Medication-related incidents in acute care hospitals among different age groups: An analysis of national patient safety report data.

PURPOSE: This study aimed to perform a nationwide analysis of medication errors (MEs) from hospitals using national reporting system data and to compare the ME patterns among different age groups. METHODS: We analyzed medication-related incidents in acute care hospitals reported to the Korean Patient Safety Reporting and Learning System (KOPS), which is a patient safety reporting system, from July 2016 to December 2020. The stages of the medication use process, type of errors, medication class involved in MEs, and degree of harm were analyzed. RESULTS: Among a total of 5071 medication-related incidents, 37.7% (1911 cases) were incidents that caused patient harm and 1.2% caused long-term, permanent, and fatal harm. The proportion of medication-related incidents that resulted in harm was the highest among the <1-year-old age group (67 cases, 51.5%), followed by the elderly (≥ 65 years) (828 cases, 40.9%). The cases leading to patient death were most frequently reported in patients aged ≥65 years. Medication-related incidents occurred mainly in the administration stage (2954 cases, 58.3%), and wrong dose was the most frequently reported ME type. The most prevalent medication class occurring in the 20-64-year age group (256 cases, 11.7%) was 'antibacterials for systemic use', whereas 'contrast media' (236 cases, 11.6%) and 'blood substitutes and perfusion solutions' (98 cases, 19.3%) were the most prevalent drug classes in the ≥65- and <20-year-old age groups, respectively. CONCLUSIONS: It is necessary to establish guidelines for the prevention of medication-related incidents according to the medication use process and patient age group.

Mediating Role of Rumination in Second Victim Experience to Turnover Intention in Psychiatric Nurses.

BACKGROUND: Psychiatric nurses often face patient safety incidents that can cause physical and emotional harm, even leading to s econd victim syndrome and staff shortages. Rumination-a common response after nurses suffer a patient safety event-may play a specific role between the second victim experience and turnover intention. Understanding these mechanisms is crucial for supporting psychiatric nurses and retaining psychiatric nursing resources. OBJECTIVES: The study aimed to explore the associations among second victim experience, rumination, and turnover intention in psychiatric nurses and confirm how second victim experience influences turnover intention through rumination and its subtypes. METHODS: A descriptive, cross-sectional study was adapted to survey 252 psychiatric nurses who experienced a patient safety incident at three hospitals in China between March and April 2023. We used the Sociodemographic and Patient Safety Incident Characteristics Questionnaire (the Chinese version of the Second Victim Experience and Support Tool), the Event-Related Rumination Inventory, and the Turnover Intention Scale. Path analysis with bootstrapping was employed to accurately analyze and estimate relationships among the study variables. RESULTS: There was a positive association between second victim experience and turnover intention. In addition, both invasive and deliberate rumination showed significant associations with second victim experience and turnover intention. Notably, our results revealed that invasive and deliberate rumination played partial mediating roles in the relationship between second victim experience and turnover intention in psychiatric nurses. DISCUSSION: The negative experience and turnover intention of the psychiatric nurse second victims are at a high level. Our results showed that invasive rumination positively mediated the relationship between second victim experience and turnover intention, and deliberate rumination could weaken this effect. This study expands the knowledge of the mechanisms underlying the effect of the second victim experience on turnover intention. Organizations must attach importance to the professional dilemmas of the psychiatric nurses' second victims. Nurse managers can reduce nurses' turnover intention by taking measures to reduce invasive rumination and fostering deliberate meditation to help second victims recover from negative experiences.

Accuracy assessment of patient safety incident (PSI) codes and present-on-admission (POA) indicators: a cross-sectional analysis using the Patient Safety Incidents Inquiry (PSII) in Korea.

BACKGROUND: Among the various methods used, administrative data collected for claims and billing purposes, such as diagnosis codes and present-on-admission (POA) indicators, can easily be employed to assess patient safety status. However, it is crucial that administrative data be accurate to generate valid estimates of adverse event (AE) occurrence. Thus, we aimed to evaluate the accuracy of diagnosis codes and POA indicators in patients with confirmed AEs in the hospital admission setting. METHODS: We analysed the diagnosis codes of 1,032 confirmed AE cases and 6,754 non-AE cases from the 2019 Patient Safety Incidents Inquiry, which was designed as a cross-sectional study, to determine their alignment with the Korean Patient Safety Incidents (PSIs) Code Classification System. The unit of analysis was the individual case rather than the patient, because two or more AEs may occur in one patient. We examined whether the primary and secondary diagnostic codes had PSIs codes matching the AE type and checked each PSI code for whether the POA indicator had an 'N' tag. We reviewed the presence of PSI codes in patients without identified AEs and calculated the correlation between the AE incidence rate and PSI code and POA indicator accuracy across 15 hospitals. RESULTS: Ninety (8.7%) of the AE cases had PSI codes with an 'N' tag on the POA indicator compared to 294 (4.4%) of the non-AE cases. Infection- (20.4%) and surgery/procedure-related AEs (13.6%) had relatively higher instances of correctly tagged PSI codes. We did not identify any PSI codes for diagnosis-related incidents. While we noted significant differences in AE incidence rates, PSI code accuracy, and POA indicator accuracy among the hospitals, the correlations between these variables were not statistically significant. CONCLUSION: Currently, PSI codes and POA indicators in South Korea appear to have low validity. To use administrative data in medical quality improvement activities such as monitoring patient safety levels, improving the accuracy of administrative data should be a priority. Possible strategies include targeted education on PSI codes and POA indicators and introduction of new evaluation indicators regarding the accuracy of administrative data.

Adverse events at the end of life of hospital patients with or without a condition relevant for palliative care: a nationwide retrospective record review study in the Netherlands.

BACKGROUND: Patient safety is crucial for quality of care. Preventable adverse events (AEs) occur in 1 of 20 patients in the hospital, but it is unknown whether this is different for patients with a condition relevant for palliative care. The majority of the limited available research on this topic is only focused on patients already receiving palliative care, and do not make comparisons with other patients at the end-of-life. We identified and compared the prevalence, preventability, nature and causes of AEs in patients with and without a condition relevant for palliative care. METHODS: A nationwide retrospective record review study was performed in 20 Dutch hospitals. A total of 2,998 records of patients who died in hospital in 2019 was included. Records were reviewed for AEs. We identified two subgroups: patients with (n = 2,370) or without (n = 248) a condition relevant for palliative care through the selection method of Etkind (2017). Descriptive analyses were performed to calculate prevalence, nature, causes and prevention strategies. T-tests were performed to calculate differences between subgroups. RESULTS: We found no significant differences between subgroups regarding AE prevalence, this was 15.3% in patients with a condition relevant for palliative care, versus 12.0% in patients without a condition relevant for palliative care (p = 0.148). Potentially preventable AE prevalence was 4.3% versus 4.4% (p = 0.975). Potentially preventable death prevalence in both groups was 3.2% (p = 0.938). There were differences in the nature of AEs: in patients with a condition relevant for palliative care this was mostly related to medication (33.1%), and in patients without a condition relevant for palliative care to surgery (50.8%). In both subgroups in the majority of AEs a patient related cause was identified. For the potentially preventable AEs in both subgroups the two most important prevention strategies as suggested by the medical reviewers were reflection and evaluation and quality assurance. DISCUSSION: Patient safety risks appeared to be equally prevalent in both subgroups. The nature of AEs does differ between subgroups: medication- versus surgery-related, indicating that tailored safety measures are needed. Recommendations for practice are to focus on reflecting on AEs, complemented with case evaluations.

A Symptom-Checker for Adult Patients Visiting an Interdisciplinary Emergency Care Center and the Safety of Patient Self-Triage: Real-Life Prospective Evaluation.

BACKGROUND: Symptom-checkers have become important tools for self-triage, assisting patients to determine the urgency of medical care. To be safe and effective, these tools must be validated, particularly to avoid potentially hazardous undertriage without leading to inefficient overtriage. Only limited safety data from studies including small sample sizes have been available so far. OBJECTIVE: The objective of our study was to prospectively investigate the safety of patients' self-triage in a large patient sample. We used SMASS (Swiss Medical Assessment System; in4medicine, Inc) pathfinder, a symptom-checker based on a computerized transparent neural network. METHODS: We recruited 2543 patients into this single-center, prospective clinical trial conducted at the cantonal hospital of Baden, Switzerland. Patients with an Emergency Severity Index of 1-2 were treated by the team of the emergency department, while those with an index of 3-5 were seen at the walk-in clinic by general physicians. We compared the triage recommendation obtained by the patients' self-triage with the assessment of clinical urgency made by 3 successive interdisciplinary panels of physicians (panels A, B, and C). Using the Clopper-Pearson CI, we assumed that to confirm the symptom-checkers' safety, the upper confidence bound for the probability of a potentially hazardous undertriage should lie below 1%. A potentially hazardous undertriage was defined as a triage in which either all (consensus criterion) or the majority (majority criterion) of the experts of the last panel (panel C) rated the triage of the symptom-checker to be "rather likely" or "likely" life-threatening or harmful. RESULTS: Of the 2543 patients, 1227 (48.25%) were female and 1316 (51.75%) male. None of the patients reached the prespecified consensus criterion for a potentially hazardous undertriage. This resulted in an upper 95% confidence bound of 0.1184%. Further, 4 cases met the majority criterion. This resulted in an upper 95% confidence bound for the probability of a potentially hazardous undertriage of 0.3616%. The 2-sided 95% Clopper-Pearson CI for the probability of overtriage (n=450 cases,17.69%) was 16.23% to 19.24%, which is considerably lower than the figures reported in the literature. CONCLUSIONS: The symptom-checker proved to be a safe triage tool, avoiding potentially hazardous undertriage in a real-life clinical setting of emergency consultations at a walk-in clinic or emergency department without causing undesirable overtriage. Our data suggest the symptom-checker may be safely used in clinical routine. TRIAL REGISTRATION: ClinicalTrials.gov NCT04055298; https://clinicaltrials.gov/study/NCT04055298.

Patient safety in surgical settings: A study on the challenges and improvement strategies in adverse event reporting from a nursing perspective.

AIMS: To explore adverse event reporting in the surgical department through the nurses' experiences and perspectives. DESIGN: An exploratory, descriptive qualitative study was conducted with a theoretical-methodological orientation of phenomenology. METHODS: In-depth interviews were conducted with 15 nurses, followed by an inductive thematic analysis. RESULTS: Themes include motives for reporting incidents, consequences, feelings and motivational factors. Key facilitators of adverse event reporting were effective communication, knowledge sharing, a non-punitive culture and superior feedback. CONCLUSION: The study underscores the importance of supportive organisational culture for reporting, communication and feedback mechanisms, and highlights education and training in enhancing patient safety. IMPLICATIONS: It suggests the need for strategies that foster incident reporting, enhance patient safety and cultivate a supportive organisational culture. IMPACT: This study provides critical insights into adverse event reporting in surgical departments from nurses' lived experience, leading to two primary impacts: It offers specific solutions to improve adverse event reporting, which is crucial for surgical departments to develop more effective and tailored reporting strategies. The research underscores the importance of an open, supportive culture in healthcare, which is vital for transparent communication and effective reporting, ultimately advancing patient safety. REPORTING METHOD: The study followed the Standards for Reporting Qualitative Research and the Consolidated Criteria for Reporting Qualitative Research guidelines. PATIENTS OR PUBLIC CONTRIBUTION: No patients or public contribution.

Nursing students' evaluation of patient safety culture in three central European countries: a cross-sectional study.

OBJECTIVES: This cross-sectional study aimed to investigate and compare the perceptions of nursing students regarding patient safety culture (PSC) during the COVID-19 pandemic in three Central European countries. METHODS: Data were collected from 624 nursing students between April and September 2021 using the Hospital Survey on Patient Safety Culture. RESULTS: The evaluation of the PSC dimensions did not reach the expected level of 75 %. Significant associations were found between the perception of the dimensions of the individual PSC and age, student status, study year, and clinical placement. The overall patient safety grade, the number of events reported, and the number of events reported by nursing students were significantly predicted by several dimensions of the PSC (p<0.05). CONCLUSIONS: The evaluation of patient safety culture by nursing students offers a unique perspective. Students come with 'fresh eyes' and provide different perspectives that can provide healthcare leaders with a practical opportunity to identify blind spots, review and improve safety protocols, and foster a more inclusive culture that prioritizes patient safety.

The Volume and Cost of Quality Metric Reporting.

Importance: US hospitals report data on many health care quality metrics to government and independent health care rating organizations, but the annual cost to acute care hospitals of measuring and reporting quality metric data, independent of resources spent on quality interventions, is not well known. Objective: To evaluate externally reported inpatient quality metrics for adult patients and estimate the cost of data collection and reporting, independent of quality-improvement efforts. Design, Setting, and Participants: Retrospective time-driven activity-based costing study at the Johns Hopkins Hospital (Baltimore, Maryland) with hospital personnel involved in quality metric reporting processes interviewed between January 1, 2019, and June 30, 2019, about quality reporting activities in the 2018 calendar year. Main Outcomes and Measures: Outcomes included the number of metrics, annual person-hours per metric type, and annual personnel cost per metric type. Results: A total of 162 unique metrics were identified, of which 96 (59.3%) were claims-based, 107 (66.0%) were outcome metrics, and 101 (62.3%) were related to patient safety. Preparing and reporting data for these metrics required an estimated 108 478 person-hours, with an estimated personnel cost of $5 038 218.28 (2022 USD) plus an additional $602 730.66 in vendor fees. Claims-based (96 metrics; $37 553.58 per metric per year) and chart-abstracted (26 metrics; $33 871.30 per metric per year) metrics used the most resources per metric, while electronic metrics consumed far less (4 metrics; $1901.58 per metric per year). Conclusions and Relevance: Significant resources are expended exclusively for quality reporting, and some methods of quality assessment are far more expensive than others. Claims-based metrics were unexpectedly found to be the most resource intensive of all metric types. Policy makers should consider reducing the number of metrics and shifting to electronic metrics, when possible, to optimize resources spent in the overall pursuit of higher quality.

Safety and effectiveness of up to 3 years' bulevirtide monotherapy in patients with HDV-related cirrhosis.

The entry inhibitor bulevirtide (BLV) received conditional approval from the EMA in July 2020 for the treatment of adult patients with compensated chronic hepatitis delta. However, the effectiveness and safety of BLV administered as monotherapy beyond 48 weeks in difficult-to-treat patients with HDV-related cirrhosis is presently unknown. Herein, we describe the first patients with HDV-related compensated cirrhosis who were treated with BLV (10 mg/day as a starting dose) for up to 3 years on a compassionate use program. Patients were also monitored for HBcrAg and HBV RNA levels, and HDV- and HBV-specific T-cell markers. In the patient who stopped BLV at week 48, after achieving a virological and biochemical response, the initial virological and biochemical rebound was followed by alanine aminotransferase normalization coupled with low HDV RNA and HBsAg levels. In the 2 patients treated continuously for 3 years, virological and biochemical responses were maintained throughout the treatment period even after dose reduction. In a patient with advanced compensated cirrhosis, liver function tests significantly improved, esophageal varices disappeared, and histological/laboratory features of autoimmune hepatitis resolved. Overall, no safety issues were recorded, as bile salt increase was asymptomatic. While serum HBV RNA levels remained undetectable in all patients, HBV core-related antigen levels showed a progressive, yet modest decline during long-term BLV treatment. No HDV-specific interferon-γ-producing T cells were detected, neither after HDV reactivation (after BLV withdrawn in Patient 1) nor during 3 years of BLV treatment. In conclusion, this report shows that continuous administration of BLV monotherapy for 3 years leads to excellent virological and clinical responses in patients with HDV-related cirrhosis who had contraindications to interferon-based therapies.

A randomized clinical trial of the efficacy and safety of sitagliptin as initial oral therapy in youth with type 2 diabetes.

OBJECTIVE: To assess the efficacy and safety of DPP-4 inhibition with sitagliptin in youth with type 2 diabetes (T2D). STUDY DESIGN: This was a 54-week, double-blind, randomized, controlled clinical trial evaluating the safety and efficacy of DPP-4 inhibition with sitagliptin 100 mg once daily as initial oral therapy in youth with T2D. The 190 participants, aged 10-17 years, had HbA1c 6.5%-10% (7.0%-10% if on insulin). All were negative for pancreatic autoantibodies and overweight/obese at screening or diagnosis. The trial was placebo controlled for the first 20 weeks, after which metformin replaced placebo. The primary efficacy endpoint was change from baseline in HbA1c at Week 20. RESULTS: Treatment groups were well balanced at baseline (mean ± SD HbA1c = 7.5% ± 1.0, BMI percentile = 97.1% ± 6.8, age = 14.0 years ± 2.0 [57.4% <15], 60.5% female). At Week 20, least squares mean changes from baseline in HbA1c were -0.01% (sitagliptin) and 0.18% (placebo); between-group difference (95% CI) = -0.19% (-0.68, 0.30), p = 0.448. At Week 54, the changes in HbA1c were 0.45% (sitagliptin) and -0.11 (placebo/metformin). There were no notable between-group differences in the adverse event profiles through Week 54. CONCLUSIONS: DPP-4 inhibition with sitagliptin did not provide significant improvement in glycemic control. In this study, sitagliptin was generally well tolerated with a safety profile similar to that reported in adults. (ClinicalTrials.gov: NCT01485614; EudraCT: 2011-002528-42).

Efficacy and safety of the addition of sitagliptin to treatment of youth with type 2 diabetes and inadequate glycemic control on metformin without or with insulin.

OBJECTIVE: To assess the efficacy and safety of sitagliptin in youth with type 2 diabetes (T2D) inadequately controlled with metformin ± insulin. STUDY DESIGN: Data were pooled from two 54-week, double-blind, randomized, placebo-controlled studies of sitagliptin 100 mg daily or placebo added onto treatment of 10- to 17-year-old youth with T2D and inadequate glycemic control on metformin ± insulin. Participants (N = 220 randomized and treated) had HbA1c 6.5%-10% (7.0%-10% if on insulin), were overweight/obese at screening or diagnosis and negative for pancreatic autoantibodies. The primary endpoint was change from baseline in HbA1c at Week 20. RESULTS: Treatment groups were well balanced at baseline (mean HbA1c = 8.0%, BMI = 30.9 kg/m2 , age = 14.4 years [44.5% <15], 65.9% female). The dose of background metformin was >1500 mg/day for 71.8% of participants; 15.0% of participants were on insulin therapy. At Week 20, LS mean changes from baseline (95% CI) in HbA1c for sitagliptin/metformin and placebo/metformin were -0.58% (-0.94, -0.22) and -0.09% (-0.43, 0.26), respectively; difference = -0.49% (-0.90, -0.09), p = 0.018; at Week 54 the LS mean (95% CI) changes were 0.35% (-0.48, 1.19) and 0.73% (-0.08, 1.54), respectively. No meaningful differences between the adverse event profiles of the treatment groups emerged through Week 54. CONCLUSIONS: These results do not suggest that addition of sitagliptin to metformin provides durable improvement in glycemic control in youth with T2D. In this study, sitagliptin was generally well tolerated with a safety profile similar to that reported in adults. (ClinicalTrials.gov: NCT01472367, NCT01760447; EudraCT: 2011-002529-23/2014-003583-20, 2012-004035-23).

Increased adherence to perioperative safety guidelines associated with improved patient safety outcomes: a stepped-wedge, cluster-randomised multicentre trial.

BACKGROUND: National Dutch guidelines have been introduced to improve suboptimal perioperative care. A multifaceted implementation programme (IMPlementatie Richtlijnen Operatieve VEiligheid [IMPROVE]) has been developed to support hospitals in applying these guidelines. This study evaluated the effectiveness of IMPROVE on guideline adherence and the association between guideline adherence and patient safety. METHODS: Nine hospitals participated in this unblinded, superiority, stepped-wedge, cluster RCT in patients with major noncardiac surgery (mortality risk ≥1%). IMPROVE consisted of educational activities, audit and feedback, reminders, organisational, team-directed, and patient-mediated activities. The primary outcome of the study was guideline adherence measured by nine patient safety indicators on the process (stop moments from the composite STOP bundle, and timely administration of antibiotics) and on the structure of perioperative care. Secondary safety outcomes included in-hospital complications, postoperative wound infections, mortality, length of hospital stay, and unplanned care. RESULTS: Data were analysed for 1934 patients. The IMPROVE programme improved one stop moment: 'discharge from recovery room' (+16%; 95% confidence interval [CI], 9-23%). This stop moment was related to decreased mortality (-3%; 95% CI, -4% to -1%), fewer complications (-8%; 95% CI, -13% to -3%), and fewer unscheduled transfers to the ICU (-6%; 95% CI, -9% to -3%). IMPROVE negatively affected one other stop moment - 'discharge from the hospital' - possibly because of the limited resources of hospitals to improve all stop moments together. CONCLUSIONS: Mixed implementation effects of IMPROVE were found. We found some positive associations between guideline adherence and patient safety (i.e. mortality, complications, and unscheduled transfers to the ICU) except for the timely administration of antibiotics. CLINICAL TRIAL REGISTRATION: NTR3568 (Dutch Trial Registry).

Inequities in quality and safety outcomes for hospitalized children with intellectual disability.

AIM: To investigate if there are inequities in quality and safety outcomes for children with intellectual disability admitted to two tertiary paediatric hospitals. METHOD: A cross-sectional study of 1367 admissions for 1018 randomly selected patients admitted for more than 23 hours to one of two tertiary children's hospitals in Sydney, Australia (1st January-31st December 2017). Electronic medical records were manually interrogated to identify children with intellectual disability (including developmental delay). Data extracted included patient demographics, length of stay, number of admissions, and reported clinical incidents. RESULTS: In total, 12.3% (n=125) of children admitted during the study period had intellectual disability, which represented 13.9% (n=190) of admissions. Sex and age at admission in children with and without intellectual disability were similar: 83 (43.7%) vs 507 (43.1%) females and 107 (56.3%) vs 670 (56.9%) males, p=0.875; median age 3 years (0-18y) vs 4 years (0-18y), p=0.122. Children with intellectual disability had significantly greater median length of stay (100.5h vs 79h, p<0.001) and cost of admission (A$11 596.38 vs A$8497.96) than their peers (p=0.001). Children with intellectual disability had more admissions with at least one incident compared to children without intellectual disability (14.7% vs 9.7%); this was not statistically significant (p=0.06). INTERPRETATION: Children with intellectual disability experience inequitable quality and safety outcomes in hospital. Engaging children and families in clinical incident reporting may enhance understanding of safety risks for children with intellectual disability in hospital.

Safety of Gastrointestinal Endoscopy in Korea: A Nationwide Survey and Population-Based Study.

BACKGROUND: Attention should be paid to endoscopy-related complications and safety-related accidents that may occur in the endoscopy unit. This study investigated the current status of complications associated with diagnostic and therapeutic endoscopy in Korea. METHODS: A questionnaire survey on endoscopy-related complications was conducted in a total of 50 tertiary or general hospitals in Korea. The results were compared to the population-level claims data from the Health Insurance Review & Assessment Service (HIRA), which analyzed endoscopy procedures conducted in 2017 in Korea. RESULTS: The incidences of bleeding associated with diagnostic and therapeutic esophagogastroduodenoscopy (EGD) and with diagnostic and therapeutic colonoscopy were 0.224% and 3.155% and 0.198% and 0.356%, respectively, in the 2017 HIRA claims data, compared to 0.012% and 1.857%, and 0.024% and 0.717%, in the 50 hospitals surveyed. The incidences of perforation associated with diagnostic and therapeutic EGD and with diagnostic and therapeutic colonoscopy were 0.023% and 0.613%, and 0.007% and 0.013%, respectively, in the 2017 HIRA claims data compared to 0.001% and 0.325%, and 0.017% and 0.206%, in the 50 hospitals surveyed. In the HIRA claims data, the incidence of bleeding/perforation after diagnostic colonoscopy in clinics, community hospitals, general hospitals, and tertiary hospitals was 0.129%/0.000%, 0.088%/0.004%, 0.262%/0.009%, and 0.479%/0.030% respectively, and the corresponding incidence of bleeding/perforation after therapeutic colonoscopy was 0.258%/0.004%, 0.401%/0.007%, 0.408%/0.024%, and 0.731%/0.055%. CONCLUSION: The incidences of complications associated with diagnostic and therapeutic EGD or colonoscopy tended to increase with the hospital volume in Korea. TRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0001728.

Safety of Recombinant Zoster Vaccine in Rheumatology Patients.

OBJECTIVES: Recombinant zoster vaccine (RZV) is Food and Drug Administration approved for the prevention of herpes zoster (shingles) in adults 50 years old and older. Immunocompromised subjects were excluded from the pivotal vaccine trials. We studied the safety of this vaccine in our university-affiliated rheumatology practice. METHODS: This was a single-center, retrospective study focusing on subjects who received RZV during 2018. We collected the demographic data, any self-reported adverse events after vaccination, C-reactive protein, Routine Assessment of Patient Index Data 3 (RAPID3) scores for subjects with rheumatoid arthritis, and available RAPID3 scores for all study subjects before and after the vaccination. RESULTS: Comparision of C-reactive protein (n = 40), RAPID3 scores for subjects with rheumatoid arthritis (n = 16), and available RAPID3 scores for all subjects (n = 21) using the paired t test, did not show significant differences before and after the administration of RZV. A total of 6.4% of patients reported adverse events after vaccination. The adverse events were mild and did not lead to hospitalization, end organ damage, or change in treatment plan. CONCLUSIONS: The RZV was safe and well tolerated among our study population.

Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019.

Importance: Patient safety is a US national priority, yet lacks a comprehensive assessment of progress over the past decade. Objective: To determine the change in the rate of adverse events in hospitalized patients. Design, Setting, and Participants: This serial cross-sectional study used data from the Medicare Patient Safety Monitoring System from 2010 to 2019 to assess in-hospital adverse events in patients. The study included 244 542 adult patients hospitalized in 3156 US acute care hospitals across 4 condition groups from 2010 through 2019: acute myocardial infarction (17%), heart failure (17%), pneumonia (21%), and major surgical procedures (22%); and patients hospitalized from 2012 through 2019 for all other conditions (22%). Exposures: Adults aged 18 years or older hospitalized during each included calendar year. Main Outcomes and Measures: Information on adverse events (abstracted from medical records) included 21 measures across 4 adverse event domains: adverse drug events, hospital-acquired infections, adverse events after a procedure, and general adverse events (hospital-acquired pressure ulcers and falls). The outcomes were the total change over time for the observed and risk-adjusted adverse event rates in the subpopulations. Results: The study sample included 190 286 hospital discharges combined in the 4 condition-based groups of acute myocardial infarction, heart failure, pneumonia, and major surgical procedures (mean age, 68.0 [SD, 15.9] years; 52.6% were female) and 54 256 hospital discharges for the group including all other conditions (mean age, 57.7 [SD, 20.7] years; 59.8% were female) from 3156 acute care hospitals across the US. From 2010 to 2019, the total change was from 218 to 139 adverse events per 1000 discharges for acute myocardial infarction, from 168 to 116 adverse events per 1000 discharges for heart failure, from 195 to 119 adverse events per 1000 discharges for pneumonia, and from 204 to 130 adverse events per 1000 discharges for major surgical procedures. From 2012 to 2019, the rate of adverse events for all other conditions remained unchanged at 70 adverse events per 1000 discharges. After adjustment for patient and hospital characteristics, the annual change represented by relative risk in all adverse events per 1000 discharges was 0.94 (95% CI, 0.93-0.94) for acute myocardial infarction, 0.95 (95% CI, 0.94-0.96) for heart failure, 0.94 (95% CI, 0.93-0.95) for pneumonia, 0.93 (95% CI, 0.92-0.94) for major surgical procedures, and 0.97 (95% CI, 0.96-0.99) for all other conditions. The risk-adjusted adverse event rates declined significantly in all patient groups for adverse drug events, hospital-acquired infections, and general adverse events. For patients in the major surgical procedures group, the risk-adjusted rates of events after a procedure declined significantly. Conclusions and Relevance: In the US between 2010 and 2019, there was a significant decrease in the rates of adverse events abstracted from medical records for patients admitted for acute myocardial infarction, heart failure, pneumonia, and major surgical procedures and there was a significant decrease in the adjusted rates of adverse events between 2012 and 2019 for all other conditions. Further research is needed to understand the extent to which these trends represent a change in patient safety.

Validating a generic cancer consumer quality index in eight European countries, patient reported experiences and the influence of cultural differences.

BACKGROUND: Taking patient centeredness into account is important in healthcare. The European Cancer Consumer Quality Index (ECCQI) is a validated tool for international benchmarking of patient experiences and satisfaction. This study aimed to further validate the ECCQI in larger and more uniform groups of high volume tumours such as breast and prostate cancer. A second objective was the verification of the influence of cultural factors of the country to determine its possible use in international benchmarking. METHODS: Data from two survey studies in eight European countries were combined. Socio-demographic correlations were analysed with Kruskall-Wallis and Mann-Whitney tests. Cronbach's alpha was calculated to validate internal consistency. Influences of masculinity (MAS), power distance (PD) and uncertainty avoidance (UA) were determined by linear regression analysis in a general model and subgroup models. RESULTS: A total of 1322 surveys were included in the analysis (1093 breast- and 348 prostate cancer patients). Cronbach's alpha was good (α ≥ 0.7) or acceptable (0.5 ≤ α ≤ 0.7) in 8 out of 9 questionnaire categories, except in the category 'Safety' (α = 0.305). Overall ECCQI scores ranged from 22.1 to 25.1 between countries on a 1-35 scale (categories had a 1-4 scale). In certain subcategories such as 'Organisation' (range 2.2 vs 3.0) and 'Supervision & Support' (range 3.0 vs 3.8) a large difference was observed between countries. Differences in 'Overall opinion' were however small: mean scores of 3.7 vs 3.9, whereas median scores were all the maximum of 4.0. Power distance was positively associated with higher patient satisfaction scores whereas Uncertainty avoidance was negatively associated with these scores. Masculinity was only associated with patient satisfaction scores in lower educated patients. We found the highest impact of culture on overall scores in Hungary and Portugal and the lowest in Romania. CONCLUSIONS: The ECCQI shows high internal consistency in all categories except 'Safety'. Especially in separate categories and overall ECCQI scores the questionnaire showed discriminative value. This study showed a positive correlation of power distance and a negative correlation for uncertainty avoidance in some countries. When using the ECCQI for international benchmarking these two dimensions of culture should be taken into account.

Hospital variation in responses to safety warnings about power morcellation in hysterectomy.

BACKGROUND: Safety warnings about power morcellation in 2014 considerably changed hysterectomy practice, especially for laparoscopic supracervical hysterectomy that typically requires morcellation to remove the corpus uteri while preserving the cervix. Hospitals might vary in how they respond to safety warnings and altered hysterectomy procedures to avoid use of power morcellation. However, there has been little data on how hospitals differ in their practice changes. OBJECTIVE: This study aimed to examine whether hospitals varied in their use of laparoscopic supracervical hysterectomy after safety warnings about power morcellation and compare the risk of surgical complications at hospitals that had different response trajectories in use of laparoscopic supracervical hysterectomy. STUDY DESIGN: This was a retrospective analysis of data from the New York Statewide Planning and Research Cooperative System and the State Inpatient Databases and State Ambulatory Surgery and Services Databases from 14 other states. We identified women aged ≥18 years undergoing hysterectomy for benign indications in the hospital inpatient and outpatient settings from October 1, 2013 to September 30, 2015. We calculated a risk-adjusted utilization rate of laparoscopic supracervical hysterectomy for each hospital in each calendar quarter after accounting for patient clinical risk factors. Applying a growth mixture modeling approach, we identified distinct groups of hospitals that exhibited different trajectories of using laparoscopic supracervical hysterectomy over time. Within each trajectory group, we compared patients' risk of surgical complications in the prewarning (2013Q4-2014Q1), transition (2014Q2-2014Q4), and postwarning (2015Q1-2015Q3) period using multivariable regressions. RESULTS: Among 212,146 women undergoing benign hysterectomy at 511 hospitals, the use of laparoscopic supracervical hysterectomy decreased from 15.1% in 2013Q4 to 6.2% in 2015Q3. The use of laparoscopic supracervical hysterectomy at these 511 hospitals exhibited 4 distinct trajectory patterns: persistent low use (mean risk-adjusted utilization rate of laparoscopic supracervical hysterectomy changed from 2.8% in 2013Q4 to 0.6% in 2015Q3), decreased medium use (17.0% to 6.9%), decreased high use (51.4% to 24.2%), and rapid abandonment (30.5% to 0.8%). In the meantime, use of open abdominal hysterectomy increased by 2.1, 4.1, 7.8, and 11.8 percentage points between the prewarning and postwarning periods in these 4 trajectory groups, respectively. Compared with the prewarning period, the risk of major complications in the postwarning period decreased among patients at "persistent low use" hospitals (adjusted odds ratio, 0.88; 95% confidence interval, 0.81-0.94). In contrast, the risk of major complications increased among patients at "rapid abandonment" hospitals (adjusted odds ratio, 1.48; 95% confidence interval, 1.11-1.98), and the risk of minor complications increased among patients at "decreased high use" hospitals (adjusted odds ratio, 1.31; 95% confidence interval, 1.01-1.72). CONCLUSION: Hospitals varied in their use of laparoscopic supracervical hysterectomy after safety warnings about power morcellation. Complication risk increased at hospitals that shifted considerably toward open abdominal hysterectomy.

Rates of Complications After Appendectomy in Children and Adolescents: Pediatric Surgical Compared to General Surgical Hospitals.

BACKGROUND: Appendectomies in children and adolescents are performed in Germany in pediatric surgical (PS) or general surgical hospitals (GS). The aim of this study is to evaluate whether the surgery in a PS or GS hospital has an influence on the postoperative course after appendectomy in children and adolescents. MATERIALS AND METHODS: Nationwide routine data from children and adolescents aged 1-17 y insured by the Local Health Insurance Fund who underwent appendectomy between 2014 and 2016 were analyzed (cohort study). Descriptive statistics were calculated both overall and in the two groups (PS and GS). Patients were additionally examined by age (1-5, 6-12, and 13-17 y), treatment (laparoscopic, open surgical, and conversion), and appendicitis type (nonacute: K36/K37/K38/R10, acute simple: K35.30/K35.8, and acute complex: K35.2/K35.31/K35.32). The influence of surgeon specialization on 90-d secondary surgery and 90-d general complications was assessed by multiple logistic regression. RESULTS: Altogether, 25,065 patients who underwent surgery in 83 PS and 906 GS hospitals were included. Logistic regression analysis revealed that PS was associated with a reduced risk of interventions in the 1-5- and 6-12-y age groups (odds ratio: 0.44, 0.62). Acute complex appendicitis, comorbidities, and open surgery significantly increased the risk for reintervention. PS was associated with an increased risk for complications in the 13-17-y age group (odds ratio: 1.66). CONCLUSIONS: PS and GS hospitals provided safe appendectomies in children and adolescents with low reintervention and complication rates. PS hospitals demonstrated advantages for patients in the 1-5- and 6-12-y age groups and GS hospitals for patients 13-17 y.

Clinical outcomes and safety of passive leg raising in out-of-hospital cardiac arrest: a randomized controlled trial.

BACKGROUND: There are data suggesting that passive leg raising (PLR) improves hemodynamics during cardiopulmonary resuscitation (CPR). This trial aimed to determine the effectiveness and safety of PLR during CPR in out-of-hospital cardiac arrest (OHCA). METHODS: We conducted a randomized controlled trial with blinded assessment of the outcomes that assigned adults OHCA to be treated with PLR or in the flat position. The trial was conducted in the Camp de Tarragona region. The main end point was survival to hospital discharge with good neurological outcome defined as cerebral performance category (CPC 1-2). To study possible adverse effects, we assessed the presence of pulmonary complications on the first chest X-rays, brain edema on the computerized tomography (CT) in survivors and brain and lungs weights from autopsies in non-survivors. RESULTS: In total, 588 randomized cases were included, 301 were treated with PLR and 287 were controls. Overall, 67.8% were men and the median age was 72 (IQR 60-82) years. At hospital discharge, 3.3% in the PLR group and 3.5% in the control group were alive with CPC 1-2 (OR 0.9; 95% CI 0.4-2.3, p = 0.91). No significant differences in survival at hospital admission were found in all patients (OR 1.0; 95% CI 0.7-1.6, p = 0.95) and among patients with an initial shockable rhythm (OR 1.7; 95% CI 0.8-3.4, p = 0.15). There were no differences in pulmonary complication rates in chest X-rays [7 (25.9%) vs 5 (17.9%), p = 0.47] and brain edema on CT [5 (29.4%) vs 10 (32.6%), p = 0.84]. There were no differences in lung weight [1223 mg (IQR 909-1500) vs 1239 mg (IQR 900-1507), p = 0.82] or brain weight [1352 mg (IQR 1227-1457) vs 1380 mg (IQR 1255-1470), p = 0.43] among the 106 autopsies performed. CONCLUSION: In this trial, PLR during CPR did not improve survival to hospital discharge with CPC 1-2. No evidence of adverse effects has been found. Clinical trial registration ClinicalTrials.gov: NCT01952197, registration date: September 27, 2013, https://clinicaltrials.gov/ct2/show/NCT01952197 .