Adverse events in British hospitals: preliminary retrospective record review.
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ABSTRACT:
SUBMITTER: Vincent C
PROVIDER: S-EPMC26554 | biostudies-literature | 2001 Mar
REPOSITORIES: biostudies-literature
Publications
Adverse events in British hospitals: preliminary retrospective record review.
Vincent C C Neale G G Woloshynowych M M
BMJ (Clinical research ed.) 20010301 7285
<h4>Objectives</h4>To examine the feasibility of detecting adverse events through record review in British hospitals and to make preliminary estimates of the incidence and costs of adverse events.<h4>Design</h4>Retrospective review of 1014 medical and nursing records.<h4>Setting</h4>Two acute hospitals in Greater London area.<h4>Main outcome measure</h4>Number of adverse events.<h4>Results</h4>110 (10.8%) patients experienced an adverse event, with an overall rate of adverse events of 11.7% when ...[more]
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Project description:IntroductionIrish healthcare has undergone extensive change recently with spending cuts and a focus on quality initiatives; however, little is known about adverse event occurrence.ObjectiveTo assess the frequency and nature of adverse events in Irish hospitals.Methods1574 (53% women, mean age 54 years) randomly selected adult inpatient admissions from a sample of eight hospitals, stratified by region and size, across the Republic of Ireland in 2009 were reviewed using two-stage (nurse review of patient charts, followed by physician review of triggered charts) retrospective chart review with electronic data capture. Results were weighted to reflect the sampling strategy. The impact on adverse event rate of differing application of international adverse event criteria was also examined.Results45% of charts were triggered. The prevalence of adverse events in admissions was 12.2% (95% CI 9.5% to 15.5%), with an incidence of 10.3 events per 100 admissions (95% CI 7.5 to 13.1). Over 70% of events were considered preventable. Two-thirds were rated as having a mild-to-moderate impact on the patient, 9.9% causing permanent impairment and 6.7% contributing to death. A mean of 6.1 added bed days was attributed to events, representing an expenditure of €5550 per event. The adverse event rate varied substantially (8.6%-17.0%) when applying different published adverse event eligibility criteria.ConclusionsThis first study of adverse events in Ireland reports similar rates to other countries. In a time of austerity, adverse events in adult inpatients were estimated to cost over €194 million. These results provide important baseline data on the adverse event burden and, alongside web-based chart review, provide an incentive and methodology to monitor future patient-safety initiatives.
| S-EPMC5284341 | biostudies-literature
Project description:OBJECTIVE:Home healthcare is an increasingly common part of healthcare. The patients are often aged, frail and have multiple diseases, and multiple caregivers are involved in their treatment. This study explores the origin, incidence, types and preventability of adverse events (AEs) that occur in patients receiving home healthcare. DESIGN:A study using retrospective record review and trigger tool methodology. SETTING AND METHODS:Ten teams with experience of home healthcare from nine regions across Sweden reviewed home healthcare records in a two-stage procedure using 38 predefined triggers in four modules. A random sample of records from 600 patients (aged 18 years or older) receiving home healthcare during 2015 were reviewed. PRIMARY AND SECONDARY OUTCOME MEASURES:The cumulative incidence of AEs found in patients receiving home healthcare; secondary measures were origin, types, severity of harm and preventability of the AEs. RESULTS:The patients were aged 20-79 years, 280 men and 320 women. The review teams identified 356 AEs in 226 (37.7%; 95% CI 33.0 to 42.8) of the home healthcare records. Of these, 255 (71.6%; 95% CI 63.2 to 80.8) were assessed as being preventable, and most (246, 69.1%; 95% CI 60.9 to 78.2) required extra healthcare visits or led to a prolonged period of healthcare. Most of the AEs (271, 76.1%; 95% CI 67.5 to 85.6) originated in home healthcare; the rest were detected during home healthcare but were related to care outside home healthcare. The most common AEs were healthcare-associated infections, falls and pressure ulcers. CONCLUSIONS:AEs in patients receiving home healthcare are common, mostly preventable and often cause temporary harm requiring extra healthcare resources. The most frequent types of AEs must be addressed and reduced through improvements in interprofessional collaboration. This is an important area for future studies.
| S-EPMC5781156 | biostudies-other
Project description:OBJECTIVES:To redesign the existing clinical review form (RF2) used in previous retrospective case record review studies in order to clarify the review process and provide a more powerful analysis of adverse events; and then to ask clinicians to pilot and evaluate the new modular review form (MRF2). The review form is divided into five sections, each with a defined purpose, providing a modular structure. DESIGN:Design and testing of the MRF2 on a sample of medical and nursing records, and evaluation of the reviewers' responses regarding the new review form. SETTING:Hospital based teams from eight countries. RESULTS:The modular review form was reported to be comprehensive, well structured, and clear. Most of the reviewers agreed with the positive statements regarding the review form. Overall, the modular structure was thought to be helpful. Several modifications have been made to the final version to take account of criticisms and suggestions. CONCLUSIONS:The full potential of case record review has yet to be explored. The benefits of this review form include a modular format which enables reviewers or project leaders to select the focus of their review based on resources and the purpose of the review, and to identify contributory factors which indicate areas for improvement and prevention. The training of reviewers is of vital importance for record review. Record review remains one of the primary methods for assessing the incidence of adverse events and the new format is suitable for both prospective and retrospective review.
| S-EPMC1758034 | biostudies-literature
Project description:ObjectiveThis study aimed to determine if the implementation of large-scale patient safety initiatives have been successful in reducing overall and preventable adverse event rates in hospital inpatients.DesignThe design used in this study was systematic review and meta-analysis.Data resourcesWe followed our published protocol (PROSPERO [CRD42019140058]) and searched the following databases: PubMed, CINAHL, PsycINFO, Cochrane Library, and Embase from inception to February 2020. The reference lists of eligible studies were also searched.EligibilityAll longitudinal retrospective record review studies that examined adverse event rates before and after the introduction of patient safety initiatives in hospital inpatients were included.Data extractionData extraction, quality, and risk of bias assessment were carried out by 2 independent reviewers. Information on study design, setting, demographics, interventions, and safety outcome measures was extracted.ResultsA total of 3894 articles were screened, and 7 articles met the eligibility criteria for our systematic review with 5 of these providing sufficient information for inclusion in the meta-analysis. The degree of heterogeneity was high among studies. The meta-analysis demonstrated a minimal risk reduction in overall adverse event rates of 0.017 (95% confidence interval, 0.002-0.032) when the lower-quality studies were excluded, with one adverse event being prevented for every 59 hospital admissions.ConclusionsThese findings are significant when the large numbers of admissions to a hospital every year are considered. Given the low numbers of large-scale implementation studies, there is a need for more research on the effectiveness of patient safety initiatives to further assess the impact of such initiatives on adverse events.
| S-EPMC7908854 | biostudies-literature
Project description:BackgroundMedication errors and adverse drug events are universal problems contributing to patient harm but the magnitude of these problems in Africa remains unclear.ObjectiveThe objective of this study was to systematically investigate the literature on the extent of medication errors and adverse drug events, and the factors contributing to medication errors in African hospitals.MethodsWe searched PubMed, MEDLINE, EMBASE, Web of Science and Global Health databases from inception to 31 August, 2017 and hand searched the reference lists of included studies. Original research studies of any design published in English that investigated adverse drug events and/or medication errors in any patient population in the hospital setting in Africa were included. Descriptive statistics including median and interquartile range were presented.ResultsFifty-one studies were included; of these, 33 focused on medication errors, 15 on adverse drug events, and three studies focused on medication errors and adverse drug events. These studies were conducted in nine (of the 54) African countries. In any patient population, the median (interquartile range) percentage of patients reported to have experienced any suspected adverse drug event at hospital admission was 8.4% (4.5-20.1%), while adverse drug events causing admission were reported in 2.8% (0.7-6.4%) of patients but it was reported that a median of 43.5% (20.0-47.0%) of the adverse drug events were deemed preventable. Similarly, the median mortality rate attributed to adverse drug events was reported to be 0.1% (interquartile range 0.0-0.3%). The most commonly reported types of medication errors were prescribing errors, occurring in a median of 57.4% (interquartile range 22.8-72.8%) of all prescriptions and a median of 15.5% (interquartile range 7.5-50.6%) of the prescriptions evaluated had dosing problems. Major contributing factors for medication errors reported in these studies were individual practitioner factors (e.g. fatigue and inadequate knowledge/training) and environmental factors, such as workplace distraction and high workload.ConclusionMedication errors in the African healthcare setting are relatively common, and the impact of adverse drug events is substantial but many are preventable. This review supports the design and implementation of preventative strategies targeting the most likely contributing factors.
| S-EPMC5825388 | biostudies-literature
Project description:BackgroundLimited data are available on adverse events among children admitted to hospital. The Canadian Paediatric Adverse Events Study was done to describe the epidemiology of adverse events among children in hospital in Canada.MethodsWe performed a 2-stage medical record review at 8 academic pediatric centres and 14 community hospitals in Canada. We reviewed charts from patients admitted from April 2008 through March 2009, evenly distributed across 4 age groups (0 to 28 d; 29 to 365 d; > 1 to 5 yr and > 5 to 18 yr). In stage 1, nurses and health records personnel who had received training in the use of the Canadian Paediatric Trigger Tool reviewed medical records to detect triggers for possible adverse events. In stage 2, physicians reviewed the charts identified as having triggers and described the adverse events.ResultsA total of 3669 children were admitted to hospital during the study period. The weighted rate of adverse events was 9.2%. Adverse events were more frequent in academic pediatric centres than in community hospitals (adjusted odds ratio [OR] 2.98, 95% confidence interval [CI] 1.65-5.39). The incidence of preventable adverse events was not significantly different between types of hospital, but nonpreventable adverse events were more common in academic pediatric centres (adjusted OR 4.39, 95% CI 2.08-9.27). Surgical events predominated overall and occurred more frequently in academic pediatric centres than in community hospitals (37.2% v. 21.5%, relative risk [RR] 1.7, 95% CI 1.0-3.1), whereas events associated with diagnostic errors were significantly less frequent (11.1% v. 23.1%, RR 0.5, 95% CI 0.2-0.9).InterpretationMore children have adverse events in academic pediatric centres than in community hospitals; however, adverse events in the former are less likely to be preventable. There are many opportunities to reduce harm affecting children in hospital in Canada, particularly related to surgery, intensive care and diagnostic error.
| S-EPMC3447037 | biostudies-literature
Project description:ObjectiveIn this systematic review, we evaluate 2 of the most used trigger tools according to the criteria of the World Health Organization for evaluating methods.MethodsWe searched Embase, PubMed, and Cochrane databases for studies (2000-2017). Studies were included if medical record review (MRR) was performed with either the Global Trigger Tool or the Harvard Medical Practice Study in a hospital population. Quality assessment was performed in duplicate. Fifty studies were included, and results were reported for every criterion separately.ResultsMedical record review reveals more adverse events (AEs) than any other method. However, at the same time, it detects different AEs. The costs of an AE were on average €4296. Considerable efforts have been made worldwide in health care to improve safety and to reduce errors. These have resulted in some positive effects. The literature showed that MRR is focused on several domains of quality of care and seems suitable for both small and large cohorts. Furthermore, we found a moderate to substantial agreement for the presence of a trigger and a moderate to good agreement for the presence of an AE.ConclusionsMedical record review with a trigger tool is a reasonably well-researched method for the evaluation of the medical records for AEs. However, looking at the World Health Organization criteria, much research is still lacking or of moderate quality. Especially for the cost of detecting AEs, valuable information is missing. Moreover, knowledge of how MRR changes quality and safety of care should be evaluated.
| S-EPMC8612912 | biostudies-literature
Project description:Six weeks of zidovudine (ZDV) is recommended for postnatal prophylaxis of HIV-exposed infants, but combination antiretrovirals are indicated if HIV transmission risk is increased. We investigated the frequency and severity of adverse events (AE) in infants receiving multiple drug prophylaxis compared to ZDV alone. In this retrospective review of 148 HIV-exposed uninfected infants born between 1997-2009, we determined clinical and laboratory AE that occurred between days of life 8-42. Thirty-six infants received combination prophylaxis; among those, a three-drug regimen containing ZDV, lamivudine, and nevirapine was most common (53%). Rates of laboratory AE grade ?1 were as follows for the combination prophylaxis and ZDV alone groups, respectively: neutropenia 55% and 39%; anemia 50% and 39%; thrombocytopenia 0 and 3%; elevated aspartate aminotransferase 3% and 3%; elevated alanine aminotransferase 0 and 1%; hyperbilirubinemia 19% and 42%. Anemia occurred more frequently in infants who received three-drug prophylaxis compared to infants who received ZDV alone (63% vs. 39%, p = 0.04); all anemia AE were grade 1 or 2 in the three-drug prophylaxis group. Overall, 75% of infants on combination prophylaxis and 66% of infants on ZDV alone developed grade ?1 AE (p = 0.32), and 17% of infants in either group developed grade ?3 AE. Stavudine was substituted for ZDV in 23 infants due to anemia or neutropenia. After this antiretroviral change, 50% of evaluable infants demonstrated improvement in AE grade, and 25% had no change. In conclusion, low grade anemia, neutropenia, and hyperbilirubinemia occurred frequently regardless of the prophylactic regimen, but serious AE were uncommon. Although most AE were typical of ZDV toxicity, the combination of ZDV with lamivudine and nevirapine resulted in an increased frequency of low-grade anemia. Further studies are needed to identify prophylactic regimens with less toxicity for infants born to HIV-infected mothers.
| S-EPMC4441417 | biostudies-literature
Project description:ObjectivesThe goal of this study was to compare the risk of cardiotoxicity with osimertinib versus all other drugs and versus epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) (erlotinib, afatinib, and gefitinib) in the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS), a pharmacovigilance database.BackgroundOsimertinib has been shown to improve outcomes in T790M-positive non-small cell lung cancer patients who progress on EGFR-TKI therapy and in the frontline setting in EGFR mutated non-small cell lung cancer. In pivotal trials, osimertinib was associated with higher rates of cardiotoxicity compared with the control arm.MethodsFAERS was queried for "Cardiac failure," "Electrocardiogram QT-prolonged," "Atrial Fibrillation (AF)," "Myocardial Infarction (MI)," and "Pericardial Effusion" secondary to "Osimertinib," "Erlotinib," "Afatinib," "Gefitinib," and all other drugs from 2016 to 2018. Disproportionality signal analysis was performed by calculating the reporting odds ratio (ROR) with its 95% confidence interval (CI). The ROR was considered significant when the lower limit of the 95% CI was >1.0.ResultsThe ROR (95% CI) for cardiac failure, atrial fibrillation (AF), QT prolongation, myocardial infarction, and pericardial effusion due to osimertinib versus all other drugs in FAERS was 5.4 (4.2 to 7.1), 4.0 (2.8 to 5.8), 11.2 (7.9 to 15.8), 1.6 (0.9 to 2.6), and 8.2 (4.8 to 14), respectively. The ROR (95% CI) for cardiac failure, AF, QT prolongation, myocardial infarction, and pericardial effusion in comparing osimertinib versus other EGFR-TKIs was 2.2 (1.5 to 3.2), 2.1 (1.3 to 3.5), 6.6 (3.4 to 12.8), 1.2 (0.6 to 2.3), and 1.6 (0.8 to 3.3).ConclusionsThe RORs for cardiac failure, AF, and QT prolongation were higher due to osimertinib compared with other TKIs. Electrocardiographic monitoring for QT prolongation and monitoring for signs and symptoms of heart failure should be considered in patients taking osimertinib.
| S-EPMC8352117 | biostudies-literature
Project description:ObjectivesTo compare the effectiveness, reliability, and acceptability of estimating rates of adverse events and rates of preventable adverse events using three methods: cross sectional (data gathered in one day), prospective (data gathered during hospital stay), and retrospective (review of medical records).DesignIndependent assessment of three methods applied to one sample.Setting37 wards in seven hospitals (three public, four private) in southwestern France.Participants778 patients: medical (n = 278), surgical (n = 263), and obstetric (n = 237).Main outcome measuresThe main outcome measures were the proportion of cases (patients with at least one adverse event) identified by each method compared with a reference list of cases confirmed by ward staff and the proportion of preventable cases (patients with at least one preventable adverse event). Secondary outcome measures were inter-rater reliability of screening and identification, perceived workload, and face validity of results.ResultsThe prospective and retrospective methods identified similar numbers of medical and surgical cases (70% and 66% of the total, respectively) but the prospective method identified more preventable cases (64% and 40%, respectively), had good reliability for identification (kappa = 0.83), represented an acceptable workload, and had higher face validity. The cross sectional method showed a large number of false positives and identified none of the most serious adverse events. None of the methods was appropriate for obstetrics.ConclusionThe prospective method of data collection may be more appropriate for epidemiological studies that aim to convince clinical teams that their errors contribute significantly to adverse events, to study organisational and human factors, and to assess the impact of risk reduction programmes.
| S-EPMC318484 | biostudies-literature