The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI)

To further scientific progress of immunization safety, comparability of data from clinical trials and surveillance systems is essential. Comparability requires the availability of standardized case definitions for adverse events following immunization (AEFI) and guidelines for case determination, recording and data presentation. METHOD: International collaborative working groups, consisting of professional volunteers from developed and developing countries, conduct systematic literature reviews to develop 50-100 AEFI definitions. Case definitions are finalized after a comment period by a reference group consisting of organizations concerned with immunization safety, and will be disseminated via the world-wide-web and other means for free world-wide use. RESULTS: Literature reviews yielded substantial diversity in data collection and presentation. We have developed standardized case definitions together with guidelines for use in clinical trials and surveillance systems. CONCLUSIONS: Diversity in safety methods leads to considerable loss of scientific information. We have built the necessary international network of currently about 300 participants from patient care, public health, scientific, pharmaceutical, regulatory and professional organizations to develop and assess standardized AEFI case definitions and guidelines. Evaluation studies, global implementation, ongoing definition development and a continuously growing network will be essential for the success of the collaboration.     

Genital mycoplasmas, including Mycoplasma genitalium, as sexually transmitted agents

Mycoplasmas are the smallest free-living organisms, widespread in nature. Several mycoplasma species have been isolated from humans. For 6 of them: Mycoplasma hominis, Ureaplasma urealyticum, M. primatum, M. genitalium, M. spermatophilum and M. penetrans, the genital tract is the main site of colonization. This review is concentrated on the role of mycoplasmas as sexually transmitted agents, with the emphasis to M. genitalium infections. M. hominis and U. urealyticum are isolated from the genital tract of healthy men and women with considerable frequency. The biological features (attachment properties, possible intracellular location) and experimental inoculation studies of M. genitalium indicate that this mycoplasma has pathogenic potential. Data from case-control studies, looking at men with non-gonococcal urethritis and women with cervicitis, have revealed that M. genitalium behave similarly to Chlamydia trachomatis and have revealed that carriage of M. genitalium and C. trachomatis is usually independent of one another. M. genitalium could be considered as a potential cause of sexually transmitted urethritis in men, including men with persistent or recurrent urethritis. More studies are expected to ascertain the role of M. genitalium in the female genital tract. Evidence-based data are needed to decide whether current non-gonococcal infection treatment principles are applicable or not for M. genitalium infections.     

Components of laxity in interference fit fixation of quadrupled hamstring grafts

We tested in vitro 15 Poly-L-lactic acid and 14 titanium interference screws in male human cadaver tibia-hamstring constructs. Elongation of the graft, displacement of the screw in the tibial tunnel, and slippage at the graft/screw interface were measured as outcomes with an infrared optical system. All constructs failed by slippage of the graft past the interference screw. On average, graft slippage accounted for 92% of total construct laxity at 5mm total construct elongation, whereas permanent stretching of the midsubstance of the graft accounted for only 8%. Movement of the interference screw in the tibial canal was minimal, averaging 0.01 (0-0.5) mm at construct failure. Inadequacy of isolated tibial interference screw fixation of soft tissue grafts may be overcome if early failure at the graft/screw interface is prevented.     

Utility of transesophageal echocardiography in determining the source of arterial embolization

Arterial embolism is frequently the product of a cardiac source. Arterial-arterial embolization and paradoxical embolization also occur. Failure to identify the point of origin may subject the patient to an important incidence of preventable events. Conventional echocardiography is insensitive in identifying a cardiac origin of emboli and is of little use in identifying sources of arterial-arterial emboli. Aortography is invasive and not as sensitive in detecting mobile aortic thrombus, which is a recently reported embolic source. Herein we describe seven cases in which transesophageal echocardiography was uniquely valuable in identifying the source or mechanism of arterial embolization. We performed chart reviews of patients with arterial emboli definitively diagnosed after utilizing transesophageal echocardiography. Four females and three males with a mean age of 68 years were included in the study. Peripheral embolization occurred in four patients, visceral embolization occurred in one patient, and two patients experienced cerebrovascular events. Six patients had transthoracic echocardiography and six patients had aortography. None of these studies identified the source of embolization. All patients were diagnosed with transesophageal echocardiography. Mobile aortic thrombus was the primary embolic source in three patients, paradoxical embolization occurred in two patients, and two patients had a combination of findings including one patient with atrial thrombus. Two patients received operative repair of the aorta and five underwent nonoperative management. There was one mortality in the operative group. The source of arterial emboli remains obscure in some patients. Transesophageal ultrasound can be valuable in identifying the source or mechanism of embolization even when angiography and conventional echocardiography are negative.     

The use of home remedies and complementary health approaches in endometriosis

Research question

Conventional treatments are often associated with adverse effects and endometriosis pain symptoms may reoccur despite treatment. Consequently, many women use complementary health approaches (CHA) and home remedies (HR) to relieve their pain. The aim of this study was to examine the frequency and the subjectively perceived efficacy of CHA/HR use by women affected by endometriosis.

Prevalence of excessive screen time and TV viewing among Brazilian adolescents: a systematic review and meta-analysis

Purpose

To evaluate the prevalence of excessive screen-based behaviors among Brazilian adolescents through a systematic review with meta-analysis.

Gonococcal surface antigens and their significance for serotyping and vaccines

Outer membrane components of Neisseria gonorrhoeae play an important role in the initial steps of infection. Precise knowledge about the surface antigens is needed for the development of a serotyping system and of a vaccine against local and systemic gonorrhea. Structure, antigenicity, and function of the best-known membrane components, i.e., lipopolysaccharide, protein I, protein II, protein III, and pili, are discussed. Lipopolysaccharide is a strong immunogen and induces bactericidal antibodies, but is unsuitable for use as a vaccine because of its toxicity. Protein I and protein III are stable proteins, not subject to antigenic variation. Antibodies against protein I, which are able to kill N. gonorrhoeae, are detectable in the serum of patients with disseminated gonococcal infection. Protein II and pili are highly variable antigens with constant, very slightly immunogenic regions. To interrupt the pathomechanism of gonococcal infection at different stages, future vaccines should contain more than one surface antigen.     

Effects of carbachol and (-)-N6-phenylisopropyladenosine on myocardial inositol phosphate content and force of contraction.

1. The effects of carbachol and the A1-adenosine receptor agonist (-)-N6-phenylisopropyladenosine (PIA) on force of contraction and inositol lipid metabolism were studied in electrically driven left auricles and papillary muscles isolated from guinea-pig hearts. Both carbachol and PIA (0.01-10 microM) had concentration-dependent negative inotropic effects in auricles. In papillary muscles PIA had no inotropic effect. Carbachol also had no inotropic effect at low concentrations (0.01-1 microM) but at 10-100 microM it exerted a slight positive inotropic effect. 2. In auricles and papillary muscles both carbachol and PIA concentration-dependently increased inositol trisphosphate (IP3; significant at 1 microM). Accordingly phosphatidylinositol bisphosphate (PIP2), the precursor of IP3, was reduced. All effects of carbachol and PIA were antagonized by atropine (10 microM) and 1,3-dipropyl-8-cyclopentylxanthine (DPCPX; 20 microM) respectively, indicating receptor-mediated effects. 3. In auricles the negative inotropic effects of carbachol and PIA preceded the increase in IP3. 4. In papillary muscles the increase in IP3 preceded the slight positive inotropic effect of carbachol, indicating that the M-cholinoceptor-mediated increase in IP3 and force of contraction may be related. However, PIA showed a comparable increase in IP3 but no inotropic effect, indicating a dissociation between those parameters. 5. In conclusion, in previous studies a close relation between increases in IP3 and force of contraction has been shown after alpha 1-adrenoceptor stimulation. The present study with carbachol supports this view. However, the present data for PIA could not show such a close relationship, questioning the role of IP3 as an endogenous regulator of force of contraction.