International Consensus Definition Research Articles

Definition and classification of chyle leak after pancreatic operation: A consensus statement by the International Study Group on Pancreatic Surgery

Recent literature suggests that chyle leak may complicate up to 10% of pancreatic resections. Treatment depends on its severity, which may include chylous ascites. No international consensus definition or grading system of chyle leak currently is available. The International Study Group on Pancreatic Surgery, an international panel of pancreatic surgeons working in well-known, high-volume centers, reviewed the literature and worked together to establish a consensus on the definition and classification of chyle leak after pancreatic operation. Chyle leak was defined as output of milky-colored fluid from a drain, drain site, or wound on or after postoperative day 3, with a triglyceride content ≥110mg/dL (≥1.2mmol/L). Three different grades of severity were defined according to the management needed: grade A, no specific intervention other than oral dietary restrictions; grade B, prolongation of hospital stay, nasoenteral nutrition with dietary restriction, total parenteral nutrition, octreotide, maintenance of surgical drains, or placement of new percutaneous drains; and grade C, need for other more invasive in-hospital treatment, intensive care unit admission, or mortality. This classification and grading system for chyle leak after pancreatic resection allows for comparison of outcomes between series. As with the other the International Study Group on Pancreatic Surgery consensus statements, this classification should facilitate communication and evaluation of different approaches to the prevention and treatment of this complication.

Cancer cachexia, sarcopenia and biochemical markers in patients with advanced non-small cell lung cancer-chemotherapy toxicity and prognostic value.

Cancer cachexia and sarcopenia are frequently observed in cancer patients and associated with poor survival. The majority of studies of cancer cachexia and sarcopenia have been done in patients with solid tumors of different origins, and there are currently no good predictors of the benefit of chemotherapy or factors that predict survival in advanced cancer. The purpose of our prospective study was to evaluate prevalence of cachexia and sarcopenia using international consensus definition and criteria for diagnosis in patients with diagnosed advanced non-small cell lung cancer (NSCLC) stage IIIB and IV and their relation to chemotherapy toxicity and survival prediction. A secondary aim was to compare several biochemical markers (CRP, IL-6, protein, and albumin) with time to tumor progression in order to assess prognostic value or to guide a treatment. Between December 2013 and April 2015, the prospective cohort study of 100 Caucasian patients with advanced NSCLC stage IIIB or IV, who were referred consecutively to Department for Respiratory Diseases "Jordanovac," was evaluated. Anthropometric measurements and biochemical data (CRP, albumin, protein, IL-6, haemoglobin) together with body composition measurements (total muscle cross-sectional area, lumbar skeletal muscle index) were obtained for each patient before starting with platinum-doublet therapy. Skeletal muscle cross-sectional area at the third lumbar vertebra was measured by computerized tomography, and sarcopenia was defined using a previously published cutoff point. Toxicity was assessed after cycle 1 of treatment and time-to-tumor progression was determined prospectively. One hundred patients with advanced lung cancer were recruited: 67 were male and median age was 64years. The median time to disease progression was 187days. The prevalence of cachexia and sarcopenia in study cohort was 69 and 47%, respectively. CRP, IL-6, and albumin concentration in cachectic compared to non-cachectic patients demonstrated statistically significant difference (p = 0.020, p = 0.040, p = 0.003). Cachexia and sarcopenia were not found to be predictors of chemotoxicity nor was time to tumor progression. On the contrary, albumin concentration with established cutoff point of 37.5g/L was clearly proved as the predictive factor of both chemotoxicity (OR (95% CI) = 0.85; p < 0.001) and survival (HR (95% CI) = 0.55). Albumin level has been shown to be more important predictive marker of chemotherapy toxicity and survival than cachexia and sarcopenia are. This approach in clinical settings can be used to guide the choice of oncologic treatment.

Utility of the Richmond Agitation-Sedation Scale in evaluation of acute neurologic dysfunction in the intensive care unit.

Utility of the Richmond Agitation-Sedation Scale in evaluation of acute neurologic dysfunction in the intensive care unit.

Insuffisance sphinctérienne et incontinence urinaire de la femme

Stress urinary female incontinence (SUI) is primary due to intrinsic sphincter deficiency (ISD) and urethral hypermobility. Despite a lack of standardised international definition, ISD needs to be clearly diagnosed in order to be correctly treated. This work is an update about the female ISD produced from a review of a published article. This review of article published on this subject in the Medline (Pubmed database), selected according to their scientific relevants, of consensus conferences and published guidelines, has been performed by the committee for women pelvic floor surgery of the French Urological Association. Although there is no international consensus definition, we can consider that the ISD is a composite concept combining urodynamic data (MUCP < 20 or 30 cmH20) and one or more clinical information (no urethral mobility, negative urethral support test, failure of a first surgery, leakage during abdominal straining, high stress incontinence scores). Imaging can provide additional evidence for intrinsic sphincter deficiency diagnosis, but the correlation between imaging and function remains low. By standardizing methodology and interpretations to better diagnose women with ISD, it may be possible to improve preoperative planning and outcomes for these patients. A retropubic midurethral sling can be performed as a first surgery. In case of a lack of urethral mobility, the artificial urinary sphincter (AUS) remains the gold standard. Adjustable continence therapy (ACT(®)) can be proposed as an alternative option. The efficacy and safety of muscle-derived cell therapy in ISD needs more studies. Injection of bulking agents may be an option according to the severity and the expectations of the patient. Bladder overactivity needs to be treated as first-line in case of mixed urinary incontinence. In elderly women, a careful evaluation of the bladder contractility and comorbidity must be performed. A geriatric evaluation can be necessary. Clinical and paraclinical assessment allow to confirm the diagnosis of female ISD, to estimate its severity, and to identify associated mechanisms of incontinence (urethral hypermobility, bladder overactivity) to choose the most adapted treatment.

Correlation Between the International Consensus Definition of the Cancer Anorexia-Cachexia Syndrome (CACS) and Patient-Centered Outcomes in Advanced Non-Small Cell Lung Cancer

ContextThe cancer anorexia-cachexia syndrome (CACS) is common in patients with advanced solid tumors and is associated with adverse outcomes including poor quality of life (QOL), impaired functioning, and shortened survival. ObjectivesTo apply the recently posed weight-based international consensus CACS definition to a population of patients with advanced non-small cell lung cancer (NSCLC) and explore its impact on patient-reported outcomes. MethodsNinety-nine patients participated in up to four study visits over a six-month period. Longitudinal assessments included measures of physical function, QOL, and other clinical variables such as weight and survival. ResultsPatients meeting the consensus CACS criteria at Visit 1 had a significantly shorter median survival (239.5 vs. 446 days; hazard ratio, 2.06, P < 0.05). Physical function was worse in the CACS group (mean Karnofsky Performance Status score 68 vs. 77, Eastern Cooperative Oncology Group Performance Status score 1.8 vs. 1.3, P < 0.05 for both), as was QOL (Functional Assessment of Cancer Therapy-General [FACT-G] Lung Cancer subscale of 17.2 vs. 19.9, Anorexia/Cachexia subscale of 31.4 vs. 37.9, P < 0.05 for both). Differences in the FACT-G and the Functional Assessment of Chronic Illness Therapy-Fatigue subscale approached but did not reach statistical significance. Longitudinally, all measures of physical function and QOL worsened regardless of CACS status, but the rate of decline was more rapid in the CACS group. ConclusionThe weight-based component of the recently proposed international consensus CACS definition is useful in identifying patients with advanced NSCLC who are likely to have significantly inferior survival and who will develop more precipitous declines in physical function and QOL. This definition may be useful for clinical screening purposes and identify patients with high palliative care needs.

An epidemiologic survey of pediatric sepsis in regional hospitals in China.

To determine the prevalence, treatment, and outcomes of sepsis at regional hospitals in Huai'an, Jiangsu, China. Prospective data registry using a descriptive clinical epidemiologic approach through a collaborative network. Pediatric departments in 11 regional city and county referral hospitals serving 843,000 children (exclusive of neonates). All admissions (n = 27,836) of patients from 28 days to 15 years old from September 1, 2010, to August 31, 2011. None. A total of 1,530 patients met the 2005 international consensus definition of sepsis, corresponding to an estimated incidence of 181/100,000 children, with 80% under 5 years old, and in 10% (153), severe sepsis or septic shock developed. The overall case fatality rate for sepsis was 3.5% (53/1,530) or 34.6% (53/153) in those in whom severe sepsis or septic shock developed. Treatment varied widely and in many instances did not conform to international guidelines as reflected by inadequate use of antibiotics, corticosteroids, vasoactive agents, and inotropes. We first report the prevalence and outcome of pediatric sepsis based on a regional hospital network in China. The diverse treatment approaches and practice at low-level clinics suggest the need for clinical implementation of internationally recognized strategy to improve the care standard in resource-limited regional hospitals.

The prevalence of cachexia among patients with solid and hematologic malignancies at a National Cancer Institute (NCI)-designated cancer center in the 12 months prior to death.

e20642 Background: An international consensus definition characterizes cancer cachexia as a multifactorial syndrome with loss of lean body mass and progressive functional impairment. The core crite...

Correlation between the international consensus definition of the cancer anorexia cachexia syndrome (CACS) and patient outcomes in advanced non-small cell lung cancer (NSCLC).

e19042 Background: CACS is a problematic clinical syndrome, difficult to objectively define. A consensus-derived, weight-based definition has been proposed. An observational study was analyzed to e...

How are eczema ‘flares’ defined? A systematic review and recommendation for future studies

Eczema is an important public health problem due to high prevalence and associated morbidity. As a chronic, relapsing disease, the ability to capture disease flares is important when evaluating treatment success, yet it is unclear how flares should be defined. This study systematically reviews and critically appraises the literature defining flares in eczema, and explores methodological and practical aspects of including eczema flares as outcome measures in trials to inform developing an international consensus definition adding details of our own recent experience. A systematic review was undertaken of flare definitions in prospective intervention studies of eczema published up until 14 February 2013. Data were double-extracted. We pre-specified that important characteristics of a good flare definition should include (i) being feasible to collect and (ii) being recorded at the time flare symptoms were experienced. Three hundred and fourteen papers were identified of which 26 included some description of eczema flares. Overall, 22 different flare definitions were used. Flares were included as the primary outcome in 17 studies (65%). Only four studies (15%) used a patient-reported flare definition. No studies fulfilled all of our pre-specified essential characteristics. No validation studies were identified. The wide variation and lack of validation of flare definitions hampers comparison of findings between studies for this chronic, relapsing disease. None of the currently used definitions seem fit for purpose. Further research should establish which aspects of worsening of disease are most important to patients, and how best to capture these data in a way that is valid, reliable and feasible in all clinical and research settings.

PROTOCOL: Predictors of youth gang membership in low‐ and middle‐income countries: A systematic review

BACKGROUND The Problem There is evidence of gang violence in low- and middle-income countries in Africa and Asia, and the prevalence of gangs is particularly well documented throughout Central and South America (Decker & Pyrooz, 2010; Gatti et al., 2011). Official estimates of gang membership in Central America estimate approximately 69,000 members, while academic estimates believe this figure to be closer to 200,000 (UNODC, 2007). Some estimates are as high as 500,000 gang members in the region including South America and the Caribbean, and gangs have been identified as “the primary threat to regional stability and security” (Muggah & Aguirre, 2013). While reporting and recording issues make it difficult to estimate rates of gang violence, the homicide rate in Colombia, Brazil, El Salvador and Guatemala are substantially higher than those of European and North American countries (Decker & Pyrooz, 2010; UNODC, 2007). Gangs are also active in South Africa, with an estimate of 100,000 members in Western Cape alone (Reckson & Becker, cited in Decker & Pyrooz, 2010); however, to date, there is limited research examining gangs in Africa and Asia...

Prevalence of sarcopenia among healthy ambulatory subjects: the sarcopenia begins from 45 years

Sarcopenia has been indicated as a reliable marker of frailty and poor prognosis among the oldest individuals. There are only few data on sarcopenia in healthy general population. We evaluated the prevalence of sarcopenia and its association with functional and clinical status in a population of healthy ambulatory subjects over 45years living at home, in Paris (France). This study was conducted selecting all ambulatory participants (n=1,445) aged 45years and older from October 2008 to September 2011, consulting in the Institute of Physiology (Institut de Jaeger) from Paris (France) for a functional and muscular evaluation, and did not have limitations to moderate physical exercise. All were healthy people. All subjects performed a medical examination, associated with evaluation of muscle mass (body composition assessment using dual-energy X-ray absorptiometry) and of muscle function (by hand grip strength). Diagnosis of sarcopenia required the documentation of low muscle mass with low muscle strength according to the current international consensus definition of sarcopenia. From 1,421 participants (553 males and 868 females) definitively enrolled, 221 subjects (135 females and 86 males) (15.5%) were identified as sarcopenic. Results from multivariate logistic regression models showed that sarcopenia was inversely associated with BMI with those participants with BMI higher than 22kg/m(2) showing a lower risk of sarcopenia relative to those with BMI less than 21kg/m(2) (OR 0.72; 95% CI 0.60-0.91). Similarly, probability of sarcopenia was lower among subjects involved in leisure physical activities for 3h or more per week (OR 0.45; 95% CI 0.24-0.93). According to the category of age [45-54; 55-64; 65-74; 75-84 and 85years or more], the prevalence of sarcopenia in women increase from 9.1; 12.7; 14.5; 19.4; to 33.3%, respectively. For the men, the percentage of sarcopenia increase with aging from 8.6; 15.6; 13.6; 63.8 to 45.5%, respectively. The present study suggests that among healthy ambulatory subjects over 45years living at home, sarcopenia is frequent, even to the youngest subjects of the studied population, taking place from 9% from 45years, until 64.3% for the subjects over 85years. Our findings support the hypothesis that muscle mass and function are associated with BMI and physical activity, whatever the age of the subject.

Interrater reliability of the international consensus definition of drug-resistant epilepsy: A pilot study

We evaluated the interrater reliability of the consensus definition of drug-resistant epilepsy proposed by the International League Against Epilepsy. According to the definition framework, outcome of each antiepileptic drug (AED) trial was categorized as “seizure freedom” or “treatment failure.” This level 1 assessment was used to determine the level 2 classification, which defined drug-resistant epilepsy as the failure of adequate trials of two or more AED schedules to achieve sustained seizure freedom. Two raters classified treatment outcomes of 150 patients independently. The patients had received a total of 428 trials of AEDs. Categorization of level 1 outcome to individual AED trials by the raters was consistent in 413 (96.5%). For the level 2 classification of drug-resistant or drug-responsive epilepsy, there was absolute agreement between the raters in 141 patients (94%), with a κ index of 0.91 (P<0.001). The definition appeared to have a high degree of interrater reliability in this setting.

Transfusion-related acute lung injury: emerging importance of host factors and implications for management

Recent insights from models of transfusion-related acute lung injury (TRALI), and from clinical reports, reveal that host factors are important in TRALI pathogenesis. Predisposing factors with lung neutrophil-priming capacity, such as sepsis and mechanical ventilation, increase susceptibility for a TRALI reaction, and can aggravate the course of disease. These findings may explain the higher incidence of TRALI in the critically ill compared with general hospital populations. The emerging importance of host factors may have implications for TRALI management. Suspected TRALI cases in which another acute lung injury risk factor is present (termed ‘possible TRALI’ in the consensus definition) should be reported to the blood bank, including patients suffering from an underlying condition. In reporting of TRALI cases, use of the international TRALI consensus definition should be used, rather then national TRALI scoring systems, to ensure a uniform approach, which may decrease variance in estimations of incidence. In terms of treatment of TRALI patients, there is a rationale to apply therapeutic strategies, which have proven to be beneficial in acute lung injury.

Analysis of Emboli during Carotid Stenting with Distal Protection Device

Background: The newly developed multi-frequency transcranial Doppler (TCD) is able to differentiate gaseous from solid emboli. Our goal was to apply this technology to initially characterize emboli detected during carotid stenting with distal protection. Methods: Patients undergoing carotid angiography and stenting were monitored with 2–2.5 MHz TCD (Embo-Dop, DWL) over the middle cerebral artery unilateral to stent deployment. Sonographers insured optimal signal recordings during the procedures. Automated emboli detection and classification software (MultiXLab version 2.0) was applied for offline count and analysis. Monitoring using the Filter Wire EX (Boston Scientific) and ACCUNET system (Guidant Corporation) was performed. Results: A total of 9,649 embolic signals were detected during 11 angiographic and 10 stenting procedures. An observer confirmed the signals using the International Consensus definition. Automated software classified these events into 5,900 gaseous and 3,749 solid emboli. During contrast injections without the protection device, 1,013 emboli were detected with 28% of these being solid. With deployment of the distal protection device, 8,636 emboli were found with 40% being solid (p < 0.001). During stenting and angioplasty with the protection device, 7,395 emboli with 42% solids were detected (p < 0.001). Finally injection of contrast after the procedure, with the protection device still deployed, yielded 1,241 emboli with 31% solids (NS). Only 1 patient developed transient hemiparesthesia during ballooning that reduced the flow velocity to zero for 14 s. Neither gaseous nor solid emboli resulted in a mean flow velocity decrease or clinical symptoms. Conclusions: Microembolization frequently occurs during stenting even with deployment of the distal protection device. More solid emboli are seen during manipulations associated with lesion crossing. Although novel TCD methods yield a high frequency of embolic signals, further validation of this technique to determine the true nature, size, and number of emboli is needed.

Lack of Hepatotoxic Effects of Parenteral Ketorolac in the Hospital Setting

No large controlled studies to date have examined the hepatic safety of parenteral ketorolac, which is used to treat acutely ill hospitalized patients who may be at greatest risk of liver injury. To measure the association between the use of parenteral ketorolac and subsequent liver injury. A nonexperimental cohort study conducted in 35 hospitals in the greater Philadelphia, Pa, region examined 10,272 courses of parenteral ketorolac (the exposed group) and 10,247 courses of parenteral opioid (the comparison group). Liver injury was defined by a modified international consensus definition that relied exclusively on liver function tests. Proportional hazards regression was used to calculate the rate ratio and 95% confidence interval for the association between ketorolac exposure and the occurrence of liver injury, controlling for potentially confounding factors, and to explore the possible effects of duration and dose. The incidence of liver injury was 1.0% in the ketorolac group and 1.2% in the opioid group, yielding an unadjusted rate ratio of 0.77 (95% confidence interval, 0.59 1.01). Simultaneously adjusting for multiple potentially confounding factors did not change this result. There was no evidence for a duration-response relationship (P = .96) or a dose-response relationship (P = .23). We were unable to identify any subgroups that were susceptible to possible hepatotoxic effects of parenteral ketorolac. This study failed to find evidence of a hepatotoxic effect of parenteral ketorolac use in the hospital setting and provides strong evidence against the existence of a clinically meaningful association between exposure to parenteral ketorolac in the hospital setting and liver injury.