Non-technical skills training in the operating theatre: A meta-analysis of patient outcomes.

BACKGROUND: Non-technical skills (NTS) failures have been implicated in a large proportion of surgical errors. The objective of this meta-analysis was to investigate whether NTS training of theatre staff improves patient outcomes. METHODS: In a systematic literature search all interventional studies evaluating the effects of NTS training of theatre staff were identified. Primary outcomes included mortality, morbidity, readmission rate and length of hospital stay. Secondary outcomes included staff NTS, checklist use and technical surgical performance. Pooled odds ratios (OR) were determined for event rates and weighted mean differences (WMD) for continuous data. An inverse variance method in a random effects model was used for meta-analysis. RESULTS: A total of 1381 records were identified and nine studies were included. Meta-analysis of mortality was not carried out because only two controlled studies with different study designs were identified. No statistically significant differences were seen in complication rate (5 studies, OR 0.91 [0.73, 1.14]; p = 0.43), readmission rate (3 studies, OR 0.90 [0.63, 1.28], p = 0.56) and length of hospital stay (3 studies, WMD -0.88 days [-2.06, 0.31], p = 0.31) after NTS training. Of the secondary outcomes, an improvement of whole team NOTECHS II scores was observed in the intervention group (3 studies, WMD 6.97 [3.88, 10.06], p < 0.0001). Technical performance and checklist use were unchanged. CONCLUSIONS: This meta-analysis failed to find a statistically significant improvement of patient outcomes. These conclusions are based on a small number of heterogeneous studies. Further appropriately powered studies are likely to improve our understanding of the effects of NTS training.

Effectiveness and Safety of Tenofovir Disoproxil Fumarate in Chronic Hepatitis B: A 3-Year Prospective Field Practice Study in Germany.

BACKGROUND AND AIMS: Multiple clinical trials have demonstrated the efficacy and safety of tenofovir disoproxil fumarate (TDF) in chronic hepatitis B (CHB). However, long-term efficacy and safety data for TDF in real-life clinical practice are limited. METHODS: Prospective German field practice study in CHB-mono-infected patients. Patients were TDF-naïve but could have been treated previously with other HBV antivirals. RESULTS: Efficacy analysis included 400 patients; 301 (75 %) completed 36 months of TDF treatment. Both treatment-naïve and treatment-experienced patients showed a rapid decline in HBV DNA within 3 months of TDF initiation. After 36 months, HBV DNA < 69 IU/mL was achieved by 91 % of treatment-naïve patients (90 and 92 % in hepatitis B "e" antigen [HBeAg]-positive and [HBeAg]-negative, respectively) and 96 % of treatment-experienced patients (93 and 97 %, respectively). Three patients experienced virologic breakthrough, all with reported non-compliance. Overall, 5.7 % HBeAg-positive and 2.2 % HBeAg-negative patients lost hepatitis B surface antigen. Safety data were consistent with the known TDF safety profile; the most commonly reported adverse events possibly related to TDF were fatigue (2.0 %) and headache (2.0 %). Few patients (1.3 %) experienced renal-related adverse reactions. Creatinine clearance remained relatively stable over time; patients responded favorably where TDF was dose adjusted per label for decreased creatinine clearance. CONCLUSIONS: TDF showed a favorable tolerability profile and induced rapid and sustained suppression of HBV DNA in patients with CHB treated for up to 3 years in routine clinical practice, irrespective of treatment history. Efficacy and safety in this heterogeneous patient population were consistent with data from clinical trials.

13C-methacetin and 13C-galactose breath tests can assess restricted liver function even in early stages of primary biliary cirrhosis.

OBJECTIVE: The 13C-methacetin breath test quantitatively evaluates cytochrome P450-dependent liver function. The 13C-galactose breath test non-invasively measures the galactose oxidation capacity of the liver. The aim of this study was to find out whether these breath tests are sensitive parameters also in non-cirrhotic patients with primary biliary cirrhosis. MATERIAL AND METHODS: Nineteen patients with early-stage primary biliary cirrhosis (no cirrhotic alterations in the liver biopsy, Ludwig stage I-III) and 20 healthy controls underwent the 13C-methacetin and 13C-galactose breath tests. RESULTS: Patients with primary biliary cirrhosis metabolized less 13C-methacetin than controls (cumulative recovery within 30 min 7.5+/-2.4% versus 14.0+/-2.6%; p < 0.001). When a cut-off > 9.8% was used for the cumulative recovery after 30 min, the methacetin breath test reached 84.2% sensitivity and 95.0 specificity. In the 13C-galactose breath test, the percentage recovery at 60 min in patients was 3.1+/-1.3%/h, and 6.3+/-1.1%/h in controls (p < 0.001). Using a cut-off > 4.7%/h, the galactose breath test reached 89.5% sensitivity and 95.0 specificity. CONCLUSIONS: In non-cirrhotic, early-stage, primary biliary cirrhosis the 13C-methacetin breath test and the 13C-galactose breath test reliably indicate decreased liver function. The 13C-galactose breath test can also predict the histological score.

The influence of sulindac on patients with primary biliary cirrhosis that responds incompletely to ursodeoxycholic acid: a pilot study.

OBJECTIVES: In 30% of patients with primary biliary cirrhosis (PBC) ursodeoxycholic acid (UDCA) causes full biochemical normalization, while 70% are incomplete responders. The only differences between the two groups are the significantly higher cholestasis indices in the incomplete responders. In these patients we investigated whether the strongly choleretic sulindac together with UDCA is superior to UDCA monotherapy. DESIGN AND METHODS: Twenty-three patients with PBC incompletely responding to UDCA monotherapy were entered in the open label study for 12 months. Eleven patients (stage II, seven; III, two; and IV, two) received UDCA (10-15 mg/kg/day) plus sulindac (100-300 mg/day) (Group I). Twelve patients (stage I, six; II, four; III, one; and IV, one) were treated with UDCA alone (Group II). Liver biochemistry, analysis of antimitochondrial, antinuclear, smooth muscle, and liver-kidney-microsomal antibodies, ultrasonography and gastroscopy were done in regular intervals. RESULTS: In Group I all liver indices, IgG, IgM and IgA significantly improved although pretreatment data and stages of the disease tended to be higher than in Group II. In five patients of Group I liver histology improved slightly. Sulindac was well tolerated. The biochemical indices did not further improve on UDCA monotherapy. CONCLUSIONS: Sulindac in combination with UDCA further improves liver biochemistries in patients with PBC who responded incompletely to UDCA alone.