Omission of tranexamic acid does not increase the amount of perioperative blood transfusions in patients undergoing one-level spinal fusion surgery: a retrospective propensity score-matched noninferiority study.

INTRODUCTION: Application of tranexamic acid (TXA) in spine surgery is very frequent even without signs of hyperfibrinolysis, although its beneficial blood-saving effects are offset by harmful adverse events such as thromboembolic incidents. Thus, we investigated whether in relatively less invasive spinal procedures such as one-level posterior spinal fusion, omission of TXA affects the requirement for blood transfusions. METHODS: We conducted a retrospective propensity score-matched noninferiority study with 212 patients who underwent one-level posterior spine fusion and who were stratified according to whether they received TXA intraoperatively at our tertiary care center. The primary endpoint was the volume of transfused packed red cells. Testing for noninferiority or equivalence was performed by two one-sided testing procedure (TOST) with a priori defined noninferiority margins ([Formula: see text]). RESULTS: After propensity score matching a total of five patients (11.6%) treated with TXA were transfused compared with five patients (11.6%) who did not receive TXA. The majority of patients (51.2%) had a risk-increasing condition. The risk difference (no TXA-TXA) of intraoperative transfusion was - 4.7% (CI 90% - 13.62 to 4.32%), and omitting TXA was noninferior ([Formula: see text] = [Formula: see text]  10%). The mean intergroup difference in transfused volume (no TXA-TXA) was - 23.26 ml intraoperatively (CI 90% - 69.34 to 22.83 ml) and - 46.51 ml overall (CI 90% - 181.12 to 88.1 ml), respectively, suggesting equivalence of TXA omission ([Formula: see text] = [Formula: see text] 300 ml). The hemoglobin decline between both groups was also equivalent (with [Formula: see text] = [Formula: see text] 1 g/dl) both on the first postoperative day ([Formula: see text] Hb = 0.02 g/dl, CI 90% - 0.53 to 0.56 g/dl) and at discharge ([Formula: see text] Hb = - 0.29 g/dl, CI 90% - 0.89 to 0.31 g/dl). CONCLUSION: We demonstrated that requirement of transfusion is rare among one-level fusion surgery and the omission of TXA is noninferior with regard to blood transfusion in high-risk patients undergoing this procedure. Therefore, the prophylactic use of TXA cannot be recommended here, suggesting to focus on alternative blood conservation strategies, if necessary.

Impaired vascular endothelial function as a perioperative risk predictor - a prospective observational trial.

BACKGROUND: In the recent years, an increasing number of patients with multiple comorbidities (e.g. coronary artery disease, diabetes, hypertension) presents to the operating room. The clinical risk factors are accompanied by underlying vascular-endothelial dysfunction, which impairs microcirculation and may predispose to end-organ dysfunction and impaired postoperative outcome. Whether preoperative endothelial dysfunction identifies patients at risk of postoperative complications remains unclear. In this prospective observational study, we tested the hypothesis that impaired flow-mediated dilation (FMD), a non-invasive surrogate marker of endothelial function, correlates with Days at Home within 30 days after surgery (DAH30). DAH30 is a patient-centric metric that captures postoperative complications and importantly also hospital re-admissions. METHODS: Seventy-one patients scheduled for major abdominal surgery were enrolled. FMD was performed pre-operatively prior to major abdominal surgery and patients were dichotomised at a threshold value of 10%. FMD was then correlated with DAH30 (primary endpoint) and postoperative complications (secondary endpoints). RESULTS: DAH30 did not differ between patients with reduced FMD and normal FMD (14 (4) (median (IQR)) vs. 15 (8), P = 0.8). Similary, no differences between both groups were found for CCI (normal FMD: 21 (30) (median (IQR)), reduced FMD: 26 (38), P = 0.4) or frequency of major complications (normal FMD: 7 (19%) (n (%)), reduced FMD: 12 (35%), P = 0.12). The regression analyses revealed that FMD in combination with ASA status and surgery duration had no additional significant predictive effect for DAH30, CCI or Clavien-Dindo score. CONCLUSION: FMD does not add predictive value with regards to DAH30, CCI or Clavien-Dindo score within our study cohort of patients undergoing abdominal surgery. TRIAL REGISTRATION: The study was registered in the German Clinical Trials Register ( DRKS00005472 ), prospectively registered on 25/11/2013.

[The global medical network Education Against Tobacco-voluntary tobacco prevention made in Germany]. / Das weltweite Medizinernetzwerk Aufklärung gegen Tabak ­ Ehrenamtliche Prävention made in Germany.

Smoking is the leading preventable cause of premature death in Germany. The network "Education Against Tobacco" (EAT) is an initiative that was founded in Germany in 2012, in which more than 3500 medical students and physicians engage in volunteer work in about 80 medical faculties in 14 countries. In this article, the concept, activities, objectives and associated research studies oft he EAT initiative are introduced.On the school level, the initiative addresses 10- to 15-year-old secondary school students. In addition to a multimodal approach, school visits use modern media such as facemorphing apps, which are not only used by students (45,000 per year in 14 countries), but by a total of over 500,000 other people as well. The effectiveness of the school-based intervention is currently being investigated in randomised long-term studies with 20,000 adolescents in Germany. A first long-term study demonstrated evidence of a protective effect regarding the onset of smoking, especially among female students, students having a low level of education and students with a migratory background.The programme educates several hundred prospective physicians at 13 (of 28 participating) German medical faculties each year in science-based elective courses for the well-established smoking cessation counselling of patients and sensitises them to the tobacco epidemic. The approved members engage in dialogue with local members of the German house of representatives as "Ärzteverband Tabakprävention".EAT motivates the prospective generation of physicians, initially through prevention in school settings, to face the challenge of national tobacco control at the university and federal level.

Evaluation of a medical student-delivered smoking prevention program utilizing a face-aging mobile app for secondary schools in Germany: The Education Against Tobacco cluster-randomized controlled trial.

BACKGROUND: To reduce smoking uptake in adolescents, the medical students' network Education Against Tobacco (EAT) has developed a school-based intervention involving a face-aging mobile app (Smokerface). METHODS: A two-arm cluster-randomized controlled trial was conducted, evaluating the 2016 EAT intervention, which employed the mobile app Smokerface and which was delivered by medical students. Schools were randomized to intervention or control group. Surveys were conducted at baseline (pre-intervention) and at 9, 16, and 24 months post-intervention via paper & pencil questionnaires. The primary outcome was the difference in within-group changes in smoking prevalence between intervention and control group at 24 months. RESULTS: Overall, 144 German secondary schools comprising 11,286 pupils participated in the baseline survey, of which 100 schools participated in the baseline and at least one of the follow-up surveys, yielding 7437 pupils in the analysis sample. After 24 months, smoking prevalence was numerically lower in the intervention group compared to control group (12.9 % vs. 14.3 %); however, between-group differences in change in smoking prevalence between baseline and 24-months follow-up (OR=0.83, 95 %-CI: 0.64-1.09) were not statistically significant (p = 0.176). Intention to start smoking among baseline non-smokers declined non-significantly in the intervention group (p = 0.064), and remained essentially unchanged in the control group, but between-group differences in changes at the 24-months follow-up (OR=0.88, 0.64-1.21) were not statistically significant (p = 0.417). CONCLUSION: While a trend towards beneficial effects of the intervention regarding smoking prevalence as well as intention to start smoking among baseline non-smokers was observed, our smoking prevention trial demonstrated no significant effect of the intervention.

Sex-related differences in functional capacity and its implications in risk stratification before major non-cardiac surgery: a post hoc analysis of the international METS study.

Background: Poor functional capacity has been identified as an important modifiable risk factor for postoperative complications. Cardiopulmonary exercise testing (CPET) provides objective parameters of functional capacity (e.g., oxygen consumption at peak exercise, peak VO2), with significant prognostication for postoperative complications. However, sex-specific thresholds for functional capacity to predict surgical risk are yet to be established. Therefore, we performed a post hoc analysis of the international, multicentre, prospective observational METS (Measurement of Exercise Tolerance before Surgery) study to evaluate if sex-specific thresholds of peak VO2 improve risk prediction of postoperative complications. Methods: We undertook a post hoc analysis (HREC/71824/PMCC) of the METS study, which was performed between March 2013 and March 2016. We investigated whether sex-specific differences exist for CPET-derived parameters and associated thresholds for predicting postoperative complications in this large cohort of patients that had major non-cardiac surgery (n = 1266). Logistic regression models were analyzed for the association of low peak VO2 with moderate-to-severe in-hospital postoperative complications. Optimal sex-specific peak VO2 thresholds were obtained by maximizing the Youden index of receiver operating characteristic (ROC) curves. Finally, multivariable logistic regression models tested the resulting sex-specific thresholds against the established non-sex-specific peak VO2 threshold (14 mL kg-1 min-1) adjusted for clinically relevant features such as comorbidities and surgical complexity. Models were evaluated by bootstrapping optimism-corrected area under the ROC curve and the net reclassification improvement index (NRI). Findings: Female patients (n = 480) had a lower mean (SD) peak VO2 than males (16.7 (4.9) mL kg-1 min-1 versus 21.2 (6.5) mL kg-1 min-1, p < 0.001) and a lower postoperative complication rate (10.4% versus 15.3%; p = 0.018) than males (n = 786). The optimal peak VO2 threshold for predicting postoperative complications was 12.4 mL kg-1 min-1 for females and 22.3 mL kg-1 min-1 for males, respectively. In the multivariable regression model, low non-sex-specific peak VO2 did not independently predict postoperative complications. In contrast, low sex-specific peak VO2 was an independent predictor of postoperative complications (OR 2.29; 95% CI: 1.60, 3.30; p < 0.001). The optimism-corrected AUC-ROC of the sex-specific model was higher compared with the non-sex-specific model (0.73 versus 0.7; DeLong's test: p = 0.021). The sex-specific model classified 39% of the patients more correctly than the baseline model (NRI = 0.39; 95% CI: 0.24, 0.55). In contrast, the non-sex-specific model only classified 9% of the patients more correctly when compared against the baseline model (NRI = 0.09; 95% CI: -0.04, 0.22). Interpretation: Our data report sex-specific differences in preoperative CPET-derived functional capacity parameters. Sex-specific peak VO2 thresholds identify patients at increased risk for postoperative complications with a higher discriminatory ability than a sex-unspecific threshold. As such, sex-specific threshold values should be considered in preoperative CPET to potentially improve risk stratification and to guide surgical decision-making, including eligibility for surgery, preoperative optimization strategies (prehabilitation) or seeking non-surgical options. Funding: There was no funding for the present study. The original METS study was funded by Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Ontario Ministry of Health and Long-Term Care, Ontario Ministry of Research, Innovation and Science, UK National Institute of Academic Anaesthesia, UK Clinical Research Collaboration, Australian and New Zealand College of Anaesthetists, and Monash University.

End-tidal carbon dioxide in the early phase of cardiopulmonary exercise testing prior to major colorectal cancer surgery associates with postoperative outcome.

BACKGROUND: Cardiopulmonary exercise testing (CPET) objectively informs preoperative risk stratification prior to major surgery. CPET facilities are resource intensive and therefore more cost-effective triage methods are desirable for scalability. We tested two dynamic CPET parameters (end-tidal CO2 (PetCO2) and heart rate (HR)) to early phase exercise and resting diffusion capacity (DLCO) as potential point of care assessments that could be used outside of formal CPET testing facilities. METHODS: We conducted a retrospective cohort study including 84 patients who underwent CPET prior to elective major abdominal cancer surgery. Data were analyzed for PetCO2 and HR in response to early phase (2 minutes) exercise as well as resting DLCO against postoperative complications and two-year survival. Complications were classified according to Clavien-Dindo classification into less severe and severe (CD>IIIb) grades. Optimal cut points for predicting outcomes were determined using the Youden Index of receiver operating characteristic (ROC) curves. Multivariate regression modeling including both logistic and Cox proportional-hazards model adjusted to age and comorbidity burden was used to analyse the association between the selected parameters and postoperative outcomes. RESULTS: PetCO2, in response to two minutes of loaded exercise was higher in survivors than in non-survivors (median (IQR) 40.0 (4.2) mmHg vs. 34.5 (5.2) mmHg, P<0.001). There was no association between chronotropic response and postoperative outcome. The optimal cut point for predicting postoperative complications and survival was 38 mmHg and 37.1 mmHg for PetCO2, respectively. Low PetCO2 was associated with considerably lower odds of survival (OR 0.12; 95% CI 0.03, 0.47; P=0.003) and additionally increased odds of severe postoperative complications (OR 6.77; 95% CI 1.45, 38.4; P=0.019). Reduced age-predicted DLCO% <80% was associated with increased mortality (HR 5.27; 95% CI 1.09, 25.5; P=0.039). CONCLUSIONS: Assessment of DLCO at rest and dynamic assessment of PetCO2 during the early phase of exercise may potentially be developed as inexpensive point-of-care triage tools to scale objective preoperative risk assessment.

Process Evaluation of a Medical Student-Delivered Smoking Prevention Program for Secondary Schools: Protocol for the Education Against Tobacco Cluster Randomized Trial.

BACKGROUND: Most smokers start smoking during their early adolescence under the impression that smoking entails positive attributes. Given the addictive nature of cigarettes, however, many of them might end up as long-term smokers and suffering from tobacco-related diseases. To prevent tobacco use among adolescents, the large international medical students' network Education Against Tobacco (EAT) educates more than 40,000 secondary school students per year in the classroom setting, using evidence-based self-developed apps and strategies. OBJECTIVE: This study aimed to evaluate the long-term effectiveness of the school-based EAT intervention in reducing smoking prevalence among seventh-grade students in Germany. Additionally, we aimed to improve the intervention by drawing conclusions from our process evaluation. METHODS: We conduct a cluster-randomized controlled trial with measurements at baseline and 9, 16, and 24 months postintervention via paper-and-pencil questionnaires administered by teachers. The study groups consist of randomized schools receiving the 2016 EAT curriculum and control schools with comparable baseline data (no intervention). The primary outcome is the difference of change in smoking prevalence between the intervention and control groups at the 24-month follow-up. Secondary outcomes are between-group differences of changes in smoking-related attitudes and the number of new smokers, quitters, and never-smokers. RESULTS: A total of 11,268 students of both sexes, with an average age of 12.32 years, in seventh grade of 144 secondary schools in Germany were included at baseline. The prevalence of cigarette smoking in our sample was 2.6%. The process evaluation surveys were filled out by 324 medical student volunteers, 63 medical student supervisors, 4896 students, and 141 teachers. CONCLUSIONS: The EAT cluster randomized trial is the largest school-based tobacco-prevention study in Germany conducted to date. Its results will provide important insights with regards to the effectiveness of medical student-delivered smoking prevention programs at school. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13508.

A Face-Aging Smoking Prevention/Cessation Intervention for Nursery School Students in Germany: An Appearance-Focused Interventional Study.

The Education Against Tobacco (EAT) network delivers smoking prevention advice in secondary schools, typically using the mirroring approach (i.e., a "selfie" altered with a face-aging app and shared with a class). In November 2017, however, the German assembly of EAT opted to expand its remit to include nursing students. To assess the transferability of the existing approach, we implemented it with the self-developed face-aging app "Smokerface" (=mixed - methods approach) in six nursing schools. Anonymous questionnaires were used to assess the perceptions of 197 students (age 18⁻40 years; 83.8% female; 26.4% smokers; 23.3% daily smokers) collecting qualitative and quantitative data for our cross-sectional study. Most students perceived the intervention to be fun (73.3%), but a minority disagreed that their own animated selfie (25.9%) or the reaction of their peers (29.5%) had motivated them to stop smoking. The impact on motivation not to smoke was considerably lower than experienced with seventh graders (63.2% vs. 42.0%; notably, more smokers also disagreed (45.1%) than agreed (23.5%) with this statement. Agreement rates on the motivation not to smoke item were higher in females than in males and in year 2⁻3 than in year 1 students. Potential improvements included greater focus on pathology (29%) and discussing external factors (26%). Overall, the intervention seemed to be appealing for nursing students.

Facial-Aging Mobile Apps for Smoking Prevention in Secondary Schools in Brazil: Appearance-Focused Interventional Study.

BACKGROUND: Most smokers start smoking during their early adolescence, often with the idea that smoking is glamorous. Interventions that harness the broad availability of mobile phones as well as adolescents' interest in their appearance may be a novel way to improve school-based prevention. A recent study conducted in Germany showed promising results. However, the transfer to other cultural contexts, effects on different genders, and implementability remains unknown. OBJECTIVE: In this observational study, we aimed to test the perception and implementability of facial-aging apps to prevent smoking in secondary schools in Brazil in accordance with the theory of planned behavior and with respect to different genders. METHODS: We used a free facial-aging mobile phone app ("Smokerface") in three Brazilian secondary schools via a novel method called mirroring. The students' altered three-dimensional selfies on mobile phones or tablets and images were "mirrored" via a projector in front of their whole grade. Using an anonymous questionnaire, we then measured on a 5-point Likert scale the perceptions of the intervention among 306 Brazilian secondary school students of both genders in the seventh grade (average age 12.97 years). A second questionnaire captured perceptions of medical students who conducted the intervention and its conduction per protocol. RESULTS: The majority of students perceived the intervention as fun (304/306, 99.3%), claimed the intervention motivated them not to smoke (289/306, 94.4%), and stated that they learned new benefits of not smoking (300/306, 98.0%). Only a minority of students disagreed or fully disagreed that they learned new benefits of nonsmoking (4/306, 1.3%) or that they themselves were motivated not to smoke (5/306, 1.6%). All of the protocol was delivered by volunteer medical students. CONCLUSIONS: Our data indicate the potential for facial-aging interventions to reduce smoking prevalence in Brazilian secondary schools in accordance with the theory of planned behavior. Volunteer medical students enjoyed the intervention and are capable of complete implementation per protocol.