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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.

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 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 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.

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.

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

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.

IthasnotyetbeenestablishedhowtoimprovetheprognosisofHFpEF,i.e.heartfailure withpreservedejectionfraction(EF).Purpose:Toclarifythedifferentialeffectsofcar- vedilol on clinical outcomes and left ventricular EF in HFpEF and heart failure with reduced EF (HFrEF). Methods and Results: A two-year prospective cohort study was conducted on 113 patients with heart failure (74.3% males; mean age 64.4 years) in cardiovascular outpatient clinic of university hospital. HFpEF (EFO 550%) and HFrEF (EF! 50%) were present in 65 (57.5%) and 48 (42.5%) patients. Carvedilol wasprescribed33.9%inHFpEFand68.8%inHFrEF.Averageofdailydoseatbaseline and the end of follow-up were higher in HFrEF than in HFpEF (7.2 vs. 3.8 mg, P ! 0.01; 10.3 vs. 4.7 mg, P ! 0.01). Two-year cardiac death and/or heart failure hos- pitalization in HFpEF were relatively lower than those in HFrEF (12.3 vs. 22.9%, P 50.15). Carvedilol significantly reduced the cardiac events in HFpEF (P 50.03) as well as in HFrEF (P! 0.01 for linear dose-response). In addition, carvedilol improved left ventricular EF only in HFrEF in a clear dose-dependent manner (P ! 0.01). Conclusions: Our results strongly confirm that the higher dose of carvedi- lol makes the prognosis better with the higher EF in HFrEF. Besides, our data suggest that carvedilol should also be indicated in HFpEF. Background: Although structural and functional changes in peripheral vasculature are involved in the progression of heart failure (HF), there have been few reports in- vestigating systemic vascular resistance in relation to the prognosis of acute decom- pensated HF. Methods & Results: Forty-nine Consecutive patients (71.6 years of age, 34 males) admitted to our intensive care unit due to HF exacerbation in 2006- 08 with pulmonary catheter monitoring were investigated. The patients were divided into 2 groups according to the systemic vascular resistance index (SVRI) at hospital- ization by the median value of 1929 dynes sec/cm 5 /m 2 .Although the clinical profile at admission including left ventricular ejection fraction, plasma BNP, cardiac index and pulmonary artery wedge pressure did not differ between the groups, a previous his- tory of HF hospitalization was less in the high SVRI group (H) compared with the low (L) (0.1 60.5 vs. 0.6 60.7 times, p 50.039). During the initial 24-hour follow-up, SVRI was somewhat increased in L, but not in H (delta SVRI: þ577 vs. -48 dynes sec/cm 5 /m 2 ,p 50.001) regardless of the administration of vasodilators. Conclusion: An initially low but then later increased SVRI level during management of acute decompensated HF using vasodilators may be a helpful indicator for predict- ing a poor prognosis.