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Informed consent for clinical trials in acute stroke is characterized by challenges related to urgency, cognitive impairment, and geographical separation. Context-appropriate approaches are needed for this setting. We conducted a mixed-methods project involving focus groups and interviews as well as collaboration with a patient advisory panel and a central institutional review board (CIRB) to design and implement a patient-driven consent process for a multicenter trial incorporating adaptive randomization. Remote consent was recognized as challenging but acceptable. Adaptive randomization was viewed positively, but significant potential for misunderstanding was appreciated. Collaboration between the patient advisory panel and the CIRB resulted in a shortened, more patient-centered consent form that was approved at all sites with few modifications. An information sheet was developed as a resource for patients and surrogates after enrollment. Collaboration between investigators, patient partners, and a CIRB can facilitate innovation and implementation of patient-centered, context-appropriate consent strategies.

PURPOSE To analyse the vision-related quality of life (vr-QoL) in stable and progressive keratoconus (KC) patients with a still good visual acuity. METHODS Combined prospective/cross-sectional study design. The Refractive Status and Vision Profile (RSVP) and the National Eye Institute Visual Functioning - 25 (NEI-25) questionnaire were used in 16 emmetropic, 32 myopic and 56 KC patients, whereby KC patients with a stable (n = 26) and patients with a progressive stage (n = 30) and some of them before and after corneal cross-linking (CXL; n = 10) were included. All patients had a DCVA in at least one eye of ≥0.7 (decimal chart). RESULTS The analyses revealed a minor decline of the vr-QoL from emmetropes to myopes to early KC patients with a stable disease. Nonetheless, sociological subscales (i.e. 'social functioning', 'role difficulties' and 'dependency') did not display statistically significant differences comparing these groups. In progressive KC, we could demonstrate a statistically significant decline also of these sociological subscales, which did not improve after CXL. CONCLUSION Due to a still high and almost unaffected vr-QoL in early KC patients and the distinct decline after progression without rehabilitation after CXL, a reconsideration of current strategies to perform CXL only after a progression is diagnosed should be re-evaluated.

Purpose To analyse tomographic changes in eyes classified as 'normal', 'keratoconus-suspect' and 'clinically manifest keratoconus' based on the established KISA% definition of Rabinowitz and Rasheed and to develop the category of 'subclinical keratoconus eyes' to expand the classification into a 'subtopographic' range. Methods Tomographic and topographic analyses of 670 eyes performed with a rotating Scheimpflug imaging system (Pentacam(®), Oculus Inc., Wetzlar, Germany) were retrospectively analysed. Based on the KISA% keratoconus classification system, eyes were assigned to a 'normal', 'keratoconus-suspect' or 'manifest keratoconus' group. In addition, a new group of 'subclinical keratoconus eyes' was analysed, comprising unsuspicious fellow eyes of patients with keratoconus. T-tests, Wilcoxon rank-sum test, receiver operating characteristics (ROC) and robust regression analyses were performed to correlate tomographic parameters with the increasing KISA% index. Results KISA%-grouped keratoconus eyes showed robust tomographic changes. By adding the subclinical group, although the concurrent topography was unchanged, we were able to demonstrate statistically significant changes for almost all tomographic parameters (parameters with highest sensitivity/specificity: ART_max, [0.69/0.69], BAD_D [0.66/0.66]). The highest coefficient of determination (R(2)) with the KISA% index was demonstrated for Ele_f_max (R(2) = 0.70), Ele_f_TP (R(2) = 0.69), Ele_b_TP (R(2) = 0.69) and BAD_D (R(2) = 0.68). Conclusion We recommend the use of the expanded KISA% index (eKISA% index) as the basis for the definition of keratoconus and normal groups in future keratoconus research projects.

Purpose: To explore eye laterality (higher refractive error in one eye) and its association with refractive state, spherical/astigmatic anisometropia, age and sex in refractive surgery candidates. Methods: Medical records of 12 493 consecutive refractive surgery candidates were filtered. Refractive error (subjective and cycloplegic) was measured in each subject and correlated with eye laterality. Only subjects with corrected distance visual acuity (CDVA) of >20/22 in each eye were enrolled to exclude amblyopia. Associations between eye laterality and refractive state were analysed by means of t-test, chi-squared test, Spearman’s correlation and multivariate logistic regression analysis, respectively. Results: There was no statistically significant difference in spherical equivalent between right (−3.47 ± 2.76 D) and left eyes (−3.47 ± 2.76 D, p = 0.510; Pearson’s r = 0.948, p 2.5 D in myopic (−5.64 ± 2.5 D versus −4.92 ± 2.6 D; p = 0.001) and in hyperopic (4.44 ± 1.69 D versus 3.04 ± 1.79 D; p = 0.025) subjects, (II) a tendency for left eye cylindrical laterality in myopic subjects, and (III) myopic male subjects had a higher prevalence of left eye laterality. (IV) Age did not show any significant impact on laterality. Conclusions: Over the full refractive spectrum, this study confirmed previously described strong interocular refractive correlation but revealed a statistically significant higher rate of right eye laterality for anisometropia >2.5 D. In general, our results support the use of data from one eye only in studies of ocular refraction.

Demographische und historische Analyse der Hamburger Hornhautbank uber 30 Jahre Purpose: To evaluate donor demographics, trends in donor tissue procurement and tissue storage over a long period. Methods: A retrospective, longitudinal, descriptive analysis was undertaken of data from the Hamburg Eye Bank Data Base (HEB-DB) that had been collected between 1981 and 2010. Data on 54 parameters of cornea donors [including clinical history, age, death cause, gender and death-to-explantation interval (DEI)]and of cultivated corneas (endothelial quality and development in culture, cultivation period, microbiological contamination) were retrieved. These data were analysed statistically, focusing on the historical development of the eye bank. Results: At the time of retrieval (June 2010), the HEB-DB contained data on 10 943 corneas (5503 donors). Most donors were men (65%) and had died from cardiopulmonary (n = 801) ⁄ cerebral (n = 261) failure or as the result of a polytraumatic accident ⁄ suicide (n = 602). Within these years, donor age,DEI and storage time increased. The percentage of stored corneas suitable forntransplantation displayed a variable but increasing trend; in 2007, almost 75% of the stored corneas were transplanted. Between 1995 and June 2010, the median microbiological contamination rate was 5.3%. A change in the procurement procedure from enucleation to corneoscleral explantation in 2008 led to a briefly increased contamination rate. Conclusion: Donor demographic data run parallel to the general demographic development. Our analysis indicates a dynamic development of the eye bank over the last 30 years and emphasizes the need for an active quality management in coping with the challenges of modern eye banking.

We examined the effects of surfactant protein A (SP-A), a collectin, on the interaction of Pneumocystis murina with its host at the beginning, early to middle, and late stages of infection. Pneumocystis murina from SP-A wild-type (WT) mice inoculated intractracheally into WT mice (WT(S)-WT(R)) adhered well to alveolar macrophages, whereas organisms from SP-A knockout (KO) mice inoculated into KO mice (KO(S)-KO(R)) did not. Substitution of WT mice as the source of organisms (WT(S)-KO(R)) or recipient host macrophages (KO(S)-WT(R)) restored adherence to that found with WT(S)-WT(R) mice. In contrast, when immunosuppressed KO and WT mice were inoculated with P. murina from a homologous source (KO(S)-KO(R), WT(S)-WT(R)) or heterologous source (WT(S)-KO(R), KO(S)-WT(R)) and followed sequentially, WT(S)-KO(R) mice had the highest levels of infection at weeks 3 and 4; these mice also had the highest levels of the chemokine macrophage inflammatory protein-2 and neutrophils in lavage fluid at week 3. Surfactant protein-A administered to immunosuppressed KO(S)-KO(R) mice with Pneumocystis pneumonia for 8 wk as a therapeutic agent failed to lower the organism burden. We conclude that SP-A can correct the host immune defect in the beginning of P. murina infection, but not in the middle or late stages of the infection.

Pneumocystis carinii are coated by abundant heterogenous major surface glycoproteins (MSGs), which facilitate interaction with the host. We have produced MSG-specific T-cell clones from the spleens of P. carinii-exposed Lewis rats and analyzed five for antigen specificity to native MSG and a recombinant form of MSG, cell surface markers, and cytokine profiles. All five of the clones were CD4+. All of the clones proliferated specifically to both the native MSG and the recombinant MSG only in the presence of antigen presenting cells demonstrating that the response is antigen/driven rather than mitogen/driven. All five of the clones secreted IL-2 and IFN-gamma, although in differing amounts, implicating a Th1 response. Only one of the clones produced any detectable IL-4. This is the first report of T cell clones responsive to a specific antigen of P. carinii, MSG. We conclude that the T cell clones will be helpful in mapping protective epitopes present in MSG and in functional studies of MSG.

SUMMARY In patients presenting with intermittent claudication, Colour Duplex Ultrasound (CDU) examination of the femoro-popliteal segment has been proposed as a screening modality. Those patients with atheromatous lesions suitable for percutaneous transluminal angioplasty (PTA) could proceed to diagnostic angiography. Patients with long segment occlusive disease demonstrated by CDU, who were not considered suitable candidates for surgery, would not require angiographic examination. This prospective study was performed on 46 limbs in 25 consecutive patients who presented for investigation of claudication. There was close correlation between the two methods in the demonstration of high-grade stenoses and occluded segments. Using angiography as the ‘gold standard’this study indicated a diagnostic accuracy for CDU of 93% with a sensitivity of 89% and a specificity of 95%. Angiography tended to show longer occluded segments than CDU. Colour Duplex Ultrasound shows promise as a screening investigation in patients with intermittent claudication to detect lesions that may be suitable for PTA.

The global 3-dimensional topology of the magnetic field of the weakly flaring active region AR 5420 in the early phase has been estimated using a series of photospheric longitudinal and vector magnetogams together with Hα filtergrams and white-light images. As a physical model for this task, we have used the assumption ofa force-free magnetic field character. An arcade-like structure of the magnetic field has been identified in the preflare phase with an apparent sheared configuration already present in the current-free field case. This system might have been an important source of generation of a field-aligned current system for the eruptions that followed. That was, in particular, suggeted by a significant extension of the active region area in the observation period from June 22 to 25, 1984, that resulted in a stronger shear of the detected arcade-like system. The atmospheric electric currents generated in such a way and the transition triggered by a large-amplitude perturbation generated by new flux emergences on June 23 at this place together might be the reason of the sequence of flares observed. Despite the changes in the Hα structure, the global force-free character of the field did not change significantly over the time of observations. The invariance (in the first order) of the force-free (nearly current-free) character of the magnetic field is consistent with the occurrence of relatively small flares only.

Les caracteristiques d'un grand nombre de regions actives complexes, grandes et developpees sont analysees. L'existence de frontieres, qui sont les lieux de separation des structures magnetiques dans la base atmosphere solaire, est etudiee

We investigated the structure of the magnetic field in the relatively small and simple solar active region SD 135/1984 in the early, relatively quiet phase on June 24. For this work we used data of the vector magnetograph of SibIZMIR and results of model calculations using a current-free approximation. We have compared the measured magnetic field with the transverse field of the model calculation. We could not find a significant nonpotential effect greater than the level of sensitivity of the transverse magnetic field, BT 200 G. Hence, we conclude that the global magnetic field structure in the investigated solar active region had a nearly potential configuration. The effects of evolution in the active region on the magnetic field structure remained negligible. Wir untersuchten die Struktur des Magnetfeldes in der relativ kleinen und einfachen solaren aktiven Region SD 135/1984 in der fruhen, relativ ruhigen Phase am 24. Juni. Fur diese Arbeit nutzten wir die Daten des Vektormagnetografen des SibIZMIR und Resultate von Modellrechnungen in der stromfreien Naherung. Wir haben das gemessene Magnetfeld mit dem Transversal-Feld der Modellrechnung verglichen. Wir konnten keinen signifikanten Nonpotential-Effekt groser als im Niveau der Sensitivitat des Transversal-Magnetfeldes BT 200 G finden. Wir schlus-folgern daher, das die globale Magnetfeldstruktur in der untersuchten solaren aktiven Region nahezu eine Potentialstruktur besas. Die Effekte der Entwicklung der aktiven Region auf die Magnetfeldstruktur scheinen vernachlassigbar zu sein.

The 115 kd band in polyacrylamide gels is a major antigen of Pneumocystis carinii. Data obtained from treatment with enzymes, binding to lectins, and labelling the surface with biotin suggest that this moiety is a glycoprotein containing mannosyl/glucosyl and N-acetylglucosamine residues, and that it is located on the cell wall of the organism. Other rat and human P. carinii antigens also are glycoproteins but differ in specific protein or carbohydrate residues or location on the organism.