Efficacy and safety of biosimilar trastuzumab (CT-P6) in routine clinical practice in the Republic of Korea: a real-world post-marketing surveillance study.

BACKGROUND: The trastuzumab biosimilar CT-P6 is approved for human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), metastatic breast cancer (MBC), and metastatic gastric cancer (MGC). The objective of this post-marketing surveillance (PMS) study was to evaluate the real-world safety and effectiveness of CT-P6 in patients with HER2-positive cancers. RESEARCH DESIGN AND METHODS: This open-label, observational, prospective, PMS study collected data via investigator surveys from 35 centers in the Republic of Korea (5 October 2018-4 October 2022). Eligible patients with HER2-positive EBC, MBC, or MGC started CT-P6 treatment during routine clinical practice, followed by 1-year observation. Evaluations included adverse events (AEs), adverse drug reactions (ADRs), and effectiveness. RESULTS: Safety was analyzed in 642 patients (494 EBC, 94 MBC, 54 MGC). Overall, 325 (50.6%) patients experienced 1316 AEs, and 550 ADRs occurred in 199 (31.0%) patients. Unexpected ADRs occurred in 62 (9.7%) patients. Unexpected ADRs and ADRs of special interest did not raise any new safety signals. Among trastuzumab-naïve patients, 34/106 (32.1%) with EBC achieved pathological complete response; 30/74 (40.5%) MBC and 24/49 (49.0%) MGC patients achieved complete or partial response. CONCLUSIONS: In a real-world setting, CT-P6 demonstrated safety and efficacy findings consistent with previous CT-P6 studies.

Learning Environments in Undergraduate Nursing Education During COVID-19: A Scoping Review.

BACKGROUND: The COVID-19 pandemic radically changed nursing education. PURPOSE: To map the existing literature on learning environments (LEs) in undergraduate nursing education during COVID-19 and identify the LE elements based on the 4 domains of Gruppen's conceptual framework: personal, social, organizational, and physical and virtual spaces. METHOD: Eligible articles were reviewed using the Joanna Briggs framework. RESULTS: The search retrieved 5003 articles, of which 80 met the inclusion criteria. Most studies were cross-sectional and conducted in the United States. Of the studies included, 68 studies focused on the personal component of students, 67 investigated physical and virtual space components, 19 examined the social domain, and 15 examined organizational aspects. CONCLUSIONS: The COVID-19 pandemic significantly influenced the LE of nursing students. Based on the current review of LE in nursing education, nurse educators and researchers can develop interventions to maintain the quality and accessibility of nursing education in future crises.

New insights on a recurring theme: A secondary analysis of nurse turnover using the National Sample Survey of Registered Nurses.

BACKGROUND: Registered nurse (RN) turnover is a recurring phenomenon that accelerated during COVID-19 and heightened concerns about contributing factors. PURPOSE: Provide baseline RN turnover data to which pandemic and future RN workforce turnover behaviors can be compared. METHODS: A cross-sectional, secondary analysis of RN turnover using U.S. National Sample Survey of Registered Nurses 2018 data. Responses from 41,428 RNs (weighted N = 3,092,991) across the United States were analyzed. Sociodemographic, professional, employment, and economic data and weighting techniques were used to model prepandemic RN turnover behaviors. DISCUSSION: About 17% of the sample reported a job turnover, with 6.2% reporting internal and 10.8% reporting external turnover. The factors common across both internal and external turnover experiences included education, employment settings, and years of nursing experience. CONCLUSIONS: Baseline RN turnover data can help employers and policymakers understand new and recurring nursing workforce trends and develop targeted actions to reduce nurse turnover.

Patient Safety Culture: The Impact on Workplace Violence and Health Worker Burnout.

BACKGROUND: Patient and health care worker safety is an interconnected phenomenon. To date, few studies have examined the relationship between patient and worker safety, specifically with respect to work safety culture. Therefore, we examined patient safety culture, workplace violence (WPV), and burnout in health care workers to identify whether patient safety culture factors influence worker burnout and WPV. METHODS: This cross-sectional study used secondary survey data sent to approximately 7,100 health care workers at a large academic medical center in the United States. Instruments included the Hospital Survey on Patient Safety Culture, a WPV scale measuring physical and verbal violence perpetrated by patients or visitors, and the Emotional Exhaustion scale from the Maslach Burnout Inventory. FINDINGS: These analyses included 3,312 (47%) hospital staff who directly interacted with patients. Over half of nurse (62%), physician (53%), and allied health professional respondents (52%) reported experiencing verbal violence from a patient, and 39% of nurses and 14% of physicians reported experiencing physical violence from a patient. Burnout levels for nurses (2.67 ± 1.02) and physicians (2.65 ± 0.93) were higher than the overall average for all staff (2.61 ± 1.0). Higher levels of worker-reported patient safety culture were associated with lower odds of WPV (0.47) and lower burnout scores among workers (B = -1.02). Teamwork across units, handoffs, and transitions were dimensions of patient safety culture that also influenced WPV and burnout. CONCLUSIONS/APPLICATION TO PRACTICE: Our findings suggest that improvements in hospital strategies aimed at patient safety culture, including team cohesion with handoffs and transitions, could positively influence a reduction in WPV and burnout among health care workers.

How Does Workplace Violence-Reporting Culture Affect Workplace Violence, Nurse Burnout, and Patient Safety?

BACKGROUND: Workplace violence (WPV) against nurses has a negative impact on the nurses and the care they provide. Formal reporting of WPV is necessary to understand the nature of violent incidents, develop proactive coping strategies, and provide support for nurses affected by WPV. PURPOSE: This study explored the relationships among nurses' WPV experiences, burnout, patient safety, and the moderating effect of WPV-reporting culture on these relationships. METHODS: This descriptive cross-sectional study used secondary data collected from 1781 nurses at a large academic medical center. RESULTS: Workplace violence increased nurse burnout, which in turn negatively affected patient safety. A strong WPV-reporting culture increased the negative effect of WPV on burnout but mitigated the negative effect of burnout on patient safety. CONCLUSIONS: The findings indicate that nurses may perceive WPV-reporting behavior as a stressor. Violence-reporting systems and procedures need to be improved to reduce the burden of reporting.

Relationships between nurses' experiences of workplace violence, emotional exhaustion and patient safety.

BACKGROUND: The rising rate of workplace violence in hospitals is a serious concern. While leading organisations recommend implementing interventions to address workplace violence, little is known about the workplace violence relationship between patients and visitors, and how it affects nurses' emotional exhaustion and their perceptions of patient safety. AIMS: The study's purpose was to understand the status of workplace violence in hospitals and the relationships between nurses' experiences of workplace violence, emotional exhaustion, and perceptions of patient safety. METHODS: This cross-sectional analysis used data from a survey conducted at a large academic medical centre using the Agency for Healthcare Research and Quality Hospital Survey on Patient Safety Culture plus additional measures of workplace violence and emotional exhaustion. RESULTS: Nurses reported more occurrences of verbal violence than physical violence. Nurses' experiences of workplace violence negatively affect nurses' emotional exhaustion and patient-safety perceptions. Moreover, nurses' emotional exhaustion mediated the relationship between verbal abuse and patient-safety perceptions. CONCLUSIONS: Interventions to reduce nurses' emotional exhaustion and strengthen resilience can mitigate the negative effects of verbal abuse and to some extent the effects of physical violence.

A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males.

BACKGROUND: CT-P16 is a candidate biosimilar of bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor that is used in the treatment of a range of advanced solid cancers. OBJECTIVE: The objective of this study was to demonstrate the pharmacokinetic equivalence of CT-P16 and European Union (EU)-approved bevacizumab (EU-bevacizumab) and US-licensed bevacizumab (US-bevacizumab) reference products. METHODS: In this double-blind, parallel-group phase I trial (ClinicalTrials.gov identifier NCT03247673), healthy adult males were randomized (1:1:1) to receive a single dose of CT-P16 5 mg/kg, EU-bevacizumab 5 mg/kg, or US-bevacizumab 5 mg/kg. Primary study endpoints were area under the concentration-time curve (AUC) from time zero to infinity (AUC∞), AUC from time zero to the last quantifiable concentration (AUClast), and maximum serum concentration (Cmax). Pharmacokinetic equivalence was shown if the 90% confidence intervals (CIs) of the geometric mean (GM) ratios of the AUC∞, AUClast, and Cmax were within the predefined bioequivalence margin of 80-125%. Safety and immunogenicity were also evaluated. RESULTS: A total of 144 subjects were randomized: 47 to CT-P16, 49 to EU-bevacizumab, and 48 to US-bevacizumab. The 90% CIs for the GM ratios of AUC∞, AUClast, and Cmax for CT-P16/EU-bevacizumab, CT-P16/US-bevacizumab, and EU-bevacizumab/US-bevacizumab comparisons were all within the bioequivalence margin. Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across all three treatment groups. CONCLUSION: CT-P16 demonstrated pharmacokinetic equivalence to EU-bevacizumab and US-bevacizumab. Safety and immunogenicity profiles were similar for CT-P16, EU-bevacizumab, and US-bevacizumab. These data support the further clinical evaluation of CT-P16 as a bevacizumab biosimilar. CLINICAL TRIALS REGISTRATION: NCT03247673.

Nurse staffing level and overtime associated with patient safety, quality of care, and care left undone in hospitals: A cross-sectional study.

OBJECTIVE: The purpose of this study was to explore the association of nurse staffing and overtime with nurse-perceived patient safety, nurse-perceived quality of care, and care left undone. DESIGN: A cross-sectional survey. SETTING AND PARTICIPANTS: A total of 65 hospitals were selected from all of the acute hospitals (n=295) with 100 or more beds in South Korea by using a stratified random sampling method based on region and number of beds, and 60 hospitals participated in the study. All RNs working on the date of data collection in units randomly selected from the list of units in each hospital were invited to participate. The analyses in this study included only bedside RNs (n=3037) and hospitals (n=51) with responses from at least 10 bedside RNs. METHODS: We collected data on nurse staffing level, overtime, nurse-perceived patient safety, nurse-perceived quality of care, nurse-reported care left undone, and nurse characteristics through a nurse survey. Facility data from the Health Insurance Review Agency (HIRA) were used to collect hospital characteristics. Multilevel logistic regression models considering that nurses are clustered in hospitals were used to analyze the effects of hospital nurse staffing and overtime on patient safety, quality of care, and care left undone. RESULTS: A higher number of patients per RN was significantly associated with higher odds of reporting poor/failing patient safety (OR=1.02, 95% CI=1.004-1.03) and poor/fair quality of care (OR=1.02, 95% CI=1.01-1.04), and of having care left undone due to lack of time (OR=1.03, 95% CI=1.01-1.05). Compared with RNs who did not work overtime, RNs working overtime reported an 88% increase in failing or poor patient safety (OR=1.88, 95% CI=1.40-2.52), a 45% increase in fair or poor quality of nursing care (OR=1.45, 95% CI=1.17-1.80), and an 86% increase in care left undone (OR=1.86, 95% CI=1.48-2.35). CONCLUSIONS: Our findings suggest that ensuring appropriate nurse staffing and working hours is important to improve the quality and safety of care and to reduce care left undone in hospitals.

The Relationships of Nurse Staffing Level and Work Environment With Patient Adverse Events.

PURPOSE: The purpose of this study was to examine the relationships of nurse staffing level and work environment with patient adverse events. DESIGN: This cross-sectional study used a combination of nurse survey data (N = 4,864 nurses), facility data (N = 58 hospitals), and patient hospital discharge data (N = 113,426 patients) in South Korea. METHODS: The three most commonly nurse-reported adverse events included administration of the wrong medication or dose to a patient, pressure ulcers, and injury from a fall after admission. Multilevel ordinal logistic regression was employed to explore the relationships of nurse staffing level (number of patients assigned to a nurse) and work environment (Practice Environment Scale of the Nursing Work Index) with patient adverse events after controlling for nurse, hospital, and patient characteristics. FINDINGS: A larger number of patients per nurse was significantly associated with a greater incidence of administration of the wrong medication or dose (odds ratio [OR] = 1.01, 95% confidence interval [CI] = 1.007-1.016), pressure ulcer (OR = 1.01, 95% CI = 1.007-1.016), and patient falls with injury (OR = 1.02, 95% CI = 1.013-1.022). A better work environment had a significant inverse relationship with adverse events; the odds of reporting a higher incidence of adverse events were 45% lower for administration of the wrong medication or dose (OR = 0.55, 95% CI = 0.400-0.758), followed by 39% lower for pressure ulcer (OR = 0.61, 95% CI = 0.449-0.834) and 32% lower for falls with injury after admission (OR = 0.68, 95% CI = 0.490-0.939). CONCLUSIONS: This study found that a larger number of patients per nurse and poor work environment increase the incidence of patient adverse events, such as administration of the wrong medication or dose to a patient, pressure ulcers, and injury from falling after admission. The findings suggest that South Korean hospitals could prevent patient adverse events by improving nurse staffing and work environment. CLINICAL RELEVANCE: Healthcare strategies and efforts to modify adequate nurse staffing levels and better work environments for nurses are needed to improve patient outcomes.

Activities of daily living in nursing home and home care settings: a retrospective 1-year cohort study.

OBJECTIVE: Korea introduced universal long-term care insurance (LTCI) for physically dependent older adults in 2008. Older adults, their family members, and policy makers in Korea want to know patient outcomes in different care modalities because older adults who have a similar functional status and LTC needs can choose either nursing home care or home care. The aim of this study was to compare activities of daily living (ADLs) in nursing home care and home care settings for physically dependent older adults in Korea. DESIGN: A retrospective 1-year cohort study using national LTCI data. SETTINGS: This study used the LTCI dataset from the National Health Insurance Service in Korea. PARTICIPANTS: Participants were identified from among those in the LTCI dataset who enrolled from July 2008 to June 2010. We extracted a sample consisting of 22,557 older adults who consistently received either nursing home care (n = 11,678) or home care (n = 10,879) for 1 year. MEASUREMENTS: The outcome variable was change in ADLs after 1 year. Covariates were an older adult's home geographical region, LTC level, age, sex, primary caregiver, Medicaid beneficiary status, bedridden status, medical diagnosis, baseline ADLs, cognitive function, behavioral problems, nursing and special treatment, and rehabilitation needs. Multiple regression analysis of all participants unmatched and a paired t-test with a propensity-score-matched cohort were performed to explain the association of changes in ADLs with the types of LTC. RESULTS: Multiple regression analysis with all participants (n = 22,557) unmatched showed that compared with older adults who received home care, those who received nursing home care had deteriorated further in terms of ADLs after 1 year (ß = 0.44108, P < .0001). After propensity-score matching, paired t-test analysis also found that the ADLs of older adults had deteriorated less in the home care group compared with the nursing home group after 1 year (P < .0001). CONCLUSIONS: The ADLs of older adults who received home care showed significantly less deterioration than those of the older adults in nursing home care after 1 year. The ADLs of older adults could differ according to the type of LTC they receive, and home care could result in better maintenance of ADLs than nursing home care.

[Suitability and readability assessment of printed educational materials on hypertension].

PURPOSE: The aim of this study was to assess the suitability and readability of printed educational materials for patients with hypertension in Korea. METHODS: A total of 33 written educational materials related to hypertension were collected from public health centers, hospitals, and internet web site. Among them, we analyzed 19 materials which fit the inclusion criteria: leaflets (n=9), booklets (n=3), and guide book (n=7). Two trained nurses evaluate the materials using suitability assessment tool (SAM; Doak, Doak, & Root, 1996a) and graded lexical items for teaching Korean (Kim, 2003). RESULTS: Overall, 14 (73.7%) of 19 materials scored adequate, and 5 (26.3%) scored inadequate. On the average, the education materials contained 36.1% to 50.5% of 1st grade reading level words and 12.9% to 21.6% of 4th grade level and over. CONCLUSION: The reading level of the materials was higher than a 6th grade reading level. It is proposed that the written educational materials should be developed by health professionals according to suitability and quality by taking the target group's literacy capacity into consideration.