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1.
Nurs Res ; 73(3): E21-E30, 2024.
Article in English | MEDLINE | ID: mdl-38300627

ABSTRACT

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.


Subject(s)
Personnel Turnover , Psychiatric Nursing , Humans , Personnel Turnover/statistics & numerical data , Female , Cross-Sectional Studies , Male , Adult , China , Surveys and Questionnaires , Nursing Staff, Hospital/psychology , Nursing Staff, Hospital/statistics & numerical data , Middle Aged , Intention , Rumination, Cognitive , Patient Safety/statistics & numerical data
2.
J Clin Nurs ; 33(6): 2324-2336, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38308406

ABSTRACT

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.


Subject(s)
Patient Safety , Qualitative Research , Humans , Patient Safety/standards , Patient Safety/statistics & numerical data , Female , Adult , Nursing Staff, Hospital/psychology , Male , Medical Errors , Risk Management , Organizational Culture , Middle Aged , Quality Improvement
3.
JAMA ; 329(21): 1840-1847, 2023 06 06.
Article in English | MEDLINE | ID: mdl-37278813

ABSTRACT

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.


Subject(s)
Hospitals , Public Reporting of Healthcare Data , Quality Improvement , Quality of Health Care , Humans , Delivery of Health Care/economics , Delivery of Health Care/standards , Delivery of Health Care/statistics & numerical data , Hospitals/standards , Hospitals/statistics & numerical data , Hospitals/supply & distribution , Quality Improvement/economics , Quality Improvement/standards , Quality Improvement/statistics & numerical data , Quality of Health Care/economics , Quality of Health Care/statistics & numerical data , Retrospective Studies , Adult , United States/epidemiology , Insurance Claim Review/economics , Insurance Claim Review/standards , Insurance Claim Review/statistics & numerical data , Patient Safety/economics , Patient Safety/standards , Patient Safety/statistics & numerical data , Economics, Hospital/statistics & numerical data
5.
Rev. baiana enferm ; 37: e48800, 2023. tab, graf
Article in Portuguese | LILACS, BDENF - Nursing | ID: biblio-1449467

ABSTRACT

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.


Subject(s)
Humans , Male , Female , Emergency Medical Services/methods , Quality Improvement , Patient Safety/statistics & numerical data , Mediation Analysis , Cross-Sectional Studies
6.
JAMA ; 328(2): 173-183, 2022 07 12.
Article in English | MEDLINE | ID: mdl-35819424

ABSTRACT

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.


Subject(s)
Hospitalization , Patient Safety , Accidental Falls/statistics & numerical data , Adult , Aged , Aged, 80 and over , Cross Infection/epidemiology , Cross-Sectional Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Heart Failure/epidemiology , Hospitalization/statistics & numerical data , Hospitalization/trends , Humans , Male , Medicare/statistics & numerical data , Medicare/trends , Middle Aged , Myocardial Infarction/epidemiology , Patient Safety/statistics & numerical data , Pneumonia/epidemiology , Postoperative Complications/epidemiology , Pressure Ulcer/epidemiology , Risk Assessment , Surgical Procedures, Operative/adverse effects , Surgical Procedures, Operative/statistics & numerical data , United States/epidemiology
8.
South Med J ; 115(2): 125-128, 2022 02.
Article in English | MEDLINE | ID: mdl-35118501

ABSTRACT

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.


Subject(s)
Arthritis, Rheumatoid/complications , Herpes Zoster/drug therapy , Patient Safety/standards , Vaccines, Synthetic/adverse effects , Adult , Aged , Arthritis, Rheumatoid/physiopathology , Herpes Zoster/prevention & control , Humans , Male , Middle Aged , Patient Safety/statistics & numerical data , Retrospective Studies , Rheumatology/methods , Rheumatology/statistics & numerical data , Vaccines, Synthetic/therapeutic use
9.
Sci Rep ; 12(1): 2622, 2022 02 16.
Article in English | MEDLINE | ID: mdl-35173222

ABSTRACT

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.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Emergency Medical Services/supply & distribution , Medication Errors/statistics & numerical data , Outpatients/statistics & numerical data , Patient Safety/statistics & numerical data , Registries , Adolescent , Adult , Aged , Drug-Related Side Effects and Adverse Reactions/prevention & control , Female , Humans , Logistic Models , Male , Middle Aged , Retrospective Studies , Severity of Illness Index , Time Factors , Young Adult
10.
JAMA Netw Open ; 5(1): e2142382, 2022 01 04.
Article in English | MEDLINE | ID: mdl-34989794

ABSTRACT

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.


Subject(s)
Health Facility Merger , Hospital Mortality , Patient Readmission/statistics & numerical data , Quality of Health Care/statistics & numerical data , Safety-net Providers , Adult , Aged , Catheter-Related Infections/epidemiology , Female , Humans , Male , Middle Aged , Patient Safety/statistics & numerical data
11.
J Korean Med Sci ; 37(4): e24, 2022 Jan 24.
Article in English | MEDLINE | ID: mdl-35075823

ABSTRACT

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.


Subject(s)
Endoscopy, Gastrointestinal/standards , Patient Safety/standards , Endoscopy, Gastrointestinal/methods , Endoscopy, Gastrointestinal/statistics & numerical data , Humans , Patient Safety/statistics & numerical data , Republic of Korea/epidemiology , Surveys and Questionnaires
12.
Br J Anaesth ; 128(3): 562-573, 2022 03.
Article in English | MEDLINE | ID: mdl-35039174

ABSTRACT

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).


Subject(s)
Guideline Adherence/statistics & numerical data , Patient Safety/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Feedback , Female , Hospitals/statistics & numerical data , Humans , Length of Stay/statistics & numerical data , Male , Middle Aged , Perioperative Care , Young Adult
13.
Pediatr Diabetes ; 23(2): 173-182, 2022 03.
Article in English | MEDLINE | ID: mdl-34779087

ABSTRACT

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).


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Patient Safety/standards , Sitagliptin Phosphate/pharmacology , Administration, Oral , Adolescent , Blood Glucose/analysis , Child , Diabetes Mellitus, Type 2/physiopathology , Double-Blind Method , Drug Therapy, Combination/methods , Drug Therapy, Combination/statistics & numerical data , Female , Glycated Hemoglobin/analysis , Humans , Hypoglycemic Agents/pharmacology , Hypoglycemic Agents/therapeutic use , Male , Metformin/pharmacology , Metformin/therapeutic use , Patient Safety/statistics & numerical data , Sitagliptin Phosphate/therapeutic use , Treatment Outcome
14.
Pediatr Diabetes ; 23(2): 183-193, 2022 03.
Article in English | MEDLINE | ID: mdl-34779103

ABSTRACT

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).


Subject(s)
Diabetes Mellitus, Type 2/drug therapy , Patient Safety/standards , Sitagliptin Phosphate/pharmacology , Administration, Oral , Adolescent , Blood Glucose/analysis , Child , Diabetes Mellitus, Type 2/physiopathology , Double-Blind Method , Drug Therapy, Combination/methods , Drug Therapy, Combination/statistics & numerical data , Female , Glycated Hemoglobin/analysis , Humans , Hypoglycemic Agents/pharmacology , Hypoglycemic Agents/therapeutic use , Male , Metformin/pharmacology , Metformin/therapeutic use , Patient Safety/statistics & numerical data , Sitagliptin Phosphate/therapeutic use , Treatment Outcome
15.
J Hepatol ; 76(2): 464-469, 2022 02.
Article in English | MEDLINE | ID: mdl-34699951

ABSTRACT

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.


Subject(s)
Lipopeptides/pharmacology , Liver Cirrhosis/drug therapy , Adult , Antiviral Agents/pharmacology , Antiviral Agents/therapeutic use , Female , Hepatitis D/complications , Hepatitis D/drug therapy , Humans , Lipopeptides/therapeutic use , Liver Cirrhosis/etiology , Liver Function Tests/methods , Liver Function Tests/statistics & numerical data , Male , Middle Aged , Patient Safety/standards , Patient Safety/statistics & numerical data , Treatment Outcome
16.
Dev Med Child Neurol ; 64(3): 314-322, 2022 03.
Article in English | MEDLINE | ID: mdl-34562021

ABSTRACT

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.


Subject(s)
Child, Hospitalized/statistics & numerical data , Developmental Disabilities , Healthcare Disparities/statistics & numerical data , Hospitalization/statistics & numerical data , Intellectual Disability , Outcome Assessment, Health Care/statistics & numerical data , Patient Safety/statistics & numerical data , Quality of Health Care/statistics & numerical data , Adolescent , Child , Child, Preschool , Cross-Sectional Studies , Developmental Disabilities/epidemiology , Developmental Disabilities/therapy , Facilities and Services Utilization/economics , Facilities and Services Utilization/statistics & numerical data , Female , Hospitalization/economics , Hospitals, Pediatric/statistics & numerical data , Humans , Infant , Intellectual Disability/epidemiology , Intellectual Disability/therapy , Length of Stay/economics , Length of Stay/statistics & numerical data , Male , New South Wales/epidemiology , Retrospective Studies , Tertiary Care Centers/statistics & numerical data
17.
Rev. baiana enferm ; 36: e43393, 2022. tab
Article in Portuguese | LILACS, BDENF - Nursing | ID: biblio-1376457

ABSTRACT

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.


Subject(s)
Humans , Male , Female , Quality of Health Care , Organizational Culture , Patient Safety/statistics & numerical data , Nursing, Team , Cross-Sectional Studies
18.
CMAJ Open ; 9(4): E1041-E1047, 2021.
Article in English | MEDLINE | ID: mdl-34815259

ABSTRACT

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.


Subject(s)
Hospitals/standards , Patient Safety/statistics & numerical data , Quality of Health Care , Canada/epidemiology , Cohort Studies , Health Care Surveys , Hospitals/classification , Humans , Safety Management , Workforce
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