• Title/Summary/Keyword: Reporting Confidence

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Application of Pharmacovigilance Methods in Occupational Health Surveillance: Comparison of Seven Disproportionality Metrics

  • Bonneterre, Vincent;Bicout, Dominique Joseph;De Gaudemaris, Regis
    • Safety and Health at Work
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    • v.3 no.2
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    • pp.92-100
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    • 2012
  • Objectives: The French National Occupational Diseases Surveillance and Prevention Network (RNV3P) is a French network of occupational disease specialists, which collects, in standardised coded reports, all cases where a physician of any specialty, referred a patient to a university occupational disease centre, to establish the relation between the disease observed and occupational exposures, independently of statutory considerations related to compensation. The objective is to compare the relevance of disproportionality measures, widely used in pharmacovigilance, for the detection of potentially new disease ${\times}$ exposure associations in RNV3P database (by analogy with the detection of potentially new health event ${\times}$ drug associations in the spontaneous reporting databases from pharmacovigilance). Methods: 2001-2009 data from RNV3P are used (81,132 observations leading to 11,627 disease ${\times}$ exposure associations). The structure of RNV3P database is compared with the ones of pharmacovigilance databases. Seven disproportionality metrics are tested and their results, notably in terms of ranking the disease ${\times}$ exposure associations, are compared. Results: RNV3P and pharmacovigilance databases showed similar structure. Frequentist methods (proportional reporting ratio [PRR], reporting odds ratio [ROR]) and a Bayesian one (known as BCPNN for "Bayesian Confidence Propagation Neural Network") show a rather similar behaviour on our data, conversely to other methods (as Poisson). Finally the PRR method was chosen, because more complex methods did not show a greater value with the RNV3P data. Accordingly, a procedure for detecting signals with PRR method, automatic triage for exclusion of associations already known, and then investigating these signals is suggested. Conclusion: This procedure may be seen as a first step of hypothesis generation before launching epidemiological and/or experimental studies.

Age of Data in Contemporary Research Articles Published in Representative General Radiology Journals

  • Kang, Ji Hun;Kim, Dong Hwan;Park, Seong Ho;Baek, Jung Hwan
    • Korean Journal of Radiology
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    • v.19 no.6
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    • pp.1172-1178
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    • 2018
  • Objective: To analyze and compare the age of data in contemporary research articles published in representative general radiology journals. Materials and Methods: We searched for articles reporting original research studies analyzing patient data that were published in the print issues of the Korean Journal of Radiology (KJR), European Radiology (ER), and Radiology in 2017. Eligible articles were reviewed to extract data collection period (time from first patient recruitment to last patient follow-up) and age of data (time between data collection end and publication). The journals were compared in terms of the proportion of articles reporting the data collection period to the level of calendar month and regarding the age of data. Results: There were 50, 492, and 254 eligible articles in KJR, ER, and Radiology, respectively. Of these, 44 (88%; 95% confidence interval [CI]: 75.8-94.8%), 359 (73%; 95% CI: 68.9-76.7%), and 211 (83.1%; 95% CI: 78-87.2%) articles, respectively, provided enough details of data collection period, revealing a significant difference between ER and Radiology (p = 0.002). The age of data was significantly greater in KJR (median age: 826 days; range: 299-2843 days) than in ER (median age: 570 days; range: 56-4742 days; p < 0.001) and Radiology (median age: 618; range: 75-4271 days; p < 0.001). Conclusion: Korean Journal of Radiology did not fall behind ER or Radiology in reporting of data collection period, but showed a significantly greater age of data than ER and Radiology, suggesting that KJR should take measures to improve the timeliness of its data.

Rodent peri-implantitis models: a systematic review and meta-analysis of morphological changes

  • Ren Jie Jacob Chew;Jacinta Xiaotong Lu;Yu Fan Sim;Alvin Boon Keng Yeo
    • Journal of Periodontal and Implant Science
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    • v.52 no.6
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    • pp.479-495
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    • 2022
  • Purpose: Rodent models have emerged as an alternative to established larger animal models for peri-implantitis research. However, the construct validity of rodent models is controversial due to a lack of consensus regarding their histological, morphological, and biochemical characteristics. This systematic review sought to validate rodent models by characterizing their morphological changes, particularly marginal bone loss (MBL), a hallmark of peri-implantitis. Methods: This review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. A literature search was performed electronically using MEDLINE (PubMed), and Embase, identifying pre-clinical studies reporting MBL after experimental peri-implantitis induction in rodents. Each study's risk of bias was assessed using the Systematic Review Center for Laboratory animal Experimentation (SYRCLE) risk of bias tool. A meta-analysis was performed for the difference in MBL, comparing healthy implants to those with experimental peri-implantitis. Results: Of the 1,014 unique records retrieved, 23 studies that met the eligibility criteria were included. Peri-implantitis was induced using 4 methods: ligatures, lipopolysaccharide, microbial infection, and titanium particles. Studies presented high to unclear risks of bias. During the osseointegration phase, 11.6% and 6.4%-11.3% of implants inserted in mice and rats, respectively, had failed to osseointegrate. Twelve studies were included in the meta-analysis of the linear MBL measured using micro-computed tomography. Following experimental peri-implantitis, the MBL was estimated to be 0.25 mm (95% confidence interval [CI], 0.14-0.36 mm) in mice and 0.26 mm (95% CI, 0.19-0.34 mm) in rats. The resulting peri-implant MBL was circumferential, consisting of supra- and infrabony components. Conclusions: Experimental peri-implantitis in rodent models results in circumferential MBL, with morphology consistent with the clinical presentation of peri-implantitis. While rodent models are promising, there is still a need to further characterize their healing potentials, standardize experiment protocols, and improve the reporting of results and methodology.

Comparison of Training Effectiveness for IV Injections: Intravenous (IV) Arm Model versus Computer Simulator (마네킹 모델과 컴퓨터 시뮬레이터를 이용한 정맥주사 실습교육의 효과 비교)

  • Hwang, Juhee;Kim, Hyunjung
    • Journal of Korean Academy of Fundamentals of Nursing
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    • v.21 no.3
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    • pp.302-310
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    • 2014
  • Purpose: The purpose of this study was to compare the effectiveness of training using an intravenous (IV) arm model versus a computer simulator for IV injections. Method: Study was a quasi-experimental study conducted with 106 nursing students. Participants were divided into two groups: the IV Arm Group using a mannequin arm model (control group) and the Computer Simulator Group using the Virtual IV demonstration (experimental group). Theoretical lectures and video presentations on IV injections were given to both groups. Each group went through the training practice using the IV arm or computer simulator. After the completion of training, questionnaires were given to the students to evaluate their learning attitudes and experiences, self-confidence in IV injection, and satisfaction with the training materials. Results: Student satisfaction with the training materials including the reality, usefulness, and educational effects showed notable differences between the two groups with the Computer Simulator group reporting more positive effects that the IV Arm group. However, there was no statistical difference between the two groups in the categories of learning attitude, learning experience, or self-confidence. Conclusion: While there was a differences in strengths and weaknesses of the two methods, both methods should be considered for practice and further study needs to be done on educational effectiveness.

Hypertension and the Risk of Breast Cancer in Chilean Women: a Case-control Study

  • Pereira, Ana;Garmendia, Maria Luisa;Alvarado, Maria Elena;Albala, Cecilia
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.11
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    • pp.5829-5834
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    • 2012
  • Background: Breast cancer is the most common cancer in women worldwide. Although different metabolic factors have been implicated in breast cancer development, the relationship between hypertension and breast cancer has not been elucidated. Aim: To evaluate hypertension as a risk factor for breast cancer in Chilean women of low and middle socio-economic status. Methods: We conducted an age-matched (1:1) case-control study in 3 hospitals in Santiago, Chile. Breast cancer cases (n=170) were histopathologically confirmed. Controls had been classified as Breast Imaging Reporting and Data System I (negative) or II (benign findings) within 6 months of recruitment. Blood pressure was measured using a mercury sphygmomanometer and standardized procedures. We used 2 hypertension cut-off points: blood pressures of ${\geq}140/90$ mmHg and ${\geq}130/85$ mmHg. Fasting insulin and glucose levels were assessed, and anthropometric, sociodemographic, and behavioral information were collected. Odds ratios and 95% confidence intervals were estimated for the entire sample and restricted to postmenopausal women using multivariable conditional logistic regression models. Results: Hypertension (${\geq}140/90$ mmHg) was significantly higher in cases (37.1%) than controls (17.1%) for the entire sample and in postmenopausal pairs (44.0% compared to 23.8%). In crude and adjusted models, hypertensive women had a 4-fold increased risk of breast cancer (adjusted odds ratio: 4.2; 95% confidence interval: 1.8; 9.6) compared to non-hypertensive women in the entire sample. We found a similar association in the postmenopausal group (adjusted odds ratio: 2.8; 95% confidence interval: 1.1; 7.4). A significant effect was also observed when hypertension was defined as blood pressure of ${\geq}130/85$ mmHg. Conclusion: A significant association was found between hypertension and breast cancer over the entire sample and when restricted to postmenopausal women. Hypertension is highly prevalent in Latin America and may be a modifiable risk factor for breast cancer; therefore, a small association between hypertension and breast cancer may have broad implications.

Patterns of Spontaneous Adverse Events Reporting on Human Papillomavirus Vaccines according to the Applicability of Brighton Collaboration Criteria in Korea from 2008 to 2017 (국내 사람유두종바이러스백신 접종 후 자발적 이상반응 보고사례의 Brighton Collaboration 기준 활용 가능성 연구)

  • Kim, Myo-Song;You, Seung-Hun;Park, Hye Min;Lee, Min-Taek;Kang, Ye-Jin;Koo, Hyunji;Jung, Sun-Young
    • Korean Journal of Clinical Pharmacy
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    • v.30 no.1
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    • pp.19-30
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    • 2020
  • Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

A Study on the Monitoring System for Green-house Gases from Electric Rolling Stock (전기철도차량 온실가스 모니터링 방안 연구)

  • Kim, Yong-Ki;Rhee, Young-Ho;Lee, Jae-Young;Lee, Cheul-Kyu;Lim, Sung-Soo
    • Proceedings of the KSR Conference
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    • 2011.10a
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    • pp.2581-2584
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    • 2011
  • Along with response of the Climactic Change Convention, the government is demanding a measuring and reporting system for green-house gas emission and energy consumption on the railroad sector in order to make a transition to a low carbon green railroad system. According to the plans to electric railway line and increase the number of electric rolling stock, the electric consumption is increasing more than the consumption of diesel. Therefore, the development of monitoring device for green-house gases became important issue. In this study we developed a prototype of the monitoring system for estimating electric consumption. This study is expected to make accurate GHG emission inventory and be used to have confidence of emission factor.

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Prevention of Falls in the Elderly: A review of exercise interventions (노인 낙상예방을 위한 운동중재에 관한 고찰)

  • Cho Mi-sook;Park Rae-joon
    • The Journal of Korean Physical Therapy
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    • v.15 no.2
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    • pp.157-167
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    • 2003
  • Falls are a leading cause of injury, disability and death among people older than 65. Even without injury, falls cause a loss of confidence that results in reduced physical activity, increased dependency and social withdrawal. Fall prevention in the eldery people is a multifaced task that includes both the identification of risk factors and their modification strategies. Fall risk factors have been identified as both intrinsic and extrinsic. Intrinsic factors are those related to the physical and cognitive function of the person. Extrinsic factors are those which are included in the environmental hazards of everyday life. Combinations of interventions aimed at modifying both intrinsic and extrinsic risk factors can result in significant fall prevention in the geriatric population. This article selectively reviews the literature reporting exercise intervention to improve strength, balance and mobility.

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Comparative study between an intensive small group teaching and a 1-year clinical practice on OSCE

  • Kim, Sinjae;Park, Minhwan;Seo, Ji-Hyun;Woo, Hyang-Ok;Youn, Hee-Shang;Park, Jung Je;Jeon, Sea-Yuoug;Hwa, Jung Seok;Mullan, Patricia;Gruppen, Larry D.
    • Kosin Medical Journal
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    • v.33 no.2
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    • pp.181-190
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    • 2018
  • Objectives: Our school introduced a new curriculum based on faculty-directed, intensive, small-group teaching of clinical skills in the third-year medical students. To examine its effects, we compared the mean scores on an OSCE between the third- and fourth-year medical students. Methods: Third- and fourth-year students did rotations at the same five OSCE stations. They then completed a brief self-reporting questionnaire survey to examine the degree of satisfaction with new curriculum in the third-year students and clinical practice in the fourth-year students, as well as their perception of confidence and preparedness. We analyzed the OSCE data obtained from 158 students, 133 of whom also completed the questionnaire. Results: Mean OSCE scores on the breast examination and wet smear stations were significantly higher in the third-year group (P < 0.001). But mean OSCE scores of motor-sensory examination and lumbar puncture were significantly higher in the fourth-year group (P < 0.05). The mean OSCE scores had no significant correlation with satisfaction. In addition, the self-ratings of confidence had a high degree of correlation with satisfaction with new curriculum (r = 0.673) and clinical practice (r = 0.692). Furthermore, there was a moderate degree of correlation between satisfaction and preparedness in both groups (r = 0.403 and 0.449). Conclusions: There is no significant difference in the effect on the degree of clinical performance and confidence between an intensive-small group teaching and a 1-year clinical practice. If combined, intensive small group teaching and clinical practice would be useful to improve the degree of ability and confidence in medical students.

Assessment for the Needs to Develop Hospice Training Program for Nurses (간호사를 위한 호스피스 연수교육 요구도 조사)

  • Kwon, So-Hi;Yang, Seong-Kyeong;Park, Myung-Hee;Choe, Sang-Ok
    • Journal of Hospice and Palliative Care
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    • v.11 no.3
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    • pp.147-155
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    • 2008
  • Purpose: This study aimed to assess the educational needs for nurses who care for terminal cancer patients and their families. To identify top needs along with key issues in consideration to develope hospice training program and provide specific recommendations. Methods: A cross-sectional design with nurses from nine universities' hospice specialist courses and seven cancer centers was used. Data were collected via e-mail or mail service from March to April in 2008. One hundred seventy three questionnaires were returned (return rate: 73.6%), and 156 questionnaires were eventually analyzed. The questionnaire consisted of Mason and Ellershaw's The Self-efficacy in Palliative Care (SEPC) and self-reporting confidence and educational needs in hospice care. Results: The mean age of the participants was 37.94 years, 82.1% were staff nurses, and 44.9% completed over six months hospice education. Mean$\pm$standard deviation score for total SEPC was $2.67{\pm}.62$, which was lower than average (score 3), with communication score being the lowest ($2.49{\pm}.69$). The lowest self-reporting confidence score was $2.03{\pm}.77$ in hospice administration and management, followed by providing complement therapy ($2.34{\pm}.77$), bereavement care ($2.34{\pm}.71$), lymph edema management ($2.35{\pm}.79$), and care planning ($2.36{\pm}.81$). The participants reported that additional education is needed in all topics, with pain management score being the highest ($3.71{\pm}.50$), followed by pain and symptom evaluation ($3.67{\pm}.52$), care for dying ($3.67{\pm}.52$), and communication and counseling ($3.63{\pm}.53$). There were significant subgroup differences in SEPC and self-reporting confidence between groups who completed 6 months hospice education or not, however, no significant difference in educational need between the groups. Conclusion: This study showed the need for developing hospice training program to improve compentency of nurses in hospice palliative care.

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