We retrospectively evaluated clinical characteristics of 41 admitted patients who were diagnosed as tuberculosis by results from Ziel-Nielsen smear test and/or culture test and or ligase chain reaction (LCR) method, from January 1999 to December 2002 at National Organization Nagasaki Medical Center in Japan. We also analyzed delay of diagnosis (Diagnostic delay: which means duration required for diagnosis after patient's symptom had appeared) especially in cases with pulmonary tuberculosis. Twenty-eight patients were male and 13 patients were female. Twenty-eight out of 37 patients were of elder age-groups (mean age, 68.4 years; range, 30-86 years). Twenty-nine patients diagnosed as pulmonary tuberculosis, 22 of them were male, and remaining 7 of them were female. Fourteen patients had a past history of pulmonary tuberculosis. Details of underlying diseases in patients with pulmonary tuberculosis were, malignant disease in 10 patients, other pulmonary diseases in 7 patients, cardiovascular diseases in 7 patients, diabetes mellitus in 5 patients, and so on. A total of 82.7% patients were classified as non-cavity type on chest X-ray films for pulmonary tuberculosis. Eleven patients (37.9%) required diagnostic delay of more than one month. Smear-negative pulmonary lung tuberculosis with LCR-positive group were diagnosed significantly earlier (p=0.012) compared to LCR-negative and/or LCR-not examined group. The reasons for late diagnosis were differentiated into two types. First, doctors didn't suspect pulmonary tuberculosis; or second, results of microbiological examinations were delayed. To improve these situations, doctors should constructively examine pulmonary tuberculosis when patients are in elder age-groups and/or have a past history of pulmonary tuberculosis, and or have immuno-compromised diseases. Further, using new diagnostic methods such as broth culture technique or IFN-γ assay with high sensitivity may lead to early diagnosis of tuberculosis. Enlightenment of tuberculosis in general hospital is necessary for avoiding secondary nosocomial infection, with infection control doctors and doctors who belong to respirologv as the leaders.

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We report four cases of double aortic arch with symptoms of prolonged stridor and respiratory distress. One patient required endtracheal intubation due to severe dyspnea. Corrective operation was performed for all patients with dissection of the vascular ring, and post operative course was uneventful. However, residual stridor persisted for at least six months. We should suspect that a patient may have double aortic arch if frequent respiratory infections or problems are seen shortly after birth. On examination, 3D-computed tomography and magnetic resonance imaging (MRI) revealed the anatomy of the complete vascular ring around the trachea and esophagus. Especially, non-invasive MRI which does not require contrast medium is useful, for the primary screening of an outpatient suspected of having double aortic arch.

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A questionnaire survey about the overall impression of responses of the chief investigator, office of clinical trial, and CRC to clinical trial related activities was given to the 27 monitors of GlaxoSmithKline who had been involved in clinical trials in institutes of National Hospital Organization from 2005 to 2006, and evaluation of each survey item was performed based on a point rating system.
Among the results of the questionnaire, all three subjects received a high score for “Easy to get an appointment, ” and the chief investigator and office of clinical trial received a high score for “Support for direct access.” In contrast, the chief investigator received a low score for, “Degree of understanding and compliance with GCP, ” while the office and CRC received high scores. The office received low scores for “Handling of documents” and “Number of visits.” The CRC received the lowest score for “Originality/ingenuity” which indicates the necessity of continuing education plan establishment.
The results of the questionnaire survey indicate the assessment of the environment of clinical trials in institutions from the sponsor side. A survey of institutions not only from the sponsor side, but also a survey of sponsors from the institution side can serve as a good communication tool to improve the environment of clinical trials.

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[in Japanese]

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[in Japanese]

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