Assessment of candidemia-attributable mortality in critically ill patients using propensity score matching analysis

[EN] Introduction: Candidemia in critically ill patients is usually a severe and life-threatening condition with a high crude mortality. Very few studies have focused on the impact of candidemia on ICU patient outcome and attributable mortality still remains controversial. This study was carried out to determine the attributable mortality of ICU-acquired candidemia in critically ill patients using propensity score matching analysis. Methods: A prospective observational study was conducted of all consecutive non-neutropenic adult patients admitted for at least seven days to 36 ICUs in Spain, France, and Argentina between April 2006 and June 2007. The probability of developing candidemia was estimated using a multivariate logistic regression model. Each patient with ICU-acquired candidemia was matched with two control patients with the nearest available Mahalanobis metric matching within the calipers defined by the propensity score. Standardized differences tests (SDT) for each variable before and after matching were calculated. Attributable mortality was determined by a modified Poisson regression model adjusted by those variables that still presented certain misalignments defined as a SDT > 10%. Results: Thirty-eight candidemias were diagnosed in 1,107 patients (34.3 episodes/1,000 ICU patients). Patients with and without candidemia had an ICU crude mortality of 52.6% versus 20.6% (P < 0.001) and a crude hospital mortality of 55.3% versus 29.6% (P = 0.01), respectively. In the propensity matched analysis, the corresponding figures were 51.4% versus 37.1% (P = 0.222) and 54.3% versus 50% (P = 0.680). After controlling residual confusion by the Poisson regression model, the relative risk (RR) of ICU- and hospital-attributable mortality from candidemia was RR 1.298 (95% confidence interval (CI) 0.88 to 1.98) and RR 1.096 (95% CI 0.68 to 1.69), respectively. Conclusions: ICU-acquired candidemia in critically ill patients is not associated with an increase in either ICU or hospital mortality.

Sviluppo, implementazione e valutazione funzionale di un nuovo modello protesico di caviglia

Total ankle arthroplasty (TAA) is still not as satisfactory as total hip and total knee arthroplasty. For the TAA to be considered a valuable alternative to ankle arthrodesis, an effective range of ankle mobility must be recovered. The disappointing clinical results of the current generation of TAA are mostly related to poor understanding of the structures guiding ankle joint mobility. A new design (BOX Ankle) has been developed, uniquely able to restore physiologic ankle mobility and a natural relationship between the implanted components and the retained ligaments. For the first time the shapes of the tibial and talar components in the sagittal plane were designed to be compatible with the demonstrated ligament isometric rotation. This resulted in an unique motion at the replaced ankle where natural sliding as well as rolling motion occurs while at the same time full conformity is maintained between the three components throughout the flexion arc. According to prior research, the design features a spherical convex tibial component, a talar component with radius of curvature in the sagittal plane longer than that of the natural talus, and a fully conforming meniscal component. After computer-based modelling and preliminary observations in several trial implantation in specimens, 126 patients were implanted in the period July 2003 – December 2008. 75 patients with at least 6 months follow-up are here reported. Mean age was 62,6 years (range 22 – 80), mean follow-up 20,2 months. The AOFAS clinical score systems were used to assess patient outcome. Radiographs at maximal dorsiflexion and maximal plantar flexion confirmed the meniscalbearing component moves anteriorly during dorsiflexion and posteriorly during plantarflexion. Frontal and lateral radiographs in the patients, show good alignment of the components, and no signs of radiolucency or loosening. The mean AOFAS score was observed to go from 41 pre-op to 74,6 at 6 month follow-up, with further improvement at the following follow-up. These early results reveal satisfactory clinical scores, with good recovery of range of motion and reduction of pain. Radiographic assessment reveals good osteointegration. All these preliminary results confirm biomechanical studies and the validity of this novel ligamentcompatible prosthesis design. Surely it will be important to re-evaluate these patients later.

Prozessevaluation einer kognitiv-verhaltenstherapeutischen Gruppentherapie bei Diabetes und Depression : Entwicklung und Validierung der Patienten- und Therapeuten- Gruppentherapiestundenbögen (GTS-P, GTS-T, GTS-TP) zur Vorhersage des Therapieerfolgs

Untersucht werden Prozess-Ergebnis-Zusammenhänge einer kognitiv-verhaltenstherapeutischen Gruppentherapie für Diabetes und Depression im Rahmen der DAD-Studie. rnAufgrund des Mangels an geeigneten Erhebungsinstrumenten der validen, ökonomischen und komplementären Sitzungsbewertung von Gruppenpatienten und -therapeuten wurden angelehnt an einen Patienten- (GTS-P) zwei Therapeutenstundenbögen entwickelt: der GTS-T zur Bewertung der Gesamtgruppe und der GTS-TP zur Bewertung einzelner Patienten. Die GTS-Bögen zeigen bei der Überprüfung der Testgüte insgesamt gute Itemparameter und Reliabilitäten. Das in den exploratorischen Faktorenanaylsen des GTS-P identifizierte zweifaktorielle Modell (1. wahrgenommene Zuversicht hinsichtlich der Gruppentherapie, 2. wahrgenommene persönliche Beteiligung) kann in den konfirmatorischen Faktorenanalysen bestätigt werden. Dazu wurden GTS-P-Daten aus einer Untersuchung mit Patienten mit somatoformen Störungen (Schulte, 2001) einbezogen. Den Ergebnissen der Item- und Faktorenanalysen folgend, wurden zwei Items des GTS-P und zwei weitere Items des GTS-T aus den Instrumenten ausgeschlossen. Für den GTS-T zeigt sich eine einfaktorielle, für den GTS-TP eine zum GTS-P parallele zweifaktorielle Struktur. rnIn den Mehrebenenanalysen zur Vorhersage des Therapieergebnisses (Post-Depressionssymptomatik) zeigt sich die Skala Zuversicht des GTS-P zu Therapiebeginn (1.-4. Sitzung) kontrolliert an der Skala Beteiligung und der Prä-Symptomatik, als valider Prädiktor. Das Item 5 „Anregungen“ (Skala Zuversicht) und Item 2 „Aktive Mitwirkung“ (Skala Beteiligung) sind am stärksten an diesem Effekt beteiligt, da diese Itemkombination das Therapieergebnis ebenfalls valide vorhersagen kann. Die Prognose ist schon durch die Werte der ersten Gruppentherapiesitzungen in der Remoralisierungsphase (Howard et al., 1993) möglich und verbessert sich nicht bei Berücksichtigung aller 10 Gruppensitzungen. Die Therapeutenbögen zeigen keine prädiktive Validität. Bedeutsame Zusammenhänge der Patienten- und Therapeutenbewertungen finden sich lediglich für den GTS-P und GTS-TP. Weitere Prädiktoren, wie der Diabetestyp, Diabeteskomplikationen und die Adhärenz, konnten nicht zur Verbesserung der Vorhersage beitragen. Für sekundär überprüfte Kriterien gelang die Prognose lediglich für ein weiteres Maß der Depressionssymptomatik und für eine Gesamtbewertung der Gruppentherapie durch die Patienten zu Therapieende. Bei der deskriptiven Betrachtung der Prozessqualität der DAD-Gruppentherapien zeigen sich positive, über den Verlauf der Gruppe zunehmende und nach Therapiephasen differenzierbare Bewertungsverläufe. rnDie Ergebnisse der Studie sprechen für die Relevanz von unspezifischen Wirkfaktoren für das Therapieergebnis von kognitiv-behavioralen Gruppentherapien. Die von den Gruppenpatienten wahrgenommene Zuversicht und Beteiligung als Zeichen der Ansprechbarkeit auf die Therapie sollte mit Hilfe von Stundenbögen, wie den GTS-Bögen, von Gruppentherapeuten zur Prozessoptimierung und Prävention von Therapieabbrüchen und Misserfolgen beachtet werden. rn

How to assess the external validity of therapeutic trials: a conceptual approach

Background External validity of study results is an important issue from a clinical point of view. From a methodological point of view, however, the concept of external validity is more complex than it seems to be at first glance. Methods Methodological review to address the concept of external validity. Results External validity refers to the question whether results are generalizable to persons other than the population in the original study. The only formal way to establish the external validity would be to repeat the study for that specific target population. We propose a three-way approach for assessing the external validity for specified target populations. (i) The study population might not be representative for the eligibility criteria that were intended. It should be addressed whether the study population differs from the intended source population with respect to characteristics that influence outcome. (ii) The target population will, by definition, differ from the study population with respect to geographical, temporal and ethnical conditions. Pondering external validity means asking the question whether these differences may influence study results. (iii) It should be assessed whether the study's conclusions can be generalized to target populations that do not meet all the eligibility criteria. Conclusion Judging the external validity of study results cannot be done by applying given eligibility criteria to a single target population. Rather, it is a complex reflection in which prior knowledge, statistical considerations, biological plausibility and eligibility criteria all have place.

What Is a Minor Stroke?

Background and Purpose— The term “minor stroke” is often used; however a consensus definition is lacking. We explored the relationship of 6 “minor stroke” definitions and outcome and tested their validity in subgroups of patients. Methods— A total of 760 consecutive patients with acute ischemic strokes were classified according to the following definitions: A, score ≤1 on every National Institutes of Health Stroke Scale (NIHSS) item and normal consciousness; B, lacunar-like syndrome; C, motor deficits with or without sensory deficits; D, NIHSS ≤9 excluding those with aphasia, neglect, or decreased consciousness; E, NIHSS ≤9; and F, NIHSS ≤3. Short-term outcome was considered favorable when patients were discharged home, and favorable medium-term outcome was defined as a modified Rankin Scale score of ≤2 at 3 months. The following subgroup analyses were performed by definition: sex, age, anterior versus posterior and right versus left hemispheric stroke, and early (0 to 6 hours) versus late admission (6 to 24 hours) to the hospital. Results— Short-term and medium-term outcomes were most favorable in patients with definition A (74% and 90%, respectively) and F (71% and 90%, respectively). Patients with definition C and anterior circulation strokes were more likely to be discharged home than patients with posterior circulation strokes (P=0.021). The medium-term outcome of older patients with definition E was less favorable compared with the outcome of younger ones (P=0.001), whereas patients with definition A, D, and F did not show different outcomes in any subgroup. Conclusions— Patients fulfilling definition A and F had best short-term and medium-term outcomes. They would be best suited to the definition of “minor stroke.”

Reproducibility and validity of video screen measurements of gait in children with spastic cerebral palsy

PURPOSE: To determine the reproducibility and validity of video screen measurement (VSM) of sagittal plane joint angles during gait. METHODS: 17 children with spastic cerebral palsy walked on a 10m walkway. Videos were recorded and 3d-instrumented gait analysis was performed. Two investigators measured six sagittal joint/segment angles (shank, ankle, knee, hip, pelvis, and trunk) using a custom-made software package. The intra- and interrater reproducibility were expressed by the intraclass correlation coefficient (ICC), standard error of measurements (SEM) and smallest detectable difference (SDD). The agreement between VSM and 3d joint angles was illustrated by Bland-Altman plots and limits of agreement (LoA). RESULTS: Regarding the intrarater reproducibility of VSM, the ICC ranged from 0.99 (shank) to 0.58 (trunk), the SEM from 0.81 degrees (shank) to 5.97 degrees (trunk) and the SDD from 1.80 degrees (shank) to 16.55 degrees (trunk). Regarding the interrater reproducibility, the ICC ranged from 0.99 (shank) to 0.48 (trunk), the SEM from 0.70 degrees (shank) to 6.78 degrees (trunk) and the SDD from 1.95 degrees (shank) to 18.8 degrees (trunk). The LoA between VSM and 3d data ranged from 0.4+/-13.4 degrees (knee extension stance) to 12.0+/-14.6 degrees (ankle dorsiflexion swing). CONCLUSION: When performed by the same observer, VSM mostly allows the detection of relevant changes after an intervention. However, VSM angles differ from 3d-IGA and do not reflect the real sagittal joint position, probably due to the additional movements in the other planes.

Fecal calprotectin correlates more closely with the Simple Endoscopic Score for Crohn's disease (SES-CD) than CRP, blood leukocytes, and the CDAI

Studies evaluating the correlation between the widely used Simple Endoscopic Score for Crohn's disease (SES-CD) and noninvasive markers are scarce. The aim of this study was to evaluate the correlation between the SES-CD and fecal calprotectin, C-reactive protein (CRP), blood leukocytes, and the Crohn's disease activity index (CDAI).

Comprehensive assessment of gesture production: a new test of upper limb apraxia (TULIA)

BACKGROUND: Only few standardized apraxia scales are available and they do not cover all domains and semantic features of gesture production. Therefore, the objective of the present study was to evaluate the reliability and validity of a newly developed test of upper limb apraxia (TULIA), which is comprehensive and still short to administer. METHODS: The TULIA consists of 48 items including imitation and pantomime domain of non-symbolic (meaningless), intransitive (communicative) and transitive (tool related) gestures corresponding to 6 subtests. A 6-point scoring method (0-5) was used (score range 0-240). Performance was assessed by blinded raters based on videos in 133 stroke patients, 84 with left hemisphere damage (LHD) and 49 with right hemisphere damage (RHD), as well as 50 healthy subjects (HS). RESULTS: The clinimetric findings demonstrated mostly good to excellent internal consistency, inter- and intra-rater (test-retest) reliability, both at the level of the six subtests and at individual item level. Criterion validity was evaluated by confirming hypotheses based on the literature. Construct validity was demonstrated by a high correlation (r = 0.82) with the De Renzi-test. CONCLUSION: These results show that the TULIA is both a reliable and valid test to systematically assess gesture production. The test can be easily applied and is therefore useful for both research purposes and clinical practice.

Validity of an automatic measure protocol in distal femur for allograft selection from a three-dimensional virtual bone bank system

Osteoarticular allograft is one possible treatment in wide surgical resections with large defects. Performing best osteoarticular allograft selection is of great relevance for optimal exploitation of the bone databank, good surgery outcome and patient’s recovery. Current approaches are, however, very time consuming hindering these points in practice. We present a validation study of a software able to perform automatic bone measurements used to automatically assess the distal femur sizes across a databank. 170 distal femur surfaces were reconstructed from CT data and measured manually using a size measure protocol taking into account the transepicondyler distance (A), anterior-posterior distance in medial condyle (B) and anterior-posterior distance in lateral condyle (C). Intra- and inter-observer studies were conducted and regarded as ground truth measurements. Manual and automatic measures were compared. For the automatic measurements, the correlation coefficients between observer one and automatic method, were of 0.99 for A measure and 0.96 for B and C measures. The average time needed to perform the measurements was of 16 h for both manual measurements, and of 3 min for the automatic method. Results demonstrate the high reliability and, most importantly, high repeatability of the proposed approach, and considerable speed-up on the planning.

Relationship between the logistic EuroSCORE and the Society of Thoracic Surgeons Predicted Risk of Mortality score in patients implanted with the CoreValve ReValving system--a Bern-Rotterdam Study

Background Surgical risk scores, such as the logistic EuroSCORE (LES) and Society of Thoracic Surgeons Predicted Risk of Mortality (STS) score, are commonly used to identify high-risk or “inoperable” patients for transcatheter aortic valve implantation (TAVI). In Europe, the LES plays an important role in selecting patients for implantation with the Medtronic CoreValve System. What is less clear, however, is the role of the STS score of these patients and the relationship between the LES and STS. Objective The purpose of this study is to examine the correlation between LES and STS scores and their performance characteristics in high-risk surgical patients implanted with the Medtronic CoreValve System. Methods All consecutive patients (n = 168) in whom a CoreValve bioprosthesis was implanted between November 2005 and June 2009 at 2 centers (Bern University Hospital, Bern, Switzerland, and Erasmus Medical Center, Rotterdam, The Netherlands) were included for analysis. Patient demographics were recorded in a prospective database. Logistic EuroSCORE and STS scores were calculated on a prospective and retrospective basis, respectively. Results Observed mortality was 11.1%. The mean LES was 3 times higher than the mean STS score (LES 20.2% ± 13.9% vs STS 6.7% ± 5.8%). Based on the various LES and STS cutoff values used in previous and ongoing TAVI trials, 53% of patients had an LES ≥15%, 16% had an STS ≥10%, and 40% had an LES ≥20% or STS ≥10%. Pearson correlation coefficient revealed a reasonable (moderate) linear relationship between the LES and STS scores, r = 0.58, P < .001. Although the STS score outperformed the LES, both models had suboptimal discriminatory power (c-statistic, 0.49 for LES and 0.69 for STS) and calibration. Conclusions Clinical judgment and the Heart Team concept should play a key role in selecting patients for TAVI, whereas currently available surgical risk score algorithms should be used to guide clinical decision making.

Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial

OBJECTIVES: We aimed to assess the predictive value of the SYNTAX score (SXscore) for major adverse cardiac events in the all-comers population of the LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. BACKGROUND: The SXscore has been shown to be an effective predictor of clinical outcomes in patients with multivessel disease undergoing percutaneous coronary intervention. METHODS: The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the LEADERS trial (patients after surgical revascularization were excluded). Post hoc analysis was performed by stratifying clinical outcomes at 1-year follow-up, according to 1 of 3 SXscore tertiles. RESULTS: The 1,397 patients were divided into tertiles based on the SXscore in the following fashion: SXscorescore>8 and score>16 (SXhigh) (n=461). At 1-year follow-up, there was a significantly lower number of patients with major cardiac event-free survival in the highest tertile of SXscore (SXlow=92.2%, SXmid=91.1%, and SXhigh=84.6%; p<0.001). Death occurred in 1.5% of SXlow patients, 2.1% of SXmid patients, and 5.6% of SXhigh patients (hazard ratio [HR]: 1.97, 95% confidence interval [CI]: 1.29 to 3.01; p=0.002). The myocardial infarction rate tended to be higher in the SXhigh group. Target vessel revascularization was 11.3% in the SXhigh group compared with 6.3% and 7.8% in the SXlow and SXmid groups, respectively (HR: 1.38, 95% CI: 1.1 to 1.75; p=0.006). Composite of cardiac death, myocardial infarction, and clinically indicated target vessel revascularization was 7.8%, 8.9%, and 15.4% in the SXlow, SXmid, and SXhigh groups, respectively (HR: 1.47, 95% CI: 1.19 to 1.81; p<0.001). CONCLUSIONS: The SXscore, when applied to an all-comers patient population treated with drug-eluting stents, may allow prospective risk stratification of patients undergoing percutaneous coronary intervention. (LEADERS Trial Limus Eluted From A Durable Versus ERodable Stent Coating; NCT00389220).