• Title/Summary/Keyword: safety outcomes

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Nursing Home Employee and Resident Satisfaction and Resident Care Outcomes

  • Plaku-Alakbarova, Bora;Punnett, Laura;Gore, Rebecca J.;Procare Research Team
    • Safety and Health at Work
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    • v.9 no.4
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    • pp.408-415
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    • 2018
  • Background: Nursing home resident care is an ongoing topic of public discussion, and there is great interest in improving the quality of resident care. This study investigated the association between nursing home employees' job satisfaction and residents' satisfaction with care and medical outcomes. Methods: Employee and resident satisfaction were measured by questionnaire in 175 skilled nursing facilities in the eastern United States from 2005 to 2009. Facility-level data on residents' pressure ulcers, medically unexplained weight loss, and falls were obtained from the Centers for Medicare and Medicaid Services Long-Term Care Minimum Data Set. The association between employee satisfaction and resident satisfaction was examined with multiple and multilevel linear regression. Associations between employee satisfaction and the rates of pressure ulcers, weight loss, and falls were examined with simple and multilevel Poisson regression. Results: A 1-point increase in overall employee satisfaction was associated with an increase of 17.4 points (scale 0-100) in the satisfaction of residents and family members (p < 0.0001) and a 19% decrease in the incidence of resident falls, weight loss, and pressure ulcers combined (p < 0.0001), after adjusting for staffing ratio and percentage of resident-days paid by Medicaid. Conclusion: Job satisfaction of nursing home employees is associated with lower rates of resident injuries and higher resident satisfaction with care. A supportive work environment may help increase quality of care in the nation's nursing homes.

Randomized, Double-blind, and Placebo-controlled a Clinical Study for Chronic Fatigue via the Analysis of Efficacy and Safety of Gongjin-dan and Ssanghwa-tang : Study Protocol (만성피로에 대한 공진단과 쌍화탕의 안전성 및 유효성 평가를 위한 무작위배정, 이중눈가림, 위약대조 임상시험 : 임상연구 프로토콜)

  • Jun-Yong, Choi;Byungmook, Lim;Hyeun-kyoo, Shin;Kibong, Kim
    • Journal of Society of Preventive Korean Medicine
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    • v.26 no.3
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    • pp.97-108
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    • 2022
  • Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4th week, and 6th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.

Comparative Efficacy and Safety of Radiofrequency Ablation and Microwave Ablation in the Treatment of Benign Thyroid Nodules: A Systematic Review and Meta-Analysis

  • Hendra Zufry;Timotius Ivan Hariyanto
    • Korean Journal of Radiology
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    • v.25 no.3
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    • pp.301-313
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    • 2024
  • Objective: The current body of evidence lacks clarity regarding the comparative efficacy and safety of radiofrequency ablation (RFA) and microwave ablation (MWA) as minimally invasive treatments for benign thyroid nodules. The primary objective of this study is to clarify these concerns. Materials and Methods: A comprehensive search was conducted using the Cochrane Library, Scopus, Europe PMC, and Medline databases until October 10th, 2023, using a combination of relevant keywords. This study incorporated literature that compared RFA and MWA for benign thyroid nodules. The primary outcome was the volume reduction ratio (VRR) from baseline to follow-up. Secondary outcomes were symptom score, cosmetic score, ablation time, major complications rate, hemorrhage, hoarseness, skin burn, cough, and sympathetic nerve injury. We used Risk of Bias in Non-randomized Studies - of Interventions (ROBINS-I) tool to assess the risk of bias in the included studies. We employed random effects models to analyze the standardized mean difference (SMD) and odds ratio for the presentation of outcomes. Results: Nine studies with 2707 nodules were included. The results of our meta-analysis indicated similar efficacy between RFA and MWA in terms of VRR during the 1 (SMD 0.06; 95% confidence interval [CI]: -0.13 to 0.26; P = 0.52) and 3 (SMD 0.11; 95% CI: -0.03 to 0.25; P = 0.12) months of follow-up. VRR was significantly higher in RFA than in MWA at the 6 (SMD 0.25; 95% CI: 0.06-0.43; P = 0.008) and 12 month of follow-up (SMD 0.38; 95% CI: 0.17 to 0.59; P < 0.001). There were no significant differences between RFA and MWA in symptom scores, cosmetic scores, or the incidence of complications, including hemorrhage, hoarseness, skin burn, cough, and sympathetic nerve injury. Conclusion: RFA showed a higher VRR than MWA at 6 and 12-month follow-ups, with a comparable safety profile.

Medical disputes related to advanced endoscopic procedures with endoscopic retrograde cholangiopancreatography or endoscopic ultrasonography for the management of pancreas and biliary tract diseases

  • Yoon Suk Lee;Jae-Young Jang;Jun Yong Bae;Eun Hye Oh;Yehyun Park;Yong Hwan Kwon;Jeong Eun Shin;Jun Kyu Lee;Tae Hee Lee;Chang Nyol Paik
    • Clinical Endoscopy
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    • v.56 no.4
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    • pp.499-509
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    • 2023
  • Background/Aims: This study aimed to evaluate the characteristics of endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasonography (EUS)-related adverse events (AEs) that eventually lead to medical disputes or claims on medical professional liability. Methods: Medical disputes for ERCP/EUS-related AEs filed in the Korea Medical Dispute Mediation and Arbitration Agency between April 2012 and August 2020 were evaluated using corresponding medical records. AEs were categorized into three sections: procedure-related, sedation-related, and safety-related AEs. Results: Among a total of 34 cases, procedure-related AEs were 26 (76.5%; 12 duodenal perforations, 7 post-ERCP pancreatitis, 5 bleedings, 2 perforations combined with post-ERCP pancreatitis); sedation-related AEs were 5 (14.7%; 4 cardiac arrests, 1 desaturation), and safety-related AEs were 3 (8.8%; 1 follow-up loss for stent removal, 1 asphyxia, 1 fall). Regarding clinical outcomes, 20 (58.8%) were fatal and eventually succumbed to AEs. For the types of medical institutions, 21 cases (61.8%) occurred at tertiary or academic hospitals, and 13 (38.2%) occurred at community hospitals. Conclusions: The ERCP/EUS-related AEs filed in Korea Medical Dispute Mediation and Arbitration Agency showed distinct features: duodenal perforation was the most frequent AE, and clinical outcomes were fatal, resulting in at least more than permanent physical impairment.

Safety of middle meningeal artery embolization for treatment of subdural hematoma: A nationwide propensity score matched analysis

  • Carson P. McCann;Michael G. Brandel;Arvin R. Wali;Jeffrey A. Steinberg;J. Scott Pannell;David R. Santiago-Dieppa;Alexander A. Khalessi
    • Journal of Cerebrovascular and Endovascular Neurosurgery
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    • v.25 no.4
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    • pp.380-389
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    • 2023
  • Objective: Middle meningeal artery embolization (MMAe) has burgeoned as a treatment for chronic subdural hematoma (cSDH). This study evaluates the safety and short-term outcomes of MMAe patients relative to traditional treatment approaches. Methods: In this retrospective large database study, adult patients in the National Inpatient Sample from 2012-2019 with a diagnosis of cSDH were identified. Cost of admission, length of stay (LOS), discharge disposition, and complications were analyzed. Propensity score matching (PSM) was utilized. Results: A total of 123,350 patients with cSDH were identified: 63,450 without intervention, 59,435 surgery only, 295 MMAe only, and 170 surgery plus MMAe. On PSM analysis, MMAe did not increase the risk of inpatient complications or prolong the length of stay compared to conservative management (p>0.05); MMAe had higher cost ($31,170 vs. $10,768, p<0.001) than conservative management, and a lower rate of nonroutine discharge (53.8% vs. 64.3%, p=0.024). Compared to surgery, MMAe had shorter LOS (5 vs. 7 days, p<0.001), and lower rates of neurological complications (2.7% vs. 7.1%, p=0.029) and nonroutine discharge (53.8% vs. 71.7%, p<0.001). There was no significant difference in cost (p>0.05). Conclusions: MMAe had similar LOS and decreased odds of adverse discharge with a modest cost increase compared to conservative management. There was no difference in inpatient complications. Compared to surgery, MMAe treatment was associated with decreased LOS and rates of neurological complications and nonroutine discharge. This nationwide analysis supports the safety of MMAe to treat cSDH.

Patient Safety Education for Medical Students: Global Trends and Korea's Status (의과대학생을 위한 환자안전 교육의 국제적 동향 및 국내 현황)

  • Roh, HyeRin
    • Korean Medical Education Review
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    • v.21 no.1
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    • pp.1-12
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    • 2019
  • This study is a narrative review introducing global trends in patient safety education within medical schools and exploring the status of Korean education. Core competences for patient safety include patient centeredness, teamwork, evidence- and information-based practice, quality improvement, addressing medical errors, managing human factors and system complexity, and patient safety knowledge and responsibility. According to a Korean report addressing the role of doctors, patient safety was described as a subcategory of clinical care. Doctors' roles in patient safety included taking precautions, educating patients about the side effects of drugs, and implementing rapid treatment and appropriate follow-up when patient safety is compromised. The Korean Association of Medical Colleges suggested patient safety competence as one of eight essential human and society-centered learning outcomes. They included appropriate attitude and knowledge, human factors, a systematic approach, teamwork skills, engaging with patients and carers, and dealing with common errors. Four Korean medical schools reported integration of a patient safety course in their preclinical curriculum. Studies have shown that students experience difficulty in reporting medical errors because of hierarchical culture. It seems that patient safety is considered in a narrow sense and its education is limited in Korea. Patient safety is not a topic for dealing with only adverse events, but a science to prevent and detect early system failure. Patient safety emphasizes patient perspectives, so it has a different paradigm of medical ethics and professionalism, which have doctor-centered perspectives. Medical educators in Korea should understand patient safety concepts to implement patient safety curriculum. Further research should be done on communication in hierarchical culture and patient safety education during clerkship.

Shift of the Safety Consciousness of Construction Superintendents due to Enforcement of the Serious Accidents Punishment Act (중대재해처벌법 시행에 따른 건설공사 관리감독자의 안전의식 변화에 대한 연구)

  • Young Ju Kim;Sung Woo Shin
    • Journal of the Korean Society of Safety
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    • v.39 no.3
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    • pp.27-35
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    • 2024
  • There are ongoing debates on the effectiveness of the Serious Accidents Punishment Act (SAPA) on ensuring safety management and accident prevention, as the annual number of fatal injuries did not decrease even after its enforcement. However, for right appraisal of the effectiveness of SAPA, it must not only be rated based on direct outcomes such as the number of fatal injuries, but also on the indirect effects related to the improvement of the safety management of firms or organizations. A construction superintendent is one of crucial persons who ensure worker safety in construction sites. They must have a high safety consciousness for effective and appropriate safety management in construction sites. In this, the impact of the enforcement of SAPA on the safety consciousness of the construction superintendents is investigated to add a new dimension in the appraisal of the effectiveness of SAPA. DAGMAR-based safety consciousness assessment model is used to measure four safety consciousness components, i.e. awareness, comprehension, conviction, and action. Three hundred and five responses obtained from a survey conducted among construction superintendents are used to analyze the shift of the safety consciousness of the construction superintendents due to the enforcement of SAPA. The results reveal that awareness and comprehension components significantly improved after the SAPA enforcement. Conversely, conviction and action components slightly improved. They also reveal that the changes are more significant for construction superintendents affiliated to principal contractors, compared to those affiliated to subcontractors.

The Regulatory Effectiveness for Appointing Safety and Health Management Officers for Small Manufacturing Companies (소규모 제조업 사업장에서의 안전보건관리담당자 제도 실효성 검증)

  • Kim, Jang-Hoon;Kwon, Min-Sung;Shin, Jong-Gyu;Kim, Sang-Ho
    • Journal of the Korea Safety Management & Science
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    • v.24 no.2
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    • pp.17-24
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    • 2022
  • It was legislated in Korea that the small-sized enterprise with fewer than 50 employees should appoint at least one managing officer in order to improve safety and health of the employees since 2016. Study on the effectiveness of this legislation is hardly found, however. This study tried to evaluate effectiveness of the regulations for appointing the safety and health management officer in small-sized manufacturing companies and make suggestions to improve it. It was done by pairwise comparison between the level of safety and health achievement of 52 companies before and after the legislation. A scorecard system and questionnaires were devised for assessing the level of safety and health achievement and surveying awareness and practice of the regulation in the field. Results from quantitative and qualitative analyses performed in the study confirm that the safety and health achievement score has increased significantly after appointing the managing officer. It is also revealed that the lack of expertise and motivation of the appointed officer would yield pointless outcomes. Recommendations to make it better the effectiveness of the regulation are: to administrate requirements more strictly to be appointed as a safety and health management officer, to revise the curriculum to train the expertise of the appointed officers, and to expand financial support of the government to settle the safety and health management system.

Sample Size Determination of Univariate and Bivariate Ordinal Outcomes by Nonparametric Wilcoxon Tests (단변량 및 이변량 순위변수의 비모수적 윌콕슨 검정법에 의한 표본수 결정방법)

  • Park, Hae-Gang;Song, Hae-Hiang
    • The Korean Journal of Applied Statistics
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    • v.22 no.6
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    • pp.1249-1263
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    • 2009
  • The power function in sample size determination has to be characterized by an appropriate statistical test for the hypothesis of interest. Nonparametric tests are suitable in the analysis of ordinal data or frequency data with ordered categories which appear frequently in the biomedical research literature. In this paper, we study sample size calculation methods for the Wilcoxon-Mann-Whitney test for one- and two-dimensional ordinal outcomes. While the sample size formula for the univariate outcome which is based on the variances of the test statistic under both null and alternative hypothesis perform well, this formula requires additional information on probability estimates that appear in the variance of the test statistic under alternative hypothesis, and the values of these probabilities are generally unknown. We study the advantages and disadvantages of different sample size formulas with simulations. Sample sizes are calculated for the two-dimensional ordinal outcomes of efficacy and safety, for which bivariate Wilcoxon-Mann-Whitney test is appropriate than the multivariate parametric test.

Feasibility and Safety of Robotic Surgery for Gynecologic Cancers

  • Manchana, Tarinee;Sirisabya, Nakarin;Vasuratna, Apichai;Termrungruanglert, Wichai;Tresukosol, Damrong;Wisawasukmongchol, Wirach
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.13
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    • pp.5359-5364
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    • 2014
  • Background: To determine surgical outcomes, perioperative complications, and patient outcomes in gynecologic cancer patients undergoing robotic surgery. Materials and Methods: Surgical outcomes, including docking time, total operative time, console time, estimated blood loss (EBL), conversion rate and perioperative complications were retrospectively reviewed in 30 gynecologic cancer patients undergoing robotic surgery. Patient outcomes included recovery time and patient satisfaction, as scored by a visual analogue scale (VAS) from 0-10. Results: The operations included 24 hysterectomies with pelvic lymphadenectomy (PLD) and/or para-aortic lymphadenectomy, four radical hysterectomies with PLD, and two radical trachelectomies with PLD. Mean docking time was $12.8{\pm}9.7min$, total operative time was $345.5{\pm}85.0min$, and console time was $281.9{\pm}78.6min$. These times were decreased in the second half of the cases. There was no conversion rate. Three intraoperative complications, including one external iliac artery injury, one bladder injury, and one massive bleeding requiring blood transfusion were reported. Postoperative complications occurred in eight patients, most were minor. Only one patient had port herniation that required reoperation. Mean hospital stay was $3.5{\pm}1.7days$, and recovery time was $14.2{\pm}8.1days$. Two-thirds of patients felt very satisfied and one-third felt satisfied; the mean satisfaction score was 9.4 +0.9. Two patients with stage III endometrial cancer developed isolated port site metastasis at five and 13 months postoperatively. Conclusions: Robotic surgery for gynecologic cancer appears to be feasible, with acceptable perioperative complication rate, fast recovery time and high patient satisfaction.