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The volume usually cited is billions of records produced at a velocity of millions each day encompassing many variable types 20 mg levitra professional. The first was a 5-year (1948–1952) study of all postoperative deaths following about 600 levitra professional 20mg,000 anesthetics at 10 academic medical centers distributed across the United States levitra professional 20 mg. The other was the National Halothane51 Study 20mg levitra professional, which reported the rate of deaths and fatal hepatic necrosis during four 491 years (1959–1962) following about 850 ,000 anesthetics at 34 hospitals . Besides the Big Data of genomics and medical images , what else does Big Data promise? Messages posted to social media and inquiries on web search engines tally in the millions each day . Authors from the search engine company Google reported that by tallying search topics , for example , “Cold/flu remedy” or “Influenza complication,” this social media data predicted accurately flu trends across several years of flu epidemics; these predictions mirrored official health statistics of the rise and fall of infections. It was proposed that by harnessing the collective53 intelligence of millions of users, even faster surveillance of disease activity was possible. A more skeptical reexamination of these social media models found them not sufficient to replace timely local and national surveillance of health trends. Even with this perioperative data, no repository or administrative database meets the definition of Big Data. The use of58 prospective genotyping of patients prior to anesthesia and surgery would also create Big Data. Reprinted by permission and is published within a Cochrane Review in the Cochrane Database of Systematic Reviews 2009, Issue 2. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Review. The experimenter must60 submit an opinion as to the generalizability of his or her work to the rest of the world. Even if there is a statistically significant difference, the experimenter must decide if this difference is medically or physiologically important. The questions an experimenter should ask about the interpretation of results are highly dependent on the specifics of the experiment. First, even small, clinically unimportant differences between groups can be detected if the sample size is sufficiently large. On the other hand, if the sample size is small, one must always worry that identified or unidentified confounding variables may explain any difference; as the sample size decreases, randomization is less successful in assuring homogenous groups. Second, if the experimental groups are given three or more doses of a drug, do the results suggest a steadily increasing or decreasing dose–response relationship? Suppose the observed effect for an intermediate dose is either much higher or much lower than that for both the highest and lowest dose; a dose–response relationship may exist, but some skepticism about the experimental methods is warranted. Third, for clinical studies comparing different drugs, devices, and operations on patient outcome, are the patients, clinical care, and studied therapies sufficiently similar to those provided at other locations to be of interest to a wide group of practitioners? This is the distinction between efficacy—does it work under the best (research) circumstances—and effectiveness—does it work under the typical circumstances of routine clinical care? Finally, in comparing alternative therapies, the confidence that a claim for a superior therapy is true depends on the study design. The strength of the evidence concerning efficacy will be least for an anecdotal case report; next in importance will be a retrospective study, then a prospective series of patients 494 compared with historical controls, and finally a randomized, controlled clinical trial. The greatest strength for a therapeutic claim is a series of randomized, controlled clinical trials confirming the same hypothesis. Statistical Resources Accompanying the exponential growth of medical information has been the creation of a wealth of biostatistical knowledge. The increased emphasis on evidence-based medicine creates a great need for educating future and current physicians in quantitative reasoning, probability, and statistics. Detailed expositions of specific and recommended topics within these domains are available. Textbooks oriented toward medical statistics and with expositions61 of basic, intermediate, and advanced statistics abound. Some medical journals, for example, the British Medical Journal, regularly publish expositions of both basic and newer advanced statistical methods. Extensive Internet resources including free online courses of data analysis methods, electronic textbooks of basic statistical methods, online statistical calculators, standard data sets, and reviews of statistical software can be easily found. High performance statistical software is freely available from the R Foundation for Statistical Computing, Vienna, Austria. Much of the improvement has been driven by epidemiologists and statisticians associated with the Cochrane Collaboration. There is a centralized resource for74 obtaining these and other guidelines at the Equator-Network. Academic anesthesia needs more workers to immerse themselves in these statistical fundamentals. Having done so, these statistically knowledgeable academic anesthesiologists will be prepared to improve their own research projects, to assist their colleagues in research, to efficiently seek consultation from the professional statistician, to strengthen the editorial review of journal articles, and to expound to the clinical reader the whys and wherefores of statistics. The clinical reader also needs to expend his or her own effort to acquire some basic statistical skills. Journals are increasingly difficult to understand without some basic statistical understanding. Finally, understanding principles of experimental design and statistical inference can prevent premature acceptances of new therapies from faulty studies. The unpredictability paradox: review of empirical comparisons of randomised and non-randomised clinical trials. Different methods of allocation to groups in randomized trials are associated with different levels of bias: a meta- epidemiological study. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Effect of formal statistical significance on the credibility of observational associations. A comparison of Bayes-Laplace, Jeffreys, and other priors: the case of zero events. Risk scores for predicting postoperative nausea and vomiting are clinically useful tools and should be used in every patient. Effective management of postoperative nausea and vomiting: let us practise what we preach! Risk scores for predicting post-operative nausea and vomiting are clinically useful tools and should be used in every patient: ‘Don’t throw the baby out with the bathwater. Independent predictors from stepwise logistic regression may be nothing more than publishable p values. Advances in measuring the effect of individual predictors of cardiovascular risk: the role of reclassification measures. Assessing the performance of prediction models: a framework for traditional and novel measures. A randomized control trial of right-heart catheterization in critically ill patients. The effectiveness of right heart catheterization in the initial care of critically ill patients. Epidural anaesthesia and survival after intermediate-to-high risk non-cardiac surgery: a population-based cohort study. Propensity scores in intensive care and anaesthesiology literature: a systematic review. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Evidence-based practice: how to perform and use systematic reviews for clinical decision-making. Systematic reviews of anesthesiologic interventions reported as statistically significant: problems with power, precision, and type 1 error protection. Statistically significant meta-analyses of clinical trials have modest credibility and inflated effects. A study of the deaths associated with anesthesia and surgery: based on a study of 599548 anesthesias in ten institutions 1948–1952, inclusive. Possible association between halothane anesthesia and postoperative hepatic necrosis. Reassessing Google Flu Trends data for detection of seasonal and pandemic influenza: a comparative epidemiological study at three geographic scales. University of Queensland vital signs dataset: development of an accessible repository of anesthesia patient monitoring data for research. What your future doctor should know about statistics: must-include topics for introductory undergraduate biostatistics. Antibiotic prophylaxis has become standard for surgeries in which there is more than a minimum risk of infection. The most commonly used antibiotic for surgical prophylaxis is cefazolin, a first-generation cephalosporin, as the potential pathogens for most surgeries are gram-positive cocci from the skin. Anesthesiologists should work in consultation 501 with surgeons to use guidelines determined by the local infection control committee to take initiative for administering prophylactic antibiotics because they have access to the patient during the 60 minutes prior to incision and can optimize timing of administration. Peripheral vasoconstriction, which results from central sympathetic control of subcutaneous vascular tone, is probably the most frequent and clinically the most important impediment to wound oxygenation and wound healing. All vasoconstrictive stimuli must be corrected simultaneously to allow optimal healing. Modifiable risks for wound infections include smoking, malnutrition, obesity, hyperglycemia, hypercholesterolemia, and hypertension. Maintenance of a high room temperature or active warming before, during, and after the operation is significantly more effective than other methods of warming, such as application of warmed blankets, circulating water blankets placed on the surface of the operating table, and humidification of the breathing circuit. Current best recommendations for volume management include replacing fluid losses based on standard recommendations for the type of surgery, replacement of blood loss, and replacement of other ongoing fluid losses (e. Pain control also appears important since it favorably influences both pulmonary function and vascular tone. Wound complications are associated with2 prolonged hospitalization, increased resource consumption, and even increased mortality. A growing body of literature supports the concept that patient factors are a major determinant of wound outcome following surgery. Comorbidities such as diabetes and cardiac disease clearly contribute, and a patient’s genetic make-up may also contribute. Environmental stressors and3 the individual response to stress are also important. In particular, wounds are exquisitely sensitive to hypoxia, which is both common and preventable. Perioperative management can be adapted to promote postoperative wound healing and resistance to infection. Along with aseptic technique and prophylactic antibiotics, maintaining perfusion and oxygenation of the wound is paramount. This chapter discusses how knowledge of the principles of infection control and the biology and physiology of wound repair and resistance to infection can improve outcomes. The graph shows the distribution of adverse events within the subcategory of operative care (7,716 operative adverse events). In 1847, Ignaz Semmelweis made the observation that women who delivered their babies in the First Clinic at the General Hospital of Vienna, staffed by medical students and physicians, had a mortality rate of 5% to 15%, largely the result of puerperal infections; this was substantially higher than the 2% rate of women who delivered at Clinic 2, which was staffed by midwife students and midwives. Students and physicians at Clinic4 1 usually started the day performing autopsies (including on patients who died of puerperal fever) and then moved on to the clinic, where they performed examinations on women in labor. Semmelweis made the connection, and although germ theory was some years off, he insisted that physicians and medical students wash their hands in a chlorinated solution when leaving the pathology laboratory. Soon, Semmelweis identified cases of transmission from an infected to an uninfected patient, and instituted the use of chlorinated solution hand washing between cases as well. He also demonstrated that the chlorinated solution was more effective than soap and water. Unfortunately, his innovation was not widely adopted, resulting from a combination of his delay in publishing his results, the reluctance of his colleagues to accept that they might be responsible for transmitting disease, and his lack of tact in trying to convince health-care workers to adopt his measures. Transient flora colonize the superficial layers of the skin and thus are easier to remove with hand hygiene. Transient flora are also the source of most health-care–associated infections, as health-care worker skin can become contaminated from patient contact or contact with contaminated surfaces. Contamination from surfaces is 504 most commonly with organisms such as Staphylococci and Enterococci, which are resistant to drying. Even “clean” activities such as taking a patient’s pulse or applying monitors can lead to hand contamination: 100 to 1,000 colony- forming units of Klebsiella species were measured on nurses’ hands following such activities in one study. No studies have related hand contamination to7 actual transmission of infection to patients; however, numerous studies, starting with those of Semmelweis, have demonstrated a reduction in health- care–associated infections following institution of hand hygiene or improved adherence to hand hygiene. The ideal agent kills a broad spectrum of microbes, has antimicrobial activity that persists for at least 6 hours after application, is simple to use, and has few side effects. Plain (not antiseptic) soap and water are generally the least effective at reducing hand contamination. Although obvious dirt is removed by the8 detergent effect of soap and the mechanical action of washing, bacterial load is not greatly reduced. Further, soap and water hand hygiene is associated with high rates of skin irritation and drying, both of which are risk factors for an increased bacterial load. Soap and water are, however, the most effective at removing spores, and therefore should be used when contamination with Clostridium difficile or Bacillus anthracis is a concern. Ethanol is most commonly used because it has6 more antiviral activity than isopropanol. Antiseptics containing 60% to 95% ethanol with a water base are germicidal and effective against gram-positive and gram-negative bacteria, lipophilic viruses such as herpes simplex, human immunodeficiency, influenza, respiratory syncytial, and vaccinia viruses, and hepatitis B and C viruses. They have little persistent activity, although regrowth of bacteria does occur slowly after use of alcohol-based products. Combination with low doses of other agents such as chlorhexidine, quaternary ammonium compounds, or triclosan can confer persistent activity.

Procalcitonin 20mg levitra professional, lipopolysaccharide-binding protein levitra professional 20 mg, interleukin-6 and C-reactive protein in community-acquired infections and sepsis: a prospec- tive study 20 mg levitra professional. Diagnostic accuracy of procalcitonin levitra professional 20mg, neutrophil-lymphocyte count ratio , C-reactive protein , and lactate in patients with suspected bacterial sepsis . Host biomarkers for distinguishing bacterial from non-bacterial causes of acute febrile illness: a comprehensive review . C-reactive protein levels correlate with mortality and organ failure in critically ill patients . C-reactive protein as a predictor of outcome after discharge from the intensive care: a prospective observational study . Procalcitonin as an early indicator of outcome in sepsis: a prospective observational study. Serum procalcitonin: an independent predictor of clinical outcome in health care-associated pneumonia. Prognostic value of procalcitonin in adult patients with sepsis: a systematic review and meta-analysis. Predictive value of procalcitonin decrease in patients with severe sepsis: a prospective observational study. Failure to reduce C-reactive protein levels more than 25% in the last 24 hours before intensive care unit discharge predicts higher in-hospital mortality: a cohort study. Early changes of procalcitonin may advise about prognosis and appropriateness of antimicrobial therapy in sepsis. Changes in circulating procalcitonin versus C-reactive pro- tein in predicting evolution of infectious disease in febrile, critically ill patients. The time course of blood C-reactive protein concentrations in relation to the response to initial antimicrobial therapy in patients with sepsis. C-reactive protein correlates with bacterial load and appropriate antibiotic therapy in suspected ventilator-associated pneumonia. Usefulness of consecutive C-reactive protein mea- surements in follow-up of severe community-acquired pneumonia. Procalcitonin versus C-reactive protein for guiding antibiotic therapy in sepsis: a randomized trial. Procalcitonin guidance of antibiotic ther- apy in community-acquired pneumonia: a randomized trial. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single- blinded intervention trial. Effcacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Use of procalcitonin to shorten antibiotic treatment dura- tion in septic patients: a randomized trial. Procalcitonin algorithm in critically ill adults with undifferentiated infection or suspected sepsis: a randomized controlled trial. Effect of sodium selenite administration and procalcitonin- guided therapy on mortality in patients with severe sepsis or septic shock: a randomized clini- cal trial. Clinical and economic impact of procalcitonin to shorten antimicrobial therapy in septic patients with proven bacterial infection in an intensive care setting. Practice patterns and outcomes associated with procalcitonin use in critically ill patients with sepsis. Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit: a random- ized trial. Effectiveness and safety of procalcitonin evalu- ation for reducing mortality in adults with sepsis, severe sepsis or septic shock. Use of plasma C-reactive protein, procalcitonin, neutrophils, macrophage migration inhibitory factor, soluble urokinase-type plasminogen acti- vator receptor, and soluble triggering receptor expressed on myeloid cells-1 in combination to diagnose infections: a prospective study. Effect of procalcitonin testing on health-care utilization and costs in critically ill patients in the United States. Procalcitonin testing to guide antibiotic therapy for the treatment of sepsis in intensive care settings and for suspected bacterial infection in emergency department settings: a systematic review and cost-effectiveness analysis. It has been esti- mated that between 30 and 50% of patients do not receive health care in accordance with best practice [2, 3]. Translating research into clinical practice to improve health-care decision-making is a major concern and is the spotlight of quality improvement programs around the world. Many local, national, and international societies develop tools to identify relevant clinical areas, reviewing applicable evidence, formulating specifc clinical questions and recommendations that they believe clinicians and their patients should follow. As a result, guideline panels have grown in size, which also poses a specifc challenge in decision-making. In this chapter, we review the methodologic considerations for the development of international clinical practice guidelines while focusing on the Surviving Sepsis Campaign guidelines and the key points in their recommendations. Sepsis is defned as a life-threatening organ dysfunction caused by a dysregulated host response to infection. Septic shock can be defned as a subset of sepsis in which underlying circulatory, cellular, and metabolic abnormalities are profound enough to cause a substantial increase in mortality. The aim was to harness the support of gov- ernments, health agencies, the public, and other health-care professionals to decrease the relative mortality of sepsis by 25% over the following 5 years. The Barcelona Declaration outlined a six-point action plan designed to improve the management of sepsis: building awareness of the problem, improving diagnosis and recognition, defning and increasing the use of appropriate treatment and care, educating health- care professionals, improving counseling and post-intensive care unit care, and developing guidelines of care. The developed guidelines followed a rig- orous process which will be discussed in this chapter (Fig. The number of guidelines developed by medical societies has increased exponentially in the last few decades. Clinicians, patients, and other stakeholders strug- gle with numerous and sometimes contradictory guidelines of variable quality [18]. Until the 1990s, most guidelines were established based on expert opinion only [19]. While the advantages of this approach were simplicity and rapidity, it was later deter- mined that these recommendations were in contradiction with systematic reviews. Reliable and valid recommendations require a rigorous methodological approach com- bining systematic review of the results of clinical research with discussed and explicit expert judgment [20]. International collaboration offers additional opportunities to enhance guideline development [22]. These groups should include diverse stakeholders, such as content experts, health-care professionals, and methodologists, with skills in evidence appraisal and synthesis. It is important that the groups involve experts from a single discipline, as groups without multidisciplinary membership have been associated with recom- mendations that are not evidence based [23–27]. Guideline chairs and members are charged with weighing published evidence, trans- forming knowledge into recommendations, illuminating areas of continuing contro- versy, discarding outdated or disproven guidance, and eventually developing the guidelines document. All of this requires deep engagement, diversity of opinion, and substantial investment of time. The guideline was generated by 55 international experts representing 25 international orga- nizations involved in the care of patients with sepsis and providing 93 recommendations on early management of sepsis and septic shock. The resulting large and diverse panels present opportunities for decision-making, such as ensuring that all participants have a voice and can infuence the results of the debate, dealing with disagreements, achieving consensus, ensuring transparency, and resolving situations in which consensus is not possible. Several systematic reviews have highlighted the infuence of conficts of interest on the opinion of experts and the conclusions of systematic reviews and guidelines [30]. An effective and neutral chair is critical and should lead the group to ensure balanced contributions from all members. The chair should facilitate discussion and consensus and have general knowledge of the topic. The group designations developed into the internal work structure of the guidelines committee. For each question, the co-chairs and group heads defned the relevant population, alternative management strategies (intervention and compara- tor), and the outcomes (e. Through discussion via e-mail, teleconferences, and face-to-face meetings, topics were prioritized and organized. Each clinical question provided the framework for formulating study inclusion and exclusion criteria and guided the search for relevant evidence (systematic reviews and original studies). The decision regarding question inclusion was reached by discussion and consensus among the guideline panel leaders with input from panel members and the methodology team within each group. Questions that were consid- ered less important or of low priority to clinicians were omitted, and new questions that were considered high priority were added (Fig. It is required to select and interpret evidence, to translate evidence into recommendations, and, in settings when there is no clear evidence, to determine how to handle these situa- tions. Most organizations use formal consensus processes, such as Delphi, nominal group technique, or formal balloting. Formal methods have been shown to result in a less biased and more evidence-based process than informal methods [24, 26, 32]. A guideline should clearly defne a quorum and document the consensus process [33–35]. In settings where consensus was not met, reformulation and revoting of the topics was required. Guideline development groups synthesize and grade evidence using a stan- dardized approach. This method uses structured approaches to collect, analyze, and summarize the relevant evidence and to use that evidence to produce and grade recommendations. It also allows the quality of evi- dence derived from observational data to be upgraded from low to moderate or high categories and the quality of evidence coming from randomized trials to be down- graded depending on the details of design and execution of the studies. This approach to determining the quality of evidence requires subjective judgment and thus invites differences of opinion. A strong recommendation refects the collective opinion of the guideline devel- opment group that the desirable effects of the intervention (e. Alternatively, a weak recommendation suggests that the desirable effects will out- weigh the undesirable ones, but the panel is not certain about trade-offs. This situa- tion occurs when key evidence is of low quality or the benefts and downsides are closely matched [47]. This grid allows members of the panel to record their views about the balance between the benefts and disadvantages of specifc inter- ventions, after review of the available evidence. This assessment is then mapped to the strength of recommendation for each intervention, which should be assigned on the basis of evaluation of the evidence, benefts and harms, consistency, clinical effect, and generalizability and applicability, as well as patient preferences. Clear identifcation of the quality of evidence and strength of clinical recommendations increases the trustworthiness and improves the implementation of clinical guide- lines [48–50]. Guideline development groups assess whether the desirable effects of adherence outweigh the undesirable effects, and the strength of a recommendation refects the degree of confdence in that balance assessment. A strong recommendation in favor of an intervention conveys the certainty the desirable effects of adherence to a recom- mendation will clearly outweigh the undesirable effects [51]. A weak recommenda- tion in favor of an intervention indicates the conclusion that the desirable effects of adherence to a recommendation probably will outweigh the undesirable effects. This occurs due to low-quality evidence—and thus uncertainty remains regarding the ben- efts and risks—or the benefts and downsides are closely balanced. Describing a recommendation as strong implies that many patients would accept that intervention and a majority of clinicians should use it in most situations. Circumstances may exist in which a strong recommendation cannot or should not be followed for an individual because of that patient’s preferences or clinical character- istics that make the recommendation less applicable. This development of a practical working plan aims to more easily convert recommendations into practice [53]. Bundles as set of elements of care, when distilled from evidence-based guidelines and implemented into a group, have an effect on outcomes beyond implementing the individual elements alone [54]. Investigators have shown comparable results in other developed countries such as the United Kingdom and Spain [56, 57]. These results revealed the sustainability of better outcomes with increased compliance. Similar results are seen in developing countries such as India, Brazil, and China [59–61]. However, adherence to guidelines remains low, specifcally among internal medicine and emergency room physicians at the forefront of managing patients with sepsis and septic shock [63]. Well-described barriers to implementation of evidence-based guidelines include lack of familiarity, lack of agreement, and an inability to overcome the inertia of existing behavior [64]. Utilization of a performance improvement program is strongly associated with improved bundle compliance [65]. Furthermore, initiatives such as educational programs, clinical decision support tools, and dedicated medi- cal staff have been introduced worldwide, which have augmented compliance with bundle implementation [65]. A multifaceted approach using early recognition strat- egies, multidisciplinary educational sessions, and continuous performance assess- ment may have an exponential value [66, 67]. Such training can be delivered in various innovative ways— from an e-learning package to simulation-based courses [68, 69]. Regular reinforcements should be scheduled to assure the program’s sustainability and to avoid a gradual decline in health-care provider awareness. Even after the implementation of educational programs, the diagnosis can be delayed. Physiologic deterioration often precedes clinical deterio- ration, and the recognition of this concept has led to the development of early warn- ing systems to enhance early identifcation of patients who are at high risk for decompensation [72]. Use of an early warning and response system which monitors real-time laboratory values and vital signs has been shown to improve early sepsis care and may reduce sepsis mortality [73]. An early warning system that brings an interdisciplinary team to the bedside should integrate the patient’s vital signs and laboratory values into the electronic medical record and establish a threshold for triggering the alert. However, there are no comparative studies of early warning systems that demonstrate a clear and signifcant difference between them. Institutional support is crucial in culti- vating an environment of early recognition and management of patients with sepsis [76]. Infrastructural platforms must be enabled by administrators and implemented by health-care providers [77].

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