Legislative Issues in Disclosing Financial Conflicts of Interest to Participants in Biomedical Research: Effectiveness and Methodology

This research focuses on the analysis regarding disclosure of financial conflicts of interest (FCOI) after Gelsinger v. University of Pennsylvania (Penn). The main legal issue was that the participants did not have enough opportunity to make an autonomous decision about participating in the research because he was not informed about the researchers' and the institution's substantial FCOI. The disclosure system was adopted by the Code of Federal Regulations. Under the regulation, researchers and institutions need to report FCOI over $5,000 to the institution, and the internal review boards have to report to the federal authority if needed. In case of human research, the disclosure to Food and Drug Administration is mandatory. FCOI disclosure system would help participants to make an autonomous decision, and increase trust to the research process and researchers. Moreover, the system would let researchers keep fiduciary duty while (possibly) lowering legal liability in case of a lawsuit. There were discussions about the disclosure methodology in the United States. However, there have not been a lot of discussions in Korea even after the “Humidifier Disinfectant” case. Therefore, new legislations need to be considered. First, the system requires disclosure funded by not only government but also private institutions. Second, like California Supreme Court, the subject would be reviewed under the reasonable person standard by participants, including patents, equity, and stock. Third, the disclosure needs to include simple or brief explanation to the FCOI to be better understood by the participants. Fourth, the disclosure should be in the informed consent process.

Temporal distribution of tuberculosis in the State of Amazonas, Brazil

Tuberculosis (TB) is one of the infectious diseases that contributes most to the morbidity and mortality of millions of people worldwide. Brazil is one of 22 countries that accounts for 80% of the tuberculosis global burden. The highest incidence rates in Brazil occur in the States of Amazonas and Rio de Janeiro. The aim of this study was to describe the temporal distribution of TB in the State of Amazonas. Between 2001 and 2011, 28,198 cases of tuberculosis were reported in Amazonas, distributed among 62 municipalities, with the capital Manaus reporting the highest (68.7%) concentration of cases. Tuberculosis was more prevalent among males (59.3%) aged 15 to 34 years old (45.5%), whose race/color was predominantly pardo (64.7%) and who had pulmonary TB (84.3%). During this period, 81 cases of multidrug-resistant TB were registered, of which the highest concentration was reported from 2008 onward (p = 0.002). The municipalities with the largest numbers of indigenous individuals affected were São Gabriel da Cachoeira (93%), Itamarati (78.1%), and Santa Isabel do Rio Negro (70.1%). The future outlook for this region includes strengthening the TB control at the primary care level, by expanding diagnostic capabilities, access to treatment, research projects developed in collaboration with the Dr. Heitor Vieira Dourado Tropical Medicine Foundation .;Fundação de Medicina Tropical Dr. Heitor Vieira Dourado (FMT-HVD).; and financing institutions, such as the project for the expansion of the Clinical Research Center and the creation of a hospital ward for individuals with transmissible respiratory diseases, including TB.

Abundant immunohistochemical expression of dopamine D2 receptor and p53 protein in meningiomas: follow-up, relation to gender, age, tumor grade, and recurrence

Meningiomas are common, usually benign tumors, with a high postoperative recurrence rate. However, the genesis and development of these tumors remain controversial. We aimed to investigate the presence and implications of a mutated p53 protein and dopamine D2 receptor in a representative series of meningiomas and to correlate these findings with age, gender, tumor grade, and recurrence. Tumor tissue samples of 157 patients diagnosed with meningioma (37 males and 120 females, mean age 53.6±14.3 years) who underwent surgical resection between 2003 and 2012 at our institution were immunohistochemically evaluated for the presence of p53 protein and dopamine D2 receptor and were followed-up to analyze tumor recurrence or regrowth. Tumors were classified as grades I (n=141, 89.8%), II (n=13, 8.3%), or grade III (n=3, 1.9%). Dopamine D2 receptor and p53 protein expression were positive in 93.6% and 49.7% of the cases, respectively. Neither of the markers showed significant expression differences among different tumor grades or recurrence or regrowth statuses. Our findings highlight the potential role of p53 protein in meningioma development and/or progression. The high positivity of dopamine D2 receptor observed in this study warrants further investigation of the therapeutic potential of dopamine agonists in the evolution of meningiomas.

Cytotoxicity and genotoxicity of intravitreal adalimumab administration in rabbit retinal cells / Citotoxicidade e genotoxicidade da administração de adalimumabe intravítreo nas células da retina de coelhos

Purpose: To assess the cytotoxicity and genotoxicity of intravitreal adalimumab treatment in an animal experimental model using cytological and molecular techniques. Methods: Eighteen rabbits were randomly assigned to three groups: control, adalimumab treatment, and placebo. Cytotoxicity on retinal cells was evaluated using flow cytometry assays to determine the level of apoptosis and necrosis. Genotoxicity was evaluated by comet assays to assess DNA damage, and quantitative real-time polymerase chain reaction (qPCR) was used to evaluate expression of apoptosis-inducing caspases (8 and 3). Results: No cytotoxicity or genotoxicity was observed in any of the two treatment groups (adalimumab and placebo) following intravitreal administration compared with the control group. Flow cytometry analysis revealed that more than 90% of the cells were viable, and only a low proportion of retinal cells presented apoptotic (~10%) or necrotic (<1%) activity across all groups. Molecular damage was also low with a maximum of 6.4% DNA degradation observed in the comet assays. In addition, no increase in gene expression of apoptosis-inducing caspases was observed on retinal cells by qPCR in both the adalimumab and placebo groups compared with the control group. Conclusion: The use of adalimumab resulted in no detectable cytotoxicity or genotoxicity on retinal cells for up to 60 days upon administration. These results therefore indicate that adalimumab may be a safe option for intravitreal application to treat ocular inflammatory diseases in which TNF-α is involved. .

Objetivo: Acessar a citotoxicidade e genotoxicidade do tratamento intravítreo de adalimumabe em um modelo experimental animal utilizando técnicas citológicas e moleculares. Métodos: Dezoito coelhos foram aleatoriamente selecionados em três grupos: controle, tratamento intravítreo com adalimumabe e placebo. Os efeitos tóxicos nas células da retina foram avaliados através de ensaios de citometria de fluxo, para a determinação de atividade apoptótica e necrótica. A genotoxidade foi avaliada através de ensaios cometa para determinar danos ao DNA e através de PCR em tempo real para avaliar a expressão genética de caspases (8 e 3) promotoras de apoptose celular. Resultados: Não foram detectadas citotoxicidade e genotoxidade nos dois grupos de tratamento, adalimumabe e placebo, em comparação com o controle. A citometria de fluxo determinou que mais de 90% das células eram viáveis após o tratamento, e uma pequena quantidade de células da retina apresentaram apoptose (~10%) ou necrose (<1%) em todos os grupos. O dano molecular também foi baixo com uma degradação no DNA de no máximo 6,4% detectados nos ensaios cometa. Adicionalmente, não foram observados aumentos na expressão genética das caspases que induzem a apoptose através dos ensaios de PCR em tempo real. Conclusão: O tratamento intravítreo com adalimumabe não promoveu nenhuma citotoxicidade e genotoxicidade detectável em células da retina por até sessenta dias. Estes resultados, portanto, indicam que o adalimumabe pode ser uma opção segura para o tratamento de doenças oculares inflamatórias em que o TNFα está envolvido. .

Dysautonomia in Narcolepsy: Evidence by Questionnaire Assessment

BACKGROUND AND PURPOSE: Excessive daytime sleepiness and sudden sleep attacks are the main features of narcolepsy, but rapid-eye-movement sleep behavior disorder (RBD), hyposmia, and depression can also occur. The latter symptoms are nonmotor features in idiopathic Parkinson's disease (IPD). In the present study, IPD-proven diagnostic tools were tested to determine whether they are also applicable in the assessment of narcolepsy. METHODS: This was a case-control study comparing 15 patients with narcolepsy (PN) and 15 control subjects (CS) using the Scales for Outcomes in Parkinson's Autonomic Test (SCOPA-AUT), Parkinson's Disease Nonmotor Symptoms (PDNMS), University of Pennsylvania Smell Test, Farnsworth-Munsell 100 Hue test, Beck Depression Inventory, and the RBD screening questionnaire. RESULTS: Both the PN and CS exhibited mild hyposmia and no deficits in visual tests. Frequent dysautonomia in all domains except sexuality was found for the PN. The total SCOPA-AUT score was higher for the PN (18.47+/-10.08, mean+/-SD) than for the CS (4.40+/-3.09), as was the PDNMS score (10.53+/-4.78 and 1.80+/-2.31, respectively). RBD was present in 87% of the PN and 0% of the CS. The PN were more depressed than the CS. The differences between the PN and CS for all of these variables were statistically significant (all p<0.05). CONCLUSIONS: The results of this study provide evidence for the presence of dysautonomia and confirm the comorbidities of depression and RBD in narcolepsy patients. The spectrum, which is comparable to the nonmotor complex in IPD, suggests wide-ranging, clinically detectable dysfunction beyond the narcoleptic core syndrome.

The Current Status of Evaluation Technologies for the Function of Human Olfaction / 한양의대학술지

The sense of smell is one of the essential tools for all living things to survive. With recent increase in diseases associated with olfactory dysfunction, the evaluation of olfactory function aims to shed light on the understanding and assessment of the human olfactory system. The methods for assessing the olfactory function are largely divided into electrophysiological and psychophysical methods. The psychophysical inspections such as University of Pennsylvania Smell Identification Test (UPSIT), The Sniffin' Stick, and T & T Olfactometer are methods mostly based on questionnaires or simple apparatus. Those have been generally used in clinical and research field due to their relatively short examination time and low cost. The electrophysiological tests evaluate olfactory function based on objective measurements like biosignals and medical imaging. Compared to the psychophysical methods, they comparably have higher reliability and are possible to assess more specific diagnosis. However, the system configuration seems to be more complicated. In this paper, we review the overall evaluation methods of olfactory functions and suggest complementary points to improve conventional technologies.

Comparative study on the radiopacity of different resin-based implant cements / 대한치과보철학회지

PURPOSE: This study was aimed to compare the radiopacity of four kinds of currently available resin based implant cements using digital radiography. MATERIALS AND METHODS: Four resin-based implant cements ((Estemp Implant(TM) (Spident, Incheon, Korea), Premier(R) Implant (Premier, Pennsylvania, USA), Cem-Implant(TM) (B.J.M lab, Or-yehuda, Israel), InterCem(TM) (SCI-PHARM, California, USA)) and control group (Elite Cement 100(TM) (GC, Tokyo, Japan)) were mixed and cured according to the manufacturer's instructions on the custom made split-type metal mold. A total of 150 specimens of each cement were prepared and each specimen (purity over 99%) was placed side-by-side with an aluminum step wedge for image taking with Intraoral X-ray unit (Esx, Vatech, Korea) and digital X-ray sensor (EzSensor, Vatech, Korea). For the evaluation of aluminum wedge equivalent thickness (mm Al), Image J 1.47 m (Wayne Rasband, National Institutes of Health, USA) and Color inspector 3D ver 2.0 (Interaktive Visualisierung von Farbraumen, Berlin, Germany) programs were used. RESULT: Among the 5 cements, Elite cement 100(TM) (control group) showed the highest radio-opacity in all thickness. In the experimental group, InterCem(TM) had the highest radio-opacity followed by Premier(R) Implant Cement(TM), Cem-Implant(TM) and Estemp Implant(TM). In addition, InterCem(TM) showed radio-opacity that met the ISO No. 4049 standard in all the tested specimen thickness. Cem-Implant on 0.5 mm thickness showed radiopacity that met the ISO No. 4049 standard. CONCLUSION: Among the implant resin-based cements tested in the study, Premier(R) Implant Cement and Estemp Implant(TM) did not show appropriate radio-opacity. Only InterCem(TM) and Cem-Implant(TM) 0.5 mm specimen had the proper radiopacity and met the experiment standard.

The Impact of Perforator Number on Deep Inferior Epigastric Perforator Flap Breast Reconstruction

BACKGROUND: Perforator flaps minimize abdominal site morbidity during autologous breast reconstruction. The purpose of this study was to assess whether the number of perforators harvested influences the overall deep inferior epigastric perforator (DIEP) flap survival and flap-related complications. METHODS: A retrospective review was performed of all DIEP flaps performed at the Hospital of the University of Pennsylvania from 2006 to 2011. The outcomes assessed included flap loss and major complications. We compared flaps by the number of total perforators (1-4) and then carried out a subgroup analysis comparing flaps with one perforator to flaps with multiple perforators. Lastly, we conducted a post-hoc analysis based on body mass index (BMI) categorization. RESULTS: Three hundred thirty-three patients underwent 395 DIEP flaps. No significant differences were noted in the flap loss rate or the overall complications across perforator groups. However, the subgroup analysis revealed significantly higher rates of fat necrosis in the case of one-perforator flaps than in the case of multiple-perforator flaps (10.2% vs. 3.1%, P=0.009). The post-hoc analysis revealed a significant increase in the flap loss rate with increasing BMI (40=42.9%, P<0.001) in the DIEP flaps, but no increase in fat necrosis. CONCLUSIONS: This study demonstrates that the number of perforators does not impact the rate of flap survival. However, the rate of fat necrosis may be significantly higher in DIEP flaps based on a single perforator. Multiple perforators should be utilized if possible to decrease the risk of fat necrosis.

Patterns of Tobacco Consumption among Indian Men with Schizophrenia Compared to Their Male Siblings

OBJECTIVE: Tobacco consumption among patients with schizophrenia has been investigated extensively in western countries, but there is a dearth of studies in India, where socio-economic and cultural variables are different. This study aims to investigate the patterns of tobacco consumption among schizophrenia patients compared with their non-psychotic siblings. METHODS: Consenting, successive male outpatients diagnosed with schizophrenia (n=100, DSM-IV criteria), and their non-psychotic brothers (n=100) were compared. Following a structured diagnostic interview, detailed information about tobacco consumption (including smokeless tobacco) was obtained using the Fagerstrom Test for Nicotine Dependence for smoked tobacco, and FTND-smokeless tobacco. The University of Pennsylvania Computerized Neurocognitive battery (CNB) was administered to a sub-group of patients (n=48). RESULTS: Schizophrenia patients initiated tobacco use at a significantly earlier age than their brothers, but there was no significant difference with regard to type, quantity or frequency of tobacco use (smoke or smokeless varieties). Patients who consumed tobacco had significantly higher positive symptom scores compared with non-users (p=0.043). There were no significant differences between nicotine dependent and non-dependent patients with regard to CNB domains except attention. CONCLUSION: Patterns of tobacco consumption were similar among schizophrenia patients and their non-psychotic brothers. Tobacco use was associated with increased positive symptom scores, but there were no significant differences in cognitive measures among nicotine dependent and non-dependent patients.

Risk factors for recurrence amongst high intermediate risk patients with endometrioid adenocarcinoma / 부인종양

OBJECTIVE: To determine risk factors associated with recurrence in patients with high intermediate risk (HIR) endometrioid adenocarcinoma. METHODS: A retrospective analysis of patients with HIR endometrioid adenocarcinoma who underwent hysterectomy, bilateral salpingo-oophorectomy, with or without pelvic/para-aortic lymphadenectomy at the University of Pennsylvania between 1990 and 2009 was performed. RESULTS: A total of 103 women with HIR endometrial cancer were identified. Multivariable analysis revealed that > or =2/3 myometrial invasion (HR, 4.79; p=0.010) and grade 3 disease (HR, 3.04; p=0.045) were independently predictive of distant metastases. The 5-year distant metastases free survival (DMFS) for patients with neither or one of these risk factors was 89%, and the 5-year DMFS for patients with both risk factors was 48% (p<0.001). CONCLUSION: Patients with both grade 3 disease and deep third myometrial invasion have a high risk of distant metastases. Identifying these patients may be important in rationally selecting patients for systemic therapy.

Risk factors for recurrence amongst high intermediate risk patients with endometrioid adenocarcinoma / 부인종양

OBJECTIVE: To determine risk factors associated with recurrence in patients with high intermediate risk (HIR) endometrioid adenocarcinoma. METHODS: A retrospective analysis of patients with HIR endometrioid adenocarcinoma who underwent hysterectomy, bilateral salpingo-oophorectomy, with or without pelvic/para-aortic lymphadenectomy at the University of Pennsylvania between 1990 and 2009 was performed. RESULTS: A total of 103 women with HIR endometrial cancer were identified. Multivariable analysis revealed that > or =2/3 myometrial invasion (HR, 4.79; p=0.010) and grade 3 disease (HR, 3.04; p=0.045) were independently predictive of distant metastases. The 5-year distant metastases free survival (DMFS) for patients with neither or one of these risk factors was 89%, and the 5-year DMFS for patients with both risk factors was 48% (p<0.001). CONCLUSION: Patients with both grade 3 disease and deep third myometrial invasion have a high risk of distant metastases. Identifying these patients may be important in rationally selecting patients for systemic therapy.

La salud de los trabajadores y la Tropical Oil Company: Barrancabermeja, 1916-1940 / The workers health and the Tropical Oil Company Barrancabermeja, 1916-1940

El artículo presenta un análisis sobre la salud de los trabajadores en los procesos de exploración y explotación petrolera adelantados en el país en la denominada Concesión de Mares, entre 1916 y 1940. Se construyó una periodización que busca dar cuenta del lugar de la problemática de la Fiebre Amarilla y las enfermedades tropicales en la situación sanitaria de la actividad petrolera en este periodo y región, pasando de ocupar un lugar central a ser desplazadas por la accidentalidad. El periodo inicial se caracteriza por la desprotección a que se ven sometidos los trabajadores al comienzo de las actividades productivas petroleras, entre 1916 y 1920; el segundo periodo se define por la implementación de medidas de protección, en el marco de un conflicto laboral con un gran peso de la problemática sanitaria, entre 1921 y 1928; y en el tercer periodo se consolida la iniciativa empresarial para hacer de la salud un dispositivo de control, pero que se acompaña de la persistencia de conflictos laborales importantes en que la accidentalidad tiene una presencia notoria, entre 1929 y 1940. Finalmente se identifican aspectos a profundizar para una caracterización de la configuración de la salud de los trabajadores petroleros en la Concesión de Mares.

This article analyses the health of workers engaged in oil exploration and exploitation in Colombia during the time of the so-called De Mares concession from 1916 to 1940. Periodisation was constructed which sought to account for yellow fever and tropical diseases within the sanitary situation related to oil exploration and exploitation during this period and region and how it became displaced from its central position by accidentally. The initial period was characterised by the lack of protection to which the workers were subjected at the start of oil-producing activities between 1916 and 1920. The second period was defined by implementing means of protection within the framework of a labour dispute accompanied by the sanitary problem's great burden between 1921 and 1928. The third period (1929 to 1940) dealt with entrepreneurial initiative becoming consolidated so as to make health become a control device, even though this was accompanied by the persistence of important labour disputes in which accidentality had a notable presence. Aspects are identified which should be gone into in greater depth for characterising oil-workers' health at the time of the De Mares concession.

A Study on Relapse Predictors in Korean Alcohol-Dependent Patients: A 24 Weeks Follow up Study

OBJECTIVES: The aim of this prospective study is to investigate predictors estimating relapse in Korean alcohol-dependent patients using variables like alcohol history, drinking craving, treatment motivation and insight. METHODS: Alcohol dependent patients(N=48) who completed questionnaires about sociodemographic variables and drinking history, Timeline Follow-Back(TLFB), Obsessive-Compulsive Drinking Scale(OCSD), Alcohol Urge Questionnaire(AUQ), Pennsylvania Alcohol Craving Scale(PACS), University of Rhode Island Change Assessment(URICA), Hanil Alcohol Insight Scale(HAIS) were followed-up for 24weeks. Subjects who drank heavily(5 standard drinking or more/day) or were not followed up anymore were classified as the relapse group. We used logistic regression analysis with backward elimination of SPSS PC+11.5 to investigate relapse estimate predictors. RESULTS: Average drinking amount per drinking day for last 1 year and HAIS score were predictors of relapse in alcohol-dependent patients. CONCLUSIONS: Our findings suggest that therapist should give more attention to alcohol-dependent patients who had more drinks per drinking day for last 1 year and had lower insight level.

Korean Immigrant Women's Meanings of Breast, Breast Cancer, and Breast Cancer Screenings / 간호학회지

PURPOSE: Koreans are one of the fastest growing Asian populations in the U.S. since 1960s. In Korean immigrant women (KIW), breast cancer was reported as the most frequently diagnosed cancer. However, their screening rates for breast cancer are lower than national guidelines; it is assumed that underlying cultural schemas of breast, breast cancer, and its screening modalities exist and need to be studied. This study was aimed to investigate cultural meanings of breast, breast cancer, and breast cancer screenings in KIW. METHODS: Using cultural models theory from cognitive anthropology, naturalistic qualitative methodology was utilized. Three focus group interviews with fifteen KIW were conducted. Thematic analysis with constant comparison technique was performed eliciting units of meaning, categories, and themes. RESULTS: The cultural schema of the meaning of breast is "mother who is breast-feeding her baby," with two themes of "balance in size," and "shyness." Regarding breast cancer, three themes, i.e., "indifference," "fear," and "uncertainty" are emerged. "Lack of information about screening modalities" is the overarching schema with reference to breast cancer screenings. CONCLUSIONS: The findings of this study demonstrate unique cultural models of KIW related to breast cancer and its screenings, which are critical to understand and penetrate their barriers to breast cancer screening.

Dimensional change and flexural strength in complete dentures fabricated by injection molding and conventional compression processing / 대한치과보철학회지

STATEMENT OF PROBLEM: Fracture and dimensional change of an acrylic resin denture are a rather common occurrence. PURPOSE: The purpose of this study was to compare differences in dimensional changes and flexural strength of separate maxillary complete dentures after immediate deflasking by injection molding and conventional compression processing. MATERIAL AND METHOD: To evaluate dimensional stability, the maxillary dentures were fabricated by using different materials and methods. Lucitone 199(Dentsply Trubyte, york, pennsylvania, USA) and Vertex(Dentimex, zeist, Netherlands) were used as materials. Compression and injection packing methods were used as processing methods. The impression surface of the dentures was measured by 3D Scanning System(PERCEPTRON, USA) and overlapped original impression surface of the master cast. To evaluate flexural strength, resin specimens were made according to the different materials, powder/liquid ratio and processing methods. Flexural strength of the complete resin specimens (64mm*10mm*3.3mm) were measured by INSTRON 467.(INSTRON, England) The data was analyzed by ANOVA, t-test and Tukey test.(p<.05 level of significance) RESULT: The results were as follows: 1. There was no significant differences between master model and denture base for each group in overall dimensional changes. 2. Palatal area was more stable than flange or alveolar area in dimensional stability. but, there was no significant differences among each area. 3. Materials and power/liquid ratio had an effect on flexural strength.(p<.05) Especially materials was most effective.(p<.05) 4. Lucitone 199(powder/liquid ratio followed by manufacturer's direction) showed higher flexural strength than Vertex. CONCLUSION: Dimensional stability or flexural strength are affected by materials rather than packing techniques.

Bankart Procedure through Lateral Capsulotomy in Traumatic Anterior Instability of the Shoulder / 대한정형외과학회잡지

PURPOSE: To determine the outcome of the Bankart procedure through lateral capsulotomy approach by objective and subjective evalua-tion in traumatic anterior instability of the shoulder. MATERIALS AND METHODS: Thirty-seven patients with traumatic anterior instability, who underwent the Bankart procedure through lateral capsulotomy, were investigated with an average follow-up of 23 months. Every effort was made to maximize the range of motion by repairing the Bankart lesion and closing the capsulotomy to allow as much external rotation as feasible. In 18 cases, superior capsular shift (13) or Neer 's capsular shift (5) were combined to deal with capsular redundancy. Outcome was assessed using range of motion, Pennsylvania Shoulder Function Score, pain, residual symptom and satisfaction. RESULTS: Recurrence of instability was not encountered. Function score increased significantly and all patients were satisfied with the results. However, 8 patients (22%) complained of feeling apprehensive about sports activities. CONCLUSION: The Bankart procedure through lateral capsulotomy appears to minimize unwanted external rotation limitations and enable capsular redundancy to be dealt with adequately.

Differences between Koreans and Americans undergoing Total Knee Replacement Arthroplasty for Primary Osteoarthritis

BACKGROUND: Total knee arthroplasty is a reliable and durable procedure in the treatment of knee arthritis. Patient selection is one scientific aspect of total knee replacement and the surgeon must develop knowledge about those patients who will benefit from total knee replacement. Authors tried to find any differences in preoperative status for Koreans and Americans undergoing total knee replacement arthroplasty(TKRA) for primary osteoarthritis(OA). Another goal of this study was to determine whether Koreans undergoing elective TKIRA for primary OA had more advanced disease preoperatively than Americans undergoing the same procedure. METHODS: Preoperative clinical and radiographic severity of knee OA was determined between Koreans who underwent TKRA at the National Medical Center in Seoul, Korea and Americans who underwent the same procedure at the Hospital of the University of Pennsylvania in Philadelphia, USA. RESULTS: There were 62 women and five men included in the group I(Koreans) compared to 60 women and thirty men in the group II(Americans). The mean age for the patients in the group I was 64.0 years and for the group II 69.5 years. The average weight for the group I was 63.8 Kg(range, 46-85 kg) with an average height of 152.4 cm(range, 133-168 cm). The corresponding data in the group II was 86.6 kg(range, 54-170 kg) and 167.4 cm(range, 147-196 cm). The mean preoperative knee score(developed by The Knee Society) for the group I was 32.7 points and the mean preoperative function score was 42.0 points. The mean preoperative knee and function scores for the group II were 38.1 and 46.2 points, respectively. The mean preoperative flexion contracture and further flexion were 11.7degrees(range, 0-40degrees) and 124.8degrees(range, 70-140degrees), respectively. The corresponding data in the group II were 4.0degrees(range, 0-15degrees) and 107.7degrees(range, 80-130degrees), respectively. The group I knees had a mean preoperative tibiofemoral angle of 4.8degrees(+/-6.0degrees) varus. For the group H knees, the preoperative tibiofemoral angle was 0.83degrees(+/-7.80degrees) valgus. Lateral FT(femorotibial) osteoarthritis was not found in any Korean patients but seen in 18 cases(17.8%) of American patients. CONCLUSION: The observed differences in the status prior to TKRA indicate that Koreans are operated on at a more advanced stage in the course of their disease than Americans. A number of important issues remain to be addressed in future research, such as the role of patient preference and different access to TKRA and the differences of their clinical presentation.

Evaluation of Clinical Validity of Cross-Cultural Smell Identification Test (CC-SIT) in Korean / 대한이비인후과학회지

BACKGROUND AND OBJECTIVES: The development of a l2-item Cross-Cultural Smell Identification Test (CC-SIT) was based upon items from the University of Pennsylvania Smell Identification Test (UPSIT), The selected CC-SIT items were familiar to most persons from American, European, and Asian cultures. Since there were no reports about its clinical validity for Koreans, we evaluated its identifiability in this study. MATERIALS AND METHODS: The CC-SIT were administered to 30 normal subjects and 32 patients with decreased sense of smell, and compared with those of the Korean K-SIT and buthanol threshold test (BTT), items of which many Koreans are familiar with. RESULTS: In the normal group, the mean percent-correct scores of CC- SIT and K-SIT were 87.5+/-7.8% and 90.5+/-9.7%, respectively. In the patient group, the scores were 48.2+/-14.1 and 49.6+/-10.2%, respectively. The results of CC-SIT showed a high correlation with the K-SIT (gamma=0.822, p < 0.001). CONCLUSION: The CC- SIT can be used as an olfactory identification test for Koreans.

Selection of Olfactory Identification Items for Koreans / 대한이비인후과학회지

BACKGROUND AND OBJECTIVES: The olfactory identification test has been used in clinical assessment of olfactory ability for the following reasons: it is fast, it yields results compatible to a threshold test, and it gives a picture of how well the patient can deal with odors of everyday life. However, items in UPSIT (University of Pennsylvania Smell Identification Test)and CCCRC (Connecticut Chemosensory Clinical Research Center)identification test which are widely used in the world are selected for western people. Accordingly, these items in the tests are not appropriate for Koreans of different cultural background. MATERIALS AND METHODS: For the selection of proper items for the olfactory identification test, 42 natural odors familiar to Koreans were applied to 40 normal subjects and 40 patients with decreased sense of smell without sinonasal diseases. Among 42 items, 16 items with high identifiability and familiarity were chosen according to the results of test-retest in normal subjects. RESULTS: The results of olfactory identification test using 16 selected items showed high correlation with olfactory threshold. CONCLUSION: These 16 items can be used for an olfactory identification test for Koreans.