Background

Symptoms of an adverse reaction to contrast agents for computed tomography are diverse ranging, and sometimes serious. The goal of this study is to create a scoring rule to predict adverse reactions to contrast agents used in computed tomography.

Methods

This was a retrospective cohort study of all adult patients undergoing contrast enhanced CT scan for 7 years. The subjects were randomly divided into either a derivation or validation group. Baseline data and clinically relevant factors were collected from the electronic chart. Primary outcome was any acute adverse reactions to contrast media, observed for during 24 hours after administration. All potential candidate predictors were included in a forward stepwise logistic regression model. Prediction scores were assigned based on β coefficient. A receiver operating characteristic (ROC) curve was drawn, and the area under the curve (AUC) and incidence of acute adverse reactions at each point were obtained. The same process was performed in the validation group.

Results

36,472 patients underwent enhanced CT imaging: 20,000 patients in the derivation group and 16,472 in the validation group. A total of 409 (2.0%, 95% CI:1.9-2.3) and 347 (2.1%, 95% CI:1.9-2.3) acute adverse reactions were seen in the derivation and validation groups. Logistic regression analysis revealed that prior adverse reaction to contrast agents, urticaria, an allergic history to drugs other than contrast agents, contrast agent concentration >70%, age <50 years, and total contrast agent dose >65 g were significant predictors of an acute adverse reaction. AUC was 0.70 (95% CI:0.67-0.73) and 0.67 (95% CI:0.64-0.70) in the derivation and validation groups.

Conclusions

We suggest a prediction model consisting of six predictors for acute adverse reactions to contrast agents used in CT.

Background

Gastric cancer is one of the most significant diseases, and esophago-gastro-duodenoscopy (EGD) is one of screening methods for gastric cancer. This study was conducted to identify the optimal screening interval for gastric cancer using EGD in healthy adults.

Methods

A retrospective cohort study was conducted on 3,723 healthy participants without a known diagnosis of gastric cancer at baseline from January 2005 to December 2010. Participants underwent annual health screenings, including EGD, at the Center for Preventive Medicine at St Luke’s International Hospital, a community teaching hospital in Japan. Participants with cytological abnormalities underwent further examination. A generalized estimating equation (GEE) was used to analyze the longitudinal data. We decided 0.5% of incidence of gastric cancer as a cutoff point for interval.

Results

The mean age (SD) of the participants was 55 (11) years, and 1,879 (50.5%) were male. During the study period, gastric cancer was detected in 35 participants. However, the incidence varied based on their ages. In the age groups <40, 40–49, 50–59, 60–69 and ≥70 years old, the 5-year cumulative incidences (95%CI) of gastric cancer were 0% (0-0%), 0.3% (0.1-1.0%), 1.0% (0.5-1.8%), 1.4% (0.8-2.4%) and 1.9% (0.8-3.8%), respectively. The odds ratios of the incidence of gastric cancer per year, which were evaluated using GEE models for the age groups 40–49, 50–59, 60–69 and ≥70 years old, were 1.51 (95%CI: 0.91-2.49), 1.94 (95%CI: 1.31-2.86), 1.59 (95%CI: 1.23-2.06) and 1.46 (95%CI: 1.06-2.02), respectively.

Conclusions

A screening for gastric cancer using EGD may be appropriate annually for healthy people over 70 years old, every two or three years for people 60–69 years old and every four years for people 50–59 years old. People younger than 50 years old may only need repeat screenings every five years or more.

Background

Accidental falls among inpatients are a substantial cause of hospital injury. A number of successful experimental studies on fall prevention have shown the importance and efficacy of multifactorial intervention, though success rates vary. However, the importance of staff compliance with these effective, but often time-consuming, multifactorial interventions has not been fully investigated in a routine clinical setting. The purpose of this observational study was to describe the effectiveness of a multidisciplinary quality improvement (QI) activity for accidental fall prevention, with particular focus on staff compliance in a non-experimental clinical setting.

Methods

This observational study was conducted from July 2004 through December 2010 at St. Luke’s International Hospital in Tokyo, Japan. The QI activity for in-patient falls prevention consisted of: 1) the fall risk assessment tool, 2) an intervention protocol to prevent in-patient falls, 3) specific environmental safety interventions, 4) staff education, and 5) multidisciplinary healthcare staff compliance monitoring and feedback mechanisms.

Results

The overall fall rate was 2.13 falls per 1000 patient days (350/164331) in 2004 versus 1.53 falls per 1000 patient days (263/172325) in 2010, representing a significant decrease (p = 0.039). In the first 6 months, compliance with use of the falling risk assessment tool at admission was 91.5% in 2007 (3998/4368), increasing to 97.6% in 2010 (10564/10828). The staff compliance rate of implementing an appropriate intervention plan was 85.9% in 2007, increasing to 95.3% in 2010.

Conclusion

In our study we observed a substantial decrease in patient fall rates and an increase of staff compliance with a newly implemented falls prevention program. A systematized QI approach that closely involves, encourages, and educates healthcare staff at multiple levels is effective.

ABSTRACT

BACKGROUND

The epidemiology of adverse drug events (ADEs) and medication errors has received little evaluation outside the U.S. and Europe, and extrapolating from these data might not be valid, especially regarding selecting and prioritizing solutions.

OBJECTIVE

To assess the incidence and preventability of ADEs and medication errors in Japan.

DESIGN

The Japan Adverse Drug Events (JADE) study was a prospective cohort study.

PATIENTS

A cohort of 3,459 adults admitted to a stratified random sample of seven medical and eight surgical wards and three intensive care units in three tertiary care hospitals over 6 months.

MAIN MEASURES

We measured ADE and medication error rates from daily reviews of charts, laboratories, incident reports, and prescription queries by on-site reviewers; presence of a signal was considered an incident. Two independent physicians reviewed incidents to determine whether they were ADEs or medication errors and to assess severity and preventability.

KEY RESULTS

We identified 1,010 ADEs and 514 medication errors (incidence: 17.0 and 8.7 per 1,000 patient-days, respectively) during the study period. Among ADEs, 1.6%, 4.9% and 33% were fatal, life-threatening and serious, respectively. Among ADEs, 14% were preventable. The rate per admission was 29 per 100 admissions, higher than in U.S. studies because associated with of the long length of hospital stay in Japan (mean, 17 days).

CONCLUSIONS

The epidemiology and nature of ADEs and medication errors in Japan were similar to other countries, although more frequent per admission. Solutions that worked in these countries might thus improve medication safety in Japan, as could shortening hospital length of stay.

OBJECTIVE

To evaluate the optimal interval for rechecking A1C levels below the diagnostic threshold of 6.5% for healthy adults.

RESEARCH DESIGN AND METHODS

This was a retrospective cohort study. Participants were 16,313 apparently healthy Japanese adults not taking glucose-lowering medications at baseline. Annual A1C measures from 2005 to 2008 at the Center for Preventive Medicine, a community teaching hospital in Japan, estimated cumulative incidence of diabetes.

RESULTS

Mean age (±SD) of participants was 49.7 ± 12.3 years, and 53% were male. Mean A1C at baseline was 5.4 ± 0.5%. At 3 years, for those with A1C at baseline of <5.0%, 5.0–5.4%, 5.5–5.9%, and 6.0–6.4%, cumulative incidence (95% CI) was 0.05% (0.001–0.3), 0.05% (0.01–0.11), 1.2% (0.9–1.6), and 20% (18–23), respectively.

CONCLUSIONS

In those with an A1C <6.0%, rescreening at intervals shorter than 3 years identifies few individuals (∼≤1%) with an A1C ≥6.5%.

ABSTRACT

BACKGROUND

The Ministry of Health, Labour and Welfare of Japan has been promoting participation in scholarly activities for physicians during residency training. However, there is debate regarding whether this is worthwhile for residents.

OBJECTIVE

To evaluate residents’ opinions of engaging in scholarly activities and identify factors associated with overall satisfaction with their training program.

DESIGN

Cross-sectional national survey.

PARTICIPANTS

1,124 second-year residents in teaching hospitals in Japan in 2007

MEASUREMENTS

Collected data included demographics, teaching hospital characteristics and resources, residents’ research experiences, including type of activities, barriers to performing scholarly activities, residents’ opinions of scholarly requirements, and resident satisfaction with their residency program.

RESULTS

1,124 residents/1,500 responded for a response rate of 74.9%. Our data showed that 60.2% of Japanese residents engaged in some type of scholarly activity. Barriers included: “No resident time”; “No mentor;” and “No resident interest.” Sixty-three percent of residents thought that research should be a residency requirement. In multivariate logistic analysis, residents’ overall satisfaction with their residency program was significantly associated with participation in research activity (odds ratio (OR), 1.5; 95% confidence interval (CI), 1.1–2.1); male gender (OR, 1.5; 95% CI: 1.1–2.2); satisfaction with residency compensation (OR, 3.8; 95% CI, 2.6–5.0), and satisfaction with the residency curriculum (OR, 19.5; 95% CI, 13.7–27.7).

CONCLUSIONS

The majority of residents surveyed thought that research activity was worthwhile. Residents’ participation in research activity was associated with higher levels of satisfaction with residency training. Implementing measures to overcome existing barriers may have educational benefits for residents.

Background

We investigated the views of newly graduating physicians on their preparedness for postgraduate clinical training, and evaluated the relationship of preparedness with the educational environment and the pass rate on the National Medical Licensure Examination (NMLE).

Methods

Data were obtained from 2429 PGY-1 physicians-in-training (response rate, 36%) using a mailed cross-sectional survey. The Dundee Ready Education Environment Measure (DREEM) inventory was used to assess the learning environment at 80 Japanese medical schools. Preparedness was assessed based on 6 clinical areas related to the Association of American Medical Colleges Graduation Questionnaire.

Results

Only 17% of the physicians-in-training felt prepared in the area of general clinical skills, 29% in basic knowledge of diagnosis and management of common conditions, 48% in communication skills, 19% in skills associated with evidence-based medicine, 54% in professionalism, and 37% in basic skills required for a physical examination. There were substantial differences among the medical schools in the perceived preparedness of their graduates. Significant positive correlations were found between preparedness for all clinical areas and a better educational environment (all p < 0.01), but there were no significant associations between the pass rate on the NMLE and perceived preparedness for any clinical area, as well as pass rate and educational environment (all p > 0.05).

Conclusion

Different educational environments among universities may be partly responsible for the differences in perceived preparedness of medical students for postgraduate clinical training. This study also highlights the poor correlation between self-assessed preparedness for practice and the NMLE.

Background

Between 2003 and 2004, when the new postgraduate medical education program was introduced in Japan, the number of university residents decreased from 5,923 to 3,264 (−31%), whereas the number of non-university residents increased from 2,243 to 4,110 (+45%).

Objective

To identify potential reasons for the shift of residents from university to non-university hospitals.

Design

Cross-sectional mailed survey.

Participants

The subjects were 1,794 2nd-year residents at 91 university hospitals and 2,010 2nd-year residents at 659 non-university hospitals.

Measurements

Data on hospital demographics, resident demographics, and resident satisfaction with training were collected in 2006 and were compared between university and non-university hospitals.

Results

Compared to non-university hospitals, university hospitals were more likely to have >700 beds (55% vs. 10%, p<0.001) and to have more teaching resources and free access to international medical journals (84% vs. 62%, p<0.001). Nevertheless, one-half (47%) of the university residents reported that they were not satisfied with the residency system and clinical skills training and attributed their dissatisfaction to “daily chores,” “low salary,” and “poor clinical opportunities.” Logistic regression analyses indicated that the proportions of residents who were satisfied with income (OR: 0.32, 95% CI: 0.26–0.40) and the residency system (OR: 0.52, 95% CI: 0.40–0.68) and clinical skills training (OR: 0.77, 95% CI: 0.60–0.99) were significantly lower for university residents than for non-university residents.

Conclusions

Hospital size and teaching resources do not overcome the other characteristics of university hospitals that lead to residents’ dissatisfaction.

Background

Health locus of control influences health-related behaviour, but its association with healthcare use is unclear.

Aim

To investigate the association between individuals' health locus of control and the use of conventional and alternative health care.

Design of study

Prospective cohort study.

Setting

A nationally representative random sample of community-dwelling adult households in Japan.

Method

Health locus of control, symptom-related visits to physicians, and the use of dietary and physical complementary and alternative medicine (CAM) was measured. Dietary CAM included supplements, such as herbs and vitamins. Physical CAM included manipulations, such as acupuncture and acupressure.

Results

Of the 2453 adult participants studied, 2103 (86%; 95% CI [confidence interval] = 84 to 88%) developed at least one symptom during the 31-day study period. Of these symptomatic adults, 639 visited physicians (30%; 95% CI = 28 to 32%), 480 used dietary CAM (23%; 95% CI = 21 to 25%), and 156 (7%; 95% CI = 6 to 9%) used physical CAM. The likelihood of visiting a physician was not related significantly to individuals' health locus of control. Increased use of dietary CAM was weakly associated with control by spiritual powers (P = 0.028), internal control (P = 0.013), and less control by professionals (P = 0.020). Increased use of physical CAM was significantly associated with control by spiritual powers (P = 0.009) indicating a belief that supernatural forces control individuals' health status.

Conclusion

The likelihood of visiting a physician is not affected by individuals' health locus of control. Control by spiritual powers is involved with increased CAM use. Internal control is weakly associated with greater use of dietary CAM; professional control is weakly associated with less use of dietary CAM.

OBJECTIVE

To assess the prevalence of medical student abuse during clinical clerkships in Japan.

DESIGN

A cross-sectional questionnaire survey.

SETTING

Six medical schools in Japan.

PARTICIPANTS

Final year (sixth-year) and fifth-year medical students in the period from September 2003 to January 2004. From a total of 559 students solicited, 304 (54.4%) returned the questionnaire, and 276 (49.4%: 178 male and 98 female) completed it.

MEASUREMENTS

Prevalence of medical student abuse in 5 categories: verbal abuse, physical abuse, academic abuse, sexual harassment, and gender discrimination; differences in abusive experience between male and female students; types of alleged abusers; reporting abusive experiences to authorities; and emotional effects of abusive experiences.

RESULTS

Medical student abuse was reported by 68.5% of the respondents. Verbal abuse was the most frequently experienced abuse (male students 52.8%, female students 63.3%). Sexual harassment was experienced significantly more often (P<.001) by female students (54.1%) than by male students (14.6%). Faculty members were most often reported as abusers (45.2% of cases). Abuse occurred most frequently during surgical rotations (42.0% of cases), followed by internal medicine (25.1%) and anesthesia rotations (21.8%). Very few abused students reported their abusive experiences to authorities (8.5%). The most frequent emotional response to abuse was anger (27.1% of cases).

CONCLUSIONS

Although experience of abuse during clinical clerkships is common among medical students in Japan, the concept of “medical student abuse” is not yet familiar to Japanese. To improve the learning environment, medical educators need to take action to resolve this serious issue.

OBJECTIVE

Screening for coronary artery disease (CAD) in asymptomatic diabetic patients with two additional atherogenic risk factors has been recommended by the American College of Cardiology/American Diabetes Association, but its cost-effectiveness is yet to be determined. The present study aims to evaluate the cost-effectiveness of screening and determine acceptable strategies.

DESIGN

Cost-effectiveness analysis using a Markov model was performed from a societal perspective to measure the clinical benefit and economic consequences of CAD screening in asymptomatic men with diabetes and two additional atherogenic risk factors. We evaluated cohorts of patients stratified by different age groups, and 10 possible combination pairs of atherogenic risks. Incremental cost-effectiveness of no screening, exercise electrocardiography, exercise echocardiography, or exercise single-photon emission-tomography (SPECT) was calculated. Input data were obtained from the published literature. Outcomes were expressed as U.S. dollars per quality-adjusted life-year (QALY).

MEASUREMENTS AND MAIN RESULTS

Compared with no screening, incremental cost-effectiveness ratio of exercise electrocardiography was $41,600/QALY in 60-year-old asymptomatic diabetic men with hypertension and smoking, but was weakly dominated by exercise echocardiography. Exercise echocardiography was most cost-effective, with an incremental cost-effectiveness ratio of $40,800/QALY. Exercise SPECT was dominated by other strategies. Sensitivity analyses found that results varied depending on age, combination of additional atherogenic risk factors, and diagnostic test performance.

CONCLUSIONS

Incremental cost-effectiveness ratio of CAD screening in asymptomatic patients with diabetes and two or more additional atherogenic risk factors is shown to be acceptable from a societal perspective. Exercise echocardiography was the most cost-effective strategy, followed by exercise electrocardiography.

BACKGROUND

Angiotensin-converting enzyme inhibitors are effective for many cardiovascular diseases and are widely prescribed, but cough sometimes necessitates their withdrawal.

OBJECTIVE

To develop and validate a model that predicts, by using information available at first prescription, whether a patient will develop cough within 6 months.

DESIGN

Retrospective cohort study with derivation and validation sets.

SETTING

Outpatient clinics affiliated with an urban tertiary care hospital.

PATIENTS

Clinical data were collected from electronic charts. The derivation set included 1,125 patients and the validation set included 567 patients.

INTERVENTIONS

None.

MEASUREMENTS

Angiotensin-converting enzyme inhibitorinduced cough assessed by predetermined criteria.

RESULTS

In the total cohort, 12% of patients developed angiotensin-converting enzyme inhibitor-induced cough. Independent multivariate predictors of cough were older age, female gender, non-African American (with East Asian having highest risk), no history of previous angiotensin-converting enzyme inhibitor use, and history of cough due to another angiotensin-converting enzyme inhibitor. Patients with a history of angiotensin-converting enzyme inhibitor-induced cough were 29 times more likely to develop a cough than those without this history. These factors were used to develop a model stratifying patients into 4 risk groups. In the derivation set, low-risk, average-risk, intermediate-risk, and highrisk groups had a 6%, 9%, 22%, and 55% probability of cough, respectively. In the validation set, 4%, 14%, 20%, and 60% of patients in these 4 groups developed cough, respectively.

CONCLUSIONS

This model may help clinicians predict the likelihood of a particular patient developing cough from an angiotensin-converting enzyme inhibitor at the time of prescribing, and may also assist with subsequent clinical decisions.

BACKGROUND

Quite often medical students or novice residents have difficulty in ruling out diseases even though they are quite unlikely and, due to this difficulty, such students and novice residents unnecessarily repeat laboratory or imaging tests.

OBJECTIVE

To explore whether or not a carefully designed short training course teaching Bayesian probabilistic thinking improves the diagnostic ability of medical students.

PARTICIPANTS AND METHODS

Ninety students at 2 medical schools were presented with clinical scenarios of coronary artery disease corresponding to high, low, and intermediate pretest probabilities. The students’ estimates of test characteristics of exercise stress test, and pretest and posttest probability for each scenario were evaluated before and after the short course.

RESULTS

The pretest probability estimates by the students, as well as their proficiency in applying Bayes's theorem, were improved in the high pretest probability scenario after the short course. However, estimates of pretest probability in the low pretest probability scenario, and their proficiency in applying Bayes's theorem in the intermediate and low pretest probability scenarios, showed essentially no improvement.

CONCLUSION

A carefully designed, but traditionally administered, short course could not improve the students’ abilities in estimating pretest probability in a low pretest probability setting, and subsequently students remained incompetent in ruling out disease. We need to develop educational methods that cultivate a well-balanced clinical sense to enable students to choose a suitable diagnostic strategy as needed in a clinical setting without being one-sided to the “rule-in conscious paradigm.”

Background

A number of previous studies have suggested that the Japanese have few opportunities to participate in medical decision-making, as a result both of entrenched physician paternalism and national characteristics of dependency and passivity. The hypothesis that Japanese patients would wish to participate in treatment decision-making if adequate information were provided, and the decision to be made was clearly identified, was tested by interview survey.

Methods

The subjects were diabetic patients at a single outpatient clinic in Kyoto. One of three case study vignettes (pneumonia, gangrene or cancer) was randomly assigned to each subject and, employing face-to-face interviews, the subjects were asked what their wishes would be as patients, for treatment information, participation in decision-making and family involvement.

Results

134 patients participated in the study, representing a response rate of 90%. The overall proportions of respondents who preferred active, collaborative, and passive roles were 12%, 71%, and 17%, respectively. Respondents to the cancer vignette were less likely to prefer an active role and were more likely to prefer family involvement in decision-making compared to non-cancer vignette respondents. If a physician's recommendation conflicted with their own wishes, 60% of the respondents for each vignette answered that they would choose to respect the physician's opinion, while few respondents would give the family's preference primary importance.

Conclusions

Our study suggested that a majority of Japanese patients have positive attitudes towards participation in medical decision making if they are fully informed. Physicians will give greater patient satisfaction if they respond to the desire of patients for participation in decision-making.

OBJECTIVE

Primary spontaneous pneumothorax (PSP) is not uncommon in young men and is associated with frequent recurrence. The frequent recurrence after conservative treatment and resultant anxiety for recurrence are sources of disability. We explored which procedure is more appropriate as the initial therapy in terms of quality-adjusted life expectancy (QALE).

DESIGN

Decision analysis using a Markov model.

DATA SOURCES

Structured literature review for clinical probability. Utility derived from patients and medical staff using time trade-off method.

SETTING

Hypothetical cohort.

PATIENTS

Twenty-year-old men with a first episode of PSP for which simple aspiration was ineffective.

INTERVENTIONS

One of the following treatment options: 1) thoracoscopic surgery, 2) pleural drainage followed by thoracoscopic surgery for recurrence, 3) pleural drainage followed by thoracoscopic surgery for the second recurrence, 4) pleurodesis followed by thoracoscopic surgery for recurrence, 5) pleurodesis followed by thoracoscopic surgery for the second recurrence, 6) pleural drainage followed by pleurodesis for the first recurrence and thoracoscopic surgery for the second recurrence.

MEASUREMENTS AND MAIN RESULTS

During the 1-year period after one of the initial treatments, the QALE was 9.49 months for thoracoscopic surgery, 9.47 for pleurodesis, and 7.80–7.99 for pleural drainage. The QALE for thoracoscopic surgery was the longest among the 6 strategies during the period from 5 to 24 months. None of the variables in sensitivity analyses altered the main results except for thoracoscopic surgical death rate. When it exceeds 0.3%, pleurodesis becomes the preferred strategy.

CONCLUSION

On the basis of the current best available data and patients' preference, thoracoscopic surgery can be considered the treatment of choice for the first episode of PSP.

Background

The purpose of this study is to explore laypersons' attitudes toward the use of archived (existing) materials such as medical records and biological samples and to compare them with the attitudes of physicians who are involved in medical research.

Methods

Three focus group interviews were conducted, in which seven Japanese male members of the general public, seven female members of the general public and seven physicians participated.

Results

It was revealed that the lay public expressed diverse attitudes towards the use of archived information and samples without informed consent. Protecting a subject's privacy, maintaining confidentiality, and communicating the outcomes of studies to research subjects were regarded as essential preconditions if researchers were to have access to archived information and samples used for research without the specific informed consent of the subjects who provided the material. Although participating physicians thought that some kind of prior permission from subjects was desirable, they pointed out the difficulties involved in obtaining individual informed consent in each case.

Conclusions

The present preliminary study indicates that the lay public and medical professionals may have different attitudes towards the use of archived information and samples without specific informed consent. This hypothesis, however, is derived from our focus groups interviews, and requires validation through research using a larger sample.

Objectives

To determine the influence of superstition about Taian (a lucky day)-Butsumetsu (an unlucky day) on decision to leave hospital. To estimate the costs of the effect of this superstition.

Design

Retrospective and descriptive study.

Setting

University hospital in Kyoto, Japan.

Subjects

Patients who were discharged alive from Kyoto University Hospital from 1 April 1992 to 31 March 1995.

Main outcome measures

Mean number, age, and hospital stay of patients discharged on each day of six day cycle.

Results

The mean number, age, and hospital stay of discharged patients were highest on Taian and lowest on Butsumetsu (25.8 v 19.3 patients/day, P=0.0001; 43.9 v 41.4 years, P=0.0001; and 43.1 v 33.3 days, P=0.0001 respectively). The effect of this difference on the hospital’s costs was estimated to be 7.4 million yen (£31 000).

Conclusion

The superstition influenced the decision to leave hospital, contributing to higher medical care costs in Japan. Although hospital stays need to be kept as short as possible to minimise costs, doctors should not ignore the possible psychological effects on patients’ health caused by dismissing the superstition.

Key messagesBelief in Taian-Butsumetsu, a superstition relating to the six day lunar calendar, is common among Japanese peopleThis study showed that the mean number of patients discharged on Taian (a lucky day) is the highest and that on Butsumetsu (an unlucky day) is the lowestPatients discharged on Taian were older, were more likely to be female, and had longer hospital stays than those discharged on other daysThe findings suggest that patients were extending their stay to leave hospital on TaianThis superstitious belief increased the cost of medical care in Japan