Objectives To 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). Design Independent assessment of three methods applied to one sample. Setting 37 wards in seven hospitals (three public, four private) in southwestern France. Participants 778 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. Results The 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 ( = 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. Conclusion The 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.
Objectives: To estimate the incidence of adverse events in medical and surgical activity in public and private hospitals, and to assess the clinical situation of patients and the active errors. Design: Prospective assessment of adverse events by external senior nursing and doctor investigators with ward staff. Setting: Random three-stage stratified cluster sampling of stays or fractions of stay in a 7-day observation period for each ward. Participants: 8754 patients observed in 292 wards in 71 hospitals, over 35 234 hospitalisation days. Main outcome measures: Number of adverse events in relation to number of days of hospitalisation. Results: The incidence density of adverse events was 6.6 per 1000 days of hospitalisation (95% CI 5.7 to 7.5), of which 35% were preventable. Invasive procedures were the source of half the adverse events, of which 20% were preventable. Adverse events related to the psychological sphere and pain were mostly considered as preventable. Ward staff found it difficult to assess the role of care management in the occurrence of adverse events: 41% of adverse events were expected because of the disease itself, and could have occurred in the absence of the related medical management. Conclusion: At the national level in France, every year 120 000-190 000 adverse events during hospitalisation can be considered as preventable. Areas such as perioperative period and geriatric units should receive closer attention. As adverse events occurred more commonly in vulnerable patients, who are not specifically targeted by clinical guidance, practising evidence-based medicine is not likely to prevent all cases. Therefore clinical risk management should prioritise empowerment of local staff, provision of favourable conditions within the organisation, and staff training based on simple tools appropriate for wardlevel identification and analysis of adverse events.
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