Excess mortality among non-COVID-19 surgical patients attributable to the exposure of French intensive and intermediate care units to the pandemic.

PURPOSE: The mobilization of most available hospital resources to manage coronavirus disease 2019 (COVID-19) may have affected the safety of care for non-COVID-19 surgical patients due to restricted access to intensive or intermediate care units (ICU/IMCUs). We estimated excess surgical mortality potentially attributable to ICU/IMCUs overwhelmed by COVID-19, and any hospital learning effects between two successive pandemic waves. METHODS: This nationwide observational study included all patients without COVID-19 who underwent surgery in France from 01/01/2019 to 31/12/2020. We determined pandemic exposure of each operated patient based on the daily proportion of COVID-19 patients among all patients treated within the ICU/IMCU beds of the same hospital during his/her stay. Multilevel models, with an embedded triple-difference analysis, estimated standardized in-hospital mortality and compared mortality between years, pandemic exposure groups, and semesters, distinguishing deaths inside or outside the ICU/IMCUs. RESULTS: Of 1,870,515 non-COVID-19 patients admitted for surgery in 655 hospitals, 2% died. Compared to 2019, standardized mortality increased by 1% (95% CI 0.6-1.4%) and 0.4% (0-1%) during the first and second semesters of 2020, among patients operated in hospitals highly exposed to pandemic. Compared to the low-or-no exposure group, this corresponded to a higher risk of death during the first semester (adjusted ratio of odds-ratios 1.56, 95% CI 1.34-1.81) both inside (1.27, 1.02-1.58) and outside the ICU/IMCU (1.98, 1.57-2.5), with a significant learning effect during the second semester compared to the first (0.76, 0.58-0.99). CONCLUSION: Significant excess mortality essentially occurred outside of the ICU/IMCU, suggesting that access of surgical patients to critical care was limited.

Feasibility and efficacy of combined pancreatic islet-lung transplantation in cystic fibrosis-related diabetes-PIM study: A multicenter phase 1-2 trial.

Cystic fibrosis-related diabetes (CFRD) is a common complication of cystic fibrosis (CF), and restoring metabolic control in these patients may improve their management after lung transplantation. In this multicenter, prospective, phase 1-2 trial, we evaluate the feasibility and metabolic efficacy of combined pancreatic islet-lung transplantation from a single donor in patients with CFRD, terminal respiratory failure, and poorly controlled diabetes. Islets were infused via the portal vein under local anesthesia, 1 week after lung transplantation. At 1 year, the primary outcome was transplant success as evaluated by a composite score including four parameters (weight, fasting glycemia, HbA1c, and insulin requirements). Ten participants (age: 24 years [17-31], diabetes duration: 8 years [4-12]) received a combined islet-lung transplant with 2892 IEQ/kg [2293-6185]. Transplant success was achieved in 7 out of 10 participants at 1-year post transplant. Fasting plasma C-peptide increased from 0.91 µg/L [0.56-1.29] to 1.15 µg/L [0.77-2.2], HbA1c decreased from 7.8% [6.5-8.3] (62 mmol/mol [48-67]) to 6.7% [5.5-8.0] (50 mmol/mol [37-64]), with 38% decrease in daily insulin doses. No complications related to the islet injection procedure were reported. In this pilot study, combined pancreatic islet-lung transplantation restored satisfactory metabolic control and pulmonary function in patients with CF, without increasing the morbidity of lung transplantation.

Cancer screening and follow-up in general practice: A French nationwide cross-sectional study.

BACKGROUND: The overall activity of general practitioners (GPs) related to cancer screening and follow-up is poorly documented. OBJECTIVES: To describe cancer screening and follow-up activities carried out in general practice and analyse them according to the socio-economic characteristics of patients. METHODS: We used data from a French nationwide, multicentre, cross-sectional study that described the distribution of health problems managed in general practice and the associated processes of care. Analyses were adjusted on age and gender when appropriate, using a multivariate, hierarchical, linear mixed-effects model. RESULTS: Among 20,613 consultations recorded, 580 involved cancer screening (2.8%) and 475 cancer follow-ups (2.3%). The most frequent cancer screening procedures concerned colorectal cancer (38.6% of screening procedures), breast cancer (32.6%), cervical cancer (17.0%), and prostate cancer (9.3%). In consultations with female patients, the most frequent types of cancer followed up were breast (44.9%) and colorectal cancer (10.5%), and with male patients, the most frequent were prostate (37.3%) and skin cancer (10.3%). After adjustment on age and gender, consultations with cancer follow-up included a mean 1.9 health problems managed in addition to cancer. Consultations with cancer screening or follow-up issue less often involved a patient on low income than other consultations (2.4% vs. 4.2%, and 1.1% vs. 4.2%, respectively). CONCLUSION: Around 5% of French general practice consultations include cancer screening or follow-up. Socio-economical inequalities demand further research.

Quality Assessment of Reporting of Economic Evaluation in Cardiac Sugery: Has it Improved?

OBJECTIVES: Cardiac surgery has seen substantial scientific progress over recent decades. Health economic evaluations have become important tools for decision makers to prioritize scarce health resources. The present study aimed to identify and critically appraise the reporting quality of health economic evaluations conducted in the field of cardiac surgery. METHODS: A literature search was performed to identify health economic evaluations in cardiac surgery. The consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement was used to assess the quality of reporting of studies. RESULTS: A total 4,705 articles published between 1981 and 2016 were identified; sixty-nine studies fulfilled the inclusion criteria. There was a trend toward a greater number of publications and reporting quality over time. Six (8.7 percent) studies were conducted between 1981 and 1990, nine (13 percent) between 1991 and 2000, twenty-four (34.8 percent) between 2001 and 2010, and thirty (43.5 percent) after 2011. The mean CHEERS score of all articles was 16.7/24; for those published between 1980 and 1990 the mean (SD) score was 10.2 (±1.4), for those published between 1991 and 2000 it was 11.2 (±2.4), between 2001 and 2010 it was 15.3 (±4.8), and after 2011 it was 19.9 (±2.9). The quality of reporting was still insufficient for several studies after 2000, especially concerning items "characterizing heterogeneity," "assumptions," and "choice of model." CONCLUSIONS: The present study suggests that, even if the quantity and the quality of health economics evaluation in cardiac surgery has increased, there remains a need for improvement in several reporting criteria to ensure greater transparency.

Unexpected discrepancies in hospital administrative databases can impact the accuracy of monitoring thyroid surgery outcomes in France.

OBJECTIVE: To determine the validity of hospital administrative databases compared to prospective collection of medical data assessing thyroid surgery complications. BACKGROUND: Administrative data are increasingly used to track surgical outcomes. METHODS: All patients undergoing thyroid surgery at three French university hospitals between April 2008 and April 2009 were prospectively included. Using diagnosis and procedural codes from hospital administrative database, we designed three indicators for measuring complications of thyroid surgery: recurrent laryngeal nerve palsy, postoperative hypoparathyroidism, and postoperative hemorrhage. Gold standard was obtained from a prospective collection of medical data after systematically screening each patient for the above-mentioned complications. Their ability to monitor surgical outcomes over time within individual hospitals was estimated using control charts. Spatial comparison between hospitals was performed by funnel plots. RESULTS: A total of 1909 patients were included. Complication rates extracted from administrative data were significantly lower compared to medical data (nerve palsy 2.4% vs. 6.7%, hypoparathyroidism 10.6% vs. 22.3%, p<0.0001). Indicator sensitivity was 30.4% for nerve palsy, 45.4% for hypoparathyroidism and 71.4% for postoperative hemorrhage. Corresponding positive predictive values were 84.4%, 95.1% and 68.2%. In two of the three hospitals, administrative data were not able to track temporal variations in complications rates. Regarding inter-hospital comparisons, 2 out of 3 hospitals were considered outliers according to administrative data despite having an average performance based on medical data. CONCLUSIONS: The ability of indicators extracted from administrative databases to measure thyroid surgery outcomes depends on the quality of underlying data coding. Validation in every center should be a prerequisite before implementing such metrics for tracking performance.

Management of postoperative inflammation after cataract and complex ocular surgeries: a systematic review and Delphi survey.

Prevention and management of postoperative ocular inflammation with corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDs) have been evaluated in several randomised controlled trials (RCTs). However, neither consensus regarding the efficacies of different regimens nor established guidelines are currently available. This has resulted in different practice patterns throughout the world. A systematic literature review found that for the management of postcataract inflammation nepafenac produced a positive outcome in three of three RCTs (3/3), as did ketorolac (1/1), bromfenac (7/7), loteprednol (3/3) and difluprednate (6/6), but not flurbiprofen (0/1). A single study found that betamethasone produced inconclusive results after retinal detachment (RD) surgery; ketorolac was effective (1/1) after vitrectomy, but triamcinolone was ineffective (0/1) after trabeculectomy. A two-round Delphi survey asked 28 international experts to rate both the inflammatory potential of different eye surgeries and their agreement with different treatment protocols. They rated trabeculectomy, RD surgery and combined phacovitrectomy as more inflammatory than cataract surgery. Vitrectomies for macular hole or epiretinal membrane were not deemed more inflammatory than cataract surgery. For trabeculectomy, they preferred to treat longer than for cataract surgery (NSAID + corticosteroid three times a day for 2 months vs 1 month). For vitrectomy alone, RD surgery and combined phacovitrectomy, the panel preferred the same treatment as for cataract surgery (NSAID + corticosteroid three times a day for 1 month). The discrepancy between preferred treatment and perception of the eye's inflammatory status by the experts for RD and combined vitreoretinal surgeries highlights the need for RCTs to establish treatment guidelines.

Determinants of operative time in thyroid surgery: A prospective multicenter study of 3454 thyroidectomies.

OBJECTIVE: To identify the determinants of operative time for thyroidectomy and quantify the relative influence of preoperative and intra-operative factors. BACKGROUND: Anticipation of operative time is key to avoid both waste of hospital resources and dissatisfaction of the surgical staff. Having an accurate and anticipated planning would allow a rationalized operating room use and may improve patient flow and staffing level. METHODS: We conducted a prospective, cross-sectional study between April 2008 and December 2009. The operative time of 3454 patients who underwent thyroidectomy performed by 28 surgeons in five academic hospitals was monitored. We used multilevel linear regression to model determinants of operative time while accounting for the interplay of characteristics specific to surgeons, patients, and surgical procedures. The relative impact of each variable on operative time was estimated. RESULTS: Overall, 86% (99% CI 83 to 89) of operative time variation was related to preoperative variables. Surgeon characteristics accounted for 32% (99% CI 29 to 35) of variation, center location for 29% (99% CI 25 to 33), and surgical procedure or patient variables for 24% (99% CI 20 to 27). Operative time was significantly lower among experienced surgeons having practiced from 5-19 years (-21.8 min, P<0.05), performing at least 300 thyroidectomies per year (-28.8 min, P<0.05), and with increasing number of thyroidectomies performed the same day (-11.7min, P<0.001). Conversely, operative time increased in cases of procedure supervision by a more experienced surgeon (+20.0 min, P<0.001). The remaining 13.0% of variability was attributable to unanticipated technical difficulties at the time of surgery. CONCLUSIONS: Variation in thyroidectomy duration is largely explained by preoperative factors, suggesting that it can be accurately anticipated. Prediction tools allowing better regulation of patient flow in operating rooms appears feasible for both working conditions and cost management.

Can we consider immediate complications after thyroidectomy as a quality metric of operation?

BACKGROUND: Permanent recurrent laryngeal nerve palsy and hypoparathyroidism are 2 major complications after thyroid operation. Assuming that the rate of immediate complications can predict the permanent complication rate, some authors consider these complications as a valid metric for assessing the performance of individual surgeons. This study aimed to determine the correlation between rates of immediate and permanent complications after thyroidectomy at the surgeon level. METHODS: We conducted a prospective, cross-sectional study in 5 academic hospitals between April 2008 and December 2009. The correlation between the rates of immediate and permanent complications for each of the 22 participating surgeons was calculated using the Pearson correlation test (r). RESULTS: The study period included 3,605 patients. There was a fairly good correlation between rates of immediate and permanent recurrent laryngeal nerve palsy (r = 0.70, P = .004), but no correlation was found for immediate and permanent hypoparathyroidism (r = 0.18, P = .427). CONCLUSION: The immediate hypoparathyroidism rate does not reflect the permanent hypoparathyroidism rate. Consequently, immediate hypoparathyroidism should not be used to assess the quality of thyroidectomy or to monitor the performance of surgeons.

Incorrect evaluation of the frequency of malnutrition and of its screening in hospitalized children by health care professionals.

RATIONALE, AIMS AND OBJECTIVES: Malnutrition screening is essential to detect and to treat patients with stunting or wasting. The aim was to evaluate the subjective perception of frequency and assessment of malnutrition by health care professionals. RESEARCH METHODS AND PROCEDURES: In a paediatric university hospital, a cross-sectional survey was conducted with a Likert scale approach to health care professionals and compared with objective measurements on a given day of frequency of malnutrition and of its screening. RESULTS: 279 health care professionals participated. The malnutrition rate, estimated versus measured, was 16.8% and 34.8%, respectively. Conversely, the estimated frequency of malnutrition screening versus measured frequency was 80.6% versus 43.1%, respectively. Furthermore, the perception of health care professionals did not differ depending on their professional category or speciality. CONCLUSIONS: In conclusion, health care staff underestimates the prevalence of malnutrition in children by half and overestimates the frequency of appropriate screening practices for detection of malnutrition. This flawed/unreliable perception may disrupt both screening and the management of malnourished children. There is an urgent need to find out the reasons behind these errors caused by subjective perception in order to develop appropriate educational training to remedy the situation.

Temporal variation in surgical mortality within French hospitals.

BACKGROUND: Surgical mortality varies widely across hospitals, but the degree of temporal variation within individual hospitals remains unexplored and may reflect unsafe care. OBJECTIVES: To add a longitudinal dimension to large-scale profiling efforts for interpreting surgical mortality variations over time within individual hospitals. DESIGN: Longitudinal analysis of the French nationwide hospital database using statistical process control methodology. SUBJECTS: A total of 9,474,879 inpatient stays linked with open surgery from 2006 through 2010 in 699 hospitals. MEASURES: For each hospital, a control chart was designed to monitor inpatient mortality within 30 days of admission and mortality trend was determined. Aggregated funnel plots were also used for comparisons across hospitals. RESULTS: Over 20 successive quarters, 52 hospitals (7.4%) experienced the detection of at least 1 potential safety issue reflected by a substantial increase in mortality momentarily. Mortality variation was higher among these institutions compared with other hospitals (7.4 vs. 5.0 small variation signals, P<0.001). Also, over the 5-year period, 119 (17.0%) hospitals reduced and 36 (5.2%) increased their mortality rate. Hospitals with improved outcomes had better control of mortality variation over time than those with deteriorating trends (5.2 vs. 6.3 signals, P=0.04). Funnel plots did not match with hospitals experiencing mortality variations over time. CONCLUSIONS: Dynamic monitoring of outcomes within every hospital may detect safety issues earlier than traditional benchmarking and guide efforts to improve the value of surgical care nationwide.

Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial.

BACKGROUND: Hospital malnutrition is an underestimated problem and as many as half of malnourished patients do not receive appropriate treatment. In order to extend the management of malnutrition in health care facilities, multidisciplinary teams focusing on clinical nutrition were established in France. The establishment of such teams within hospital facilities remains nonetheless difficult. We have consequently developed a multifaceted intervention coordinated by a Nutritional Support Team (NST). Our study aims to evaluate the impact of this multifaceted intervention coordinated by a NST, in adherence to recommended practices for the care of malnourished children, among health care workers of a paediatric university hospital. METHODS/DESIGN: We carried out 1) a six-month observational phase focusing on the medical care procedures relative to malnourished children followed by 2) a cluster randomised controlled trial phase to evaluate the impact of a multidisciplinary nutrition team over an 18 month time frame.Based on power analyses and assuming a conservative intracluster correlation coefficient, 1289 children were needed to detect a 25% difference in rates between the two groups of the cluster trial.The implementation of our intervention was coordinated by the NST and had three major components: a) access to a computerised malnutrition screening system associated with an automatic alert system, b) an awareness campaign directed toward the health care workers and c) a leadership based strategy.Main outcomes included the number of daily weighings during hospitalisation, the investigation of malnutrition etiology and the management of malnutrition by a dietician and/or the NST.Due to the clustered nature of the data with children nested in departments, a generalized estimated equations approach will be used to analyse the impact of the multifaceted intervention on primary and secondary outcomes. DISCUSSION: Our results will provide an overall response regarding the effectiveness of our multifaceted intervention and we should be able to suggest an organization and mode of operation of NST. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01081587.

Outcome of cystic fibrosis-related diabetes two years after lung transplantation.

BACKGROUND: Although transplantation is known to impair glucose tolerance, evolution of pre-existing diabetes after lung transplantation (LT) in cystic fibrosis (CF) has never been described. OBJECTIVES: We aimed to assess the outcome of CF-related diabetes (CFRD) after LT, with the hypothesis that suppressing chronic inflammatory foci may improve glucose tolerance in some patients. METHODS: In a retrospective study of 29 CF diabetic patients treated with insulin and undergoing LT, CFRD control was assessed 3 months before LT and 1 (n = 27) and 2 (n = 18) years after LT by measuring insulin dosage, fasting blood glucose and glycosylated hemoglobin (HbA1c) levels. Patients with HbA1c ≤7% and an insulin dose ≤1 UI/kg/day were defined as having controlled CFRD (group A). Other patients were assigned to group B. RESULTS: Before LT, 19 (65.5%) patients were in group A. At 2 years, 6 of 10 (60%) patients who were in group B prior to LT had moved into group A, which then comprised 77.8% of all patients. Insulin could have been stopped in 5 patients. Uncontrolled CFRD before LT (OR = 16) and a long delay between the diagnosis of CFRD and LT (OR = 1.3) were significant predictors of uncontrolled CFRD at 1 year. CONCLUSIONS: LT does not seem to worsen CFRD in some patients, suggesting that in some cases, glucose tolerance may be improved by the suppression of chronic pulmonary infection.

Development of a charting method to monitor the individual performance of surgeons at the beginning of their career.

BACKGROUND: Efforts to provide a valid picture of surgeons' individual performance evolution should frame their outcomes in relation to what is expected depending on their experience. We derived the learning curve of young thyroidectomy surgeons as a baseline to enable the accurate assessment of their individual outcomes and avoid erroneous conclusions that may derive from more traditional approaches. METHODS: Operative time and postoperative recurrent laryngeal nerve palsy of 2006 patients who underwent a thyroidectomy performed by 19 young surgeons in five academic hospitals were monitored from April 2008 to December 2009. The database was randomly divided into training and testing datasets. The training data served to determine the expected performance curve of surgeons during their career and factors influencing outcome variation using generalized estimating equations (GEEs). To simulate prospective monitoring of individual surgeon outcomes, the testing data were plotted on funnel plots and cumulative sum charts (CUSUM). Performance charting methods were utilized to present outcomes adjusted both for patient case-mix and surgeon experience. RESULTS: Generation of performance curves demonstrated a gradual reduction in operative time from 139 (95% CI, 137 to 141) to 75 (71 to 80) minutes, and from 15.7% (15.1% to 16.3%) to 3.3% (3.0% to 3.6%) regarding the nerve palsy rate. Charts interpretation revealed that a very young surgeon had better outcomes than expected, whereas a more experienced surgeon appeared to be a poor performer given the number of years that he had already spent in practice. CONCLUSIONS: Not considering the initial learning curve of surgeons exposes them to biased measurement and to misinterpretation in assessing their individual performance for thyroidectomy. The performance chart represents a valuable tool to monitor the outcome of surgeons with the expectation to provide safe and efficient care to patients.

Influence of experience on performance of individual surgeons in thyroid surgery: prospective cross sectional multicentre study.

OBJECTIVE: To determine the association between surgeons' experience and postoperative complications in thyroid surgery. DESIGN: Prospective cross sectional multicentre study. SETTING: High volume referral centres in five academic hospitals in France. PARTICIPANTS: All patients who underwent a thyroidectomy undertaken by every surgeon in these hospitals from 1 April 2008 to 31 December 2009. MAIN OUTCOME MEASURES: Presence of two permanent major complications (recurrent laryngeal nerve palsy or hypoparathyroidism), six months after thyroid surgery. We used mixed effects logistic regression to determine the association between length of experience and postoperative complications. RESULTS: 28 surgeons completed 3574 thyroid procedures during a one year period. Overall rates of recurrent laryngeal nerve palsy and hypoparathyroidism were 2.08% (95% confidence interval 1.53% to 2.67%) and 2.69% (2.10% to 3.31%), respectively. In a multivariate analysis, 20 years or more of practice was associated with increased probability of both recurrent laryngeal nerve palsy (odds ratio 3.06 (1.07 to 8.80), P=0.04) and hypoparathyroidism (7.56 (1.79 to 31.99), P=0.01). Surgeons' performance had a concave association with their length of experience (P=0.036) and age (P=0.035); surgeons aged 35 to 50 years had better outcomes than their younger and older colleagues. CONCLUSIONS: Optimum individual performance in thyroid surgery cannot be passively achieved or maintained by accumulating experience. Factors contributing to poor performance in very experienced surgeons should be explored further.

Impact of practice recommendations on patient follow-up and cystic fibrosis centres' activity in France.

INTRODUCTION: The French cystic fibrosis (CF) practice recommendations were published at the end of 2002. They advise each patient to be checked up at least once every 3 months in a reference centre for cystic fibrosis. OBJECTIVE: To describe the activity of the four reference centres in the Rhône-Alpes area and the patients' follow-up. METHODS: All patients with cystic fibrosis consulting one of the four CF centres between 1996 and 2005 were retrospectively included. All outpatient visits were recorded and classified according to (i) patient and year; and (ii) month and year. The two series were assessed graphically to determine a transition threshold, that is, the 2 consecutive years between which practices differed the most. RESULTS: A total of 616 patients were included, representing 17 594 outpatient visits. The average number of visits per patient increased from 3.7 in 1996 to 5.0 in 2005, the graphical representation showed a sharp change between 2000 and 2001. Among patients with less than 4 visits in 2000, 88 of them visited a centre 4 times or more in 2001 (44%). The annual number of outpatient visits went from 1035 to 2420. The monthly average number of outpatient visits was 86 in 1996 and 202 in 2005. The graphical representation of activity also showed a sharp change from 2001. CONCLUSION: We showed that the implementation of guidelines occurred the year before its official publication. We also showed that the growth of this implementation was sharp rather than gradual.

Impact of the number of infusions on 2-year results of islet-after-kidney transplantation in the GRAGIL network.

BACKGROUND: Insulin independence after islet transplantation is generally achieved after multiple infusions. However, single infusion would increase the number of recipients. Our aim was to evaluate the results of islet-after-kidney transplantation according to the number of infusions. METHODS: Islets were isolated at the Geneva University, shipped, and transplanted into French patients from the Swiss-French GRAGIL network, on the "Edmonton" immunosuppression protocol between 2004 and 2010. RESULTS: Nineteen patients were transplanted with 33 preparations. Fifteen patients reached 24 months follow-up; eight subjects were single-graft recipients and seven were double-graft recipients. Finally, single-graft recipients received a median of 5312 islet equivalents/kg (5186-6388) vs. 10,564 (10,054-11,375) for double-graft recipients (P=0.0003) with similar islet mass at first infusion. Insulin independence was achieved in five of eight single-graft subjects (62.5%) versus five of seven in double-graft subjects (71.4%), not significant. Median insulin independence duration was 4.7 (3.1-15.2) months after one infusion vs. 19 (9.6-20.8) months after two infusions (not significant). At 24 months posttransplant, comparing single- with double-graft patients, insulin doses were 0.23 (0.11-0.34) U/kg vs. 0.02 (0.0-0.23) U/kg, P=0.11; HbA1c was 6.5% (5.9%-6.8%) vs. 6.2% (5.9%-6.3%), P=0.16; and basal C-peptide was 302 (143-480) pmol/L vs. 599 (393-806) pmol/L, P=0.05. Only 37.5% of single-graft patients had a ß-score ≥4 compared with 100% of double-graft patients (P=0.03). Two recipients experienced postinfusion bleeding, and two patients (13%) showed renal dysfunction in the absence of biopsy-proven rejection. CONCLUSIONS: One infusion achieves good glycemic control and sometimes insulin independence. However, double-graft patients remain insulin-free longer, tend to have lower HbA1c, and show better graft function 24 months after transplant.

[Classifications and definitions of adverse events in primary care: a systematic review]. / Classifications et définitions des événements indésirables associés aux soins primaires: une synthèse de la littérature.

UNLABELLED: In an aim to standardize the terminology used in patient safety research, the World Health Organization (WHO) has recommended the use of internationally acceptable patient safety concepts for the collection and classification of adverse events and near misses in health care settings worldwide. OBJECTIVE: The principal aims of this study were to clarify patient safety terminology and concepts, to suggest a comprehensible definition of medical error, and to propose patient safety classifications for use in primary health care. DESIGN: Systematic review and synthesis of the international medical literature. METHODS: In order to define "medical error" as a health care term and to identify various published or unpublished classifications of medical errors, we searched the Medline, Web of Science, Cochrane Library, Pascal, and French Data Bank of Public Health bibliographical medical databases for the years 2000 through 2011. A grey literature search was carried out using the Google and Google Scholar search engines. We used the recommendations of WHO to analyze these classifications. The principal key words used were: primary care, family practice, patient safety event, adverse event and taxonomy. RESULTS: The online search identified 191 documents; among these, 51 articles, eight reports and two books were deemed appropriate. Twelve classifications were analyzed and compared using WHO recommendations. Eight definitions of medical error were identified during this analysis. CONCLUSION: The WHO Alliance for Patient Safety has clarified the definition of several terms - medical error, adverse event, patient safety event, and near miss - through the development of the International Patient Safety Event Classification. This conceptual framework and classification for patient safety should be applicable across the full spectrum of health care, including primary health care.

Impact of a multifaceted program to prevent postoperative delirium in the elderly: the CONFUCIUS stepped wedge protocol.

BACKGROUND: Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Although several interventions have proved their effectiveness to prevent it, the Cochrane advises an assessment of multifaceted intervention using rigorous methodology based on randomized study design. Our purpose is to present the methodology and expected results of the CONFUCIUS trial, which aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly. METHOD/DESIGN: Study design is a stepped wedge cluster randomized trial within 3 surgical wards of three French university hospitals. All patients aged 75 and older, and admitted for scheduled surgery will be included. The multifaceted program will be conducted by mobile geriatric team, including geriatric preoperative consultation, training of the surgical staff and implementation of the Hospital Elder Life Program, and morbidity and mortality conference related to delirium cases. The primary outcome is based on postoperative delirium rate within 7 days after surgery. This program is planned to be implemented along four successive time periods within all the surgical wards. Each one will be affected successively to the control arm and to the intervention arm of the trial and the order of program introduction within each surgical ward will be randomly assigned. Based on a 20% reduction of postoperative delirium rate (ICC = 0.25, α = 0.05, ß = 0.1), three hundred sixty patients will be included i.e. thirty patients per service and per time period. Endpoints comparison between intervention and control arms of the trial will be performed by considering the cluster and time effects. DISCUSSION: Better prevention of delirium is expected from the multifaceted program, including a decrease of postoperative delirium, and its consequences (mortality, morbidity, postoperative complications and length of hospital stay) among elderly patients. This study should allow better diagnosis of delirium and strengthen the collaboration between surgical and mobile geriatric teams. Should the program have a substantial impact on the prevention of postoperative delirium in elderly, it could be extended to other facilities. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01316965.

Influence of intraoperative neuromonitoring on surgeons' technique during thyroidectomy.

BACKGROUND: When assessing the value of intraoperative nerve monitoring (IONM) during routine thyroidectomy, it is necessary to consider its influence on the surgeon's dissection technique. We investigated the effect of IONM on individual surgeon performance by determining the learning curve associated with this tool. METHODS: A one-year prospective study was conducted between May 2008 and April 2009 within a team of three experienced endocrine surgeons. The measure of surgical performance was based on the detection of immediate postoperative recurrent laryngeal nerve palsy by laryngoscopy. Individual learning curves associated with IONM acquisition were drawn with the cumulative sum (CUSUM) chart. Each surgeon was questioned about possible changes he had experienced in his own surgical technique after the introduction of IONM. RESULTS: A total of 475 consecutive patients who underwent thyroid surgery with IONM were included. The pattern of learning curves varied among surgeons and ranged from 35 to 304 procedures required for complete IONM acquisition. The surgeon with the longest learning curve also described a drastic modification of his technique related to nerve dissection. CONCLUSIONS: Intraoperative nerve monitoring can induce changes in surgical practice. The different learning curve patterns among surgeons may reflect the variable degree to which surgeons will modify their own dissection technique. Such an effect on learning must be considered when assessing the impact of using IONM on patient safety.