Cluster randomized trial to evaluate the impact of team training on surgical outcomes.

BACKGROUND: The application of safety principles from the aviation industry to the operating room has offered hope in reducing surgical complications. This study aimed to assess the impact on major surgical complications of adding an aviation-based team training programme after checklist implementation. METHODS: A prospective parallel-group cluster trial was undertaken between September 2011 and March 2013. Operating room teams from 31 hospitals were assigned randomly to participate in a team training programme focused on major concepts of crew resource management and checklist utilization. The primary outcome measure was the occurrence of any major adverse event, including death, during the hospital stay within the first 30 days after surgery. Using a difference-in-difference approach, the ratio of the odds ratios (ROR) was estimated to compare changes in surgical outcomes between intervention and control hospitals. RESULTS: Some 22 779 patients were enrolled, including 5934 before and 16 845 after team training implementation. The risk of major adverse events fell from 8·8 to 5·5 per cent in 16 intervention hospitals (adjusted odds ratio 0·57, 95 per cent c.i. 0·48 to 0·68; P < 0·001) and from 7·9 to 5·4 per cent in 15 control hospitals (odds ratio 0·64, 0·50 to 0·81; P < 0·001), resulting in the absence of difference between arms (ROR 0·90, 95 per cent c.i. 0·67 to 1·21; P = 0·474). Outcome trends revealed significant improvements among ten institutions, equally distributed across intervention and control hospitals. CONCLUSION: Surgical outcomes improved substantially, with no difference between trial arms. Successful implementation of an aviation-based team training programme appears to require modification and adaptation of its principles in the context of the the surgical milieu. Registration number: NCT01384474 (http://www.clinicaltrials.gov).

Is it possible to limit the risks of thyroid surgery?

OBJECTIVE: Inferior laryngeal nerve (ILN) palsy and hypocalcemia remain the two most frequent major complications after thyroid surgery. Their occurrences may be explained by the influence of factors related to the patient, the surgical procedure, thyroid pathology, or the surgeon's technique. This study aims To assess whether systematically following a rigorous surgical technique during thyroidectomy affects postoperative complications and long-term patient recovery. METHODS: We conducted a multicenter, cross-sectional study of prospectively collected data in five high-volume referral centers enrolling all patients who underwent thyroid surgery between April 2008 and December 2009. Inferior laryngeal nerve (ILN) palsy and hypocalcemia were systematically assessed during hospitalization based on objective criteria. A six-month follow-up was conducted in cases of early complications. Multivariate regression models were computed to quantify their relationship with potential risk factors. RESULTS: A total of 3574 thyroid procedures were completed. Non-visualization of the ILN during dissection and a large thyroid mass were major risk factors for permanent ILN palsy (OR, 4.17 and 2.61, p<0.01) and persistent complications after initial injury (OR, 4.17 and 2.42, p<0.05). The presence of thyroiditis on the surgical specimen was an independent risk factor for permanent hypoparathyroidism and poor recovery after initial dysfunction (OR, 1.76 and 1.88, p<0.05). CONCLUSIONS: Thorough meticulous technique in thyroid surgery is a determinant of ILN function but fails to prevent persistent hypoparathyroidism.

[Screening and management of glucose metabolism disorders in cystic fibrosis patients. Practices survey in 4 French reference centers]. / Dépistage et prise en charge des troubles du métabolisme glucidique chez les patients atteints de mucoviscidose. Etude de pratiques au sein du réseau EMERA.

OBJECTIVE: Glucose metabolism disorders are a new point of interest in cystic fibrosis (CF) management. Cystic fibrosis-related diabetes mellitus (CFRD) increases alteration of pulmonary function as well as patients' morbidity and mortality. In France, CF patients are exclusively followed up in reference centers. We conducted a practices survey on screening and diagnosis of glucose metabolism disorders at 4 French CF centers. The objective of this study was to assess adherence to practice guidelines developed in 2002 at these centers. METHODS: This study was conducted in 2 sessions: 60 medical records were randomly selected in 2005 and in 2007 for patients aged over 10 years followed up at 4 CF centers. A questionnaire survey was completed for each patient with questions on CFRD screening, diagnosis, monitoring and treatment. Our guidelines recommend random blood glucose (RBG) at each standard biological test, annual glycosylated haemoglobin and an oral glucose tolerance test (OGTT) at 10, 15 and 18 years of age, then every 2 or 3 years. RESULTS: An annual RBG was performed in 82% of patients in 2005 and 91.5% in 2007. HbA1c screening was performed annually for 77% of patients in the 1st session and for 90% of patients for the 2nd session (p<0.10). Adherence to OGTT guidelines was better for adults than children: 96% had an OGTT during the 3 years of the first session and 79% during the second session, while fewer than 50% of children had their OGTT at 15 and 18 years of age. Taking the OGTT at 10 years of age could not be assessed because no patients were 10 years old during the study period. Screening for neurological complications of CFRD was assessed in the majority of diabetic patients, while half or less than half had annual fundus oculi or microalbuminuria dosage. DISCUSSION: There was an improvement in screening for CFRD and glucose metabolism disorders between 2005 and 2007, even though practices could still be improved. This shows that clinical guidelines can be implemented and followed. However, screening and management criteria for glucose metabolism disorders must be consensus-based with higher evidence in order to limit the variability of practices and prevent CFRD-related complications.

Effectiveness of home treatment for patients with cystic fibrosis: the intravenous administration of antibiotics to treat respiratory infections.

Patients with cystic fibrosis (CF) experience repeated infectious respiratory exacerbations leading to a continuous decline in lung function. The exacerbations are treated in hospital or at home. Our aim was to compare the clinical outcome for patients undergoing intravenous antibiotic treatment either in hospital or at home. A retrospective 10-year study was performed in four regional CF Centers. The outcome measures were percentage changes in forced expiratory volume in 1 sec (FEV(1)), forced vital capacity (FVC) and weight for age z-score (WZS). FEV(1), FVC, and WZS changes were calculated for the entire study period and for each course. A total of 1,164 courses were analyzed. For each course, the mean improvement in FEV(1) and FVC was significantly higher when performed in hospital than when performed at home (P < 0.05). FEV(1) and FVC values were 10.2%, 9.5% respectively in the hospital group and 7.3%, 6.8% in the home group. A total of 153 patients were analyzed (51 inpatients matched to 102 patients treated at home). The two groups had no significant differences in any outcome variable at baseline. The mean variation per year in FEV(1) was greater in the hospital group versus the home group (-0.4% vs. -1.8%; P = 0.03). The mean variation per year in WZS was greater in the hospital group versus the home group (P < 0.01). Clinical outcome, as defined by spirometric parameters and body weight, was better after a course of treatment in hospital than after a home treatment. This benefit was maintained throughout of the study period.