Contributory factors in surgical incidents as delineated by a confidential reporting system

Background Confidential reporting systems play a key role in capturing information about adverse surgical events. However, the value of these systems is limited if the reports that are generated are not subjected to systematic analysis. The aim of this study was to provide the first systematic analysis of data from a novel surgical confidential reporting system to delineate contributory factors in surgical incidents and document lessons that can be learned. Methods One-hundred and forty-five patient safety incidents submitted to the UK Confidential Reporting System for Surgery over a 10-year period were analysed using an adapted version of the empirically-grounded Yorkshire Contributory Factors Framework. Results The most common factors identified as contributing to reported surgical incidents were cognitive limitations (30.09%), communication failures (16.11%) and a lack of adherence to established policies and procedures (8.81%). The analysis also revealed that adverse events were only rarely related to an isolated, single factor (20.71%) – with the majority of cases involving multiple contributory factors (79.29% of all cases had more than one contributory factor). Examination of active failures – those closest in time and space to the adverse event – pointed to frequent coupling with latent, systems-related contributory factors. Conclusions Specific patterns of errors often underlie surgical adverse events and may therefore be amenable to targeted intervention, including particular forms of training. The findings in this paper confirm the view that surgical errors tend to be multi-factorial in nature, which also necessitates a multi-disciplinary and system-wide approach to bringing about improvements.

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An analysis of general practitioners’ perspectives on patient safety incidents using critical incident technique interviews

Family Practice ◽

10.1093/fampra/cmz012 ◽

2019 ◽

Vol 36 (6) ◽

pp. 736-742 ◽

Cited By ~ 3

Author(s):

Ciara Curran ◽

Sinéad Lydon ◽

Maureen E Kelly ◽

Andrew W Murphy ◽

Paul O’Connor

Keyword(s):

Patient Safety ◽

General Practitioners ◽

Critical Incident ◽

Improve Patient Safety ◽

Critical Incident Technique ◽

Contributory Factor ◽

Contributory Factors ◽

Safety Incident ◽

The Impact ◽

Patient Safety Incidents

Abstract Background General practitioners report difficulty in knowing how to improve patient safety. Objectives To analyse general practitioners’ perspectives of contributing factors to patient safety incidents by collecting accounts of incidents, identifying the contributory factors to these incidents, assessing the impact and likelihood of occurrence of these incidents and examining whether certain categories of contributory factors were associated with the occurrence of high-risk incidents. Methods Critical incident technique interviews were carried out with 30 general practitioners in Ireland about a patient safety incident they had experienced. The Yorkshire Contributory Factors Framework was used to classify the contributory factors to incidents. Seven subject matter experts rated the impact and likelihood of occurrence of each incident. Results A total of 26 interviews were analysed. Almost two-thirds of the patient safety incidents were rated as having a major-to-extreme impact on the patient, and over a third were judged as having at least a bimonthly likelihood of occurrence. The most commonly described active failures were ‘Medication Error’ (34.6%) and ‘Diagnostic Error’ (30.8%). ‘Situational Domain’ was identified as a contributory domain in all patient safety incidents. ‘Communication’ breakdown at both practice and other healthcare-provider interfaces (69.2%) was also a commonly cited contributory factor. There were no significant differences in the levels of risk associated with the contributory factors. Conclusions Critical incident technique interviews support the identification of contributory factors to patient safety incidents. There is a need to explore the use of the resulting data for quality and safety improvement in general practice.

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Serious Adverse Events and Fatal Outcomes Following COVID-19 Vaccination in the UK: Lessons for Other Countries

The International Journal of Community and Social Development ◽

10.1177/25166026211053485 ◽

2021 ◽

pp. 251660262110534

Author(s):

Mrigesh Bhatia ◽

Venkata R. P. Putcha ◽

Laxmi Kant Dwivedi ◽

D. P. Singh

Keyword(s):

Adverse Events ◽

Reporting System ◽

Fatal Outcome ◽

Efficacy And Safety ◽

Yellow Card ◽

Serious Adverse Events ◽

Successful Model ◽

The World ◽

The Uk ◽

Card Reporting

Vaccines have taken the centre stage in the fight against COVID-19 pandemic, and in reducing hospitalisation and associated mortality. Countries around the world are heavily dependent on the successful rollout of their vaccination programmes to open up the societies and re-start their economies. However, the success of any vaccine programme, to a large extent, depends upon the efficacy and safety of the vaccines. Given that UK has been way ahead in vaccinating its population, is considered a successful model compared to other countries in Europe and elsewhere and has a yellow card reporting system for adverse events, we use UK as an example to understand the side effects and fatal outcomes following vaccinations. Our results show that AstraZeneca seems to be underperforming in terms of overall reporting of minor adverse events, serious incidents and fatal outcomes following vaccination. The risk of serious anaphylactic reaction and fatal outcome was 1.36 and 1.17 times more in case of AstraZeneca vaccine when compared with Pfizer BioNTech vaccine. The analysis has implications for vaccine policies and programmes both at nation-state and global levels.

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Adverse Events Reporting System as Experienced by Critical-Care Nurses in KwaZulu-Natal, South Africa

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/2456 ◽

2018 ◽

Vol 20 (1) ◽

Author(s):

Thusile Mabel Gqaleni ◽

Busisiwe Rosemary Bhengu

Keyword(s):

South Africa ◽

Critical Care ◽

Adverse Events ◽

Patient Care ◽

Family Involvement ◽

Reporting System ◽

Legal Framework ◽

Critical Care Nurses ◽

Kwazulu Natal ◽

Life Threatening

Critically ill patients admitted to critical-care units (CCUs) might have life-threatening or potentially life-threatening problems. Adverse events (AEs) occur frequently in CCUs, resulting in compromised quality of patient care. This study explores the experiences of critical-care nurses (CCNs) in relation to how the reported AEs were analysed and handled in CCUs. The study was conducted in the CCUs of five purposively selected hospitals in KwaZulu-Natal, South Africa. A descriptive qualitative design was used to obtain data through in-depth interviews from a purposive sample of five unit managers working in the CCUs to provide a deeper meaning of their experiences. This study was a part of a bigger study using a mixed-methods approach. The recorded qualitative data were analysed using Tesch’s content analysis. The main categories of information that emerged during the data analysis were (i) the existence of an AE reporting system, (ii) the occurrence of AEs, (iii) the promotion of and barriers to AE reporting, and (iv) the handling of AEs. The findings demonstrated that there were major gaps that affected the maximum utilisation of the reporting system. In addition, even though the system existed in other institutions, it was not utilised at all, hence affecting quality patient care. The following are recommended: (1) a non-punitive and non-confrontational system should be promoted, and (2) an organisational culture should be encouraged where support structures are formed within institutions, which consist of a legal framework, patient and family involvement, effective AE feedback, and education and training of staff.

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Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Current Drug Safety ◽

10.2174/1574886313666181026100000 ◽

2019 ◽

Vol 14 (1) ◽

pp. 21-26 ◽

Cited By ~ 2

Author(s):

Viswam Subeesh ◽

Eswaran Maheswari ◽

Hemendra Singh ◽

Thomas Elsa Beulah ◽

Ann Mary Swaroop

Keyword(s):

Data Mining ◽

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Disproportionality Analysis ◽

Positive Signal ◽

Data Mining Algorithms ◽

Mining Algorithms

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

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The Association between Ranitidine Use and Gastrointestinal Cancers

Cancers ◽

10.3390/cancers13010024 ◽

2020 ◽

Vol 13 (1) ◽

pp. 24

Author(s):

Gerald McGwin

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Large Body ◽

Science Research ◽

Gastrointestinal System ◽

Gastrointestinal Cancers ◽

H2 Antagonists ◽

Study Results ◽

Risk Of Cancer

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19–4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.

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Systematic analysis of safety profile for darunavir and its boosted agents using data mining in the FDA Adverse Event Reporting System database

Scientific Reports ◽

10.1038/s41598-021-91549-w ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Xiaojiang Tian ◽

Yao Yao ◽

Guanglin He ◽

Yuntao Jia ◽

Kejing Wang ◽

...

Keyword(s):

Data Mining ◽

Adverse Event ◽

Reporting System ◽

Proportional Reporting Ratio ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Reporting Odds Ratio ◽

Systematic Analysis ◽

Event Reporting ◽

Exfoliative Dermatitis

AbstractThis current investigation was aimed to generate signals for adverse events (AEs) of darunavir-containing agents by data mining using the US Food and Drug Administration Adverse Event Reporting System (FAERS). All AE reports for darunavir, darunavir/ritonavir, or darunavir/cobicistat between July 2006 and December 2019 were identified. The reporting Odds Ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN) were used to detect the risk signals. A suspicious signal was generated only if the results of the three algorithms were all positive. A total of 10,756 reports were identified commonly observed in hepatobiliary, endocrine, cardiovascular, musculoskeletal, gastrointestinal, metabolic, and nutrition system. 40 suspicious signals were generated, and therein 20 signals were not included in the label. Severe high signals (i.e. progressive extraocular muscle paralysis, acute pancreatitis, exfoliative dermatitis, acquired lipodystrophy and mitochondrial toxicity) were identified. In pregnant women, umbilical cord abnormality, fetal growth restriction, low birth weight, stillbirth, premature rupture of membranes, premature birth and spontaneous abortion showed positive signals. Darunavir and its boosted agents induced AEs in various organs/tissues, and were shown to be possibly associated with multiple adverse pregnant conditions. This study highlighted some novel and severe AEs of darunavir which need to be monitored prospectively.

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Adverse events following adenovirus type 4 and type 7 vaccine, live, oral in the Vaccine Adverse Event Reporting System (VAERS), United States, October 2011–July 2018

Vaccine ◽

10.1016/j.vaccine.2019.08.087 ◽

2019 ◽

Vol 37 (44) ◽

pp. 6760-6767 ◽

Cited By ~ 2

Author(s):

Michael M. McNeil ◽

Iwona Paradowska-Stankiewicz ◽

Elaine R. Miller ◽

Paige L. Marquez ◽

Srihari Seshadri ◽

...

Keyword(s):

United States ◽

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adenovirus Type ◽

Adverse Event Reporting ◽

Event Reporting

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Comparison of Bone Mineral Density among Residents of a Mountain Village and a Fishing Village in Japan

Journal of Orthopaedic Surgery ◽

10.1177/230949900301100103 ◽

2003 ◽

Vol 11 (1) ◽

pp. 6-9 ◽

Cited By ~ 5

Author(s):

A Sudo ◽

N Miyamoto ◽

Y Kasai ◽

T Yamakawa ◽

A Uchida

Keyword(s):

Bone Mineral Density ◽

Bone Mineral ◽

Metacarpal Bone ◽

Analysis Of Covariance ◽

Contributory Factor ◽

Mineral Density ◽

Fishing Village ◽

Contributory Factors ◽

Mountain Village ◽

Measure Bone Mineral Density

Objective. To compare the bone mineral density of residents of a mountain village with that of residents of a fishing village in Mie Prefecture, Japan. Methods. Microdensitometry was used to measure bone mineral density of the second metacarpal bone of 202 participants living in a mountain village and of 852 participants living in a fishing village to identify contributory factors for osteoporosis. The participants were interviewed using a questionnaire on alcohol consumption, fish intake, milk intake, and daily activity. Results. Analysis of covariance revealed that bone mineral density was significantly higher among the participants living in a fishing village than among those living in a mountain village (2.5–2.9 versus 2.1–2.7 mmAl; p<0.001). A higher proportion of women in the fishing village than of those in the mountain village consumed alcohol (17% versus 10%; p<0.05). Conclusion. Nutrition may be a contributory factor to the lower incidence of osteoporosis among residents of the fishing village compared with those of the mountain village.

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