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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.

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.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.Correlations were generally strong between the DDRQOL-R factors extracted by factor analysis and each SF-36 subscale. Cronbach'sOur 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.

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.

Naoko P Kato,1–3 Koichiro Kinugawa,1 Miho Sano,4 Asuka Kogure,4 Fumika Sakuragi,5 Kihoko Kobukata,4 Hiroshi Ohtsu,6 Sanae Wakita,4 Tiny Jaarsma,2 Keiko Kazuma7 1Department of Therapeutic Strategy for Heart Failure, TheUniversity of Tokyo Graduate School of Medicine, Tokyo, Japan; 2Department of Social and Welfare Studies, Faculty of Health Sciences, Linköping University, Linköping, Sweden; 3JSPSPostdoctoral Fellow for Research Abroad, Tokyo, 4Department of Nursing, 5Department of Pharmacy, The University of Tokyo Hospital, 6Department of Clinical Data Management, 7Department of Adult Nursing, The University of Tokyo Graduate School of Medicine, Tokyo,Japan 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. Keywords: discharge education, disease management, hospitalization, knowledge, nursing, patient education

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.

Thirty to forty-five percent of ulcerative colitis (UC) patients show non-adherence to aminosalicylates, and non-adherence has been reported to increase the risk of clinical relapse. Because Japan differs from Western countries in terms of health care and drugs administered, adherence to aminosalicylates in Japan may differ from that elsewhere. Therefore, we examined aminosalicylate adherence and its relationship to the risk of clinical relapse of UC in Japan. A 1-year, prospective cohort study was conducted in 104 outpatients with UC in remission who had taken aminosalicylates >6 months. Aminosalicylate adherence was evaluated using data from a self-administered questionnaire and medical records. Non-adherence was defined as taking

Summary Background Little is known about depressive symptoms in heart failure with preserved ejection fraction (HFpEF, EF ≥50%). We aimed to assess the prevalence of depression, to clarify the impact of depressive symptoms upon clinical outcomes, and to identify factors associated with these symptoms in HF with reduced EF (HFrEF, EF Methods and results A total of 106 HF outpatients were enrolled. Of them, 61 (58%) had HFpEF. Most patients were male (HFrEF 80%, HFpEF 70%) and the mean of plasma B-type natriuretic peptide (BNP) level in the HFrEF group was similar to that in the HFpEF group (164.8 ± 232.8 vs. 98.7 ± 94.8 pg/mL). HFrEF patients were treated more frequently with beta-blockers compared with HFpEF patients (71% vs. 43%, p = 0.004). Depressive symptoms were assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). The prevalence of depression (CES-D score ≥16), and CES-D score did not significantly differ between HFrEF and HFpEF (24% vs. 25%, 14.1 ± 8.3 vs. 12.1 ± 8.3, respectively). During the 2-year follow-up, depressed patients had more cardiac death or HF hospitalization in HFrEF (55% vs. 12%, p = 0.002) and HFpEF (35% vs. 11%, p = 0.031). Cox proportional hazard analysis revealed that a higher CES-D score, indicating increased depressive symptoms, predicted cardiac events independent of BNP in HFrEF [hazard ratio (HR) 1.07, 95% confidence interval (CI) 1.01–1.13] and HFpEF (HR 1.09, 95%CI 1.04–1.15). Multiple regression analyses adjusted for BNP showed that independent predictors of depressive symptoms were non-usage of beta-blockers and being widowed or divorced in HFrEF. On the other hand, usage of warfarin was the only independent risk factor for depressive symptoms in HFpEF (all, p Conclusions Depressive symptoms are common and independently predict adverse events in HFrEF/HFpEF patients. This study suggests that beta-blockers reduce depressive symptoms in HFrEF. In contrast, treatment for depression remains to be elucidated in HFpEF.

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.

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.

Background. The aim of this study is to summarize the opinions of physicians regarding problems and tasks involved in the medical care system for patients with adult congenital heart disease (ACHD) in Japan. Methods and Results. We conducted a semistructured interview with 30 subjects consisting of 13 pediatric cardiologists, 11 cardiovascular surgeons, and six cardiologists who were selected from among the randomly sampled medical facilities meeting each of the following institutional criteria: (1) facilities with ≥50 ACHD outpatients; (2) facilities with ACHD-specialized outpatient clinic; (3) facilities that are members of the Japanese Association of Chirdren's Hospitals and Related Facilities. The interview time was 27–91 minutes (mean, 70.0). The age of the subjects ranged from 36 to 62 years (mean, 46.7), and they had 0.5–34 years (mean, 16.2) of experience in treating congenital heart disease. From an analysis of interview details, the following four themes were extracted (in descending order of the number of comments): “(1) Who should treat ACHD” (comments by 29 subjects), “(2) Centralization of medical care” (comments by 29 subjects), “(3) What is the role of children's hospitals in ACHD?” (comments by 24 subjects), and “(4) Psychosocial problems” (comments by 24 subjects). Conclusions. Regional ACHD centers need to be established to promote centralization of patients, physicians, and educational function. This will provide higher quality medical service to more patients in the near future.

Lynch syndrome (HNPCC) is an autosomal dominant hereditary cancer syndrome, and members of affected families are at-risk for developing colorectal and other associated tumors. Such individuals should disseminate familial genetic information, so they can seek specific medical assessment or genetic testing to reduce mortality and morbidity rates by early detection. Since published results have been encouraging, we explored which factors influence the likelihood of good communication within families regarding medical assessment. We studied 40 individuals from 33 families who satisfied the Japanese clinical criteria for Lynch syndrome and their relatives at our hospital. We determined the status of relatives of the 40 individuals after genetic counseling and testing using questionnaires and semi-structured interviews based on pedigree charts. We also examined their knowledge or perception of colorectal cancer syndrome, levels of intimacy and whether or not they encouraged their relatives to have specific medical assessments. We found that 75% of the individuals advised their relatives to seek medical assessment, and any significant background factors that promoted such encouragement were observed. They tended to encourage first degree relatives and discuss the issue with other family members such as spouses before undertaking such attempts at encouragement. The reasons and methods of imparting encouragement were essentially identical. We also found that genetic testing for at-risk or more distant relatives was not encouraged so often. Therefore, providing individuals who have been tested for Lynch syndrome with opportunities for disseminating familial genetic information through appropriate genetic counseling is important.

This retrospective cohort study was conducted to demonstrate how allocation of nurses specialized in HIV care influences clinical outcomes of antiretroviral therapy (ART) for people living with HIV (PLWH). Methods: The medical records of 116 PLWH who started ART between January 2002 and December 2004 were analyzed. Occurrence of viral suppression and viral relapse after suppression achievement and their time from baseline were observed as clinical outcomes related to ART. Clinical outcomes were obtained from medical records between January 2002 and December 2006. PLWH were classified into two groups according to allocation (n = 95, nurse allocated group) or nonallocation (n =21, nurse nonallocated group) of nurses specialized in HIV. Results: Survival analysis showed that HIV viral load was suppressed more rapidly and continuously in nurse allocated group than nonallocated group (p < .0001). Viral relapse after suppression achievement occurred easily in nurse nonallocated group than allocated group (p = .003). Conclusions: The present findings demonstrated that the role of specialized nurses is critically important from the viewpoint of clinical outcome.

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

Background Adherence to self-care behavior is important for patients with heart failure (HF) to prevent exacerbation of HF. The aim of this study was to evaluate adherence, identify associated factors, and clarify the impact of previous HF hospitalizations on adherence in outpatients with HF. Methods A total of 116 outpatients completed a questionnaire, including the Japanese version of the European Heart Failure Self-Care Behavior Scale, to assess adherence. Results Regardless of previous hospitalizations, adherence to seek help if HF worsened was poor. Multivariate analysis adjusted for age and brain natriuretic peptide showed that diabetes mellitus and being employed were independent predictors of poorer adherence to self-care behavior ( P = .03, P = .02, respectively), but the experience of previous HF hospitalizations was not a predictor. Conclusions Self-care strategies for HF should target patients with diabetes mellitus and employed patients. Further study is necessary to develop effective programs for such patients.

The aim of this study was to clarify patients' characteristics and the level of symptom management in the transition to specialized home palliative care, and to examine prospectively real-time evaluation of both terminal cancer patients and their families. This study was conducted at one of the largest institutions offering specialized home palliative care in Japan. We asked both the patient's and the family's health status at the initial assessment and 2 weeks later. One hundred sets of patients and their families were included in this study. Regarding patient characteristics at the time of referral to the specialized home palliative care service, patients referred from outpatient settings had more severe physical symptoms than patients referred from inpatient settings. The specialized home palliative care service could contribute to patients' symptom and families' psychosocial status.

重症心身障害児（者）看護の質向上に資するため，重症心身障害児施設で働く看護師が経験を基盤に親への関わりにおける認識と実践を変化させていくプロセスを記述することを目的に，重症心身障害児施設で働く20名の看護師に半構造化面接を行い，グラウンデッド・セオリー・アプローチの手法を用いて分析を行った．その結果，子のケアをしっかりすることで親も満足すると考え〈子へのケアの充実〉を行う段階，できる限り親の要望を表出させ，子のケアに生かす〈親の要望の反映〉の段階，看護師と親がお互い納得できるケアを模索する〈共通認識の模索〉の段階，施設の限られた資源の中でスタッフ間のケアの統一と子一人ひとりを尊重しようとする意識をもつことを目指す〈平等性の追求〉の段階の4段階のプロセスが抽出された．《親には安心して子を預けてもらいたい》という思いがこのプロセスを推し進める原動力となっていた．

Background Patients' advice-giving behaviour could be a useful preventive strategy for type 2 diabetes. Aim To investigate the conditions under which patients offer advice to their offspring and to assess the factors that facilitate advice giving. Design of study Cross-sectional observational study. Setting A general hospital with a diabetes clinic in a metropolitan suburb in Japan. Method Parents with type 2 diabetes ( n = 221) who had offspring aged 20–49 years inclusive without diabetes completed a self-administered questionnaire containing items relating to advice-giving behaviour, demographic characteristics, risk perception, and their disease status. Results A total of 184 (83.3%) patients responded that parental advice-giving behaviour is needed for their offspring, while 138 (62.4%) actually advised their offspring. Multiple logistic regression analysis showed that patients who were female (odds ratio [OR] = 1.94, 95% confidence interval [CI] = 1.03 to 3.65, P = 0.041), living with their offspring (OR =1.92, 95% CI = 1.04 to 3.57, P = 0.038), had complications (OR = 2.74, 95% CI = 1.25 to 6.00, P = 0.029), or perceived that their offspring had a high risk of developing diabetes (OR =1.45, 95% CI = 1.09 to 1.93, P = 0.011) were most likely to advise their offspring. Conclusion Patients with type 2 diabetes recognised the need to give advice about preventive behaviour to their offspring but were not necessarily engaging in advice-giving behaviour. Advice-giving behaviour was affected by the parents' own disease status, their perception of their offspring's risk of developing diabetes, and the relationship between the patients and their offspring.

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.

Summary The study aimed to determine the status of disease management activities that patients under conservative treatment actually performed and to examine the relevant factors in performing or not performing the activities. A survey was conducted with hip OA patients of the orthopaedic outpatient service of one university hospital in Japan. Results indicated that it is necessary to advise patients at an earlier stage of the disease to perform the management activities and to develop a program to link the advice to actual performance of the activities.

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.

Objectives:The aim of the study was to clarify the care experience of primary caregivers when caring for a terminal cancer patient in the home with the assistance of a home palliative care service. Participants were asked to provide background data and to evaluate their experience of caregiving and of the patient's response throughout the period of home palliative care, up to the time of death.Methods:One hundred twelve primary family caregivers were a mailed self-report questionnaire, and 74 valid questionnaires were returned (response rate 66%).Results:Ninety percent felt that the patient's condition of mind and body was reasonably stable, and 75% felt that the death was peaceful. About 90% reported a deepening of their bond with the patient and that the bond of other family members deepened also. Sixty percent reported that the burden of caregiving was not too great or not felt at all. Approximately 90% judged that the patient retained his or her own personal qualities to the end. Ninety percent also felt that they had done their best in their caregiving and judged that home care had been beneficial for the deceased, for the primary caregiver him/herself, and for other family members. These primary caregivers' evaluations of caring for a terminally ill patient at home in conjunction with a home palliative care service were both high and positive.Significance of results:Our findings suggest that it is important to maintain the patient's personal qualities up to the time of death through appropriate symptom management, to respect the family bond of the household, and to provide professional support in order to reduce the load on the family. If appropriate care is provided, peaceful home death will be possible, resulting in significant benefits for patients and their families in Japan.

The purpose of this pilot study (N=26) was to investigate dietary intake and body composition and problems associated with dietary intake (such as unnecessary dietary restriction) in Japanese patients in remission from ulcerative colitis. Findings revealed the macronutrient intake and dietary fiber (absolute amount) were lower than the national average in men, but this may have been due to differences in the methods used to measure dietary intake. Although the fat intake (%E) of ulcerative colitis patients in this study was similar to that of the Japanese population, it differed greatly from that of people in Western countries. No significant differences in weight, height, or body mass index were found when comparing the sample of individuals living with ulcerative colitis with the general Japanese population. Seventeen patients (65.4%) reported being cautious about what they ate even though in remission, and 6 patients were even more cautious about what they ate now than they had been in the past. The authors suggest further research to clarify the problems that unnecessary dietary restriction cause for ulcerative colitis patients who are in remission.

The authors examined the influence of diet (dietary fat intake and dietary temperance) on relapse of patients with Crohn disease. A 1-year prospective study of 76 patients with Crohn disease was conducted. The criterion for eligibility was a Crohn Disease Activity Index score of 150 or lower for at least 1 month. The primary end point was defined as the relapse-free interval from the baseline until the first relapse. Fat intake was assessed using a validated diet history questionnaire. The degree of dietary temperance was assessed using a single-item nominal scale. The Cox proportional hazards model was used to evaluate the influence of diet. Crohn disease relapse was seen in 25 patients (33%), and 47 patients (62%) remained in continuous remission. A decreased ratio of n-6 polyunsaturated fatty acid (PUFA) to n-3PUFA (odds ratio = .38; p = .005) was associated with a poor prognosis. Dietary temperance also was significantly associated with prognosis (p = .014). More moderate dietary temperance decreased the risk of relapse (odds ratio = .22; p = .006). Effective prevention of relapse for Crohn disease patients might be achieved through moderate dietary temperance, particularly when the disease condition is unstable.

Summary In Japan, osteoarthritis of the hip secondary to acetabular hypoplasia has a high prevalence. For long periods of their life, patients receive conservative treatment, but so far no survey has been done. Because the progression of the symptoms is slow with gradually increased pain and increased limitation of the range of motion during 10–30 years, the disease is characterized by its long-term course after the diagnosis is established. Three hundred and thirty patients receiving conservative treatment were assessed to describe the reality of the patients experiencing difficulty in their activities of daily life. The 30 items in five domains were focused on whether the patients felt that the contents of the items were difficult in their daily life. For many of the items, severity of disease was found to be correlated to level of difficulty in daily life for patients with OA in either one or both hips.

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

Aim: The aim of the present study was to investigate changes in alcohol consumption and related factors in diabetic men. Methods: A cross-sectional survey using a self-administered questionnaire and a complementary interview about alcohol consumption was carried out among male diabetic outpatients at a university hospital in Japan (n = 126, 97.0% response rate). Results: Half of the eligible participants had reduced their alcohol consumption by more than 50% between the time of diagnosis of diabetes and the time of the investigation. Of the 65 subjects who consumed more than 200 g/week of alcohol at the time of diagnosis, 70.8% had reduced their alcohol consumption by more than 50% at the time of the investigation and 46.2% had reduced it by more than 80%. Factors related to the reduction in alcohol consumption at the time of the investigation by the 65 subjects whose alcohol consumption at the time of diagnosis was more than 200 g/week were: awareness of diabetic retinopathy (P < 0.01), the presence of acute symptoms at the time of diagnosis of diabetes (P = 0.03), and age

Objective:The aim of this study was to clarify the state of pain management in Japanese patients with advanced cancer who initiated opioid therapy in an outpatient setting.Methods:Interview surveys using questionnaires were conducted and medical records were reviewed. Pain relief was defined as >33% decrease in worst pain intensity score, and significance of early pain relief was investigated in terms of changing self-efficacy for activities of daily living (ADL). Factors related to early pain relief were also investigated.Results:The study was conducted between June and December 2003, on 20 patients (13 women, 7 men; mean age, 59 years). Compared to score at initiation of opioid administration (Numerical Rating Scale, 8.3 ± 1.3), pain relief was generally insufficient at 2 weeks (early pain relief ratio was only 42%). Patients with sufficient pain relief at 2 weeks displayed significant improvements in numerous ADL functions and symptom-coping efficacy (p= 0.037), confirming the importance of early pain relief. Early pain relief was associated with high frequency of hospital visits before opioid administration and absence of sudden excavation within the first 2 weeks.Significance of results:Result of this study indicated insufficient pain relief at an outpatients setting with advanced cancer patients. In the meantime, patients had who their pain decrease after 2 weeks also had improved ADL and self-efficacy at the same time. These findings suggest that to achieve early pain relief in an outpatient setting, clinical staff must assess pain earlier and inform patients of possible breakthrough pain following opioid administration and available treatments for such occurrences.

Aim: Colostomy patients must lead a stable life after discharge. However, little is known about the feeling of stability in the daily life of these patients. The purpose of the present study was to identify the associated factors. Methods: The subjects were outpatients who met all of the following criteria: (i) a permanent colostomy for the treatment of colonic, rectal, or anal cancer; (ii) under 80 years of age; (iii) a colostomy history of less than 10 years; and (iv) no significant prior physical or psychiatric disorders. Data were collected by conducting interviews using a questionnaire, examining medical records, and asking the nurses responsible for patients’ care. The following measures were evaluated: patients’ feeling of stability in the daily life, patients’ characteristics, physical condition, support resources, self-evaluation of their current life, and hospital characteristics. Statistical analysis was performed using t-tests, Spearman's rank correlation coefficients, and structural equation model. Results: Data from 133 patients were available for analysis. The final model fitted the data well. All estimated parameters were significant. The opportunity to attend periodic stoma clinics and support from nurses contributed to the feeling of stability in the daily life and had a positive effect on patients’ self-evaluation of their current life. Conclusions: The results of this study corroborated the necessity for an outpatient support system to enhance the feeling of stability in the daily life after hospital discharge. This finding supports the need to improve stoma care systems and to make such systems more available.

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.

BACKGROUND To the authors' knowledge, there have been few studies of the psychologic distress after disclosure of genetic test results for hereditary nonpolyposis colorectal carcinoma (HNPCC). The objectives of this study were to identify the prevalence rates and predictors of psychologic distress and to evaluate the feelings of guilt after disclosure of the test results in Japanese probands and unaffected relatives. METHODS Probands and unaffected relatives were interviewed immediately after the first genetic counseling session for HNPCC and again 1 month after disclosure of the genetic test results. The prevalence of major and minor depression, acute stress disorder (ASD), posttraumatic stress disorder (PTSD), and posttraumatic stress symptoms (PTSS) were assessed using the Structured Clinical Interview based on the Diagnostic and Statistical Manual of Mental Disorders, 3rd edition revised (DSM-III-R) or the DSM-IV; feelings of guilt were investigated using a numeric scale and a semistructured interview. RESULTS Among 47 participants who completed the baseline interview, 42 participants (89%) completed the 1-month follow-up interview. Although none of the participants met the criteria for major depression, ASD, or PTSD at the follow-up interview, 3 of 42 participants (7%) met the criteria for minor depression and 2 participants (5%) had PTSS. The only predictor of psychologic distress found was the presence of a history of major or minor depression (odds ratio, 19.41; 95% confidence interval, 1.42–264.95; P < 0.05). Five of 42 participants (12%) had feelings of guilt. CONCLUSIONS Disclosure of genetic test results for HNPCC may not cause significant psychologic distress in Japanese probands or relatives. However, healthcare providers should not neglect to assess these individuals for psychologic responses, such as minor depression and PTSS. Cancer 2004. © 2004 American Cancer Society.

Health-care providers engaged in palliative care experience difficulty with the practice of team care. However, the details of the difficulties have not been not clarified. To obtain an overview of team care in the Japanese palliative inpatient care setting, a descriptive and cross-sectional study was performed. The participants were physicians, nurses, dietitians, medical social workers (MSWs), and pharmacists. A representative from each discipline was selected. They were asked about their participation in services provided by government-approved palliative care units (PCUs) and the practice of team care. A total of 38 institutions participated in this study. In these institutions, 97% of physicians, 37% of dietitians, 39% of MSWs, 27% of pharmacists, and 13% of physical therapists attended PCU care meetings once a week or more, and 35% of religious workers and 11% of counselors attended. About 70% of institutions held regular care meetings with more than three types of health-care providers. Physicians and nurses had different perceptions regarding the practice of team care. The former had a positive perception of team care and the latter had a negative perception. In addition, nurses' perception of overall team care was related to their perception of care meetings ( P=0.052) and the number of types of professional participating in care meetings ( P=0.054). To promote team care in the Japanese palliative care setting, it is necessary to consider a practical standard of team care, and to conduct effective care meetings.

This study was conducted to elucidate factors that influence the self-evaluation of physical condition and perception of difficulties of life in ulcerative colitis patients. A survey and clinical examination were carried out in 171 outpatients with ulcerative colitis. Self-evaluation of physical condition was assessed according to a five-grade system. Perception of difficulties of life was assessed using a scale developed by the authors and others. Physical condition of patients was assessed according to their disease state, disease symptoms, and nutritional state. Additional related factors such as mental condition, demographic attributes, and psychosocial states were also investigated. Multiple regression analyses was used to assess the relationships among variables and showed that perception of difficulties of life and disease symptoms were the main explanatory factors for the self-evaluation of physical condition. Perception of difficulties of life was comprised of physical and mental conditions, the latter being further influenced by the patients' psychosocial state.

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.

Purpose Increased fibrinogen levels may trigger cardiac events in patients with atherosclerosis. Early control of fibrinogen levels before the progression of atherosclerosis that occurs with aging and menopause may benefit women, but the effects of exercise on fibrinogen levels as a preventive value have not been examined in early to middle adulthood women with lack of regular exercise. The present study aims to identify the effect of an off-site walking-based exercise program on fibrinogen levels in such women. Methods A prospective, 12-week, randomized and controlled study was used. Fifty-two women aged 32 to 57 years who did not exercise regularly or exercised with a weak intensity level were randomly assigned to either an intervention group (IG, n = 26) or a control group (CG, n = 26) for a 12-week study. Exercise energy expenditure (EEE) was measured using a microelectronic device. Fibrinogen levels were assessed using the clotting time method before and after the exercise program. Results The mean change from baseline EEE was 1.17 ± 0.98 kcal/kg/day in IG subjects (n = 24) and 0.46 ± 0.68 kcal/kg/day in CG subjects (n = 25), a 30% difference between groups (p = .01). The mean change in fibrinogen levels was –8.0 ± 34.5 mg/dl (3% decrease) in IG subjects (n = 24) and –3.6 ± 40.0 mg/dl (1% decrease) in CG subjects (n = 25). No significant difference in fibrinogen levels was seen between groups (F = 1.179, p = .279). Conclusion EEE increased significantly, but fibrinogen levels did not decrease significantly. The effects of a 12-week off-site walking program on fibrinogen levels were inconclusive. As implications for nursing practice, our findings have suggested fibrinogen levels are not a novel cardiovascular risk factor any more, and provide important information on safe exercise to minimize adverse effects from fibrinogen arising from exercise intensity, especially in women with advanced atherosclerosis when nurses increase exercise intensity levels. Further studies with larger sample sizes in women to confirm the effect of exercise on reducing fibrinogen levels are necessary. [Asian Nursing Research 2008;2(1):35–45]

Previous reports have demonstrated that breast cancer patients felt that news of their recurrence was more upsetting than their initial diagnosis. However, no studies have examined the factors that are correlated with mental adjustment in breast cancer patients who experienced recurrence. The authors investigated factors that are correlated with mental adjustment styles of fighting spirit or helplessness/hopelessness in women with breast cancer with a first recurrence. Fifty-five participants were interviewed and completed the Mental Adjustment to Cancer scale. Factors that correlated significantly with fighting spirit were performance status and history of major depression, while factors that correlated significantly with helplessness/hopelessness were age, pain, and history of major depression. These findings suggest that it is necessary to provide intervention for first recurrent breast cancer patients who have such biomedical factors, as young age, poor performance status, pain, and history of major depression to help them better cope with cancer.

This research investigated the relationships among the severity of inflammation, the extent of fatigue, and fatigue symptoms, and the relationship between fatigue and coping behavior in patients with rheumatoid arthritis (RA). Our study group consisted of 177 female patients with RA (105 women with CRP > 0.5 mg/dl and ESR > 30 mm/h (inflammatory group) and 72 women with CRP ≦ 0.5 and ESR ≦ 30 (noninflammatory group)) and 81 age-matched healthy women (control group) who were given self-assessment questionnaires. The extent of fatigue was higher in the inflammatory group than in the noninflammatory and control groups. The characteristics of fatigue symptoms in the inflammatory group were "decline in the strength to carry on the activities of daily life" and "difficulty in performing daily activity." The patients in the inflammatory group adopted a technique of "reducing the burden on the body" as a pattern of coping behavior for reducing fatigue. The extent of fatigue and fatigue symptoms perceived by RA patients is strongly related to the severity of inflammation, and these patients adopt a coping behavior in response to the extent of fatigue and subjective symptoms.

Aims To investigate the effect of a computer-supported indirect-form lifestyle-modification program using Lifestyle Intervention Support Software for Diabetes Prevention (LISS-DP), as a clinically feasible strategy for primary prevention, on diet and physical activity habits in adults with a family history of type 2 diabetes. Methods This was a two-arm, randomized controlled trial: (1) lifestyle intervention (LI) group (n = 70); (2) control (n = 71). Healthy adults aged 30–60 years with a history of type 2 diabetes among their first-degree relatives were recruited. LI group received three times of lifestyle intervention using LISS-DP during six-month intervention period via mail. Results Lifestyle intervention group showed significantly greater decrease in energy intake six months after baseline, compared to control (−118.31 and −24.79 kcal/day, respectively, p = 0.0099, Cohen's d = 0.22), though the difference disappeared 1 year after from baseline. No difference was found in physical activity energy expenditure. Conclusions A computer-based, non-face-to-face lifestyle intervention was effective on dietary habits, only during the intervention period. Further examination of the long-term effects of such intervention and physical activity is required.

An evaluation scale is indispensable for the promotion of continuing, effective postkidney transplantation self-management behaviors. We aimed to develop and validate a new self-management scale for kidney transplant recipients to improve their long-term outcomes and prevent the recurrence of CKD complications. Two hundred and thirty-nine Japanese patients who had undergone kidney transplantation were recruited from three hospitals. The scale’s validity and reliability were evaluated using exploratory factor analysis and intraclass correlation coefficients. Scale items were selected by considering the findings of a clinical importance survey of 17 experts. Four subscales were identified by the factor analysis: “Self-monitoring” (six items), “Self-care behavior in daily living” (seven items), “Early detecting and coping with abnormalities after kidney transplantation” (four items), and “Stress management” (three items). Cronbach’s alpha coefficients for the subscales ranged from 0.61 to 0.87. A further four items with high clinical importance were added to the scale. The final scale comprised 24 items within four subscales and four single items. The intraclass correlation ranged from 0.88 to 0.95 in each subscale and the weighted kappa coefficient for the single items ranged from 0.33 to 0.72. The validity and reliability of our new self-management scale were confirmed by a patient-based field survey.

The aim of this study is to investigate the effect of diabetes genetic counseling on attitudes toward diabetes and its heredity in relatives of type 2 diabetes patients. This study was an unmasked, randomized controlled trial at a medical check-up center in Japan. Subjects in this study are healthy adults between 30 and 60 years of age who have a family history of type 2 diabetes in their first degree relatives. Participants in the intervention group received a brief genetic counseling session for approximately 10 min. Genetic counseling was structured based on the Health Belief Model. Both intervention and control groups received a booklet for general diabetes prevention. Risk perception and recognition of diabetes, and attitude towards its prevention were measured at baseline, 1 week and 1 year after genetic counseling. Participants who received genetic counseling showed significantly higher recognition about their sense of control over diabetes onset than control group both at 1 week and 1 year after the session. On the other hand, anxiety about diabetes did not change significantly. The findings show that genetic counseling for diabetes at a medical check center helped adults with diabetes family history understand they are able to exert control over the onset of their disease through lifestyle modification.

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.

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 (P0.05). 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.