Improving the safety climate in hospitals by a vignette-based analysis of adverse events: a cluster randomised study.

OBJECTIVE: To assess the impact of a vignette-based analysis of adverse events (AEs) on the safety climate (SC) of care units. DESIGN: Prospective, open, cluster (a unit) randomised controlled trial. SETTING: Eighteen acute care units of seven hospitals in France. PARTICIPANTS: Healthcare providers who worked in the units. INTERVENTION: Vignette-based analyses of AEs were conducted with unit's providers once per month for six consecutive months. The AEs were real cases that occurred in other hospitals. The hospital risk manager conducted each analysis as follows: analysis of the immediate and root causes of the AE; assessment of the care unit's vulnerabilities and existing barriers in the occurrence of an identical AE and search for solutions. MAIN OUTCOME MEASURE: SC was measured using the French version of the Hospital Survey on Patient Safety Culture questionnaire. The primary outcome was the difference in the 'Organisational learning and continuous improvement' dimension score, from before to after the analyses. RESULTS: Median participation rate in the analyses was 20% (range: 7-45%). Before intervention, the response rate to the SC survey was 80% (n = 210) in the intervention group and 73% (n = 191) in the control group. After intervention, it was 59% (n = 141) and 63% (n = 148), respectively. The dimension score evolved differently for the groups from before to after intervention (intervention: +10.2 points ±8.8; control: -3.0 points ±8.5, P = 0.04). Side effects were not measured. CONCLUSIONS: Vignette-based analysis was associated with the improvement of the perception of participants regarding their institution's capacity for organisational learning and continuous improvement.

Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

BACKGROUND: We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. METHODS: A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P < 0.05. RESULTS: One hundred comparative evaluations of pulmonary auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P < 0.0001). Compared with Littmann Cardiology III, auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (ß = 0.9 [95% confidence interval, 0.5-1.3]). CONCLUSIONS: An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

[Specificities of war surgery, and capacities of the military health service]. / Spécificité de la chirurgie de guerre et capacités du service de santé des armées.

In view of the recent evolution of military conflicts, particularly in the Afghan theater, and the conditions in which wounded warriors are managed in the field prior to hospitalization, the authors examine the technical specificities of medical teams, based on studies of avoidable mortality. War surgery has become a separate specialty, following the disappearance in France of the general surgical specialty, of which it was the military coun-terpart. The authors stress the role of hemorrhaging and its treatment, based on three strategies: damage control resuscitation, blood transfusion, and early evacuation within the "golden hour ". The French Armed Forces Health Service, in a new strategic plan, is refocusing its activity on war traumatology, through better education and training of medical-surgical teams and by opening up its scholarship structures to the French civilian public health service sector.

Anaphylaxis during anesthesia in France: an 8-year national survey.

BACKGROUND: More attention should be paid to rare serious adverse events such as anaphylaxis to increase the safety of anesthesia. OBJECTIVE: To report the results of an 8-year survey of anaphylaxis during anesthesia in France. METHODS: Data from patients who experienced anaphylaxis between January 1, 1997, and December 31, 2004, were analyzed. Estimated incidences were obtained by combining this database with data from the French pharmacovigilance system by using a capture-recapture method. The number of patients exposed to the offending agents was obtained from data collected during the national survey of anesthesia practice. RESULTS: A total of 2516 patients was included. A diagnosis of IgE-mediated reaction was established in 1816 cases (72.18%). The most common causes were neuromuscular blocking agents ([NMBAs]; n = 1067; 58.08%), latex (n = 361; 19.65%), and antibiotics (n = 236; 12.85%). The median annual incidence per million procedures was higher for females 154.9 (5th-95th percentile, 117.2-193.1) than for males 55.4 (5th-95th percentile, 42.0-68.0). It reached 250.9 (5th-95th percentile, 189.8-312.9) for women in cases of allergic reactions to NMBAs. In children, a diagnosis of IgE-mediated reactions was obtained in 122 cases (45.9%). The most common causes were latex (n = 51; 41.8%), NMBAs (n = 39; 31.97%), and antibiotics (n = 11; 9.02%). In contrast with adults, no female predominance was observed. CONCLUSION: The incidence of allergic reactions during anesthesia, estimated on a national basis, is higher than previously estimated. These results should be taken into account in the evaluation of the benefit-to-risk ratio of the various anesthetic techniques in individuals. The similar incidence of reactions according to sex before adolescence suggests a role for sex hormones in the increase of anaphylaxis observed in women.

[The nurse, a key player in transfusion safety]. / L'infirmière, acteur clé de la sécurité transfusionnelle.

In the chain of transfusion safety, the nurse is the last line of defence in the battery of controls to avoid transfusion errors. The final pre-transfusion test carried out at the patient's bedside is a meticulous procedure. It involves cross-referencing documents, checking the identity of the patient and determining the ABO blood group through an agglutination test.

Adverse events in medicine: easy to count, complicated to understand, and complex to prevent.

The performance of patient safety initiatives has not met expected targets for reasons that are gradually being understood. They have been too hospital-centered and too process- and "silo"-driven in their search for the causes of adverse events (AEs). Information technology could help overcome many obstacles, but only if the tools developed are based on a relevant safety model. We have applied the distinction between easy, complicated, and complex problems and strategies in healthcare to changes that need to be made in the detection and analysis of AEs. We propose a triple shift: (i) adopting an outcome-driven rather than a process-driven policy when defining and counting AEs (relatively easy), (ii) applying a patient- and not silo-driven approach and extending the timeframe when analyzing AEs (more difficult), and (iii) taking a systemic view of all care delivered to a patient during their life-span in order to erect barriers against the risks identified (highly complex).

Impact of an Original Methodological Tool on the Identification of Corrective and Preventive Actions After Root Cause Analysis of Adverse Events in Health Care Facilities: Results of a Randomized Controlled Trial.

OBJECTIVE: The aim of the study was to assess the effectiveness of a new methodological tool for the identification of corrective and preventive actions (CAPAs) after root cause analysis of health care-related adverse events. METHODS: From January to June 2010, we conducted a randomized controlled trial involving risk managers from 111 health care facilities of the Aquitaine Regional Center for Quality and Safety in Health Care (France). Fifty-six risk managers, randomly assigned to two groups (intervention and control), identified CAPAs in response to two sequentially presented adverse event scenarios. For the baseline measure, both groups used their usual adverse event management tools to identify CAPAs in each scenario. For the experimental measure, the control group continued using their usual tools, whereas the intervention group used a new tool involving a systemic approach for CAPA identification. The main outcome measure was the number of CAPAs the participants identified that matched a criterion standard established by eight experts. RESULTS: Baseline mean number of identified CAPAs did not differ between the two groups (P = 0.83). For the experimental measure, significantly more CAPAs (P = 0.001) were identified by the intervention group (mean [SD] = 4.6 [1.7]) than by the control group (mean [SD] = 2.8 [1.2]). CONCLUSIONS: For the two scenarios tested, more relevant CAPAs were identified with the new tool than with usual tools. Further research is needed to assess the effectiveness of the new tool for other types of adverse events and its impact on patient safety.

Quality of postoperative care after major orthopedic surgery is correlated with both long-term cardiovascular outcome and troponin Ic elevation.

BACKGROUND: The aim of this study performed in patients undergoing major orthopedic surgery was to assess the impact of changes in practice on both the incidence of postoperative myocardial ischemia (PMI) detected by serial measurements of troponin Ic and long-term cardiac outcome. METHODS: During a 3-yr period, troponin Ic was measured on the first 3 days after major orthopedic surgery in a multidisciplinary hospital. After 16 months of study, postoperative care was improved. Cardiac death, myocardial infarction, and cardiac failure were considered major adverse cardiac events and were recorded during the hospital stay and the first postoperative year. The incidences of PMI and major adverse cardiac events were used as result indicators for quality of care and compared before (P1) and after (P2) quality enhancement. RESULTS: Three hundred seventy-eight surgical procedures were included (P1, 123; P2, 255). Incidences of PMI and major adverse cardiac events were 8.9 versus 3.9% (P=0.04) and 8.1 versus 1.9% (P=0.004) for P1 and P2, respectively. Using a multivariate Cox regression analysis adjusted for baseline data, independent factors associated with the occurrence of a major adverse cardiac event were phase P1 (hazard ratio=4.5; 97.8% confidence interval [CI], 1.1-17.4) and PMI (Hazard ratio=6.4; 97.8% CI, 1.6-26.4). CONCLUSIONS: Our postoperative care policy after major orthopedic surgery strongly correlated with both short-term cardiac outcome (i.e., PMI with troponin Ic release) and long-term cardiac outcome. Thus, in a given surgical population, variation of incidence of troponin Ic elevations could be used as a result indicator for postoperative care policy.

[The pre-anesthetic consultation]. / Un progrés important imposé par la loi. La consultation d'anesthésie.

The French law of December 4, 1994 has made the preanaesthetic consultation a mandatory part of the perioperative process. This consultation should be performed several days before surgery when the procedure is scheduled. This law has established that every patient undergoing surgery or an invasive procedure requiring anaesthesia should have a medical encounter with an anaesthetist to evaluate the risks associated with the procedure, inform the patient about the process and obtain his (her) agreement for the planned clinical pathway. During this encounter, the anaesthetist will also assess the perioperative risks related to an underlying disease (especially cardiac, respiratory and renal) while optimisation of a pre-existing condition is sometimes necessary before surgery. Patient's regular treatment might require some changes related to the effect of anaesthesia (antihypertensive drugs and risk of hypotension) or to the surgery (bleeding and anticoagulants/antiplatelet drugs). It is believed that the role of the general practitioner will increase significantly in the next years both in the preoperative period (drug adjustment, specific investigations) and in the postoperative period (especially after ambulatory surgery or in situations associated with a short hospital stay).