The role of CRP and Pentraxin 3 in the prediction of systemic inflammatory response syndrome and death in acute pancreatitis.

Pentraxin 3 (PTX3) is an acute phase protein. Our goal was to assess PTX3 as a predictor of systemic inflammatory response syndrome (SIRS), death and disease severity in acute pancreatitis (AP) in comparison to C-reactive protein (CRP) and the APACHE II score. From April 2011 to January 2015, 142 patients with AP were included in this single center post hoc analysis of prospectively collected data at the University Hospital Basel, Switzerland. Disease severity was rated by the revised Atlanta criteria (rAC). Inflammatory response was measured by the SIRS criteria. PTX3, CRP and APACHE II score were measured. Patients median PTX3 plasma concentrations in AP were higher in moderate (3.311 ng/ml) and severe (3.091 ng/ml) than in mild disease (2.461 ng/ml). Overall, 59 occurrences of SIRS or death were observed. In the prediction of SIRS or death, PTX3 was inferior to CRP and APACHE II, with modest predictive discriminatory ability of all three markers and AUC of 0.54, 0.69 and 0.69, respectively. Upon combination of CRP with PTX3, AUC was 0.7. PTX3 seems to be inferior to CRP and APACHE II in the prediction of SIRS or death in AP and does not seem to improve the predictive value of CRP upon combination of both parameters.

Cost Estimates for Human Immunodeficiency Virus (HIV) Care and Patient Characteristics for Health Resource Use From Linkage of Claims Data With the Swiss HIV Cohort Study.

BACKGROUND: Comprehensive and representative data on resource use are critical for health policy decision making but often lacking for human immunodeficiency virus (HIV) infection. Privacy-preserving probabilistic record linkage of claim and cohort study data may overcome these limitations. METHODS: Encrypted dates of birth, sex, study center, and antiretroviral therapy (ART) from the Swiss HIV Cohort Study (SHCS) records for 2012 and 2013 were linked by privacy-preserving probabilistic record linkage with claim data from the largest health insurer covering 15% of the Swiss residential population. We modeled predictors for mean annual costs adjusting for censoring and grouped patients by cluster analysis into 3 risk groups for resource use. RESULTS: The matched subsample of 1196 patients from 9326 SHCS and 2355 claim records was representative for all SHCS patients receiving ART. The corrected mean (standard error) total costs in 2012 and 2013 were $30462 ($582) and $30965 ($629) and mainly accrued in ambulatory care for ART (70% of mean costs). The low-risk group for resource use had mean (standard error) annual costs of $26772 ($536) and $26132 ($589) in 2012 and 2013. In the moderate- and high-risk groups, annual costs for 2012 and 2013 were higher by $3526 (95% confidence interval, $1907-$5144) (13%) and $4327 ($2662-$5992) (17%) and $14026 ($8763-$19289) (52%) and $13567 ($8844-$18288) (52%), respectively. CONCLUSIONS: In a representative subsample of patients from linkage of SHCS and claim data, ART was the major cost factor, but patient profiling enabled identification of factors related to higher resource use.

Exercise, Arterial Crosstalk-Modulation, and Inflammation in an Aging Population: The ExAMIN AGE Study.

Background: Age is a key determinant for the development of cardiovascular disease and higher age coincides with an increased prevalence of obesity and physical inactivity. The study examines the influence of physical activity on aging processes of physiological systems focusing on the mechanisms of vascular aging. Methods/Design: The study consists of two parts. The cross-sectional approach aims at examining the association of physical fitness and cardiovascular risk with large and small artery function in healthy older active (HOA, n = 40) and sedentary (HOS, n = 40) persons as well as older sedentary individuals with increased cardiovascular risk (OSR, n = 80) aged 50-80 years. In the interventional approach, the OSR group is randomized into a 12-week walking-based high intensity interval training (HIIT) group or a control condition, aiming at examining the effects of HIIT on arterial function in diseased older adults. Active lifestyle is defined as >9 metabolic equivalent of task (MET) per week and sedentary as ≤3 MET/week. Inclusion criteria for OSR are overweight or obesity (body mass index ≥30 kg/m2) plus at least one additional cardiovascular risk factor. The primary outcome is arterial stiffness as determined by aortic pulse wave velocity (PWV). The secondary outcomes are retinal arterial and venous diameters. Further cardiovascular assessments include peripheral PWV, central haemodynamics, retinal endothelial function, carotid intima media thickness, cardiac strain and diastolic function as well as autonomic function and inflammation. Physical fitness is measured by a treadmill-based spiroergometry to determine peak oxygen uptake. Discussion: The aim of the study is to demonstrate the importance of and need for specific physical activity programs for seniors to achieve healthier aging as a long-term goal. Vascular function defines disease- and age-related end organ damage and represents the potential to contain health at older age. This research will identify cardiovascular biomarkers that best resemble underlying cardiovascular risk in age and disease. The integrated approach will help define new recommendations for treatment guidance of exercise therapy in an aging population. ClinicalTrials. gov: NCT02796976; registered 02 June 2016 (retrospectively registered).

Retinal Vessel Diameters and Physical Activity in Patients With Mild to Moderate Rheumatic Disease Without Cardiovascular Comorbidities.

Objectives: Low-grade systemic inflammation is responsible for atherosclerotic lesions in patients with rheumatic diseases. Vascular dysfunction is a precursor of atherosclerosis and can be improved by physical activity (PA). Our aim was to asses micro- and macrovascular function as well as PA and cardiorespiratory fitness (CRF) in patients with rheumatic diseases in the absence of cardiovascular (CV) comorbidities compared to controls. Methods: Fifty-one patients without CV comorbidities were compared to 35 controls. Retinal microvascular diameters were assessed using a Retinal Vessel Analyzer. Arterial stiffness (AST) was measured by applanation tonometry. CRF was assessed as peak oxygen consumption and PA was assessed with a questionnaire. Results: Retinal venular diameters were significantly wider in patients [median 221 µm (interquartile range (IQR) 211, 231)] compared to controls [median 215 µm (IQR 196, 223); p = 0.01]. One hour increase of PA per week led to a venular constriction of -0.56 µm (95%CI -1.09, -0.03; p = 0.04). In our patients with low disease activity (median DAS28 1.9; median BASDAI 2.8), no differences in AST were evident compared to controls. The association of PA and CRF with AST was not independent of blood pressure. Conclusions: Patients with rheumatic disease and mild-to-moderate disease activity show an impairment of the retinal microvasculature but not of large artery stiffness. Retinal vessel analysis seems to be a sensitive biomarker to unmask vascular impairments even in the absence of classic CV risk factors. PA may have the potential to counteract the development of small artery disease at early stages of rheumatic disease.

Cortisol Outperforms Novel Cardiovascular, Inflammatory, and Neurohumoral Biomarkers in the Prediction of Outcome in Acute Pancreatitis.

OBJECTIVES: The aims of this study were to assess whether copeptin, pro-atrial natriuretic peptide, proadrenomedullin, and cortisol are associated with disease severity in patients with acute pancreatitis (AP) and to compare their ability in predicting organ failure or death. METHODS: From April 2011 to January 2015, 142 patients with AP were included in this prospective single-center study and observed for 4 days. Disease severity was rated by the Atlanta 1992 and 2012 criteria and organ failure by the modified Marshall score. The aforementioned laboratory markers, C-reactive protein, and procalcitonin were measured. RESULTS: Patients with moderate to severe AP showed significantly higher plasma concentrations of all biomarkers than did those with mild AP. Overall, 30 organ failures or deaths occurred. All biomarkers except cortisol had only modest discriminatory ability, with areas under the receiver operating characteristic curve (AUCs) between 0.44 and 0.66. Cortisol showed an AUC of 0.78 compared with the Acute Physiology and Chronic Health Evaluation II score with an AUC of 0.75. CONCLUSIONS: Cortisol was the best predictor of organ failure or death. All biomarkers were associated with disease severity to a similar degree as C-reactive protein, the criterion-standard marker in AP. Further studies are warranted to define their clinical role.

Effect of E-Bike Versus Bike Commuting on Cardiorespiratory Fitness in Overweight Adults: A 4-Week Randomized Pilot Study.

OBJECTIVE: To assess if active commuting with an electrically assisted bicycle (e-bike) during a 4-week period can induce increases in cardiorespiratory fitness measured as peak oxygen uptake (V[Combining Dot Above]O2peak) in untrained, overweight individuals, and if these changes are comparable with those induced by a conventional bicycle. DESIGN: Four-week randomized pilot study. SETTING: Controlled laboratory. PARTICIPANTS: Thirty-two volunteers (28 men) participated. Seventeen {median age 37 years [interquartile range (IQR) 34, 45], median body mass index [BMI] 29 kg/m [IQR 27, 31]} were randomized to the E-Bike group and 15 [median age 43 years (IQR 38, 45), median BMI 28 kg/m (IQR 26, 29)] to the Bike group. INTERVENTIONS: Participants in both groups were instructed to use the bicycle allocated to them (e-bike or conventional bicycle) for an active commute to work in the Basel (Switzerland) area at a self-chosen speed on at least 3 days per week during the 4-week intervention period. MAIN OUTCOME MEASURES: V[Combining Dot Above]O2peak was assessed before and after the intervention in an all-out exercise test on a bicycle ergometer. RESULTS: V[Combining Dot Above]O2peak increased by an average of 3.6 mL/(kg·min) [SD 3.6 mL/(kg·min)] in the E-Bike group and by 2.2 mL/(kg·min) [SD 3.5 mL/(kg·min)] in the Bike group, with an adjusted difference between the 2 groups of 1.4 mL/(kg·min) [95% confidence interval, -1.4-4.1; P = 0.327]. CONCLUSIONS: E-bikes may have the potential to improve cardiorespiratory fitness similar to conventional bicycles despite the available power assist, as they enable higher biking speeds and greater elevation gain.

Colon Perfusion Patterns During Colorectal Resection Using Visible Light Spectroscopy.

BACKGROUND: The impact of blood supply to the anastomosis on development of anastomotic leakage is still a matter of debate. Considering that bowel perfusion may be affected by manipulation during surgery, perfusion assessment of the anastomosis alone may be of limited value. We propose perfusion assessment at different time points during surgery to explore the dynamics of bowel perfusion during colorectal resection and its impact on outcome. METHODS: In this prospective cohort study, patients undergoing elective colorectal resection were eligible. Colon perfusion was evaluated using visible light spectroscopy. Main outcome was the difference in colon perfusion, quantified by measuring tissue oxygen saturation (StO2) in the colonic serosa, before and after anastomosis during surgery. RESULTS: We included 58 patients between July 2013 and November 2015. Colon perfusion increased by an average of 5.9% StO2 during surgery (95% confidence interval 3.1, 8.8; P < 0.001). The number of patients with abnormal perfusion (defined as StO2 < 65%) decreased from 50% at the beginning to 24% by the end of surgery. Six patients (10%) developed anastomotic leaks (AL), of which five patients had abnormal perfusion at the beginning of surgery, whereas four patients had normal StO2 at the anastomosis. CONCLUSION: Colon perfusion significantly increased during colorectal surgery. Considering that one quarter of patients had suboptimal anastomotic perfusion without developing AL, impaired blood flow at the anastomosis alone does not seem to be critical. Further investigations including more patients are necessary to evaluate the impact of perioperative parameters on colon perfusion, anastomotic healing and surgical outcome.

Effects of bright and blue light on acoustic reaction time and maximum handgrip strength in male athletes: a randomized controlled trial.

PURPOSE: To assess which type of evening light exposure has the greatest effect on reaction time and maximum handgrip strength. These were pre-specified secondary outcomes in a trial which primarily investigated the influence of light on cycling performance. METHODS: Seventy-four male athletes were allocated at random to either bright light (BRIGHT), monochromatic blue light (BLUE), or a control condition (CONTROL). Light exposure lasted for 60 min and started 17 h after the individual midpoint of sleep. Reaction time, handgrip strength, and melatonin levels were measured before and after the light exposure. We used analysis of covariance to compare the groups with respect to the investigated outcomes. RESULTS: Two participants had to be excluded retrospectively. The remaining 72 participants had a median age of 23 years. The adjusted difference in reaction time was -1 ms [95% confidence interval (CI) -8, 6] for participants in BRIGHT and 2 ms (95% CI -5, 9) for participants in BLUE, both relative to participants in CONTROL. The adjusted difference in handgrip strength was 0.9 kg (95% CI -1.5, 3.3) for participants in BRIGHT and -0.3 kg (95% CI -2.7, 2.0) for participants in BLUE, both relative to participants in CONTROL. After the light exposure, 17% of participants in BRIGHT, 22% in BLUE, and 29% in CONTROL showed melatonin concentrations of 2 pg/ml or higher. CONCLUSIONS: The results suggest that bright light might reduce melatonin levels but neither bright nor blue light exposure in the evening seem to improve reaction time or handgrip strength in athletes.

Prime Time Light Exposures Do Not Seem to Improve Maximal Physical Performance in Male Elite Athletes, but Enhance End-Spurt Performance.

Many sports competitions take place during television prime time, a time of the day when many athletes have already exceeded their time of peak performance. We assessed the effect of different light exposure modalities on physical performance and melatonin levels in athletes during prime time. Seventy-two young, male elite athletes with a median (interquartile range) age of 23 (21; 29) years and maximum oxygen uptake (VO2max) of 63 (58; 66) ml/kg/min were randomly assigned to three different light exposure groups: bright light (BRIGHT), blue monochromatic light (BLUE), and control light (CONTROL). Each light exposure lasted 60 min and was scheduled to start 17 h after each individual's midpoint of sleep (median time: 9:17 pm). Immediately after light exposure, a 12-min time trial was performed on a bicycle ergometer. The test supervisor and participants were blinded to the light condition each participant was exposed to. The median received light intensities and peak wavelengths (photopic lx/nm) measured at eye level were 1319/545 in BRIGHT, 203/469 in BLUE, and 115/545 in CONTROL. In a multivariate analysis adjusted for individual VO2max, total work performed in 12 min did not significantly differ between the three groups. The amount of exposure to non-image forming light was positively associated with the performance gain during the time trial, defined as the ratio of the work performed in the first and last minute of the time trial, and with stronger melatonin suppression. Specifically, a tenfold increase in the exposure to melanopic light was associated with a performance gain of 8.0% (95% confidence interval: 2.6, 13.3; P = 0.004) and a melatonin decrease of -0.9 pg/ml (95% confidence interval: -1.5, -0.3; P = 0.006). Exposure to bright or blue light did not significantly improve maximum cycling performance in a 12-min all-out time trial. However, it is noteworthy that the estimated difference of 4.1 kJ between BRIGHT and CONTROL might represent an important performance advantage justifying further studies. In conclusion, we report novel evidence that evening light exposure, which strongly impacts the human circadian timing system, enables elite athletes to better maintain performance across a 12-min cycling time trial.

Mobile Exergaming for Health-Effects of a serious game application for smartphones on physical activity and exercise adherence in type 2 diabetes mellitus-study protocol for a randomized controlled trial.

BACKGROUND: Exergaming is a novel approach to increase motivation for regular physical activity (PA) among sedentary individuals such as patients with type 2 diabetes mellitus (T2DM). Because existing exergames do not offer fitness-level adjusted, individualized workouts and are normally stationary (TV bound), thus not enabling PA anywhere and at any time, we developed a smartphone-based, game-like software application (MOBIGAME) specifically designed for middle-aged T2DM patients to induce a healthier, more active lifestyle as part of successful T2DM treatment and management. In a randomized controlled trial we aim to examine whether our smartphone-based game application can lead to increases in daily PA in T2DM patients that are persistent in the mid to long term and whether these increases are greater than those in a control group. METHODS: This study is designed as a randomized controlled trial. We plan to recruit a total of 42 T2DM patients [45-70 years, body mass index (BMI) ≥25 kg/m2, low daily PA, regular smartphone use]. The experimental intervention (duration 24 weeks) includes individualized multidimensional home-based exercise and daily PA promotion administered through MOBIGAME. The control intervention consists of a one-time standard lifestyle counseling including the promotion of baseline activities. The primary outcome is daily PA measured as steps per day. Secondary outcome is exercise adherence measured via the usage data from the participants' smartphones (experimental intervention) and as self-recorded exercise log entries (control intervention). We will test the hypothesis that there will be differences between the experimental and control group with respect to post-interventional daily PA (as well as all other outcomes) using analysis of covariance. For each analysis, an estimate (with 95% confidence interval) of the difference in outcome between both groups will be reported. DISCUSSION: This research will investigate the effectiveness of a novel smartphone-based, game-like software application to be used as a way to promote regular daily PA among inactive T2DM patients. The results of this trial may have important implications for future PA-promoting interventions and provide relevant information for the general transferability of such applications to be used as part of the treatment in other chronic diseases. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02657018 . Registered on 11 January 2016. Last status update on 3 May 2016. Kofam.ch, SNCTP-number:SNCTP000001652. Registered on 21 January 2016.

High prevalence of physical inactivity among patients from the Swiss HIV Cohort Study.

Physical activity (PA) can improve cardiorespiratory status, strength, body composition and quality of life for patients infected with HIV. Evidence from HIV-uninfected populations also shows that PA is associated with a lower risk of mortality, primarily death due to cardiovascular causes. There is, however, a lack of data on how physically active HIV-infected patients are. In this study, we assessed levels of self-reported PA over time in patients enrolled in the Swiss HIV Cohort Study, a large multicentre prospective observational cohort study. We included a total of 10,540 patients who completed at least one report of PA between December 2009 and November 2014 during routine clinical follow-up (scheduled every 6 months). In the first year after December 2009 there was a higher rate of non-response so these data are of a lesser reliability. Over the next four years, the percentage of patients reporting no free-time PA at all declined from 49% to 44%. In contrast, in two "Sport Switzerland" surveys of the general population in 2008 and 2014, the percentage of individuals reporting no sports activities at all was considerably lower and relatively stable over time (27% in 2008; 26% in 2014). In our analysis, the percentage of patients reporting sedentary activity at work increased from 23% to 26% over the four years. Subgroup findings suggest differences between women and men and between patients classified by their age, stage of infection and CD4 cell count. Integrating PA counselling into the routine care of HIV-infected patients and promoting PA among this population has the potential to improve the general state of health and quality of life for HIV-infected patients and reduce their risk of cardiovascular disease.

ZumBeat: Evaluation of a Zumba Dance Intervention in Postmenopausal Overweight Women.

Physical inactivity is a major public health concern since it increases individuals' risk of morbidity and mortality. A subgroup at particular risk is postmenopausal overweight women. The aim of this study was to assess the feasibility and effect of a 12-week ZumBeat dance intervention on cardiorespiratory fitness and psychosocial health. Postmenopausal women with a body mass index (BMI) >30 kg/m² or a waist circumference >94 cm who were not regularly physically active were asked to complete a 12-week ZumBeat dance intervention with instructed and home-based self-training sessions. Before and after the intervention, peak oxygen consumption (VO2peak) was assessed on a treadmill; and body composition and several psychometric parameters (including quality of life, sports-related barriers and menopausal symptoms) were investigated. Of 17 women (median age: 54 years; median BMI: 30 kg/m²) enrolled in the study, 14 completed the study. There was no apparent change in VO2peak after the 12-week intervention period (average change score: -0.5 mL/kg/min; 95% confidence interval: -1.0, 0.1); but, quality of life had increased, and sports-related barriers and menopausal symptoms had decreased. A 12-week ZumBeat dance intervention may not suffice to increase cardiorespiratory fitness in postmenopausal overweight women, but it increases women's quality of life.

Fullerenols and glucosamine fullerenes reduce infarct volume and cerebral inflammation after ischemic stroke in normotensive and hypertensive rats.

Cerebral inflammation plays a crucial role in the pathophysiology of ischemic stroke and is involved in all stages of the ischemic cascade. Fullerene derivatives, such as fullerenol (OH-F) are radical scavengers acting as neuroprotective agents while glucosamine (GlcN) attenuates cerebral inflammation after stroke. We created novel glucosamine-fullerene conjugates (GlcN-F) to combine their protective effects and compared them to OH-F regarding stroke-induced cerebral inflammation and cellular damage. Fullerene derivatives or vehicle was administered intravenously in normotensive Wistar-Kyoto (WKY) rats and spontaneously hypertensive rats (SHR) immediately after transient middle cerebral artery occlusion (tMCAO). Infarct size was determined at day 5 and neurological outcome at days 1 and 5 after tMCAO. CD68- and NeuN-staining were performed to determine immunoreactivity and neuronal survival respectively. Cytokine and toll like receptor 4 (TLR-4) expression was assessed using quantitative real-time PCR. Magnetic resonance imaging revealed a significant reduction of infarct volume in both, WKY and SHR that were treated with fullerene derivatives. Treated rats showed an amelioration of neurological symptoms as both OH-F and GlcN-F prevented neuronal loss in the perilesional area. Cerebral immunoreactivity was reduced in treated WKY and SHR. Expression of IL-1ß and TLR-4 was attenuated in OH-F-treated WKY rats. In conclusion, OH-F and GlcN-F lead to a reduction of cellular damage and inflammation after stroke, rendering these compounds attractive therapeutics for stroke.

Functional results after chest wall stabilization with a new screwless fixation device.

OBJECTIVES: This is the experience with the Stratos system in two surgical centres for the management of two types of rib fractures: flail chest and multiple dislocated rib fractures with significant chest wall deformity. METHODS: From January 2009 to May 2012, 94 consecutive patients were included. Selected indications were extended anterolateral flail chest (n = 68) and dislocated painful rib fractures (n = 26). The open reduction internal fixation (ORIF) system consists of flexible titanium rib clamps and connecting plates. The postoperative course was assessed. Clinical and functional outcomes were evaluated at 6 months. Functional assessment consisted of measurement of the functional vital capacity (FVC) and magnetic resonance imaging (MRI) examination with determination of the radiological vital capacity (rVC) in patients with a flail chest. RESULTS: The median operation time and length of hospital stay were 122 min and 19 days, respectively, in patients with a flail chest, and 67 min and 11 days, respectively, in patients with dislocated painful rib fractures. The morbidity rate was 6.4% and the overall 30-day mortality rate was 1.1%. Clinical evaluation and pulmonary function testing at 6 months revealed no deformity of the chest wall, symmetrical shoulder girdle mobility in 88% and a feeling of stiffness on the operated side in 19% of the patients operated for a flail chest. Median ratio of FVC was 88%, not suggesting any restriction after stabilization. MRI was performed in 53% (36 of 68) of the patients with a flail chest. The analysis of the rVC showed, on average, no clinically relevant restriction related to the operation, with a mean rVC of the operated relative to the non-operated side of 92% (95% confidence interval: 83, 100). Stabilization of more than four ribs was associated with a lower median rVC than stabilization of four or less ribs. CONCLUSIONS: Our results suggest that stabilization of the chest wall with this screwless rib fixation device can be performed with a low morbidity and lead to early restoration of chest wall integrity and respiratory pump function, without clinically relevant functional restriction. Owing to the simplicity of the fixation technique, indications for stabilization can be safely enlarged to selected patients with dislocated and painful rib fractures.

Effect of different warm-up strategies on simulated laparoscopy performance: a randomized controlled trial.

OBJECTIVE: The objective of this trial was to assess which type of warm-up has the highest effect on virtual reality (VR) laparoscopy performance. The following warm-up strategies were applied: a hands-on exercise (group 1), a cognitive exercise (group 2), and no warm-up (control, group 3). DESIGN: This is a 3-arm randomized controlled trial. SETTING: The trial was conducted at the department of surgery of the University Hospital Basel in Switzerland. PARTICIPANTS: A total of 94 participants, all laypersons without any surgical or VR experience, completed the study. RESULTS: A total of 96 participants were randomized, 31 to group 1, 31 to group 2, and 32 to group 3. There were 2 postrandomization exclusions. In the multivariate analysis, we found no evidence that the intervention had an effect on VR performance as represented by 6 calculated subscores of accuracy, time, and path length for (1) camera manipulation and (2) hand-eye coordination combined with 2-handed maneuvers (p = 0.795). Neither the comparison of the average of the intervention groups (groups 1 and 2) vs control (group 3) nor the pairwise comparisons revealed any significant differences in VR performance, neither multivariate nor univariate. VR performance improved with increasing performance score in the cognitive exercise warm-up (iPad 3D puzzle) for accuracy, time, and path length in the camera navigation task. CONCLUSIONS: We were unable to show an effect of the 2 tested warm-up strategies on VR performance in laypersons. We are currently designing a follow-up study including surgeons rather than laypersons with a longer warm-up exercise, which is more closely related to the final task.

Surgery for ischemic colitis: outcome and risk factors for in-hospital mortality.

PURPOSE: Surgery for ischemic colitis is associated with high perioperative morbidity and mortality, but the risk factors for mortality and major surgical complications are unclear. METHODS: In this retrospective single institution cohort study of all patients undergoing colorectal surgery for histologically proven ischemic colitis between 2004 and 2010, we evaluated surgical outcomes and risk factors for in-hospital mortality and major surgical complications. RESULTS: For the 100 patients included in the study, in-hospital mortality was 54 %; major surgical complications, defined as anastomotic leakage or rectal stump and stoma complications, occurred in 16 %. In the multivariable analysis, hospital death was more likely in patients with right-sided (odds ratio [OR] 3.8; 95 % confidence interval [CI] 1.2, 12; P = 0.022) or pan-colonic ischemia (OR 11; 95 % CI 2.8, 39; P < 0.001), both relative to left-sided ischemia. Decreased preoperative pH level (OR 2.5 per 0.1 decrease; 95 % CI 1.5, 4.1; P < 0.001) and prior cardiac or aortic surgery (OR 2.4; 95 % CI 0.82, 6.8; P = 0.109) were further important risk factors for in-hospital mortality. Major postoperative surgical complications were more likely in patients with ischemic alterations at the resection margin of the histological specimen (OR 3.7; 95 % CI 1.2, 11; P = 0.022). CONCLUSIONS: Colonic resection for ischemic colitis is associated with high in-hospital mortality, especially in patients with right-sided or pan-colonic ischemia. In patients developing acidosis, early laparotomy is essential. Since resection margins' affection seems to be underestimated upon surgery, resections should be performed wide enough within healthy tissue.

How to write a surgical clinical research protocol: literature review and practical guide.

BACKGROUND: The study protocol is the core document of every clinical research project. Clinical research in studies involving surgical interventions presents some specific challenges, which need to be accounted for and described in the study protocol. The aim of this review is to provide a practical guide for developing a clinical study protocol for surgical interventions with a focus on methodologic issues. DATA SOURCES: On the basis of an in-depth literature search of methodologic literature and on some cardinal published surgical trials and observational studies, the authors provides a 10-step guide for developing a clinical study protocol in surgery. CONCLUSIONS: This practical guide outlines key methodologic issues important when planning an ethically and scientifically sound research project involving surgical interventions, with the ultimate goal of providing high-level evidence relevant for health care decision making in surgery.

Procalcitonin guidance to reduce antibiotic treatment of lower respiratory tract infection in children and adolescents (ProPAED): a randomized controlled trial.

BACKGROUND: Antibiotics are overused in children and adolescents with lower respiratory tract infection (LRTI). Serum-procalcitonin (PCT) can be used to guide treatment when bacterial infection is suspected. Its role in pediatric LRTI is unclear. METHODS: Between 01/2009 and 02/2010 we randomized previously healthy patients 1 month to 18 years old presenting with LRTI to the emergency departments of two pediatric hospitals in Switzerland to receive antibiotics either according to a PCT guidance algorithm established for adult LRTI or standard care clinical guidelines. In intention-to-treat analyses, antibiotic prescribing rate, duration of antibiotic treatment, and number of days with impairment of daily activities within 14 days of randomization were compared between the two groups. RESULTS: In total 337 children, mean age 3.8 years (range 0.1-18), were included. Antibiotic prescribing rates were not significantly different in PCT guided patients compared to controls (OR 1.26; 95% CI 0.81, 1.95). Mean duration of antibiotic exposure was reduced from 6.3 to 4.5 days under PCT guidance (-1.8 days; 95% CI -3.1, -0.5; P = 0.039) for all LRTI and from 9.1 to 5.7 days for pneumonia (-3.4 days 95% CI -4.9, -1.7; P<0.001). There was no apparent difference in impairment of daily activities between PCT guided and control patients. CONCLUSION: PCT guidance reduced antibiotic exposure by reducing the duration of antibiotic treatment, while not affecting the antibiotic prescribing rate. The latter may be explained by the low baseline prescribing rate in Switzerland for pediatric LRTI and the choice of an inappropriately low PCT cut-off level for this population. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN17057980 http://www.controlled-trials.com/ISRCTN17057980.

Impact of an intensive 2-day endovascular training course on technical performance of trainees.

BACKGROUND: The objective of this study was to evaluate the effect of a 2-day international endovascular training course on the performance of trainees as compared with a control group, assessed in a bench model-based task using an objective structured evaluation protocol. METHODS: A total of 50 trainees, 28 course participants of 2 consecutive identical courses and a control group of 22 participants with a similar level of experience without course attendance, underwent baseline and final assessment (simulated arterial access task). The evaluation form consisted of a global assessment (GA), task-specific checklist percentage score (CL), and global rating scale percentage score (GR), with both percentage scores ranging from 0% (worst performance) to 100% (best performance). RESULTS: Course participants were more likely to pass the GA at final testing than the control group (odds ratio=59; 95% confidence interval [CI] 9.5-656; P<0.001). The estimated difference in percentage score at final testing between course participants and the control group was 26% (95% CI 18-34; P<0.001) for the CL and 29% (95% CI 19-40; P<0.001) for the GR. CONCLUSIONS: A 2-day structured endovascular training course significantly improves endovascular performance in a simulated environment. These results are important for the design of endovascular training curricula with the ultimate goal of contributing to patient safety.