Objective  This study aimed to identify the types, frequency, and clinical significance of altered interpreta-tion in clinical settings.Methods  Routine outpatient encounters involving Portuguese-speaking Brazilian patients, Japanese doctors, and hospital-provided interpreters were digitally recorded and transcribed. Segments of consecutively interpreted utterances were coded as “altered,” in which the interpreter changed the meaning of the source utterance, or “unaltered (accurate),” and the types and frequency of occurrence were analyzed. Altered interpretations were categorized as clinically negative or positive and classified into four categories: omission, addition, substitution, or voluntary intervention. Incidents resulting from alterations were investigated. Reliability was assessed by examining the correlation between random independently coded samples.Results  In total, 111 encounters were analyzed. The mean segments per encounter was 67.9 (range 14-186), and the mean frequency (standard deviation) of altered interpretations per 100 segments was 46.7 (14.3) for accurate interpretations; 46.1 (17.9) for negative or not significant alterations, including 27.2 (10.3) for omissions, 6.0 (5.0) for additions, 10.4 (6.9) for substitutions, and 2.5 (2.7) for voluntary interventions; 0.0 (0.2) for alterations potentially leading to an incident; and 26.2 (11.9) for positive alterations, including 1.8 (2.6) for positive omissions, 7.7 (4.7) for positive additions, 7.8 (6.3) for positive substitutions, and 8.8 (5.2) for positive voluntary interventions. The frequency of negative alterations was weakly negatively correlated with number of segments per minute (r＝−0.339). Conclusion  Trained healthcare interpreters with fewer clinically significant altered interpretations were effective. Professional medical providers should recognize the importance of positive alterations by healthcare interpreters and collaborate with them to provide safe medical care for foreign patients. To facilitate the provision of appropriate medical care to a growing foreign population with diverse cultural and linguistic needs, undergraduate medical education should teach aspiring medical professionals how to collaborate with healthcare interpreters and foreign patients.

Background/Aims: 5-Aminosalicylic acid (ASA) causes intolerance reactions in some patients. This study was performed to examine the prognosis of patients with ulcerative colitis (UC) and 5-ASA intolerance, and to evaluate the potential interaction between 5-ASA intolerance and the intestinal microbiota. Methods: We performed a retrospective cohort study of patients with UC who visited participating hospitals. The primary endpoint was to compare the incidence of hospitalization within 12 months between the 5-ASA intolerance group and the 5-ASA tolerance group. The secondary endpoint was to compare the risk of adverse clinical outcomes after the start of biologics between the 2 groups. We also assessed the correlation between 5-ASA intolerance and microbial change in an independently recruited cohort of patients with UC. Results: Of 793 patients, 59 (7.4%) were assigned to the 5-ASA intolerance group and 734 (92.5%) were assigned to the 5-ASA tolerance group. The admission rate and incidence of corticosteroid use were significantly higher in the intolerance than tolerance group (P< 0.001). In 108 patients undergoing treatment with anti-tumor necrosis factor biologics, 5-ASA intolerance increased the incidence of additional induction therapy after starting biologics (P< 0.001). The 5-ASA intolerance group had a greater abundance of bacteria in the genera Faecalibacterium, Streptococcus, and Clostridium than the 5-ASA tolerance group (P< 0.05). Conclusions In patients with UC, 5-ASA intolerance is associated with a risk of adverse clinical outcomes and dysbiosis. Bacterial therapeutic optimization of 5-ASA administration may be important for improving the prognosis of patients with UC.

BACKGROUND/AIMS: Although the risk of bleeding after endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is low, the safety of EUS-FNA in patients prescribed antithrom-botic agents is unclear. Therefore, this study evaluated the incidence of bleeding after EUS-FNA in those patients. METHODS: Between September 2012 and September 2015, patients who were prescribed antithrombotic agents underwent EUS-FNA at 13 institutions in Japan were prospectively enrolled in the study. The antithrombotic agents were managed according to the guidelines of the Japanese Gastrointestinal Endoscopy Society. The rate of bleeding events, thromboembolic events and other complications within 2 weeks after EUS-FNA were analyzed. RESULTS: Of the 2,629 patients who underwent EUS-FNA during the study period, 85 (62 males; median age, 74 years) patients were included in this stduy. Two patients (2.4%; 95% confidence interval [CI], 0.6% to 8.3%) experienced bleeding events. One patient required surgical intervention for hemothorax 5 hours after EUS-FNA, and the other experienced melena 8 days after EUS-FNA and required red blood cell transfusions. No thromboembolic events occurred (0%; 95% CI, 0.0% to 4.4%). Three patients (3.5%; 95% CI, 1.2% to 10.0%) experienced peri-puncture abscess formation. CONCLUSIONS: The rate of bleeding after EUS-FNA in patients prescribed antithrombotic agents might be considerable.
Abscess ; Asian Continental Ancestry Group ; Endoscopic Ultrasound-Guided Fine Needle Aspiration* ; Endoscopy, Gastrointestinal ; Erythrocyte Transfusion ; Fibrinolytic Agents* ; Hemorrhage* ; Hemothorax ; Humans ; Incidence ; Japan ; Male ; Melena ; Prospective Studies*

A 77-year-old man was admitted to our hospital with sudden anterior chest pain followed by shock. An echocardiography showed enlargement of the sinus of Valsalva, severe aortic regurgitation and pericardial effusion. A chest CT scan showed a crescent sign in the ascending aorta. The preoperative diagnosis was a ruptured Stanford type A acute aortic dissection and an emergency operation was performed. In the operative findings, a bloody pericardial effusion, a hematoma around the ascending aorta and a tear (less than 2 cm) of the ascending aorta just distal area of the sinotubular junction were observed. In this case, since the enlargement of the sinus of Valsalva and the severe aortic regurgitation were observed, we performed a replacement of the ascending aorta including the aortic root with an artificial vascular graft (J graft 28 mm) and a biological valve (Magna EASE 25 mm). The pathologic examinations revealed a rupture of ascending aorta in all layers and a hematoma outside the adventitia. The pathologic diagnosis showed a spontaneous aortic rupture. The postoperative course was good and he was discharged 1 month after the surgery. A spontaneous aortic rupture is defined as an aortic rupture without a trauma, an aneurysm or a dissection. It is rare but fatal and it is said that surgical treatment is necessary. We report a successful surgical case of the spontaneous aortic rupture which was difficult to distinguish from a Stanford A type acute aortic dissection.

Objective: The Japanese risk management plan (RMP) contains the risk minimization action plans for important potential risks of drugs.  One of the basic risk minimization action plans is reminding on package insert; however, we found that some potential risks were not described in package inserts.  In this study, we investigated the description of potential risks on package inserts.
Design: Document analysis.
Methods: We collected all posted RMP documents and the package inserts of corresponding products from the Pharmaceutical and Medical Devices Agency website on January 31, 2015 and investigated the risk minimization action plans of important potential risk items and whether the items had been described in each package insert.
Results: Of 268 important potential risk items in 81 products, 56 items were not described on package insert.  The major reason for not including the risk items on the package insert was “causality was not indicated sufficiently” and some items had no written reason.
Conclusion: About 20% of important potential risks are not described in package inserts.  Because most post-marketing pharmacovigilance plans depend on spontaneous reporting by healthcare personnel, description on package insert, the most frequently referred drug information resource, should be considered.

A 71-year old woman, who underwent direct closure of an atrial septal defect with mild tricuspid regurgitation (TR) 18 years previously, suffered terminal cardiac failure with extreme cardiomegaly, mitral regurgitation and severe TR. Medical treatment gradually became ineffectual and we decided to perform surgical therapy. Mitral annuloplasty with a prosthetic ring, tricuspid valve repair, plications of extended bilateral atrium walls and epicardial ventricular pacemaker implantation were performed. In tricuspid valve repair, anterior tricuspid leaflet was augmented by use of glutaraldehyde-preserved autologus pericardial patch and tricuspid annuloplasty with addition of a slightly larger prosthetic ring. Atrio-ventricular regurgitations disappeared and she was discharged 63 days after the operation. Valve extension is a very effective technique to treat severe secondary TR, and long term follow-up is necessary.

Pulmonary artery aneurysm (PAA) may be associated with congenital shunt disease such as patent ductus arteriosus, and its frequency and management are often controversial. We report successful surgical treatment of PAA following an operation for atrial septal defect (ASD). The patient was a 47-year-old woman who underwent closure of ASD at the age of 9. When she was investigated because of thyroid tumor, enlargement of her main pulmonary artery was pointed out and she was admitted to our hospital. Several examinations revealed a diagnosis of pulmonary valve insufficiency and 70mm PAA with dilatation extending to both proximal arteries. We performed replacements of pulmonary valve and pulmonary artery with a bioprosthetic valve and T-shaped graft. The patient is doing well 2 years after operation.

We evaluated long-term results of 126 consecutive bypass surgeries for chronic limb ischemia including 54 aorto-femoral (AF), 26 femoro-femoral crossover (FF), 7 axillo-femoral (AxF), and 39 femoro-above the knee popliteal (FP) bypasses. Patients who had undergone FF bypasses were significantly older than those who received AF bypasses (p<0.01). Preoperative ankle brachial pressure indices (ABI) of the AxF and FF patients were significantly lower than those of AF patients (p<0.05). Compared with AF patients, the AxF and FF groups included significantly higher percentages of Fontaine III and IV limbs treated by limb salvage surgery (p<0.05). The cumulative graft patency rates 5 years after AF, FF, and FP bypasses were 94.7%, 91.3%, and 64.3%, respectively. In the FP group, patients with intermittent claudication before surgery showed a 5-year graft patency rate of 82.5%, while that in patients who underwent surgery for limb salvage was 43.3%. The secondary graft patency rates 5 years after AF, FF, and FP bypasses were 94.6%, 91.3%, and 83.3%, respectively. All patients whose bypass grafts were occluded were male and were smokers. Poor run-off and insufficient anticoagulation therapies were also associated with graft occlusion. Two of the 12 patients who developed graft occlusion underwent limb amputation.