1.8-week Safety Profile of Tapentadol Extended Release Tablets Switched from Other Opioids for Well-controlled, Moderate to Severe, Chronic Malignant Tumor-related Pain: Constipation, Nausea, Vomiting and Somnolence
Keiichiro Imanaka ; Takashi Yoshimura ; Yushin Tominaga ; Hiromi Koga ; Keiichiro Hirose
Palliative Care Research 2016;11(1):116-122
It was previously reported the safety and efficacy of oral tapentadol ER switched from other opioids for 8 weeks in subjects with moderate to severe cancer pain, who received opioid analgesics prior to study participation. All treatment emergent adverse events were evaluated in previous safety analysis. In this report, the incidence and timing of opioid specific adverse events related to tapentadol administration were analyzed and compared with those of morphine SR as a reference. Fifty subjects each was randomized to the tapentadol ER group and the morphine SR group. The incidences of major adverse events that are considered related to treatment in the tapentadol ER group and the morphine SR group were nausea (8.0%, 14.0%), vomiting (2.0%, 24.0%), constipation (8.0%, 20.0%), and somnolence (8.0%, 18.0%), the incidences of these events were lower in the tapentadol ER group. These results suggest that tapentadol ER is a orally opioid which has well safety profiles, and is a new option of cancer pain therapy.
2.A Multicenter, Open-label Study of Tapentadol Extended-release Tablets in Opioid-naïve and Opioid-switching Subjects with Moderate to Severe Cancer Pain
Keiichiro Imanaka ; Takashi Yoshimura ; Yushin Tominaga ; Hiromi Koga ; Keiichiro Hirose
Palliative Care Research 2016;11(2):147-155
The present multicenter, open-label study evaluated the efficacy and safety of tapentadol ER administered at 50 mg/day to 500 mg/day in opioid-naive and opioid-switching subjects with moderate to severe cancer pain. For opioid-naive subjects, the initial dose was tapentadol ER 50 mg/day. For opioid-switching subjects, the initial dose was determined depending on previously used opioid and was dose-adjusted for each subject. The study design consists of two parts of titration period and maintenance period to which a patient who achieves dose adjustment can proceed. The percentage of subjects achieving dose adjustment in the titration period was 93.3% for opioid-naive subjects and 80.6% for opioid-switching subjects. The percentage of subjects who maintained adequate analgesia throughout the maintenance period (primary endpoint) was 89.7% for opioid-naive subjects and 92.9% for opioid-switching subjects. The most frequent adverse events were were nausea, vomiting, somnolence, and constipation, all of which were commonly reported with the use of opioids. These findings showed that tapentadol ER was well tolerated in the dose range of 50 mg/day to 500 mg/day.
3.Factors Influencing a Sense of Care Burden Related to Interpersonal Trust in Family Caregivers of Elderly Dementia Patients Living at Home
Hiromi KIMURA ; Midori NISHIO ; Kayoko KOGA ; Hiroko KUKIHARA
Journal of the Japanese Association of Rural Medicine 2020;69(2):111-120
The purpose of this study was to clarify the effects of and factors that influence the burden of caregiving in relation to the caregiver's personality and interpersonal trust. The study targeted family members who were primary caregivers of elderly patients with dementia living at home and using care services such as home-visit nursing services and outpatient rehabilitation in Prefecture A. The survey was conducted using a self-administered questionnaire battery delivered to and completed at the subject's home. The battery contained questions about the subject's personal profile, the Interpersonal Trust Scale, Zarit-8 (Japanese version), the Family Adaptation and Cohesion Evaluation Scales (FACES III Japanese version), and the Medical Outcome Study MOS 8-Item Short-Form Health Survey (Japanese version SF-8). We made a comparison of the sense of care burden for elderly dementia patients living at home after dividing the subjects into two groups based on the average caregiver score on the Interpersonal Trust Scale. The group with higher interpersonal trust scores reported a significantly lower sense of care burden. It was speculated that the ability to consult with family and friends about how to build trust with others and cope with the needs of nursing care was related to the caregiver's sense of interpersonal trust. The study found that influencing factors for a sense of care burden were interpersonal trust, supporters other than family members, and family type. The findings also suggest that interpersonal trust could influence the sense of care burden.
4.Effects of Physical and Emotional Interventions on Stress in Elderly People With Alzheimer's Disease Who Show Behavioral and Psychological Symptoms of Dementia
Hiromi KIMURA ; Kayoko KOGA ; Hiroko KUKIHARA ; Midori NISHIO
Journal of the Japanese Association of Rural Medicine 2022;71(1):12-21
The purpose of this study was to evaluate the stress accompanying behavioral and psychological symptoms of dementia (BPSD) and to validate the care that brings eustress through physical and emotional interventions. The participants were 57 elderly people with BPSD who used or lived in long-term care facilities, group homes, small-scale multifunctional home care services, and community-based specified facilities in prefecture X. The study included a 2-week control period and a 12-week intervention period in which square-stepping exercise (SSE) was introduced and the validation method was used for communication. Results showed that stress levels were higher when BPSD appeared. After SSE, amylase activity levels decreased in 70% of the participants, although the decrease was not statistically significant, and facial expression significantly improved in Face Scale (FS) assessment. Also, after validation communication, amylase activity levels showed a significant decrease and facial expression significantly improved in the FS assessment. Even though most of the participants in this study were elderly people with moderate dementia, SSE appeared effective for enjoying physical activity and making friends, and validation can be expected to have the effect of sharing time and relieving stress.
5.Depression and Associated Factors Among Community-Dwelling Elderly People
Hiromi KIMURA ; Midori NISHIO ; Kayoko KOGA
Journal of the Japanese Association of Rural Medicine 2021;70(4):325-333
The aim of this study was to clarify the current status of depression among healthy community-dwelling elderly people and to examine the association between depression and their sense of purpose in life. A self-administered questionnaire survey was conducted with 213 elderly people who attended a public lecture at University A. The outcome measures were the Geriatric Depression Scale (GDS), the K-1 Scale for the Feeling That Life Is Worth Living Among the Aged (Ikigai Scale), the Social Support Scale for the Elderly (Social Support Scale), and a basic checklist (Frailty Scale). Using a cut-off of 4/5 points on the GDS, respondents were divided into a non-depressive group (≤ 4 points) and a depressive group (≥ 5 points). Each variable was compared between the two groups. Multiple regression analysis was performed to examine factors associated with depression. Among the 213 people who received the survey, 196 responded (response rate: 92.0%) and 185 provided valid responses after excluding those with missing data (valid response rate: 86.9%). Of these 185 respondents, 80 were classified into the non-depressive group (35 men, 45 women) and 52 into the depressive group (14 men, 38 women), which showed a significant sex difference. Mean age was 73.2 (SD 6.9) years in the non-depressive group and 76.1 (SD 7.74) years in the depressive group, which also showed a significant difference. The Ikigai Scale score was significantly higher in the non-depressive group compared with the depressive group. The Ikigai subscale scores for “self-realization and will”, “sense of life fulfillment”, “will to live”, and “sense of existence” were significantly higher in the non-depressive group. In the multiple regression analysis, factors associated with depression were sense of life fulfillment (β=-0.36), health status (β= 0.24), will to live (β=-0.17), age (β= 0.24), negative support (β=0.18), and healthy habits (β=0.12). These results suggest that depression is associated with self-realization, sense of life fulfillment, will to live, and sense of existence, indicating the importance of activities that create a sense of purpose in life for preventing depression in the community-dwelling elderly people.
6.Retraction: Depression and Associated Factors Among Community-Dwelling Elderly People
Hiromi KIMURA ; Midori NISHIO ; Kayoko KOGA
Journal of the Japanese Association of Rural Medicine 2021;70(4):325-333
This article was retracted.
7.Development of a Care Needs Scale for Family Caregivers of Older Adults with Early Cognitive Dysfunction
Hiromi KIMURA ; Kayoko KOGA ; Midori NISHIO ; Hiroko KUKIHARA
Journal of the Japanese Association of Rural Medicine 2024;72(5):374-384
This study aimed to develop a scale for identifying care needs to enable family caregivers to provide appropriate care to community-dwelling elderly people with early cognitive dysfunction. We developed a draft scale taking into account 32 items of care needs for elderly people with early cognitive dysfunction based on previous studies, and we conducted a questionnaire survey with 86 primary caregivers of elderly people who attended memory loss consultations at Regional Comprehensive Support Center A and the Outpatient Memory Loss Clinic in the Department of Neurology at University Hospital B. Exploratory factor analysis revealed 3 factors consisting of 14 items: (1) family's lack of understanding of early cognitive dysfunction and caregiving, (2) confusion about caregiving and consultations, and (3) caregiving methods and prevention of deterioration with early cognitive dysfunction. Cronbach’s alpha was calculated to be 0.83 for all items, confirming the reliability of the results. In the results of confirmatory factor analysis, the model fit was goodness of fit index (GFI) = 0.89, adjusted GFI = 0.88, comparative fit index = 0.90, and root mean square error of approximation = 0.08. The Care Needs Scale for Elderly People with Early Cognitive Dysfunction consists of 14 items, and this study suggests that the scale can be used to help caregivers of elderly people with early cognitive dysfunction provide appropriate care.
8.Care needs of caregivers of the elderly with early-stage dementia
Hiromi KIMURA ; Kayoko KOGA ; Midori NISHIO
Journal of Rural Medicine 2024;19(2):57-65
Objective: This study aimed to identify the care needs of family caregivers of elderly patients with early-stage dementia and examine support measures.Materials and Methods: We conducted a self-administered questionnaire survey with 115 primary caregivers of outpatients who visited A City Community General Support Center or B University Hospital Department of Neurology for memory loss consultation. The questionnaire content included demographic characteristics, the care needs scale for caregivers of the elderly with early-stage dementia (Care Needs Scale), and the Japanese short version of the Zarit Burden Interview. The Medical Ethics Committee of Fukuoka University approved this study (approval number: M047). Of the 115 participants, 104 were included in the analysis after excluding 11 respondents with missing data. We divided the participants into a young group (under 65 years of age) and an old group (65 years of age or older) and compared the variables and each scale score using the Mann–Whitney U test. We also compared the correlations between the total score and subscale scores of the Care Needs Scale and each variable, in addition, we performed multiple regression analyses using the total score of the Care Needs Scale as the dependent variable.Results: The young caregivers wanted to know how to take care, prevent deterioration, and deal with symptoms of early-stage dementia. They were trying to balance caregiving with work and housekeeping and reduce the stress and burden of long-term care. Older caregivers were confused about caregiving and wanted someone to talk about their situations.Conclusion: Both groups shared that the family’s lack of understanding about caregiving and personal and role strains were associated with the care needs of caregivers of the elderly with early-stage dementia.
9.Specialties of Public Health Nurses at a Comprehensive Community Support Center :
Kayoko KOGA ; Hiromi KIMURA ; Midori NISHIO ; Hiroko KUKIHARA
Journal of the Japanese Association of Rural Medicine 2020;68(5):634-
It has been reported that a comprehensive community support center cannot maintain boundaries between particular specialties (ie, public health nurses, social workers, and the chief care manager), resulting in excessive workload, staff shortages, and resignations. Nurses are beginning to acknowledge poor interprofessional interactions among themselves and are now concerned with improving nursing practice. In this study, we aimed to clearly specify the specialties of nurses in order to obtain relevant basic data for establishing an educational training system for community health nurses. We conducted text mining analysis using KH Coder open source software by targeting 8 community health nurses with over 3 years of experience in Prefecture A. The following 5 clusters of specialties were extracted: “Ability to provide consultation, maintain good relationships, and make good decisions”, “Good knowledge of medical care in general, care of the elderly with dementia and mental illness, and their situation at home”, “Services that prevent the elderly from becoming dependent”, “Collaboration with other professions by participating in home visits or community center visits”, and “Work that requires comprehensive guidance on health within the community”. To clarify the nursing specialty, it is desirable to comprehensively support a team approach by utilizing each specialty in 3 job types. In addition, we suggest that general community nursing roles can be better demonstrated by developing a vision, providing accessible consultation and supervision, and outlining a clear career path as part of the educational system.
10.The role of caregiver burden in the familial functioning, social support, and quality of family life of family caregivers of elders with dementia
Hiromi KIMURA ; Midori NISHIO ; Hiromko KUKIHARA ; Kayoko KOGA ; Yuriko INOUE
Journal of Rural Medicine 2019;14(2):156-164
Objective: The present study aimed to examine the role that caregiver burden plays in the familial functioning, social support, and quality of family life (QOFL) of caregivers of elderly family members with dementia. Methods: A survey was conducted with 200 primary caregivers of elderly dementia patients who resided in prefecture “S”. The questionnaire consisted of items that required demographic information, the Japanese versions of the Zarit Burden Inventory (ZBI) and the Family Adaptability and Cohesion Evaluation Scales (FACES II), and scales that measure quality of family life and social support. On the basis of the median ZBI score (i.e., 30.8), participants were divided into two groups: group A (i.e., ZBI score < 30) and group B (i.e., ZBI score > 30). Stepwise multiple regression analysis was conducted with QOFL as the dependent variable. Version 24 of the Statistical Package for the Social Sciences for Windows was used to conduct all the statistical analyses; the statistical significance level was specified as 0.05. Results: Group A and B obtained average ZBI scores of 18.5 and 43.8, respectively. The study targeted 81 patients from group A (average age = 61.0 years) and 77 patients from group B (average age = 61.7 years). Time that was spent on caregiving tasks was significantly higher for group B, when compared to group A. In addition, significant differences in cohesion and adaptability, which are two dimensions that are measured by the FACES II, and QOFL emerged between the two groups. The results of the multiple regression analysis showed that cohesion (β = 0.38), practical support (β = 0.32), adaptability (β = 0.30), and living arrangement (β = −0.12) significantly predicted QOFL. Conclusion: Family cohesion and adaptability are indicators of healthy familial functioning. In order to improve the QOFL of caregivers of elderly dementia patients, it is necessary to strengthen emotional ties, maintain emotional attachment, and flexibly respond to the burden of nursing care and changes in power structures and role relationships.