Clinical research and patient protection

Clinical trials are the flower of clinical research. Recently such clinical trials occur increasingly on a global scale. Korea is also one of the countries newly involved in global clinical trials, with resulting scientific, economic, industrial, and ethical implications. The sweeping and meticulous precautions must be introduced to these global clinical trials promoting patient protection through the public, national and international surveillance. These many guidelines in clinical trials are based on the Declaration of Helsinki of the World Medical Association (WMA). Fortunately, we were proud to be able to host the WMA 2008 meeting in Seoul, where the sixth edition of this declaration was announced. Thus, KMA insists that all clinical trials in Korea maintain strict standards and that all our member physicians follow the Declaration of Helsinki and be observers.

Vision of the Korean Institute of Medical Education and Evaluation / 한국의학교육

No abstract available.

The Effect of Weight Training and Aerobic Exercise on Men's Sex Hormone / 대한비뇨기과학회지

PURPOSE: The detrimental effect of strenuous exercise is well documented. The effect of moderate exercise (weight training and aerobic exercise) in healthy men was evaluated by analyzing the trend of hormones responsible for male reproduction. MATERIALS AND METHODS: The subjects were divided into 3 groups: systemically trained by a combination of bench press, sit-up and leg squat by 70% of 1RM for 10 weeks in the weight training group (n=5), systemically trained by a combination of treadmill running or walking by 70% of HRmax for 10 weeks in the aerobic exercise group (n=5), and non-training control group (n=5). RESULTS: In the weight training group, there were significant reductions of serum testosterone, FSH and LH during exercise (p>0.01). There was no difference in hormone values between weight training and aerobic groups for any of the hormones measured. CONCLUSIONS: Weight training and aerobic exercise lowered the serum FSH and LH levels, suggesting that moderate exercise may positively affect the reproductive hormonal status of males.

The Exploratory Study for Medical Aptitude Constructs / 한국의학교육

PURPOSE: The aim of this study is to explore the individual traits needed for the successful performance of a doctor's duties as well as to establish primary criteria for the Medical Education Eligibility Test. METHODS: This study conducted qualitatively by interviewing 43 persons: medical school professors, residents, and medical reporters. The analysis of data were applied a content analysis. RESULTS: 1) The important intelligent abilities revealed were problem solving, verbal expression, and memory. 2) The personality traits included sincerity, sociability, respectability, gentleness, and reflective thinking. 3) The biology, chemistry, and physics were important in the natural science background knowledge, and 4) linguistics, philosophy, and social science were important in human and social science background knowledge. CONCLUSION: The medical aptitude could be constructed intelligent ability, personality trits, and background knowledges, and include specific aspects depended on Korean context.

The Development Tasks of Medical School Accreditation in Korea / 한국의학교육

The Accreditation Board for Medical Education in Korea, ABMEK, is nongovernmental appraisal organization that was established at July 2, 1998. The organization is contributing to the improvement of medical education by progressing the first cycle accreditation successfully. But, the organization has various problems and subjects related to the accreditation system. The authors examined the related literature focusing on the current status and problems of accreditation system. The result of this research was as follows. First, the ABMEK needs to propel legal personality of organization and should install independent executive office. Second, the ABMEK should establish the alteration procedure of accreditation standards and develop the accreditation standards of the second cycle that take into account international flowing of medical education. Third, the ABMEK must decide forms and scope to investigate medical college present situation. Finally, to propel development tasks effectively, it needs to get the recognition of Ministry of Education and Human Development.

Curriculum Design for Problem-Based Learning on a Volunteer Basis: A Yonsei Approach

Innovative new medical programs such as Problem Based Learning (PBL) are being developed worldwide. An increasing number of medical schools are starting to introduce these programs into or even to replace the existing curriculum. At Yonsei University College of Medicine (YUCM), we developed our own PBL curriculum and evaluation method. In order to develop a program suitable for our school, we suggest that for trial purposes, a small number of student and teacher volunteers should be selected and that the tutors involved in the program be given adequate training.

A Study on Educational Accountability of Faculty in Medical Schools / 한국의학교육

PURPOSE: A college or university faculty can be regarded as an educator, researcher, and service provider. The purpose of this study is to evaluate the accountability of medical school professors focusing on the educational duties and to propose the solution and strategy for accountability evaluation of medical school faculty. METHODS: The study used questionnaires which was developed in five big categories asking basic information of the faculty, educational activities, subject of the accountability evaluation, and the primary disturbing factor in accomplishing the educational accountability. The questionnaires were asked to 61 faculty members in Yonsei University College of Medicine. RESULTS: The accountability importance of the medical school faculty was research(37.13%), teaching(31.80%), practice medicine(21.97%) and service(9.10%). Much weight was given for research(40.00%) and education(19.42%). The faculty concentrated mostly on delivering learning objectives as their educational activities. The biggest problem affecting the faculty from concentrating on educational accountability was the over workload. Insufficient incentives and lack of interest in education came next. The faculty also showed dissatisfaction with the obscurity of accountability assessment in operation, uniformity of the measurement and the absence of objective assessment standard. CONCLUSION: Medical schools need to create an environment in support of the faculty to focus on the educational activities. And when evaluating their accountability, the assessment standards need to be systematized and differentiated according to their specialities.

Current Indications for Open Stone Surgery in the Treatment of Renal and Ureteral Calculi after Introduction of ESWL / 대한비뇨기과학회지

PURPOSE: The developments and advances in extracorporeal shock wave lithotripsy and endourological procedures have greatly diminished the need for open surgery in the treatment of renal and ureteral stones. We reviewed our experience of open stone surgery to determine current indications and efficacy of this treatment modality. MATERIALS AND METHODS: We undertook a review of hospital and office charts, operative records, and pertinent radiographic studies of all patients that had undergone open stone surgery from May 1986 to June 2001 at a single tertiary university hospital. Of 5,533 procedures performed for stone removal, 355 were open surgical procedures (6.4%), these included ureterolithotomy in 215 (60.6%), pyelolithotomy in 50 (14.1%), anatrophic nephrolithotomy in 43 (12.1%), and nephrectomy in 47 (13.2%). RESULTS: The indications for open surgery were complex stone burden (61%), failure of extracorporeal shock wave lithotripsy or endourological treatment (9%), other co- operation (10.4%) and anatomical abnormalities, such as: ureteropelvic junction obstruction, infundibular stenosis and/or renal caliceal diverticulum (6.5%). Stone free rate, following surgery, was 90.7%. All patients had minor postoperative complications that were resolved with appropriate therapy. CONCLUSIONS: Open stone surgery continues to be a reasonable alternative modality for a small proportion of patients with urinary stones. Those patients with large urinary stone, failed less invasive method, anatomical abnormality and serious medical diseases would be recommended for open stone surgical correction.

Age-Specific Reference Ranges for Serum Prostate-Specific Antigen: Community-based Survey in Namhae Region / 대한비뇨기과학회지

PURPOSE: To establish the relationship between serum prostate specific antigen (PSA) concentration and age in a community-based population without clinically evident prostate cancer, a population based screening study was performed in a rural area in Southern Korea. MATERIALS AND METHODS: From January 1999 to December 1999, 1,278 volunteer men aged from 40 to 89 years in Namhae, Korea participated in a clinical examination that included a serum PSA determination (TANDEM-R assay), digital rectal examination and transrectal ultrasonography. The subjects who had clinical evidence of prostate cancer and high PSA concentration (>10ng/ml) were excluded. The PSA levels were compared with age using Pearson correlation and linear regression analysis. RESULTS: The serum PSA concentration correlated with patient age (r=0.129, p=0.001). The observed 95th percentile increased from 1.37ng/ml for subjects in the 40's to 6.18ng/ml for subjects in the 80'2. The reference range for serum PSA (95 percentile) for men in the 40's was 0.24 to 1.37ng/ml; for 50 to 59 years, 0.27 to 2.68ng/ml; for 60 to 69 years, 0.25 to 4.00ng/ml; for 70 to 79 years, 0.29 to 4.55ng/ml; and for 80 to 89 years, 0.31 to 6.18ng/ml. CONCLUSIONS: Our data showed that the serum PSA concentration directly correlated with patient age (Pearson correlation coefficient=0.129, P=0.001). Thus, rather than relying on a single reference range regardless of different age groups, it may be more appropriate to have age-specific reference ranges. Our data were lower than that of the Western data, and could provide an adjunctive information in interpreting PSA data in Korean men, especially in the elderly population.

Urethral Diverticulo-Rectal Fistula in AIDS

A 41-year-old heterosexual African man was evaluated for persistent urethral discharge, pneumaturia and watery diarrhea. Radiographic and endoscopic procedures established the diagnosis of a rectourethral fistula. The differential diagnosis of an acquired rectourethral fistula and the significance of AIDS are discussed.

Proximal Migration of Ureteral Stent after Extracorporeal Shock Wave Lithotripsy / 대한비뇨기과학회지

Double-pigtail ureteral stent has been used to prevent the ureteral obstruction from calculi and to pass the urine easily after extracorporeal shock wave lithotripsy (ESWL). One of the complications in stent indwelling is the migration of the stent. Especially the proximal migration of double-pigtail ureteral stents is rare. One of the several theories that have been proposed to account for cephalad migration is a stent movement in conjunction with kidney movement during respiration. The reason is that the respiration makes the kidney move in both upward and downward directions while the stent, held by fragemented ureteral stone, moves only in upward direction. We call this cause of the proximal migration of the stent, 'Jack' phenomenon. Therefore, if the residual calculi remain after ESWL with ureteral stent, we need close observation.

Technical Refinement of 99mTc-RBC Scrotal Scan for Evaluating Varicocele / 대한남성과학회지

PURPOSE: The association of varicoceles and subfertility has been well documented. Although varicoceles remain the most common surgically correctable cause of male infertility the subjective diagnosis of varicocele, especially the small ones remains a challenge. MATERIALS AND METHODS: We evaluated 40 young men (16 volunteers, 24 varicocele patients) with scrotal blood pool scan using 99mTc RBC. RESULTS: Complete correlation between physical findings and the scrotal scan was found. The postoperative scans of 12 patients with surgically corrected high grade varicoceles demonstrated symmetrical photon accumulation in the scrotum. The technique which most accurately correlated the clinical grade was the varicocele index using total count at Valsalva maneuver. CONCLUSIONS: We believe that the 99mTc RBC scrotal scan with technical refinement is a useful procedure in the objective diagnosis and followup of varicoceles.

Prostate Volume Variation with Age: Community-based Survey in Namhae Region / 대한남성과학회지

PURPOSE: The size of prostate increases with age, but there has been few Korean data on the prostate size in the general population. We thereby report the size of prostate with respect to age in Korean men residing in Namhae, Korea. MATERIALS AND METHODS: To determine the prostate size, 1421 men from Namhae, Korea underwent transrectal ultrasonography. Size of the prostate was estimated as a weight by the elliptical method. RESULTS: The mean prostate weight was 33.5 10.6 ml. The relationship between prostate volume and age was statistically significant in 1421 men (Pearson correlation coefficient=0.156, p=0.0001). Also, between the normal group and the groups of men with lower urinary tract symptoms (LUTS), there was significant correlation with age (Pearson correlation coefficient=0.162, p=0.0001), while results were insignificant with size (Pearson correlation coefficient= 0.170, p=0.0001). CONCLUSIONS: Size and rate of growth of the prostate were smaller compared to the Western society, nevertheless, prostate size increased with age. For accurate and reasonable age-specific size of the prostate of Korean male, more community based multicenter study will be needed with more refined measurement techniques such as step-section planimetry for the prostatic volume estimation.

Effect of Carbon Monoxide on the Relaxtion of the Rabbit Corpus Corpus Cavernosal Smooth uscle / 대한비뇨기과학회지

PURPOSE: Carbon monoxide (CO) is produced during the degradation of hemoglobin to heme (iron protoporphyrin) and present in various tissues including brain. CO is believed to activate soluble guanylate cyclase to exert its action on the smooth muscles. the effects of CO and its relationships to adrenergic or cholinergic mechanisms were studied using the isolated rabbit corpus cavernosal strips, and the effects of CO and NO were further investigated. MATERIALS AND METHODS: Using adult New Zealand rabbits, the corpus cavernosal strip was carefully prepared from rabbit penis and suspended in an 10ml organ bath containing Tyrode solution. When a stable tension level of the strip had been attained, drugs were added to the organ bath the change of motility of the strip was recorded on a computerized polygraph. RESULTS: The NO donor, sodium nitroprusside (SNP) and CO caused a dosedependent relaxation of the cavernosal strip of the rabbit penis. Pretreatment of SNP and CO had no effect on contraction induced by adrenergic drugs and the effects of SNP and CO was not affected by atropine. The relaxation effects of SNP were inhibited by NO scavenger pyrogallol, inhibitor of soluble guanylate cyclase 1H-[1,2,4] oxadiazolo[4,3-a] quinoxalin-1-one (ODQ) and methylene blue. The relaxation effects of CO were significantly inhibited by ODQ and methylene blue. the relaxation effects by acetylcholine were inhibited by NO synthase inhibitor L-nitroarginine methyl ester (NAME) and deendothelialization, but not affected by zinc protoporphyrin (ZnPP), the heme oxidase inhibitor. On the immunostaining of heme oxidase (HO) in corpus cavernosal smooth muscle strip, the positive staining for HO was observed in the perivascular nerve fibers. CONCLUSIONS: The relaxation effect of NO was confirmed, and CO exerts an endothelium dependent relaxing effect on the cavernosal strip of the rabbit penis similar to NO. This action is seem to be mediated by soluble guanylate cyclase, and the actions of CO is also mediated by similar guanylate cyclase system.

A Study on Evaluation of Clinical Clerkship / 한국의학교육

Since 1998, Yonsei University College of Medicine attempted a curriculum reform focusing on clinical clerkship. The reform concentrated on the next three categories; (1) minor clinical courses following major clinical courses, (2) selecting 9 minor clinical courses out of 18, (3) introducing 'Specialized Elective Course' at the first semester of fourth year of medical school. The opinions from students and teachers on such matter were taken into consideration. The study draws its conclusion as follows; first, 'Specialized Elective Course' satisfy students' learning disposition and give guidance in shaping one's career. Second, taking the major clinical course prior to minor clinical courses give students integrated clinical experience and closer connection among the subjects. Third, switching the minor course into elective course provide expanded choice of course selection and reinforce students' motivation to learn. In general, the last two years of the new clinical clerkship showed a satisfactory result. Nevertheless, successive effort of preparing alternative measures should be made regarding the negative opinions in part. In order to do this, a school wide support system must be carried out along with the continuing interest from the students and teachers. The new attempt and study of such curriculum will outgrow the uniform and rigid education, reflecting upon the differences among students and learning goals, which ultimately help medical education to be more successful.

Is There a Decrease in Semen Parameters among Korean Men? / 대한남성과학회지

A study was conducted in three large populations to determine whether sperm quality has changed in Korea between January 1995 to November 1999. We reviewed sperm concentration, motility and semen volume on two tertiary general hospitals in Korea, data of which collected since 1995 till 1999 according to the WHO guidelines(1987). The data were collected in healthy young Korean men in one center and those who visited urologic clinic in another center, There was no statistically significant difference at each year(p>0.05). Also semen volume and motility were not changed during that times. The data was collected in 1999 in both centers and monthly trends were also compared. No significant change was observed. No changes were observed in the semen parameters analysed in this two distinct populations, showing no evidence of deteriorating sperm quality in Korea over recent years. Furthermore, more data is required to draw any conclusion about the trend of semen qualities in Korea.

A Study to Develop a Medical Aptitude Test in Korea / 한국의학교육

Medical aptitude tests are usually for screening students in the field of medical science by testing the capability and aptitude to study medicine. There are various medical aptitude tests with powerful predicting validity such as the Medical College Admission Test(MCAT) in the U.S., the Graduate Australia Medical School Admission Test(GAMSAT) in Australia, and the Eignungsprufung fur Medizin Studium(EMS) in Switzerland. However, in Korea, there have been no medical aptitude test developed yet. This study is primarily to develop a medical aptitude test relevant to Korean circumstances, and secondly to suggest devise specific direction in applying the test at individual medical schools. We reviewed the existing medical aptitude test of other countries through literature, and examined the feasibility of those tests by consulting experts opinion. The Medical Education Eligibility Test(MEET) developed in this study consists of four areas including biological and physical science, verbal reasoning, space perception, and writing. The advisory committee will update the contents of the MEET every year. Executing the test will be administered either by a newly established Institute for Evaluating Medical Education(IEME), or by existing institutes like Korean National health personnel licensing examination board Korea or Korean Institute of Curriculum & Evaluation(KICE). A preliminary test should be necessary to examine the validity and reliability of the MEET developed from this study later on.

A Study on the Development of M.D.-Ph.D. Program / 한국의학교육

This study is to develop M.D.-Ph.D. program of medical school in Korea. The authors examined the related literature focusing on the current status and problems of training biomedical scientists. Next step was to make a collection of data related to American M.D.-Ph.D. program. The search for the materials was made through February 2000. The developed M.D.-Ph.D. program was modified and revised by the experts in the area and through public speech. The results of the study are as follows; first, the validity of M.D.-Ph.D. program was convicted by the need of interdisciplinary study, social needs, current problems of medical education and financial problems. Second, the development M.D.-Ph.D. program consists of educational period, admission procedure, entree examination, curriculum and its administration, degrees, school registration management, medical license examination, grants and problems related to military service. The expectations of the results are; first, M.D.-Ph.D. program will make Korea one of the leading countries in biomedical scientists and medical knowledge, and will activate the interdisciplinary research. Second, M.D.-Ph.D. program will facilitate to revise the educational problems of graduate school of medicine and medical schools.

A Case of High-flow Priapism Treated by Superselective Embolizations of Bilateral Cavernosal Arteries / 대한비뇨기과학회지

We report a case of priapism secondary to bilateral rupture of the cavernosal arteries following perineal blunt trauma in a 34 year old man. He complained of painless but persistent erection for the period of 1 week. We confirmed non-ischemic high-flow priapism by arterial blood gas analysis, Doppler ultrasonography and arteriography. Arteriography showed a leakage on both sides of the end of the cavernosal arteries and the leakage was blocked by superselective cavernosal artery embolization. After the embolization, tumescence began to disappear and the detumescence process was completed on the third day. The examination of the patient after 4 months following embolization revealed that the patient was fully free of priapism and returned to the normal erectile status like before his priapism. During 2 years of follow up, the patient had no complications such as priapism or impotence.

Effect of Alpha Adrenergic Drug on Serotonin Release in Rat Hippocampal Slices / 대한비뇨기과학회지

PURPOSE: Peripheral adrenergic nervous system controls the penile erection and alpha adrenoceptors greatly outnumber beta adrenoceptors. It is known that adrenaline has a facilitatory effect but serotonin has an inhibitory effect on sexual drive centrally. But few about the effect of central alpha adrenergic drug to the release of serotonin centrally are known. Major adrenergic and serotoninergic innervation is found at the hippocampus. This study was performed to investigate the effect of alpha adrenergic drugs on serotonergic nervous system in rat hippocampal slices. MATERIALS AND METHODS: The hippocampus from the male rat brain was sliced. After 30 minutes` preincubation in the normal buffer, the slices were incubated for 20 minutes in a buffer containing 0.1 microM [3H]5-hydroxytryptamine(5-HT) for uptake, and washed. After administration of phenylephrine or clonidine, the release of [3H]5-HT into the buffer was measured and the radioactivities in each buffer and the tissue were counted and the results were expressed as a percentage of the total activity. The value of released [3H]5-HT was expressed as percent of the value at 50 minutes when a steady state of [3H]5-HT release was obtained. RESULTS: After administration of phenylephrine(10-5 M), clonidine(10-5 M), the values(mean+/-SE) were 133.4+/-7.3, 103.0+/-0.3 at 60 minutes and 128.8+/-4.6, 100.4+/-4.1(%) at 70 minutes compared to the values of control group, 96.6+/-1.9 % at 60 minutes and 89.6+/-2.3% at 70 minutes. The release of serotonin was increased significantly after administration of phenylephrine. CONCLUSIONS: It is suggested that alpha-1 adrenergic drugs may increase the release of serotonin and therefore the integration of these two neurotransmitters may be considered.