• Title/Summary/Keyword: assessment of safety

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TheAssessment of risk of bias in randomized controlled trials published in the Korean Journal of Physical Therapy: A 2018~2022 review (한국 물리치료 학술지에 무작위대조연구의 비뚤림 위험 평가: 2018~2022년 검토)

  • Jae Hyun Lim;Chi Bok Park;Byeong Geun Kim
    • Journal of Korean Physical Therapy Science
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    • v.30 no.4
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    • pp.82-91
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    • 2023
  • Background: Randomized controlled trials (RCTs) provide evidence on the effectiveness and safety of interventions and inform systematic reviews and guideline preparation for clinical application. However, methodological flaws can occur in many RCTs, and Cochrane's risk of bias version 2 (RoB2) can be used to evaluate RCTs' risk of bias (RoB). However, physical therapy RCTs in Korea did not confirm RoB. Therefore, the purpose of this study was to evaluate RoB using RoB2 in RCTs published in the Korean Physical Therapy Journal. Design: Review. Methods: The RCTs subject to evaluation were RCTs published in 11 physical therapy journals in Korea from 2018 to 2022. RoB2 evaluated a total of five domains: bias arising from the randomization process, bias due to deviations from intended interventions, bias due to missing outcome data, bias in measurement of the outcome, and bias in selection of the reported result. Results: A total of 616 RCTs were evaluated. As for bias arising from the randomization process, high risk was the highest at 555 (90.1%), followed by low risk at 41 (6.7%) and some concerns at 20 (3.2%). For bias due to deviations from intended interventions, the proportion of some concerns was the highest at 390 (63.3%), followed by high risk at 218 (35.4%) and low risk at 8 (1.3%). As for the bias due to missing outcome data, the rate of low risk was the highest at 399 (64.8%), followed by high risk at 159 (25.8%) and some concerns at 58 (9.4%). As for bias in measurement of the outcome, high risk was the highest at 294 (47.7%), followed by low risk at 224 (36.4%) and some concerns at 98 (15.9%). In the bias due to missing outcome data, the ratio of high risk was the highest at 610 (99%), followed by low risk at 4 (0.7%) and some concerns at 2 (0.3%). Conclusion: Most of the RoB evaluation results of RCTs published in the Korean Physical Therapy Journal were rated as high risk. Methodological quality of RCTs needs to be improved.

Analysis of Hazard Factors for Domestic General Purpose Ventilator using Usability Assessment (사용적합성 평가를 적용한 국산 범용인공호흡기의 위험요인 분석)

  • Gyeongmin Kwon;Seung hee Kim;You Rim Kim;Won Seuk Jang
    • Journal of Biomedical Engineering Research
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    • v.45 no.1
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    • pp.10-19
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    • 2024
  • The purpose of this study is to conduct a summative evaluation of the usability of a general-purpose ventilator to determine whether it can be used for its intended purpose in the intended environment by the intended user and to find possible errors in use. The importance of ventilators has increased due to the accelerated aging of the population and the impact of the pandemic. In addition, patients who require ventilators are often in critical condition, so even a small error in use can be fatal. Therefore, it is important to ensure that the ventilator has sufficient stability and can be used satisfactorily without inconvenience to the user. In this study, we conducted a usability test with 17 respiratory nurses with more than 3 years of experience using the ventilator. We analyzed the task success rate, satisfaction, and opinions of the intended users while going through a total of 17 scenarios. Satisfaction was captured through an ASQ questionnaire and subjective opinions were captured through a detailed opinion questionnaire. The results showed a high level of satisfaction with an average score of 6.3 for the use scenarios. Evaluators expressed satisfaction with the overall visibility and versatility of the features, but noted that improvements were needed for calibration tasks with low task success rates. As the calibration method is different from other equipment, it was suggested that specific explanations of the calibration method and the picture that appears when calibrating are needed, and that if relevant training is provided, the equipment can be used without problems. If the usability evaluation is not limited to securing efficiency and satisfaction from the intended users, but also continuously receives feedback from users to prepare for use in emergency environments such as pandemic situations, it will be very helpful to seize opportunities such as emergency authorization in future situations, and ultimately contribute to patient safety by reducing use errors.

Assessment of Environmental Pollution in Korean Stream Sediments by Chemical Analyses and Insect Immune Biomarkers

  • Ryoo, Keon-Sang;Byun, Sang-Hyuk;Hong, Yong-Pyo;Cho, Ki-Jong;Bae, Yeon-Jae;Kim, Yong-Gyun
    • Korean Journal of Environmental Biology
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    • v.26 no.4
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    • pp.330-342
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    • 2008
  • A comprehensive quality survey for PCDDs/PCDFs and coplanar PCBs as well as heavy metals (Cu, Zn, Cd and Pb) in sediments has been investigated in August 2006, Korea. Monitoring was undertaken at five streams representing different surrounding environments throughout Juwang and Gapyeong streams (reference sites), Jungrang stream (dense population site), Ansan stream (mixed small population and industrial site), and Siheung stream (heavy industrial site). The levels of heavy metal in samples were found to be significantly higher in sediment from Siheung stream compared to those of other stream sites. The heavy metal concentrations (dry weight basis) in sediment from Siheung stream were as follows; Cd (3.7 ${\mu}g$/g), Pb (1,295 ${\mu}g$/g), Cu (713.4 ${\mu}g$/g) and Zn (358.1 ${\mu}g$/g). Among 12 coplanar PCBs and 17 PCDDs/PCDFs selected as target compounds in this study, PCB (IUPAC no. 118) and OCDD were the most abundant congeners found in all sediment samples, followed by 1,2,3,4,6,7,8-HpCDD, OCDF and 1,2,3,4,6,7,8HpCDF as well as PCB (IUPAC no. 105). These results were shown to be in the same trend as the sediment samples of other countries. The levels of PCDDs/PCDFs/coplanar PCBs in sediment samples were expressed as concentrations and WHO- TEQ values. The PCDDs/PCDFs/coplanar PCBs concentrations and their WHO-TEQ values in sediment from Siheung stream were remarkably high. The levels detected were 788.16 pg/g and 36.080 pg WHO-TEQ/g dry weight for PCDDs/ PCDFs and 314 pg/g and 0.4189 pg WHO-TEQ/g dry weight for coplanar PCBs, respectively, beyond the safety level of sediment value 20 pg WHO-TEQ/g. Sediment samples of the five streams were also monitored by sensitive biomarkers using insect immune responses: hemocyte-spreading behavior and immune-associated enzyme activities of phospholipase A$_2$ (PLA$_2$) and phenoloxidase. Organic extracts of Siheung and Jungrang sediments significantly interfered with the hemocytespreading behavior, whereas those of Ansan, Gapyeong, and Juwang did not. These organic extracts did not inhibit the PLA$_2$ and phenoloxidase activities. However, phenoloxidase was highly susceptible to exposure to aqueous extracts in all site sediments. In comparison, PLA$_2$ activities of the hemocytes were significantly inhibited only by aqueous extracts of Siheung, Jungrang, and Gapyeong sediments, but not by those of Ansan and Juwang. Despite some disparity between bioand chemical monitoring results, the biomarkers can be recommended as a device warning the contamination of biohazard environmental chemicals because of a fast and inexpensive detection method.

Abiraterone for Treatment of Metastatic Castration-resistant Prostate Cancer: a Systematic Review and Meta-analysis

  • Zhou, Zhi-Rui;Liu, Shi-Xin;Zhang, Tian-Song;Xia, Jun;Li, Bo
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.3
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    • pp.1313-1320
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    • 2014
  • Introduction: Although most prostate cancers initially respond to castration with luteinizing hormonereleasing analogues or bilateral orchiectomy, progression eventually occurs. Based on the exciting results of several randomized controlled trials (RCTs), it seems that patients with metastatic castration-resistant prostate cancer (mCRPC) might benefit more from treatment withabiraterone. Therefore we conducted a systematic review to evaluate the efficacy and toxicity of abiraterone in the treatment of mCRPC. Methods: Literature was searched from Embase, PubMed, Web of Science, and Cochrane Library up to July, 2013. Quality of the study was evaluated according to the Cochrane's risk of bias of randomized controlled trial (RCT) tool, then the Grading of Recommendations Assessment, Development and Evaluation (GRADE) System was used to rate the level of evidence. Stata 12.0 was used for statistical analysis. Summary data from RCTs comparing abiraterone plus prednisone versus placebo plus prednisone for mCRPC were meta-analyzed. Pooled hazard ratios (HRs) for overall survival (OS), radiographic progression-free survival (RPFS) and time to PSA progression (TTPP); Pooled risk ratios (RR) for PSA response rate, objective response rate and adverse event were calculated. Results: Ten trials were included in the systematic review; Data of 2,283 patients (1,343 abiraterone; 940 placebo) from two phase 3 trials: COU-AA-301 and COU-AA-302 were meta-analyzed. Compared with placebo, abiraterone significantly prolonged OS (HR, 0.74; 95% confidence interval [CI], 0.66 to 0.84), RPFS (HR, 0.59; 95% CI, 0.48 to 0.74) and time to PSA progression (HR, 0.55; 95% CI, 0.43 to 0.70); it also significantly increased PSA response rate (RR, 3.63; 95% CI, 1.72 to 7.65) and objective response rate (RR, 3.05; 95% CI, 1.51 to 6.15). This meta-analysis suggested that the adverse events caused by abiraterone are acceptable and can be controlled. Conclutios: Abiraterone significantly prolonged OS, RPFS and time to progression patients with mCRPC, regardless of prior chemotherapy or whether chemotherapy-na$\ddot{i}$ve, and no unexpected toxicity was evident. Abiraterone can serve as a new standard therapy for mCRPC.

Subgrouping of N1a Stage Papillary Thyroid Carcinoma with Positive Node Ratio (갑상선유두상암의 중앙림프절 전이율에 따른 N1a병기의 세분화)

  • Lee, Min-Wan;Cho, Jin-Seong;Cho, Dong-Hoon;Ryu, Young-Jae;Park, Min-Ho;Yoon, Jung-Han
    • Korean Journal of Head & Neck Oncology
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    • v.32 no.1
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    • pp.13-19
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    • 2016
  • Background : The 2015 American thyroid association (ATA) guidelines greatly expanded section on risk stratification of thyroid cancer. Definition of "Low risk of recurrence" has expanded, by inclusion of small volume lymph node involvement, such as less than 5 lymph node metastases each smaller than 2mm in central compartment. Purpose : We evaluated the number of positive nodes, Positive node ratio (PNR), recurrence, and radioablation therapy. Also, evaluated the safety of omitting strategy of radioablation after total thyroidectomy with PTC, especially on low-PNR N1a patients compared with high-PNR N1a patients. Methods : Consecutive 147 N1a and 216 N0 patients who underwent total thyroidectomy with central neck dissection between 2003 and 2004 were enrolled. We divided 147 N1a patients into two groups, such as 96 high-PNR versus 51 low-PNR group according to 50% of PNR, and compared these two groups with N0 group. Results: 7.2% (26/363) recurrences were occurred, and 21/147 (14.3 %) recurrences were on N1a patients, and 5/216 (2.3 %) were on N0 patients. Of these 21 recurrences in N1a stage patients, 20 (95.2 %) recurrences were occurred in high-PNR N1a group and only 1 (4.8 %) recurrence was in low-PNR N1a group. The recurrence of low-PNR N1a group was significantly lower than high-PNR N1a group (Log-rank p value = 0.003), but significantly not different from N0 group (Log-rank p value = 0.889). Although this study was a retrospective non-randomized trial with small number of patients, the 10-year recurrence of omitting RAI in low-PNR N1a patients with less than 50% of PNR were shown to be comparable with 216 N0 low risk patients. Conclusion : Positive node ratio could be a useful predictor of recurrence and useful guidance postoperative management -rather than absolute number of positive node.

Characteristics of Achilles Tendon Insertion on Posterior Aspect of the Calcaneus without Pathological Deformity in Adults: A Magnetic Resonance Imaging Study (성인에서의 병적 위치 변형이 없는 아킬레스건 종골 후방 부착부의 특징: 자기공명영상 계측 연구)

  • Gwak, Heuichul;Jung, Daewon;Park, Hyungtaek;Ha, Dongjun;Kwak, Jaeyong;Kim, Uicheol
    • Journal of Korean Foot and Ankle Society
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    • v.20 no.3
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    • pp.112-115
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    • 2016
  • Purpose: We aimed to investigate the safety zone for Achilles tendon insertion in the posterior aspect of the calcaneus via the use of magnetic resonance imaging (MRI) when planning for insertional Achilles tendinopathy. Materials and Methods: This study included 95 patients. The MRI of midsagittal plane of the ankle joint was used to measure the proximal and distal insertion point for the Achilles tendon in the posterior aspect of the calcaneus. Patients were divided into three groups according to the proportion of the distal insertion point out of the entire calcaneal length: the proximal, middle, and distal insertion groups. Results: The mean proximal and distal insertion points for the Achilles tendon were measured as 1.05 cm (0~2.11 cm) and 2.36 cm (1.60~2.93 cm), respectively. When the posterior aspect of the calcaneus was used as the reference plane, none of the patients was in the proximal insertion group, while 75 and 20 patients were in the middle and distal insertion groups, respectively. The insertion portion was longer in the distal insertion group ($1.47{\pm}0.25cm$) than in the middle insertion group ($1.27{\pm}0.35cm$). Statistically significant differences with respect to the length of the insertion portion were observed between the two groups (p=0.008). Conclusion: Removal of more than 1 cm below the superior margin of the posterior calcaneus may be dangerous. An MRI study on the Achilles tendon of patients without hindfoot deformity or tendinopathy revealed various insertional characteristics. Preoperative MRI evaluation is safer than relying solely on the simple radiological assessment when planning for insertional Achilles tendinopathy.

A Case Series of Survival Outcomes in Patients with Advanced-stage IIIb/IV Non-small-cell Lung Cancer Treated with HangAm-Plus

  • Bang, Sun-Hwi;Yoon, Jeung-Won;Cho, Chong-Kwan;Shin, Ji-Eun;Lee, Yeon-Weol;Yoo, Hwa-Seung
    • Journal of Pharmacopuncture
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    • v.15 no.2
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    • pp.31-35
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    • 2012
  • Background and Objectives: Non-small-cell lung cancer (NSCLC) represents approximately 80% of all lung cancers. Unfortunately, at their time of diagnosis, most patients have advanced to unresectable disease with a very poor prognosis. The oriental herbal medicine HangAm-Plus (HAP) has been developed for antitumor purposes, and several previous studies have reported its therapeutic effects. In this study, the efficacy of HAP was evaluated as a third-line treatment for advanced-stage IIIb/IV NSCLC. Methods: The study involved six patients treated at the East- West Cancer Center (EWCC) from April 2010 to October 2011. Inoperable advanced-stage IIIb/IV NSCLC patients received 3,000 or 6,000 mg of HAP on a daily basis over a 12-week period. Computed tomography (CT) scans were obtained from the patients at the time of the initial administration and after 12 weeks of treatment. We observed and analyzed the patients overall survival (OS) and progression-free survival (PFS). Results: Of the six patients, three expired during the study, and the three remaining patients were alive as of October 31, 2011. The OS ranged from 234 to 512 days, with a median survival of 397 days and a one-year survival rate of 66.7%. In the 12-week-interval chest CT assessment, three patients showed stable disease (SD), and the other three showed progressive disease (PD). The PFS of patients ranged from 88 to 512 days, the median PFS being 96 days. Longer OS and PFS were correlated with SD. Although not directly comparable, the OS and the PFS of this study were greater than those of the docetaxel or the best supportive care group in other studies. Conclusion: HAP may prolong the OS and the PFS of inoperable stage IIIb/IV NSCLC patients without significant adverse effects. In the future, more controlled clinical trials with larger samples from multi-centers should be conducted to evaluate the efficacy and the safety of HAP.

Dynamic Structural Response Characteristics of Stiffened Blast Wall under Explosion Loads (폭발 하중을 받는 보강된 방폭벽의 동적 구조 응답 특성에 관한 연구)

  • Kim, Sang Jin;Sohn, Jung Min;Lee, Jong Chan;Li, Chun Bao;Seong, Dong Jin;Paik, Jeom Kee
    • Journal of the Society of Naval Architects of Korea
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    • v.51 no.5
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    • pp.380-387
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    • 2014
  • Piper Alpha disaster drew attention to the damage likely to arise from explosions and fires on an offshore platform. And great concerns have been increased to prevent these hazards. Blast wall is one of the passive safety systems; it plays a key part of minimizing the consequences. However, a buckling due to explosion loads is a factor which can reduce the strength of blast wall. The buckling often occurs between web and flange at the center of blast wall. This study aims to find a solution for reinforcing its strength by installing a flat plate at the spot where the buckling occurs. First of all, ANSYS finite element method is adopted to numerically compute the structural resistance characteristic of blast wall by using a quasi-static approach. Sequentially, the impact response characteristics of blast wall are investigated the effect on thickness of flat plate by using ANSYS/LS-DYNA. Finally, pressure-impulse diagrams (P-I diagram) are presented to permit easy assessment of structural response characteristics of stiffened blast wall. In this study, effective use is made to increase structural intensity. of blast wall and acquired important insights have been documented.

A Study on the Occurrences of Accidents among 1 st to 3rd Grade Rural Elementary Students (농촌지역 초등학교 저학년 학생들의 안전사고 발생실태)

  • Kim, Bok-Ju;Kim, Chung-Nam;Ryu, Mi-Kyung
    • Research in Community and Public Health Nursing
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    • v.12 no.3
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    • pp.815-827
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    • 2001
  • Accidents involving students are an important cause of death and disability. They also have enormous financial implications. In order to prevent childhood accidents. research and education for safety should be strengthened. The purpose of this study was to determine how often lower grade elementary students have accidents and what factors affect the accident rate. The study population consisted of 676 students who were in the 2nd, 3rd and 4th grades of twelve elementary schools located in Kun Wi Gun. The questionnaires were distributed to all of the 2nd to 4th grade student in the Kun Wi Gun to be completed by their parents about all the accidents which happened last one year and collected during the period of March 19, to March 30, 2001. The data were analyzed by using SPSS WIN 10.0 statistical package. The results of the study are as follow: 1. Among 676 students. 270 students had 540 accidental injuries during the study period. 2. The month, the day and the time with the highest accident rate were April. Monday. and between 1 and 4 p. m. each. 3. In the analysis of the location where the injury took place, the most frequent place was on school, around their homes and. then inside the home. 4. Most of accidents were caused by carelessness on the part of the students and the most frequent type of injury was an abrasion. 5. Students most injured part of the body was their legs. 6. They were treated at home most often and usually emergency treatment was performed by family members with disinfectant as first aid measure. Cost of the treatment of the accident ranged from 10.000 to 30,000 won in most cases. 7. Students' personality. type of family composition. mother's age and parents' education level were statistically significant. As a conclusion. 1st to 3rd grade rural elementary students need their assessment for accident involving condition. This study gave a very useful and important data to prepare accident prevention teaching program and to prepare accident prevention strategies.

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A Review of the Deterioration and Damage of the Top Flange of the Highway PSC Box Girder Bridge based on the Condition Assessment Results (상태평가 결과 기반 고속도로 PSC Box 거더교 상부플랜지 열화·손상 실태 고찰)

  • Ku, Young-Ho;Han, Sang-Mook
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.26 no.6
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    • pp.23-32
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    • 2022
  • Although PSCB girder bridges account for 4% of the bridges in use on highways, they do not account for much, but 98% of PSCB girder bridges are 1st type and 2nd type of bridge. Also, the total length of the PSCB girder bridge is 16% (192km) of the total length of the highway bridge. Thus, the PSCB girder bridge can be one of the bridge types where maintenance is important. In order to analyze the damage types of PSCB girder bridges, a detailed analysis was conducted by selecting 62 places (477 spans) precision safety diagnosis reports considering ratio of the construction method and snow removal environment exposure class. Analysis of report and a field investigation was conducted, and as a result, most of the causes of deterioration damage were caused by rainwater (salt water) flowing into the bridge pavement soaking in between the top flange and the interface. After concrete slab deteriorate occurred then bridge pavement cracking and breaking increased and exfoliation of concrete occurred by corrosion and expansion of the reinforcing bars occurred. In addition, the cause of cracks in the longitudinal direction on the bottom of the top flange is considered to be cracks caused by restrained drying shrinkage. In conclusion, for reasonable maintenance considering the characteristics of PSCB girder bridges, it should be suggested in the design aspect that restrained drying shrinkage crack on top flange. Also, it is believed that differentiated maintenance method should be proposed according to snow removal environment exposure class.