts should be directed to ensuring prompt access to diagnostic facilities for patients with rare cancers and providing sufficient support to younger patients.

The impact that family members' health care experiences have on patients' trust in physicians.

BACKGROUND: A family member's negative experiences with medical care have long-term effects on a patient's attitudes and emotions. However, the impact of family members' experiences on patients' trust in their own physicians and in physicians generally is poorly understood. This study aims to quantify these associations. METHODS: A cross-sectional online survey involving adults with non-communicable diseases (cardiac disease, diabetes, cancer, depression, and rheumatic disease) was conducted in Japan during April 2020. The main exposure variable was dissatisfaction with the medical care that family members had received. The main outcomes were patients' (N = 661) own trust in their personal physicians and in physicians generally. The study adopted the Japanese version of the Abbreviated Wake Forest Physician Trust Scales. Both 5-item scales (general and individual physician trust) were translated and validated for the study. The total scores were transformed into a scale of 0-100 points. A series of linear mixed-effects models with consideration for clustering effect by prefectures were fit. RESULTS: The results showed a lower rating for trust in physicians generally as compared to trust in the respondent's personal physician (mean 57.0 vs. 66.4 points; p < 0.001). Furthermore, dissatisfaction with a family member's medical care was associated with lower trust in physicians generally (mean difference - 9.58, 95 %CI -12.4 to -6.76). Interestingly, dissatisfaction with a family member's care was also associated with lower trust in the respondent's personal physician (mean difference - 3.19, 95 %CI -6.02 to -0.36), but the magnitude of this association was weaker. The lower trust in personal physicians may be mediated by reduced trust in physicians generally. CONCLUSIONS: We suggest that physicians enquire about past patients' negative experiences, including dissatisfaction with family members' medical care, to repair hidden loss of trust, when they sense that patients doubt them or physicians generally.

U-TEST, a simple decision support tool for the diagnosis of sarcopenia in orthopaedic patients: the Screening for People Suffering Sarcopenia in Orthopedic cohort of Kobe study (SPSS-OK).

We aimed to develop and validate a new simple decision support tool (U-TEST) for diagnosis of sarcopenia in orthopaedic patients. We created seventeen candidate original questions to detect sarcopenia in orthopaedic patients with sarcopenia through expert opinions and a semi-structured interview. To derive a decision support tool, a logistic regression model with backward elimination was applied to select variables from the seventeen questions, age and underweight (BMI < 18·5 kg/m2). Sarcopenia was defined by Asian Working Group for Sarcopenia 2019 criteria. After assigning a score to each selected variable, the sum of scores was calculated. We evaluated the diagnostic performance of the new tool using a logistic regression model. A bootstrap technique was used for internal validation. Among a total of 1334 orthopaedic patients, sixty-five (4·9 %) patients were diagnosed with sarcopenia. We succeeded in developing a 'U-TEST' with scores ranging from 0 to 11 consisting of values for BMI (Underweight), age (Elderly) and two original questions ('I can't stand up from a chair without supporting myself with my arms' (Strength) and 'I feel that my arms and legs are thinner than they were in the past' (Thin)). The AUC was 0·77 (95 % CI 0·71, 0·83). With the optimal cut-off set at 3 or greater based on Youden's index, the sensitivity and the specificity were 76·1 and 63·6 %, respectively. In orthopaedic patients, our U-TEST scoring with two questions and two simple clinical variables can help to screen for sarcopenia.

Patient Journey and Disease-Related Burden in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension: A Mixed Methods Study.

BACKGROUND: Understanding patient journey and burden of disease in patients with chronic thromboembolic pulmonary hypertension (CTEPH) helps improve diagnostic and treatment processes. OBJECTIVES: This study aimed to explore patient journey from time of disease onset to a definitive diagnosis and disease burden in Japanese patients with CTEPH. METHODS: A mixed-methods study exploring patient journey and disease burden of 33 Japanese patients with a definitive diagnosis of CTEPH. The patients from 2 university hospitals underwent semistructured interviews. Data were transcribed into verbatim records, and 2 independent researchers conducted thematic analyses. Data concerning patient journey were also analyzed quantitatively with supplementary use of medical records. RESULTS: Median times from initial onset of symptoms to a confirmed diagnosis and first visitation to a medical institution to a definitive diagnosis of CTEPH were 32 and 20 months, respectively. Thematic analyses found that, for patients, reasons for delay in seeking initial consultations included misattribution of symptoms to aging or lack of physical strength. For healthcare providers, reasons for delays in diagnosis included poor recognition of CTEPH and difficulty in recalling the disease as a differential diagnosis. Burdens of CTEPH were caused by physical symptoms, and mental and social issues, including restriction of daily activities owing to oxygen therapy, disappointment with the intractable nature of the disease, poor understanding of the disease by other people, and lack of social networks. CONCLUSIONS: This study highlighted physical, mental, and social burdens in patients with CTEPH and possible missed opportunities in making the diagnosis of CTEPH during the patient journey. Increasing disease awareness in healthcare providers and networking among patients may contribute to better patient care.

Psychological Flexibility and Depression in Advanced CKD and Dialysis.

RATIONALE & OBJECTIVE: Depression is prevalent and highly associated with mortality among patients with chronic kidney disease (CKD). Psychological flexibility can be captured as acceptance in psychology, and its improvement by behavioral therapy is associated with reduced depression in some clinical settings. However, no study has been reported on patients with CKD. This study aimed to examine the association between psychological flexibility and depression in patients with CKD. STUDY DESIGN: Cohort study. SETTING & PARTICIPANTS: This multicenter study of 5 hospitals in Japan included patients with nondialysis stage 3-5 CKD or stage 5D CKD receiving hemodialysis or peritoneal dialysis. PREDICTOR: Psychological flexibility measured using the 7-item Acceptance and Action Questionnaire (AAQ-II). OUTCOMES: The prevalence and incidence of depression after 1 year, which was defined by a score ≥ 16 points on the Center for Epidemiologic Studies Depression (CES-D) questionnaire. ANALYTICAL APPROACH: Gamma regression was used in the examination of correlates of the psychological flexibility value. Modified Poisson regression models were fit for the prevalence and incidence of depression. RESULTS: The cross-sectional and longitudinal analyses included 433 and 191 patients, respectively. Lower (ie, worse) psychological flexibility levels were associated with hemodialysis and peritoneal dialysis. Higher (ie, better) psychological flexibility levels were associated with lower prevalence of depression (per 5-point increase; adjusted prevalence ratio, 0.75; 95% CI, 0.70-0.80) and lower incidence of depression (per 5-point increase; adjusted risk ratio, 0.72; 95% CI, 0.61-0.85). LIMITATIONS: Depression was assessed using the CES-D questionnaire. Cultural differences may exist in the interpretation of AAQ-II scores. CONCLUSIONS: Better psychological flexibility was associated with lower prevalence and incidence of depression in patients with CKD. Further studies are warranted to determine the possible prevention and treatment of depression by the development of behavioral interventions to improve psychological flexibility.

Association between health-related hope and adherence to prescribed treatment in CKD patients: multicenter cross-sectional study.

BACKGROUND: In chronic kidney disease (CKD), patients' adherence to prescriptions for diet and for medications might depend on the degree to which they have hope that they will enjoy life, and that hope could vary with the stage of CKD. The aims of this study were to quantify both the association of CKD stage with health-related hope (HR-Hope), and the association of that hope with psychological and physiological manifestations of adherence. METHODS: This was a cross-sectional study involving 461 adult CKD patients, some of whom were receiving dialysis. The main exposure was HR-Hope, measured using a recently-developed 18-item scale. The outcomes were perceived burden of fluid restriction and of diet restriction, measured using the KDQOL, and physiological manifestations of adherence (systolic and diastolic blood pressure [BP], and serum phosphorus and potassium levels). General linear models and generalized ordered logit models were fit. RESULTS: Participants at non-dialysis stage 4 and those at stage 5 had lower HR-Hope scores than did those at stage 2 or 3 (combined). Those at non-dialysis stage 5 had the lowest scores. HR-Hope scores of participants at stage 5D were similar to those of participants at stage 4, but they were lower than the scores of participants at stage 2 or 3 (combined). Higher HR-Hope scores were associated with lower perceived burdens of fluid restriction and of diet restriction (adjusted ORs per ten-point difference were 0.82 and 0.84, respectively). Higher HR-Hope scores were associated with lower systolic BP (adjusted mean difference in systolic BP per ten-point difference in HR-Hope scores was - 1.87 mmHg). In contrast, HR-Hope scores were not associated with diastolic BP, serum phosphorus levels, or serum potassium levels. CONCLUSIONS: Among CKD patients, HR-Hope is associated with disease stage, with psychological burden, and with some physiological manifestations of adherence.

Development of a profile scoring system for assessing the psychosocial situation of patients with chronic musculoskeletal pain.

Chronic pain is a manifestation of interactions among physical, psychological, and social conditions, but the latter two, that is, the nonphysical correlates of chronic pain, are only rarely measured. This study aimed to develop a profile scoring system for assessing the psychosocial situation of patients with chronic musculoskeletal pain. An expert panel chose social and psychological domains considered to be relevant to patients with chronic pain and wrote questions asking about each of those domains. The questionnaire was completed by 252 patients with chronic musculoskeletal pain. Factor analysis was used to select questionnaire items for each domain. Associations and interactions of pain severity and each domain score with pain-related quality of life (PRQOL) were examined using linear regression models. Five domains were chosen: work, family, sleep, mental health, and PRQOL. Then, a total of 17 questions were created for the work, family, and sleep domains. Using the likelihood-ratio test, we found significant interactions with PRQOL in four pairs: severity-family, severity-mental, family-sleep, and work-mental. The association between pain severity and PRQOL was related to each patient's social and psychological situation. These results suggest that interventions for patients with chronic pain may be personalized to account for each individual's psychosocial situation.

Development and Validation of a Disease-Specific Instrument to Measure Diet-Targeted Quality of Life for Postoperative Patients with Esophagogastric Cancer.

BACKGROUND: Patients who have undergone esophagectomy or gastrectomy have certain dietary limitations because of changes to the alimentary tract. This study attempted to develop a psychometric scale, named "Esophago-Gastric surgery and Quality of Dietary life (EGQ-D)," for assessment of impact of upper gastrointestinal surgery on diet-targeted quality of life. METHODS: Using qualitative methods, the study team interviewed both patients and surgeons involved in esophagogastric cancer surgery, and we prepared an item pool and a draft scale. To evaluate the scale's psychometric reliability and validity, a survey involving a large number of patients was conducted. Items for the final scale were selected by factor analysis and item response theory. Cronbach's alpha was used for assessment of reliability, and correlations with the short form (SF)-12, esophagus and stomach surgery symptom scale (ES(4)), and nutritional indicators were analyzed to assess the criterion-related validity. RESULTS: Through multifaceted discussion and the pilot study, a draft questionnaire comprising 14 items was prepared, and a total of 316 patients were enrolled. On the basis of factor analysis and item response theory, six items were excluded, and the remaining eight items demonstrated strong unidimensionality for the final scale. Cronbach's alpha was 0.895. There were significant associations with all the subscale scores for SF-12, ES(4), and nutritional indicators. CONCLUSIONS: The EGQ-D scale has good contents and psychometric validity and can be used to evaluate disease-specific instrument to measure diet-targeted quality of life for postoperative patients with esophagogastric cancer.

Computational psychological study of the Brief Scale for Psychiatric Problems in Orthopaedic Patients (BS-POP) for patients with chronic low back pain: verification of responsiveness.

BACKGROUND: We developed the Brief Scale for Psychiatric Problems in Orthopaedic Patients (BS-POP, physician and patient versions) and have previously shown that the BS-POP is reliable and has construct validity, criterion validity, and reproducibility. The present study aimed to proactively verify the responsiveness of the BS-POP with regard to chronic low back pain (LBP) patients. METHODS: The study subjects included 193 chronic LBP patients (81 males, 112 females; mean age 62 years) who had suffered from persistent LBP for ≥3 months. During the first test (before the treatment), the BS-POP, the Minnesota Multiphasic Personality Inventory (MMPI), the Profile of Mood States (POMS), the 36-item Short-form Health Survey version 2 (SF-36 v2), and the Roland-Morris Disability Questionnaire (RDQ) were conducted. The BS-POP, POMS, SF-36 v2, and RDQ for the third test were conducted (4-6 weeks after treatment) on all patients who had participated in the first test to determine the responsiveness of the BS-POP. The responsiveness of the BS-POP was investigated statistically. RESULTS: The total crude BS-POP scores were significantly lower for both physician and patient versions in the third test than in the first test. Moreover, the crude RDQ scores and SF-36 v2 items, physical functioning (PF), bodily pain (BP), MH, VT, and GH, and POMS items, tension-anxiety (T-A), D, F, and confusion (C) improved significantly, confirming responsiveness to treatment. DISCUSSION: The present findings indicate that the BS-POP possesses sufficient responsiveness from a computational psychology perspective. The BS-POP constitutes a tool enabling orthopaedists to easily identify psychiatric problems in orthopaedic patients.

Dietary patterns and clinical outcomes in hemodialysis patients in Japan: a cohort study.

BACKGROUND & OBJECTIVES: Little is known about actual dietary patterns and their associations with clinical outcomes in hemodialysis patients. We identified dietary patterns in hemodialysis patients in Japan and examined associations between dietary patterns and clinical outcomes. DESIGN, SETTING, PARTICIPANTS, MEASUREMENTS: We used data from 3,080 general-population participants in the Hisayama study (year 2007), and data from 1,355 hemodialysis patients in the Japan Dialysis Outcomes and Practice Patterns Study (JDOPPS: years 2005-2007). Food intake was measured using a brief self-administered diet-history questionnaire (BDHQ). To identify food groups with the Hisayama population data, we used principal components analysis with Promax rotation. We adjusted the resulting food groups for total daily energy intake, and then we used those adjusted food-group scores to identify dietary patterns in the JDOPPS patients by cluster analysis (Ward's method). We then used Cox regression to examine the association between dietary patterns and a composite of adverse clinical outcomes: hospitalization due to cardiovascular disease or death due to any cause. RESULTS: We identified three food groups: meat, fish, and vegetables. Using those groups we then identified three dietary patterns: well-balanced, unbalanced, and other. After adjusting for potential confounders, we found an association between an unbalanced diet and important clinical events (hazard ratio 1.90, 95% C.I. 1.19-3.04). CONCLUSIONS: Hemodialysis patients whose diet was unbalanced were more likely to have adverse clinical outcomes. Thus hemodialysis patients might benefit not only from portion control, but also from a diet that is well-balanced diet with regard to the food groups identified here as meat, fish, and vegetables.

Lumbar spinal stenosis-specific symptom scale: validity and responsiveness.

STUDY DESIGN: Cross-sectional study. OBJECTIVES: To test the validity and responsiveness of the lumbar spinal stenosis (LSS)-specific symptom scale (FLS-25 [Fukushima LSS Scale 25]). SUMMARY OF BACKGROUND DATA: The FLS-25, a self-administered questionnaire designed to comprehensively cover various symptoms of LSS, has been developed to address the need to measure symptoms specific to this disorder. METHODS: One hundred sixty-seven patients with confirmed LSS who required conservative therapy were asked to complete a questionnaire including questions regarding walking capacity and the FLS-25. These patients also underwent a lumbar extension test and a walking stress test, which are stress tests designed to objectively evaluate LSS symptoms, to measure standing time, walking distance, and walking time. Relationship between the FLS-25 scores and these external standards was analyzed to evaluate the criterion validity of the FLS-25. The patients underwent the same evaluations after 8 weeks of conservative therapy. The relationship between changes from baseline to week 8 in FLS-25 scores and changes in the 3 external standards was analyzed to evaluate the responsiveness of the FLS-25. RESULTS: The distribution of FLS-25 scores among patients was symmetric, and there were no ceiling or floor effects. FLS-25 scores increased as self-reported walking capacity decreased (P=0.006). The mean standing time in the lumbar extension test was 165 (SD=109) seconds, and FLS-25 scores increased as standing time decreased (P=0.003). In the walking stress test, mean walking distance and mean walking time were 213 (SD=154) m and 236 (SD=114) seconds. FLS-25 scores increased as walking distance (P=0.002) and walking time (P=0.054) decreased. Changes from baseline to week 8 in FLS-25 scores correlated with changes in the stress test standing time (P=0.014), walking distance (P<0.001), and walking time (P<0.001). CONCLUSION: The criterion validity and responsiveness of the FLS-25 were confirmed. The use of FLS-25 in clinical and investigational settings is warranted to monitor patients and evaluate therapeutic efficacy. LEVEL OF EVIDENCE: 3.

Development and validation of a symptom scale to evaluate postoperative patients with esophagogastric cancer.

BACKGROUND: Postgastrectomy or esophagectomy symptoms can be a significant burden for patients. However, no standard scale for evaluating these symptoms has been established. We recently developed a postoperative symptom-specific scale. STUDY DESIGN: After a draft scale was prepared based on a pilot study, psychometric methods were used to assess its reliability and validity. This study involved specialized and multifaceted discussions by a team consisting of gastrointestinal surgeons, gastroenterologists, psychologists, and epidemiologic researchers. The draft questionnaire included 40 questions and 3 domains. A factor analysis was carried out to refine the items and subscale design. To assess the reliability, Cronbach's alpha and score distributions were estimated. To assess the criterion-related validity, the correlations with the Short Form (SF)-12, Gastrointestinal Symptom Rating Scale (GSRS), endoscopic findings, and nutritional indicators were analyzed. RESULTS: A total of 344 patients were enrolled in this study. In an exploratory factor analysis (principal factor method), the eigenvalue attenuation data showed 4 domains. The final scale, named the Esophagus and Stomach Surgery Symptom Scale (ES(4)), included 23 items and 4 domains; 7 items for cervico-thoracic symptoms, 6 for abdominal hypersensitivity symptoms, 4 for abdominal distention symptoms, and 6 items for systemic symptoms. Cronbach's alphas for these domains were 0.82, 0.81, 0.79, and 0.74, respectively. The scale scores were normally distributed, and there were significant associations with the endoscopic findings, nutritional indicators, the summary score of the SF-12, and the GSRS. CONCLUSIONS: The ES(4) scale has high psychometric validity and can evaluate the profiles and severity of postoperative symptoms. This scale is applicable as an outcomes measure for various interventional studies on esophagogastric surgery aimed at alleviating postoperative symptoms.

Developing a scale to measure family dynamics related to long-term care, and testing that scale in a multicenter cross-sectional study.

BACKGROUND: As Japan's population ages, more frail elderly people are cared for by members of their family. The dynamics within such families are difficult to study, in part because they are difficult to quantify. We developed a scale for assessing family dynamics related to long-term care. Here we report on the development of that scale, and we present the results of reliability testing and validation testing. METHODS: Two primary-care specialists drafted questions about family dynamics, and discussed them with other primary-care physicians and clinical researchers. The final questionnaire asked about four problems or undesirable situations: disengagement (emotional distance), scapegoating (inappropriate blame), transfer of problems across generations (transfer of unnecessary burden from older to younger generations, trans-generationally displaced revenge), and undesirable behavior (co-dependence). Next, at six general-medicine clinics, doctors evaluated families that had a caregiver and a patient requiring long-term care. The results were analyzed by factor analysis. Cronbach's α was computed, and criterion-related validation tests were done with three types of criteria: relationship before caregiving, ability to do activities of daily living (ADL), and the duration of care. RESULTS: Results were obtained from 199 families. Among the caregivers, 79% were women and their mean age was 63 years. Among the patients, 71% were women and their mean age was 84 years. The results of factor analysis indicated that the scale was unidimensional. Cronbach's α was 0.73. Not having a good relationship before caregiving was associated with significantly worse family dynamics scores, as was greater dependence regarding ADL. CONCLUSIONS: We developed a scale that enables physicians to assess the dynamics of families with a patient and a family caregiver. The scale's scores are reliable and the results of validation testing were generally good. This scale holds promise as a tool both for research and for primary-care practice.

Development and Validation of a Symptom Scale Specific for Ascites Accompanied with Cirrhosis: The ASI-7.

OBJECTIVES: Ascites markedly affects the quality of life of patients with cirrhosis; however, there is currently no scale to measure the symptoms of ascites. We developed a scale to measure ascites-specific symptoms according to psychometric procedures. METHODS: A team consisting of specialists developed constructs representing the symptoms of ascites and question item pool. The constructs were verified in a qualitative study involving a small number of patients. The item pool was improved through a pilot study, and a prototype of the scale was prepared. To establish the scale and assess its properties, a questionnaire survey was conducted on 175 patients with ascites accompanied with cirrhosis. RESULTS: On the basis of the results of factor analysis and item response theory-based analyses, seven items, covering a wide range of severities and diverse symptoms, were selected to comprise the final scale (Ascites Symptom Inventory-7; ASI-7). The ASI-7 had a unidimensional factorial structure and high reliability (Cronbach's α coefficient of 0.96). The scale score was correlated with the degree of ascites evaluated by physicians, Short Form-36 (SF-36) physical functioning (PF), and SF-36 vitality (VT; P<0.001 each), indicating the criterion validity. The responsiveness after treatment was demonstrated by the mean standardized response of 1.18. Moreover, responses in the scale score were correlated with those in the degree of ascites, body weight, SF-36 PF, and SF-36 VT, respectively (P<0.001 each). CONCLUSIONS: An ascites-specific symptom scale was developed and its reliability, validity, and responsiveness were demonstrated. This simple scale may be used for the evaluation of ascites treatment and monitoring of treatment responses in patients with ascites.

Development of a short version of the visual function questionnaire using item-response theory.

PURPOSE: In clinical ophthalmology as in other fields, measuring patient-reported outcomes imposes a burden on patients. To decrease that burden, we used item-response theory (IRT) to develop and test a short version of the National Eye Institute's Visual Function Questionnaire (VFQ). METHODS: We analyzed VFQ data from 276 adults in Japan. Most of them had glaucoma, cataract, or macular degeneration. Their visual acuity (Snellen fraction) averaged 20/120 (range: 20/13 to 20/2000) for the better eye, and 20/200 (range: 20/13 to 20/2000) for the worse eye. We used a polytomous IRT model, the Generalized Partial Credit Model as implemented in software for parameter scaling of rating data (PARSCALE). To select items for inclusion in the short version we examined each item's location on the latent-trait continuum, its slope, and its frequency of missing data. We also ensured representation of all 7 domains that are important in Japan. To examine the characteristics of the resulting scale, we computed its test information (an index of precision that can vary with the value of the latent trait), and carried out validation testing. RESULTS: From 32 of the original VFQ items, we selected 11. The scale comprising those 11 items (the VFQ-J11) had test information greater than 9 for values of the latent trait between -2.0 and +0.8. The item thresholds were well-targeted for patients with vision problems. Scores on the VFQ-J11 correlated strongly and in the expected direction with measures of visual field and corrected visual acuity. As expected for a valid measure, those scores also improved by a large amount (almost one standard deviation) after cataract surgery. CONCLUSION: This 11-item instrument can provide reliable and the valid data on visual functioning in patients with ophthalmic problems. It is expected to be less of a burden on respondents, while it maintains good psychometric properties.