Critical Adverse Events Research Articles

Audit of critical adverse events associated with opioid administration in postoperative patients managed by an acute pain service

Van der Elst, S.; Steyaert, A.; Scholtès, J. -L.; France, M. -N.; Lavand'homme, P. Author Information

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UNLABELLED What's known on the subject? and What does the study add? Adjuvant intravesical BCG therapy is the most effective regimen for non-muscle-invasive bladder cancer. Previously, patients who experienced recurrences after BCG therapy tended to be lumped together as patients with 'BCG failure', but BCG failure was defined inconsistently in each study and several studies indicated that patients with a particular pattern of BCG failure had a worse prognosis. We divided patients with BCG failure into four groups, which were based mainly on the responsiveness to BCG therapy and duration until tumour recurrence. Patients in the BCG-refractory group, in particular, had a higher risk for subsequent stage progression and disease-specific death over a long duration compared with patients in the other BCG-failure groups. As the definitions of BCG failure used to date have been decidedly heterogeneous, we recommend that standardized treatment decisions, protocols and recommendations be established according to individual BCG failure patterns. OBJECTIVE To investigate the differences in the clinical features and subsequent stage progression and disease-specific survival among patients with Bacillus Calmette-Guerin (BCG) failure, after dividing these patients into BCG-refractory, -resistant, -relapsing, and -intolerant groups. PATIENTS AND METHODS We identified 173 patients with initial BCG failure from 521 patients who had undergone induction BCG therapy for non-muscle-invasive bladder cancer, excluding CIS, between 1987 and 2009. Patients were stratified into four BCG-failure groups, and each prognostic outcome was evaluated. RESULTS Median follow-up period from initial BCG failure was 4.7 years. A total of 42 patients (24.3%) were stratified into the BCG-refractory, three (1.7%) into the BCG-resistant, 106 (61.3%) into the BCG-relapsing, and 22 (12.7%) into the BCG-intolerant group. Twenty-four patients (13.9%) experienced stage progression during follow-up. Multivariate analysis showed that pathological G3 at BCG failure (P = 0.014; risk ratio 2.84) and BCG-refractory (P < 0.001; risk ratio 4.68) were independent predictors for stage progression. The 10-year progression-free survival rates were 53.2%, 91.1% and 93.8% in the BCG-refractory, BCG-relapsing and BCG-intolerant groups, respectively. The stage progression rate was higher in the BCG-refractory than in the BCG-relapsing (P < 0.001) and BCG-intolerant (P = 0.007) groups. Similarly, the 10-year disease-specific survival rate in the BCG-refractory group was significantly worse than those in the other BCG failure groups (P < 0.001). CONCLUSIONS Stratification of BCG failure into the above-mentioned four groups can identify patients with BCG-failure in terms of their prognosis. The potential risk for critical adverse events was higher in the BCG-refractory group than in the other BCG-failure groups, despite the fact that patients in each group all underwent induction BCG therapy, therefore, treatment decisions, protocols and recommendations should be established based on each individual BCG-failure pattern.

Prognostic significance of Bacillus Calmette‐Guérin failure classification in non‐muscle‐invasive bladder cancer

What's known on the subject? and What does the study add? Adjuvant intravesical BCG therapy is the most effective regimen for non-muscle-invasive bladder cancer. Previously, patients who experienced recurrences after BCG therapy tended to be lumped together as patients with 'BCG failure', but BCG failure was defined inconsistently in each study and several studies indicated that patients with a particular pattern of BCG failure had a worse prognosis. We divided patients with BCG failure into four groups, which were based mainly on the responsiveness to BCG therapy and duration until tumour recurrence. Patients in the BCG-refractory group, in particular, had a higher risk for subsequent stage progression and disease-specific death over a long duration compared with patients in the other BCG-failure groups. As the definitions of BCG failure used to date have been decidedly heterogeneous, we recommend that standardized treatment decisions, protocols and recommendations be established according to individual BCG failure patterns. To investigate the differences in the clinical features and subsequent stage progression and disease-specific survival among patients with Bacillus Calmette-Guérin (BCG) failure, after dividing these patients into BCG-refractory, -resistant, -relapsing, and -intolerant groups. We identified 173 patients with initial BCG failure from 521 patients who had undergone induction BCG therapy for non-muscle-invasive bladder cancer, excluding CIS, between 1987 and 2009. Patients were stratified into four BCG-failure groups, and each prognostic outcome was evaluated. Median follow-up period from initial BCG failure was 4.7 years. A total of 42 patients (24.3%) were stratified into the BCG-refractory, three (1.7%) into the BCG-resistant, 106 (61.3%) into the BCG-relapsing, and 22 (12.7%) into the BCG-intolerant group. Twenty-four patients (13.9%) experienced stage progression during follow-up. Multivariate analysis showed that pathological G3 at BCG failure (P = 0.014; risk ratio 2.84) and BCG-refractory (P < 0.001; risk ratio 4.68) were independent predictors for stage progression. The 10-year progression-free survival rates were 53.2%, 91.1% and 93.8% in the BCG-refractory, BCG-relapsing and BCG-intolerant groups, respectively. The stage progression rate was higher in the BCG-refractory than in the BCG-relapsing (P < 0.001) and BCG-intolerant (P = 0.007) groups. Similarly, the 10-year disease-specific survival rate in the BCG-refractory group was significantly worse than those in the other BCG failure groups (P < 0.001). Stratification of BCG failure into the above-mentioned four groups can identify patients with BCG-failure in terms of their prognosis. The potential risk for critical adverse events was higher in the BCG-refractory group than in the other BCG-failure groups, despite the fact that patients in each group all underwent induction BCG therapy, therefore, treatment decisions, protocols and recommendations should be established based on each individual BCG-failure pattern.

Contributing Factors Associated With Impulsivity-Related Falls in Hospitalized, Older Adults

Impulsivity-related falls (IRFs) sustained by hospitalized, older adults can lead to critical adverse events. The purpose of this study was to determine whether 7 common fall risk factors contributed to the occurrence of IRF in hospitalized, older adults. This study found that 31% of falls were classified as IRF. Logistic regression indicated that inattention and mobility were contributors to IRF. Early identification of these 2 risk factors could improve identification of potential IRFs and reduce fall rates.

Randomized Clinical Trial Comparing Intravenous Antimicrobial Prophylaxis Alone with Oral and Intravenous Antimicrobial Prophylaxis for the Prevention of a Surgical Site Infection in Colorectal Cancer Surgery

The use of preoperative oral antibiotics during preparation for elective colorectal surgery remains controversial. This was a prospective randomized clinical trial to compare the efficacy of intravenous antimicrobial prophylaxis alone with combined oral and intravenous antimicrobial prophylaxis for surgical site infection (SSI) in patients undergoing elective colorectal surgery. Five hundred patients were enrolled in this study. Of these, 491 were randomly assigned to receive either intravenous antimicrobial prophylaxis or combined oral and intravenous antimicrobial prophylaxis. The primary outcome was the incidence of SSI within 6 weeks of elective colorectal surgery. The incidence of SSI was similar in the two treatment groups: intravenous alone, 10.7%; and oral and intravenous, 7.0% (difference 3.7%; 95% confidence interval -4.8% to 5.6%). No critical adverse events were reported. The addition of oral antibiotics to intravenous antimicrobial prophylaxis showed no advantage in the prevention of SSI.

Pediatric anesthesia in the nonoperating room setting

The paper will review the few studies that have been published recently on nonoperating room pediatric anesthesia/sedation. These studies target gaps in our understanding of critical factors associated with the provision of nonoperating room anesthesia safety and reliability in children. More objective data regarding the safety and reliability of this practice have become available. Video can accurately capture a child's state and allow comparison of different sedation techniques more objectively than is possible with available literature. The use of standard simulated events allows rescue performance in actual care systems to be tested for their ability to manage a rare, but critical respiratory depression episode. Preliminary findings from a large multicenter study from the Pediatric Procedural Sedation Research Consortium suggests critical adverse events are rare (one cardiac arrest in over 30,000 sedation encounters), but that potentially critical events occur commonly (one in 400 procedures was associated with stridor, laryngospasm, wheezing or apnea). Research into the critical factors that impact safety and reliability in the performance of nonoperating room anesthesia for children is providing objective observational techniques along with large outcomes databases that should enable targeted improvements in the safety and reliability of this growing practice.

Transport of critically ill children in a resource-limited setting.

To audit paediatric intensive care unit (PICU) transfer activity and transfer-related adverse events in a resource-limited setting. Twenty-two bed regional PICU of a university children's hospital in Cape Town, South Africa. Prospective 1-year audit of all children transferred directly from other hospitals. Data were collected for patient demographics, diagnostic category, referring hospital, transferring personnel, mode of transport, and technical, clinical, and critical adverse events. Data are median (interquartile range) or percentages. The transfers of 202 children, median age 2.8 months (1.1-14), median weight 3.5 kg (2.5-8.1) were analysed. Most transfers were performed by paramedic personnel (82%) and via road ambulance (76%). One or more technical adverse events occurred in 36%, clinical adverse events in 27%, and critical adverse events in 9% of children. Retrievals by intensive care staff (10%), all from rural hospitals, had a lower incidence of technical adverse events (0%). Children transferred from non-academic hospitals within the metropolitan area had the highest incidence of technical (44%), clinical (39%), and critical (17%) adverse events. Crude mortality was 17% ( n=34). Technical adverse events were not associated with mortality. Non-survivors were more likely to develop shock (32%) or hypoxia (26%) during transfer than survivors (10% and 11%, respectively). There is a high incidence of transfer-related adverse events, most commonly in transfers from non-academic metropolitan hospitals. Further studies are needed to assess the impact of regional paediatric life support training or a specialised retrieval team on clinical adverse events and mortality.

Error and safety in primary care: no clear boundaries.

This paper examines the notions of adverse events, error, critical incidents and safety from the specific viewpoint of primary care. We conclude that each term can be defined, but existing work which we reviewed uses many of the terms interchangeably. We recognise that trying to access medical error objectively within primary care can be problematic. Regardless of definitions, reflection on critical incidents, adverse events or other notable events is important, but requires time and resources to be conducted effectively.