Relationship of Concomitant Medications on Infusion Related Reactions to Infliximab： A Case-Control Study Using Individual Case Safety Reports Database / 薬剤疫学

Objective：Infliximab is a chimeric monoclonal antibody against tumor necrosis factor (TNF) -α that is indicated in the treatment of chronic inflammatory diseases. Infliximab is administered by intravenous infusion and may be associated with infusion related reactions (IRRs). Recent study showed that the use of concomitant antihistamines associated with an increased incidence IRR, using an observational registry database in Canada. The aim of this study was to determine whether the use of concomitant antihistamines associated with an increase in the proportional reporting ratio (PRR) of IRR, using individual case safety reports (ICSRs) with infliximab as one of the suspected drugs, not only from Canada, but also from the United States of America (US), the United Kingdom (UK), and Japan.Design：Case-control studyMethods：We used VigiBase, the WHO's global safety report database, in this study. One-to-one propensity-matching analysis was performed in each country using IBM SPSS version 24 to evaluate outcomes. The primary endpoint was the assessment of concomitant medications associated with IRR in the cases treated with infliximab.Results：There were 35,729, 19,095, 4,618, and 1,565 ICSRs in which some adverse events were reported with infliximab as one of the suspected drugs in Canada, the US, the UK, and Japan, respectively, after the exclusion of ICSRs with unknown patient age or unknown patient sex. IRRs were reported in 2,293, 1,427, 303, and 69 ICSRs, respectively. The use of concomitant antihistamines was significantly associated with an increased PRR of IRR in Canada (p<0.001). The uses of concomitant antihistamines were also significantly associated with an increased PRR of IRR in the US (p<0.001), the UK (p<0.001), and Japan (p＝0.007).Conclusion：The uses of concomitant antihistamines were associated with an increased PRR of IRR with infliximab in the case-control study using ICSRs from Canada, the US, the UK, and Japan.

Relationship of Concomitant Medications on Infusion Related Reactions to Infliximab： A Case-Control Study Using Individual Case Safety Reports Database / 薬剤疫学

Objective ： Infliximab is a chimeric monoclonal antibody against tumor necrosis factor (TNF) -α that is indicated in the treatment of chronic inflammatory diseases. Infliximab is administered by intravenous infusion and may be associated with infusion related reactions (IRRs). Recent study showed that the use of concomitant antihistamines associated with an increased incidence IRR, using an observational registry database in Canada. The aim of this study was to determine whether the use of concomitant antihistamines associated with an increase in the proportional reporting ratio (PRR) of IRR, using individual case safety reports (ICSRs) with infliximab as one of the suspected drugs, not only from Canada, but also from the United States of America (US), the United Kingdom (UK), and Japan.Design ： Case-control studyMethods ： We used VigiBase, the WHO's global safety report database, in this study. One-to-one propensity-matching analysis was performed in each country using IBM SPSS version 24 to evaluate outcomes. The primary endpoint was the assessment of concomitant medications associated with IRR in the cases treated with infliximab.Results ： There were 35,729, 19,095, 4,618, and 1,565 ICSRs in which some adverse events were reported with infliximab as one of the suspected drugs in Canada, the US, the UK, and Japan, respectively, after the exclusion of ICSRs with unknown patient age or unknown patient sex. IRRs were reported in 2,293, 1,427, 303, and 69 ICSRs, respectively. The use of concomitant antihistamines was significantly associated with an increased PRR of IRR in Canada (p<0.001). The uses of concomitant antihistamines were also significantly associated with an increased PRR of IRR in the US (p<0.001), the UK (p<0.001), and Japan (p＝0.007).Conclusion ： The uses of concomitant antihistamines were associated with an increased PRR of IRR with infliximab in the case-control study using ICSRs from Canada, the US, the UK, and Japan.

The burden of introducing the Japanese language version of the Liverpool Care Pathway（LCP-J）for dying patients in general wards and their families：experience of health care professionals in a university hospital

The purpose of this study was to explore the burden of introducing LCP-J in two wards（medical oncology and respiratory medicine）in Tohoku University Hospital. We administered audit evaluations about dying cancer patients and interviewed 2 doctors and 8 nurses regarding LCP-J intervention. LCP-J was used for 22 patients（38％）, and no significant difference in infusion, potent opioid analgesic and sedative medication within last 48 hours were seen between users and nonusers. Responses were categorized into［confirm directions about dying care among health care professionals］, and［training in dying care in a structured way］as usefulness facets of the LCP-J, and［difficulty in assessment of dying］,［burden of health care professionals］, and［difficulty using LCP-J without knowledge and training in dying care］as burdens of the LCP-J. We explored the burden of LCP-J in general wards, and found that use of the LCP-J could need education in dying care and backup of the palliative care team.

Difficulty with cancer care and related factors among nurses at Tohoku University Hospital

The purposes of this study were to describe nurses’ difficulty with cancer care and explore factors related to the difficulty of cancer care. Self－reported questionnaires were distributed to 512 nurses who are engaged in cancer care at Tohoku University Hospital. Responses from 344 (67％) nurses were subjected to analysis. The results revealed that nurses felt that “communication” was the most difficult aspect of cancer nursing followed by “hospital system and regional alliances” and “knowledge and skill.” Nurses did not feel that “collaboration with doctors” “disclosure and explanation of disease” or “death and dying” had particularly high levels of difficulty, however, their levels of difficulty could be improved. Greater difficulty with cancer care was reported by nurses working on the general ward and nurses with limited cancer care experience in the last year. Communication skill training,education (especially for less experienced nurses), expansion of palliative care, and restructuring of discharge planning and regional collaboration systems might contribute to decreasing nurses’ difficulty with cancer care.

Development of scale to measure nurses' difficulty with cancer care (NDCC)

<b>Purpose</b>: This study was to develop a scale to measure difficulties encountered by cancer care by nurses and to evaluate the reliability and the validity of the scale. <b>Methods</b>: Self-reported questionnaires were administered to nurses who are engaged in cancer care in Tohoku University Hospital. <b>Results</b>: Of 512 questionnaires distributed to nurses, 356 were completed and returned 70%. We selected 49 items in 6 domains, including "communication" "knowledge and skill" "collaboration with doctor" "disclosure and explanation of disease" "hospital system and regional alliances" and "death and dying" using explanatory factor analysis. Cronbach's α coefficient was 0.68 across domains and ranged from 0.69 to 0.74 for each domain. Construct validity was demonstrated and the scaling success rates were 100% for all domains on multitrait scaling analysis. In terms of the known groups validity, the score for the nurses in the palliative care unit was significantly lower than for nurses on the general wards. <b>Conclusion</b>: This study showed that the scale has sufficient reliability and validity. This scale may contribute to cancer nursing by assessing hospital nurses' perception of cancer care and as a method of determining outcomes of educational or organizational interventions.