Identifying adverse events: reflections on an imperfect gold standard after 20 years of patient safety research

Shojania, Kaveh G; Mheen, Perla J Marang-van de

doi:10.1136/bmjqs-2019-009731

Cited by 33 publications

(32 citation statements)

References 49 publications

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“…Similarly, this study's primary outcomes (overall AEs and preventable AEs) even when subcategorised are likely to be simplistic, heterogeneous and may not detect differences in patient safety interventions over time as smaller targeted improvements may be statistically neutralised when calculated using such composite measures. 50 Traditionally, changes in national AE prevalence rates have been measured by retrospective chart review studies. 9 51-53 Such uncontrolled before and after studies have been criticised for overestimating Figure 2 Classification of preventable adverse events thought to be targeted by the national programmes and guidelines comparing 2009 to 2015.…”

Section: Limitationsmentioning

confidence: 99%

“…54 This approach may not capture nuanced changes, which more rigorously controlled designs (eg, a prospective time-series design) may achieve. Such an approach should aim to capture established measures for determining specific patient safety outcomes as suggested by Shojania et al 50 (eg, prospective laboratory-based surveillance of hospital-associated infections 55 and a prospective registry for monitoring surgical outcomes 56 ).…”

Section: Limitationsmentioning

confidence: 99%

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The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

et al. 2021

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ObjectivesTo quantify the prevalence and nature of adverse events in acute Irish hospitals in 2015 and to assess the impact of the National Clinical Programmes and the National Clinical Guidelines on the prevalence of adverse events by comparing these results with the previously published data from 2009.Design and methodsA retrospective chart review of 1605 admissions to eight Irish hospitals in 2015, using identical methods to those used in 2009.ResultsThe percentage of admissions associated with one or more adverse events was unchanged (p=0.48) at 14% (95% CI=10.4% to 18.4%) in 2015 compared with 12.2% (95% CI=9.5% to 15.5%) in 2009. Similarly, the prevalence of preventable adverse events was unchanged (p=0.3) at 7.4% (95% CI=5.3% to 10.5%) in 2015 compared with 9.1% (95% CI=6.9% to 11.9%) in 2009. The incidence densities of preventable adverse events were 5.6 adverse events per 100 admissions (95% CI=3.4 to 8.0) in 2015 and 7.7 adverse events per 100 admissions (95% CI=5.8 to 9.6) in 2009 (p=0.23). However, the percentage of preventable adverse events due to hospital-associated infections decreased to 22.2% (95% CI=15.2% to 31.1%) in 2015 from 33.1% (95% CI=25.6% to 41.6%) in 2009 (p=0.01).ConclusionAdverse event rates remained stable between 2009 and 2015. The percentage of preventable adverse events related to hospital-associated infection decreased, which may represent a positive impact of the related national programmes and guidelines.

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Section: Limitationsmentioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

et al. 2021

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“…The prevalence of PSIs in the record reviews from our review is near the midpoint of the range for hospital care—despite the fact that hospitalized patients experience many more clinical encounters as compared to a patient in prehospital care. Establishing an estimate of the overall prevalence of PSIs in prehospital care is useful for highlighting the issue of patient safety and justifying resource allocation and additional research into safety [ 49 ]. However, such a broad metric of past harm fails to detect important components of safety performance and fails to provide a complete and comprehensive understanding of an organization’s safety.…”

Section: Discussionmentioning

confidence: 99%

How safe is prehospital care? A systematic review

O’Connor

O’Malley

Lambe

et al. 2021

International Journal for Quality in Health Care

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Background As compared to other domains of healthcare, little is known about patient safety incidents (PSIs) in prehospital care. The aims of our systematic review were to identify: how the prevalence and level of harm associated with PSIs in prehospital care are assessed; the frequency of PSIs in prehospital care; and the harm associated with PSIs in prehospital care. Method Searches were conducted of Medline, Web of Science, PsycInfo, CINAHL, Academic Search Complete, and the grey literature. Reference lists of included studies and existing related reviews were also screened. English-language, peer-reviewed studies reporting data on number/frequency of PSIs and/or harm associated with PSIs were included. Two researchers independently extracted data from studies and carried out a critical appraisal using the Quality Assessment Tool for Studies with Diverse Designs (QATSDD). Results Of the 22 included papers, 16 (73%) used data from record reviews, and six (27%) from incident reports. The frequency of PSIs in prehospital care was found to be a median of 5.9 per 100 records/transports/patients. A higher prevalence of PSIs was identified within studies that used record review data (9.9 per 100 records/transports/patients) as compared to incident reports (0.3 per records/transports/patients). Across the studies that reported harm, a median of 15.6% of PSIs were found to result in harm. Studies that utilised record review data reported that a median of 6.5% of the PSIs resulted in harm. For data from incident reporting systems, a median of 54.6% of incidents were associated with harm. The mean QATSDD score was 25.6 (SD=4.1, range=16-34). Conclusions This systematic review gives direction as to how to advance methods for identifying PSIs in prehospital care and assessing the extent to which patients are harmed.

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“…[22][23][24] Critics of the record review method point to this and object to low rates of reproducibility. 25,26 However, the records review method is comprehensive and provides unique insight into the patient experience of medication-related harm. 9 Reviewer training and feedback was used to improve reviewer concordance.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

Medication-related harm in New Zealand general practice: a retrospective records review

et al. 2021

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Background: The extent of medication-related harm in general practice is unknown. Aim: To identify and describe all medication-related harm in electronic general practice records. Design and Setting: Retrospective cohort records review study in 44 randomly selected New Zealand general practices for the three years 2011-2013. Methods: Eight general practitioners reviewed 9076 randomly selected patient records. Medication-related harms were identified when the causal agent was prescribed in general practice. Harms were coded by type, preventability, and severity. The number and proportion of patients who experienced medication-related harm was calculated. Weighted logistic regression was used to identify factors associated with harm. Results 976/9076 study patients (10.8%) experienced 1,762 medication-related harms over three years. After weighting, the incidence rate of all medication-related harms was 73.9 harms per 1000 patient-years, and the incidence of preventable or potentially preventable medication-related harms was 15.6 per 1000 patient-years. Most harms were minor (1390/1762, 78.9%), but one in five harms were moderate or severe (373/1762, 21.1%); three patients died. Eighteen study patients were hospitalised; after weighting this correlates to a hospitalisation rate of 1.1 per 1000 patient-years. Increasing age, number of consultations, and number of medications were associated with increased risk of medication-related harm. Cardiovascular medications, antineoplastic and immunomodulatory agents, and anticoagulants caused most harm by frequency and severity. Conclusion Medication-related harm in general practice is common. This study adds to the evidence about the risk posed by medication in the real world. Findings can be used to inform decision-making in general practice.

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Identifying adverse events: reflections on an imperfect gold standard after 20 years of patient safety research

Cited by 33 publications

References 49 publications

The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

The Irish National Adverse Event Study-2 (INAES-2): longitudinal trends in adverse event rates in the Irish healthcare system

How safe is prehospital care? A systematic review

Medication-related harm in New Zealand general practice: a retrospective records review

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