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Background Adverse events (AEs) affect 10% of in-hospital patients, causing increased costs, injuries, disability and mortality. Patient safety culture (PSC) is an indicator of quality in healthcare services and is thus perceived as a proxy for the quality of care. Previous studies show variation in the association between PSC scores and AE rates. The main objective of this scoping review is to summarise the evidence on the association between PSC scores and AE rates in healthcare services. In addition, map the characteristics and the applied research methodology in the included studies, and study the strengths and limitations of the evidence. Methods We applied a scoping review methodology to answer the broad research questions of this study, following the PRISMA-ScR checklist. A systematic search in seven databases was conducted in January 2022. The records were screened independently against eligibility criteria using Rayyan software, and the extracted data were collated in a charting form. Descriptive representations and tables display the systematic mapping of the literature. Results We included 34 out of 1,743 screened articles. The mapping demonstrated a statistical association in 76% of the studies, where increased PSC scores were associated with reduced AE rates. Most of the studies had a multicentre design and were conducted in-hospital in high-income countries. The methodological approaches to measuring the association varied, including missing reports on the tools` validation and participants, different medical specialties, and work unit level of measurements. In addition, the review identified a lack of eligible studies for meta-analysis and synthesis and demonstrated a need for an in-depth understanding of the association, including context complexity. Conclusions We found that the vast majority of studies report reduced AE rates when PSC scores increase. This review demonstrates a lack of studies from primary care and low- and- middle-income countries. There is a discrepancy in utilised concepts and methodology, hence there is a need for a broader understanding of the concepts and the contextual factors, and more uniform methodology. Longitudinal prospective studies with higher quality can enhance efforts to improve patient safety.

Hospitals under financial pressure may struggle to maintain quality and patient safety and have worse patient outcomes relative to well-resourced hospitals. Poor predictive validity may explain why previous studies on the association between finances and quality/safety have been equivocal. This manuscript employs principal component analysis to produce robust measures of both financial status and quality/safety of care, to assess our a priori hypothesis: hospital financial performance is associated with the provision of quality care, as measured by quality and safety processes, patient outcomes, and patient centered care. This 2014 cross-sectional study investigated hospital financial condition and hospital quality and safety at acute care hospitals. The hospital financial data from the Centers for Medicare and Medicaid Services (CMS) cost report were used to develop a composite financial performance score using principal component analysis. Hospital quality and patient safety were measured with a composite quality/safety performance score derived from principal component analysis, utilizing a range of established quality and safety indicators including: risk-standardized inpatient mortality, 30-day mortality, 30-day readmissions for select conditions, patient safety indicators from inpatient admissions, process of care chart reviews, CMS value-based purchasing total performance score and patient experience of care surveys. The correlation between the composite financial performance score and the composite quality/safety performance score was calculated using linear regression adjusting for hospital characteristics. Among the 108 New York State acute care facilities for which data were available, there is a clear relationship between hospital financial performance and hospital quality/safety performance score (standardized correlation coefficient 0.34, p<0.001). The composite financial performance score is also positively associated with the CMS Value Based Purchasing Total Performance Score (standardized correlation coefficient 0.277, p = 0.002); while it is negatively associated with 30 day readmission for all outcomes (standardized correlation coefficient -0.236, p = 0.013), 30-day readmission for congestive heart failure (standardized correlation coefficient -0.23, p = 0.018), 30 day readmission for pneumonia (standardized correlation coefficient -0.209, p = 0.033), and a decrease in 30-day mortality for acute myocardial infarction (standardized correlation coefficient -0.211, p = 0.027). Used alone, operating margin and total margin are poor predictors of quality and safety outcomes. Strong financial performance is associated with improved patient reported experience of care, the strongest component distinguishing quality and safety. These findings suggest that financially stable hospitals are better able to maintain highly reliable systems and provide ongoing resources for quality improvement.

Adverse events during hospitalization are a major cause of patient harm, as documented in the 1991 Harvard Medical Practice Study. Patient safety has changed substantially in the decades since that study was conducted, and a more current assessment of harm during hospitalization is warranted. We conducted a retrospective cohort study to assess the frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during the 2018 calendar year. The occurrence of adverse events was assessed with the use of a trigger method (identification of information in a medical record that was previously shown to be associated with adverse events) and from review of medical records. Trained nurses reviewed records and identified admissions with possible adverse events that were then adjudicated by physicians, who confirmed the presence and characteristics of the adverse events. In a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care-associated infections (11.9%). Adverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement. (Funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.).

Patients with advanced sarcomas have a poor prognosis and few treatment options that improve overall survival. Chemotherapy and targeted therapies offer short-lived disease control. We assessed pembrolizumab, an anti-PD-1 antibody, for safety and activity in patients with advanced soft-tissue sarcoma or bone sarcoma. In this two-cohort, single-arm, open-label, phase 2 study, we enrolled patients with soft-tissue sarcoma or bone sarcoma from 12 academic centres in the USA that were members of the Sarcoma Alliance for Research through Collaboration (SARC). Patients with soft-tissue sarcoma had to be aged 18 years or older to enrol; patients with bone sarcoma could enrol if they were aged 12 years or older. Patients had histological evidence of metastatic or surgically unresectable locally advanced sarcoma, had received up to three previous lines of systemic anticancer therapy, had at least one measurable lesion according to the Response Evaluation Criteria In Solid Tumors version 1.1, and had at least one lesion accessible for biopsy. All patients were treated with 200 mg intravenous pembrolizumab every 3 weeks. The primary endpoint was investigator-assessed objective response. Patients who received at least one dose of pembrolizumab were included in the safety analysis and patients who progressed or reached at least one scan assessment were included in the activity analysis. Accrual is ongoing in some disease cohorts. This trial is registered with ClinicalTrials.gov, number NCT02301039. Between March 13, 2015, and Feb 18, 2016, we enrolled 86 patients, 84 of whom received pembrolizumab (42 in each disease cohort) and 80 of whom were evaluable for response (40 in each disease cohort). Median follow-up was 17·8 months (IQR 12·3–19·3). Seven (18%) of 40 patients with soft-tissue sarcoma had an objective response, including four (40%) of ten patients with undifferentiated pleomorphic sarcoma, two (20%) of ten patients with liposarcoma, and one (10%) of ten patients with synovial sarcoma. No patients with leiomyosarcoma (n=10) had an objective response. Two (5%) of 40 patients with bone sarcoma had an objective response, including one (5%) of 22 patients with osteosarcoma and one (20%) of five patients with chondrosarcoma. None of the 13 patients with Ewing's sarcoma had an objective response. The most frequent grade 3 or worse adverse events were anaemia (six [14%]), decreased lymphocyte count (five [12%]), prolonged activated partial thromboplastin time (four [10%]), and decreased platelet count (three [7%]) in the bone sarcoma group, and anaemia, decreased lymphocyte count, and prolonged activated partial thromboplastin time in the soft-tissue sarcoma group (three [7%] each). Nine (11%) patients (five [12%] in the bone sarcoma group and four [10%] in the soft-tissue sarcoma group) had treatment-emergent serious adverse events (SAEs), five of whom had immune-related SAEs, including two with adrenal insufficiency, two with pneumonitis, and one with nephritis. The primary endpoint of overall response was not met for either cohort. However, pembrolizumab showed encouraging activity in patients with undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma. Enrolment to expanded cohorts of those subtypes is ongoing to confirm and characterise the activity of pembrolizumab. Merck, SARC, Sarcoma Foundation of America, QuadW Foundation, Pittsburgh Cure Sarcoma, and Ewan McGregor.

Have you ever experienced the burden of an adverse event or a near-miss in healthcare and wished there was a way to mitigate it? This book walks you through a classic adverse event as a case study and shows you how. It is a practical guide to continuously improving your healthcare environment, processes, tools, and ultimate outcomes, through the discipline of human factors. Using this book, you as a healthcare professional can improve patient safety and quality of care. Adverse events are a major concern in healthcare today. As the complexity of healthcare increases-with technological advances and information overload-the field of human factors offers practical approaches to understand the situation, mitigate risk, and improve outcomes. The first part of this book presents a human factors conceptual framework, and the second part offers a systematic, pragmatic approach. Both the framework and the approach are employed to analyze and understand healthcare situations, both proactively-for constant improvement-and reactively-learning from adverse events. This book guides healthcare professionals through the process of mapping the environmental and human factors; assessing them in relation to the tasks each person performs; recognizing how gaps in the fit between human capabilities and the demands of the task in the environment have a ripple effect that increases risk; and drawing conclusions about what types of changes facilitate improvement and mitigate risk, thereby contributing to improved healthcare outcomes.

Background Adverse events (AEs) seriously affect patient safety and quality of care, and remain a pressing global issue. This study had three objectives: (1) to describe the proportions of patients affected by in-hospital AEs; (2) to explore the types and consequences of observed AEs; and (3) to estimate the preventability of in-hospital AEs. Methods We applied a scoping review method and concluded a comprehensive literature search in PubMed and CINAHL in May 2017 and in February 2018. Our target was retrospective medical record review studies applying the Harvard method–or similar methods using screening criteria–conducted in acute care hospital settings on adult patients (≥18 years). Results We included a total of 25 studies conducted in 27 countries across six continents. Overall, a median of 10% patients were affected by at least one AE (range: 2.9–21.9%), with a median of 7.3% (range: 0.6–30%) of AEs being fatal. Between 34.3 and 83% of AEs were considered preventable (median: 51.2%). The three most common types of AEs reported in the included studies were operative/surgical related, medication or drug/fluid related, and healthcare-associated infections. Conclusions Evidence regarding the occurrence of AEs confirms earlier estimates that a tenth of inpatient stays include adverse events, half of which are preventable. However, the incidence of in-hospital AEs varied considerably across studies, indicating methodological and contextual variations regarding this type of retrospective chart review across health care systems. For the future, automated methods for identifying AE using electronic health records have the potential to overcome various methodological issues and biases related to retrospective medical record review studies and to provide accurate data on their occurrence.