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).

[ORION®: a simple and effective method for systemic analysis of clinical events and precursors occurring in hospital practice]. / Méthode Orion(®) : analyse systémique simple et efficace des événements cliniques et des précurseurs survenant en pratique médicale hospitalière.

PURPOSE: Morbimortality review is now recommended by the French Health Authority (Haute Autorité de santé [HAS]) in all hospital settings. It could be completed by Comités de retour d'expérience (CREX), making systemic analysis of event precursors which may potentially result in medical damage. As commonly captured by their current practice, medical teams may not favour systemic analysis of events occurring in their setting. They require an easy-to-use method, more or less intuitive and easy-to-learn. It is the reason why ORION(®) has been set up. METHODS: ORION(®) is based on experience acquired in aeronautics which is the main precursor in risk management since aircraft crashes are considered as unacceptable even though the mortality from aircraft crashes is extremely low compared to the mortality from medical errors in hospital settings. The systemic analysis is divided in six steps: (i) collecting data, (ii) rebuilding the chronology of facts, (iii) identifying the gaps, (iv) identifying contributing and influential factors, (v) proposing actions to put in place, (vi) writing the analysis report. When identifying contributing and influential factors, four kinds of factors favouring the event are considered: technical domain, working environment, organisation and procedures, human factors. Although they are essentials, human factors are not always considered correctly. The systemic analysis is done by a pilot, chosen among people trained to use the method, querying information from all categories of people acting in the setting. RESULTS: ORION(®) is now used in more than 400 French hospital settings for systemic analysis of either morbimortality cases or event precursors. It is used, in particular, in 145 radiotherapy centres for supporting CREX. CONCLUSION: As very simple to use and quasi-intuitive, ORION(®) is an asset to reach the objectives defined by HAS: to set up effective morbi-mortality reviews (RMM) and CREX for improving the quality of care in hospital settings. By helping the efforts of medical teams, ORION(®) is an essential tool contributing to the patients' security.

[From Crex mutualisation to clinical audit]. / De la mutualisation des comités de retour d'expérience (Crex) à l'audit des pratiques cliniques.

In mid-2004, following a Mission nationale d'expertise et d'audits hospitaliers (MeaH) proposal, three voluntary cancer centres started setting up a safety procedure in radiotherapy. Their work made it possible to single out the need to continue elaborating a repository, aiming at a "minimal written reference", to take into account the human factor as one of the four families of factors contributing to a systemic deviation and to build collectively, in radiotherapy departments, the experience feedback committee (comité de retour d'expérience [Crex]). Formalizing a comité de retour d'expérience is unavoidable in any safety-management system (SMM or MGS). The comité de retour d'expérience enables every active member of a department to listen to any of the events of the month (incidents and precursors), to select the event which will be under scrutiny for the next systemic analysis (Orion(©) method) and above all to choose the most appropriate correcting action and ensure its proper implementation. That approach has been approved and then acknowledged by the Autorité de sûreté nucléaire (ASN) before being extended to the other radiotherapy departments. The use of the comité de retour d'expérience, which is a safety management tool, should not be limited to a local circle of insiders, but shared to benefit everybody. Putting comité de retour d'expérience together - a move that was hoped for and brought up as soon as the tool was created - is now being implemented. Several initiatives have already permitted to assess its collective interest; other steps have yet to be taken to enable a true collective sharing of experience. On this basis, the definition of quality/safety practices in radiotherapy will allow the professionals to implement clinical audits in 2012.

[Crex and Orion analysis in radiation oncology: towards a mutualisation of corrective actions]. / Crex et analyse Orion en radiothérapie: vers une mutualisation des actions correctives.

After working on treatment organization in radiotherapy (bonnes pratiques organisationnelles en radiothérapie--action pilote MeaH 2003), the development of a security policy has become crucial. With the help of Air France consulting and the MeaH, three cancer centers in Angers, Lille et Villejuif worked together on the implantation of experience feed back committees (Crex) dedicated to the registration, analysis and correction of precursor events. This action has now been implemented in all the FNCLCC centers. It seems now important to have a program of mutualisation of corrective actions for all participants. This will allow to review the Orion method of events analysis.

[Towards global security in radiation oncology. Using event notification feed-back]. / Vers une "politique sécurité" en oncologie-radiothérapie. La mise en oeuvre du retour d'expérience.

Large modifications are on going in our medical practice in oncology (cancer incidence, ageing, rules, authorizations, billings...). To obtain the best results as possible implies a quality control of the equipments (drugs, machines...), of the professionals (certification) and of the organisations (accreditations). Radiation oncology plays a key role in the multidisciplinary treatment of cancer ant is very sensitive to quality assurances due to its specificities: different tumours, various patients, multiple sequences of treatment with high tech machines and information systems. From 2003, a progress policy has been developed with the MeaH (Mission d'évaluation et d'audit hospitalier). Rapidly, the transfer of security policies from industry to medicine has been considered. This paper will present the first results and their potential implications in the field of oncology.