Difficulties in Performing Mesalazine Enemas and Factors Related to Discontinuation Among Patients With Ulcerative Colitis.

Current first-line treatment of ulcerative colitis consists of a combination of mesalazine enemas and oral mesalazine; however, many patients may discontinue mesalazine enemas. In this single-center, cross-sectional study, 165 outpatients with ulcerative colitis completed a self-administered questionnaire regarding the frequency of mesalazine enemas, difficulties in performing these enemas, and factors possibly associated with their discontinuation, as well as patient clinical and demographic characteristics. Of 165 patients, 34 (20.6%) discontinued mesalazine enemas because of a lack of efficacy. Five of the 13 items assessing difficulties were answered affirmatively by the majority of patients. Discontinuation of enema application was associated with a perceived lack of efficacy, four or more bowel movements per day, and lower scores on measurement of the doctor-patient relationship. Application of mesalazine enemas by patients with ulcerative colitis may be improved by discussions with peers and healthcare professionals and by adjusting the frequency of application or the time of starting the enema based on worsening of ulcerative colitis.

Validation of the Japanese version of the EORTC hepatocellular carcinoma-specific quality of life questionnaire module (QLQ-HCC18).

BACKGROUND: This Study Examined The Measurement Properties Of The Japanese Version Of The European Organisation for Research and Treatment of Cancer (EORTC) Hepatocellular Carcinoma-Specific Quality of Life Questionnaire (QLQ-HCC18). METHODS: EORTC quality of life (QOL) translation guidelines were followed to create a Japanese version of the EORTC QLQ-HCC18. This was then administered to 192 patients with hepatocellular carcinoma along with the EORTC QLQ-C30 and FACT-Hep questionnaires. Tests for reliability and validity were conducted including comparison of scores between the EORTC and FACT questionnaire and detailed assessment of the new scales and items in clinically distinct groups of patients. RESULTS: Multi-trait scaling analysis confirmed three putative scales in the QLQ-HCC18, fatigue, fever and nutrition. Cronbach's alpha for these scales were between 0.68 and 0.78. The QLQ-HCC18 scales correlated with scales measuring similar items in the FACT-Hep and the questionnaire was stable over time with an intra-class correlation score of 0.70 for almost all scales. The questionnaire had the ability to distinguish between patients with different Karnofsky Performance Status, and Child-Pugh liver function class. CONCLUSIONS: The Japanese version of EORTC QLQ-HCC18 is a reliable supplementary measure to use with EORTC QLQ-C30 to measure QOL in Japanese patients with hepatocellular carcinoma.

Development of self-care educational material for patients with heart failure in Japan: a pilot study.

This study assessed the need for information regarding heart failure and self-care, developed self-care educational material, and investigated the feasibility of the material. A total of 22 hospitalized heart failure patients (mean age: 63 years) completed a self-administered questionnaire. We found that more than 90% of patients desired information, particularly about heart failure symptoms, time to notify healthcare providers, prognosis, and exercise/physical activity. After examining the eight existing brochures for Japanese heart failure patients, we developed self-care educational material. This was based on heart failure guidelines and on the results of our inquiry regarding information needs. Finally, a pilot study was conducted in nine hospitalized heart failure patients (mean age: 57 years). None of the patients had difficulty reading or understanding the educational material. The self-administrated questionnaire survey revealed that comprehension of the following improved after the educational sessions with the material: heart failure symptoms, medication, weighing, sodium intake, and fluid intake (P < 0.05). In conclusion, heart failure patients have a great need for information about heart failure. Our pilot study suggests that the material was readable and had a beneficial effect on heart failure comprehension.

Difficulties in taking aminosalicylates for patients with ulcerative colitis.

Aminosalicylates are effective in inducing remission and are also useful in preventing relapse of ulcerative colitis (UC); however, previous studies have reported a 30%-45% rate of nonadherence to prescribed medication among UC patients. Enumerating and conceptualizing the difficulties in taking aminosalicylates enable us to assess and support patients more effectively. The aim of this study was to investigate the difficulties in taking aminosalicylates among Japanese UC patients and explore factors related to these difficulties. Outpatients with UC (n = 242) completed a questionnaire supported by a semistructured interview on the basis of a literature review. Twelve items about difficulties in taking aminosalicylates were processed by factor analysis and the related factors regarding difficulties were analyzed. The following three independent domains were identified: Domain 1: diminished sense of priority for medication; Domain 2: concern about side effects; and Domain 3: burden of taking the prescribed drug. Factors related to the difficulties in taking aminosalicylates included the disease state, psychosocial factors, and demographic characteristic variables. On the basis of the results, we recommend the creation and validation of a program aimed at decreasing the difficulties in taking aminosalicylates.

Quality of life as an independent predictor for cardiac events and death in patients with heart failure.

BACKGROUND: Little is known about health-related quality of life (QOL) in Japanese patients with heart failure. The purpose of this study was to identify factors related to QOL using a disease-specific QOL instrument, and to clarify whether QOL independently predicts clinical outcomes among Japanese patients with heart failure. METHODS AND RESULTS: A total of 114 outpatients with heart failure were enrolled (mean age 64.7 ± 15.8 years; 73.7% males). The Minnesota Living with Heart Failure Questionnaire (MLHFQ) to assess patient's QOL was used. At baseline, depressive symptoms and chronic kidney disease were significantly associated with worse QOL in multiple regression analysis. During a 2-year follow up, patients with a MLHFQ score ≥ 26, indicating worse QOL, had a higher incidence of the combined endpoint of cardiac death or hospitalization for heart failure, and a higher all-cause mortality than those with a score < 26 (25.3% vs. 7.5%, P = 0.011; 18.5% vs. 6.4%, P = 0.018; respectively). Multivariate Cox proportional hazard models demonstrated that a higher MLHFQ score was significantly associated with increased risks of cardiac events (hazard ratio, 1.02, 95% confidential interval, 1.001-1.05, P = 0.038) and of all-cause death (hazard ratio, 1.04, 95% confidential interval, 1.02-1.07, P = 0.001). CONCLUSIONS: Depressive symptoms and chronic kidney disease are major determinants of impaired QOL, and the MLHFQ score is an independent predictor of both cardiac events and death among Japanese patients with heart failure.

Multiple evaluation of a hospital-based palliative care consultation team in a university hospital: activities, patient outcome, and referring staff's view.

OBJECTIVE: Although the number of hospital-based palliative care consultation teams (PCCTs) is rapidly increasing in Japan, there is limited information available concerning the activities and usefulness of PCCT in the country. The aim of this study is to clarify the activities, patient outcome, and referring staff's view of an established PCCT in Japan. METHOD: This was a prospective study to follow patients referred to a PCCT for 28 days over a 1-year period. Patients were assessed by the Support Team Assessment Schedule-Japanese version (STAS-J) and EORTC QLQ C-30 at the time of referral and on days 7, 14, and 28. A staff survey was implemented using a questionnaire after each observation period. RESULTS: Of 180 patients referred, 53 patients were eligible for the study. Although the median of the number of the reasons for referral was 1, the PCCT provided several kinds of support: pain management, 94%; emotional support for the patient, 49%; and emotional support for the family, 36%. On day 7 after referral, of the items of STAS-J and the EORTC QLQ C-30 subscales, only insomnia improved significant whereas "other physical symptoms" and constipation were significantly exacerbated. In the staff survey, of the 98 respondents, more than 90% considered the effect of the PCCT as "excellent" or "good" and were satisfied with the support provided. SIGNIFICANCE OF RESULTS: This study showed that the PCCT performed comprehensive assessments on referred patients and provided extra support. No patient's QOL 1 week after referral was improved with the exception of insomnia. Referring staff highly evaluated the activities of the PCCT. In the evaluation of PCCTs, further research about the variation of clinical activities of PCCTs, their applicability, and benefit is needed.

Response shift in quality-of-life assessment in patients undergoing curative surgery with permanent colostomy: a preliminary study.

The purpose of this preliminary study (N 13) was to investigate the impact of response shift in quality of life for cancer patients undergoing surgical resection with resultant permanent colostomy. Response shift was measured using a "then-test" approach. Quality of life was measured using the 36-Item Short Form Health Survey version 2 (Japanese version). Baseline data (pretest scores) were collected before surgery when subjects completed the 36-Item Short Form Health Survey. Two months after the surgery, subjects were asked to respond again to the 36-Item Short Form Health Survey to assess their postsurgery quality-of-life (posttest score) level and their presurgery quality-of-life level (then-test score). Norm-based scoring for pretest, posttest, and then-test scores for each of the 36-Item Short Form Health Survey domains was calculated. Response shift was assessed by the difference between pretest and then-test scores and effect size. Findings revealed that a moderate but significant response shift was observed in the bodily pain domain. A small response shift was observed in the role physical and vitality domains. The then-test score was higher than the pretest score. The same trend was observed in all other domains except general health. The results indicate that the unit of comparison in the subjects was changed by surgery. Knowledge of these phenomena would allow a better understanding of quality of life of these subjects.

Relationship of depressive symptoms with hospitalization and death in Japanese patients with heart failure.

BACKGROUND: Depressive symptoms are risk factors for poor outcomes and are positively associated with disease severity in patients with heart failure (HF). However, little is known about this association in the Japanese population. Therefore, we evaluated the prevalence of depressive symptoms and whether depressive symptoms predicted hospitalization for HF and death independent of disease severity and other factors in HF patients. METHODS AND RESULTS: A 2-year prospective cohort study was conducted on 115 outpatients with HF (73.9% males; mean age 64.7 years) in Tokyo. Of these, 27 patients (23.5%) were classified as having depressive symptoms (Center for Epidemiologic Studies Depression Scale score >or=16). Patients with depressive symptoms had higher rates of 2-year cardiac death or HF hospitalization (34.0% vs. 10.3%; P < .01), HF hospitalization (27.4% vs. 9.2%; P = .01), and all-cause death (27.4% vs. 7.2%; P < .01). Multivariate Cox regression analyses indicated that depressive symptoms were predictors of cardiac death or HF hospitalization (hazard ratio [HR], 3.29; P = .02), HF hospitalization (HR, 3.36; P = .04), and all-cause death (HR, 5.52; P = .01), independent of age and brain natriuretic peptide. CONCLUSIONS: Depressive symptoms were common and independent predictors of poor outcomes in Japanese patients with HF.

Hypoglycemia-like symptoms after restorative proctocolectomy for UC: a preliminary study.

This study was conducted to explore the hypoglycemia-like symptoms sometimes noted after proctocolectomy for ulcerative colitis. Eighty-three patients who underwent restorative proctocolectomy at least 1 year before December 2001 (staged procedure, n = 50; one-staged procedure, n = 33) were requested to answer three questionnaires at the stage of temporary diverting ileostomy and/or after completion of the operation (after stoma closure). The questionnaires evaluated the presence of 18 items of hypoglycemia-like symptoms, subject recognition of the cause, and whether the symptoms were improved after eating or drinking. Seven subjects (14%) experienced at least one of the three items considered to be specific symptoms of hypoglycemia ("cold sweats," "trembling of hands," and "extreme desire for sweets") at the stage of temporary ileostomy. Ten (20%) and 9 (27.3%) subjects experienced those specific symptoms at the stage after completion of the operation by staged procedure and by one-staged procedure, respectively. There was no significant difference between the stages. Hypoglycemia-like symptoms were found to be experienced in a considerable number of patients after proctocolectomy for ulcerative colitis.

Attitude of outpatients with neuromuscular diseases in Japan to pain and use of analgesics.

The prevalence of pain and its impact on outpatients with neuromuscular disease, and their attitude towards the use of analgesics were studied. Seventy-eight outpatients at the university hospital, Tokyo, diagnosed with Parkinson's disease, spinocerebellar degeneration, amyotrophic lateral sclerosis, or multiple sclerosis were asked whether they had experienced pain in the preceding week. The Brief Pain Inventory, Japanese version was used to interview participants reporting pain, about its intensity and interference with activities, the way they dealt with it, attitudes to pain and use of analgesics, and desire for treatment. Forty-six participants experienced pain in the preceding week (59%). The mean pain intensity was 4.1 out of 10, and 20% of participants reported that the degree of interference with mobility was at least 6 out of 10. Most participants dealt with their pain without medication, by changing posture frequently or massage. Approximately 80% of participants regarded pain as something they should endure. Half of the participants wanted more information on methods for pain relief. Approximately 80% of participants were anxious about adverse reactions of analgesics. These findings suggest that medical staffs should provide appropriate information and educate their patients.

Feelings of living donors about adult-to-adult living donor liver transplantation.

This study investigated the feelings of living donors about adult-to-adult liver transplantation. We interviewed 18 donors about their feelings before and after transplantation using semistructured interviews and then conducted a content analysis of their responses. Before transplantation, many donors reported that they wanted recipients to live for the donor or his or her family, and there was no one else to donate. Many donors were not anxious, did not feel coerced, and did not consider donation dangerous. Some reported being excited at facing a new experience. Some said they would not mind whatever happens. Others were anxious or unsure about the operation. Diagnostic testing and preoperative blood banking were painful. Donors experienced increasing stress just before the operation. After transplantation, some donors verbalized feeling more grateful to others and that they gained maturity. Throughout the process, donors were concerned about their recipients. Our results suggest that donors might act for themselves or their family. It is important to recognize the varied responses of donors' feelings toward liver transplant recipients.

Effectiveness of lifestyle counseling by certified expert nurse of Japan for non-insulin-treated diabetic outpatients: a 1-year randomized controlled trial.

We examine whether one-to-one lifestyle counseling for non-insulin-treated diabetic outpatients by a Certified Expert Nurse (CEN) can improve patients' health outcomes. Participants were randomly assigned to a 1-year lifestyle intervention (n=67) or to a usual care group (n=67). Main outcome measures were changes from baseline in: HbA(1C) and score of health related quality of life scales (SF-36 and Problem Areas in Diabetes Scale). Cognitive/behavioral modification for 1 year and satisfaction in CEN counseling was also measured by self-produced items. We found no significant differences in HbA(1C), BMI, blood pressure, serum lipids, or health related quality of life over 1 year between the two groups. Patients in the intervention group, however, showed modest but more favorable modification of cognition (p=0.004) and behavior (p<0.001) than subjects in usual care group. The low attrition rate (9%), more frequent hospital visit (12+/-2 times versus 11+/-3 times; p=0.03) and high degree of satisfaction (95%) in the intervention group indicate feasibility of the monthly CEN counseling in the outpatient settings of Japanese hospitals. Future research should confirm the long-term effectiveness of the CEN counseling on clinical outcomes and the cost effectiveness of a possibly time-consuming intervention.

Process and contents of telephone consultations between registered nurses and clients with HIV/AIDS in Japan.

Antiviral therapy is essential for HIV/AIDS patients, but many variables impede patients' adherence to therapy. To facilitate adherence, trained registered nurses in Japan provided consultation by phone at the AIDS Clinical Center. This study describes the process and content of this intervention and explores the predictors for length of time of phone consultations. The study was completed over 1 month using a time study, checklist, and medical record inquiry. A total of 175 consultations were described. Mean time was 4.8 +/- 3.8 min, and longer for patients with complications or comorbidity. Although the contents of conversations differed according to the phase of highly active antiretroviral therapy, major identified themes included need for medical consultation, symptom control, provision of information, and active listening. The results are useful for those trying to find ways to use telephone consultation effectively to reinforce adherence.

Reliability and validity of revised and short form versions of diabetes diet-related quality of life scale.

OBJECTIVE: To develop both a revised version of the Diabetes Diet-Related Quality of Life (DDRQOL-R) scale that can be applied to patients with nephropathy and a short form of the DDRQOL-R. METHOD: A total of 184 outpatients with type 2 diabetes were asked to complete the self-administered DDRQOL-R scale to confirm its psychometric properties. A short-form version was developed, based on two methods: the result of the developed DDRQOL-R scale and consensus using the Delphi method among medical experts. RESULTS: Correlations were generally strong between the DDRQOL-R factors extracted by factor analysis and each SF-36 subscale. Cronbach's α coefficients were at least 0.7, and intraclass correlation coefficients were between 0.59 and 0.78. The nine items that showed high factor loadings were also assessed as important by the medical experts and were selected for the short form of the scale. The reliability and validity of the short form were found to be similar to those of the DDRQOL-R scale. DISCUSSION: Our findings indicate that the DDRQOL-R scale and its short form have acceptable reliability and validity. The revised version is highly versatile, and the short form can be conveniently administered.

Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials.

BACKGROUND: Clinical research coordinators play a pivotal role in phase I cancer clinical trials. PURPOSE: We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators' perspective on patients' expectations and understanding of these trials. METHOD: Fifteen clinical research coordinators participated in semi-structured interviews regarding clinical practices; perceptions of patients' expectations; and the challenges that occur before, during, and after phase I cancer clinical trials. DISCUSSION: Qualitative content analysis showed that most clinical research coordinators observed that patients have high expectations from the trials. Most listened to patients to confirm patients' understanding and reflected on responses to maintain hope, but to avoid excessive expectations; clinical research coordinators considered avoiding unplanned endings; and they aimed to establish good relationships between patients, medical staff, and among the professional team. CONCLUSIONS: Clinical research coordinators were insightful about the needs of patients and took a meticulous approach to the phase I cancer clinical trial process, allowing time to connect with patients and to coordinate the inter-professional research team. Additionally, education in advanced oncology care was valuable for comforting participants in cancer clinical trials.

Evaluation of care for leukemia and lymphoma patients during their last hospitalization from the perspective of the bereaved family.

We aimed to evaluate care for leukemia and lymphoma patients during their last hospitalization from the perspective of the bereaved family. Questionnaires were sent to the bereaved family members of adult leukemia and lymphoma patients. We used the Care Evaluation Scale (CES) and asked the bereaved family members about care satisfaction and "good death" factors during the patient's last week of life or last admission period. We distributed 177 questionnaires and were able to analyze 103 (58.2%) responses. Compared with the results of a previous study of palliative care units in Japan, the CES scores were significantly lower in 9 out of 10 domains. Assessment of the "good death" components revealed that only 33% of respondents agreed that the patient had been relieved as far as possible of pain and physical distress during the last week of life. Only 21.4% of respondents agreed that the patient had been relieved as far as possible of psychological distress, and 57% of caregivers were not satisfied with the level of care. During the last hospitalizations of leukemia or lymphoma patients, their care was insufficient and a good death was not often achieved. Improvement of end-of-life care for leukemia and lymphoma patients is needed.

How effective is an in-hospital heart failure self-care program in a Japanese setting? Lessons from a randomized controlled pilot study.

BACKGROUND: Although the effectiveness of heart failure (HF) disease management programs has been established in Western countries, to date there have been no such programs in Japan. These programs may have different effectiveness due to differences in health care organization and possible cultural differences with regard to self-care. Therefore, the purpose of this study was to evaluate the effectiveness of a pilot HF program in a Japanese setting. METHODS: We developed an HF program focused on enhancing patient self-care before hospital discharge. Patients were randomized 1:1 to receive the new HF program or usual care. The primary outcome was self-care behavior as assessed by the European Heart Failure Self-Care Behavior Scale (EHFScBS). Secondary outcomes included HF knowledge and the 2-year rate of HF hospitalization and/or cardiac death. RESULTS: A total of 32 patients were enrolled (mean age, 63 years; 31% female). There was no difference in the total score of the EHFScBS between the two groups. One specific behavior score regarding a low-salt diet significantly improved compared with baseline in the intervention group. HF knowledge in the intervention group tended to improve more over 6 months than in the control group (a group-by-time effect, F=2.47, P=0.098). During a 2-year follow-up, the HF program was related to better outcomes regarding HF hospitalization and/or cardiac death (14% vs 48%, log-rank test P=0.04). In Cox regression analysis after adjustment for age, sex, and logarithmic of B-type natriuretic peptide, the program was associated with a reduction in HF hospitalization and/or cardiac death (hazard ratio, 0.17; 95% confidence interval, 0.03-0.90; P=0.04). CONCLUSION: The HF program was likely to increase patients' HF knowledge, change their behavior regarding a low-salt diet, and reduce HF hospitalization and/or cardiac events. Further improvement focused on the transition of knowledge to self-care behavior is necessary.

Nurses' perception of adequacy of care for leukemia patients with distress during the incurable phase and related factors.

Leukemia patients experience distress during the incurable phase of illness. Adequacy of care (i.e., extent to which care relieves the patients' suffering) was described from the nurses' viewpoint, and institutional factors related to adequacy of care were explored. A self-administered questionnaire was completed by 425 nurses working in 26 hematology wards. Nurses tended to rate the care as inadequate. In particular, care for social distress needs to be improved. Our findings suggest that communication among health professionals, utilization of hospital resources, and palliative care education for staff were important in palliative care for leukemia patients during the incurable phase.

Development of a diabetes diet-related quality-of-life scale.

OBJECTIVE: The purpose of this study was to assess the reliability and validity of the Diabetes Diet-Related Quality-of-Life (DDRQOL) scale, which is a measure of the influence of diet therapy on patients' quality of life (QOL). RESEARCH DESIGN AND METHODS: Patients with type 2 diabetes (n = 236) who were being treated on an outpatient basis were asked to complete the self-administered DDRQOL instrument. The factor validity, convergent and discriminant validity, internal consistency, and reproducibility of the DDRQOL scale were then assessed. Spearman's rank correlation coefficients among the DDRQOL scale and each of the SF-36 subscale scores were calculated to evaluate its convergent and discriminant validity. RESULTS: Based on the results of the factor analysis, the following seven subscales were adopted for the DDRQOL: "satisfaction with diet," "burden of diet therapy," "perceived merits of diet therapy," "general perception of diet," "restriction of social functions," "vitality," and "mental health." As hypothesized, the DDRQOL scale was associated with each of the SF-36 subscales, with convergent and discriminant validity being generally exhibited. Cronbach's alpha-coefficient was between 0.71 and 0.84, suggesting strong internal consistency. The intraclass correlation coefficient of the subscales, with the results of a test-retest conducted 2 weeks later, was between 0.46 and 0.75, suggesting some degree of reproducibility. CONCLUSIONS: These findings indicate that the DDRQOL scale has a reasonable degree of reliability and validity, and its application for the assessment of the needs of a patient's diet and the evaluation of diet education with regard to QOL is awaited.

Effects of an off-site walking program on energy expenditure, serum lipids, and glucose metabolism in middle-aged women.

The present study aims to identify the effects of systematic walking on exercise energy expenditure (EEE) and blood profiles in middle-aged women. Fifty-two female nurse managers, aged 32 to 57 years (42.0 +/- 6.2), were randomly assigned to an intervention group (IG) and a control group (CG) for a 12-week study of the walking program. EEE was measured using a microelectronic device. Blood profiles were assessed before and after the walking program. The mean EEE (kcal/kg/d) in the IG and CG was 4.73 +/- 1.02 and 3.88 +/- 0.81 (P = 0.01), indicating an increase of 1.17 +/- 0.98 and 0.46 +/- 0.68 from baseline (P = 0.01), respectively. The mean change in high-density lipoprotein cholesterol in the IG and CG was 1.8 +/- 8.3 mg/dL and -2.9 +/- 7.0 mg/dL (P = 0.051); that in insulin was -4.5 +/- 7.5 microU/dL and -0.6 +/- 4.3 microU/dL (P = 0.046), respectively. These results show that systematic walking increases EEE and improves blood profiles.