Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity

Background  

It is often stated that external validity is not sufficiently considered in the assessment of clinical studies. Although tools for its evaluation have been established, there is a lack of awareness of their significance and application. In this article, a comprehensive checklist is presented addressing these relevant criteria.     

Incidence and Clinical Significance of Ventricular Late Potentials in Idiopathic Dilated Cardiomyopathy Compared to Coronary Artery Disease

Objective: This prospective study was designed to compare incidence and clinical significance of ventricular late potentials between patients with idiopathic dilated cardiomyopathy (IDC) and postinfarct patients (CAD) using exactly the same method of signal-averaged electrocardiography (SAECG) in both patient groups. Methods: Time-domain analysis of SAECG was performed in 120 consecutive patients with IDC, 120 patients with CAD, and 60 healthy controls. Ventricular late potentials were detected in 27 of 120 patients with IDC (23%) compared to 41 of 120 patients with CAD (34%; P < 0.05). Results: Ventricular late potentials were found in 2 of 60 controls (3%). During 15 ± 7 months follow-up, serious arrhythmic events occurred in 17 of 120 patients with IDC (14%) and in 13 of 120 patients with CAD (11%). The sensitivity of ventricular late potentials for future arrhythmic events was 35% for IDC compared to 77% for CAD (P < 0.05). The positive predictive value of late potentials detected by time-domain analysis was 22% for IDC versus 24% for CAD (P = ns). Conclusion: In this selected patient population with IDC and CAD, time-domain analysis of SAECG revealed a lower incidence of ventricular ate potentials in patients with IDC as compared to postinfarct patients. Whereas ventricular late potentials had a high sensitivity but a low positive predictive value for identification of postinfarct patients with serious arrhythmic events during follow-up, both sensitivity and positive predictive value of ventricular late potentials for future serious arrhythmic events were low in the setting of IDC.     

Intramolekulare Aromatenalkylierungen, 17. Mitt. Synthese von trans-3,10b-Dimethyl-1,2,3,4,4a,5,6,10b-octahydrobenzo(f)isochinolin

Intramolecular Alkylations of Aromatic Compounds, XVII¹⁾: — Synthesis of trans-3,10b-Dimethyl-1,2,3,4,4a,5,6,10b-octahydrobenzo(f)isoquinoline From the cyanhydrine 5b , easily obtained from 4 and trimethylsilyl cyanide, the lactone 6 is prepared, hydrogenation of which gives a mixture of the lactam 7a and the lactone 8 . Compound 7a is reduced to the secondary base 9 , which by treatment with acid is dehydrated to 10 and rearranges to give the isomer 11 , too. Attempted cyclization of the aminoalcohol 12 fails to give 9 or 10 . Rather, the furan 13 is isolated as the final product. N-methylation 10 → 14 and subsequent hydrogenation furnish the 4:1 trans/cis-mixture 2a, b , from which the title compound is separated by column chromatography. From 11 the stereomers 18a, b can be prepared analogously.     

Das kleinzellige Bronchialkarzinom – neue Entwicklungen nach ASCO 2007

Wiener Medizinische Wochenschrift - Aggressives Tumorwachstum, frühe Metastasierung und hohe Assoziation mit intensivem Nikotinkonsum sind die Charakteristika des kleinzelligen...     

Social relations and smoking behavior: Results from the first MONICA survey Augsburg

Summary This study examines the relationship between various aspects of social relations and the prevalence of smoking, using data from the first MONICA Survey, Augsburg, FRG, 1984/85. Study population of the survey was a two-stage cluster sample of 5312 men and women aged 25 to 64. The response was 79.4%. The measurement of social relations included a modified form of the Syme/Berkman social network scale, as used in the Alameda County Study. Analyses were carried out separately for the total four-level social network index in relation to smoking, and for specific components of that index (marital status, contacts with friends and relatives, activities in informal groups). The results showed for both men and women, that there was a significant association between the social network index and the prevalence of smoking: the more social ties and contacts, the lower the percentage of smokers. The results from multiple logistic regression analyses indicated an effect of social relations on smoking, that is at least partly independent of age, gender and educational level. In general, the findings may contribute to a better understanding of risk groups, and the possible pathways leading from social relations to health and disease.

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Soziale Beziehungen und Rauchverhalten. Ergebnisse der ersten MONICA-Augsburg- Querschnittsstudie

Zusammenfassung Mit Daten der ersten MONICA-Querschnittsstudie Augsburg, 1984/ 85, wurden die Zusammenhänge zwischen verschiedenen Merkmalen des «sozialen Netzwerks» und dem individuellen Rauchverhalten untersucht. Die Studienpopulation umfasste 5312 Männer und Frauen einer zweistufigen Zufallsstichprobe im Alter zwischen 25 und 64 Jahren. Die Teilnahmerate betrug 79,4%. Die sozialen Beziehungen wurden in einem Fragebogen zum Selbstausfüllen mit Hilfe eines «Sozialen Netzwerk Indexes» (SNI) erfasst, der sowohl den Familienstand, die Kontakte zu Verwandten und engen Freunden als auch Aktivitäten in Gruppen und Vereinen beinhaltete. Die Ergebnisse zeigten für Männer und Frauen statistisch signifikante Zusammenhänge zwischen den Gesamtscores des SNI und der Prävalenz des Rauchens: Je mehr soziale Beziehungen und Kontakte, desto geringer war der Anteil Raucher. Die Analysen einzelner Komponenten des SNI ergaben: Es fanden sich keine konsistenten Zusammenhänge zwischen den Aktivitäten in Freizeitclubs und dem Rauchverhalten, jedoch zwischen familiären Beziehungen, Kontakten zu engen Freunden oder Verwandten und der Häufigkeit des Rauchens. Besonders auffallend war der hohe Anteil Raucher bei den geschiedenen oder getrenntlebenden Männern. 70% von ihnen waren Raucher im Vergleich zu 37% der verheirateten Männer. Die entsprechenden Anteile bei den Frauen waren 42% bzw. 22%. Die Ergebnisse der multiplen logistischen Regressionen zeigten einen Effekt der interpersonellen Beziehungen auf das Rauchverhalten, der unabhängig war von den Faktoren Alter, Geschlecht, Bildungsstand und (bei Frauen) von der Erwerbstätigkeit. Die Resultate könnten zu einer besseren Erklärung und Identifizierung von Risiko-Gruppen und damit zu einer erfolgreicheren Bekämpfung des Rauchens beitragen.

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Rapports sociaux et consommation de la cigarette

Résumé Les relations entre les différentes propriétés du «réseau social» et les habitudes individuelles en ce qui concerne la consommation de la cigarette ont été examinées à l'aide des données d'une première étude transversale, faite en région augsbourgeoise, dans le cadre du projet MONICA. L'échantillon aléatoire, divisé en deux étapes, comportait une population de 5312 hommes et femmes âgés de 25 à 64 ans. 79,4% des personnes interrogées participaient à l'enquête. Le recensement des rapports sociaux s'effectuait au moyen d'un questionnaire individuel à «l'Index du Réseau Social» (IRS) qui englobait aussi bien les données sur l'état civil que les sujets relatifs aux contacts sociaux et familiaux. Les résultats ont montré qu'il y avait une correspondance significative entre les valeurs totales du IRS et la prévalence de la consommation de la cigarette. Plus une personne avait de contacts sociaux, moins elle fumait de cigarettes. L'analyse des divers composants du IRS révèle un manque de relations cohérentes entre les activités dans les clubs de loisirs et la consommation de la cigarette. Cependant, la correspondance entre les rapports de famille, les contacts avec amis et parents et la fréquence de la consommation du tabac s'avérait révélatrice. Particulièrement frappant était le taux élevé de fumeurs chez les hommes divorcés ou vivant séparés. 70% d'entre eux étaient fumeurs par rapport à 37% des hommes mariés. Le taux correspondant chez les femmes était de 42% resp. 22%. Les résultats de la régression logistique multiple signalaient un effet des relations interpersonnelles sur la consommation de la cigarette, un effet qui était indépendant des facteurs tels que l'âge, le sexe, le niveau d'instruction et (chez les femmes) des activités professionnelles. Ces résultats pourraient contribuer à une meilleure identification et caractérisation des groupes à risque, et par la suite à combattre d'une manière plus efficace la consommation de la cigarette.

     

A staphylococcal radioimmunoassay for detection of antibodies toMycoplasma pneumoniae

A radioimmunoassay (RIA) which depends on the property of protein A ofStaphylococcus aureus to combine with the Fc-fragment of immunoglobulins was developed.This technique was employed to measure antibodies in human and various animal sera. It could be demonstrated that the staphylococcal RIA was at least as sensitive as the previously described radioimmunoprecipitation technique in detecting antibodies toM.pneumoniae in human sera. In addition, antibodies toM.pneumoniae could be demonstrated in sera of hamsters intranasally inoculated with the organisms. Antibodies could also be demonstrated in rabbit sera after immunization withM.pneumoniae. The test proved to be considerably more sensitive than conventional tests for detection of antibodies to the organisms. The test requires only small amounts of reagents and is relatively inexpensive.The results were presented in a preliminary form at the annual meeting of the Local Branch of the American Society for Microbiology, Frankfurt, March 1976 and the 77th ordinary meeting of the Society for General Microbiology, Glasgow, September 1976     

Distinct expression and localization of serine protease HtrA1 in human endometrium and first-trimester placenta.

Mammalian embryos cannot survive without the placenta. Development of the human placenta requires trophoblast proliferation, differentiation, and invasion as well as highly coordinated modulation of the maternal uterus. HtrA1 is a member of the recently identified mammalian HtrA (high temperature requirement factor A) serine protease family with a high level of expression in the placenta. In this study, we examined whether HtrA1 expression (mRNA and protein) is associated with placental development in the human. HtrA1 is up-regulated in both endometrial glands and decidual cells during endometrial preparation for embryo implantation and during first-trimester pregnancy at placentation. HtrA1 expression was also detected in certain trophoblast subtypes during early pregnancy. The villous syncytiotrophoblast and cytotrophoblast showed the strongest expression while the interstitial extravillous trophoblast showed the lowest or no expression of HtrA1. The distinct distribution of HtrA1 at the maternal-trophoblast interface suggests that HtrA1 may play a role in placental development.     

Ligand and cytokine dependence of the immunosuppressive pathway of tryptophan catabolism in plasmacytoid dendritic cells

Murine plasmacytoid dendritic cells (pDCs) have been credited with a unique ability to express indoleamine 2,3-dioxygenase (IDO) function and mediate immunosuppression in specific settings; yet, the conditions of spontaneous versus induced activity have remained unclear. We have used maneuvers known to up-regulate IDO in different cell types and have examined the relative efficacy and mechanisms of the induced activity in splenic pDCs, namely, after specific receptor engagement by CTLA-4-Ig, CD200-Ig or CD28-Ig, the latter in combination with silenced expression of the suppressor of cytokine signaling 3 (SOCS3) gene. We found that pDCs (CD11c+ mPDCA-1+ 120G8+) do not express IDO and are not tolerogenic under basal conditions. B7-1 engagement by CTLA-4-Ig, CD200R1 engagement by CD200-Ig and B7-1/B7-2 engagement by CD28-Ig in SOCS3-deficient pDCs were each capable of initiating IDO-dependent tolerance via different mechanisms. IFN-gamma was the major cytokine responsible for CTLA-4-Ig effects, and type I IFNs for those of CD200-Ig. Immunosuppression by CD28-Ig in the absence of SOCS3 required IFN-gamma induction and IFN-like actions of IL-6. Therefore, although pDCs do not mediate IDO-dependent tolerance constitutively, multiple ligands and cytokines will contribute to the expression of a tolerogenic phenotype by pDCs in the mouse.     

Improvement of cytomegalovirus avidity testing by adjusting the concentration of CMV-specific IgG in test samples.

BACKGROUND: Human cytomegalovirus (CMV) is the most common cause of viral intrauterine infection. Primary CMV infection in early pregnancy bears a high risk of fetal damage. Accurate measurement of CMV-specific IgG avidity may help to improve the serodiagnosis of CMV-infected women by determining the time of infection and fetal outcome. OBJECTIVES: To study the performance of the CMV avidity assay with the fully automated Vidas analyzer (bioMérieux) as a function of the concentration of CMV-specific IgG present in the serum sample. STUDY DESIGN: Eighty-two serum samples were investigated from 3 clinical scenarios: 18 individuals with sera negative for CMV-specific IgG and IgM (control group), 20 pregnant women (44 samples) containing CMV-specific IgG- and IgM-antibodies suggesting acute or recent primary infection and 20 patients with evidence of past infection (CMV-IgG positive and CMV-IgM negative). RESULTS: In the group with presumed acute or recent primary infection 12 of 44 sera had CMV-specific IgG values above 100 arbitrary units (AU, bioMérieux)/ml and in these cases an increase in AI was measurable upon dilution of the serum sample. In two cases, AI's were shifted towards or above the cut-off value of AI>or=0.8, indicative of past infection. Dilution of sera which were CMV-specific IgM positive and had specific IgG concentrations of 相似文献