Background: Re-revision of the Ethical Guidelines for Clinical Study (EGCS) in Japan is planned in 2013. It is important to ascertain the current situation of physicians' understanding to conduct clinical trials. It seems that the difference in regulatory processes between commercial and non-commercial clinical trials has caused significant confusion for physicians in conducting clinical trials in Japan.
This survey was undertaken in order to improve awareness of the differences between both types of clinical trials. Furthermore, this survey examined whether it was effective to promote about clinical trials under newly introduced regulatory guidelines and to examine the subsequent willingness of physicians to conduct such clinical trials. Methods: From 24th March to 24th April 2009 inclusive, a questionnaire survey was conducted targeting 286 physicians working at Shiga University of Medical Science Hospital. A follow-up survey was conducted among 109 participants at a lecture about clinical trials on 8th July 2009. Results: Physicians who had prior knowledge of the regulations, purposes, or support systems for commercial and non-commercial clinical trials responded positively that they were more likely to conduct clinical trials, while physicians who had no prior knowledge of them responded negatively. Both groups reported that their daily working pressures and cumbersome regulatory processes prevented them from conducting clinical trials. Conclusion: Japanese physicians lack knowledge and information about clinical trials, leading to negative perceptions and reduced willingness to conduct such studies. Thus, the introduction of any strict and complex regulations should be approached carefully when the environment for clinical trials has not yet been established.
Background: Urosepsis is a potentially fatal syndrome that is sometimes difficult to diagnose. Thus, the aim of the present study was to clarify the clinical and laboratory characteristics and pitfalls in the diagnosis of urosepsis. Methods: We enrolled the study participants based on clinical records of patients with urosepsis treated between January 2009 and April 2012 inclusive, in the Department of General Internal Medicine, Toyama University Hospital and retrospectively surveyed underlying diseases, clinical symptoms, physical findings, and laboratory data, respectively. Results: Ten definitive patients were selected (nine females and one male; age, 55–86 years). Fever was the most frequent symptom followed by nausea. Lower back pain was the chief complaint in only two patients. One patient complained of dysuria, and on examination half of the patients lacked costovertebral angle (CVA) tenderness. Five patients showed elevated liver enzymes without evidence of hyperbilirubinemia. Conclusions: There were no specific clinical characteristics of urosepsis, and symptoms in some patients resembled digestive diseases such as cholangitis. Our results demonstrate that use of dipstick urinalysis and microscopic urinalysis are essential for the diagnosis in patients with sepsis. Abdominal ultrasonography and/or computed tomography should also be considered to rule out false negative results of urinalysis related to urinary tract obstruction, and to detect other focal infections when appropriate.
Introduction: Minority ethnic populations have experienced poor health and barriers to accessing care, including Asian American and Pacific Islanders (AAPIs) in the US. Despite some evidence, there is inadequate understanding of the shortcomings of access to care for AAPIs due to substantial variations in health status among AAPI sub-ethnicities. In order to illuminate the access to care issue, we aimed to determine the prevalence of health insurance coverage and health maintenance visits to primary care among one of the major AAPI ethnicities, Japanese in the US city of Pittsburgh, Pennsylvania. Methods: Japanese in Pittsburgh registered at an urban primary care clinic where bilingual providers are available were surveyed in terms of health insurance and health maintenance exam. The key results were compared to age- and gender-matched Japanese averages from Japan's national data (Japanese National Health and Nutrition Survey, J-NHANS). Results: Of 97 identified for inclusion, all responded (Response rate, 100.0%). The majority of respondents (87.5%) had US-based health insurance. Only 38.5% of men and 17.5% of women visited their primary care physicians for annual health maintenance visits within a year (P < .001 compared to J-NHANS). Only 38.6% of the Japanese women in Pittsburgh who had primary care physicians had annual gynecological exams within a year. The prevalence of annual dental exams within a year was 55.0% and 68.4% in men and women, respectively. Conclusions: Despite the high rate of health insurance coverage, Japanese in Pittsburgh had far less health maintenance visits than expected. Improving access to preventive care may help to reduce unnecessary disease.
Purpose: The Schedule for the Evaluation of Individual Quality of Life - Direct Weighting (SEIQoL-DW) is designed to investigate an individual's perspective on their own quality of life (QOL) and has been used widely among various clinical populations, including cancer patients and those with chronic kidney disease, in addition to healthy participants. While the original SEIQoL-DW is a semi-structured interview, other formats have been developed; recently computer-based versions have yielded equivalent results comparable to paper-based versions. However, no previous study has examined differences between the computer-based version and its original interview-based design. The purpose of this study is to assess the feasibility and validity of a computer-based version of the SEIQoL-DW, compared with the original interview-based format. Methods: We conducted a non-randomized crossover study with 13 medical students from November 2008 to January 2009 at a municipal university in Yokohama, Japan. Both the computer-based and interview-based versions of SEIQoL-DW were administered to all study participants. Wilcoxon-signed rank test was used to compare differences in mean SEIQoL Index score between computer-based and interview-based results. The intra-class correlation coefficient and the Bland and Altman limits of agreement methods were used to compare formats. Results: No significant differences were found in the SEIQoL-DW Index between the computer-based and interview versions after analysis with Wilcoxon-signed rank test (p = 0.501). The intra-class correlation between formats was 0.94 (CI: 0.81–0.98). The limit of agreement analysis showed that 53.3% of the observations were within ±1–5 units of the average score, while 46.7% were within ±5–10 units. In total, 100% of observations were within ±1–10 units. Conclusions: The computer-administered version of SEIQoL-DW may be feasible and acceptable and provides a valid alternative, at least in healthy subjects, to the more cumbersome interview version. Use of the computer-based version will facilitate its application to larger patient populations in various clinical settings.
Objective: The aim of this study was to investigate diagnostic characteristics to distinguish bacterial meningitis (BM) from aseptic meningitis (AM) in meningitis patients. Indicators from the initial consultation were combined with a measure of time since the onset of fever. Methods: This was a retrospective chart review. We examined the sensitivity and specificity of the clinical information for BM. The diagnostic characteristics for BM were analyzed by considering the duration of fever for each patient at consultation, together with the presence or absence of changes in their mental status.The study examined 117 inpatients diagnosed with meningitis in their clinical record at the time of admission. The patients were admitted into two emergency hospitals in Japan between 2001 and 2011. Meningitis was defined as the presence of five or more cells per mm3 of CSF. Results: Twenty-five patients were diagnosed with BM and 92 patients with AM. There was no single clinical symptom that could distinguish BM from AM in patients suspected of meningitis. The sensitivity and specificity of the clinical information for fever duration and disturbance of consciousness at consultation were 95.0% and 40.3%, respectively, for BM patients with disturbance of consciousness or with duration of fever less than three days. Thus, the proportion of BM patients without disturbance of consciousness for three or more days after fever onset was only 5%. Conclusions: Patients without disturbance of consciousness for three or more days after fever onset are rarely suffering from BM.
Spontaneous renal artery dissection (SRAD) is uncommon and hence diagnosis is often delayed when ideally a quick one is preferred. We report a case of a 53 year-old male, with a known history of nephrolithiasis, who was admitted into hospital complaining of sudden onset left-sided back pain. Ultrasound showed a right-sided calculus instead of the expected left. A subsequent contrast computed tomography (CT) scan was done showing an infarcted segment of the left kidney. Further investigation with angiography and intravascular ultrasound (IVUS) revealed the presence of two left renal arteries with the distal originating left renal artery having dissected.
A 51-year-old woman presented with a 3-month history of left-sided chest pain. The pain was colicky, without associated tenderness, and involved the T5-8 thoracic dermatomes. We suspected referred pain from peptic ulcer, and upper gastrointestinal endoscopy revealed multiple ulcers in the middle-third of the gastric lesser curvature. As the patient was on non-steroidal anti-inflammatory drug (NSAID) treatment for tension headaches, NSAID-induced peptic ulcer was diagnosed. Proton-pump inhibitor (PPI) treatment resulted in prompt pain relief. There are few reports of chest pain as the sole presenting symptom of peptic ulcer. Nevertheless, although rare, peptic ulcer should also be considered in the differential diagnosis of chest pain.