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.

Problemas na cultura de segurança do paciente em uma unidade de pronto atendimento: análise causal / Problemas en la cultura de seguridad del paciente en una unidad de emergencia: análisis de la cadena causal / Problems in the patient safety culture in an emergency care unit: causal analysis

Objetivo: construir uma matriz de análise para identificação dos problemas relacionados à cultura de segurança do paciente em uma unidade de pronto atendimento no sul do Brasil. Método: a primeira etapa, com delineamento transversal descritivo, ocorreu de julho a agosto de 2018, com enfermeiros, por meio da autoaplicação do instrumento "Safety Attitudes Questionaire - SAQ Short Form 2006". Na segunda etapa, com delineamento exploratório descritivo, as questões do SAQ passaram por análise interpretativa, realizada por enfermeiras dedicadas ao estudo da temática, em abril de 2021. Resultados: os problemas na cultura de segurança do paciente na unidade de pronto atendimento relacionaram-se à estrutura, processos de gestão e processos clínicos, principalmente de caráter organizacional. Conclusão: a utilização da análise de cadeia causal permitiu a construção de uma matriz de análise, facilitando a identificação dos principais problemas relacionados à cultura de segurança do paciente na unidade de pronto atendimento.

Objetivo: to develop an analysis matrix to identify problems related to the patient safety culture in an emergency care unit in southern Brazil. Método: the first stage, with a descriptive cross-sectional design, occurred from July to August 2018, with nurses, through the self-application of the instrument "Safety Attitudes Questionaire - SAQ Short Form 2006". In the second stage, with a descriptive exploratory design, the SAQ questions underwent an interpretative analysis, carried out by nurses dedicated to the study of the subject, in April 2021. Resultados: the problems in the patient safety culture in the emergency care unit were related to the structure, management processes and clinical processes, mainly of an organizational nature. Conclusión: the use of causal chain analysis allowed the construction of an analysis matrix, facilitating the identification of the main problems related to the patient safety culture in the emergency care unit.

Objective: to evaluate the clinical predictors for dry eye and the nursing diagnosis Risk of dry eye in postoperative patients in the Post-Anesthesia Care Unit. Method: cross-sectional study conducted between May and August, 2017. The sample was 157 adult patients undergoing elective surgical procedures. Data were analyzed using descriptive and inferential statistics. Results: the clinical diagnosis of dry eye prevailed in 85.35% of patients, and the nursing diagnosis Risk of dry eye in 14.65%. Statistical differences were observed between hyperemia, excessive tearing and insufficient Schirmer test with the diagnosis of ocular dryness in the right eye and with the diagnosis Risk of dry eye. In the left eye the Schirmer test was insufficient. Conclusão: hyperemia, excessive tearing and insufficient Schirmer test are relevant perioperative clinical predictors to promote preventive measures and/or early detection of dry eye.

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.

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.

Retrospective identification of medication related adverse events in the emergency medical services through the analysis of a patient safety register.

Adverse drug events encompass a wide range of potential unintended and harmful events, from adverse drug reactions to medication errors, many of which in retrospect, are considered preventable. However, the primary challenge towards reducing their burden lies in consistently identifying and monitoring these occurrences, a challenge faced across the spectrum of healthcare, including the emergency medical services. The aim of this study was to identify and describe medication related adverse events (AEs) in the out-of-hospital setting. The medication components of a dedicated patient safety register were analysed and described for the period Jan 2017-Sept 2020. Univariate descriptive analysis was used to summarize and report on basic case and patient demographics, intervention related AEs, medication related AEs, and AE severity. Multivariable logistic regression was used to assess the odds of AE severity, by AE type. A total of 3475 patient records were assessed where 161 individual medication AEs were found in 150 (4.32%), 12 of which were categorised as harmful. Failure to provide a required medication was found to be the most common error (1.67%), followed by the administration of medications outside of prescribed practice guidelines (1.18%). There was evidence to suggest a 63% increase in crude odds of any AE severity [OR 1.63 (95% CI 1.03-2.6), p = 0.035] with the medication only AEs when compared to the intervention only AEs. Prehospital medication related adverse events remain a significant threat to patient safety in this setting and warrant greater widespread attention and future identification of strategies aimed at their reduction.

Quality and Safety Outcomes of a Hospital Merger Following a Full Integration at a Safety Net Hospital.

Importance: Hospital consolidations have been shown not to improve quality on average. Objective: To assess a full-integration approach to hospital mergers based on quality metrics in a safety net hospital acquired by an urban academic health system. Design, Setting, and Participants: This quality improvement study analyzed outcomes for all nonpsychiatric, nonrehabilitation, non-newborn patients discharged between September 1, 2010, and August 31, 2019, at a US safety net hospital that was acquired by an urban academic health system in January 2016. Interrupted time series and statistical process control analyses were used to assess the main outcomes and measures. Data sources included the hospital's electronic health record, Centers for Medicare & Medicaid Services Hospital Compare, and nursing quality reports. Exposures: A full-integration approach to the merger that included: (1) early administrative and clinical leadership integration with the academic health system; (2) rapid transition to the academic health system electronic health record; (3) local ownership of quality metrics; (4) system-level goals with real-time actionable analytics through combined dashboards; and (5) implementation of value-based and other analytic-driven interventions. Main Outcomes and Measures: The primary outcome was in-hospital mortality. Secondary outcomes included 30-day readmission, patient experience, and hospital-acquired conditions. Results: The 122 348 patients in the premerger (September 2010 through August 2016) and the 58 904 patients in the postmerger (September 2016 through August 2019) periods had a mean (SD) age of 55.5 (22.0) years; the total sample of 181 252 patients included 112 191 women (61.9%), the payor mix was majority governmental (144 375 patients [79.7%]), and most admissions were emergent (121 469 patients [67.0%]). There was a 0.71% (95% CI, 0.57%-0.86%) absolute (27% relative) reduction in the crude mortality rate and 0.95% (95% CI, 0.83%-1.12%) absolute (33% relative) in the adjusted rate by the end of the 3-year intervention period. There was no significant improvement in readmission rates after accounting for baseline trends. There were fewer central line infections per 1000 catheter days, fewer catheter-associated urinary tract infections per 1000 discharges, and a higher likelihood of patients recommending the hospital or ranking it 9 or 10. Conclusions and Relevance: In this quality improvement study, a hospital merger with a full-integration approach to consolidation was found to be associated with improvement in quality outcomes.

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.

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).

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).

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.

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.

Cultura de segurança do paciente em três instituições hospitalares: perspectiva da equipe de enfermagem / Cultura de seguridad del paciente en tres instituciones hospitalarias: perspectiva del equipo de enfermería / Patient safety culture in three hospital institutions: nursing team perspective

Objetivo: avaliar a cultura de segurança do paciente em três instituições hospitalares, sob a perspectiva da equipe de enfermagem. Método: estudo quantitativo e transversal analítico realizado com 303 profissionais de enfermagem de três hospitais mineiros. Aplicou-se o questionário Hospital Survey on Patient Safety Culture. Foram realizadas análises estatísticas descritivas e inferencial bivariada. Resultados: pela perspectiva da enfermagem, nenhum dos três hospitais apresentou dimensões fortes para a cultura de segurança. O hospital filantrópico obteve melhores avaliações em quatro dimensões em relação aos hospitais da rede pública. A dimensão com maior fragilidade em todos os hospitais foi "Retorno da informação e comunicação sobre erro". Conclusão: sob a perspectiva das equipes de enfermagem, todas as dimensões da cultura de segurança do paciente revelaram fragilidades nos hospitais em estudo.

Objetivo: evaluar la cultura de seguridad del paciente en tres instituciones hospitalarias, desde la perspectiva del equipo de enfermería. Método: estudio analítico cuantitativo y transversal realizado con 303 profesionales de enfermería de tres hospitales de Minas Gerais. Se aplicó el cuestionario Hospital Survey on Patient Safety Culture. Se realizaron análisis estadísticos bivariados descriptivos e inferenciales. Resultados: desde la perspectiva de la enfermería, ninguno de los tres hospitales presentó dimensiones fuertes para la cultura de seguridad. El hospital filantrópico obtuvo mejores evaluaciones en cuatro dimensiones en relación a los hospitales públicos. La dimensión con mayor fragilidad en todos los hospitales fue "Retorno de información y comunicación sobre error". Conclusión: desde la perspectiva de los equipos de enfermería, todas las dimensiones de la cultura de seguridad del paciente revelaron debilidades en los hospitales en estudio.

Objective: to evaluate the patient safety culture in three hospital institutions, from the perspective of the nursing team. Method: quantitative and cross-sectional analytical study conducted with 303 nursing professionals from three hospitals in Minas Gerais. The Hospital Survey on Patient Safety Culture questionnaire was applied. Descriptive and inferential bivariate statistical analyses were performed. Results: from the perspective of nursing, none of the three hospitals presented strong dimensions for the safety culture. The philanthropic hospital obtained better evaluations in four dimensions in relation to public hospitals. The dimension with greater fragility in all hospitals was "Return of information and communication about error". Conclusion: from the perspective of nursing teams, all dimensions of the patient safety culture revealed weaknesses in the hospitals under study.

The role of hospital characteristics in patient safety: a protocol for a national cohort study.

BACKGROUND: Substantial expenditures on health care safety programs have been justified by their goal of reducing health care associated-harm (adverse events), but adverse event rates have not changed over the past 4 decades. The objective of this study is to describe hospital-level factors that are relevant to safety in Canadian hospitals and the impact of these factors on hospital adverse events. METHODS: This is a protocol for a national cohort study to describe the association between hospital-level factors and adverse events. We will survey at least 90 (35%) Canadian hospitals to describe 4 safety-relevant domains, chosen based on the literature and expert consultation, namely patient safety culture, safety strategies, staffing, and volume and capacity. We will retrospectively identify hospital adverse events from a national data source. We will evaluate organization-level factors using established scales and a survey, codesigned by the study team and hospital leaders. Hospital leaders, clinical unit leaders and front-line staff will complete the surveys once a year for 3 years, with an anticipated start date of winter 2022. We will use national health administrative data to estimate the rate and type of hospital adverse events corresponding to each 1-year survey period. INTERPRETATION: Analysis of data from this project will describe hospital organizational factors that are relevant to safety and help identify organizational initiatives that improve hospital patient safety. In addition to biyearly reports to the leaders of the participating hospitals, we have a multifaceted and tailored dissemination strategy that includes integrating the knowledge users into the study team to increase the likelihood that our study will lead to improved hospital patient safety.

Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial.

Importance: Tourette syndrome is a neurodevelopmental disorder characterized by childhood onset of motor and phonic tics; treatments for tics are associated with safety concerns. Deutetrabenazine is a selective vesicular monoamine transporter 2 inhibitor approved for the treatment of chorea associated with Huntington disease and tardive dyskinesia in adults. Objective: To examine whether deutetrabenazine is effective and safe for the treatment of Tourette syndrome in children and adolescents. Design, Setting, and Participants: This phase 2/3, randomized, double-masked, placebo-controlled, parallel-group, dose-titration study included children and adolescents (aged 6-16 years) with Tourette syndrome with active tics causing distress or impairment (ie, Yale Global Tic Severity Scale-Total Tic Score [YGTSS-TTS] ≥20). The trial was conducted over 12 weeks, with 1 week of follow-up from February 2018 to November 2019 at 36 centers in the United States, Canada, Denmark, Russia, Serbia, and Spain. Data analysis was conducted from January 31 to April 22, 2020. Intervention: Patients were randomized (1:1) to receive deutetrabenazine or placebo, titrated during 7 weeks to an optimal level, followed by a 5-week maintenance period. The maximum total daily deutetrabenazine dose was 48 mg/d. Main Outcomes and Measures: The primary efficacy end point was change from baseline to week 12 in YGTSS-TTS. Key secondary end points included changes in Tourette Syndrome-Clinical Global Impression, Tourette Syndrome-Patient Global Impression of Impact, and Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life Activities of Daily Living subscale score. Safety was assessed based on treatment-emergent adverse events, vital signs, questionnaires, and laboratory parameters. Results: A total of 119 participants were randomized to deutetrabenazine (59 participants; mean [SD] age, 11.5 [2.5] years; 53 [90%] boys; 49 [83%] White; 3 [5%] Black) and placebo (60 participants; mean [SD] age, 11.5 [2.6] years; 51 [85%] boys; 53 [88%] White; 3 [5%] Black). At week 12, the difference in YGTSS-TTS score was not significant between deutetrabenazine and placebo (least squares mean difference, -0.7; 95% CI, -4.1 to 2.8; P = .69; Cohen d, -0.07). There were no nominally significant differences between groups for key secondary end points. Treatment-emergent adverse events were reported for 38 patients (66%) and 33 patients (56%) receiving deutetrabenazine and placebo, respectively, and were generally mild or moderate. Conclusions and Relevance: In this study of deutetrabenazine in children and adolescents with Tourette syndrome, the primary efficacy end point was not met. No new safety signals were identified. These results may be informative for future studies of treatments for tics in Tourette syndrome. Trial Registration: ClinicalTrials.gov Identifier: NCT03452943.

Six Sigma in surgery: how to create a safer culture in the operating theatre using innovative technology.

Safe delivery of patient care in the operating theatre is complex and co-dependent of many individual, organisational, and environmental factors, including patient, task and technology, individual, and human factors. The Six Sigma approach aims to implement a data-driven strategy to reduce variability and consequently improve safety. Analytical data platforms such as a Black Box ought to be embraced to support process optimisation and ultimately create a higher level of Six Sigma safety performance of the operating theatre team.